Pfizer

Dizziness, nausea, sweating, throat swelling, hard to swallow, dry mouth, headache, shaky, feeling hot/cold

12/18/20 08:00PM Mild headache; 12/19/20 headache resolved; chills, loose bowel movement, fatigue. 12/20/20 loose bowel movement, rash on back and disappeared face red lips swollen. 12/21/20 symptoms continued medications taken Benadryl. Imodium; rash resolved and loose bowel movements later in the day. Abd discomfort, pain and nausea present since vaccine given.

Fatigue on Friday 1/1/21 (2 naps resolved fatigue on 1/1/21) and daily napping resolve fatigue 1/2/21-1/4/21 Headache on Saturday, 1/2/21. Took nap to resolve Blurry vision Sunday when reading began on 1/3/21 and has not resolved as of 1/5/21. Pain behind left eye on morning of 1/5/21

Patient experienced a bit of flushing, itchiness in nose, eyes, tingling in mouth/scalp, and a little throat tightness after initial monitoring period of 15 minutes. Occurred 1-2 hours after dose admin. Resolved with no treatment, though Benadryl was recommended.

Palpitations; Weakness; sore throat; Burning sensation and the soreness in tongue; Burning sensation and the soreness in tongue; vomiting severely 5 times; could not eat and breathe; could not eat and breathe; abdomen was upset; cramps and pain; cramps and pain; diarrhea; This is a spontaneous report from a contactable nurse (patient). A 60-year-old female patient received the receive bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot Number: EK5730), via an unspecified route of administration on 21Dec2020 at 60-years-old at a single dose for COVID-19 immunization. Medical history included high cholesterol from an unknown date and unknown if ongoing. Concomitant medications included rosuvastatin calcium (CRESTOR) taken for high cholesterol from an unspecified date to an unspecified date. The patient experienced the following events and outcomes: palpitations (non-serious) on 22Dec2020 with outcome of unknown , weakness (non-serious) on 22Dec2020 with outcome of unknown, sore throat (non-serious) on 22Dec2020 with outcome of unknown, burning sensation and the soreness in tongue (non-serious) on 22Dec2020 with outcome of unknown, vomiting severely 5 times (non-serious) in Dec2020 with outcome of unknown, could not eat and breathe (non-serious) in Dec2020 with outcome of unknown, abdomen was upset (non-serious) in Dec2020 with outcome of unknown, cramps and pain (non-serious) in Dec2020 with outcome of unknown, diarrhea (non-serious) in Dec2020 with outcome of unknown. The nurse stated she received the COVID vaccine on 21Dec2020. The nurse stated she did not have any adverse reaction immediately on the first day but on the second day, after 24 hours, she started to have "little bit palpitations that too for a short period of time and a little bit weakness for a short period of time and sore throat. It is not just soring or swelling but it is burning sensation and, on my tongue, also I feel the same thing, burning sensation and the soreness. That was for a small period of time but on my tongue, it is still there, and my throat is still there and last night I experienced vomiting severely 5 times. After the vomiting, I could not eat and breathe." Then, the nurse slept about 3-5 hours, and woke up and her abdomen was upset. The nurse had cramps and pain and when she went to the bathroom and she had huge diarrhea, 2 times."

Blurred vision that was mild in nature (but noticeable, nonetheless). Began 15 minutes after vaccine received. Lasted 10 minutes. Resolved on its own. NOT accompanied by any other effect (i.e. nausea, vertigo, lightheadedness); This is a spontaneous report from a contactable nurse. A 60-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: EL0140), via an unspecified route of administration on the right arm on 23Dec2020 10:15 at single dose for COVID-19 immunisation. Medical history included gastrooesophageal reflux disease (GERD) on an unspecified date and Ductal carcinoma in situ (DCIS) on the left breast in 2008. Concomitant medications included omeprazole and cetirizine (CETIRIZINE). On 23Dec2020 at 10:30, the patient had a blurred vision that was mild in nature (but noticeable, nonetheless). It began 15 minutes after vaccine received and lasted for 10 minutes. It resolved on its own and not accompanied by any other effect (i.e. nausea, vertigo, lightheadedness). No therapeutic measure was taken as a result of the event. Clinical outcome of the event was recovered on 23Dec2020 at 10:40. No follow-up attempts are possible; information about lot/batch number cannot be obtained.

Pfizer BioNTech COVID-19 Vaccine EUA Patient given vaccine and nurse used CDC screening check list. Patient's noted yes to allergies made nurse talk to lead nurse regarding allergies. Plan of care was to vaccinate but have patient stay at least 20 minutes. During the 20 minute wait, the observer was notified by patient she was having some throat tickling and tightening. Observer notified lead nurse. Lead nurse approached patient and had her move from waiting area back into her nurses room. Patient complained of throat tickling and tightening but stated she was fine. Nurses noted increasing coughing. Pulse ox and respirations checked. Patient continued to state she was fine and was not in physical distress. Nursing director was called and nurses advised to give epi and follow protocol. Epi given in left thigh. Patient vitals monitored and patient was able to tell throat started to loosen and coughing stopped. 911 called but patient refused transport after EMS assessed patient. Nursing Director discussed patient incident with Medical Director and nurses were advised to administer a IM dose of benadryl. Patient agreed and verbalized understanding her risks of not going to ER for monitoring. Patient signed refusal for treatment form and planned to call her doctor when she left. Patient vitals were stable and patient left clinic on her own accord around 11:00 am.

Pfizer-BioNTech COVID-19 Vaccine Patient received Pfizer Covid-19 vaccine at 1043. Patient complained of tingling throat, no swelling noted. Patient alert, oriented and talking/answering questions appropriately. Voice noted to become hoarse with continued conversation. EMS alerted and took over care at 1107.

Chills, extreme weakness, and excruciating bone and muscle pain, diarrhea lasting 48 hours. Improved with Meloxicam. The keratitis flared up. Developed keratitis after the first dose on 12/17/2020. Lot EK5730. The keratitis presented with dry eyes, photophobia and reduced reading ability. I am treated with steroid drops and artificial tears.

She experienced head ache, neck pain, sinus pain, weakness, aches, very short of breath on exertion and when wearing a mask. Aching in left arm, in chest and in right arm pit. Very dry eyes and bloodshot. Sweating and very warm. Temperature 1-11-21 96.2°F

Discomfort in throat caused coughing which then led to Bronchospasm. Patient used own Albuterol Inhaler for 3-4 inhalations. Given Epinephrine, Benadryl, Solu-Medrol IM injections administered. 2L O2 via NC applied. Elevated BP and HR noted. Patient transported to ER. Duo-Neb nebulizer treatment provided. Bronchospasm and Wheezing subsided after approximately 45 minutes. Patient discharged hone with Prednisone and EPI pen prescriptions.

I lost the sense of taste; I am getting the same sensation on my tongue that I got when I tested positive with Covid; I am smelling a chemical smell; This is a spontaneous report from a contactable nurse. A 60-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular on an unspecified date at a single dose for COVID-19 immunisation. Medical history included hypertension and COVID-19 (tested positive with COVID), which the patient elaborated, "I could not taste a thing as I normally would so I went out to drink some coffee to taste the coffee and you know I am getting the same sensation on my tongue that I got when I tested positive with COVID but that's all. I have never experienced before until I became positive about 2 months ago and that was in the first of November and I, that has never happened before and now, then it came back while I was quarantined and now, you know I was eating earlier and I had the taste everything I ate and then just called all of a sudden I couldn't taste I was snacking on so." Concomitant medication included hydrochlorothiazide, triamterene (TRIAMTERENE AND HYDROCHLOROTHIAZIDE). On an unspecified date, the patient lost the sense of taste; she was getting the same sensation on her tongue that she got when she tested positive with COVID. She was also smelling a chemical smell. No therapeutic measures was taken as a result of the event. Clinical outcome of the events was unknown. Information on the lot/batch number has been requested.

Around day 2-3, started having left eye spasm and has now been about 1 week and still having left eye spasm

Initially, sore throat, body aches and headache, then on 1/11/21 she developed red raised rash on her neck and chest. Denies difficulty breathing however she reports her throat is very painful, scratchy, dry and irritated. For treatment patient took a zyrtec 24 hour 10 mg tablet on 1/11/21 which reduced some inflammation of rash, however still present 1/12/21. Has increased fluids, is taking tylenol and tea with honey. These were self care done by patient. MD suggested to Zyrtec every 6-8 hours as needed for symptom control. Ibuprofen / tylenol as needed for headache if no provider has told you not to use these in the past. If any progressive Sx than you should be seen at URI clinic.

Pfizer-BioNTech COVID-19 vaccine EUA - Client reports "after 45 minutes post injection, started having mild itching in my trunk, arms and left Hand. itching increased so took Benadryl 50 mg PO, stayed for 15 minutes then left work to go home. Once home itching increased, eyes started swelling and started losing my voice. Husband took me to the ER at Hospital, arrived approx. 6.10 pm. Treated with Benadryl, Solu medrol and Pepcid, all thru IV. Condition improved and client sent home with script for Pepcid, Medrol dose pack and Atarax.

About 22 hours after administration I had chills, headache,blood shot eyes, total body aches and extreme fatigue. I slept off and all day and at 3:00 am 1/13/2021 I woke up and felt much better. chills, headache and body aches all gone. Some fatigue still lingers. I did not have fever at any time.. My arm injection site was less sore than the first vaccine.

Ringing in ears; Triggered to migraine; Cannot hear, Sounded like everything was muffled; Headache; This is a spontaneous report from a contactable Nurse. A 60-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, batch/lot number EK9231), via an unspecified route of administration on 04Jan2021 14:56 at SINGLE DOSE for COVID-19 immunisation. Medical history included hypertension, previously had an allergic reaction to just one antibiotic. Concomitant medication included nifedipine, carvedilol. Consumer stated, "About 15 minutes into after getting the injection, I was sitting to the site they asked me to stay longer because I previously had an allergic reaction to just one antibiotic (Unspecified Medication).So that was within the 15 minute mark I started getting ringing in my ears and at the 20 mark I had migraine. I had them since I was about 9, they were diagnosed, it triggered a migraine. Although the ringing had gotten better in the last year but it is really bad in the right and it is now causing me (incomplete sentence)." Consumer stated, "I am probably say like I am yelling at you. I cannot hear and my son keeps telling me mom you are yelling. I did not see that I am 'ringing to your sheath' ringing in the ear, the headache. I just see my headache is better today. I had a little bit of it but nothing you know Excedrin or something would take care of not enough for me to go take that but it is the ringing and I cannot hear out of that ear. I put my phone up and ringed up. Consumer stated, "Recently my mom had COVID (further not clarified), I barely heard it. On the 23rd of Dec and I keep in contact with my family,they are 13 of us and I picked up the phone and instinctively put it to my right ear, I could not hear and I kept looking at the phone and I thought wait a minute and I put it to my left seems to be okay. It is the right I cannot hear." Consumer further added, "I am a Nurse so you expect this, that is why I waited this long because I got the injection at like 3 O'clock yesterday and I waited even longer thinking maybe it will just go away and So I know you guys want to know everything that is going on. So I said wise better to call." Date of vaccination: Consumer stated, "04Jan2021 (Clarified as 04Jan2021) and the time was 2:56 PM." Consumer further added, "It is the only thing I could think of. It is the only thing that I could think of that I did differently out of my daily habits to go get this injection. I would say within 15 minutes it just started turning my head and I was like wait a minute I am having ringing and then they had music playing above our head, it sounded like everything was muffled then I turn my head to the right I could hear better and they kept turning my head and one of the administrators at the table started looking at me so I get up and I said you know what I am having ringing in my ear so they had me seated there a bit longer." Dose and route of administration: Consumer stated, "I think she pulled up one cc that I saw and I got it in my left deltoid." Treatment: Consumer stated, "No." Causality: Consumer stated, "I would have to say because it started like say in the 15 minute mark and then the headache came in about 20 minute mark." The outcome of the event Headache was resolved while the outcome of the other events was unknown.

About 15 minutes after injection c/o mild tingling to lips. No other symptoms. VSS (BP 103/68, O2 99%, RR 17, HR 68). no wheezing, SOB, swelling, chest pain, dizziness, abd pain, NV. about 15 minutes later, lip tingling improved but began c/o generalized urticaria with mild erythema to left upper chest. patient well appearing at that time, A&Ox3, no increased WOB, SOB, hives, facial swelling, facial redness. Patient reports she experienced same urticaria about 24-48 hours after 1st COVID vaccine dose, treated at home with po benadryl with improvement. Placed on continuous monitoring and administered 25 mg Benadryl po with improvement in symptoms. About 30 min after benadryl administration symptoms resolved. Offered ER evaluation to which patient declined. She works within hospital and agrees to seek emergency medical care should symptoms return or worsen. can continue to take benadryl at home and monitor closely.

Right after shot body felt on fire, within 5 minutes tongue start swelling, face, neck and injection site red, BP went to 170/120, very fatigued and throat closing.

Soreness at injection site x 48 hours--no treatment Slight twitching in left eyelid x 48 hours--no treatment--still have a little twitching in the eye but seems to be getting better

I lost my voice, my face tingled, my eyes Got puffy, itchy, and watery, extreme fatigue, and minor difficulty breathing. I had an increased you can buildup up in my throat and nose, with coughing. I took two Benadryl; about 45 minutes later my breathing improved. I took the Benadryl at 8:15 AM. It?s now 2:25 PM and my eyes are getting itchy and starting to feel puffy again. My voice is still very hoarse.

Within 15 mins of receiving the vaccine I had slight tingling in my R cheek. Within 2 hrs of the vaccine I had R facial numbness from maxillary to ear and lower jaw. Within 6 1/2 hrs from the vaccine, I had R lateral calf numbness. Within 8 hrs of the vaccine, I had R hand and arm numbness, R side of mouth and tip of tongue numb, R orbital swelling, scratchy R eye, maxillary tenderness. Advil was taken 9 1/2 hrs after the vaccine. Symptoms improved by next am, and gone by 24 hrs post vaccine.

pt described itching throat, pt was given 25mg of diphenhydramine and recovered without additional complications

patient states that she had a reaction with the first vaccine but not until after she left the clinic here. She states she had tingling in her lips and throat, she states she has already taken Benadryl 25mg prior to coming here today. Within 10 minutes of receiving vaccine she began with tingling of throat and lips, feeling woozy and ears itching. After speaking with healthcare worker the patient was given Benadryl 25mg IM. A medical alert was then called due to patient c/o chest pain. She was taken to the ER as a precaution.

Metallic taste in mouth, tingling of sides of tongue, dry throat/unable to clear throat. Resolved within 1 hour of injection.

Within approximately 2 hours of receiving vaccine, patient experienced slurred speech, dilated pupils, and was slow to respond to questions. Patient felt "foggy," similar to waking up from anesthesia.

began having tingling to face & tongue @ approx 0915 progressed to tongue and mouth swelling and rash to face

On 12-24-2020 I started to have a metallic taste in my mouth and at 2:35pm I experienced rapid heart beat with chest tightness. On the next day I felt two places in body begin with hives and it grew with itchiness till the third day. I had under-skin itchiness which grew into hives. I did a telemedicine consult with a doctor who started me on Benadryl, for me to take it 3 times a day for Monday and Tuesday after Christmas (12-28-2020 and 12-29-2020).

Pt was seen @ urgent care on 1/14/2021 after vaccine @ 1:30 PM that same day. She reported that ~ 45 mins after receiving the vaccine her lips began tingling & burning. She did 0 have any swelling or SOA.

Day 1-3: had headache, generalized itching and swelling of the right side of the face and eyelid. Took Tylenol Day 6: diagnosed with Bells Palsy by PCP 1/8: went to doctors for evaluation by PCP of symptoms currently patient still experiencing swelling of the right side of face and slight itching

1. Fever lasting 30 hours. It began approximately 11 hours after my shot, and ended 30 hours later. Fever ran about 102 degrees most of the time. 2. Chills 3. Loss of appetite and body aches lasting approximately 3 days 4. Hives in armpits, worse on the side of the injection. I noticed it 48 hours after the injection, and I still have them 1 week later. They are much better, but still visible and itchy. 5. Sensitive and painful gums

taking new meds for allergic; red spots on roof of mouth; bumps on roof of mouth; rash around the corners of my mouth; sore arm; nausea; headache; This is a spontaneous report from a contactable consumer. This consumer reported for that the 60-year-old female patient who received first dose of bnt162b2 (Pfizer Pfizerbiontech covide-19 Vaccine EUA), via an unspecified route of administration on 03Jan2021 10:00 AM on Left arm at single dose for covid-19 immunisation. She is not pregnant. Medical history included Known allergies: Penicillin sulfa. No other vaccine in four weeks. Concomitant medications included in two weeks: escitalopram oxalate (LEXAPRO), valaciclovir hydrochloride (VALTREX). The patient experienced Day 1 sore arm, nausea, headache from 05Jan2021 12:00AM, Day 2 nausea from 06Jan2021, Day 3 rash around the corners of my mouth from 07Jan2021, Day 4 bumps on roof of mouth from 08Jan2021, Day 5 red spots on roof of mouth from 09Jan2021, Day 6 Continued red spots went to Doctor, Day 7 taking new meds for allergic reaction from 11Jan2021, Day 8 headache mouth improving. AE resulted in Doctor or other healthcare professional office/clinic visit. The outcome of the events was recovering. Treatment was received included Doxycycline. No covid prior vaccination. No covid tested post vaccination. No follow-up attempts are possible; information about batch/lot number cannot be obtained.

Pain in trachea w/pain radiating up to right ear. Pain increased momentarily w/each inhaled breath. Felt like someone kicked me in the wind pipe from the inside. Sides of throat sensitive to touch. No sore throat or impairment to swallowing. No relief from Motrin taken at 15:15 or 19:30 or 23:00. Pain continued thru 15:00 next day. Of note, I rec'd 2 injections in face during dermatology skin biopsies, ICD10 D48.5 AT 1400 TO 1430.

Within an hour of the vaccine face was hot and muscle in face were painful in the jaws, sinuses up in nose felt weird and dry like menthol. Put ice on face. Took Tramadol. Having fatigue. Next day felt better, then started having brain fog difficulty remembering, vision is blurry, no energy and feel exhausted.

Pain through whole body and tremoring; Pain through whole body and tremoring/ whole body was sore; Things started looking funny/ Funny feeling in her ears; Deaf and couldn't hear; Leg cramps in both legs and toes curled out/ muscle spasming; Dizzy; nauseous; Threw up twice; Bruise at injection site; This is a spontaneous report from a contactable nurse (patient). A 60-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Batch/lot number: EL3246) via an unspecified route of administration on the arm left on 05Jan2021 around 12:00 PM at single dose for COVID-19 immunization. The patient used to get legs cramps when she was pregnant with her twins, but it was only one leg. The patient stated she delivered six children, was in car accidents, and had surgeries. And the patient stated the pain from the COVID-19 Vaccine was beyond any other pain she has experienced. The patient needed glasses to read patient card. And stated her eyesight was going. The patient was pretty healthy. There were no concomitant medications. The patient had no prior vaccinations within 4 weeks. And the patient did not receive additional vaccines on same date that administered BNT162B2. The patient experienced deaf and couldn't hear on 06Jan2021 09:00, leg cramps in both legs and toes curled out on 05Jan2021 19:00, dizzy on 05Jan2021, nauseous on 05Jan2021, threw up twice on 05Jan2021, things started looking funny on 06Jan2021 09:00, pain through whole body and tremoring on 06Jan2021 10:00, bruise at injection site on Jan2021. All the events (except for event bruise at injection site) were reported as seriousness as life threatening. Clinical course: the patient worked nightshift. Laid down that afternoon to take a nap and got up around 10:00. Around 05Jan2021 19:00 PM had sever leg cramps in both legs where her toes were curled out. Leg cramps after vaccine wouldn't go away and it was in both legs. Just wouldn't go away. Around 05Jan2021 21:00 PM it went away. The patient was dizzy, nauseous, and threw up twice on the night of 05Jan2021, and going into 06Jan2021. The patient went to the couch in the hotel room and started going deaf. She couldn't hear anything on 06Jan2021 around 09: 00 AM. Things started looking funny on 06Jan2021 around 09: 00 AM. Woke up at 09:35. Hour after that there was pain through her whole body and everything was hurting at 10:00 AM on 06Jan2021. The patient was tremoring at 10:00 AM on 06Jan2021. Couldn't reach the phone to dial 9-11. Thought she was going to die. Last until about noon and then started to go away. Doesn't know if it is safe to take the second vaccine. Doesn't know if these are thing that should have happened to her. She started to get real concerned. Went into hotel room and started feeling dizzy again. Stopped haring things. Funny feeling in her ears. Was seeing things, got dizzy, and everything got dark. Everything lasted until 12:00 PM on 06Jan2021. Everything was good now. The patient had a bruise where injection was in Jan2021. Stated it was nothing compared to what she went through. Woke up around 10:00 AM. Then went back to sleep and got up around 18:00 PM. She felt fine. Her whole body was sore from the muscle spasming. The outcome of the event bruise at injection site was unknown, of the event leg cramps in both legs and toes curled out was recovered around 05Jan2021 21:00, the outcome of other remain events was recovered on 06Jan2021 12:00. The reporter considered (method of assessment: Global Introspection) that all the events were related to BNT162B2.; Sender's Comments: All the reported events were possibly related to the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), due to temporal relationship. However, it is worth noting that the 60-year-old female patient had car accidents history and had surgeries. All the events started when she worked nightshift, including leg cramps in both legs and toes curled out, nauseous, threw up twice, pain through whole body, tremoring and transient deafness. Patient did not get rest after vaccination may a risk factor to the onset of the events. The case will be reassessed should additional information become available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.

I had a rash on my face, started with itchy nose and eyes. The hives spread to the neck. I told the male nurse that was present and he said that had Epinephrine, I had benadryl and he said that I could take one. Half an hour later my rash got worse and I took 20 mg prednisone that I had for my asthma. During the next two days I have had palpitations, fatigue and tiredness. Today my blood pressure was high and I have never had it like that before.

Swollen lip within minutes of 2nd Covid 19 vaccination. Blood pressure elevated at 206/110, heart rate 97, pulse 97.8. Gave patient 50mg of oral diphenhydramine and monitored vitals and symptoms post dose for approximately 1 hour and 45 minutes. 1/2 hour post vaccination dose BP=180/100. At 1 hour post injection BP was returning to patients normal BP 164.98, pulse 81, Lip swelling is reducing. Also took patients blood sugar to check 1 hour post vaccination , it was 120.

Temperature 101.7; Back pain/pain in her back; Right upper jaw pain that felt like sinus; Heart rate 130's; Oxygen Saturation dropping; Headache/head felt like it would explode; Ringing in the ears; Thighs are burning; calf pain/Calves were sore in back; Calves were sore in back and felt like DVT; Chest pressure; she sound like a hypochondriac; flu like symptoms; can barely walk; Nausea; Shivering; weak; felt miserable; dry hives; This is a spontaneous report from a contactable Nurse reporting for herself. A 60-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) Batch/lot number: EL1283, Expiry Date: 30Nov2021, intramuscularly into right deltoid on 11Jan2021 07:15 at single dose at the hospital for Precaution as frontline healthcare worker. Medical history included Wolff-Parkinson-White (WPW) syndrome from 2000, heart surgery in the past on unknown date, had surgery that was in 2000. Years of chest pain and PVC after that; allergic to Sulfa with hives: One time she mixed it up with a medication of her sons and took it by mistake and did not realize it and she did not have any reaction, she has not had in years. It was an injection and she doesn't have the name, lot or expiration. Family medical history included Mother was diabetic and sister was prediabetic and was 61. There were no concomitant medications. The patient previously received the first dose of BNT162B2 (Lot E49899) on 18Dec2020 at 10:30 am injected in Right Deltoid for COVID-19 immunisation and experienced shivering; same body aches, she took TYLENOL; had major headache all night long, all over her head; It was a pressure headache; Someone gave her MOTRIN and within 3 hours she was totally fine. The patient stated she received the Pfizer COVID vaccine second dose on 11Jan2021 and has had problems since then. She has been miserable, took paracetamol (TYLENOL), headache, have ringing the ears, head was exploding, back aches, calf pain, temperature at 8 am 101.7 and 101.7 at 10:40 on 12Jan2021, feeling very weak, nausea, dry hives, Right upper jaw pain that felt like sinus, all in Jan2021. Her heart rate was in the 130's at 3:30-4:00 on 12Jan2021 and now down to 115-108. Her Oxygen saturation has been 91-95 %. She just had a miserable night (Jan2021). She had this pressure in her chest. Her heart rate was 130 and O2 was 93%. Her O2 saturation last night (on 11Jan2021) was 91-94%, mostly about 93%. Chest Pressure began around 3am on 12Jan2021. She called healthcare provider and was waiting to get advice from them if she needs an EKG. She was still having a little bit of mild pressure. She noticed that her oxygenation was 93% when this was happening. It went up to 95% for a second last night. Her heart rate was now between 112-115. When she walked, it went to 125-130. It started around 3:30-4:00 this morning (on 12Jan2021) and was mildly improved. she was feeling the chest pressure back pain had lesson, but had pain in the upper jaw, flu like symptoms on 12Jan2021. she said she could not get out of the bed right. She did have a heart surgery in the past, her legs were burring, and week. she said after the first dose she did had a reaction but took MOTRIN and went to work the next day. The patient wanted to know about the heart rate being high and ringing in the ears. She wanted to know if it was supposed to drop your saturation and increase your heart rate. Is she just behaving like the norm or should her O2 be much higher. Her first shot was not as bad as this reaction. There was no prescriber. The temperature just began now as she just took it. Oxygen Saturation dropping began when she woke up in middle of night around 3:30- 4:00. She used her pulse oximeter and noticed it then. It was associated with her ears ringing and her head felt like it would explode at 3:30 on 12Jan2021. She felt better with headache but still had it. She was so weak on 12Jan2021, she did not want to go anywhere. Her oxygenation had worsened to 93% on average. She had a headache last time but did not have ringing in her ears. She woke up about 3:30 with it. The headache now was all over head from front to back and comes and goes. Last time she went to work after receiving the first one and today (on 12Jan2021), there was no way she could go to work. She took TYLENOL when she got home because she was shivering and took more at 3:30 because she felt miserable because of her chest. She took 1 gram. Her headache did not go away. She got to sleep after she took the TYLENOL. Her back and jaw was bothering her. It felt like the flu. She had upper jaw pain and pain in her back. She didn't have a good back and just aches. After the first one, it took 10 hours for the shivering to start. This time it was very similar. The shivering started about 10 hours later, at 9pm on 11Jan2021. Back pain starting at 05:00 on 12Jan2021 was stated as being sharp on right side scapula and feel like the flu. It is to the right of spinal vertebrae. She thought she would go to bed and lie down. She has had back pain before. The jaw pain started around 05:00 on 12Jan2021. She felt it in her cheek. It was a little bit better. Nausea started at 11:00 pm on 11Jan2021 and got worse at 03:30 when she got up to go to the bathroom around midnight. She felt like she could vomit and felt better, but she couldn't. Her thighs were burning at 03:30 on 12Jan2020. It was persistent weak and burning. She can barely walk. The areas that have hurt like when you get the flu, she was having now in the same places, so she thought it was from the shot. Calves were sore in back and felt like a DVT (Deep vein thrombosis), started at 03:30 of 12Jan2021 and was still sore. She said she sound like a hypochondriac. It was in back of calf towards knee. She did not think it was a blood clot. It was feeling better. It was still sore but nothing like it was at 03:30. It is just an odd pain. She did not want to leave the house and surprised that her oxygen saturation was low. She just wanted to go back to sleep for a bit. Oxygen Saturation dropping was reported as worsened. The outcome of events Chest pressure, Heart rate 130's, Headache/head felt like it would explode, Right upper jaw pain that felt like sinus, calf pain/Calves were sore in back and Calves were sore in back and felt like DVT was recovering. The outcome of events Oxygen Saturation dropping, Ringing in the ears, Shivering, Back pain/pain in her back, Nausea, and Thighs are burning was not recovered. The outcome of events Temperature 101.7, she sound like a hypochondriac, dry hives, flu like symptoms, weak, felt miserable and can barely walk was unknown. The reporter considered events Heart rate 130's, Temperature 101.7, Oxygen Saturation dropping, Right upper jaw pain that felt like sinus and Thighs are burning were related to BNT162B2. The reporter considered events Chest pressure, Heart rate 130's, Temperature 101.7, Oxygen Saturation dropping, Headache, Ringing in ears, Shivering, Back pain, Nausea, Thighs are burning, Right upper jaw pain that felt like sinus and Calves were sore in back and felt like DVT as serious due to Medically significant.; 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.

Patient has history of anaphylaxis, and carries her own EpiPen. Patient received dose 2 at 1640, and was instructed to wait in observation area for 30 minutes. At 1650 patient reported that her tongue and back of throat were beginning to itch. No other symptoms. No difficulty breathing. Vital signs stable. Symptoms persisted, so decision was made to send patient to hospital emergency department. Patient did not want emergency transport, and was stable, and husband transported to hospital in POV. Onsite and hospital care team agreed to this plan. RN escorted patient from clinic to car. Patient and husband knew how to use EpiPen and drove directly to nearby ED for observation.

Left eye: redness,, tearing,, discharge, blurry and markedly diminished vision. Seen by both optometrist and ophthalmologist on 1/26/2021. Diagnosis: Keratitis . Treatment: Tobramycin-Dexamethasone Ophthalmic Suspension and Bepreve eye drops. To return to Ophthalmologist's office in 1 week..

Pfizer BioNTech COVID-19 Vaccine EUA approximately 10 minutes after receiving her second dose, patient report throat tingling and tightness. Later started to have an intermittent cough

weird taste in mouth; like a burnt oatmeal taste; Nausea; This is a spontaneous report from a contactable nurse. A 60-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number EL1283, expiry date not reported), intramuscular on 09Jan2021 12:00 at a single dose in the left arm for COVID-19 immunization. Medical history included had known allergies to sulfa and patient had the COVID virus back in Oct2020 to an unknown date. The patient was not pregnant at the time of vaccination. Concomitant medication included celecoxib (CELEBREX). The patient had the first dose of BNT162B2 on an unknown date for COVID-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The most recent COVID-19 vaccine was administered in the hospital. Patient wanted to report a side effect and was reading a little about it. She had her second dose of the Pfizer Covid-19 vaccine last Saturday, 09Jan2021 and has like a weird taste in her mouth on 11Jan2021. It's like a burnt oatmeal taste. Patient wanted to know if anyone has ever reported that. Patient reported nausea with weird taste in my mouth, not a loss of taste but taste of burnt oatmeal. Patient had the COVID virus back in Oct2020 and she didn't have taste or smell at all then and now she has a taste so it's not like she has COVID again. No treatments received in related to the events reported. Since the vaccination, the patient has not been tested for COVID19. The outcome of the events "weird taste in mouth; like a burnt oatmeal taste" and nausea was not recovered. Information on the batch/lot has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021025273 Pfizer

like an anaphylactic reaction but not in her throat; itching and inflammation, in eyes as well/eyes were swollen and itchy; itching and inflammation, in eyes as well; swelling on her eyes and itching on her eye lids; swelling on her eyes and itching on her eye lids; welts; whelps on her hip, inflamed and itchy/general arthritis symptoms; Headache dull; shingle like rash on tailbone, genital area / raised itchy rash on the tailbone like shingles; itching on her face that she couldn't see / raised itchy area on her left cheek and eyes; rash / rash down her thighs/rash that was across her body; rash vulva; swelling / vulva was swollen; itching / itching around the genital area, vulva; itching / itching around the genital area, vulva; This is a spontaneous report from a Pfizer-sponsored program. A contactable Nurse (patient) worked in outpatient mental health reported that a 60-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL1284, Expiry Date: Apr2021) via an unspecified route of administration on 04Jan2021 at 16:20 in the left arm at single dose for COVID-19 vaccination. Vaccine administered at hospital and not military facility. No additional vaccines administered on same date of the Pfizer suspect. Medical history included ongoing Graves' disease (the patient had her thyroid irradiated away for Grave's disease 25 years ago). Family Medical History was none. Concomitant medication included ongoing levothyroxine 1.25 mcg once daily by mouth Graves' disease taking for 25 years. Prior vaccination within 4 weeks was none. The patient received her Pfizer COVID 19 vaccine on 04Jan2021. Since then she started to experience a genital itch immediately; a rash that was across her body; eyes were swollen and itchy; new itchy rash 13Jan2021. She felt okay going home then she started to have itching around the genital area. She thought she might have a yeast infection but she didn't have any other symptoms for a yeast infection. Her vulva became swollen from 05Jan2021 and itchy from 04Jan2021 and she noticed rash around her body. It all started in the genital area. The next day the rash spread down her thighs and she noticed an itchy place on her face, but you couldn't see it. Her thighs were inflamed and she noticed patches of angry whelps on her hips as well as a itchy rash area on her tailbone that seemed more like shingles; size of a quarter; raised, itchy, rash, that felt like it was radiating out. Then she noticed the rash on her face on her cheek, general swelling on her eyes and itching on her eye lids. Now the genital itching was less and most of her symptoms were improved but her eye was driving her crazy and it was more swollen on the outside. She tried to treat her eyes with eye drops Dry Eye Relief (manufacturer Similasan; no UPC seen, lot number: 15942; expiration date: Sep2022, ingredients include Belladonna) but it didn't help. They were still itchy and weepy. The eye drops were not working. She also treated the rash and itching with Benadryl at night and it improved the symptoms overall. She took Tylenol (UPC 300043760; lot number: PMA003; expiration date: Aug2022) and Bayer Aspirin (81mg; lot number: NAA93E1; expiration date: Feb2023. No UPC code on bottle) every day for general arthritis symptoms, but they didn't touch her dull headache she has had on and off since the vaccine. Before she got the vaccine, she had a little tag on her vulva, it was tiny. Now after experiencing the itching, swelling, rash on her vulva, the tag was gone. It just took a layer of skin right off. It was not uncomfortable but the whole layer of the skin was gone. It was very uncomfortable while it was happening but now it was okay. When she noticed these symptoms, she tried to call occupational health and a institute but didn't get anyone. She also contacted her HCP but had not heard back. It seemed to her like a lot of side effects and a lot of itching. She didn't have it in her throat, but all that itching seems a lot like an anaphylactic reaction. She was curious whether we would recommend her to take the second dose since they say the reaction to the second dose was worse. She had multiple COVID tests that have all come back negative. A friend tested positive so she had a test; and she had a test when she traveled. The events did not require a visit to physician or emergency room. The patient had reactions: itching, rash, swelling, welts, shingle like rash on tailbone, genital area, hips moving to her face, itching and inflammation, in eyes as well. She wanted to know if the 2nd dose was recommended. It was "like an anaphylactic reaction but not in her throat." itching around the genital area, vulva started from 04Jan2021, vulva was swollen started from 05Jan2021; Rash vulva started from 06Jan2021 to 10Jan2021; rash down her thighs started from 07Jan2021; Raised itchy rash on the tailbone like shingles started from 06Jan2021, whelps on her hip, inflamed and itchy from 07Jan2021; itching on her face that she couldn't see started from 06Jan2021; raised itchy area on her left cheek and eyes started from 07Jan2021; Headache dull started from 06Jan2021. The events Headache dull, itching on her face that she couldn't see; whelps on her hip, inflamed and itchy and raised itchy rash on the tailbone like shingles were reported as non-serious by the reporter and other events were considered as medical significant by the reporter. Investigation assessment for the events was reported as No. The outcome of the event anaphylactic reaction, inflammation in eye, welts was unknown, outcome of the event Rash vulva was recovered on 10Jan2021; of Headache dull, swelling eye was not recovered, of other events was recovering.; Sender's Comments: A possible causal association between administration of BNT162B2 and the onset of anaphylaxis cannot be excluded, considering the plausible temporal relationship and the known adverse event profile of the suspect product. Severe allergic reaction is the known risk for the product. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.

tongue on the side is bruised; it was a big black spot that she noticed this morning while brushing her tooth; right arm being sore started after 1.5 hours after the shot; This is a spontaneous report from a contactable consumer (patient). A 60-years-old female patient received first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot EL3247, expiry date not reported), via an unspecified route of administration on 13Jan2021 at a single dose in the right arm for covid-19 (immunization). There were no medical history and concomitant medications. Patient had got her Pfizer Covid vaccine on 13Jan2021 and thought she had a reaction and wanted to know if anyone had this reaction. On 14Jan2021, patient stated on right side where got shot on that her tongue on the side was bruised. She stated that her arm hurt last night. She stated this was her first dose. She later clarified that it was her right arm. Patient stated that it was a big black spot that she noticed this morning while brushing her tooth (14Jan2021). Her right arm being sore started after 1.5 hours after the shot (13Jan2021). No treatments received in response to the events reported. The events "tongue on the side was bruised" and "it was a big black spot that she noticed this morning while brushing her tooth" were not recovered. The outcome of the event "right arm being sore started after 1.5 hours after the shot" was recovered on 14Jan2021.

Fatigue; headache; earache; sore throat; fever of 101.4 for 24 hours; Diarrhea; Could do nothing but sleep; administration date=15Jan2021 (dose number: 2); administration date=23Dec2020 (dose number=1); This is a spontaneous report from a contactable other health professional (patient). A 60-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EK9231), via an unspecified route of administration on 15Jan2021 at 13:30 at a single dose in the left arm for COVID-19 immunization. The patient's medical history included allergies when younger, known allergies to wheat, dairy, cats, and mold. There were no concomitant medications. The patient previously took levofloxacin (LEVAQUIN) and nitrous oxide and experienced allergies; also had her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EK9231) on 23Dec2020 at 11:30 for COVID-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. On 15Jan2021, the patient experienced fatigue, headache, earache, sore throat, and fever of 101.4 for 24 hours, and diarrhea. The patient could do nothing but sleep. The patient did not receive any treatment for the reported events. The patient was not pregnant at the time of vaccination. The outcome of the events was recovering.

slurred speech/ responded slowly to questions within 2 hours of receiving the vaccine; dilated pupils; "foggy."; This is a spontaneous report from a contactable other hcp. A 60-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EL3248), intramuscular on 19Jan2021 09:15 at a SINGLE DOSE for covid-19 immunisation. Medical history included hypertension and oedema. Concomitant medication included phentermine hydrochloride (ADIPEX-P), olmesartan medoxomil (BENICAR), furosemide (LASIX), amlodipine besilate (NORVASC), doxycycline (VIBRAMYCIN). The patient previously took Ciprofloxacin, Clopidogrel, Meperidine, Flagyl, Macrobid, Penbutolol and experienced drug hypersensitivity. The patient had the first dose of vaccine on 20Dec2020 (Lot number=EK5730). The patient exhibited slurred speech, dilated pupils and responded slowly to questions within 2 hours of receiving the vaccine. The patient felt like she just woke up from anesthesia and was "foggy" and 19Jan2021. The outcome of the events was unknown.

02/05/21 Developed headache 3-4 hours after receiving COVID vaccine, along w/ metallic taste in mouth & tingling in right hand. 6 hours after COVID vaccine had tingling in both hands. 02/06/21 4 AM felt chilled. 8 AM had mild headache & fatigue, tingling in both hands continued all day. 02/07/21 Tingling in both hands continued. Then developed tingling in left foot & increased tingling in left hand. 02/08/21 Increased tingling in both hands, worse in left 3rd digit. 6 PM had increased tingling in left hand & tingling up into left elbow. 9 PM had increased tingling in right hand. 02/09/21 Tingling in both hands continued all day. Fingers feel cold off &on. 02/10/21 Tingling in both hands continued all day. Fingers feel cold off & on. Tingling in feet, left leg up to knee in evening. 02/11/21 Tingling in both hands continues, fingers feel cold in both hands. Tingling in feet.

Tightness in chest, throat swelling, tongue tingling. Lasted about 45 minutes. Did NOT use epipen. Went to ER on site, received saline IV, was thoroughly checked and monitored, stayed 2 hours.

On Tuesday she woke up with a headache that gradually worsened. The headache was behind the right eye, the right ear, and the teeth on the right side also hurt. Nothing helped taking Acetaminophen; Ibuprofen. She went to sleep around 4:00 am finally, and then woke up 6 hours and the headache was gone. Then you had hives located behind the right ear and down the neck, into the right shoulder. They are also in her scalp. They have now down to the tops of her legs, hips, and back and are spreading. She called her doctor who called her in some prescriptions.

shortness of breath, heart rate high, dizziness, low blood pressure, dry mouth, feeling faint, weakness, fatigue all over, numbness in feet and hands, two -three weeks of morning anxiety, difficult to operate a car, two tp three weeks stiffness in joints, and headache.

About 30 hours after vaccine I had bumps on my shoulder blade on left side where I received the vaccine - a rash that itched. It lasted about 4 or 5 hours - I put Calamine lotion on it and that soothed it. I also experienced a little itching of eyes and a slight itching in mouth. About 9:30 pm I had a rapid heartbeat for about 30 or 40 minutes. The itching sensation continued off and on the next day but bumps weren't visible any longer. The itchy eyes continued off and on for the next day as well.

2MIN AFTER DOSE DIZZY, VERY CONFUSED, SLIGHT CHEST PRESSURE, 30 MIN LATER SLIGHT SWELLING OVER EYELIDS, 1 HR LATER STILL VERY CONFUSED IN A FOG. VERY CONGESTED , SNEEZING, ITCHY EYES, STUFFY EARS, VERY CONFUSED. STRANGE FEELING INSIDE MY BODY - TINGLING . FEELING OUT OF BODY .... NOT MY SELF ...ITCHING. VERY CONFUESED AND VERY DIZZY FOR ABOUT 4 HR... SEVERED HEADACHES. NAUSAUES. 6 HRS LATER SWOLLEN FACE RIGFHT SIDE.

12/19/2020 130 vaccination. When got up to leave, near syncope episode. Monitored for 15+ more minutes. Left after. Later that evening, I felt like I was on 'speed'. Chills, HA, couldn't sleep. HR was increased. I wasn't able to eat; no appetite. Symptoms lasted for several days. Don't think I ran a fever. I was very dizzy, double vision, extreme fatigue. Did what i could with work online. *HX of aura migraines and happened during this episode. Within that week, saw NP.

Right after the vaccine I felt a little funny. Within 10 minutes of receiving the vaccine I started coughing, lost my voice, Itchy eyelids, my chest was pounding, and overall just did not feel right. EMS Took my blood pressure and it was 255, then they waited a smidge and decided to give me an injection of Benadryl, within 10 minutes of the Benadryl my blood pressure went down to 225, and I overall felt a little bit better. My eyelids were still swollen and itchy and I didn?t have a voice, they took my blood pressure again and it went down to 218. They stayed with me. I was starting to feel a little bit better. My blood pressure went down to 180 and there?s no wheezing in my chest. They let me leave shortly after that. I still do not have a voice. My eyelids are still swollen slightly and very itchy and my lips tingle.

Felt like tongue was swelling. EMS evaluated. Given 10more minutes to wait instructed if gets worse to go to ER. Can take benadryl. If uses epi pen need to go to ER. Hx of having in past.

Within 30 seconds: Dry Throat, patient requested water, request was denied. 1 minute after vaccination: Coughing and difficulty breathing 2 minutes after vaccination: Patient refuses EpiPen administration stating she will not go to the hospital and not to call 911. 3 minutes after vaccination: Patient attempts to leave observation area to go use her own EpiPen in her apartment. 4 minutes after vaccination: Patient agrees to EpiPen administration into left leg and 911 is called. 5 minutes after vaccination: Patient continues to cough and clear throat. Patient throws herself out of her chair onto the floor while coughing. 6 minutes after vaccination: Patient hoarsely requests a second administration of EpiPen. EpiPen is administered into right leg. 7-10 minutes after vaccination: Patient is breathing easier however is forcing herself cough. 11 minutes after vaccination: EMTs arrive. Patient's HR: 141 bpm, SpO2: 96% 13 minutes after vaccination: Patient's SpO2: 99% 18 minutes after vaccination: Patient goes outside with EMTs 20 minutes after vaccination: Patient signs "Against Medical Advice" form - refusing to go to the hospital 22 minutes after vaccination: Patient is walked by to her apartment by EMTs.

Extreme fatigue, nausea, chills, headache, dizziness 18-20 hours after receiving the 2nd vaccine for about 10-12 hours, then lessening to feeling tired, bouts of vertigo and occasional headache. Five days later on 1/25 I experienced blurry vision, nausea, confusion, dizziness, and impaired speech (to a co-worker). This lasted about an hour.

presented 1/27 to ED with rigors, dyspnea chest pain and R ear pain post COVID vaccine, thought to initially be systemic SEs from the vaccine but found to have re-collapse of the BI on chest CT with probable post obstructive pneumonia. still admitted as of 2/23/2021

Pt reported slight tongue "tingling" and also has a small patch of flat erythematous area on her skin about 8 minutes after the vaccine was administered. She does report the reddened area is itchy. She denies SOB, denies airway tightness, denies chest pain. Her vitals at 1356 hours are a HR of 66, BP of 139/74, RR of 18, Sats 100%, RR 16. Pt took a PO benadryl at 1347 hours per her request as she had already declined further EMS care (ALS and ambulance declined). Her Sxs resolved by 1356 hours. She stayed a few more minutes to be sure her symptoms were completely resolved and left POV at 1407 hours. She will follow up with her physician as soon as she leaves. She has been notified that her symptoms could return.

1010 pt c/o eyes draining clear fluid, generalized tingling, redness Dr notified and assessed order received to administer po benadryl 25 mg po 1030 symptoms resolving continued to monitor for additional 30 min. 1100 pt stable and symptoms resolved left premises this time.

Strong metallic taste in my mouth about 5-10 min after vaccination (lasted about 45 min); morning stiff shoulders and back of neck (still have it but it's better); This is a spontaneous report from a contactable consumer (patient). A 60-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL9265), via an unspecified route of administration on 26Jan2021 12:30 at a single dose for COVID-19 immunization. Medical history included PVCs (Premature ventricular contractions), coronary artery disease (CAD) and allergies to NSAIDS, artificial sweeteners, sulfa, and mango. The patient was not pregnant at the time of vaccination. The patient was not diagnosed with COVID-19 prior to vaccination. Concomitant medications included nicotinic acid (NIASPAN), vitamin d nos, metoprolol tartrate (LOPRESSOR), omega-3-acid ethyl ester (LOVAZA) and Nexlizet. No any other vaccines received within 4 weeks prior to the COVID vaccine. On 26Jan2021 12:45, the patient experienced strong metallic taste in her mouth about 5-10 min after vaccination and morning stiff shoulders and back of neck (still have it but it's better). No treatment was received for the events. The patient has not been tested for COVID-19 since the vaccination. The patient was recovering from the events.

Eyelids and face swollen, itching on the jaw, tingling sensation and possible stomach upset and some shortness of breath.

Patient reported dizziness and blurred vision initially. Vital signs checked, BP 174/73, HR 87, SpO2 97% on intial check. She also reported a right frontal headache 5/10. Moved to cot to lie down, VS re-checked. Dizziness did not resolve with lying down. BP remained elevated as well. Once lying down, patient also reported "heaviness" in chest. A nurse remained with patient throughout entire incident and VS assessed frequently. After about 45 minutes, patient still reported HA, dizziness. Patient reported chest heaviness had resolved, but BP and dizziness did not resolve. Discussed calling EMS with patient, she agreed to allow us to call EMS. She was transported to local hospital by EMS at approximately 11:30am.

slight fever for 2 days, then flu-like symptoms (body aches, fever, chills, lack of appetite, loss of taste and smell, fatigue) since Wednesday 2/24/21. Missed work due to symptoms on Thursday 2/25/21. Returned to work amidst continuing flu-like symptoms on Friday 2/26/21. As of Sunday, 2/28/21, symptoms continue; maybe slightly diminished.

Headache, Low grade fever, cough, loss of appetite, hot flashes, Lost my voice. Didn't feel well Friday night, started coughing and feeling unwell. I had a fever in the morning and had lost my voice but wasn't coughing anymore. Today no fever but no voice and I just don't feel well. No appetite today either.

240 pm :Patient complaint of burning right ear and numbness in her mouth. Vitals T 97.3, P 74, R 16, BP 120/90. 315 pm: Symptoms subsided per patient. Patient discharged from clinic.

Dizziness, Numbness of tongue and lightheadedness. 50mg PO Benadril. Monitored for 30 minutes. All symptoms resolved. No further intervention required. Patiient released to home with spouse.

pain in lymphoma area; pain in lymphoma area; Multiple headaches; neck pain; inner ear pressure; jaw pain; This is a spontaneous report from a contactable consumer, the patient. A 60-year-old non-pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot: EL3247), via an unspecified route of administration in the left arm on 21Jan2021 at 11:45 (at the age of 60-years-old) as a single dose for COVID-19 immunization. Medical history included type 2 diabetes and overweight, and the patient had no known allergies. The patient was not diagnosed with COVID-19 prior to the vaccination. Concomitant medications included lisinopril, metformin, metoprolol, sitagliptin (JANUVIA). The patient did not receive any other vaccine within 4 weeks of the vaccination. On 01Feb2021 at 09:00, the patient experienced multiple headaches, neck pain, pain in lymphoma area, inner ear pressure, jaw pain. The patient was not treated for the events. Since the vaccination, the patient was not tested for COVID-19. The clinical outcomes of multiple headaches, neck pain, pain in lymphoma area, inner ear pressure, jaw pain was resolving.

I started to get mild nausea within about 15 mins. then a chemical taste in my mouth. Later I was getting some sputum or phlegm coming up,, no cough, on short of breath no nasal discharge. During the night I woke up because the phlegm was much worse and abundant I wanted to sleep so at first was swallowing it, then it was so much that I got up and went to the bathroom. That is when I noticed that the palms of my hands were scarlet red. on both hands and not on the wrists or any where else. by morning it was gone but I did have diarrhea and still a cold mild nausea feeling in my stomach. Yesterday , 3 days later, still had diarrhea and nausea and was tired,,symptoms are not severe, but since these are not typical symptoms for me. I figured they will go away, but also I figured that I should communicate the reaction . I am scheduled for my 2nd shot in 3 weeks,

At first I didn't feel anything or any different. I started to get a weird sensation behind my eyes like before with the first vaccine. The muscles of my eyes and eye lids feel weak and difficult to focus. I started having extreme nausea and could not go to work. No appetite either. I now have Oscillopsia and feel sick.

Being a diabetic, my blood sugar was in the 300's, and even after changing my insulin pump because I believed there may have been an issue with delivery, my blood sugar continued to rise. I did not eat anything until about 6 PM when my blood sugar began to lower. At that time, I tried to eat some chicken soup, but after a few mouthfuls, my throat began to constrict and my tongue and the inside of my mouth began to itch. This continued every time I began to try to eat something and I still could feel what felt like some constriction in the back of my throat the next day (Monday).

Left upper abdominal pain after receiving COVID vaccine radiating to left jaw rapid response, had patient remove mask and reported facial drooping. Transferred to ED for acute, painless, unilateral facial paralysis with no forehead sparing most likely secondary to Bell?s Palsy. Patient was monitored and discharged with prescriptions for valacyclovir 1000mg tid and prednisone 50mg qday x 7 days

Pt experienced blurry vision to both eyes and slight headache. Onset approximately 25 minutes after receiving vaccination. Pt did not lose LOC, did not lose vision completely. No problems with gait. Alert and oriented. Episode was transient and all sx's went away after about 30 minutes. After sx's resolved, pt refused transport to hospital for further evaluation, signing CFD refusal form stating able to drive self home.

Metallic taste in mouth that dissipated after about an hour, redness/swelling at injection site and itching that persisted for 3-4 days.

continued mild headache; eye strain and sensitivity to bright light; eye strain and sensitivity to bright light; This is a spontaneous report from a contactable consumer, the patient. A 60-year-old non-pregnant female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot: EM9810), via an unspecified route of administration in the left arm on 06Feb2021 at 10:15 (at the age of 60-years-old) as a single dose for COVID-19 immunization. Medical history included hypertension (HTN), obstructive sleep apnoea (OSA), periodic limb movements of sleep (PLMS), arthritis, asthma, allergies to Band-aid adhesive, steristrips and lanolin. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications were not reported, but the patient did receive concomitant medications within 2 weeks of the vaccination. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot: EL3247) on 16Jan2021 at 16:30 (at the age of 60-years-old) in the left arm for COVID-19 immunization. The patient did not receive any other vaccinations within 4 weeks prior to the COVID-19 vaccination. On 07Feb2021 at 00:00, the patient experienced continued mild headache, eye strain and sensitivity to bright light. The patient was not treated for the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of continued mild headache, eye strain and sensitivity to bright light was not resolved.

COVID Vaccine Adverse Event Documentation After vaccination with COVID Vaccine Dose #1, patient developed evidence of Immediate (within 4 hours of dose) adverse reaction starting 3/5/2021 2:02 PM. Signs/Symptoms: Dry Mouth, Flushing, Lightheadedness, Nausea/Vomiting and Other (see comments) Reaction Comments: Skin blotchiness, dizziness, shaky, responsive but limp Treatment Administered: Cold Compress and Sips of Water Treatment Comments: Crackers, put in supine position Disposition: Home Disposition Comments: Next vaccine should be supine when receiving it. Additional Documentation: Pt became faint immediately after vaccine, warm, shaky and went limp I her chair but was responsive. BP: (!) 150/94 Pulse: 75 Supervising Provider Notified of Reaction: MD

Received Pfizer COVID19 injection at 9:57 am on March 4 at the . As is usual for any shot or IV on me, I immediately tasted something weird in my mouth. It was not as metallic tasting as usual. More plasticy. Shot did not hurt. Was told to stay in 30 minutes waiting area.I did. The taste remained in my mouth. I left at 10:34 am feeling OK, except for weird taste. As I drove off the parking lot, I noticed that my mouth and tongue were tingling, with worst of it on my left side. My throat did not seem to be affected, so I continued driving. Some nasal congestion and coughing. The tingling turned into numbness in my mouth and tongue, all the way back to top of throat. I called my primary care doctor at 12:10 pm and left a message. I received a call back at 2:15 pm from nurse. She told me to take Benadryl and have someone take me to Urgent Care right away to get my vitals checked. I did not take Benadryl, as CDC said it could mask anaphylactic reaction. I called a friend and she took me . I noticed that my lymph nodes in my neck were swelling and painful. We arrived at 2:45 pm. My vitals were checked, heart and breathing listened to and was checked briefly for swelling in mouth and throat. There was no swelling. He said he had never heard of this tingling reaction and claimed it is just a side effect and not a serious reaction and that it would probably last a couple of days. He recommended that I watch for new symptoms and take Benadryl. That was $30. We left at 3:10. We left. I noticed that the numbness was spreading to my lips and up the left side of face and I was getting super tired. Also, my mid to lower back started hurting a lot. I took a Benadryl. 4:30 pm still have same numbness. My eyes got super dry and itchy. My head started to hurt. Some coughing. 5:10 pm dry eye and numbness, more swollen lymph nodes and chills. Pain in calves, upper back, same on both sides. 6:38 weirdly, from the bottom of my thumb to halfway up my arm there is pain. Both arms simultaneously. Worse on the left. 8:11 pm after bundling up and using a heating pad, plus extra heat, chills are lessened. Lymph nodes very sore in neck. Eyes are not quite as dry. Everything else is the same. 8:48 pm jaw really aches. Intestinal discomfort. Going to bed. 10:39 pm pain from jaw extended up into left ear. Upper part of throat hurts. March 5, 2021 4:00 am. Body aches have lessened. Left arm sore at shot area. 5:45 am eyes definitely dry, but not nearly as dry as yesterday. Numbness in mouth , tongue and face has lessened, but still uncomfortably present. Definitely worse on the left side. Little bit of tingling on the left, mostly on cheek from chin to ear. Headache gone. Lymph nodes sore and swollen . 7:00 am went on a walk. Noticed some achyness throughout body. Very tired. 10:51 am The tingling and numbness remain in my mouth, tongue and cheek up to my left eye. Very tired. Lymph nodes still swollen and sore.

Pt in 30 min waiting area. At 10:36 am reported tongue feeling funny. Upon assessment tongue was thick , interfering with speech. BP: 186/93, Heart Rate : 66, Oxygen Saturation 99%, Temperature 97.6 F. Epinephrine 0.3 mL administered on left thigh at 10:42 am and 911 called. Pt reported inability to swallow and chest tightening at 10:51 am. Ambulance arrived.

I had a retinal artery occlusion that resulted in blindness in the lower half of my right eye within 5.5 hours of receiving the vaccine.

Approximately 15 minutes after the vaccine was administered, the patient reported feeling lightheaded and tingling sensation of the face; patient also stated that she "feels like tongue is swollen." Patient vital signs were taken by EMS on site. Vital signs were within normal limits.

Throat tight, tongue feels numb, chest pressure. Evaluated by EMS- Transported to Emergency room/department or urgent care.

swelling, itchy spots: , itchy knot on hip, itchy spots: under breasts, ears, and palms-- swollen lips

Lip tingling, palpitation, flushing and wheezing/slight SOB within 15-30 mins and sensation that she was unable to swallow while driving home. Used rescue inhaler when she reached home for relief. Symptoms now resolved. H/O asthma

Since the week after the first Pfizer vaccine, I began struggling with symptoms of diabetes. I experienced extreme thirst, frequent urination and I lost 17 pounds in the 3 weeks following the first dose. I never associated it with the vaccine, initially, because I never heard of any side effects like increased glucose, and my dad and sister have type 2 diabetes, so I was altering my diet, but the symptoms did not subside. I proceeded to get the second vaccine and that?s when I knew something was seriously wrong. That afternoon my blood sugar was 528, my vision was blurred, and I experienced a strange feeling in my heart. I was diagnosed by my GP with diabetes, and put on medication (Metformin and Glipizide). I proceeded to see an endocrinologist, I was put on insulin and after additional blood tests was diagnosed with Latent Autoimmune Diabetes , and Premature Atrial Complexes.

This is a 60-year-old female who just received her second Pfizer dose of the Covid vaccine earlier today when she says she felt immediately a flushing of her left arm where she had received the vaccination and then some tingling and abruptly followed with difficulty swallowing tongue enlargement, and feeling like she had to "search for my air". This required her to turn her head leftward to assist in her breathing. She has no associated pruritus. She was given an intramuscular injection of epinephrine at the clinic where she received the vaccination and EMS was activated. She did not demonstrate any changes in her phonation or signs of stridor and there was no wheezing or signs of facial or oral swelling on arrival of paramedics. She received additional intramuscular injection of epinephrine and IV Benadryl and Solu-Medrol at that time followed by an albuterol inhalation treatment and transported here as a medical alert. She reports the symptoms are similar to what she is experienced with multiple bee sting allergic reactions in the past. She is never required intubation. She never develops any facial swelling or urticaria.

Within 15 minutes after 2nd COVID-19 mRNA vaccination (Pfizer) today, patient reported itching of left forearm (vaccine administered in left deltoid), which then also started in right arm and upper back. Slight redness noted on left forearm where patient had been scratching but no visible hives or rash. Patient denied any difficulty breathing, shortness of breath, throat tightness or itching. Diphenhydramine 25mg PO x1 dose administered. A few minutes after diphenhydramine administration, patient reported that her eyes had become itchy. 20 minutes after diphenhydramine dose, patient denied any worsening of symptoms, reported lessened itching and opted to leave clinic.

Vaccination was a 7:45 am Monday. On Tuesday at mid morning I started showing an allergic reaction. Itchy red spots all over head, ears and neck, some on lower part of body. Swollen lip. Took two benadryl at 1:45 am Wednesday . This helped to ease the itching. Had a headache so on Wednesday morning I took two Tylenol and made a Dr. appt. Also was weak and faintish on Wednesday when I got up. Dr's said to keep taking anti-histamines and report to ER if tongue or throat starts to swell.

within a couple of minutes after receiving the shot, I felt a sudden flash of warmth throughout my body. Then my heart started racing. This lasted about a minute. I just sat there since I wasn't sure if this was normal. I started to feel like my heart was going back to normal so I just sat there for the specified 15 minutes. After I left and was driving home, I stated to feel a shortness of breath and difficulty getting air. I also felt like a hard to swallow. I was about 1 mile from venue so this happened with 30 minutes of receiving the shot. This only lasted what seemed like a short time and then I started to feel like I could get my breath. By the time I returned home I was breathing ok but my lips were a little tingly. I felt fine by 5:00 pm.

Approximately 5-10 minutes from injection; felt a metallic flavor in my mouth. No other side effects as of this time , 4 hours after the vaccination.

Stated tongue feeling big and coming through her teeth. States she cannot take epinephrine. Benadryl 25mg PO given at 1322. Symptoms began to improve within minutes. Symptoms reported by patient to have resolved. Left with her husband at 1355. Instructed to seek medical care if symptoms return and to follow up with her primary care physician before receiving her second dose.

Tinnitus - ringing in ears. Persistent. Not present prior to vaccines. Started soon after the 1st vaccine (not sure of exact date of onset) . I have listed info for both doses - first given on 2/8/2021, second on 3/5/2021

Extreme energy within 30 minutes of injection Followed about 2 hours later by extreme fatigue (slept over 3 hours between 11am and 3pm) Severe pain at the injection site and muscles surrounding it (approx. 8pm) continuous as of this report (3/14/21 12:45am) Pain in the lower left jaw (approx 9pm) continuous as of this report (3/14/21 12:45am)

My tongue swelled slightly and the right side of it became numb. This lasted for 30 minutes. If it had gotten worse I would have gone to a hospital but it went away. Also, starting around 8 PM on Thursday and lasting until Saturday evening, my hips and lower back were extremely stiff and achy.

3-9-21 2:49PM 'TONGUE SWELLING'. STATES SHE DID TAKE BENADRYL @ 1PM TODAY. A/O, PINK, W/D, RESP WITHOUT ANY DISTRESS. 2:53PM TOOK BENADRYL 50MG PO (HER OWN). 3PM 'FEELS BETTER'. 3:14PM STATES SHE FEELS LIKE SHE CAN GO HOME-'FEELING BETTER'. 3:30PM HOME WITH HUSBAND PER S.C.A.T.

Lip swelling and shortness of breath that began about 10 hours after injection. Other common post vaccine symptoms were observed.

my tongue was tingling and was slightly swollen; difficulty swallowing saliva but could swallow water; my tongue was tingling and was slightly swollen; I felt some tingling in my face; I felt light headed right after the shot; This is a spontaneous report from a contactable consumer (patient). A 60-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Formulation: Solution for injection; Lot Number: EM9810), via an unspecified route of administration in the left arm on 04Feb2021 at 16:15 (at the age of 60-years-old) as a single dose for COVID-19 vaccination. Medical history included depression, anxiety and the patient was diagnosed with COVID-19 prior to vaccination. No allergies to medications, food, or other products. Concomitant medications received within 2 weeks of vaccination included 6 prescribed meds daily plus vitamins. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Since the vaccination, the patient was not tested for COVID-19. Upon vaccination on 04Feb2021 at 16:15, patient felt light headed right after the shot. She waited 15 minutes and started driving home. she felt some tingling in her face. By the time she got home, 35 minutes after the shot, her tongue was tingling and was slightly swollen. She had some difficulty swallowing saliva but could swallow water. Her tongue was still slightly swollen the next morning but did not tingle. No seriousness criteria was reported. The patient did not receive any treatment for the events. The outcome of events was recovered on an unspecified date of Feb2021.

3/12 ? Got vaccine at 1:40 pm and within about 1-2 minutes, I felt a sensation of heat in my throat and upper chest. It got a bit worse and then improved over the next few hours. I also experienced a scratchy/itchy sensation in my throat and a slightly itchy feeling on the skin of my neck and upper chest. No wheezing or swelling. Took 25 mg Benadryl at bedtime. 3/13 ? Sensations continued, still fairly mild, but with occasional tingling on lips in addition to other symptoms. Took 25 mg Benadryl at bedtime. 3/14 ? Feeling about the same; still experiencing intermittent sensations of heat/scratchiness in throat and upper chest and occasional tingling on lips. Took 25 mg Benadryl at bedtime. 3/15? Symptoms continue to improve, but I?m still experiencing intermittent sensations of heat/scratchiness in throat and upper chest and occasional tingling on lips. Took 25 mg Benadryl at bedtime.

Within the first 30 min of receiving first COVID vaccine pt report feeling dizzy and nauseated. Pt taken to vaccine clinic observation area to be closely monitored. Pt placed on gurney and given water to drink. VS stable. Pt report headache 5/10, feeling sensitive to light, and nauseated. While in observation area pt reports feeling what she describes as "feeling weird wavey sensation over entire body, warm head, and cool body." Pt offered but declined to go to ED. explained risks and benefits to pt. Pt states that she drove herself to vaccine clinic. Pt advised that it it would be unsafe to drive herself home and advised to to contact husband for ride home. Pt called her husband to pick her up. After several min pt states stated that she was "feeling a little better" and "headache was also a little better" 3/5 on pain scale but still feeling dizzy and chest feeling a little tight. " Pt states having a history of Asthma. Pt again offered to be treated in ED and accepted. Pt transported to ED by gurney accompanied by three RN's.

experienced chills and body pain on the 3rd day after receiving the 2nd dose vaccine . chills and body pain lasted for 2 days . on the fifth day felt like black curtain in front of my eyes and felt dizzy. checked my blood pressure was 170/90. Blood pressure went up to 200/100 . went to the hospital emergency and was admitted for observation overnight. CT, MRI , blood work done. BP controlled with medication Nefidefine 60mg. discharge home next day. was still having very light headedness and BP will shoot up to 190/90. physician had to change the medications couple of time. felt very exhausted . could not go to work almost 3 weeks because of the symptoms like lightheadedness. lasted at least 4 weeks to get back to work normal. never experienced this before. I was taking Olmasartan 5mg for blood pressure and my Bp always stated 130/80s

60 yo woman who 3-5 minutes post vaccination developed facial itching and erythema, initially in her eyes and nose. Administered 50 mg diphenhydramine PO. In the minutes thereafter, the pruritis spread to the upper lip, then face and scalp, and became more generalized (but mild) on limbs. She also reported a "dry throat" sensation, but denies throat tightness or itching and did not have any respiratory compromise for the hour that she remained under observation. Symptoms subsided and patient left the facility. Followed up with her later by phone to inform her that her immediate allergic reaction was a contraindication to her receiving the second Pfizer COVID-19 vaccine and that she should not return for a second appointment. Advised that she seek allergist consultation given her history of multiple allergies, and to determine whether there was a common substrate for any of them. Said that she could possibly consider the Johnson&Johnson vaccine thereafter, if she did not have any known allergies to components of it.

As I pulled up for the 15 minute wait period the symptoms started 5 minutes after I received my vaccine. A tingling feeling up my left arm to back of my neck. My neck stiffened and then my throat started to close. Not to where I can't swallow but just like when I eat food that I'm allergic too, it closes up. The nurse that was overseeing me was holding the umbrella over my car window with the rainfall. All of a sudden their was lightning & thunder. The nurse threw the umbrella because she was shocked from the lightning. She started to talk to all the other around her and forgot about me. Since I could still swallow I didn't get her attention. When she returned she asked me the time so I had to pull my phone out. She didn't know the time of my 15 minutes and sent me away. As soon as I got out of the parking area but still inside amusement park, I started to feel my cheeks becoming numb and my right eye was blurry. I quickly moved over to the side lane still inside of amusement park and waited. I called my husband and told him that with the heavy rain I didn't feel safe driving with my right eye being blurry. I waiting another 15 minutes before driving home. That evening the blurriness came back, my eye's & forehead was tender to touch but no headache. Only pressure in my head. My symptoms of closed throat, swollen cheeks, pressure in my head and blurriness continued on Friday, March 12th, Saturday, March 13th, Sunday, March 14th and Monday, March 15th. As of today, no other systems other than feeling my body has inflammation.

Week after receiving vaccine: Extreme bout of dizziness Aggravated existing tinnitus (left ear only) Appeared to be further hearing loss in left ear Sensations in face

Bad taste in my mouth for about 48 hours. I'm reporting only because I've heard that others have had the same experience and believe people should be told that (like they do for Lunesta which also had the same effect on me).

I had no side effects except a sore arm with both doses of the vaccine. Only this week I started to experience ringing in my ears (tinnitus) and I have never had that before. The only reason I thought it was related to the vaccine was that my husband experienced the same symptoms recently as well and he received both doses of Moderna vaccine in January. I find it very strange that we are experiencing these symptoms now after more than a month of getting a second dose of the vaccine.

3 days after 2nd dose of Pfizer vaccine I started getting itching, rashes and hives all over. Went to bed about 10:30. Got up about 4:30 am to use bathroom, felt lightheaded and blacked out and apparently hit my head on something. Realized ears were closing up and had soreness in chest that made deep breath's difficult. Called 911 and nursing line and decided to go to Emergency Dept. Did CT scan for bumps on head and IV and gave me epinephrine and Pepcid. Was discharged with prescription for Epi Pen, Zyrtec, and Pepcid. Still have rash and hives but not as extensive, comes and goes.

Felt lousy about hr after arm tender to lift up, ,headache,then jaw pain w worsened malaise,nausea, violent headache, chills fevers ,dry heaves, red and hot arm developed after couple days lasted about six days spread to 4x6 inches got itchy then sore to touch. Became vague and almost disoriented, had to sleep due to overwhelming fatigue w vile headache

5 minutes after the shot, a feeling of warmth went through my upper body to my head & my tongue was tingling. It lasted about 30 seconds. It happened again about 1/2 hour later (11:12 am) but not as strong or as long.

3-22-21 11AM TC: PT STATES ON '3-19-21 7PM SHE HAD SWELLING OF HER TONGUE AND RT SIDE OF FACE AND NECK; SHE CALLED HER PCP WHO HAD HER SUE HER EPI PEN - THE SWELLING RESOLVED. ON 3-20-21 SHE ALSO HAD A EARACHE, HEADACHE AND BLOODY NOSE. HAS TAKEN TYLENOL.'

Sialadenitis (salivary gland inflammation); glossitis (tounge inflammation); inflammation of the mucosal lining of the oral cavity with cherry red discoloration and swelling of the lips; inflammation of the mucosal lining of the oral cavity with cherry red discoloration and swelling of the lips; inflammation of the mucosal lining of the oral cavity with cherry red discoloration and swelling of the lips; Tingling; prickly sensation on tongue when eating; cold items felt opposite of what they should, more like burning sensation; This is a spontaneous report from a contactable consumer (patient). A 60-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EN6202), via an unspecified route of administration in the left arm on 27Feb2021 12:45 as single dose for COVID-19 immunization. Medical history included known allergies to Sulph. The patient was not pregnant. Concomitant medications included aceclofenac (BIOFLEX [ACECLOFENAC]), calcium (CITRICAL [CALCIUM]) and vitamin D (VITAMIN D [VITAMIN D NOS]). On 01Mar2021 08:00, the patient experienced sialadenitis (salivary gland inflammation), glossitis (tounge inflammation), inflammation of the mucosal lining of the oral cavity with cherry red discoloration and swelling of the lips. Tingling, prickly sensation on tongue when eating, cold items felt opposite of what they should, more like burning sensation were also reported. Onset of symptoms Monday morning, symptoms peaked Wednesday evening through midday Thursday, greatly improved by Friday morning. The patient had a COVID test on Friday to be sure and it was negative. There were no treatment for events. No COVID prior vaccination. The patient had a COVID test type post vaccination-Nasal Swab (Covid 2 PCR) on 05Mar2021 which was negative. The patient had The outcome of the events was recovered on unspecified date in Mar2021.

Due to 4 days progressive worsen skin lesion. Lesion as erythema multiform, generalized on hand, forearm, body and lower leg; Oral ulcer; Chill; Body ache; Joint pain; Joints swelling; Diarrhea; This is a spontaneous report from a contactable other healthcare professional (HCP). A 60-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EN6201), via unspecified route of administration in the left arm on 17Feb2021 as single dose for COVID-19 immunization. Medical history included hyperlipidemia. The patient had no known allergies. The patient is not pregnant. There were no vaccine in four weeks. Other medications in two weeks included cholesterol med. The previously received the first dose of BNT162B2 on 26Jan2021 12:00 intramuscular at left arm (lot number: EL9262) for COVID-19 immunization. The patient was seen at urgent care on 04Mar2021 due to 4 days progressive worsened skin lesion. Lesion as erythema multiform, generalized on hand, forearm, body and lower leg from 28Feb2021 (12:00 AM). Patient presented with chill, body ache, joint pain, joints swelling and diarrhea since second dose of vaccine on 17Feb2021. She also has oral ulcer at the same time when rash started on 28Feb2021. Vital sign was stable, no shortness of breath (SOB) and no chest pain. Events resulted in Doctor or other HCP office/clinic visit. The treatment for the events included Hydroxyzine 25 mg prn. It was unknown if patient had COVID prior vaccination or if COVID tested post vaccination. The outcome of the events was not recovered.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of event Erythema multiforme cannot be excluded. The case will be reassessed if additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.

Within 1 hour after receiving vaccine, approx 45 min., Both ears suddenly felt as if I was on a plane and was blocked as you would feel by altitude change. I kept trying unblock by swallowing etc. That last 15ish minutes followed by a constant sound in both ears as if someone was rubbing sand paper back and forth in front of each year. That lasted 40-50 minutes. Approximately 32 hours after feel like I have to keep swallowing to unblock my ears. That altitude flucuation again feeling but not as bad as the first encounter. This was related to the vaccine. No doubt in my mine. Never had anything like this before unless on an airplane. Sand paper sound, never. I let my physician know tonight via email. In addition I felt dizzy within 5 minutes of receiving the injection. Subsided within 15 -20 minutes. Felt aloof the remainder of the day. Also arm hurt so bad the next day I had to cancel golf. Low grade fever plus headache

Red swollen eyes, runny nose, congestion, fatigue, and small amount of shortness of breath. Lasted about two days

Swollen face; Swollen puffy eyelids and below eye; itchy rash on face,neck, and chest; This is a spontaneous report from a contactable consumer (patient). A 60-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date were not provided), via an unspecified route of administration in left arm on 14Feb2021 at 12:30 at single dose for COVID-19 immunization. Medical history included allergies to dust mites, dogs, and corn; Hashimoto's thyroid; and high blood pressure. Prior to vaccination, the patient was not diagnosed with COVID-19. She was not pregnant and did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medications included fluvoxamine maleate (LUVOX), thyroid (ARMOUR THYROID), and amlodipine. The facility where the most recent COVID-19 vaccine was administered was reported as other. The patient experienced swollen face, swollen puffy eyelids and below the eye, and itchy rash on face, neck, and chest on 14Feb2021 at 17:30. The events resulted in doctor or other healthcare professional office/clinic visit. The patient was told to take ALLEGRA and PEPCID in the morning and CLARITIN AND PEPCID in the evening by the allergist. Since the vaccination, the patient has not been tested for COVID-19. The outcome of the events was not recovered. The events were assessed as non-serious. Information on the lot/batch number has been requested.

received the Pfizer COVID vaccine dose 1 (lot ER8732, expiration 7/2021) at 0915. Patient reported to at 0920 that she was experiencing a bitter and metallic taste in her mouth and cramping in her wrist. Vital signs: O2 98%, pulse 73, blood pressure 140/82, respirations 16. Patient reported the taste had disappeared but the cramping radiated up her arm to the axilla. Medical conditions include: diabetes mellitus type II, pacemaker, status post stroke in 2017, hysterectomy in 2012, breast cancer in 1998 in remission, hypertension. Patient reported her normal blood pressure is 140s/80s. Medications: synthroid, levothyroxin, novolin, Humulin R, niacin and fish oil. Allergies include corticosteroids, codeine, sulfa, citric acid. Patient denied edema, tingling, pain, or dizziness. Patient reported she had not eaten breakfast and only drank a few sips of water with her morning medications. EMT advised patient to move arm and wrist continuously to promote circulation. At 930, offered Benadryl that patient declined, also advised patient to notify provider and signs when to contact 911. Patient drank approximately 8 oz of water, ate a small snack of pistachios, and reported improvement in cramping and taste resolved. At 940, vital signs: O2 97%, pulse 65, respirations 16, blood pressure 142/86. Patient reported symptoms had resolved. At 0952 vital signs: O2 99%, pulse 64, respirations 16, blood pressure 140/82. Patient left walking with steady gait.

Patient presented to emergency department at Hospital 30 minutes after receiving vaccine, complaining of tingling in tongue/lips. Patient was evaluated and given diphenhydramine and famotidine. Symptoms were improved and patient was discharged. Patient returned to emergency department approximately 4 hours later with general weakness/lightheadedness, rapid heartbeat, feeling of throat closing. Solu-medrol and IV fluids were administered. Patient felt much better and was discharged with a prescription for oral prednisone. **Note, this information was reported from patient's primary care office. An event have already been reported to VAERS for this patient by Hospital**

As per ER report from medical center, pt first reported tingling in tongue and lips 30 min post vaccine admin. Was discharged from ER, but returned later for general weakness/lightheaded, heart racing, felt throat was closing.

Initially, mild nausea, immediately (with 15 minutes of administration) . Resolved promptly within 30 minutes of injection. Then, three hours after administration (at approx. 12.30 p.m.), the following symptoms in order of severity: 1. Severe tiredness/fatigue. Lasted 4 hours. Resolved when I took a half hour nap. 2. Sore throat. Still present at 10.30 pm. 3. Swollen lymph nodes (lymphadenopathy). Significant improvement after 4 hours from onset (3 hours after administration). However, still present at 10.30 p.m. 4. Feeling unwell/malaise. Resolved after I took a nap. 5. Dry eyes. I had to remove my contact lenses and put on eyeglasses when I got home at approx. 2pm. 6. Dry mouth. Unresolved, even with drinking a lot of water and tea. Symptoms were fairly severe. I had to leave work and go home to rest. I was unable to drive myself home.

Patient reported facial swelling to the right cheek area and pain around the left eye socket. These symptoms appeared overnight, and the patient first noticed them upon awakening.

Received the vaccine shot in the morning of March 24th, as the day wore on the vision in my right eye changed, becoming cloudy and somewhat obscured, it felt like i had some pressure or the right eyeball was swollen a bit, I had difficulty focusing close up, difficulty reading. When looking at distant objects, such as a street light, the light source looked like a spiky ring of light. The vision in the left eye was a bit cloudy but that was gone by the morning of the 25th. The vision issues in the right eye continued through most of the 25th though the feeling of pressure diminished and the vision issues also lessened. The eye/vision is still not completely back to normal on the 26th but is much better.

2nd dose of Pfizer COVID vaccination at 1pm. Had sudden onset itchiness, erythema, difficulty breathing and lip swelling at 7pm. Brought to ED, given epipen and methylprednisolone. Monitored closely overnight, symptoms resolved by AM.

1-After 5 minutes of taking the vaccine I started to sneeze few minutes later it pass. At about 12midnight My arm was sore and in pain and very warm to the touch 2- on Tuesday morning I was very cold and very tired . 3- Around none or so I notice my self cleaning my mouth the left side , it feel like you just where out of the Dentist , like went you anesthesia from the dentist is running out. I have feeling but it almost feel like my drooling like my saliva is out of my mouth and also my left eye felt heavy and at first very watery and the dry . My left side of my mouse feel different and I?m connately cleaning my mouth.

Patient received 2nd Pfizer COVID vaccine today; completed 15 min RN observation; however, described to nursing staff she was starting for feel dizziness, tingling of hands, feet and " sudden odd, metallic taste" in mouth. A/O x 4 VS stable; reports dizziness, tingling to hand and feet bilaterally. Patient was assisted w/transfer from chair to wheelchair and transported to UC department accompanied safely by RN. RN/COM advised of incident.

First dose I was fine,second dose I had reactions next day with face swelling lip swelling tired next day swelling went down then I have big lymph node knots on both sides of neck with chills and fatigue. I am on third day and still have nodes on neck and tired with chills. My eyes fill little swollen also.

Patient walked to medical tent complaining of itchy, blotchy skin chest and hand; voice breaking; throat uncomfortable, shaking BP 164/74 P 111 02 97%. Epi 0.3mg IM administered transferred to EMS for hospital transfer.

I have taken Pfizer-BioNTech COVID-19 Vaccine EUA Three days later I have muscle pain, ear infection, headache, stomach very up set, feeling not well

Patient immediately reported onset of a throbbing headache, consistent with her first shot. A few minutes later she noted that she had some "tingling" sensation along the back of her throat with the sensation of tightness, though she denied any shortness of breath, chest pain, or any difficulty breathing. Pt examined intermittently without any progression of symptoms. At 4:50 pm, pt checked out,

felt nausea and dizziness on day of vaccine. 2-3 days after sore throat, hard to swallow, 5 days after vaccine lost voice and/or voice change. no fever at any time

Potential hearing loss; Dizziness about one week after receiving which lasted about 3 hours; More intense tinnitus symptoms than usual; More intense tinnitus symptoms than usual; This is a spontaneous report from a contactable consumer (patient). A 60-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot: EL9629), via an unspecified route of administration, administered in left arm on 08Mar2021 13:00 (at the age of 60-years-old) as single dose for covid-19 immunisation. The patient was not pregnant at the time of vaccination. The vaccination facility type was a pharmacy/drug store. No other vaccine in four weeks. The patient did not have COVID prior vaccination and was not COVID tested post vaccination. Medical history included tinnitus, allergy to PCN and "Thygeson's Disease". Concomitant medication included ciclosporin (RESTASIS). The reported adverse events were dizziness about one week after receiving which lasted about 3 hours; more intense tinnitus symptoms than usual and potential hearing loss, all on 15Mar2021 at 17:00. The events resulted in doctor or other healthcare professional office/clinic visit. There was no treatment for the events. The outcome of the events was recovering.

07:50 Client noiticed metalic taste in her mouth, tingling of her tongue and lower lip. 07:58 154/82 98%pso2 heart rate 81 said thought she should mention it once tingling of her tongue started. No signs of distress. 08:09 tingling gone just feels a sensation on her tongue does not want to be seen in ER or continued to be monitored. States she feels safe to go. Informed to seek medical attention for further problems. Also informed to notify her MD of the event so he can advise for 2nd covid vaccine. 140/82 pso298% heart rate 77. No signs of distress.

dizziness, ear fullness after 10 minutes from getting vaccine. 125/79,76,98% drank some water and stated felt better, refused transport to ED

My face started tingling 15-20 minutes after vaccine and then my lips and tongue went numb. It felt like I had been to the dentist .

Due to reported allergy to shellfish, patient told to wait 30 minutes for monitoring. Approximately 10 minutes after the injection, patient reported tingling, redness and swelling of lips only. She said it was the same as how she reacts to shellfish. Patient was checked regularly and stayed a total of 50 minutes after the injection. At that time, it was not yet significantly better, but had gotten no worse. Patient was advised to take Benadryl after she gets home and seek medical attention immediately if worsens. Patient also advised to check in with doctor particularly about receiving another Covid vaccination.

pt. c/o of tingle on her lip & back of her throat a little redness on nose & cheeks. no shortness of breath. lungs all clear & vitals BP=142/88; P=82; O2=95%. Hx= tachycardia

After leaving facility, lips were tingling and tongue felt swelling. Little chest pain. Got home and took 2 Benadryl. Symptoms stopped in about 20 min.

Within 5 minutes, patient began to have blurry vision, chest pounding, and trouble breathing. Epinephrine (patient thinks 2 doses) and Benadryl administered in the field. Patient brought to hospital by ambulance where she received IV SoluMedrol, Pepcid, Benadryl, and fluids scheduled throughout hospitalization. Patient improved and was discharged the following day (3/27/21).

History of orofacial granulomatosis, neurofibromatosis type 2, Sjogren's and trigeminal neuralgia. Around 10 minutes after reaching vaccine developed tinnitus, severe vertigo and left sided facial pain in typical character and pattern of her trigeminal neuralgia and then at 14:24 some lower lip swelling typical of what she develops with her orofacial granulomatosis patient took 1200 mg of her own IR gabapentin. Symptoms progressively worsened

Pt called to report an adverse event after receiving the Pfizer vaccine rec'd 3/27 and had a severe reaction about 6 hours later, my tongue started swelling I immediately took Benadryl. The next morning around 11am, I went to an urgent care and they told me to go to the ER and I drove to hospital ER and was given steroids, my tongue is still swollen today.

BP 100/100 mmHg, HR 72 History of Orofacial granulomatosis, neurofibromatosis type 2 and Sjogren's and trigeminal neuralgia Around 10 minutes after receiving the vaccine developed tinnitus, severe vertigo and left sided facial pain in typical character and pattern of her trigeminal neuralgia and then at 14:24 some lower lip swelling typical of what she develops with her orofacial granulomatosis patient took 1200 mg of her own IR gabapentin. Symptoms progressively worsened.

Ringing in ears began 3 days after dose and was intermittent until 3/31/21 when it became persistent and louder.

30 minutes after receiving COVID 19 vaccine, patient began to experience blurry/double vision, hypertension and a tingling sensation to her tongue and lips.

Shot 3/3/2021 9:05am, headache started around 7:00pm, overnight also had fever and chills. 3/4-Headache and fever continued, also had nausea and vomiting. On 3/5/3021, other symptoms resolved, but woke with double vision due to 6th cranial nerve palsy. This is the fourth acute occurrence of the nerve palsy. As of today, 4/2/2021, the double vision is still acutely present.

Morning after the vaccine, I woke up with Itchy eyes, runny nose and sneezing. Tried over the counter products (Eye drops: Systane, Allergy Pills: Zyrtec and Xyzal) for two days (3/24/21/& 3/25/21) with no relief. Had a teleconference 3/26/21 with Physicians Assistant. Medicine prescribed: Montelukast - 10mg and Azelastine - eye drops) After 5 days on the medication (3/31/21) - called the Doctor to report that Montelukast was not effectively keeping me from having a runny nose and sneezing. Prescribed addition RX of Mometasone Furate Nasal Spray - 50mg. As of 4/2/21, all symptoms have subsided enough for me to resume all activities without discomfort.

Patient walked outside after waiting 15 minutes and felt like throat was closing and re-entered the building and went to paramedic.

2nd vaccine - at 20 mins of administration, I felt my lower part of my tongue and epiglottis area was swelling. BP (R) arm 189/103 Pulse-106 . Benadryl 25mg was given ..After 10 mins BP 132/74. My taste was altered when I had chicken soup an hour after the vaccine.

I felt OK for the first 3 days and then I started having worse symptoms of my MCAS and POTS condition. Note, I had NOT had POTS symptoms for 7 years. I was originally diagnosed with POTS in 2010 but slowly got better over 3 -4 years time and have not had issues with POTS since until after the 1st dose of the Covid 19 vaccine. Once my mast cell issues seemed to improve after the first week or so then the POTS symptoms kept getting worse. I am now one month out from the first shot and my heart rate and blood pressure are so bad I'm mostly couch ridden. I'm seeing a cardiologist on Monday. Heart rate even when sleeping at night is shooting up to 125-136 without exertion, just sleeping or standing. I have almost passed out while driving 5 times. Until I improve I won't be driving on major freeways. My vision has also been severely effected. Very blurry and one time all I could see were prisms blinding my view of almost everything. Also very weak all of the time and a lot of pressure in my head, it feels like someone is pushing my head forward. Some ringing of the ears as well.

Headache, metallic taste, nausea. BP 156/81 (pulse 59). Final BP 160/76 (pulse 52). Sent to ED, but left upon arrival, as she felt OK.

Flushing /redness of face starting 50 minutes after vaccine Hot feeling of face & mouth & slight tingling in mouth that lasted 3-4 hours Low grade fever 99.4 about 3-4 hours after vaccine All resolved within 5-6 hours

Day 1 - within 5 minutes I felt extremely sleepy and my eyelids were heavy 15 - 20 minutes of receiving the vaccine, I was experiencing itchiness - like hives or from allergic reaction (I had them previously from allergy test reactions and allergic reactions). It was generally all over, but then I started itching under my arms. At that point, we informed the medical person who was monitoring our waiting section. He asked if I had any Benadryl, and I responded that I did. I took 12 ml (?) of Benadryl liquid and the effects subsided somewhat. I slept and when I woke up, I was itchy again and my stomach was cramping. I took more Benadryl and over the next 5 days got better.

my body is killing me; body pains; fever/Had a 101 fever at night; experienced ulcer on the side of her tongue; eye stye/I started with some kind of infection like stye something; felt terrible/ I am just feeling bad/Started freaking out; Swollen eyes/more puffy; irritable; stressed/Shot stressed my body; headache; Drug sensitivity/Reaction to medicine; I didn't have a taste; my 'eye' also started getting kind of sore; And then 3 days later, it started with an ulcer in eye; This is a spontaneous report from a contactable consumer, the patient. A 60-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Formulation: Solution for injection, Lot number: EN6204; Expiration Date: 30Jun2021), via an unspecified route of administration, in the left arm on 12Mar2021 around 1:15- 01:20 PM (at the age of 60-years-old) as 0.3 mL, single for covid-19 immunisation. Medical history included arthritis, anxiety and I had the virus in November. Concomitant medications included meloxicam (MOBIC) taken for arthritis as needed; alprazolam (XANAX) at 1 mg daily for anxiety. On an unspecified date in Mar2021, the patient had body pains, had a 101 fever at night, headache, ulcer on tongue, swollen eyes, stye in eye, felt terrible/started freaking out, irritable, drug sensitivity/reaction to medicine, shot stressed my body. Consumer stated, I had gotten the vaccine the other day, Friday. You don't know me but if you know me, I am going to have the side effects and it's going to happen, and it happened. From the next day my body is killing me. I had a 101 fever at night, felt terrible. Anyway, the next day, I felt better, whatever. And then yesterday, I felt pretty good except I started with all of a sudden, I got ulcer on my tongue. Now, I have got like, I don't know a stye happening on my eye and I know, it's all due to that vaccine because I have reactions to the medicines. I got to watch what I do. And I was scared to get this thing anyway, I already didn't want to get the shot and I did it. But anyway, right now, I am just feeling bad because of my tongue and I kind of looked up that and it did say that it can be caused from like a drug sensitivity. I do know it's all because of that." Consumer further stated, "Like 3 days later, I started with some kind of infection like stye something on my eye. Yesterday it started, and also, I have an ulcer on my tongue now. But I guess what I am afraid of, in less than 3 weeks, I have got to take this vaccine again. The patient had the virus in November, and I did test positive at some point for the antibodies and when I looked up something, as I was running a high fever. I started looking up stuff and it said if you already have a pre-existing immunity which I did due to the antibodies. I believe it's still there because it has been 4 months, but you might get. It says you will get side effects worse; you will get side effects. People that have never got exposed and have antibodies, don't get the side effects but I got them. So, I guess what I am afraid of because now I am like, I know it's a reaction to the medicine. And now I got ulcers on my tongue. And my eye, yesterday it started with the stye thing, and I never get them, it was swollen. I know this was a reaction from that vaccine, I know it was. I don't have fever and none of that no more, the body aches have left me. It was pretty bad, but it left me. But I am scared to get that next vaccine. Consumer stated, my 'eye' also started getting kind of sore and now it's swollen and I know this was a reaction to that because my body did not like that's all I can tell you. I am afraid if I get the next vaccine which was on 02Apr2021 (later confirmed), am I going to get, I am scared that something worse is going to happen to me. Because everybody knows if you had the vaccine, any of them, nobody and they say with the first vaccine usually you don't get anything, it's the second one. Well, I know, it was going to happen to me, and it did happen to me. So, I am scared what's going to happen with the second one. If my body still has antibodies from the virus, it did say or I read, maybe it's not true but what I read, it said 89 or 87% people that have already been having pre-existing immunity which would be me because I had the antibodies, you won't get the side effects more than people that never had the antibodies or had the virus. I didn't have a taste because I was having a high fever initially when I had the virus. It was weird. I cannot explain the feeling. I was laying down that night, that Saturday night, I thought let me check my temperature and it was like 99.5 and then maybe an hour later 100 and at 1:30 in the morning, it was 101 and then a couple of hours later, I checked it and it was like down to 100.5. I was calling a Pharmacist when I started freaking out on that. And they said no, nothing was going to happen. On Sunday morning, it was 99.5 and then when I checked it yesterday, I had nothing, no more fever. But then I started with ulcer and I looked it online and it said that it could be due to the stress and I was very stressed out because of getting a shot. I didn't want to do it and I did it but one of the things, it said a sensitivity to foods and drugs can cause ulcers in the mouth and I know it was that and then my eye, I don't know about the eye, it's swollen underneath. I know this was a reaction, I know it was. Eye was a little worse. I guarantee you, it's due to the shot. Shot stressed my body. That was just my reaction to that shot because it started all the side effects. And then 3 days later, it started with an ulcer in eye. And I guess that it's just too coincidental. It just stressed my body bottom line. The eye was a little bit worse today. The ulcer was going to go away, but it is at its peak right now. I am worried about the eye. It started sore yesterday and then today it is more puffy and I kind of put my contact lenses on it. It's not in the eye. It's on the tissue of bottom lid near the edge of the eye. The patient underwent lab tests and procedures which included blood test which showed okay, everything was okay. Therapeutic measures were taken as a result of ulcer on the tongue included had a mouth wash that she used and had done great to my teeth. The ulcers are going to go away, but the eye was. I am just kind of watching it if it gets like whatever tomorrow. I might go to emergency room. It's not in the eye. It's in the lower lid. It's very tender and close to eye." Consumer further stated, "I want to know an answer. This is really important to me because this time, I have to take a nerve because as soon as they put the needle in me, my nerves, I just had a panic attack. I was scared. I need to know do I need to afraid to get next vaccine because I won't do it if I knew something worse going to happen, I won't do it. I already have the reaction, but I don't want to risk our lives again. I got the side effects. Consumer stated, I'm a little sensitive to the medicines. I keep a check on what do I take. The outcome of the events body pains and fever recovered on Mar2021, ulcer on the side of her tongue, felt terrible/ I am just feeling bad/started freaking out was recovering, swollen eyes/more puffy; eye stye/I started with some kind of infection like stye something; my 'eye' also started getting kind of sore; And then 3 days later, it started with an ulcer in eye was not recovered and other events was unknown. Causality assessment for events had a 101 fever at night, ulcer on tongue, swollen eyes with BNT162B2 was related per reporter.

I have had mild tinnitus for four years. Three days of taking the first dose of the Pfizer vaccine my tinnitus suddenly became louder and debilitating. It has not subsided.

Started feeling unusual burning in right arm ( opposite from vaccine side), from wrist to elbow then elbow to shoulder. Attributed it to tennis elbow from strenuous hitting, then got raised welts like hives following evening on right shoulder. Rash appeared and I started to suspect shingles. ( have never had before) saw doctor on 3/30/2021 and got shingles diagnosis. I believe it is due to the vaccine and have spoken to multiple medical professionals that believe there is a connection. I have had racing heartbeat, numbness on right side of face, severe pain in right ear.

Immediate taste of an antibiotic in mouth, numbing of lips and tongue within 3 minutes of vaccine. Slight swelling on right side of face. Reported to primary physician and referred to neurologist. Second dose was canceled.

Massive headache at front of head, dizziness, ringing in ear, nausea, restless, diarrhea, stomachache, shallow breathing, hearing sensitivity, exhaustion, sleep sweat, lack of appetite.

On the day of the 2nd vaccine, I experienced pronounced ringing in my ears. It subsided for the most part within a few hours, but at times I notice a lingering effect. Prior to this, I did not have tinnitus.

Received first shot on 3/15/21. On 3/25/21, I developed a rash (hives) around 6:30-7pm. After dinner, around 7:30pm I noticed that my lips were swollen and the rash was spreading. Took one Benadryl and waited 1 hour. Condition worsened so left for ER around 8:45pm. Once there, I was diagnosed with an anaphylatic reaction. I was given Prednisone, Pepcid and Benadryl intervaneously. The Benadryl injection caused my throat to close for a few seconds. Things calmed down so we waited an hour to see if I was responding. There was not a lot of improvement so ER doctor decided to use Epinephrine (EP pen injection). After 2 hours of observation, I was set home to follow up with primary care physcian.

TINGLING IN THE CHEST ABOUT 1/2 HOUR AFTER SHOT, FEELING OF SWOLLEN LIPS STARTING ABOUT 2HRS AFTER SHOT LASTING ABOUT 4 HOURS..THEN TONGUE AND FACE FELT TINGLING ..TONGUE FELT SWOLLEN METAL TASTE IN MOUTH AND A VERY FUZZY FEELING FOR THE DAY OF AND DAY AFTER SHOT WENT TO WALK IN CLINIC AT 620 PM ON 4/3. RECOMMENDED BENEDRYL RATHER THAN STEROID METAL TASTE AND FEELING OF SWOLLEN TONGUE SUBSIDING....FACE TINGLE REMAINS ON 4/6/21

Tinnitus and whooshing sound , stuffiness in both ears and feeling of ears being blocked , bilateral hearing loss, symptoms more severe in left ear since last week of February. It took me a few weeks to get an ENT appointment scheduled. ENT surgeon consulted , Bilateral hearing loss as evidenced by two audiograms, ENT surgeon advised more tests including another audiogram. Saw ENT on March 24 ,2021, next appointment scheduled for April 9th No history of any hearing problems before this event started, no history of any health problems , no chronic diseases or on any medication.

I have existing non-stop Tinnitus in my left ear and occasional quieter tinnitus in the right ear. The day after the vaccine the volume in the left ear more than doubled to the point it is so loud I am having a hard time hearing conversations. The right ear which before the vaccine only occasionally had tinnitus has it now nearly constantly. The volume has not subsided and I am very concerned that this could be a permanent problem.Where before the tinnitus was live able, this is awful and makes it hard to hear and understand. I don't know what to do about a second dose, if this stays at this level or gets worse it will be intolerable.

March 28: Bright red cheeks, extreme thirst, cold sores, severly chapped lips, clammy sweat (continued through entire series of symptoms) March 31 - April 2: Fever, Chills, Excrutiating muscle and joint pain, nausea, severe headache. Unable to function, think clearly, or eat/drink. No vomiting April 2 - April 5: Severe upper stomach pain and burning/soreness under right side rib cage. Uncontrollable watery diahhrea. Unable to eat the first two days of this. Able to drink some. April 5 to current: Still fighting the diahhrea but pain stopped. Have been on the BRAT diet since April 4th. Began taking a prescription from doctor to help with diahhrea on April 8. Still experiencing dizzyness, lack of clarity.

1358 60 y/o female received 1st Covid vaccine and was sitting in observation room for 30 minutes. At the 30 minute mark pt stated that she felt dizzy when she tried to stand up. Brought Pt to backroom for evaluation she stated that her tongue felt thick and her lips felt numb. Vitals BP 136/75 P 74 Temp 99.3 . Pt was evaluated by Dr and he determined that she needed to be observed. 1412 Asked pt how she was feeling "Right eye feels funny like pressure and her throat was tight. At this time Dr determined that pt needed Epi Pen. 1413 Epi Pen administered to right thigh EMS was called. Vitals BP 174/86 P 75 R 22. Denied difficulty breathing. Pt became very emotional and stated she was scared. Reassured pt she was going to be fine and provided additional blankets for her chills. 1419 EMS took over her care

I started with a headache the next day on my right eye. That lasted for two days and then developed into a swollen eye. By the forth day I started getting a rash on my forehead and scabs which was finally diagnosed on the 5th day as shingles. The Shingles lasted about a week, but the side effects of the shingles now is terrible. It has developed in to neuralgia. Right side of face is still numb and my eyes are very sensitive to light.

Pt c/o tingly feeling to hand s/p 2nd vaccine . states had similar reaction after 1st vaccine. Pt also informed paramedics that she had a "metallic taste" in her mouth also.

Numbness and tingling of tongue and lips. Patient reports she felt and still feels nervous and anxious about COVID vaccine. Vitals when arrived at meds observation at 11:09 am, HR96, resp 18, BP 183/89, 98% SaO2. BY 11:11 resolving numbness and tingling of mouth. Vitals at 11:12am, HR 95, Resp 18, BP 171/85, 98% SaO2. At 11:20 am, patient reports only slight numbness and tingling in tongue, lips resolved. Vitals at 11:20, HR 94, Resp 18, BP 165/80, SaO2 98%. Patient came back from bathroom( assisted to & from bathroom by med obs RN), vitkas when back at 11:33 Hr81, resp 18, BP 194/82, SaO2 100%. Rechecked vitals 11:39, Hr 88, Resp 18, BP 180/80, SaO2 97%. Vitals at 11:56 am, patient reports most of tongue tingling is gone, Vitas at 11:56, HR84, Resp 18, BP 174/87 , SaO2 98%. Vitals at 11:49, HR 93, Resp 18, BP 164/83, SaO2 97%. Patient anxious and wants to leave. Vitals at 12:05, HR 86, resp 16, BP 184/84, SaO2 97%. Spoke with provider about patient's situation. Okay for patient to leave since being worked up by PCP for HTN. Patient instructed to check BP once she got home (has been monitoring BPS at home due to HTN) and notify PCP about BPs while here. Patient's vitals at time of leaving via own personal vehicle, HR 90, Resp 16, BP 183/83, SaO2 98%. Patient reported only a little tingling in tongue when she left.

All over rash and hives and itching on body including face around eyes and mouth, scalp itching and tongue feeling funny at times but no swelling as far as I can tell. As of 04/09/2021 I have started taken Benadryl in hopes that would help. A little headache here and there. Have taken Tylenol for that.

Pt reports left-sided tongue tingling and swelling sensation with onset 15 minutes after vaccination. Denies shortness of breath, wheezing, difficulties swallowing. Pt brought to observation area. Symptoms improved and continued to improve throughout visit.

Got extremely cold day after. On Saturday 4/3 I woke up and mouth was numb. As morning went on I went to Urgent care and they diagnosed me as having Bell's Palsy. Followed up with my personal doctor and she said it was from the Covid shot

vomiting; diarrhea/Lingering diarrhea into second day; ringing in my left ear. LOUD!; excessive urination; eyes feeling like they were popping out; tunnel vision; 104 fever; severe chills and quaking; severe chills and quaking; the worst headache in my life/slight headache on the back of my head, and continued into today; felt like broken shins; hip joints on fire; This is a spontaneous report from a contactable consumer herself (patient). A 60-years-old female patient received second dose bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection), via an unspecified route of administration, administered in Arm Left on 22Mar2021 (Batch/Lot Number: EN6204) Solution for injection as Single Dose for covid-19 immunisation. Medical history included asthma, mild HP (Hypersensitivity pneumonitis) and I am fat. Concomitant medications included lovastatin, eszopiclone (LUNESTA), lisinopril and gabapentin. The patient previously took first dose of BNT162B2 (EN6198), on Left arm on 27Feb2021 for Covid-19 immunization. On 23Mar2021 02:00 patient experienced 104 fever, severe chills and quaking, the worst headache in my life, what felt like broken shins another friend said she had this as well, hip joints on fire, eyes feeling like they were popping out, vomiting after hours 26, tunnel vision, excessive urination, diarrhea started at hour 28. Lingering diarrhea into second day, slight headache on the back of her head, and continued into today, ringing in her left ear. The patient underwent lab tests and procedures which included body temperature: 104 on 23Mar2021. Patient did not test covid post vaccination. Patient did not have covid prior vaccination. The outcome of all events was recovered with sequelae.

1) I hour after 2nd dose was dizzy 2) 2 hours after had vertigo, hands felt like vibrating for 2-3 minutes, nauseous, vomiting, diarrhea, elevated tinnitus 3) taken to ER at Hospital and sat there with no treatment for several hours. Symptoms were resolving on own. Given an IV and Benadryl. 4) started again (similar to after 1st dose) on Meclizine 5) after light exercises this morning got dizzy, vertigo and nauseous- lasted for over 4 hours!!

Numbness (not pins and needles) developed in left middle finger immediately, then developed on left side of nose, left upper gums, left ear within 30-45 minutes. Tightness in head , sight headache and sticky eyes which dissipated quickly. The numbness subsided in about 2 -3 hrs. Slightly elevated temp in the evening which abated by bedtime. All better next day.

Chills, nausea, vomiting, diarrhea - Wednesday night 04/07/21 Very severe heartburn, body aches, headaches, pain behind eyes - Thursday all day 04/08/21 Headaches - back of neck, pain behind the eyes, side of face - Friday and Saturday all day 04/09/21 and 04/09/21

Please describe the adverse event(s) (up to 1000 characters): After the first Vaccine, I developed a constant sense of smelling smoke. This smell was so strong that at times, I could even taste it. This continued the entire 3 weeks until the 2nd vaccine. After the second vaccine, the smoke smell noticeably decreased, disappearing the 2nd day after the 2nd vaccine. But a new smell developed in its place; a smell that is more difficult to label. I am describing it as soured olive oil. This new smell is much more problematic, because now, everything I eat tastes like soured oil. An experiment: Since those who sell perfume clear their sense of smell with a sachet of coffee beans, I took a whiff of some ground coffee but it only smelled like a stronger version of the sour oil. I can taste nothing however spicy, nor anything that is savory. It all tastes like the dull, almost rancid taste of oil. Since there is no third vaccine to change my smell/taste, how long should I expect this condition last?

4-12-21 10AM TC: PT STATES HER 'TINNITUS HAS BEEN WORSE THAN USUAL (HAS HX OF SAME) SINCE GETTING COVID SHOT'. SHE DID CALL HER PCP AND DISCUSS IT.

Within 30 minutes I had a headache, fatigue that lasted 2 days. I had small hives on my face starting day 2 lasting 2 days. I had a lump behind left ear that lasted 5 days. I have had ringing in my ears, louder in the left ear, since the injection, for 2 weeks now. It is quite loud and annoying. I have recovered from all side effects except the ear ringing.

Rash at injection site, severe itching at injection site, continued headaches, stomach issues, metal taste in mouth, fatigue.

pt states after receiving vaccine about one minute after pt states she felt arm tingling and pins and needles feeling in left arm and metallic taste in mouth, and very anxious pt shaking and was unable to sit still in stretcher, refused wheelchair to observation area and ambulated self without difficutly. pt also very guarded and did not want to talk about health history or meds upon assessment. pt state feeling hot and cold chills as well. pt anxious about previous anaphylaxis had in past with darvocet. denies feeling symtpoms of anaphylaxis, site of injection healthy no observed hives or redness in area. vs as noted, pt feeling better and wanting to be sent home pt ambulated to exit with husband at 1438 vs: 1410 bp123/81 hr 84 rr 18 o2 97 1415 bp 140/96 rr 18 hr 78 o2 98 1420 bp 137/80 hr 80 rr 18 o298 1425 131/89 hr 80 rr 18 o2 99

Brain fog and memory loss, since vaccine 1st dose, 04/07/2021 On 04/08/2021 I woke up to find my left eye with filled with blood over most of the sclera. Severe joint pain. Muscle pain, and lethargy. Extremely forgetful with new onset 04/07/2021. Eye pain left eye. L eye hemorrhage is not resolved yet.

I have suffered from tinnitus for a very long time but about a week after receiving the vaccine I woke up to a ramped up ringing in my ears that has not subsided. The noise level increased at minimum 50% and it causes brain fogginess I have not previously experienced.

Three days after receiving her first vaccine dose, patient developed a sore throat that felt like she had a foreign body in her throat. Throat began to swell, had trouble breathing. Patient was driven to urgent care where she received a steroid shot and antihistamine. Patient felt better the next day but woke with eyes swollen shut. She took Benadryl and made an emergency appointment with an ophthalmologist. Patient was prescribed prednisone drops.

Immediate trigeminal nerves triggered, mouth tingled, slightly dizzy, blurred vision. 1/2 hr later felt like skin burning on face and arms looking like a sunburn, small fiber neuropathy kicked up throughout body. Next morning slight headache and slight dizziness, slight sweating. Subnormal temp all day. Burning feeling, sunburned skin continues as it comes and occasionally lessens.

Bad taste in mouth (mild; soap/detergent/metallic like taste) 1 week after first vaccine that got worse after second vaccine

I felt fine following vaccination so kept appointment to donate blood 3 days later. I've donated many, many times in past without any side effects. It was uneventful. The following AM, I felt exhausted, dizzy, had mild headache, thirsty, and had minimal nausea. And when I tried to do my daily walk of 3 miles, I was SOB on hills so I stopped. I had no F/C, cough, CP, palpitations or resp symptoms at rest. I pushed fluids and rested. I held my BP meds thinking I was a bit dehydrated and maybe my BP was low. After 4 days of no improvement, I went to see my internist. Exam, ECG and CBC, Chem 7 were all normal. BP was mildly elevated so I restarted my meds. These symptoms slowly resolved over next several days and now I feel back to normal. So I don't know if these were delayed side effects to COVID vaccine or due to the blood donation. I'm a bit worried about receiving the #2 vaccine.

All over rash and hives and itching on body including face around eyes and mouth, scalp itching and tongue feeling funny at times but no swelling as far as I can tell. As of 04/09/2021 I have started taken Benadryl in hopes that would help. A little headache here and there. Have taken Tylenol for that.

In 15 min I felt my tongue was numb I left and my face on the right side was drupping My eye was cold because the bottom lid was dripping so I held it closed 3 hour later it went back to normal.

Client reported receiving COVID vaccine second dose on 04/12/21 at 1:30 pm, adverse reaction began later that day at 3:30 pm. Client report a rash started on both arms, then felt rash went to her ears, they felt like they were getting bigger as well. Rash moved to other parts of her body such as face, trunk, and legs. Rash is itchy, reddish in color, warm to touch, and very painful all over. Client also report getting the same rash after first COVID vaccine on 03/22, but that rash only lasted 2 days. Client seen by PCP for this recent reaction, prescribed hydroxyzine and a hydrocortisone cream. Client report no improvement and plan to contact PCP again regarding rash.

Since this vaccine I now have frequent painful mouth ulcers and tiredness. I seem to lose my breath more easily than before. I am afraid to get the second dose. There is a study that COVID has these sores as a symptom - why are we not learning of this? Also, no one provided me with any information that would indicate the vaccine could create a problem if given while taking other medications. I have all of my paperwork from that first shot. Yet at this site there is a file full of possible adverse interactions.

I experienced muscle and joint aches, headache and overall malaise. Approximately 14 days after the first vaccine , started having vision deficits in my left eye out of the blue. I experienced a fuzziness and haziness in the vision of the left eye and pain above the left eye brow. Was seen urgently in the eye clinic on 3/29/21 and had a battery of tests - a swollen and inflamed left optic nerve was observed and some deficits to vision and peripheral vision. Had second vaccine on 3/31/21 and eye seemed to get worse. Seen by Optical Nerve Specialist on 4/5/21 and had battery of tests and optic nerve worse. Dr. diagnosed as ischemic optical neuropathy likely due to giant cell artritis (GCA). I had urgent/emergent temporal artery biopsy on 4/6/21 to determine if giant cell artritis. Received results from biopsy on 4/13/21 and negative for GCA. Saw Optical Nerve Specialist on 4/14/21 and diagnosed with ischemic optical neuropathy but cause can not be specified. Optic nerve is still swollen and vision impacted. I am to return to clinic in 8 weeks and see if improvement. I have never had any issue like this in the past.

Numbness in arms and tongue. She self medicated with 25mg of benedryl. Appeared well, no acute distress, no difficulty breathing. Declined ER transport. Had support person to drive her home. Instructed to report to ER if throat swelling or difficulty breathing occurred.

She stated that after vaccination, she was feeling numbness in arms and tongue. No difficulty breathing, appeared well, in no acute distress. No throat swelling. Heart rate 70, SpO2 99%. She medicated herself with 25mg of Benedryl PO. Instructed to go to ER if difficulty breathing or throat swelling occurred. She was accompanied by support person to drive her home.

pt experienced a metalic taste in mouth at the site, and the 24 hours later experienced lip swelling.

her eye looks like a bee stung her eyelid, it is swollen; hives on face; rash on her legs and her legs were itching; rash on her legs and her legs were itching; This is a spontaneous report from contactable consumer (patient). A 60-year-old female received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; solution for injection; Batch/lot number: EK9231; Expiration Date 30Apr2021) via unspecified route of administration in right on 11Jan2021 at 16:00 as single dose for COVID-19 immunisation. The patient medical history not reported. historical vaccine included BNT162B2 (First dose: 21Dec2021; Lot number: EL0140; Expiration Date: Mar2021) and concomitant medications were not reported. patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 20Jan2021, the patient reported hives on face that were red and bumpy. They are not as bumpy but it is still red like her face looks sunburned red and her eye is swollen, rash on her legs and her legs were itching, on 03Feb2021 her eye looks like a bee stung her eyelid it is swollen. Treatment received for the events with Prednisone. The outcome of the events (Urticaria, rash, pruritus) was unknown, her eye looks like a bee stung her eyelid, it is swollen was not recovered. Description of Product complaint: Caller was calling about the Pfizer COVID vaccine. She says she wanted to report having a reaction. She had hives, like a rash and her eye looks like a bee stung her eyelid, it was swollen. She had a rash on her face and her legs and her legs were itching, it was like hives on her face that were red and bumpy. They are not as bumpy but it was still red. She has been taking Prednisone and she was not sure if that is why its getting a little bit better but it was still really red and itching and the swollen eye was a new thing. Her Prednisone was in an amber color pharmacy bottle and does not see an NDC lot or expiration on there.

Noted blurriness/change in vision starting 3/29/21, became so prevalent could not read print by 4/5/21. Saw Retinal Specialist on 4/6/21, diagnosed with posterior uveitis in both eyes. Ran full blood and x-ray panel to rule out immuno compromise. All tests normal/unremarkable. Follow up visit on 4/15/21 showed clearing in right eye, doctor inserted corticosteroid injection in posterior of left eye.

itchy lips, then itchy scalp and feet. started 45min after shot. lips may have been swollen or may have seemed that way because of itchiness. I could not see them. lips issues ended within an hour from starting and the rest of itchiness ended after 2-3 hours. headache next day and lifting arm soreness next day.

Lost sense of taste completely one week later 4/10 for one week through 4/16. Sense of small only slightly affected. Very alarming.

Shot 1: Site soreness (severe) lasting 1 week, fever, chills, headache, tiredness 48 hours. Shot 2: Site soreness (not as bad as shot 1) for 1 week. 48 hours tiredness, headache, chills, fever. Next 48 hours: tired, headache. One week later starting experiencing dizziness, fatigue, tinnitus. Continuing off and on one month after 2nd vaccine. Have a good then several bad days. Seems to be getting worse and more chronic. Wake up tired but not dizzy and within 45 minutes dizziness starts up and continues through until late afternoon. Fatigue is chronic and fairly bad no matter how much sleep I get. Tinnitus (which I have never had before) is consistent but not super severe. Never had dizzy spells or vertigo before either.

left side headache, left eye pain, severe vomiting, full body pain, neck pain, chills as of Sunday some had subsided but not all. tylenol of no use!

Patient had her first covid vaccine injection at 0722 this am. She was escorted to the observation room where she told her nurse that she was experiencing tingling and numbness on the right side of her face from the nose down to the middle of her lip including half her tongue at 0730. Patient verbalized she had a TIA 10 years ago and this is how she felt when she had that event. She states she has a history of hypertension and a recently diagnosed aneurysm in her spleen. vital signs were obtained blood pressure 168/121, Heart rate 68, O2 sat on room air 99 % She denied any pain. Asked patient to stick her tongue out and it was midline before vitals slightly deviated after vitals were finished. Patient then states she feels like her face is swelling on the right side. ER was called. Patient taken to ER by wheelchair for follow up evaluation. Event documented on patient consent and event reported. Patient later admitted to hospital.

Redness to face/arms, Itching to body Shortness of breath, Feeling it move to my mouth, throat, nose, so far some symptoms have lasted 3 days

APPROXIMATELY 4 DAYS AFTER GETTING THE FIRST SHOT OF THE COVID-19 VACCINE, MS. THREATT EXPERIENCED NAUSEA, BODY ACHES, VOMITING (FOR FOUR DAYS), AND A CHANGE IN TASTE BUDS. SHE SAYS SHE NO LONGER CAN DRINK ANYTHING BUT WATER AND CLEAR LIQUIDS AND THAT FOOD SUCH AS MEAT AND BREAD ARE NO LONGER ABLE TO BE EATEN.

Tinnitus in both ears, noted the morning after second dose and fairly constant since then (4 days). Loud enough to interfere with sleep at night. I hope it goes away!

patient experienced blurry vision approximately 15 minutes after receiving vaccine and the blurry vision lasted 10 mins. She also reported experiencing a headache on the left side which also last 5min. She indicated feeling dizzy for a few minutes. Recovered completely by 3:15 Ppm

3-12-21 5 minutes after eyes began to feel warm/hot latsted about a minute 3-13-21 Early afternoon neck and shoulders began to ache followed sharp pains to my right eye and right foot 3-14-21 Morning began to feel a tingling sensation throughout whole body.. Pins and needles. 3-17-21 Went to primary physician. No knowledge of this side effect left with no real information and or treatment. 4-22-21 Symptoms have subsided, but still very present and activates upon anxiousness do to condition of sensations.

Received Pfizer COVID vaccine on 2/6/21 and 1/15/21. On 4/17/2021 developed loss of taste/smell. Positive COVID test.

After receiving the 2nd dosage of vaccine, 2 days later I began having problems with my vision, which was on Sunday 4/4/21, I went to bed thinking it would correct itself. I woke up on Monday 4/5/21 and had double vision so I immediately went to the ER at hospital where my BP was 190/95. At the hospital they did a CT Scan and an MRI which both came back normal, I was eventually diagnosed with 6th Nerve Palsy and referred to see a neurologist, I am currently under Dr's care at facility who is a neurologist in the specialty eye clinic. I am currently wearing a patch over my right eye to prevent the double vision which is still present.

Patient with PMH type 2 DM, cataracts and dry eyes and allergy to penicillin (anaphylaxis) recevied Pfizer Covid19 vaccine at 1529 3/31/21 (lot #ER8733) in left deltoid. No known sequela after first shot. Patient received her second dose of Pfizer vaccine (lot #EW0162) in her left deltoid on 4/21/21 at 1556. During initial observation period, she felt dizzy. At 1614, she felt tingling in her throat and tongue. VSS and no other symptoms. Patient was given juice and monitored x10 additional minutes without resolution of symptoms. Provider was made aware and assessed the patient. 25 mg IM diphenhydramine was given via right deltoid. Patient monitored an additional 30 minutes and symptoms resolved.

Severe dizziness, rare front or left headache with pain, pain in both eyes and left eyelid tremor, diarrhea, muscle and joint pain, stiff fingers, feet and leg muscles, rash all over the body, fatigued and shortness of breath, tiredness.

6 hours after the injection, i developed lymph node swelling on my collar bone approx. 3 in x 3in area, headache, watery ices and sneezing that lasted 48hours. As of today, April 24th the swollen lymph node is still present

Describe the adverse event(s), treatment, and outcome(s), if any: (symptoms, signs, time course, etc.) lump in my throat; turned red on my face and neck and chest and arms; when I get nervous; between my eyes on my forehead felt like a round circle (no bump) (past the bridge above eyebrows). It didn't hurt, but I felt something; felt odd; felt like my eyes were moving back and forth; very very cold; hands were ice cold; This is a spontaneous report received a contactable consumer, the patient. A 60-year-old adult female received the first dose BNT162b2 (solution for injection; batch/lot and expiry information not reported) as a single dose via unspecified route on 14Mar2021 (at 60-years-old), for COVID-19 immunisation. Relevant medical history included high blood pressure, and diabetes. There were no concomitant medications or past drug history reported. The patient reported that she had a couple of reactions the first day, so she was afraid to take the second one. The patient stated that within eight minutes she had a lump in her throat, which she gets when she is nervous and was unsure if from shot or nervousness. The patient reported that then she turned red on her face, neck, chest, and arms. The patient reported that the redness lasted about six or seven hours and did not bother her at all. The patient explained that then between her eyes on her forehead felt like a round circle (no bump) past the bridge above eyebrows. The patient stated that it did not hurt but felt like something. The patient also stated that she felt like she was going to get headache, though did not. The patient reported that it just felt odd. The patient also stated that she felt like her eyes were moving back and forth. Though when she looked in the mirror, they were fine. The patient stated that the eyes happened three times but by the time she looked in the mirror they looked fine. The patient added that she never felt sick or anything though about six or eight hours later she got very very cold which only lasted about a minute. The patient stated that her hands were ice cold and then it all went back to normal. The outcome of the events turned red on my face and neck and chest and arms was recovered on an unspecified date in Mar2021 after 6-7 hours. The outcome of the event she got very very cold was recovered on an unspecified date in Mar2021 after one minute. The outcome of the events hands were ice cold, and felt like my eyes were moving back and forth was recovered on an unspecified date in Mar2021. The outcome of the events, lump in my throat, get nervous, between my eyes on my forehead felt like a round circle (no bump), felt something, and felt odd, was unknown. Information on lot/batch number has been requested. Follow-up attempts are completed. No further information is expected.

it felt like my head would pop off at one point; hearing muffled; left ear was clogged and ringing; This is a spontaneous report from a contactable consumer. A 60-year-old non-pregnant female patient received dose of bnt162b2 (PFIZER BIONTECH COVID mRNA VACCINE, solution for injection, Lot Number: EN6205), via an unspecified route of administration, administered in arm Left on 27Feb2021 at 12:00 as SINGLE DOSE for covid-19 immunization. Medical history included Acid Reflux and known allergies to Bananas. The patient had no other vaccine in four weeks. Concomitant medication(s) in two weeks included rabeprazole (RABEPRAZOLE) taken 20 mg dose for an unspecified indication, start and stop date were not reported.The patient reported that about 28 hours after the vaccination her left ear was clogged and ringing and then both ears were clogged, and it felt like her head would pop off at one point. The patient was literally thought that she was going deaf. This had never happened to her before. It has gotten better at about 34 hours in, but left ear still feels clogged and hearing muffled. On 28Feb2021 at 16:00, the patient experienced hearing muffled and it felt like my head would pop off at one point and left ear was clogged and ringing. The patient not had covid prior vaccination; not tested covid post vaccination. The patient did not receive any treatment for the events. The outcome of the events is recovering. No follow-up attempts are possible. No further information is expected.

Bell's Palsy; right side of mouth felt numb; freezing cold; This is a spontaneous report from a contactable consumer (patient). A 60-year-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number: EN6207), via an unspecified route of administration administered in right arm on 01Apr2021 15:15 (at the age of 60-year-old) as SINGLE DOSE for COVID-19 immunisation. The patient was not pregnant at the time of vaccination. The patient had no other vaccine in four weeks. The patient had no COVID prior vaccination and was not COVID tested post vaccination. Medical history included high blood pressure. The patient had known allergies with Allegra. Concomitant medications included pravastatin; ascorbic acid, betacarotene, cupric oxide, tocopheryl acetate, zinc oxide (PRESERVISION); cetirizine hydrochloride (ZYRTEC [CETIRIZINE HYDROCHLORIDE]); and bupropion. Historical vaccine includes first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number: EN6199), administered in the left arm on 14Mar2021 at 04:00 PM for COVID-19 immunisation. On 02Apr2021 at 13:00, the patient got freezing cold. The patient was cold for several hours. On 03Apr2021, the patient woke up and right side of mouth felt numb. The patient went to urgent care and was diagnosed with Bell's Palsy on 03Apr2021. The events resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were taken as a result of bell's palsy, freezing cold, and right side of mouth felt numb. The patient had not yet recovered from the events.

possible hearing loss; episodes of elevated tinnitus (pre-existing); vertigo; dizzy; hands felt like vibrating; nauseous; threw up; diarrhea; chills; This is a spontaneous report from a contactable consumer (patient). A 60-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) (at 60 years of age), dose 2 via an unspecified route of administration, administered in arm left on 05Apr2021 13:00 (Batch/Lot Number: EP7533) as a single dose for COVID-19 immunisation. Medical history included tinnitus and penicillin allergy, both from an unknown date and unknown if ongoing. Concomitant medications included ciclosporin (RESTASIS) and vitamin d nos (VITAMIN D NOS), both taken for an unspecified indication, start and stop date were not reported. Historical vaccine included PFIZER BIONTECH COVID 19 VACCINE (lot number: EL9629) (at 60 years of age), dose 1 in the left arm on 08Mar2021 13:00 for COVID-19 immunisation. The patient was not pregnant. The patient did not receive any other vaccine in four weeks prior to covid vaccine. The patient had no covid prior to vaccination. The patient has not been covid tested post vaccination. The patient experienced repeated night time episodes of elevated tinnitus (pre-existing), possible hearing loss, vertigo, dizzy, hands felt like vibrating, nauseous, threw up, diarrhea, and chills, all on 05Apr2021 14:00 PM with outcome of recovered/resolved with Sequel. The events resulted to Emergency room/department or urgent care. No treatment received for the events.

1st vaccine - immediate metal taste in my mouth. This taste comes and goes but it seems there is a persistent 'metal' / yucky taste in my mouth now. 2nd vaccine - about 3-4 weeks after this dose my ears started ringing. For about 2 weeks it sounded like the ocean was in my head. It seemed to go away for awhile or almost. Now there is light ringing all of the time. When I am busy doing things I do not hear it but when I stop, it is there. I did not have tinnitus prior to these vaccine doses.

Stroke - Cerebellar hemorrhage. Had to have brain surgery to relieve the pressure and a drain placed. She has a history of low blood pressure, never high. They did an angiogram that came back normal and an MRI as well. They have been unable to find a cause of the stroke at this time. She was in ICU for four days then Neuro PCU for about 4 days and now she is in inpatient rehab. She is currently learning to walk and has weakness on her whole left side. Vision issues. And motor control issues of the left arm. The stroke came on very sudden and she felt fine before her sudden ?worst migraine ever?. Luckily my brother was with her and took her to get help straight away before she became unconscious.

Pfizer-BioNTech COVOD-19 Vaccine EUA: At 30 minutes after injection of vaccine, I experienced numbness of my lips and tongue. This lasted approximately 5 hours.

Approximately 1 1/2 hours after injection, ears began ringing very loudly. It is now 72 hours after injection and ears are still ringing. Does not come and go, but is constant.

Tingling in lungs, mouth for 15 minutes Tingling and numbness in jaws for over a month Tinnitus for 2 weeks Migraine/headaches: a week

Had prior pain from shoulder blade up to neck and ear. Lasted 3-4 days. Had been increasingly Itchy. On 4/23/2021, rash on shoulder neck. Went to dr rash not there. Treated for shingles. Rash reappeared later that evening. Husband received vaccine same date/time. Being Treated for shingles. He reported his event

Extremely confused and agitated. Vision was reduced significantly. Not able to understand or comprehend simple tasks. This went on for 3 days.

1/11/2021: Within 40 minutes of receiving 2nd dose Pfizer vaccine, began having tingling bilateral arms proximal & distal. Following day, developed a temperature to 102F which remained x4 days. Since this time, has had continued tingling of the arms & low grade temperature (99F) & has begun having weakness of her upper extremities only with hypersensitivity to heat, as well as touch, but interestingly having decreased sensation to touch of her fingers, feeling as though she wears gloves, with no weakness anywhere else on her body. She has also beginning to develop a sense of decrease cognition. She has been seen by Neurology who felt this was a neurologic hypersensitivity reaction. Initially when she began having complaints following injections/day 1, she was given Benadryl with no improvement beyond causing her to sleep. Since this time she has also been placed on prednisone with no interval improvement. Relates no cutaneous lesions beyond mottling of her arms/no frank urticaria dermatitis etc., and has had no GI complaints or cardiovascular sequela. 4/19/21: This 60 y.o., female is referred by MD for evaluation of bilateral hand pain, weakness and numbness starting shortly after the 2nd dose of her COVID vaccine (5 her). The patient has generally been in excellent health. On Monday, January 11th at 9:20 a.m. she received the 2nd dose of COVID vaccine (Pfizer), in the left deltoid. She had no immediate reaction but while driving about 45 min later developed numbness and tingling bilaterally in her face, lips, tongue and hands. She awakened at about 3:00 a.m. with fever of 102, no abnormal sensations in her face but pain, redness and sensitivity in both hands. Systemic symptoms resolved in several days. Hand symptoms have continued to date. Pain can range as high as 8/10. She has marked sensitivity such that if she or someone else touches her hands it is extremely painful. She sleeps with opera gloves to protect them. She has not had neck pain but has developed grip weakness and has to use 2 hands to hold a cup of coffee. She has never had adverse reactions to vaccines in the past. She has had no immunologic disorders. She initially saw Dr. who tried a short course of steroids without benefit. She took gabapentin 200 mg followed by 100 and slept for hours without a change in the pain. NSAIDs have been ineffective. No other medications have been tried. She has had nothing to suggest a symptomatic COVID infection. 4/23/21: The patient continues to have bilateral hand sensitivity and temperature lability. The EMG showed diffusely slow sensory conductions, consistent with the non correctable low temperature of her hands. Motor conductions were notable for slowing in the right median motor with drop in amplitude proximally but with waveforms that did not suggest conduction block. All motor terminal latencies and F response latencies were normal. Overall the study is probably normal within technical limitations but if necessary should be repeated in about a month with her hands warmer. The nortriptyline was just approved yesterday and the blood tests 2 days ago. She will start the nortriptyline over the weekend and let me know if it is tolerable or effective. She will get the blood work done early next week and I will review the results with her. HISTORY: This patient with bilateral hand dysesthesias and temperature lability following COVID vaccination comes in for neurophysiologic testing. Notably the nortriptyline was just approved and she has not yet started taking it. Similar the blood test were just approved 2 days ago and she will have them drawn next week. Her symptoms have not changed since he was here last.

Driving home my eyes were sensitive to light and I couldn't see, very sensitive, and soon as I got home I experience flashes of light, then string of lights going off and on, by Thursday, the string of lights were wider and were everywhere. There were flashes of light like being on the red carpet and you can t see because of the flash of lights. I also had heart palpitations. Now I have blurry eye vision and my eyes are puffy and feels like something is inside my eye.

Bell's Palsy; I started to have sharp pain behind my ear; sinus congestion; deep sore throat; dry left eye; This is a spontaneous report from a contactable other healthcare professional (HCP; patient). A 60-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration, administered in left arm on 27Mar2021 at 16:00 (Lot Number: ER8733, expiry date not reported) at the age of 60-years-old at a single dose for COVID-19 immunisation. The patient was not pregnant at the time of vaccination. The vaccination facility type was facility. The patient received no other vaccine in four weeks. The patient had no COVID prior to vaccination and was not tested for COVID post vaccination. Medical history included penicillin-rash; high cholesterol being treated with Repatha; slightly high blood pressure being treated with lisinopril; cysts in pancreas, thyroid and kidneys-all benign. Concomitant medications included evolocumab (REPATHA) for high cholesterol; lisinopril for slightly high blood pressure; spironolactone for an unspecified indication and testosterone for an unspecified indication, all start and stop dates were not reported. The patient received the first dose of the Pfizer-BioNtech Covid-19 vaccine on 27Mar2021, 4 days later on 31Mar2021 20:30 she developed Bell's Palsy. She would like to know if in the clinical trials those who experienced this adverse event was after the first or the second dose of the vaccine. She already reported this adverse event to Safety, online and verbally. She would like to know if Pfizer recommends for people who develops Bell's Palsy after the first dose of the vaccine not to receive the second dose and if there's information about the cases of Bell's Palsy after receiving the vaccine during the vaccination to larger populations. She's also wondering if there is information about how long it takes to resolve. Patient reported that four days after vaccination on 31Mar2021 at 20:30, she started to have sharp pain behind her ear, sinus congestion, deep sore throat, and dry left eye, went to bed, next morning she woke up with Bell's palsy on left side of face (also reported to have occurred on 31Mar2021 20:30). These resulted in a doctor or other healthcare professional office/clinic visit. The patient was treated with high dose prednisone and Valtrex. The outcome of the events was not recovered.; Sender's Comments: Bell's palsy is not uncommon in general population, however the causal association between bell's palsy and the usage of the vaccine BNT162B2 cannot be excluded because of strong temporal association. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.

terrible pain that would surge from low level to unbearable over 5 days (headache, eye pain, neck and shoulders, lower back, throat), sensitivity to light, dizziness, ringing in hears

Caller states the patient had an anaphylactic reaction twice that caused her to go to the emergency room; couldn't swallow; right side of the patient's face swelled up and her lips were numb; right side of the patient's face swelled up and her lips were numb; face numb; hands itching; tongue had swelled up; voice was scratchy; This is a spontaneous report from a contactable consumer, Reporter's sister via Pfizer-sponsored. A 60-year-old female patient received the second dose of BNT162b2 (Pfizer-Biontech COVID-19 vaccine, Solution for injection, Lot number: unknown, NDC number: Unknown, Ex-piry Date: Unknown) via an unspecified route of administration on 01Mar2021 on an unknown ana-tomical location as a single dose for COVID-19 immunization. Caller provided that her sister got the vaccine for COVID Prevention and because the patient has a handicapped, bedridden husband who has MS and is immune compromised, and it was to help prevent him from getting sick. Caller reported that the patient received the product during the daytime, all the women at the patient's job, which was home health payroll, everyone left to get the vaccine during work hours, like in the AM at around lunch time. Patient's medical history and concomitant medications were unknown. Patient has not received any prior vaccinations within 4 weeks. Patient had no other vaccines on the same day as the suspect product. Patient received first dose of BNT162b2 (Pfizer-Biontech COVID-19 vaccine, Solution for injection, Lot number: unknown, NDC number: Unknown, Expiry Date: Unknown) on 08Feb2021 with no reaction. She worked for a health agency and the whole office went and got it. Caller provided that her sister had a reaction the first time, on 03Apr2021, where her sister woke up with itching started in her hands and ended up migrating to her whole body. By morning patient's tongue had swelled up, couldn't swallow and her voice was scratchy, like the caller couldn't understand her sister's speech well. Caller provided that her sister went to the ER and said there was a whole team giving her urgent care, medication, and such. Caller reported that her sister said the ER didn't find anything in her bloodwork, and the caller did not think the patient was being treated for any other medical conditions, and caller did not think her sister is on any medications, but caller said to not quote her on that. Caller knew her sister had a weight problem, but she did not know if her sister needed blood pressure medication or anything. Caller reported her sister said that the bloodwork from the ER did not find any-thing, and the patient was not admitted to the hospital. Caller reported that at this time, her sister's adverse events were no longer ongoing as her sister was given Steroids, like Prednisone, Benadryl and Famotidine, and she took those products as recommended by the doctor. Caller did not know the end date of her sister's events; all she knew was that the reaction initially started on 03Apr2021. Caller stated that her sister was allergic to nothing, and she has never had incidences of itching like that, where the itching was so bad that she was stripping down and the patient's daughter was patting the patient down with witch hazel. Caller stated that ER released the patient and gave her some medications and such. Caller stated that a day or so later, there was a second round of reaction: the right side of the patient's face swelled up and numb and her lips were numb, like when people have a dental procedure. Lips were numb for a while. Upon completion of the medications she was given, the reactions stopped. Patient regularly saw the family doctor. She would go back to see her Doctor on Thursday. HCP Information was unknown to the caller, but caller stated that her sister had been recommended to go to her PCP and get an Epi Pen. Caller stated that knock on wood, so far, her sister was holding her own, and it had not happened again. Caller stated that she was reporting the data that her sister gave to her after having the Pfizer vaccination. Caller stated the patient had an anaphylactic reaction twice that caused her to go to the emergency room. No relevant tests were done. Caller stated that she had the dates that she had her shots and where she had her shot at. Caller stated somebody called and reported it already. Caller stated she was trying to press three but never could figure out which prompts was. Caller stated they said if she called this number, they would tell her at the medical information department if this occurrence has happened to other people, like statistics. Caller stated they tried to call this number, but it was too long of a wait. Caller stated that she did not have the vaccination card, she never asked for them. Caller does not have card with her at time of call for LOT, NDC, Expiry date. Caller stated that she knew that all the COVID vaccines are just in the Emergency Use Authorization stage and in clinical trials, but caller really thought that all manufacturers should be advertising that they would like feedback from patients. Caller has not heard anything from any of the manufacturers saying that people are welcome to reach out and report side effects. Caller states that she only knew to call because she used to be a Home Health Worker, and she thought this is an important data. Caller has never seen on any of her 19 TV channels about calling to report. Caller stated that the girl who first answered her call, read a clinical data sheet about joint pain being seen in 23% of patient's and not knowing a percentage for anaphylactic reactions, caller was wondering if this was true. Caller verified that she just wanted to ask basically that patient was not alone, if other people might have had that happen too. Caller stated that she tried to call, and it would ask another question and it would say press 1 or 2, then it would ask other questions and it would say press 1 or 2, she never got an option 3. Caller asked: how much percentage, has anyone reported this side effects weeks after the second dose. Caller was wondering if this reaction could have been from the vaccine. Investigation Assessment: No. The outcome of the events were unknown. Information on the lot/batch number has been requested.

At 10 minutes, throat became scratchy and uncomfortable, became lightheaded. Throat discomfort eased at about 10 minutes later. Lightheadedness lasted about 15 more minutes. Was not as severe as anaphylacsis.

Very high pitched loud tinnitus in my right ear; This is a spontaneous report from a contactable other HCP (healthcare professional, patient). A 60-year-old non-pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; solution for injection; Lot Number: ER8737) via an unspecified route of administration on 02Apr2021 at 15:15 (at the age of 60-years-old) as a single dose in the right arm for COVID-19 immunisation. Medical history included Ehlers Danlos Hypermobility, known allergies: Sulfa drugs and known allergies: narcotics, all from unspecified dates and unspecified if ongoing. The patient was not diagnosed with COVID-19 prior to vaccination. Concomitant medications ("other medications in two weeks") included levothyroxine sodium (LEVOXYL), fexofenadine hydrochloride (ALLEGRA), gabapentin and escitalopram oxalate (LEXAPRO), all taken for unspecified indications on unspecified dates. The patient did not receive any other vaccine within four weeks prior to receiving the COVID-19 vaccination. On 02Apr2021 at 15:15, the patient experienced very high-pitched loud tinnitus in my right ear. The event was serious for disability or permanent damage. The clinical course was reported as follows: "immediately after receiving the injection, I began experiencing very high-pitched loud tinnitus in my right ear. It has not resolved and awakens me at night. I am afraid to receive the second shot." The patient had not received treatment for the adverse event. The clinical outcome of the event very high-pitched loud tinnitus in my right ear was not recovered/not resolved. Since the vaccination, the patient was not tested for COVID-19.; Sender's Comments: A causal association between BNT162B2 and the reported events cannot be excluded based on a compatible temporal relation. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.

has mild tinnitus prior to being vaccinated, but started having really bad tinnitus a week later to the date after receiving first dose Pfizer Covid 19 Vaccine; nausea and vertigo kind of feelings; nausea and vertigo kind of feelings; This is a spontaneous report received from a contactable consumer (patient) reported for herself. A 60-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Expiry Date: 31Jul2021, Lot Number: ER8733) in right upper arm on 30Mar2021 at single dose at 60-year-old for COVID-19 immunization. Medical history included, on a low dose blood pressure medication. Mild tinnitus prior to being vaccinated. There were no additional vaccines administered on Same Date of the Pfizer Suspect, did not even get the flu shot. There were no prior vaccinations within 4 weeks. Concomitant medications were not reported. Past drugs included steroids make blood pressure go up that was all. States like zithromax (Z-paks) or dexamethasone or whatever, makes blood pressure go up. Patient took the Covid vaccine 2 weeks ago. One week after taking the vaccine she contracted tinnitus. She is calling to inform Pfizer she feels they should put this on the list of side effects so patients can have the option of receiving the Pfizer vaccine or not. She went to a specialist and the doctor stated he has seen several patients that this has happened to. She would like to speak with someone about this. She is in good health and is on a low dose blood pressure medication (she would not give name of medication). Patient was a consumer who received the Pfizer Covid 19 Vaccine dose one on 30Mar2021. Reports wearing KN95 masks and haven't gone anywhere. One week later on 06Apr2021, after receiving the first dose Pfizer Covid 19 Vaccine caller started having really bad tinnitus. Caller reports she has mild tinnitus prior to being vaccinated, but started having really bad tinnitus a week later to the date after receiving first dose Pfizer Covid 19 Vaccine. Caller states she doesn't know how much, like how much of her personal life she wants to give. Just thought her husband is the superintendent and was calling to report the side effects, wanted to be a good citizen. Caller reports trying to be responsible and feel like caller is doing the right thing. Caller is going to sit down now. Was walking around the kitchen while on hold, was on hold for a while. Caller reports having a history of tinnitus, but very mild. All of a sudden, the tinnitus got really like the volume turned up, and has just been like that since. Reports also having nausea and vertigo kind of feelings on 06Apr2021. Tinnitus is very profound. Reports the vertigo and nausea kind of feelings come with the tinnitus. Reports the tinnitus, nausea and vertigo kind of feelings have been the same since last Tuesday. Caller states she has so many KN95, so many masks, because her husband is the superintendent. The KN95 masks are all they have worn for the past year. Inquires if caller should still be wearing KN95 mask even after being vaccinated. Caller states she is just making conversation, she uses KN95 masks all the time, the mask question has nothing to do with what the caller is reporting. Caller's husband is so organized being who he is, caller has the time in the calendar. Caller got to the administration site at 16:55. There was no adverse event required a visit to Emergency room or Physician office. Patient talked to the Doctor on the phone about how to deal with the symptoms. Patient was scheduled for second dose Pfizer Covid 19 Vaccine not this Wednesday, but the next Wednesday. There was no adverse event following prior vaccinations. The only thing that caller has bad reactions to are steroids, caller did not do well with steroids. Caller is unable to provide NDC/lot/expiration for the steroids. States, no just like caller's whole life, steroids make caller's blood pressure go up that's all. States like Z-paks or Dexamethasone or whatever, makes blood pressure go up. Caller is not able to provide NDC/lot/Expiration for the Z-pak or Dexamethasone drugs. States no, just been caller's whole life steroids tend to make blood pressure rise. No family medical history relevant reported, stated her Mom is dead and father just passed away. Caller request an email that she spoke to agent. Caller asks how this information will be used, if it even matter caller reported events. Caller requests specific information on what happens to Safety reports and how many adverse events are reported. Caller states she probably will not call again, was just being a good citizen and reporting events. Outcome of events was not recovered. No follow-up attempts are needed. No further information is expected.

anaphylactic reaction; anti kell antibodies in her blood; nausea; her left and her right hips, both, had severe pain/her right knee joint is in severe pain; she could barely walk and she couldn't bend at all; really weak; had leg aches; she couldn't stay awake/she couldn't sleep again; diarrhea; severe pain at the back of her neck with a headache; severe pain at the back of her neck with a headache; had extreme fatigue; lightheadedness; upper back pain; bloody nose; she couldn't see out of her left eye for about 2 hours; she couldn't breathe; This is a spontaneous report from a contactable consumer. A 60-year-old female patient received her second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: ER8731), via an unspecified route of administration, administered in Arm Right on 08Apr2021 10:41 as SINGLE DOSE for covid-19 immunisation (Age at vaccination: 60 years). Medical history included ongoing chronic obstructive pulmonary disease, ongoing chronic kidney disease and Positive ANA. The patient's concomitant medications were not reported. The patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: ER8727) on 18Mar2021 for covid-19 immunisation and experienced First dose: a little bit of soreness and swelling all on the site. The patient stated that during her second dose last Thursday on 08Apr2021, she had an anaphylactic reaction and she couldn't breathe and long story short she had to go to the emergency room and she was given all kinds of epi shots and treatment and stuff and eventually she had to be kept in the ICU unit. She is not sure why she had such a severe reaction. She wanted to report that since then she has kept track every day on how she has been and she actually thought yesterday was the first day that she had felt better. She had extreme fatigue, lightheadedness, upper back pain and even a bloody nose on 10Apr2021 and also she couldn't see out of her left eye for about 2 hours. Then on 11Apr2021, she had severe pain at the back of her neck with a headache that lasted about 20 minutes and she couldn't move her neck. She had diarrhea and the only temperature she had was on 12Apr2021, it was only 99.5 degrees Fahrenheit, which isn't bad, but she had really bad diarrhea on 12Apr2021 and she took Imodium. She had a headache and slight breathing difficulties and things like that. On 13Apr2021 she had a headache, was really weak, had leg aches, fatigue that was really bad and she couldn't stay awake and her temperature that day was 98.7 degrees Fahrenheit which is normal. Then yesterday, 15Apr2021, she thought she was over all the things and that she was feeling better from the fatigue, nausea (occurred on an unspecified date), lightheadedness but she couldn't sleep again. She didn't sleep since Wednesday morning until last night finally and she only slept for an hour since Wednesday morning. She woke up on 15Apr2021 and had no symptoms except her left and her right hips, both, had severe pain and she could barely walk and she couldn't bend at all. All she could do it take Tylenol and she used a heating pad and the pain was excruciating. She went to bed last night and she did sleep for maybe a total of 2 hours and when she woke up this morning her left hip seemed to be a little better but her right hip is still in severe pain and now her right knee joint is in severe pain too. Other than that, she has no other symptoms just the joint pain. She didn't know it would go on for this long, it has been over a week now and she just wanted to let us know about this. The patient was hospitalized for the event anaphylactic reaction from 08Apr2021 to 08Apr2021. The patient underwent lab tests and procedures which included Blood typing: anti kell antibodies (doctor randomly decided to do a blood typing and they found anti kell antibodies in her blood) on an unspecified date, temperature: 99.5 degrees fahrenheit on 12Apr2021, temperature: 98.7 degrees fahrenheit on 13Apr2021. Therapeutic measures were taken as a result of anaphylactic reaction, dyspnoea, diarrhea and arthralgia. Outcome of the event anaphylactic reaction was recovered with sequelae on 09Apr2021 while outcome of the events nausea, dyspnea, arthralgia, sleep disorder and movement disorder was unknown. Outcome of the event vision impairment was recovered on 10Apr2021 while outcome of the event neck pain was recovered on 11Apr2021. Outcome of the remaining events was recovered on 15Apr2021.

My right eye twitched continually for two weeks after the second injection. Although it was not painful or itchy, the twitch was disruptive to me at work and during various other activities requiring sight.

Patient had tingling in her lips 7 minutes after receiving her vaccine (11:07). She reported this to the vaccine clinic monitor who alerted me. 50 mg of diphenhydramine was administer at 11:08. Followed at 11:09 with an EPIPEN. Patient was transferred by me to Medical Center Emergency Room at 11:13. She was monitored at the ER and was given PEPCID and a steroid. She was discharged later that day.

Intense increase in volume of ringing in my ears sometime around my second dose. I have had mild tinnitis for >5 years, but sudden increase in volume (and absolute volume) of ringing was noticeable. Whereas previously I had to concentrate or focus to hear it, it is now loud and intrusive-- much harder to ignore, much more disruptive to sleep, thought, etc.

Patient was working in the traffic area of the parking lot. The patient was exiting the area after the 15 min observation period. She reported no symptoms or complications prior to leaving the area and no usual behavior was noted at this time. Patient was accompanied by her husband and son. Near the parking lot the patient was witnessed losing consciousness and falling to the ground. Patient immediately assisted the patient and also called for assistance. I was notified immediately and myself, the paramedics on sight, and NP responded to the patient incident. The patient was diaphoretic and had abnormal vital signs that were repeated multiple times. The set I obtained were 117 heart rate, 99% oxygen on room air, 167/94, 225/112, both taken lying down. Patient complained of severe headache, blurry vision, tinnitus, and dizziness over the past 2 days prior to days. Patient reports having only one medical condition, psoriasis, and takes a cream for it, but also reports she has not seen a doctor in "many years". No stroke symptoms were observed.

Pt arrived to med obs #1 via wheelchair with ODI c/o dizziness, lightheadedness, and diaphoresis. Pt has holter monitor in place, placed yesterday (5/3/21) by pt cardiologist for ongoing s/s of palpitations and dizziness per her report. Pt also c/o tingling to bilateral hands and abdomen, and "strange sensation" in throat. Denies difficulty swallowing, soreness, or tightness of throat. Pt cannot elaborate further on the way her throat feels. Pt accepted water, declined snack. Pt began c/o worsening dizziness, placed in trendelenburg position with relief. Orthostatic VS obtained. Pt reports her BP tends to run low at baseline. VSS. Pt declined wheelchair to exit, escorted by staff with pt son to exit. VS are as follows: 1640: BP 128/55, HR 81, RR 12, O2 sat 96% on RA 1650: BP 117/60, HR 74, RR 14, O2 sat 96% on RA 1655 (lying): BP 110/55, HR 72, RR 16, O2 sat 95% on RA 1657 (sitting): BP 119/62, HR 83, RR 16, O2 sat 97% on RA 1659 (standing): BP 115/55, HR 77, RR 16, O2 sat 97% on RA

Adverse event is HEARING LOSS in the left ear. Right now being treated with steroids orally. May have to get steroid injections in ear drum. Hearing is completely gone. No signs, just suddenly came on briefly.

On the day after second dose, patient experienced new onset horizontal double vision which has not resolved over the course of the past 20 days

1557: Pt went up to nursing staff ~15 minutes after vaccine administration, to report tongue and throat itching. VS assessed: BP 169/101, HR 109, O2 99%. Pt then c/o chest pain and discomfort, was seen gripping chest for relief. Code MET called 1602: Code MET team transported pt to ER for higher level of care Pt received diphenhydramine PO and methylprednisolone IV in the ED

A few seconds after the injection my eyes started burning. This lasted for a few minutes, then cleared up and hasn't returned as of today. Then a few hours after the injection, the inside of my body had an electric / itchy / shaking feeling which lasted for approx. 2 days -- it cleared up and hasn't returned as of today.

Itching on her hands and her feet; Chills; Clammy; Sensitivity to light; inflammation; Under her eyes it is swollen; She was having severe diarrhea; having severe dry heaves; vomiting bile; It had dehydrated her/lead to dehydration; Her throat closing up and it being sore from vomiting and dry heaving; couldn't swallow to get any fluids in; Her throat closing up and it being sore from vomiting and dry heaving; she was struggling with having a dry mouth; puffiness; Headache; severe muscles aches/Muscles pain; feeling nauseous; Was a little warm on her arms/ it was warm to the touch; it just looked like a bee sting and it wasn't super sore; sensitive to the touch; It had big red spots; had a little tiredness; This is a spontaneous report from a contactable consumer (patient). A 60-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration, administered in left arm on 16Apr2021 at 10:00 (at age of 60 years old, Lot Number: EW0ISO) as single dose for covid-19 immunization. Medical history included she had lupus, sjogren's syndrome. The patient's concomitant medications not reported. The patient previously took Pneumonia Vaccine on 04Mar2021 (Anatomical Location: Left arm); took the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration, administered in left arm on 26Mar2021 at 10:00 (at age of 60 years old, Lot Number: the lot number starts with ER something and then it ends with a 3) as single dose for covid-19 immunization; took azathioprine for lupus and had allergic reaction; took belimumab (BENLYSTA), subcutaneous from an unspecified date (Lot Number: PV7G; Expiration Date: Jun2023, NDC: 49401-088-01, Number on the side: 0147098) to an unspecified date, self injection once a week for lupus. She gets it through the VA and it is subcutaneous use and the manufacturer is company. she was immunocompromise, she had lupus, so she was off of her medication (BENLYSTA) for a month per the CDC guidelines. She wanted to let Pfizer know that as well. For her first COVID vaccine she was originally scheduled to go 6 to 7 days after she had her pneumonia shot and they told her that she would have to wait 2 weeks before having her COVID shot and she did. Other than that she had followed the guidelines and she had been able to take her regular medications but she had to stop her Benlysta because of her immune system and everything. She had been following through on what the CDC has said. Patient stated that she just did a follow up with her doctor because of what happened after her second Pfizer COVID vaccine and her doctor recommended her to let Pfizer know about the side effects that she was having. On Friday 16Apr2021 she had her shot at 10 AM and it was no big deal, it was a little warm on her arms. She stated that it just looked like a bee sting and it wasn't super sore, it was warm to the touch and sensitive to the touch. It had big red spots and there has really been no change since it began. It looks about the size of a bee sting and it was still there. She had a little tiredness and she was not hungry but when she woke up at 06:40 the next morning (17Apr2021) on Saturday she was having severe dry heaves and vomiting bile and she could not get it under control. It had dehydrated her and she was having severe muscles aches. She had the severe dry heaves and the vomiting that lead to dehydration and then she went to the emergency room and she got replenished and they had given her something for feeling nauseous and eventually she was released 3 to 4 hours later. They gave her pills as well so she was doing well now and she hasn't done anything since she went to the emergency room with the vomiting and feeling nauseous. She went there about 1030 to 1040. Before she went she couldn't stop and she told herself that if it didn't stop on the 5th time then she was going to go to the emergency room and it got really bad so she had to call 911 to come and get her. Then she was having severe diarrhea on Sunday (18Apr2021) and the only way she could stop that was for her husband to pick up antidiarrheal pills. That only went away because of the medicine from the pharmacy. She had the over the counter medicine and she took Imodium. She hasn't been eating a lot so she hasn't had a bowel movement since she took that medication. When she had diarrhea there was no substance, it was very watery. And now today (unspecified date) she was having another reaction that she was seeing and it was just itching on her hands and her feet. She had been continuing to take the Benadryl and something that they gave her in the emergency room and she had taken Tylenol for the little headache that she has had. She had a slight headache and she was still taking Tylenol like they had recommended. This began the same time as she was vomiting on 17Apr2021 when she was going through all of that she had the slight headache. But her biggest concern was during this time when initially on Saturday (17Apr2021), her throat closing up and it being sore from vomiting and dry heaving, she was having the dry heaves her airway closed shut and she couldn't swallow to get any fluids in. Her concern was that the back of her throat was killing her and it was totally closed up so she had to go to the emergency room. She had recognized this because in the past she has had a medication where she had an allergic reaction (she thinks it is the medication that they gave her for lupus because she has been on several different things. She thinks azathioprine but she can't recall exactly but she thinks that might of been the one that did it to her) and it had closed her esophagus up the same way like this. This time it got worse to where she couldn't even swallow water no less a pill. This was on 17Apr2021. When she went to the emergency room they gave her the hydrocortisone to take it down and she actually had felt better while she was waiting for the saline drop. She was able to swallow when her airway was opened again by the time they treated it with the hydrocortisone. Around 16:00 she was better when she left the emergency room that same day 17Apr2021. She doesn't really have a sore throat, it is pretty fine. It seems to be okay she thinks that once the dry heaves and all that stopped it helped to relax that. She was a little raspy from the whole thing and she was struggling with having a dry mouth but that even had been resolved as far as her throat. She had no other reactions than what she explain but she also had a lot of muscles pain but that was to be excepted because it says that on all that she has read. She had had all of the reactions listed except for fever. She had had chills and then when clammy and then was clammy and had chills. She had all of those side effects listed on the sheet and when she went on Saturday following her vaccine to the emergency room most of the side effects were treated in emergency room. They gave her Pepcid, hydrocortisone through her IV and gave her Zofran for the vomiting and they said to keep taking acetaminophen. They gave her cetirizine for allergy or the itching or whatever and they also gave her famotidine which she thinks is Pepcid. Since being off the lupus drug she was getting her symptoms again such as sensitivity to light, inflammation and the dry heaves didn't help so under her eyes it was swollen and she just takes it as it was because she was not on her medication and she had something else injected inside of her. Also, she had Sjogren's disease too so her eyes were already drier than normal and she had had puffiness since 17Apr2021 when she was vomiting. She just wanted to make sure that Pfizer got that information because she didn t see that listed. The only side effect she was related was the swollen glands and she has glands in her throat but she wanted to be sure that Pfizer had that data just in case if it could help someone else. Again, she wants to reiterate that with her first dosage she had no problems. She couldn t even see the mark and all of this is stemming from the second dose of the COVID vaccine. The outcome of the events "Dry heaves, Bilious vomiting, Dehydration, Her throat closing up and it being sore from vomiting and dry heaving, Unable to swallow, Dry mouth, Nauseous" was recovered on 17Apr2021. The outcome of events "Feeling of warmth, Vaccination site pain, Hyperaesthesia, Vaccination site erythema, Tiredness" not recovered. The outcome of the event "Headache" was recovering. The outcome of other events was unknown. No follow up attempts are needed. No further information is expected.

High fever of 107.5 degree Fahrenheit; Dizziness; Nausea; Headache; Fatigue; Joint and muscle pain; Joint and muscle pain; Blurred vision; Persistent cough; My glands started hurting; My ears hurt specially on the right where the shot was given everything is the worse; Sore throat; Jaw pain; my neck under my chin is swollen and painful; my neck under my chin is swollen and painful; Abscess in my gum and swelling and blisters in my mouth; Abscess in my gum and swelling and blisters in my mouth; Abscess in my gum and swelling and blisters in my mouth; This is a spontaneous report from a contactable consumer(patient). A 60-years-old female patient received first dose of bnt162b2 (BNT162B2, solution for injection, Lot Number: EW016) via an unspecified route of administration in right arm on 19Apr2021 at 17:15 as SINGLE DOSE for covid-19 immunization. Patient was 60 years old at the time of vaccination. Medical history included rheumatoid arthritis, COPD, chronic empyema, asthma, chronic bronchitis, gastritis, irritable bowel syndrome, blood pressure high and digestive disorder, all from an unknown date and unknown if ongoing. Concomitant medications included quetiapine fumarate (SEROQUEL), POTASSIUM CHLORIDE, albuterol sulfate (ALBUTEROL), budesonide, formoterol fumarate (SYMBICORT), FLUNISOLIDE, FLUOXETINE, HYDROCHLOROTHIAZIDE, IPRATROPIN, METOPROLOL, MONTELUKAST, PANTOPRAZOLE, FAMOTIDINE and LOSARTAN, all taken on unspecified date for unknown indication. In Apr20, the patient had high fever of 107.5 degree fahrenheit, dizziness, nausea, headache, fatigue, joint and muscle pain, blurred vision, persistent cough, my glands started hurting, my ears hurt specially on the right where the shot was given everything was the worse, sore throat, jaw pain and neck pain, my neck under my chin is swollen and painful, abscess in my gum and swelling and blisters in my mouth. On unspecified date, the patient underwent lab tests and procedures which included body temperature 107.5 degree F, blood test which she does every year and she had a follow up every 6 months. Outcome of the events was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained.

body aches; Headache; sleepiness; Fatigue; Chills; body temperature: 97.5-98.7; Ear pain; sense of fullness in ears and lymph nodes; sense of fullness in ears and lymph nodes; I feel pretty awful after this first dose.; This is a spontaneous report from a contactable Nurse reporting for herself. A 60-year-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in arm left on 03Feb2021 17:40 (Batch/Lot Number: EL9269) as single dose at the age of 60-year-old for COVID-19 immunisation, offered at the health system she works for and administered at hospital. Medical history included ongoing acoustic neuroma on 8th cranial nerve left side, on the side she felt the intense ear pain, diagnosed 2007-2008, thyroid cancer from 2004 and thyroid removed, her hormone levels are normal, COVID-19 in Dec2020. No history of all previous immunization with the Pfizer vaccine considered as suspect. No additional vaccines administered on same date of BNT162B2. No prior vaccinations (within 4 weeks). There were no concomitant medications. The patient experienced I feel pretty awful in Feb2021 with outcome of unknown, ear pain on 03Feb2021 with outcome of not recovered, sense of fullness in ears and lymph nodes on 03Feb2021 with outcome of recovered on 05Feb2021, body aches on 04Feb2021 with outcome of not recovered, headache on 04Feb2021 with outcome of recovering, sleepiness on 04Feb2021 with outcome of not recovered, fatigue on 04Feb2021 with outcome of not recovered, chills on 04Feb2021 with outcome of not recovered, body temperature: 97.5-98.7 on 04Feb2021 with outcome of unknown. The events did not require a visit to Emergency Room or Physician Office. The course of events was as follows: Patient expected that since she just had COVID in Dec2020, she thought her response to the vaccine would not be severe because she already had some immunity from the infection. The evening of the vaccine, on 03Feb2021, she experienced ear pain and a sense of fullness in her ears and lymph nodes. The ear pain was almost immediate after vaccination. On 04Feb2021, the next day, she woke up with a headache. It was an unusual headache. It did not go away with Tylenol. Then about halfway through the day, she developed significant body aches like when she had COVID. She also experienced extreme sleepiness like when she had COVID too. She took Motrin and had to lie down during her work day. The Motrin did help. Then mid morning 04Feb2021, she got a chill. She couldn't get warm enough. She had no fever. She checked multiple times. Her temps ranged from 97.5-98.7 on 04Feb2021. She experienced fatigue. She did not know the seriousness for any of the side effects she experienced. As of 05Feb2021, her headache has improved. She was still experiencing sleepiness and fatigue. The chills she developed mid day. She had not them right now. She has better and worse moments just like when she had COVID. She was worried about the second one. The patient underwent lab tests and procedures which included body temperature: 97.5-98.7 on 04Feb2021, COVID-19: positive in Dec2020. No other relevant tests. Therapeutic measures were taken as a result of headache and sleepiness. A Product Complaint was filed.

12 hours after the 2nd injection I developed sudden severe nausea that lasted 24 hours non-stop. I was also very thirsty and had chills. The nausea stopped as suddenly as it started but I had fatigue for a few days afterward. I had slight left arm pain. I had fatigue for several days after I recovered from the nausea.

Chest pain and couldn't hardly breathe and hard to get up off the bed; Chest pain and couldn't hardly breathe and hard to get up off the bed; Sweats; Hot and Cold; Chills; Sweats; Hot and Cold; Chills; Sweats; Hot and Cold; Chills; Body Aches where can't walk; Body Aches where can't walk; Fatigue; Nauseated and Can't Eat; Vomiting Dry Heaves; Nauseated and Can't Eat; Vomiting Dry Heaves; Nauseated and Can't Eat; Vomiting Dry Heaves; Nauseated and Can't Eat; Vomiting Dry Heaves; Dehydrated and Dry Mouth and Mucous; Dehydrated and Dry Mouth and Mucous; Dehydrated and Dry Mouth and Mucous; Fever 102F; Weak and Can't Hardly Walk; Diarrhea; Blurred Vision in Both Eyes; Right Arm Pain; Headache; Lightheadedness; flu bug, virus in her body; This is a spontaneous report received from a contactable consumer (patient). A 60 years old female patient received the first dose of bnt162b2 (Pfizer COVID 19 vaccine) via unspecified route of administration in right arm on 09Apr2021 09:10 AM at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were reported as no. No history of all previous immunization with the Pfizer vaccine considered as suspect ad no additional vaccines administered on same date of the Pfizer suspect. No prior vaccinations within 4 weeks. No family medical history. The patient experienced diarrhea on 18Apr2021, blurred vision in both eyes on 18Apr2021, sweats; hot and cold; chills on 19Apr2021, body aches where can't walk on 19Apr2021, really bad fatigue on 19Apr2021, nauseated and can't eat; vomiting dry heaves on 19Apr2021, dehydrated and dry mouth and mucous on 19Apr2021, fever on 19Apr2021, weak and can't hardly walk on 19Apr2021, chest pain and couldn't hardly breathe and hard to get up off the bed from 20Apr2021 to 20Apr2021, right arm pain from 09Apr2021 to 12Apr2021, headache from 09Apr2021, lightheadedness comes and goes from 09Apr2021. Right after the shot her headache started and the soreness in the arm. The patient stated she didn't know how to ride out her headaches, they were so severe like bricks in her brain. For diarrhea, the patient stated it is like water and she is going to the bathroom right now. For Nausea, the patient stated if she eats or drinks anything she is throwing up, further clarifies that nothing comes up but dry heaves. For fever, the patient stated her temperature was 102F 19Apr2021 night, 100F 20Apr2021 morning, and it is 101F at the reporting time. The patient stated she had a cold rag on her forehead. For weakness, she has to use a cane to get up and move around because of the weakness. The patient received none treatment. The events did not require a visit to Emergency Room or Physician Office. The PCP stated he is treating it like flu bug and said she just has to ride it out. The patient stated she was supposed to go back for her second shot 28Apr2021, but she is hesitant because she can't take care of her children because she is sick. The patient stated she didn't know if she was going to take the second vaccine and didn't know what to do for her side effects. The patient asked, with these symptoms, if recommended she get the second shot, because it is like a virus in her body. The outcome of the events sweats; hot and cold; chills was resolving. The outcome of the event chest pain and couldn't hardly breathe and hard to get up off the bed, right arm pain was resolved. The outcome of the other events was not recovered. Diarrhea, blurred vision in both eyes worsened. No follow-up attempts are possible; information about lot/batch number cannot be obtained.

Same-day reactions -within 5 minutes: hives in face and neck - a few more minutes later: swollen lips (had to take Benadryl and 20 mg of prednisone that I was carrying because the hospital only had the epipen) - within 24 hours: shortness of breath, palpitations - couple of days later: admitted to the ER with pneumonia and PVC arrhythmia

pharmacist denied giving her the second dose; developed swollen lips for approximately 3 days.; This is a spontaneous report from a contactable consumer (patient). A 60-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), Solution for injection, Batch/Lot number was not reported) via an intramuscular route of administration in left arm on 30Mar2021 as single dose for COVID-19 immunization. The patient was 60-years-old at the time of vaccination. The patient medical history was not reported. The patient's concomitant medications were not reported. It was reported that, the day after receiving the vaccine on 31Mar2021, she developed swollen lips for approximately 3 days. She had no difficulty breathing and didn't go to urgent care. She wanted to receive her second dose but the pharmacist denied giving her the second dose stating she needed more medical supervision than what was available at the pharmacy. When she called the hospital they told her she had to receive her second dose where she received her first dose. Her primary care doctor said he could not advise her to get the second dose of the vaccine or not because he did not see the lip swelling. The outcome of the event lip swelling was recovered and for pharmacist denied giving her the second dose was unknown. No follow-up attempts are needed. Information about lot/batch number cannot be obtained.

tinnitus rt. side dominant. beginning < 7 days after last dose; This is a spontaneous report from a contactable consumer. A 60-year-old non-pregnant female patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration, at age 60 years, administered in right arm on 18Feb2021 15:30 (Batch/Lot number was not reported) as single dose, for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient did not have COVID prior to vaccination. No other vaccine in four weeks and no other medications in two weeks. Patient historically took first dose of BNT162B2 on 28Jan2021 03:30 AM, on the right arm at age 60 years for COVID-19 immunisation. On 23Feb2021, the patient experienced tinnitus rt. side dominant. beginning < 7 days after last dose and ongoing to date. Therapeutic measures were taken as a result of tinnitus includes offer of biotherapy. AE resulted in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. The patient underwent lab tests and procedures which included Nasal Swab COVID test: negative on 13Apr2021 (post-vaccination). Facility type vaccine was other. The outcome was not recovered. Information about lot/batch number has been requested.

tooth pain; This is a spontaneous report from a Pfizer sponsored program via medical information team. A contactable consumer (patient's husband) reported that a 60-year-old female patient (reporter's wife) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN), via an unspecified route of administration, on 07Apr2021 as a single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. Patient was developing tooth pain in Apr2021 and went to the dentist. She was prescribed amoxicillin 500mg capsules yesterday (22Apr2021), and she already took 1000mg last night. She was taking Amoxicillin 500mg three times daily. Patient was scheduled for the second dose this coming Wednesday, 28Apr2021. Reporter asked if it is okay for her to receive the second dose. Event required physician office visit. The outcome of the event was unknown. No follow-up attempts are needed; information about lot/batch number cannot be obtained.

throat closed up and my tongue feels thick; throat closed up and my tongue feels thick; I couldn't swallow; severe itching in the shot area; severe itching in chest area; This is a spontaneous report from a contactable consumer (patient). A 60-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EW0170) via unspecified route on right shoulder (right arm) unknown single for COVID-19 immunization on 23Apr2021 at 60-year-old. Medical history and concomitant medication were not reported. 15 minutes after the patient took the shot (23Apr2021), patient throat closed up and tongue felt thick, the patient couldn't swallow but the patient was medical services at the bin where the patient had the shot. After about 30 or 40 after minutes (23Apr2021), maybe 30 minutes after the shot, the patient started doing lot of itching, severe itching in the shot area in the shoulder in chest area, severe itching was given some diphenhydramine hydrochloride (BENADRYL) and it did a help so but still had itching in chest area. Outcome of the event severe itching in chest area was not resolved, outcome of the other events was unknown. No follow-up attempts are needed. No further information is expected.

I awoke on April 5th at 6 am. I was deaf in both ears except the sound of my own saliva in the right ear. Upon attempting to rise I was exceedingly dizzy/light-headed. I went to the ground and then extreme loud - extremely loud sound in head. I held my head in my hands and attempted to stand again and could not. Finally I was able to stand and get myself to the bathroom. The loud sound and deafness continued for about 20 to 30 minutes at that intensity, then lessened. Was back to "normal" about an hour later, except fullness in right ear. I really should have called 911, yet I was in a rural area with my 99 year old mother and did not want to startle her. One week later, April 13th, tinnitus, lower volume, and vertigo returned. Vertigo was intermittent; tinnitus has been 24/7 since April 13th. I saw ENT, on April 7th. He thought I either had a stroke or a vestibular migraine, yet he was not aware of the 24/7 tinnitus. He ordered MRI. Results negative for stroke or tumor. I have an appointment with ENT next week. (Was visiting my mom and family at time of initial acute onset.)

Within a few days following the first COVID shot I started to experience ringing in my ears. I did not think much of it at first but when it did not resolve itself I became concerned. I saw reports on-line that it may be linked to a possible adverse reaction to the covid shot. Subsequently I went to my doctor's office. She administered a basic hearing test and looked in my ears. There were no significant findings on examination. The ringing is persistent. It is a very high pitch, annoying, continuous "buzz".

Since my first vaccine shot, I have had noticeable, high-pitched ringing in both ears (tinnitus). I have had it in the past, but had not had for many years before my vaccination. It does not feel life-threatening in any way, but I am a musician, so it does add to my stress and detracts from my quality of life.

severe swelling of lips and tongue, severe itching and rash; severe swelling of lips and tongue, severe itching and rash; severe swelling of lips and tongue, severe itching and rash; severe swelling of lips and tongue, severe itching and rash; This is a spontaneous report from a contactable consumer (patient). A 60-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: ER8732), dose 2 via an unspecified route of administration, administered in arm left on 22Apr2021 12:30 as 2nd dose, single for covid-19 immunisation. Medical history included fibromyalgia, ongoing diabetes type2, non-Alcoholic Cirrhosis, ongoing Chronic fatigue syndrome (CFS), spinal degeneration, hypo thyroid, gallbladder removal, hernia repair, hysterectomy, restless leg syndrome, sleep apnea, Known allergies with Wellbutrin, Naltrexone, tape. Concomitant medications were not reported. The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN6198) administered in arm left on 23Mar2021 12:30 for COVID-19 Immunization. The patient reported to ER with severe swelling of lips and tongue, severe itching and rash on 30Apr2021 09:15. The adverse event result in emergency room/department or urgent care. The patient received treatment (IV of Solumedrol and Benedryl) for the adverse event. 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 been tested for COVID-19. Covid test post vaccination with Nasal swab and result was negative. The outcome of the events was resolved with sequelae.

Patient reported symptoms ~ 2mins after receiving vaccine per administering clinician. Patient noted to have coughing. Patient reported lip numbness and mild shortness of breath. Patient then continued to say that she was having difficulty swallowing. EMS was contacted. Patient awake, alert, oriented. Patient refused EPI administration at vaccine site. Patient taken by EMS to ED. Per medical record patient received IV antihistamines and steroids and was observed.

I administered Pfizer dose 2 to a patient at 1:35 pm on 5/16/2021 . Prior to administration, I asked if the patient tolerated the 1st shot and patient reported that everything was fine with the 1st shot. So I proceeded with the shot. In about 10 minutes after I administered the shot, she reported feeling that her throat is tingling and afraid it might close up. I used Epipen and called 911. 911 arrived within 5 minutes. I contacted the patient at 5 pm to check how she was doing and she reported doing fine, she was home.

Anaphylaxis (lip swelling, generalized hives, shortness of breath) within 30-45 minutes of vaccine. Because patient has a history of anaphylaxis, she was able to treat it by giving herself epinephrine, oral antihistamines, and nebulizer treatment with levalbuterol every few hours for the next 3 days. She recovered and did not report this until 5/12/21.

Tinnitus, ringing in my left started 6 hours after the first dose and has continued non-stop for a week.

Since the 1st Covid vaccine on 3/16/2021, i have lost most of my smell and taste, had a mild sore throat and constantly smell smoke.

I have been sick; couldn't eat anything down; lost consciousness; Trigeminal neuralgia attack; Trigeminal neuralgia attack; massive vertigo attack; eye was so swollen; This is a spontaneous report from a contactable consumer (patient). This 60-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 09Apr2021 (at the age of 60-year-old) (Batch/Lot number was not reported) as single dose for COVID-19 immunisation. Relevant medical history included trigeminal neuralgia, head injury, pulmonary problems, severe migraine and tumor in lymph node. Concomitant medications were not reported. On 09Apr2021, the patient lost consciousness; in Apr2021, she experienced trigeminal neuralgia attack, massive vertigo attack and eye was so swollen; on an unspecified date she experienced also sickness and couldn't eat anything down. The patient specified that right after she got the injection, they make you to sit there for 15 minutes to see. She lost consciousness, it was like they gave her a shot before you go on for surgery and the doctor had come over, they had to wake her up. She didn't know what happened, so that was the first thing and the doctor said that's out of all the 1000's of people they vaccinated she was the first one that passed out right after the injection. So, she thought may be that should be noted somewhere and she didn't get a headache that she has a condition called Trigeminal neuralgia which was extremely painful and it's like only 3% of the population get it and it's usually caused after major head injury, was the very next day her shot was on the Friday and then Saturday the pain was terrific and she had the trigeminal pain for a week, took a week to go away and then right after that the next week she had a massive vertigo attack. And she really didn't know all these things or side effects from her head injury. But her conditions are pretty rare, you only get them if you've got massive concussions and fractured skull and stuff like that which happened a long time ago. So she didn't know if the shot had anything to do with it. She has pulmonary problems so she was getting it no matter what because she can't go anywhere hery Pulmonologist won't let her leave the house unless she has to go to a doctor or an emergency room. And she did go to the emergency room because her pain medication wasn't working at all (Unspecified medication). She used to have migraine but after the head injury the migraine went away which she was very happy because she had severe migraine. What she didn't know was this Trigeminal neuralgia the nerve pain. The consumer further specified that she was so happy with the vaccine and she mean she doesn't care what the normal side effects are, she didn't have any other side effects her arm never hurts, she never had any fatigue or headache but she didn't know it was odd, the very morning she woke up Saturday she was in excruciating pain, its nerve pain that went down to the jaw, right under her eye and over the forehead and it's the most extremely painful thing that people get. She takes medication (Unspecified medication) daily to try to control it but sometime the pain is really really bad. She had been sick for the 3 weeks, she did not think anything had to do with the vaccine except the trigeminal. But it could have caused a massive vertigo attack which lasted 8 or 9 days. Today was the first day she was eating food in a week because she couldn't eat anything down. The patient was on a lot of steroids, she was reducing but she was still very plump so she thinks it's about 270 pounds right now. At the time of the report, the outcome of the events was unknown. The information on the batch number has been requested.

Numbness; Headache; Dizziness; extreme fatigue; muscle aches; she saw white flashes in front of the eyes; She got some bumps that are itchy on the ankle; Bell's palsy; facial paralysis; Lyme disease/had a bunch a symptom and flare up; Lyme disease/had a bunch a symptom and flare up; This is a spontaneous report from a contactable consumer (patient). A 60-year-old female patient received first dose bnt162b2 (BNT162B2), via an unspecified route of administration, administered in Arm Left on 15Apr2021 12:00 (Batch/Lot Number: EW0158) at single dose for COVID-19 immunisation. Medical history included High Blood pressure, Chronic Lyme's Disease, Rocky mountain spotted fever, Psoriasis. She had Bells Palsy with her Lyme's disease 15 years ago. She also added that she was diagnosed about a year with rocky mountain spotted fever. Lyme's disease and rocky mountain spotted fever are both tick born diseases. She also had Bells palsy with the rocky mountain spotted fever. She had mild psoriasis, once a year she got little spots on both arms little patches of skin that were scaly, other then shots been. Concomitant medications included routine blood pressure medication .Patient stated she reported the side effects to the nurse on the other line. she wanted to know if you have information on the vaccine given to individual with Lyme disease. she received the first shot of the Pfizer COVID-19 shot on 15Apr2021. she had a bunch a symptom and flare up. she had facial paralysis which began 24 hours after receiving the vaccine. she worried about getting my second shot. Patient also wanted some clarification on the reported Bell palsy post vaccination. Patient stated that she was calling about the covid vaccine, she had had chronic Lyme disease for a long time and when she got the vaccine it triggered a lot of old symptoms. She was trying to call doctor and health department. She was scheduled for the second dose on this coming Monday 03May2021. She wanted to question if there was research on people with Lyme's diseased. The symptoms she experienced was bells palsy, noticeable numbness in lips to nose to cheeks that occurred about an hour and a half after shot, the bells ballsy was in the center of her face clarifying on both sides of the face. She spoke for a living and her face went numb that didn't make sense. She also still had a headache for 2 weeks every day, she saw white flashes in front of the eyes, some dizziness, extreme fatigue, and muscle aches. She also went to the chiropractor once a week for back pain and it hadn't been helping. The Chiropractor said that a bunch of patients have been complaining since the shot that the chiropractic wasn't working as well. She got some bumps that are itchy on the ankle, no bugs are outside yet, it's a couple itchy bumps, she didn't know if it's related. Patient clarifies that the bumps she had was 1 on ankle and 1 on hip, and 1 below belly button, it started a couple days ago. No follow-up attempts are needed. No further information is expected.

Rash on face; Rash on neck; swollen tongue; swollen lips; swollen face; itchy hands/Itchy; Lip tingling; Swelling of the arms; swelling and tingling; swelling and tingling; This is a spontaneous report from a Pfizer sponsored program support. A contactable consumer (patient) reported that a 60-year-old non pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EN6206, Expiry Date of Covid-19 Vaccine: Unknown), via an unspecified route of administration on 05Mar2021 03:00 PM in the left arm at 1st dose, single for COVID-19 immunisation. The patient age at vaccination was 60 Years. Medical history included vertigo, migraines, Sjogren's syndrome (diagnosed about 10 year ago), thyroid cancer, diabetes and high blood pressure. known allergies included Latex, daptomycin, ceftaroline fosamil, doxcycline, fremanezumab-vfrm. The patient had second shingles shot with Shingrex and she got a few chicken pox rash around the shot itself but that's pretty normal, the onset age was 58 years and at the age of 60 years old at the time of the last flu vaccine, and has received multiple flu shots in the past with unknown brand of flu vaccine. On 05Mar2021 03:15 PM, the patient experienced rash on face, rash on neck, swollen tongue, swollen lips, swollen face, itchy hands/Itchy, lip tingling, swelling of the arms and swelling and tingling. The report received as, on 05Mar2021, received her first Pfizer Covid vaccine dose. 10 minutes later patient had an allergic reaction which included swelling of her lips and tongue, rash on her body, and swollen and itchy hands. The patient reported a second reaction on 07Mar2021, which were the same symptoms as the first and then another (3rd) reaction on 12Mar2021. She has been to the ER 3 times and was prescribed oral steroids and was given a steroid injection each time. She feels that each time the steroid injection wears off, the symptoms return. She wants to know how long this side effect could last. The patient had allergic reactions to it and patient as now had three allergic reactions to it and was wondering have you had other people that have had multiple allergic reactions if the steroid they were given has run out. The patient was given Decadron on day 1 and it ran out in a couple of days because it's a short-acting steroid, then they gave her the longer-acting five-day steroid, betamethasone, patient was taking oral, but it's not as good as the beta methasone shot, patient was asking to have we had other people who have needed more steroids even though the shots have stayed in their system. She wants to know if she is going to have more allergic reactions down the road as the steroids' run out. The patient had three injectable rounds of steroid shots on 05Mar2021, 07Mar2021, and 12Mar2021 and had two courses of oral steroids on 05Mar2021 and 12Mar2021. The patient said 10 to 15 minutes after receiving the shot, had lip swelling and tingling, rash on face, then within a half hour started to swell up. The patient stated that at the center where she got her vaccination, they gave her Benadryl but noticed her symptoms getting worse, packed her up in an ambulance to hospital, and there they gave her Decadron and Pepcid and more Benadryl. The patient states it wasn't anaphylaxis but was an allergic reaction. This was on 05Mar2021, right after getting the shot. It is explained the events improved when given the medications at the ER. She still gets a little itchy once in a while but she is on oral steriods and 50 mg of Benadryl every day. This is her third injectable and second round or oral steriods. Caller has not NDC, Lot, or Expiry for those product as they are from the pharmacy. She also has no NDC, Lot, or Expiry for the Benadryl being used, it is also from the pharmacy. The patient informed as, this was her first Covid vaccination and she was not getting the second one. The patient husband and daughter have had their Covid vaccines and had no reactions at all. The patient was not had covid prior and post vaccination. The patient was not received other vaccine in four weeks. Abd received many daily prescriptions and supplements medications in two weeks. Adverse events resulted in emergency room/department or urgent care. Therapeutic measures were taken as a result of events and treated with Benedryl, Steroids, Pepcid. Outcome of the events itchy hands/Itchy, swelling of the arms, swelling and tingling was unknown, for remaining events outcome was recovering. Follow-up attempts are required. Further information was expected.

sensitive stomach. She reports that this can happen not only with the Pfizer vaccine; significant hearing loss; ringing in the ears; This is a spontaneous report from a contactable consumer (patient). A 60-year-old female patient received first dose of bnt162b2 (BNT162B2), via an unspecified route of administration on 12Apr2021 (Lot number was not reported) as single dose (at age of 60-year-old) for covid-19 immunisation. Medical history and concomitant medications were not reported. On unknown date in Apr2021 patient experienced significant hearing loss, ringing in the ears, also reported as ear ringing like crazy and lost significant hearing. On unknown date she experienced sensitive stomach (she reported that this can happen not only with the pfizer vaccine). Patient stated that after receiving the first dose of Pfizer COVID-19 Vaccine, 10 hours later she developed a ringing in the ears (also reported as her ears started buzzing like ringing like crazy) to which she has seen her health care professional (HCP) and an ear specialist and has under gone hearing tests and states "has significant hearing loss" to which she is on steroids to help, she would like to know if Pfizer had any documented cases on this and what she needed to do about this. She has been going to an ear specialist and he said that she lost significant hearing in that ear where she heard the noise. For treatment, they are doing an injection into her ear. She is still having to go for injections but it does not sound like anything. She researched the internet and there is a whole group of people who experienced this with the Pfizer and Moderna and the other vaccine. Patient added that a doctor did not want to give an opinion or say anything. They did not know if this was permanent or will go away. Patient stated that a lot of people are out there, there are a lot of people with the same problem. She does not know which vaccines they got. She is halfway vaccinated because she is afraid to take the second one. She read comments of people who took the second, and people say it was worse. They discussed with doctors that it should go away eventually. Some say it went away in 9 weeks, some still had the hearing problem and it is uncomfortable. Patient added that it is all day ringing in the air, in her left ear. She went to the emergency room because it was so unbearable, and they did not know what to do. Patient did not take any medications like she did not have any issues, no blood pressure or nothing. Patient said that she cannot take steroids by mouth because she has a sensitive stomach. She reports that this can happen not only with the Pfizer vaccine, it happened with people taking Moderna, Astra Zeneca and Johnson and Johnson reported that. It is all over the internet. A bunch of people are having this problem. Therapeutic measures were taken as a result of significant hearing loss and ringing in the ears. Outcome of the events was unknown. Patient skipped the second dose because she does not want to make it worse. Information on the lot/batch number has been requested.

swollen lips four days after each vaccination. Second time it has not resolved as of today. Have scheduled with allergist.

Since having COVID in November 2020 still experiencing shortness of breath and ringing in ears. After the shot , Felt fine first day, next morning woke up nauseous and dizzy, achy in muscles , especially in legs, pain in knees. Worsen shortness of breath with even short distances . Ringing in ears louder and high pitched. Brain fog. Each day the symptoms got worse, more intense. By the 8th day, pain in muscles so bad , had to be helped to walk or use a cane. Breathing was gasp for breath within short distances.Stayed in bed for several days and muscle pain got better. Breathing got better.

BP 169/101; HR 109; tongue and throat itching; tongue and throat itching; chest pain; discomfort; This is a spontaneous report from a non-contactable pharmacist. A 60-years-old non-pregnant female patient received bnt162b2 (BNT162B2), at the age of 60 years-old, dose 2 intramuscular, administered in Arm Left on 14Apr2021 (Batch/Lot Number: ER8733) as a single dose for covid-19 immunisation. And dose 1 Lot number: ER8727Administration route: Intramuscular, Administration Date: 24Mar2021, Vaccine location: Left arm. Medical history and concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Vaccination was given in a hospital. on 14Apr2021, at 1557: Pt went up to nursing staff 15minutes after vaccine administration to report tongue and throat itching. VS assessed: BP 169/101, HR 109, O2 99%. Pt then c/o chest pain and discomfort, was seen gripping chest for relief. Code MET called 1602: Code MET team transported pt to ER for higher level of care. Pt received diphenhydramine 50 mg PO and methylprednisolone 125 mg IV in the ED as well as cardioversion (as reported). Prior to vaccination, the patient was not diagnosed with COVID-19, nor was tested after vaccination. The outcome of the events was unknown. No follow-up attempts are needed. No further information is expected.

First vaccine on April 5th, 24 hours later I had painful blisters in my chest Second vaccine on April 26. Had no immediate symptoms but on May 13 I started having pain in my gums, then severe canker sores all over my mouth. Could not eat, sleep or talk. I thought it was mouth infections and went to see my dentist but I was told they were canker sores. He thought it was unusual to have that many especially when I had not diet change, eat home cooked meals, with normal stress level. He asked about the vaccine. Later I googled on the internet and found out other Pfizer patients had same reaction.

Client c/o tightness in chest, dry mouth and shortness of breath 20 min. after vaccination. Care initiated by onsite EMS. Client placed on stretcher. O2 applied. EMS transported client to ambulance for transport to hospital. Client's son and niece declined transport. EMS monitored client in the ambulance for 10-15 min. Client stated that she felt "okay". Declined transport to hospital. Client signed papers provided by Fire Rescue. Client exited ambulance, ambulating with assist by son and niece. Stated that she was "okay". Encouraged client to follow up with Emergency Services and PCP as needed. Verbalized understanding. Driven off site by son.

2.5 days after my second dose, the gum behind my right wisdom tooth & inside cheek became swollen, which I have never experiences. After 2 weeks, my cheek was basically ok & about 2.5-3 weeks the swelling of my gum subsided. I did go to the dentist the weekend after my vaccination & she didn't find any dental issues. I took Tylenol for 6 days, but it was not really helpful, then Advil which reduced the swelling immediately! Also, I used hot/cold compresses outside of my cheek & warm tea bags on my gum.

On May 16th after the shot I got a slight headache then 3 days later was feeling very tired and went to bed, woke up a few hours later with numb legs and feeling very faint with numb lips..became unresponsive and Fire Rescue responded and took me o the hospital where they said all test were ok.

Felt pinpoint pressure 1 minute after receiving the vaccine in the middle of the back of her head. Resolved within 24 hours. Felt pressure building up that she thought was a headache developing although she does not really get headaches. Does not take any medications regularly. While driving home, she began to feel very woozy and developed vertigo. 10 minutes after getting home developed pressure in head that was very intense between ears - ears were popping like she was on a plane. Lasted on and off for over a week. Pressure has diminished a lot but still present - about 25% of what it initially was. She realized that she could not focus when she sat down at the computer soon after that. Any time she looked at her devices could not focus and device would blur out. When she tried to focus her eyes would get woozy and pressure in head would get more intense. Currently can only spend about 1/2 the amount of time she normally can at her computer. Reports that I appear blurry to her on video visit. When she went to lay down that day had tingling and numbness of R side of face. Could not go to sleep because there was a sensation change. Did not improve with position change. Still present about 80%. No facial droop.

Sore arm on injection site. Next day, headache, body aches and tired for about 3 days. Twitch in left eye from day 2 and still happening. No treatment needed medically so far.

Severe Ear ache; This is a spontaneous report from a contactable non-health care professional, the patient. A 60-year-old non-pregnant female patient received BNT162B2 (BNT162B2) Lot/batch no: EP7534, via an unspecified route of administration in the left arm on 15Mar2021 at 11: 00 (at the age of 60-year-old) as first dose, single for COVID-19 immunization. Medical history included complex regional pain syndrome (CRPS). The patient did not have any allergies to medications, food or other products. Concomitant medications included dexamethasone and ropivacaine for unknown indications. 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 15Mar2021 at 19:15, the patient experienced severe earache. The patient was not recovered from the event. No follow-up attempts are needed. No further information is expected.

Tongue swelling, facial numbness, rash to both arms, tachycardia, headache, eye pain, elevated b/p 210/103, dizziness, and shaky. Epinephrine given with relief of swelling within 20 min. Two hours later reports vomiting and diarrhea.

Eye discomfort; This is a spontaneous report from a non - contactable other healthcare professional. A 60-years-old female patient received a single dose of BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE ) ( Lot number = not known ) via an unspecified route of administration in left arm on 11Mar2021 ( at the age of 60-years-old ) at 09:45am as a first dose for COVID-19 vaccination. Medical history included that patient was diabetic. Since the vaccination patient had not been tested for covid-19. The patient had took diabetic medicines as a concomitant medications within two weeks of vaccination. The patient did not received any other vaccine within four weeks prior to the vaccination. On 12Mar2021, after 24 hours post vaccination the patient experienced discomfort in the ocular eye. Patient did not experienced any pain. The outcome of this reaction is not recovered. Information about lot/batch number cannot be obtained and no further information is expected.

Sweating profusely; could not even move her body it was so sore; flushed/this is like a hot feeling in her face; tingling feeling on the side of her face, above the eye; tingling feeling on her lip; numb feeling on the side of her face, above the eye and on her lip; numb feeling on her lip; fever of 100; arm started hurting really bad; felt really tired/exhausted; This is a spontaneous report from a contactable consumer (patient). A 60-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Left on 03May2021 (Lot Number: EW0171; Expiration Date: Aug2021) as 2nd dose, single for covid-19 immunisation. Medical history and concomitant drugs were reported as no. The patient previously received 1st dose, single of bnt162b2 on 12Apr2021 (Batch/lot number - ER8729, Expiry Date: Jul2021) for covid-19 immunisation, and she was fine but then the next day her arm was a little sore if she touched it. Caller stated she just needs to ask a question because she is getting concerned. Caller stated then she went Monday to get the second dose and right after the shot her arm started hurting really bad which is a common side effect and she felt really tired so when she got home she went to bed. Caller stated then she noticed on the side of her face felt like she had Novocaine where she had this tingling and numb feeling on the side of her face, above the eye and on her lip and she was also still sore on her arm on Tuesday. Caller stated then Wednesday she was still experiencing a little bit of this tingling and numb feeling, was exhausted, and her arm was killing her. Caller stated on Thursday she was like ok she is feeling really good and starting to get back to normal. Caller stated and she just wanted to let this DSU agent know she has not been sick with anything not even a cold for over three years so this is not common. Caller stated then last night (was early this morning on 07May2021) she woke up sweating profusely and she could not even move her body it was so sore like she got beat up as it was just like an ache from her head to toes (this was like she had exercised and was really sore like that type of soreness) and also her arm was killing her still and she had a fever of 100. Caller stated she was calling because she is not sure if this is common? By Thursday she started feeling better from tired and made it through the whole day until last night she got really tired again and is still tired now. Caller stated she is just flushed (like a hot feeling in her face) now since the sweating had stopped. Caller stated she had a fever the first day on 03May2021 and then went away on Tuesday and she had recovered completely. But then she and woke up early this morning in the middle of the night on 07May2021 and the fever had started back. Caller stated she still has a fever as of now and it has stayed the same since she first noticed it early this morning. Treatment included: Tylenol and Ibuprofen. The outcome of sweating was recovered. The outcome of arm started hurting really bad, could not even move her body it was so sore and flushed was not recovered. The outcome of fever was unknown. The outcome of others was recovering. Information on Lot/Batch number was available. Additional information has been requested.

I am 61, received Pfizer-BioNTech Covid Vaccine on 3-19-21, & 4-9-21. On 5-2-21, after doing some gardening, I felt a sharp pain in my right eye resulting in the sclera part of eye becoming red/bloodshot. I saw PCP, then ophthalmologist on 5-5-21, diagnosing it as right sub conjunctival hemorrhage. I did not lose any vision, but as of today, I still have some residual redness in sclera. My younger sister who had the same above vaccine on same above dates, also experienced right eye redness on 5-11-21, stating no trauma to area.

lost most smell and taste; lost most smell and taste; sore throat (mild); constantly smell smoke.; This is a spontaneous report from a contactable 60-year-old female consumer reported for herself. A 60-year-old non-pregnant female patient (not pregnant at the time of vaccination) received BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/lot number: EN6199 and Expire Date: unknown), via unspecified route of administration on 16Mar2021 at 14:00 (at the age of 60-year-old) as single dose for covid-19 immunisation. Medical history was not reported. Concomitant medications included Celexa [CELECOXIB], Esomeprazole. The patient had no known allergies. Facility where the most recent COVID-19 vaccine was administered was Pharmacy or Drug Store. The patient did not any other vaccines within 4 weeks prior to the COVID vaccine. Medications the patient received within 2 weeks of vaccination was Celexa, Nexium and birth control. Prior to and since vaccination the patient was not diagnosed with COVID-19. On 17Mar2021, after10 hours of vaccination, the patient lost most smell and taste, experienced a sore throat (mild) and constantly smell smoke. The patient not received any treatment for events. The events were considered as non-serious by reporter. The outcome of events was not recovered.

Vaccine given in the afternoon of 1/16, a Saturday. By Sunday am on the 17th, the hearing was gone in my right ear. Got into the ENT doctor on Monday the 18th. Had an exam and hearing test. Started high dose of steroids on 1/19. Had to be out of work for 1 month. About 80% ish of the hearing returned in that ear. Had 1 steroid injection into ear drum of that ear. Throughout the month, had many ENT appointments and hearing tests. Hyperbaric chamber was recommended by the dr. But my insurance would not cover it.

Approximately a week after the 2nd dose I experienced extreme ringing in both ears. It has been constantly present ,sometimes worse than others..I thought it would subside and when it didn?t I made an appt to see an ear doctor. My ear doctor has confirmed there has been recent complaints re tinnitus after receiving vaccine. I will be scheduled for hearing test. Also was informed there is no current treatment. Suggested white noise to mitigate the severity of the ringing. It is very debilitating to have constant noise in my ears

Watery itchy eyes; Watery itchy eyes; Itchy nose; itchy nose and throat; itchy head, neck, and body; headache; Tiredness; This is a spontaneous report from a contactable consumer. A 60-year-old non-pregnant female patient received first single dose of BNT162B2 (lot Number: PFIZER BION TECH MANUFACTURING) via an unspecified route of administration into left arm on 13Mar2021 at 09.30 AM for COVID-19 Immunisation. Medical history included allergy to salmon, carbamazepine (TEGRETOL), ketorolac tromethamine (TORADOL), lithium, morphine (MORFINE), nova cane, ciprofloxacin (CIPRO), Sulfa, hyoscyamine sulfate methenamine methylthioninium chloride phenyl salicylate phosphoric acid sodium (URELLE), and contrast media allergy. Prior to vaccination patient was not diagnosed with covid-19, and since the vaccination the patient had not been tested positive for COVID-19. Concomitant medications were not reported. The patient experienced watery itchy eyes, itchy nose and throat, itchy head, neck, and body, headache and tiredness on 13Mar2021 at 09.45 am. The adverse events resulted in doctor or other healthcare professional office/clinic visit]. The patient was administered with 2 diphenhydramine hydrochloride (BENADRYL) as a therapeutic measure on an unspecified date. The patient was recovering from all the adverse events at the time of reporting. No follow-up attempts are needed. No further information is expected.

Ringing in ear.; This is a spontaneous report from a contactable Consumer (patient, reported for self) A 60-Years-Old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection; Batch/Lot Number: EM9809; Expiration date: UNKNOWN), via an unspecified route of administration, administered in Left arm on 07Feb2021 as single dose for COVID-19 immunisation. Other medical history includes Asthma from an unspecified date and unknow if ongoing. The patient had no known allergies. The patient was not diagnosed with COVID-19 prior to vaccination. The patient had earlier received first dose of BNT162B2 (Lot number: EL3247, Vaccine location: Left arm) on 17Jan2021. The patient did not receive any other vaccines within four weeks nor received any other medications in two weeks prior to the COVID vaccine. The patient had no known allergies. Patient's concomitant medications were not reported. On 12Feb2021 (at 09:30 PM) the patient experienced adverse event, Ringing in ear. Thought it would go away. Still experiencing the constant ringing 17 days after the vaccine. It was unknown If patient received treatment for the event. The patient was not tested for COVID-19 since the vaccination. The adverse event was non-serious. Outcome of the event was reported as not recovered.

The first day when I woke up I had really bad back pain and I was really sleepy. towards the afternoon I became very itchy. The itching and hives would become increasingly worse. I didn't take it for anything. On Saturday I went to work still itching I called the nurse at work on the hotline and explained what was happening. I was told to take Benadryl but could not because it would make me drowsy. I finished work and took the Benadryl after. I also started to break out into hives, the itching was turning into hives. On Sunday I got up for work and the hives were large and like welts. This was all over my body. The itching was still present as well. I was advised to go to an urgent care or a doctor. On Monday morning I woke up and everything was swollen: my face, my lips. I went to the Dr's office where they gave me steroids and an epi pen as well as oral steroids. After the steroids, the swelling went down after a few days. The itching had also ceased. The itching lasted from Friday up until Monday when I got the steroid shot on Thursday.

shot entry is the size of an apple; heart palpitations; diarrhea; blisters in her mouth on her cheeks and roof of her mouth on her tongue, the back of her throat and lips; Because of the blisters she had a hard time breathing and couldn't can't eat; had a fever of 102°F; weak; tooth throbbing; body aches; food tasted like crap for anything that she could get into there; Because of the blisters she had a hard time breathing and couldn't can't eat; Her injection arm was "swollen so bad" from her neck to her fingertips. She couldn't lift up her arm because of the swelling; injection arm was "swollen so bad" from her neck to her fingertips; vomiting; lightheaded, dizziness; Migraine headache/migraine; her arms swollen down to her fingertips which she could not sleep on her left side; could not get out of bed; This is a spontaneous report from a contactable consumer (patient). A 60-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration, administered in Arm Left on 18May2021 (Batch/Lot Number: EWO182) as single dose for COVID-19 immunisation. Medical history included allergic reaction to back yard tree and had sniffles and watery eyes prior to shot. There were no concomitant medications. The patient received her first Pfizer Covid vaccine dose on 18May2021. That evening she began to experience side effects. Her injection arm was "swollen so bad" from her neck to her fingertips. She couldn't lift up her arm because of the swelling. She had Migraine headache and vomiting. At 5 AM the following day 19May2021, she was vomiting, had diarrhea, a migraine, and then developed blisters in her mouth. Because of the blisters she had a hard time breathing and couldn't can't eat, had a fever of 102 degree F, was feeling weak, had to crawl to bathroom. She reported that 24May2021, was the first day that she felt ok. It was reported that her arms swollen down to her fingertips which she could not sleep on her left side, blisters in her mouth on her cheeks and roof of her mouth on her tongue, the back of her throat and lips, stated that she could not go to her dentist appointment the following day because of blisters and her tooth was throbbing on 19May2021. Stated that she had migraine headaches with vomiting, diarrhea, heart palpitations, weak, 102 fever, food tasted like crap for anything that she could get into there. The patient is supposed to go on 08Jun2021 for her second shot and was told that the second is worst than the first. Stated that she refused second shot. Stated that she could not get out of bed. Stated that she has a 7 and 8 year old to take care of by herself. Stated that the shot entry is the size of an apple on 24May2021. Clarified that she had the shot in her left arm. Caller stated that she had the Covid shot 18May2021 and she still does feel well today. Clarified that the blisters all started at the same time. Stated that she has had no heart palpitations since 5am this morning (24May2021). Stated that her fever is 99.9 Caller keeps rambling on; unable to clarify details with each event. Stated that the migraine is now a headache. She wants to know what would happen if she doesn't get the second dose of the vaccine. The patient received no treatment. Outcome of the events could not sleep on her left side, could not get out of bed was unknown; peripheral swelling was recovered with sequelae on 23May2021, vomiting was recovered with sequelae on 24May2021; Heart palpitations was recovered on 24May2021; Fever, migraine, couldn't lift up her arm, hard time breathing was recovering; all other events was not recovered. Follow up attempts needed. Further information is expected

A little soreness in her arm; Metal taste; This is a spontaneous marketing program report from a contactable consumer or other non hcp (patient herself). A 60-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE solution for injection), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as 2nd dose, single for covid-19 immunization. The patient's medical history included Multiple sclerosis from an unknown date patient taking Immunosuppressant Ocrevus. Historical vaccination included the patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE solution for injection), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as 1st dose, single for Covid-19 immunization.The patient's concomitant medications were not reported. On an unspecified date the patient experienced with A little soreness in her arm, Metal taste patient state that it was like I ate hot soup. The patient enquired about the information about the individuals with MS or taking immunosuppressants who received the vaccination. The outcome of the event Metal taste patient state that it was like I ate hot soup was not resolved and while "A little soreness in her arm was unknown. Information on Lot/Batch number has been requested.

odd sensation in her mouth; difficulty swallowing; mouth full of saliva; Her face, neck and chest were all very red and flushed; Her face, neck and chest were all very red and flushed; This is a spontaneous report from a contactable consumer (patiemt). A 60-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6205), via an unspecified route of administration on 04Mar2021 13:00 (at the age of 60-years-old) as 1st dose, single for COVID-19 immunisation. Medical history included shellfish allergy from 2011 and ongoing (patient had an Epi-pen prescription on her patient portal information but she has never filled or used that prescription), pneumonia in 2017 and 2018 (occurred 2 years in a row, probably around 2017 and 2018), bronchitis from 2016 (one year bronchitis without Pneumonia, may have been 2016), prediabetic (Onset date: Probably 2015), obesity (Onset Date: Probably 2000), compromised immune status, blood pressure and thyroid. Concomitant medications included lisinopril taken for blood pressure from 2016 and ongoing; atenolol taken for blood pressure from an unspecified start date and ongoing; amlodipine taken for blood pressure from an unspecified start date and ongoing; hydrochlorothiazide taken for blood pressure from an unspecified start date and ongoing; levothyroxine taken for thyroid from 2016 and ongoing. On 04Mar2021 about at 13:50 the patient experienced odd sensation in her mouth, difficulty swallowing, mouth full of saliva, and her face, neck and chest were all very red and flushed. The patient stated that it was a slight reaction. The patient reported that she received her first dose of Pfizer COVID-19 Vaccine on 04Mar2021. She waited the 30 minutes and then left. As she was driving home felt she felt an odd sensation in her mouth, had difficulty swallowing and her mouth filled with saliva; so she pulled over and she looked in the mirror she was all red, her face, neck and chest were very flushed. She just did some breathing and tried to relax. She called her doctor and waited to hear back from her but didn't yesterday. She tried to drink water and just relax; she did not feel like she had to go to the emergency room. Her doctor got back to her today and had a teleconference. The patient did not have other vaccinations within four weeks prior to the first administration. The outcome of events was recovering. No follow-up attempts are possible. No further information is expected.

a week after the 1st dose, i start having a migraine behind my left ear for a while and then it moves at the back of my head and after on the right side. I also have body ache at night and lower back pain. it comes and goes until the time come for the second dose. at first, I simply take tylenol and green tea. After the second dose, the next day, i discover a swollen lymph nod between my neck and my shoulder but closer to my neck area. The following day, I went to my doctor who prescribes a steroid and an antibiotic. However the med is over and i am still having the migraine from time to time and when have it, i also have lower back pain. This week i also feel pain in my ears

Hypersensitivity; I feel like I have a arthritis like rheumatoid arthritis in my hands; little tender on the arm; little tender on the arm and it is swollen and little itchy; itchiness on the arm; little tender on the arm and it is swollen and little itchy; itchiness on the arm/ feet are swollen; mild chills; body aches; weird muscle; fatigue; Diarrhea; had marking on my legs actually in elbow area; had like ulcers in my mouth; I lost in the meantime, currently now I am 108 pounds; Bone Ache; blistering in the mouth; blisters; sandpaper like rash on the hands and the feet's; mild rash and itchiness on the arm; This is a spontaneous report from a contactable consumer reported for self. This 60-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 on 17Feb2021 Arm Left at the age of 60-year-old as 2nd dose, single (Lot # EN6201) for covid-19 immunisation. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) Anatomical location: Left Arm for covid-19 immunisation. The patient had it, 2nd one was then on 17Feb2021, 10 days later had a guess what you call hypersensitivity because that is the thing can relate to and the they had at the urgent care (emergency room visit) and then the hospital (further not clarified) because had therapy in multiforme. Symptoms on 27Feb2021 and then had gone through an urgent care that following Tuesday and Thursday went back. So, thought it was from that. She had the initial little tender on the arm and it is swollen and little itchy and then had mild chills and body aches initially and did not take, that is better than other people are having with headaches and everything else but it was 10 days later that had this multiforme beginning of this blisters (27Feb2021), sandpaper like rash on the hands and the feet's (27Feb2021), blistering in the mouth (27Feb2021) and had that everything multiforme all over body it is in neck and head. After the 2nd shot on 17Feb2021. She have been mild rash and itchiness on the arm and then little bit of mild chills and mild body ache, it was nothing serious or anything took a steroid and then 10 days later have little bit of sensitivity on index finger and middle finger and then from the next day had marking on legs actually in elbow area, thought it was mosquito bit because of the experienced of itchiness and then it progressed and migrated upward had sandpaper and blisters on face, hands and feet. The rash was on under, it progressed from the ankle and up through the shoulder and had the blister and sandpaper, rash feeling on hands and on feet and then had like ulcers in her mouth. She also had weird muscle and bone aches, body aches and fatigue and diarrhea and everything but she still had she felt like she had a arthritis like rheumatoid arthritis in hands and feet are swollen. She lost in the meantime, currently now was pounds. Treatments included a corticosteroid shot (Further not clarified) and took steroid for the 5 days at the hospital (further clarification unknown) they give her the shot, corticosteroid shot and then took the pills for the 5 days. Outcome of the events was unknown.

Right away the vaccine made my arm tingle and it was painful. I woke up that morning and I had chills and I felt very nausea. I had body aches and I was breaking out into sweats. I took some Tylenol , I had a headache. The nausea was very horrible, and I didn't have much dizziness. The brain fog is the worst thing that I have experienced. I have severe brain fog . I have no appetite and certain smells will bother me and make me more nausea. When I am sitting still , I feel a dizziness where I feel like I am seeing stars. After the vaccine I wasn't able to keep up anything not even ginger ale or water.

metal taste in her mouth; This is a spontaneous report from a contactable consumer (patient) via a Pfizer sponsored program. A 60-year-old female patient received BNT162B2 (PFIZER BIONTECH COVID-19 VACCINE, solution for injection), dose 1 via an unspecified route of administration, administered in Arm Left on 10Mar2021 10:00 (at the age of 60 years old) (Lot Number: El1283) as first dose, single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine nor any other medication within 2 weeks of vaccination. On 10Mar2021 10:30 (also reported as 11:00), the patient had a metal taste in her mouth within 30mins of having vaccine lasting about 10 mins then shorter duration of metal taste on day 2. The patient did not receive any treatment for the event. Since the vaccination, has the patient not been tested for COVID-19. The outcome of the event was recovered. No follow-up attempts are needed. No further information is expected.

auditory hallucinations; Initial extreme fatigue; weakness; worsening tinnitus; This is a spontaneous report from a contactable consumer, the patient. A 60-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot: not reported), via an unspecified route of administration in the left arm on 15Apr2021 at 14:30 (at the age of 60-years-old) as a single dose for COVID-19 immunisation. Medical history included allergy to cashews and pine nuts; back pain associated with herniated discs, major recurrent depression severe, generalized anxiety disorder. The patient was not diagnosed with COVID-19 prior to vaccination. Concomitant medications included bupropion hydrochloride (WELLBUTRIN), lamotrigine (LAMICTAL), calcium levomefolate (DEPLIN), acetylsalicylic acid (ASPRIN), celecoxib (CELEBREX). There were no other vaccinations within four weeks of the vaccine. On 16Apr2021 at 23:45, the patient experienced initial extreme fatigue and weakness which had been replaced by auditory hallucinations and worsening tinnitus. It was unknown if the patient was treated for the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of initial extreme fatigue, weakness, auditory hallucinations, and worsening tinnitus was not resolved. Information on the Batch/Lot number has been requested.

throat swelling/numbness; throat swelling/numbness; lips feeling numb; Her face up to below her eyes was starting to feel numb; the rest of her left side of her head, and her ear was feeling numb; Her left arm was feeling a little bit less sensation than her other arm; a little tired; short of breath; Her esophagus going down the first few inches of her chest was feeling numb; This is a spontaneous report from a contactable consumer (patient). A 60-years-old female patient received first dose of bnt162b2 (BNT162B2, Solution for injection, Lot Number: EN6200, Expiration date: Unknown) via intramuscularly administered, in left arm on 09Mar2021 at 07:10 am (At the age of 60-years-old) as 1 ST DOSE, SINGLE for Covid-19 immunization. The patient medical history included Asthma, gastrooesophageal reflux disease (GERD), Hypertension, Migraines, Anxiety, Hypothyroidism. The patient concomitant medications were not reported. The patient has seasonal allergies and often rashes and reactions to drugs. Patient makes the comment that patient was canary in a coal mine. It was reported that all medical history were long-term and patient has had them all for more than 20 years, and some conditions, she has had longer than 20 years. It was reported that there were no prior vaccinations within 4 weeks of vaccination. It was reported that the patient received the vaccine on 09Mar2021 at 7:10 am in the morning and she felt fine until the afternoon. By 1:00 pm, patient started feeling a little tired, may be a little short of breath, very slightly. At about 3:00 pm, patient started feeling like her throat was swelling, like it might swell shut. It was only on her left side. By that time, patient drove herself to the (emergency room) ER and when she got there, it was 3:45 pm. Patient's throat felt numb, and it felt like it was swelling. Her face up to below her eyes was starting to feel numb and lips were feeling numb. Patient clarifies the numbness was only on the left side and esophagus going down the first few inches of her chest was feeling numb. It was all on the left side. Then, the rest of her left side of her head, and her ear was feeling numb. Her left arm was feeling a little bit less sensation than her other arm. Patient was checked out and looked at the ER and was told, there was no swelling, no muscle weakness, no drooping or swelling of her face or mouth. Patient just had that feeling of numbness. She confirms all of the numbness was on the left side which is where patient received the vaccine. Patient confirms that she was not admitted into the hospital. She was only seen and discharged from the ER. They checked patient to make sure she did not have a stroke, or bells palsy. On 09Mar2021, the patient had blood test and EKG showed unknown. Patient was seen at the ER and treated with Benadryl, Pepcid, and sent home last night. About midnight, patient took a couple of Benadryl because it had worn off and patient was feeling numbness again. Patient took 20 mg of Pepcid AC which she takes for reflux anyway this morning. Patient was only experiencing a little bit of numbness, very slight. The outcome of all the events were recovering. Description of product complaint was as follows: When probed for any product information for the medication patient has taken in treatment of her symptoms, patient explains she doesn't know what they gave her in the hospital. Patient took Benadryl last night at home and clarifies its probably a generic that came from pharmacy . Patient clarifies its out of the package so she cannot provide a specific name for what she was taking. (Manufacturer: , Lot: P120251, Expiry date: May2023). Patient clarifies she took a pharmacy Generic of Pepcid AC, 20mg (Lot: 0CE2921A, Expiry date: Jan2022). No further details were provided or obtained. No follow up attempts were possible. No further information was expected.

Significant increase in volume of tinnitus causing a loss of ability to hear other sounds. The volume is almost unbearable.

The afternoon after getting the vaccine, my lips started tingling and the next morning they were swollen. They were visably swollen for most of a day but after that, they still continued to feel like something is inside of them. In addition to that, I just felt sick for a day and everything tasted like metal. The swelling is what concers me about getting the 2nd dose of the vaccine.

Insomnia only on the night of vaccination happened with the first shoot also. Have absolutely no history of any hearing issue, but woke up 6/11/21 with this strange noise in my left ear. Whenever I spoke or someone else spoke there would be this strange noise. By Sunday if got worse whereby there?s would be this continuous strange noise in my ear, and it was getting more difficult hearing what people were saying. Saw doctor yesterday 6/14/21 who spent less than 5 minutes with me took out some wax, but never asked me any questions about anything, By late evening I realized that I Have lost hearing in my left ear

lost sense of taste; felt really tired; Her whole face and neck was really red and felt like it was on fire; trouble breathing; face felt like it was on fire; headache; This is a spontaneous report from a contactable consumer (patient herself). A 60-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EW0168), via an unspecified route of administration, administered in left arm on 19May2021 09:00 (age at vaccination: 60 years) as 1st dose, single dose for covid-19 immunisation. The patient's medical history included ongoing multiple allergies. She has had allergies her whole life. Concomitant medication included rosuvastatin calcium (CRESTOR OD) taken for blood cholesterol increased which she has taken it for 15 or 20 years; fenofibrate (LIPOFEN) taken for blood cholesterol increased, which probably she has taken it for 15. On 19May2021, she experienced multiple symptoms 15 minutes after initial vaccination including, trouble breathing which started maybe an hour after she had the vaccine, face felt like it was on fire which lasted for 2 or 3 days, headache, felt really tired and her whole face and neck was really red and felt like it was on fire; on 21May2021, the patient lost sense of taste. Her sense of taste is back now. She thinks her tiredness has gone away. The adverse events did not require emergency room visit or a physician's office visit. The patient did not get other vaccinations within four weeks prior to the first administration date of the suspect vaccine. The patient feels hesitant about getting her second dose of the vaccine tomorrow and would like some guidance, asking if she should get her second dose or not. The outcome of the event dyspnoea was reported as not recovered; burning sensation, erythema was unknown; headache was recovered on 24May2021, Ageusia was recovered on 23May2021 and tiredness was recovered on May2021. Information on Lot/Batch number was available. Additional information has been requested.

When she took her Pfizer vaccine on 5/29/2021, she had a feeling of pressure around her heart that made her anxious on Day 2 and Day 3, Lymph node under her left arm was swollen the size of a credit card for Days 3 & 4 post vaccine. Had a fever on Day 4 & 5 after the Covid Vaccine. Would wake up in the night with her bed soaked with sweat and she would have to change her clothes. She had a horrible smell in her nostrils. Had diarrhea.

numbness on the top of the lip and bottom lip and my nose; numbness on the top of the lip and bottom lip and my nose; This is a spontaneous report from a contactable consumer. A 60-years-old female patient received the first dose of BNT162B2 Pfizer-BioNTech COVID-19 mRNA Vaccine administered via an unspecified route of administration, in left arm on 15Mar2021 17:30, at 60 years of age, (Batch/Lot Number: EN6208) as single dose for COVID-19 immunization. The patient medical history included allergy to sulfamethoxazole/trimethoprim (BACTRIM). She didn't receive any other vaccine in the prior 4 weeks. The patient was not diagnosed with COVID-19 prior vaccination and was not tested for COVID-19 post vaccination. Concomitant medication included magnesium sulfate taken for an unspecified indication, since an unknown date. On 15Mar2021 she waited for 15 minutes and maybe a few minutes after she left (also reported at 18:00) the patient experienced a mild reaction: numbness on the top of the lip and bottom lip, around the outside of her mouth and nose. The area around her mouth including the mustache area and below her lower lip and nose went numb. She had already left the pharmacy, she was in traffic so it was hard to go back to the pharmacy. It didn't get worse. The numbness lasted for 4-5 hours and gradually started to get better. By 10 o'clock that night it had dissipated without any treatment. The events resolved on 15Mar2021. No follow-up attempts are needed. No further information is expected.

Loss of vision Started on 05/26/2021 and dizziness on 05/27/2021, was admitted to hospital from 05/27/2021 to 05/31/2021. The dizziness was treated during hospital stay but vision was declining. Went to see eye doctor but no problem was found in eyes. Till 06/04/2021 left eye was completely blind and red eye can only see light coming through but wasn't able to walk independently. Went back to hospital and admitted from June 4th to June 20th 2021. During this stay, Patient was diagnosed with Neuromyelitis optica and treated by steroids, plasmapheresis and Rituximab.

Not feeling good 4 days after shot; Dry mouth on and off since shot.; This is a spontaneous report from a contactable patient. A 60-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER BIONTECH mRNA COVID-19 vaccine; Lot number: UNKNOWN) via an unspecified route of administration in the left arm on 15Mar2021 at 17:30 hours (at the age of 60-year-old) for COVID-19 immunisation. Medical history was not reported. Concomitant medications reported as clonazepam (MANUFACTURER UNKNOWN) taken within prior two weeks of vaccination. The patient was reported to be allergic to codeine and dilladid. Prior to vaccination, the patient was not diagnosed with COVID-19. Since vaccination, the patient has not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to vaccination. On 15Mar2021 at 18:00 hours, the patient experienced dry mouth on and off and on 19Mar2021, the patient was feeling unwell. No therapeutic measures were taken by the patient for the events. The clinical outcome of event dry mouth was not recovered, while the outcome of feeling unwell was unknown at the time of report. No follow-up attempts are possible; information about lot number cannot be obtained.

Right after injections no issues at all 4 months later May 17th had right thalamus stroke etiology unknown was on vacation. No pre-symptoms normal blood pressure, no headaches, no cough, no fever. Got up in the morning. picked up shoes and had extreme dizziness and double vision, slight drift of left arm. No other symptoms

Within 4 hours of receiving the vaccine, I developed chills and an fever of 101.5. I had muscle aches, pains, stomach upset, and nausea. At night I had difficulty breathing so I had to take extra medicine for my asthma. My temperature had went down to 100. I had severe body pains, abdominal pains, and vomiting. I was told to take Tylenol and stay hydrated by my doctor. He sent me to ER on March 11th. I went to ER and they ruled out a Covid or flu infection and any other infections. They said it was caused by the vaccine. They administered IV fluids, pain medicines, and vomiting medicines. 9 hours later after waiting, I decided to leave the ER and continued with taking pain and vomiting medicines. The symptoms lasted for 16 days. I met with my PCP and decided to get the 2nd shot three weeks later. I got similar symptoms as 1st shot with 2nd dose. Off and on I have been having adnominal discomfort. I have been having a hard time swallowing and chewing food. June 2nd I seen my PCP, and he said there was a problem with food processing into my stomach. He sent me to a gastroenterologist on June 22nd and they are scheduling a procedure to take a look into my esophagus and stomach to see the issue.

Loss of smell; Loss of taste; Slightly swollen lymph nodes; This is a spontaneous report from a contactable consumer, the patient. A 60-years old female patient received first dose of BNT162b2(PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EP7534), via an unspecified route of administration in the left arm on 20Mar2021 at 16:30 (at the age of 60-year-old) as a single dose for COVID-19 immunisation. Medical history was not reported. The patient had allergies to sulfur ingredient. 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. Concomitant medications included vyvanse (MANUFACTURER UNKNOWN), dosage 40mg 1xday for unknown indication, omeprazole DR (MANUFACTURER UNKNOWN), dosage 40mg for unknown indication from unknown date. On 21Mar2021 at 08:00 (as reported), patient experienced loss of smell, loss of taste and slightly swollen lymph nodes. The clinical outcome of the events of loss of smell, loss of taste, slightly swollen lymph nodes were unknown at the time of reporting. No follow-up attempts are needed. No further information is expected.

Pt was on 15 min observation following injection. After approximately 10 min pt began to complain of feeling like her heart was racing, dry mouth and feeling "Jittery", dizzy and weak

Patient complained of swollen neck, ear, and jaw tendon. Wanted it to be reported. It happened about 5 days after she received the vaccine.

4 Days after 2nd injection I woke up having pulsing in my ears, I was very lightheaded and nauseous as if I was having motion sickness at 11 a.m. I checked my blood pressure and it was extremely high, Over the course of 15 minutes, I got a pain in my shoulders, and could barely walk. I check my blood pressure again it was 180/120. My stomach was upset and I had to crawl to the bathroom, too dizzy to walk. I checked my blood pressure again and it was 178/130. My head was pounding and I was losing my ability to walk. I was taken to the Emergency Room, I wasn't sure if this was a stroke or Heart attack, or neuro problem. I was admitted for two nights and released on January 19, 2021. I still had extremely high blood pressure and motion sickness. The hospital did several tests and ruled out a heart attack and stroke. As of today, I am still undergoing treatment for high blood pressure. I had no issue with this before the vacine

This is a spontaneous report from a contactable consumer or other non health care professional. A 60-years-old female patient received bnt162b2 (PFIZER-BIONTECH mRNA COVID-19 VACCINE, solution for injection, Lot Number: 9W0187), intramuscular, administered in upper Arm Left on 17Jun2021 14:15 (Age at vaccination: 60 years) as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. It was reported that she don't know if she has high blood pressure or diabetes at that time. Patient did not received any vaccinations prior to COVID vaccine. It was reported that she haven't took any medicine since Thursday morning (further not clarified). On 17June2021 the patient experienced fever went highest as 104 but it's down to 101 today, lot of pain, headache, muscle ache, tiredness, chills, joint pain, Feeling unwell, severe nausea, pain in her ear, severe vomiting, really draining she haven't eaten anything since Thursday at 6 pm, everything keeps 'coming', diarrhea, pain in 'neck area'. Consumer stated that I don't have my, the card with me, I am downstairs on the couch I don't have the card in front of me and I don't have enough energy to go upstairs to get it. Consumer stated, "I got the Pfizer shot (COVID Shot) on Thursday and Thursday evening I have been having the problems and it's still going today 20Jun2021 and I got the call from the pharmacist and he concerns about the side effects, I am not sure what caused all of this 'up again', I was fine before the shot and now that evening different things started happening, not feeling well." Patient did not had swelling. Consumer was suggested to share information and a safety report will be filed by the call handler which is going to be forwarded and if consumer want to speak to someone then call back attempt can be done in order to get a person. The patient underwent lab tests procedures which included body temperature was 104 , body temperature was 101 on 20Jun2021. Patient did not received any treatment for the events. last night something to control diarrhea Ammonia AD, that was the only thing that she took, to stop the diarrhea. But the pain was still there, diarrhea stopped. The patient was recovered from diarrhea in Jun2021,Outcome of Lot of pain was not recovered ,the outcome of the rest of the events was unknown.. Consumer was informed about the role of Pfizer Medical Information and offered the number. Information on the lot/ batch number has been requested.

In the week after receiving the second vaccine, I developed various joint pains and muscle pains, at times severe. The first event was both knees becoming very stiff and sore. It lasted about 24 hours. A day later, both my hands became swollen and stiff. Ibuprofen seemed to alleviate the problem. Since that time, at approximately 3-4 day intervals I developed pains in hands and knees again as well as ankles, bicep muscles, wrists, and jaw. This has continued for the last 3 months, and is now only in one of the pair of joints at a time, as in just one knee, not both at the same time. My right wrist is most commonly affected.

Urticarial vasculitis; Pruritic raised bullseyes blotches with bruises in the middle; Pruritic raised bullseyes blotches with bruises in the middle; Pruritic raised bullseyes blotches with bruises in the middle; Pruritic raised bullseyes blotches with bruises in the middle; This is a spontaneous report received from a contactable nurse (patient). A 60-year-old non-pregnant female patient (not pregnant at the time of vaccination) received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: el1284 expiration date: unknown), via an unspecified route of administration in left arm on 06Jan2021 at 10:00 AM (at the age of 60 years old), as single dose for covid-19 immunization. Medical history included gastrooesophageal reflux disease from an unknown date and unknown if ongoing. The patient had known allergies to sulfa and Wellbutrin. Concomitant medications the patient received within 2 weeks of vaccination included famotidine; and vitamin d for an unspecified indication, start and stop date were not reported. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: EK5730 expiration date: unknown), via an unspecified route of administration in right arm on 16Dec2020 at 10:00 AM (at the age of 60 years old) for covid-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient experienced urticarial vasculitis developed symptoms On 06May2021, with pruritic raised bullseyes blotches with bruises in the middle. Treated with unspecified iv steroid, antihistamines and continued steroids and taper to colchicine. The adverse event result in: Doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care, hospitalization. The patient was hospitalized for one day. The outcome of events of Urticarial vasculitis, Pruritic raised bullseyes blotches with bruises in the middle was recovering. Reporter considered events as serious. Information on Lot/Batch number was available. Additional information has been requested. ; Sender's Comments: Based on the information in the case report and a plausible temporal relationship, a possible causal relationship between the events and suspect drug BNT162B2 cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.

Within 1 hour of receiving the 1st of 2 vaccine doses my mouth became extremely dry; Extremely thirsty; Suffered from a mild headache; Nausea; This is a spontaneous report from a contactable consumer, the patient. A 60-year-old non-pregnant female patient received her first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: ER2613), via an unspecified route of administration on left arm 20Mar2021 at 12:15 (at the age of 60-years-old), as a single dose for COVID-19 immunisation. The patient medical history included colon issues. The patient had allergies which included codeine, cipro and flu meds. The patient did not receive any medication within 2 weeks of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. On 20Mar2021 at 13:30 the patient reported her mouth became extremely dry and extremely thirsty within 1 hour of receiving the first of 2 vaccine doses. Patient did not get enough to drink. Later on the same day patient suffered from a mild headache and nausea. Therapeutic measures were not taken as a result of the events. The outcome of the events mouth became extremely dry, extremely thirsty, mild headache and nausea were recovered on an unknown date in Mar2021. No follow-up attempts are needed. No further information is expected.

face/hand sensation/Tingling; Elevated tinnitus; Night sweats; Sweats; light-headed; Vertigo; Dizzy; Nausea; vomiting; diarrhea; hands sizzling; chills; Tinnitus/Tinnitus in other ear; This is a spontaneous report from a contactable consumer (patient) reported in response to Non-HCP letter sent in cross referenced case. A 60-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot number: EP7533, Expiration Date: not reported) via intramuscular, administered in left arm on 05Apr2021 at 13:00 as dose 2, single for COVID-19 immunization. Prior vaccination within 4 weeks was none. Medical history included vitamin d deficiency, dry eye, and Injury. Concomitant medication included vitamin d [vitamin d nos] taken for vitamin d deficiency and ciclosporin (RESTASIS) taken for dry eye. The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection) on 08Mar2021 at 13:00, and experienced vertigo, dizzy, hearing loss, tinnitus, nauseous, diarrhea, chills, sweating, Hands felt like vibrating, and vomiting. The patient experienced vertigo, dizzy, nausea, vomiting, diarrhea, hands sizzling, chills and tinnitus/tinnitus in another ear on 05Apr2021 at 14:00. On 10Apr2021, the patient experienced light-headed. On 15Apr2021, the patient experienced sweats and on 19Apr2021, night sweats. Elevated tinnitus on 20Apr2021, face/hand sensation/tingling on 24Apr2021. The patient underwent lab tests and procedures which included blood test: all else normal, eosinophil count: low Eosinophil absolute- low, full blood count: normal, lymphocyte count: low and neutrophil count: high on 05Apr2021. The events recovered but reoccurred again. The patient did not received treatment for the events. The outcome of the events was unknown. Follow-up attempts are completed. No further information is expected.

fever, sore arm at site, flu-like symptoms for 32 hours following the vaccine Today (7/6/21) I have dry mouth, dry eyes, sores on torso, tender thyroid, cracking skin, constant metallic taste in mouth, food tastes awful and irritates my mouth. Water helps to calm but symptoms never go away.

AFTER RECEIVING MY FIRST DOSE I WENT TO WAIT IN THE WAITING ROOM AND BEGAN HAVING A RACING HEARTBEAT ABOUT 10 MINUTES AFTER THE SHOT. I BEGAN TO FEEL DIZZY, MY HEART WAS RACING, MY PULSE SHOT UP FROM 64 TO 154 PER MY WATCH AND MY MOUTH GOT DRY. I ASKED FOR A NURSE AND THEY ESCORTED ME BACK TO A ROOM. I WAS FEELING LIKE I WAS GOING TO PASS OUT SO THEY LOWERED ME ON THE THE TABLE. THEY CHECKED MY PULSE AND 02. MY MOUTH WAS DRY AND MY LEGS AND HANDS WERE TINGLING. MY HEART WAS POUNDING AND I FELT SICK TO MY STOMACH. THEY CHECKED MY BP WHICH IS USUALLY LOW AND IT WAS REALLY HIGH. I WAS FEELING WEAK AND UNABLE TO STAND SO THEY TOLD ME THEY WERE TRANSPORTING ME TO THE ER. I WAS SHAKING, FREEZING, MY MUSCLES WERE CRAMPING IN MY ARMS AND LEGS. MY HEART CONTINUED TO RACE, I WAS DIZZY AND REALLY WEAK. I HAVE CONTINUED TO HAVE A RACING HEART BEAT AT RANDOM TIMES DURING THE DAY, STILL FEEL DIZZY AND FATIGUED. MY HEART ALSO POUNDS AT RANDOM TIMES DURING THE DAY. I AM NOT FEELING WELL.

I couldn't work, I could not function; I am sick, I feel horrible if it is I don't get another one; it cause permanent damage; I couldn't work, I could not function; I am sick, I feel horrible if it is I don't get another one; it cause permanent damage; Inflammation in neck and inside ears; Inside of head feels really heavy; massive dizziness; headaches; vestibular system all messed up; I feel like I have an ear infection; I thought it was vertigo; have been miserable for 3 months; This is a spontaneous report from a contactable consumer (patient). A 60-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: ER8737, Expiration date: 31Jul2021), via an unspecified route of administration, administered in left arm on 31Mar2021 as dose 1, single for covid-19 immunisation. Medical history included ongoing high cholesterol (a couple of years ago), ongoing arthritis of neck (5-7 years ago), covid-19 from 25Jan2021 to an unknown date. Family history included diabetes (her sister has diabetes, patient reported that she thought that her sister got gestational diabetes and within a couple of years after that, ended up with diabetes). Concomitant medication included atorvastatin taken for cholesterol at 40 mg daily, start and stop date were not reported. No prior vaccinations were given within 4 weeks. On an unspecified date, she couldn't work, she could not function; she was sick, she felt horrible if it was, she does not get another one; it causes permanent damage. On an unspecified date of Apr2021, the patient experienced massive dizziness, headaches, vestibular system all messed up, felt like she has an ear infection; she thought it was vertigo, have been miserable for 3 months, inflammation in neck and inside ears and inside of head feels really heavy. The event Massive dizziness resulted in emergency room and physician office. Patient stated, she got her first shot on 31Mar2021 and within 4 days, she has experienced massive dizziness, headaches, vestibular system all messed up. She felt like she has an ear infection, she has been to all her doctors the ear, nose, and throat, then they send her the ER. She had CT scans of her head, she had X-rays on her lungs everything, they ruled everything out and the only thing we got left is that she is having a bad reaction to the vaccine. First, she thought it was vertigo, she tried the exercises, and they said no that's not vertigo that's some different that's why they send her to the hospital and what she wants to know she keep asking what she do if it was the vaccine (Unspecified Vaccine). Does it wear off, how she fixes this, can she flush this out of my system she does not know what to do but she has been miserable for 3 months and it doesn't seem like its ending. She had to retire from the post office she works there, and she was planning on retiring next year but she couldn't work she could not function. When paraphrased the above concern, Patient stated, What she asking you was when she went, she only had one shot she refused to get the next one because she told the doctor she was sick, she felt horrible if it is she don't get another one until she felt better, so we were trying to little down what it was but she told the lady when she got the vaccine that literally 60 days ago, she actually had COVID and she said it was ok for her to get the shot and that's what she need to know how does this stuff that Pfizer (hence checked the Pfizer tab) shoot in me does it wear off or has it cause permanent damage. Patient reported that she had Covid-19 in late Jan2021, 25Jan2021. Patient reported that she informed the vaccination facility staff member that she just had Covid-19 2 months ago and inquired if it was ok to get the Covid-19 vaccine. Patient reported that the staff member asked if the caller had gotten plasma and something else. Patient reported that she had not gotten plasma or anything else. Patient reported that she really wasn't very sick, she was sneezing a lot and ended up with a sinus and ear infection from the drainage. Patient reported that the staff member gave her the Covid-19 shot and within 3-4 days, everything went to hell and she's been suffering since. Patient reported that she went to the doctor. She was not dizzy when she turns her head. Patient reported that she feels like she's walking on a rocking boat. Patient reported that when she's walking, she looks fine, but her head feels like it's going side to side. Patient reported that she was sent to the emergency room from the doctor's office. Patient reported that she had a CT scan of her head and neck to make sure there were no blockages. Patient reported that she also had blood work drawn, and everything came back fine. Patient reported that she asked her physicians why she was so dizzy and miserable and if it could be from getting the Covid-19 vaccine so close to having Covid. Patient reported that her physicians said they didn't know. Patient reported that she has been through 5 doctors and her last appointment was with a physical therapist to help with the dizziness. Patient reported that the physical therapist informed her that her dizziness could possibly be from the Covid-19 vaccine. Patient reported that her physical therapist stated that he has seen a lot of people with what happened to the caller come in after the got the Covid-19 vaccine. Patient reported that no one knows what to do. Patient inquired if there was a way to flush the vaccine out. Patient inquired if the side effects will wear off or will she have it the rest of her life. Weight: Patient reported that she is a little overweight right now. Massive dizziness: Patient reported that when it first started, she got into the doctor. Patient reported that the doctor said it was vertigo and that there was a lot of wax in the patient's ear. Patient reported that the physician put oil in her ears, said to leave it for 4 days, then come back to the nurse's station to get them flushed out. Patient reported that after they flushed out her ears, the dizziness got way worse. Patient reported that the physicians thought that she may have had some dis embarkment syndrome as she had taken a trip to (withheld) and had taken an airplane and went on a boat ride. Patient reported that she did not think it was dis embarkment syndrome, as she had been back for over a week and it usually sets in when you get off the plane or a couple of hours later, but it had been a couple of days since she got back. Patient reported that she has been out on sick leave since 13Jun2021 because her head was splitting, and she was spinning. Patient reported that she experiences the dizziness only when she walks or moves. Patient reported that she can turn her head and look up and down, it's only when she walks forward that she feels unbalanced. Patient reported that she knows there were some temporary side effects from the Covid-19 vaccine, such as inflammation and dizziness. Massive dizziness: Caller reported that the dizziness began on Sunday 04Apr2021 or Monday 05Apr2021, following the Covid-19 vaccine. Patient reported that she didn't get any indications of dizziness immediately after the Covid-19 vaccine on 31Mar2021. Patient reported that the dizziness has gotten way worse from when it started, but now it has stayed worse. Headache: Patient reported that she thinks the headache is evolving from her moving and trying to compensate for the rocking boat motion in her head. Patient reported that when she's walking the inside of her head is going side to side, and she thinks if she does too much of that, she ends up with a headache whether she was taking Advil or not. Patient reported that the headache has gotten worse since it first started. Patient reported that for maybe a month or, so the headache was not that bad, it was just in the last month and a half to 2 months that the headache got worse, and it stayed there. Inflammation in neck and inside ears: Patient reported that she has arthritis in her neck from 30 years of carrying mail and her neck's not in great shape. Caller reported that she thinks because of the inflammation and postal work, it caused the inflammation in her neck to get way worse. Patient reported the inflammation started a few weeks after receiving the Covid-19 vaccine. Patient reported that she has put in for her retirement. Patient reported that she thinks the inflammation just slowly seeped in. Patient reported that she's had arthritis in her neck for a very long time, but she doesn't even take anything for it. Patient reported that she was told that she had arthritis in her neck and her neck was curved the wrong way, and that maybe way later on she'd have to deal with it. Inside of head feels really heavy: Patient reported that her side effects started with vertigo, not crazy, but that got worse. Patient reported that when the vertigo got worse, that's when she noticed the inflammation or the heaviness in her ears. Patient reported that they say it's her vestibular system that's out of whack and causing the dizziness. Patient reported that was why she went to physical therapy; it's actually called vestibular physical therapy. Patient reported that she is doing exercises every day, and she looked up the exercises online, but it doesn't do anything. Atorvastatin: Patient reported that she was going to get off the Atorvastatin, but her doctor inquired why. Patient reported that her doctor informed her that it will protect her from heart attack and stroke, and she should just keep taking it. Investigations: Patient reported that everything was normal with her blood work and CT scan. Caller reported that the next step was neurology, but neurology refused to take her because they said that the dizziness was related to the (address) trip, but she had been back for a week. Patient reported that she got back from (address) on 28Mar2021 and 3 days after she got back, 31Mar2021, she did get the Covid-19 vaccine. Patient reported that before getting the Covid-19 vaccine, she wasn't having any dizziness or anything. Patient reported that she was working, and everything was fine. Patient reported that she went to urgent care twice. Patient reported that the second urgent care trip is when the sent her to the emergency room at (address). Patient reported that's when they did the CT scan, chest X-ray, and all the blood work. Patient reported that she thinks it was the last week of May2021 that she was sent to the emergency room from urgent care. Patient reported that the first time she went to urgent care, she had her ears done. Patient reported that she went back because the dizziness got worse, not better. Patient reported that she was working and trying to deal with the rocking boat feeling and dizziness. 3-4 days after vaccination, she had massive dizziness, headache, inflammation in the neck and ears and they were very heavy. The dizziness has worsened, and it has stayed in that worsened state. Patient wanted to know how long it would last and would it be permanent She said that she was amazed that Pfizer has no information about dizziness after getting the Pfizer COVID-19 vaccine. She has information about various people having dizziness after getting the vaccine. The patient underwent lab tests and procedures which included blood test: normal on unspecified date of May2021, chest x-ray: normal on unspecified date of May2021, computerised tomogram: normal on unspecified date of May2021, sars-cov-2 test: positive on 25Jan2021, x-ray: unknown results on unspecified date of May2021, blood test; everything came back fine on an unspecified date. The outcome of she couldn't work, she could not function; she was sick, she felt horrible if it was, she does not get another one; it causes permanent damage was unknown and not recovered for other events. Information about the lot/batch number has been requested.

Swelling in glands/lymph nodes; earache (right ear); burning and tightness in chest; burning and tightness in chest; Aches; Fatigue; This is a spontaneous report from a contactable consumer, the patient. A 60- years-old non pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: ep6955) via unspecified route of administration in the left arm on 15Mar2021 at 15:15 (at the age of 60-years old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced swelling in n glands/lymph nodes, earache (right ear), burning and tightness in chest, aches and fatigue on 19Mar2021. The patient underwent lab tests and procedure which included COVID test (Nasal swab) on an unknown date and tested negative. The events resulted in doctor or other healthcare professional office/clinic visit. The patient did not receive treatment for the reported events. The clinical outcome of events swelling in n glands/lymph nodes, earache (right ear), burning and tightness in chest, aches and fatigue was not resolved. No follow-up attempts are needed. No further information expected.

Had a sore throat and ear pain on the day of june 8th was going on for weeks. On june 29th she contacted her doctor because she was in severe pain. Doctor prescribe her doxycyline it started to clear up but still is having ear pain.

Approximately one week after first Pfizer vaccine, I developed pronounced and constant high pitched ringing in my ears(tinnitus). It never stops. Surges louder. Hearing test shows unusual partial loss of hearing on left side as well. Oral steroids did not help. Steroid injection into ear drum has not helped.

Ringing in both ears; This is a spontaneous report from a contactable consumer, the patient. A 60-year-old non pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: ER 8732) via an unspecified route of administration in the left arm on 24Mar2021 at 10:45 (at the age of 60-year-old), as a single dose for COVID-19 immunisation. Medical history included Chronic Obstructive Pulmonary Disease (COPD). The patient was allergic to collins, sulpha base and blue berries. Concomitant medications included NAZARETH (unspecified medication) and albuterol inhaler (MANUFACTURER UNKNOWN) for an unknown indication. 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 been tested for COVID-19. The patient experienced ringing in both ears on 24Mar2021 at 20:30. The patient did not receive treatment for the reported events. The events neither resulted in doctor or other healthcare professional office/clinic visit nor emergency room/department or urgent care. The clinical outcome of ringing in both ears was not resolved at the time of this report. No follow-up attempts are possible. No further information is expected.

I was suspected to have Covid infection Feb 2020. About 2 months after the 2nd dose vaccination, I started having pain in my ear, very bad pressure and I took my nasal spray since I thought it was allergies. The pain increase and I developed a dry cough, nasal congestion,fever, vetigo, nausea, fatigue, and feeling sick. I went to see the doctor and both my ears were perforated and inflammed and I was treated for sinus infection. I was prescribed Amoxicillin for 10 days. Infection did not go away. I was prescribed Cefdinir 300mg twice a day for 7day. The Cedfinir did help to resolve my infection.

Face bright red & swollen, red rash all over my body, headache, dizziness within the first few hours of vaccination. The first evening my headache got significantly worse. I was extremely thirsty, very tired, nauseous, vomiting, diarrhea, muscle pain, chills, fever, my left arm was very sore & swollen @ the injection site. I slept for longer periods of time than normal, very disoriented & not clear on my thoughts & memory for days after.

Symptomatic, started on 7/9/21 with cough, runny nose, muscles aches, nausea, loss of smell & taste, sore throat, nasal congestion, fever, headache, fatigue abdominal pain, & ear ache.

I woke up around 2:30 in the morning of the 18th and I was having pain that went across my shoulders. In half an hour, it was going down both arms, up my neck and in my jaw. I started having chest pains. I went to the ER and they sent me to another hospital where they gave me blood thinners. They think something affected my heart or I had a blood clot. I was discharged two days later and was given an MRI of my heart. They determined that the lining of my heart was swollen. I am now on blood pressure meds and cholesterol meds and am not allowed to spike my heart rate for the next 3-6 months. The doctors believe it was caused by the vaccine.

hives on my knees; light sensitivity; concentration difficult throughout experience; felt very dizzy; Knees swollen; neck discomfort; headache; area swollen from nose to chin; sore injection site,; fatigue; foggy during day; felt my heart beating hard within 5 minutes of vaccine; my lips were numb; I felt a little trouble swallowing.; Had chills; had swelling around lips/mouth; This is a spontaneous report received from a contactable consumer, the patient. A 60-year-old non pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot/batch no : ER8727) via an unspecified route of administration in the left arm on 24Mar2021 at 11:300 (at the age of 60-year-old), as a single dose for COVID-19 immunisation. The patient had no Medical history. Concomitant medications included with supplements. The patient previously received Sulpha Drugs on an unknown date for unspecified indication and experienced a sulfonamide 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 24Mar2021 at 11:00, the experienced heart beating hard within 5 minutes of vaccine and her lips were numb and she felt a little trouble swallowing, and had chills, and had swelling around lips/mouth. On 25Mar2021, the Patient experienced area swollen from nose to chin and Had headache, sore injection site, fatigue, foggy during day. On 26Mar2021, the patient experienced Fatigue and neck discomfort. On 27Mar2021, the patient experienced very dizzy, Knees swollen and Could not sleep on injection site. On 28Mar2021, the experienced hives on her knees, Light sensitivity and concentration difficult throughout experience. The patient underwent lab tests and procedures, which included Blood pressure on unknown date and resulted normal. The patient called clinic for instructions and receive Benadryl for lips numbness, heart beating hard, trouble swallowing and chills. Patient had called doctor and awaited to call back. The clinical outcome of felt heart beating hard, numb lips, trouble swallowing, chills, area swollen from nose to chin, headache, fatigue, foggy during day, neck discomfort, dizzy, swollen knees, hives on knees, light sensitivity and concentration difficult was not recovered and of the vaccination site pain was recovered on 26mar2021. No follow-up attempts are possible. No further information is expected.

The patient reports not being able to walk for two days following the vaccine (the following Saturday and Sunday) as well as having uterine cramps, despite being post-menopausal. Patient also reports extreme thirst and flu-like symptoms after the vaccine.

Woke up with a huge left blood shot eye; Everything was so bright; This is a spontaneous report from a contactable consumer, the patient. A 60-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: Er8730), via an unspecified route of administration in the left arm on 22Mar2021 at 17:00 (at the age of 60-years-old) as a single dose for COVID-19 immunisation. Medical history included asthma, laser surgery for a detached retina one and half years ago and allergy to latex gloves. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient received unspecified concomitant medications within two weeks of vaccination. The patient previously received oxycodone; aspirin (PERCODAN) and experienced drug allergy. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On 22Mar2021 at 22:00, the patient was watching television, and all of a sudden, she had to turn off the television and lights because everything was so bright and the patient went to bed. On 23Mar2021 at 06:30, the patient woke up with a huge left blood shot eye. It was reported that the patient had never experienced a blood shot eye before, and this was the eye she had laser surgery for a detached retina one and half years ago. The patient had just gone to retina doctor two weeks prior to the vaccine and her eye was doing great. The adverse events resulted in a visit to the doctor or other healthcare professional office/clinic visit. The patient did not receive any treatment for the events everything was so bright and woke up with a huge left blood shot eye. The clinical outcomes of the events everything was so bright and woke up with a huge left blood shot eye were recovering at the time of the report. No follow-up attempts are needed. No further information is expected.

Patient fully vaccinated with Pfizer COVID vaccine. Patient experienced COVID symptoms including: headache, sore throat, chills, body aches, chest pain, shortness of breath, cough, nausea, congestion, runny nose, change in taste started on 7/11/21. Patient initially tested COVID negative via antigen test on 7/12/21. Patient then tested COVID positive via PCR swab on 7/18/21. Patient had to be seen at urgent care for chest pain, shortness of breath, cough, and severe headache on 7/18/21 prompting 2nd COVID test.

Noticed my eyeglasses "weren't working". Have since had prescription changed 2 times by optometrist, seen an ophthalmologist for full eye exam including retinal scans, etc. AND had an MRI. None has shown a reason for my vision change. THE ONLY THING DIFFERENT was the COVID Vaccine. I've been on the same RX's for years. Ophthalmologist whom I saw on July 1st was the one who inquired about any changes in medicines or any new vaccinations; that's why I'm sending this report. I AM A STAFF ACCOUNTANT. WITHOUT CLEAR VISION, I CAN'T DO MY JOB EFFICIENTLY!

COVID - Positive test for COVID was after the vaccination - on the 18th January; I started having symptoms on the 16th - no treatment - just quarantine; Low grade fever; cough, tiredness; Loss of taste and smell and a little runny nose. Those symptoms lasted for about a week. April - I had a Biopsy - and that showed it was a cancerous tumor in left breast. Surgery - has been completed and I have started the radiation therapy. I get the radiation therapy at Radiation Center

Sore throat; ear pain; fever; This is a spontaneous report from a contactable consumer, the patient. A 60-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 31Mar2021 at 09:00 (at the age of 60-year-old) as a single dose for COVID-19 immunisation. Medical history included asthma and high blood pressure. 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 31Mar2021 at 20:00, the patient experienced sore throat, fever and ear pain. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the reported events. The clinical outcome of the events of sore throat, fever and ear pain were unknown at the time of this report. No follow-up attempts are needed; information about lot/batch number cannot be obtained.

pain/heaviness in left arm; pain/heaviness in left ram; pain/heaviness in left arm; sweats; chills; diahrea; Weakness; nausea; fatigue; low tolerance to sound and light; low tolerance to sound and light; vertigo; feeling cold; headaches; muscle/joint pain in all extremities; muscle/joint pain in all extremities; diminished sense of taste; blurred vision; confusion; mood changes; increased sleep; physical agitation; difficulty breathing; Aggravation/exacerbation of underlying neurological/ pulmonary conditions; Pain in injection arm persists; This is a spontaneous report from a contactable consumer or other healthcare professional (patient). A 60-years-old non pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, lot number: EL9261) via an unspecified route of administration in Arm Left on 29Jan2021 07:00 (age at vaccination 60 years old, Pregnant at Time of Vaccination No) as single dose for covid-19 immunisation. Medical history included asthma from an unknown date and unknown if ongoing, hypothyroidism from an unknown date and unknown if ongoing, vertigo from an unknown date and unknown if ongoing, migraine from an unknown date and unknown if ongoing None in past 5-6 years, arthritis from an unknown date and unknown if ongoing, affective disorder from an unknown date and unknown if ongoing, nervous system disorder from an unknown date and unknown if ongoing. The patient had unknown allergies Darvon. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medication(s) included umeclidinium bromide, vilanterol trifenatate (ANORO); levothyroxine sodium (UNITHROID); valproate semisodium (DEPAKOTE); paliperidone (PALIPERIDONE). All taken for an unspecified indication, start and stop date were not reported. The patient had historical vaccine of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/lot number: EK9231) via an unspecified route of administration in Arm Left on 07Jan2021 17:00 (age at vaccination 60years old, Pregnant at Time of Vaccination No) as single dose for covid-19 immunisation. Since the vaccination, the patient had not been tested positive for COVID-19. The patient experienced after second dose pain/heaviness in left ram, sweats, chills, diahrea, nausea 3 days. Weakness and fatigue for 3 weeks, low tolerance to sound and light, vertigo, feeling cold, headaches, muscle/joint pain in all extremities, diminished sense of taste, blurred vision, confusion, mood changes, increased sleep, physical agitation, difficulty breathing. These lasted 5 weeks. Mood changes, breathing difficulties, vertigo, muscle and joint pain persist. Aggravation/exacerbation of underlying neurological/ pulmonary conditions. Pain in injection arm persists on unspecified date. Therapeutic measures were taken as a result events which included injection of a medication with high NSAID levels. AE resulted in Doctor or other healthcare professional office/clinic visit. The clinical outcome of the events was recovered with sequelae in 2021. No follow-up attempts are possible. No further information is expected.

I was fine for about 2 months then I noticed I had no taste while I was eating. It?s still this way as of today. Loss of taste.

On March 30 2021, she received her second Pfizer Covid-19 vaccination. Four days after receiving the vaccine she started losing her vision, it was hard to focus and she had double vision. She went to the ER where they did an EKG, chest x-ray, cat scan and lab work and was told to see an ophthalmologist. On April 6 the ophthalmologist told her she had Six Cranial Nerve Palsy on the right side of her eye. She was referred to a neurologist. An MRI was performed on the head to look for additional causes, where nothing additional was found. She has a past history of Bell?s Palsy on both sides of her face. She was not able to tolerate a steroid, so she was seen every 4 weeks for 3 months. After the 3 months her vision started to return during the daytime with double vision still at night. Her sight returned after another 2 to 3 weeks.

Conjunctivitis- pink eye; This is a spontaneous report from a non-contactable consumer, the patient. A 60-year-old non-pregnant female patient received the 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 12:45 (at the age of 60-years-old) as a single dose for COVID-19 immunisation. The patient also received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8727), via an unspecified route of administration in the left arm on 30Mar2021 at 15:30 (at the age of 60-years-old) as a single dose for COVID-19 immunisation. Medical history included rheumatoid arthritis. 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 COVID-19 vaccination. On an unspecified date in Mar2021, the patient experienced conjunctivitis- pink eye. The patient reported that this event occurred for both the doses of the vaccine. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the event experienced. The clinical outcome of the event conjunctivitis- pink eye was not resolved at the time of this report. No follow-up attempts are needed. No further information is expected.

the aches and pains were severe and affected all of her joints; cramping up in her calves and it hurts; sight issues; She could barely move; arthritis; she has real sensitivity to light; She still has pain in her knees when she walks, it's almost like her knees want to give out. Severe pain in hips; severe pain was also in her back, hips and neck; severe pain was also in her back, hips and neck; aches and pains; Diarrhea; Severe fatigue; a little bit of swelling; pain at the site; This is a spontaneous report from a contactable consumer (patient). A 60-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EW0169; Expiration Date: Aug2021, at the age 60-year-old), dose 1 via an unspecified route of administration, administered in arm left on 27Apr2021 13:00 as dose 1, single for covid-19 immunisation. The patient medical history was not reported. Prior vaccinations (within 4 weeks), adverse events following prior vaccinations, patient's medical history (including any illness at time of vaccination), family medical history relevant to adverse events and relevant tests: none. Caller stated she had the shot and a reaction with the first shot and haven't had the second. She clarified she was referring to the covid 19 shot. On 27Apr2021, she had the first vaccine. The day of the vaccine, she experienced normal swelling, a little bit of swelling (not much), and pain at the site, which was normal. The pain went away but she doesn't know it went away. No treatment received. Then, after a few days, she started out with aches and pains but then it got to the point, the aches and pains were severe and affected all of her joints. She could barely move. Her husband had to help her on and off the toilet and that lasted a good week. She also mentions she had diarrhea. She doesn't know. It was probably a couple days later after receiving the vaccine. She was still having diarrhea, but it had improved. She has been taking Imodium. Patient reported that 2 days after she got the shot, she was severely fatigued and that's when the aches and pains started. Caller doesn't know the exact date. If she stands for more than 5 minutes, she has cramping up in her calves and it hurts. She confirms she has recovered with lasting affects. She adds she also has arthritis which might be a factor. She clarifies the aches and pains started on third day. She believes the third day, she is not exactly sure. The aches and pains got worse. When she says severe fatigue, she means she was in bed all day. Time of onset: She would say the fatigue started the 2nd or 3rd day. She provides the start date as: 29Apr2021. The severe fatigue is better than it was but hasn't gone away. She makes the comment she doesn't know why she reacted so bad to the first vaccine. She mentioned she was supposed to go on 18May2021 and get second shot, but she cancelled it. She explains this is one of the reasons she is calling. She needs to know should she get the second shot. Patient wanted to be protected against covid the best she could, her husband has major heart issues and she can't have him being exposed to the virus and she needs to get a shot. She's scared. DSU agent stated we suggest caller reach out to her primary care provider if she has questions on whether or not to get the second vaccine we wouldn't be able to provide her with any medical advice over the phone. Caller stated her doctor said not to take the second shot because she had such a severe reaction to the first one. Her main problem is that she is having sight issues. She has her husband read off the product information from her vaccine record card because she can't really see it. She has always been near sighted but this is to the point, she has real sensitivity to light, that's her main concern right now. First, she had severe pain and then had sight issues. She explained the sight issues started about two weeks in after receiving the first dose, it was right after the severe pain. It has persisted. She has an appointment on Thursday to see her ophthalmologist. She mentions its hard to get into her ophthalmologist. The severe pain started on the 4th day after receiving the first dose, around 30Apr2021. The severe pain lasted a good week, week and a half. She still has pain in her knees when she walks, it's almost like her knees want to give out. Other than that, it's better. She mentions the severe pain was also in her back, hips and neck. Her doctor prescribed diclofenac, 50 mg. She mentions she can see this dose because its bolded and its bigger. No emergency visit. The doctor said to call and see what Pfizer had to say about the second shot because she is really nervous. The outcome of event a little bit of swelling was resolved, diarrhea, fatigue was was not recovered and outcome of all other events was unknown. No follow-up attempts are needed. No further information is expected.

This is a spontaneous report from a contactable consumer, the patient. A 60-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the arm left on 25Mar2021 at 10:30 (at the age of 60-years-old) as a single dose for COVID-19 immunisation. Medical history included Hashimoto's thyroiditis. The patient was allergic to REGLAN and codeine (MANUFACTURER UNKNOWN) and also allergic to mangoes (fruit allergy). Concomitant medications included levothyroxine 75milligrams (MANUFACTURER UNKNOWN). 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 28Mar2021 at 14:30, the patient experienced severe tinnitus, prior she had manageable tinnitus. 3 days after the vaccine, the tinnitus suddenly got much louder. It was severe and debilitating and has not subsided, she experienced fullness in the ears. The 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 the event severe tinnitus and fullness in the ears were not recovered at the time of this report. No follow-up attempts are needed; information about lot/batch number cannot be obtained.

Loud tinnitus; This is a spontaneous report from a contactable consumer, the patient. A 60-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0170) via an unspecified route of administration in the left arm on 21Apr2021 at 11:00 (at the age of 60-years-old), as a single dose for COVID-19 immunisation. Medical history included unidentified autoimmunity issues. The patient did not receive any other medication within two weeks of vaccination. The patient previously took gluten, tree nuts and some antibiotics. The patient previously received varicella zoster vaccine rge (CHO) (SHINGRIX) on an unknown date for immunisation. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8737) via an unspecified route of administration in the left arm on 31Mar2021 at 11:00 (at the age of 60-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 22Apr2021, the patient experienced loud tinnitus. The clinical outcome of the event loud tinnitus was not resolved at the time of this report. No follow-up attempts are needed. No further information is expected.

Tinnitus; This is a spontaneous report from a contactable consumer. A 60-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number: EW0171, Expiry date: unknown), via unspecified route, administered on left arm, as dose 2, single, for covid-19 immunisation on 22Apr2021 at 09.00AM. Patient medical history was not reported. Concomitant medications included Bupropion, metformin, spironolactone and Prilosec (omeprazole). The patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number: ER8732 Expiry date: unknown), via unspecified route, administered on left arm, as dose 1, single, for covid-19 immunisation on 01Apr2021 at 02.00PM. 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. No allergies. The patient experienced tinnitus on 29Apr2021. The patient did not receive any treatment for the event. The outcome of the event was not recovered.

Patient to clinic 07/29/21 to receive first dose Pfizer vaccine. Later c/o tingling of tongue and headache. No c/o swelling or indication of anaphylaxis. Airway unobstructed. No apparent swelling of tongue. Vital signs: BP 186/98 HR 99 RR 20 Temp 99 O2 s sat 98%. Onsite paramedic offered ibuprofen for headache, patient received 400mg of ibuprofen at 5:09 P.M.. Patient advised to seek emergency care due to elevated BP. Patient refused.

Lips and left side of face numbness and tingling about 10 minutes after first dose of Pfizer COVID-19 vaccination. Started first on the lips and then spread to left side of face and continued for 45 minutes to an hour after vaccination.

I experienced a metallic taste in my mouth about a minute after receiving the vaccine. It lingered for approximately six hours.

I went to the emergency room which after the Pfizer injection I had numbness sensation to my face and upper lips, nose and mouth. I feel a pulling sensation to her lips and nose. I have brain fog. I feel the injection affected a nerve in my face. She went to see her primary doctor put her on anti-histamine medication. She states she has no itching at the moment.

Shortly following vaccination, employee reported tongue tingling. She had no difficulty swallowing or breathing. She was evaluated by the physician present at the clinic who felt it might be angioedema. She was observed for an extended time and cleared to return to work at the hospital. No treatment was given.

worry; frustration; regrets/wishing she would have never taken it; phlegm; can't talk; taking her voice, she felt like she was losing her voice; scary/"scaring" her; coughing/cough; difficult for her to catch her breath/lost her breath, couldn't catch her breath/couldn't breath; allergic reaction to the vaccine; This is a spontaneous report from a contactable consumer (patient). A 61-year-old female patient received first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number EL1284, expiry date 30Apr2021) intramuscular on 29Dec2020 09:16 at 0.3 mL, single for Covid-19 immunization in a hospital. Medical history included diabetic, allergy reactions, blood pressure (abnormal), cholesterol (abnormal); all ongoing, and reaction to dust. Concomitant medications included ongoing amlodipine;hydrochlorothiazide;valsartan for blood pressure, ongoing potassium for unspecified indication, BP pills (unspecified) and has cholesterol medications. The patient informed that yesterday (29Dec2020), she got the COVID vaccine shot at work, received it at 9:16 am and was monitored for 30 minutes post administration. The patient went to work and was holding the babies. The patient worked in transport in the NICU at a hospital. Few hours after the injection, while working in the NICU, she experienced coughing to the point where it was difficult for her to catch her breath. The patient started coughing so bad, she had no control. She mentioned trying to drink water and continued coughing more. The patient lost her breath, couldn't catch her breath, she had to call for the charge nurse (manager), as she couldn't breath and they took her to the ER and consulted at the ER of her facility. The patient informed that she kept coughing and couldn't catch her breath. They made her drink water. The patient has allergies, so she always has an epi pen with her. The patient felt like she had an allergic reaction to the vaccine. The doctor there explained that her symptoms were not related the Covid-19 vaccine she received earlier. The patient specified that the last time she had a similar reaction was at work and was due to dust. The patient explained that she was perfectly fine before receiving the vaccine, laughing, and so what can her symptoms be related to, if it was not the vaccine. The patient was coughing all night, can't get rid of the cough. She has called her doctor. The nurse said just to watch herself for now. The patient informed that she was supposed to go back to work tomorrow and she was afraid to go around the babies. The patient informed that today (30Dec2020), she gargled apple cider vinegar and salt water, and phlegm came out. The patient continued saying that she has still been coughing, can't talk and that it was scary. The patient informed that she was taking her voice, she felt like she was losing her voice. It was "scaring" her. She was unsure if it was the Pfizer vaccine. The patient attempted to reach her HCP and that she cannot be seeing at her clinic due to her cough. The patient mentioned that she won't have access to a respiratory clinic until Tuesday. The patient expressed her concerned about returning to work with babies and asked if she should return to work tomorrow. The patient pursued verbalizing her worry and frustration. The patient asked if she can decide not to get the second dose. The patient voiced her regrets on receiving the first dose of the COVID-19 vaccine. She stated wishing she would have never taken it and that all who have an EpiPen should not receive it. The outcome of the event cough was not recovered, Dyspnoea, Allergy to vaccine, Productive cough, Speech disorder, Aphonia, Nervousness, Anxiety, Frustration tolerance, Depressed mood was unknown.

Pt stated that she was feeling a tickle in her throat 10 minutes after administration of the vaccine. Pt stated that her throat is dry and feels a sensation to cough. Pt stated that started feeling swelling of the tongue 30 minutes after administration of the vaccine. Pt was given water and says that it helped relieve itching. Pt was given benadryl 25mg IM and is being monitored. Charge nurse is taking over monitoring and care of patient.

Employee received vaccine at 8:10AM. Slight throat tightness was reported at 8:24AM. Patient given Benadryl suspension 25 mg at 8:26am. Patient then reported throat felt, "a little better". Vital signs BP=189/88; P=90; Oxygen saturation 97% room air; Temp 97.3. At 8:30 patient reports throat feels "worst". Pt. noted to have bumps on tongue - 1 size of chick pea and smaller bumps on back of tongue. Oxygen sats 91%. Epi pen administered at 8:37am and EMS called. 8:45 SAFD on site.BP = 207/81; P=110;oxygen sat = 100% room air. 8:41 Bumps on tongue decreased in size. Oxygen sats 99% room air. 8:52 Paramedics arrive and patient taken to hospital.

First dose given 12/18/20 with expected muscle stiffness soreness later that evening and the next day. Dose two given on 01/07/21 with onset of shaking chills on 01/08/21 at 2:00am, ensuing fever max 101.7 degrees Fahrenheit, at 4:00 am noticed redness of eyes, face flushed with burning feeling, headache, dizziness, blood pressure of 184/96 and heart rate of 153. This required medical evaluation and treatment with IV fluids and Toradol for resulting headache. Patient also self administered 1000mg oral Tylenol prior to ER evaluation.

Red cheeks hot face dizzy shortly after. Had to pull over and needed my son to come get me. Two hours later cheeks still red not as red. Am home. Don?t feel normal. Very dry mouth and throat.

metallic taste in my mouth; This is a spontaneous report from a contactable nurse (patient). A 61-year-old female patient received first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; lot number: EL1284; expiration date: not known), via an unspecified route of administration on right arm on 06Jan2021 07:15 at single dose for covid-19 immunization, administered at hospital. Medical history included pacemaker for bradycardia w/syncopal episodes; and allergy to poppy seeds and pineapple. The patient is not pregnant at the time of vaccination. Concomitant medications included rosuvastatin calcium (CRESTOR), colecalciferol (VIT D3), and an unspecified multivitamin (other medications received within two weeks of vaccination). No other vaccines received within four weeks prior to covid vaccine. The patient previously took morphine and experienced drug allergy. The patient was not diagnosed with covid-19 prior to vaccination and had not been tested with covid-19 since the vaccination. The patient experienced metallic taste in her mouth approximately one minute after receiving the vaccine on 06Jan2021 07:15; it lingered for about six hours (13:15). The event was reported non-serious. The patient did not receive treatment for this event. The outcome of the event was recovered on 06Jan2021 13:15.

Was premedicated with Medrol, Singulair and Zyrtec 20 minutes after vaccine developed paresthesias of both sides of lower face, lips and face swelling. This resolved in @ 20 minutes. Next day developed excessive fatigue with difficulty talking and a heavy sensation in the chaste with an event of fullness sensation of the right soft palate and tongue.. This became worse on the second day for which needed treatment with Medrol pack and antihistamins.

About 30 minutes after taking the vaccine, when I was driving home, my face got very hot and red. I also started feeling lightheaded like I might faint. I pull over into a parking lot and had a family member come get me to drive me home. I was extremely thirsty and drank a lot of water at home. Eventually, my redness went away and my face did not feel as hot. I did feel other more typical symptoms too such as painful arm, and flu like symptoms. I am mainly concerned about the reaction I had when driving home since it was similar to what happens when I take cortisone or Doxycycline. I am needing information as to whether it is safe for me to take my second dose of the covid vaccine.

Pfizer-BioNTech COVID-19 Vaccine EUA. //Symptoms began 12 hours after with increase soreness at injection site radiating up and down arm and up into neck ; Body aches especially lower back developed within 24 hours with a severe throbbing type headache and ringing in the ears. Elevation of temperature by 1-2 degrees normal for me runs 97 degrees F and was up to 99 degrees F. Headache intensified with movement(ex. .bending over ,etc) Treated arm soreness and lower back with heat compresses... elevated temp and headache with rest and a lot of water. It is now over 48 hours since vaccination and all symptoms are subsiding but still present with temperature normal for me and no arm soreness. Scheduled day off from work day after vaccination but also a second day due to the severe headache mostly.

immediate metallic taste in mouth accompanied by tachycardia to 120 (usu pulse is 65) followed by unusual feeling in mouth, not itchy, but tingly-type sensation. lasted about 1 1/2 hours, same reaction happened with both first and second doses, the second time was a little more intense and longer lasting.

2nd and 3rd branches of trigeminal nerve, bilateral, more left than right: odd feeling throughout muscles, tongue felt thick, mild tongue coordination alteration. Left 2nd and 3rd branch trigeminal nerve mild numb sensation though unclear if I have mild paresis too. Mildly reduced tongue coordination continues.

Was cold, took a shower, got out , couldn't get warm. Freezing and shaking, nausea, tingling in left side of face, joint pain, headache and neck pain. Lasted about 3 hours, shaking stopped but had chills that lasted all night. The next day, no appetite but when she ate something, she vomited. Worse things were shakes, headache and neck pain and vision. . Had vision problems. Eyes were swollen and jittery and hard to focus. The swelling went away but still unable to focus. Everything has gone except vision issue.

Systemic: 6 hours after vaccine lost voice, 8 hours after mouth, tongue, throat itching. next morning had face and lip swelling and tingling. self treated with antihistamines. resolved after 3 days.

she had blister on the right side of the tongue /has blisters on her tongue or maybe ulcers; she had blister on the right side of the tongue /has blisters on her tongue or maybe ulcers; rash on the neck; which was burning /burning on skin where the rash is; had difficulty in breathing due to congestion in throat; had difficulty in breathing due to congestion in throat; This is a spontaneous report from a contactable consumer (patient). A 61-year-old female patient started to receive BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EJ1685 and expiration date not provided), via an unspecified route of administration (right arm) first dose on 07Jan2021 15:45 at single dose for covid-19 immunisation. The patient's medical history ongoing Asthma, ongoing Psoriasis, ongoing Eczema, and ongoing Osteoporosis. There were no concomitant medications. The patient stated yesterday she got the vaccine, about a half hour later her neck started to get red like a rash, and as the evening went on it felt like burning on her skin at the rash. She had a hard time breathing last night and had to sit up to sleep. Then this morning she had a blister on her tongue.The patient clarified the first dose of vaccine was on 07Jan2021 at 15:45 PM in the right arm. She noticed about 30 minutes later, a rash on the neck and then burning on the skin where the rash was that evening; then that night she had a hard time breathing and had to sit up to sleep due to congestion in her throat. She had to keep clearing her throat. This morning (08Jan2021) she noticed she has blisters on her tongue or maybe ulcers, just on the right side. Asking should she take some Benadryl? Was this expected side effects?. The patient wanted to know find out if she should get the next dose? The patient relevant tests include COVID 19 test on 07Dec2020 and it was negative. The outcome of the event Neck rash was recovering and not recovered for the remaining events.

After waiting 15 mins I developed a dry throat and walked to my car (8-10 mins later). Began to develop difficulty swallowing by the time I reached my car. Waited a few minutes and it did not abate and continued worsen,. Went to hospital's ER and was seen by Dr. At that time, my voice had become coarse and gravely. Was given oral steroid and a Benadryl. Symptoms lessened a bit and were gone after about 2 hours. While at first I thought my breathing wasn't affected, after symptoms cleared, I realized that my breathing was easier. Symptoms did not reoccur.

Slightly sore left deltoid, cleared up in a few days. 16 hours after shot, experienced the dramatic sensation of tilting while sitting on a couch. Had I been driving, this would likely have caused an accident. This is the first time I have ever experienced this feeling. There were 2 or 3 other episodes of feeling like I was falling. 2 of this happened while lying down. They were sudden sensations that made me gasp. Spent most of 1 week in bed with fatigue, vertigo, and 2 times vomiting. Vomiting occurred day 2 post vaccine. Fatigue was continuous for about a week. At day 16 now, certain movements still illicit vertigo. All vertigo symptoms have lasted under 1 minute. However, some have been back to back, such as after repositioning multiple times in bed. Ears have felt very full for almost 2 weeks. Certain head positions or movements, still illicit sensations of the room moving. There was no specific headache, but my head did not feel good for about 2 weeks. There was no fever, but there was chilling one night, a couple of days after the vaccine. I don't know if getting 2nd vaccine is wise.

Dose 2 given at 1208 on 1/20/2021. At 1232 pt noticed flushing in the arms b/l, persistent pins and needles in arms, hands, and feet b/l, with "slight tingle" in lips. Unusual taste in mouth (that happened after 1st dose as well). Small wave of nausea. Sensation of heat in chest. At 1301 on 1/20/2021, 50 mg of IM Benadryl administered to RD (Lot # 080010, Exp 8/20/2022) by NP. At 1320, arms were less flushed, however b/l pins and needles persistent in both arms and feet, with "tingling" still in lips. Pt will wait until symptoms improve further to d/c to home. NP checking in continuously.

mild tingling of lips after injection - within 1st hour. Fever- up to 101.6 degrees- noticable after 15 hours of the vaccine Chills- off and on after about 15 hours of vaccine Body aches and pains/ fatigue Headache- severe

Due to hx of allergic reactions, pt was told to wait for 30 minutes in observation prior to vaccination. At 1208 on 1/20/2021 pt received 2nd dose of COVID Pfizer vaccine. Immediately after vaccination, pt experienced unusual taste in mouth, flushing, and feeling of heat in chest. At 1232, pt noticed flushing on arms and feelings of heat and pins and needles in both arms, hands, chest, both feet, and back. Sensation was persistent, so at 1301, 50 mg of IM Benadryl administered to RD by NP. By 1320 flushing on arms and chest subsided, feeling of pins and needles persisted but was not as severe as initial reaction. By 1345 flushing on arms returned, pins and needles sensation worsened again in all locations noted prior, spread to scalp, and tingling sensation occurred on lips. Pt communicated with Dr advised to stay under observation, but transfer to ED not medically necessary. At 1415, pt was advised to go home with supervision of partner and monitor symptoms from there.

Second, dose 1/16/21 Pfizer LOT: EL3248 Saturday 11:30 am ? Side Effects started about 1.5 - 2 hours after injection (I took 2 Tylenol and took a 3 hour nap) o Tired o Left Eye twitch o Blurred double vision o Headache o Nauseous ? Side Effects started about 5 - 6 hours after injection (I took 2 Tylenol a Benadryl and used my Ventolin inhalator) o Tired o Watering eyes o Sore tongue o Headache o Nauseous o Heavy feeling in chest ? Side Effects started some time during the night after injection o Muscle cramping in both legs and opposite arm of injection site o Low fever 100.3 Sunday side Effects (I took 2 Tylenol and took a 3-4 hour nap) o Tired o Left Eye twitch o Watering eyes o Sore tongue o Excessive thirst o Swollen neck glands o Nauseous (only after eating) o Muscle cramping in both calves o Blurry vision in the evening o Runny nose Monday side Effects (Went to work) o Tired o Left eye lid twitch o Swollen neck glands o Nauseous o Runny nose o Achy body o Diarrhea Tuesday side Effects (Went to work) o Left eyelid twitch o Swollen neck glands o Runny nose o Sore throat o Diarrhea BLOODY Wednesday side Effects (went to work) o Swollen neck glands o Runny nose o Sore throat Note: I have several Allergies that require me to take an allergy pill every day. I also use an inhaler as needed. My symptoms were not any worse than when I have a bad allergic reaction, I have received shots of Epinephrine for my allergies and did not feel one was necessary.

Pt received dose 2 of 2 dose series of Pfizer COVID-19 vaccination at 1200 on 1/25/2021. At 1220, pt. reported "tingly feeling on tongue" and swelling of lips. NP notified and assessed pt. Benadryl advised, but pt. refused 50 mg of IM Benadryl because it has cholinergic effect, leading to agitation, tachycardia, racing thoughts. Pt. advised to stay under observation until symptoms resolved fully. At 13:02, at time of filling out form, pt. reported symptoms had decreased, denies tingling of tongue.

Patient seated in observation area for a 30 minute observation after injection of Covid 19 vaccine. Patient after 5-10 minutes stated she had tingling to tongue and lips. Shaking noted to hands and patient stated she felt numbness to upper extremities with dizziness then felt light headed. Patient transported to first aid room for further assessment and observation. Patient was A&O x4, lungs clear to auscultation, patient stated she felt like she needed to take a "deep breath". Patient had O2Sat of 95% on RA and B/p of 130/80. at 1016 covering provider ordered to give patient given 12.5mg of Benadryl liquid with 16oz of Water intake during observation period. Continued to monitor patient and noted that was able to ambulate at 1025 to bathroom with assistance but still experiencing dizziness. Patient monitored for a total of 45 minutes then discharged home.

Chills, low grade fever right away. Next 9 days--severe stomach burning, nausea, unable to hold fluids down, "metal taste"--by day 9 went from 103 kg to 92 kg. Slowly got better after this with time and Pepto Bismol.

During 15 min observation after receiving vaccine, patient reported tingling in lips and diaphoresis. Patient was administered diphenhydramine 50 mg PO while in vaccine clinic, rapid response was called and patient was transported to the ED. Patient was administered famotidine 40 mg PO and prednisone 50 mg PO and released from ED 5 hrs later.

1453: complained of tingling to tongue; Dr. examined, ordered Benadryl 25 mg IM, temp: 98.1, BP 135/61, HR: 59 1456: Benadryl given 1508: reports tongue feels better, examined by MD, MD released to home after 30 more mins of observation Assessment: lungs clear, no SOB, VS stable, no rash, resolving after 15 mins post benadryl

After first dose I felt an overall odd feeling . no shortness of breath etc, just odd. I was thinking it may have been just some anxiety. I left the center after 15 minutes and came back to Pediatric office where I work. I did take a Zyrtec and felt completely better after approx. an hour. After the 2nd dose I did mention I had felt odd after 1st dose and decided to sit for 30 min. I felt about the same as I did after the 1st dose so I left. when I got to my car my face was flushed. I was not tachycardia just a very odd felling in my head and then my tongue did start to itch (or feel funny) . I took a Zyrtec and went home. I never had any swelling of lips or tongue, no trouble breathing. Pulse stayed constant around 80. This time the symptoms lasted approx. 4 hours. I I did continue to take Zyrtec for 3 days after injection.

A day after getting the vaccine, had fatigue, body ache, headache, fever of 101, sore throat, bitter taste, dizziness.

My eye is swollen, I have knots on my forehead over my right eye. I thought it was a spider bite but now I am not sure

about 30-45 minutes later started feeling numbness on left side of face; left lower lip remained slightly numb; This is a spontaneous report from a contactable nurse. A 61-year-old female nurse reported that she received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number EJ1686), intramuscular at single dose into the left arm on 08Jan2021 at 03:30 PM for COVID-19 immunization. First dose of BNT162B2 was received on 18Dec2020. Medical history included rheumatoid arthritis, coronary artery disease and hypertension. Past drug history included NSAIDS which caused bleeding. The patient's concomitant medications were not reported. The patient reported that about 30-45 minutes after vaccination she started feeling numbness on left side of face and left lower lip remained slightly numb. The events were reported as non-serious. The patient did not receive any treatment for the events. Since the vaccination, the patient has not been tested for COVID-19. The outcome of the events was not recovered.

10 -15 minutes after shot: Swelling of tongue; drainage from nose and back of throat;gourde voice; trouble swallowing : elevated blood pressure Told nurse 25 minutes later.given benedryl injection Things improved and an hour later tongue began to swell again and blood press increased Paramedics called and they transported me to the ER where I was given an Epi injection and steroids. Monitored for three hours and sent home with prescription for steroids: epi pen; and zyrtec Still experiencing fatigue , headache and lots of drainage off and on

This is a spontaneous report from a contactable physician (patient). A 61-year-old female patient (not pregnant) received second dose of bnt162b2 (Pfizer-BioNTech COVID-19 mRNA vaccine, Lot Number: EL3294 and Expiration Date unknown) via an unspecified route of administration on 11Jan2021 07:15 AM (Right arm) at single dose for COVID-19 immunisation. Previous vaccine included first dose of bnt162b2 (Pfizer-BioNTech COVID-19 mRNA vaccine, Lot Number: EK5730 and Expiration Date unknown) via an unspecified route of administration on 21Dec2020 03:45 PM (Left arm) at single dose for COVID-19 immunisation.No covid prior vaccination, no covid tested post vaccination and no known allergies.Other medical history included thyroiditis and scleritis The concomitant medications included Levothyroxine, Vitamins, paracetamol (TYLENOL), Pepsid, Melatonin. No other vaccine in four weeks. Patient experienced, fatigue, left under eye bruise, right eye injection, joint swelling, gum bleeding with brushing on 13Jan2021 08:00 AM, resulted in Doctor or other healthcare professional office/clinic visit. The outcome of events was not recovered with unknown treatment.

Bells Palsy Signs and Symptoms Right Side for the last 72 hours with ear pain and eye twitches. noticeable onset this morning 1/30 with right eye right and upper lip involvement.

alost fainted- very pale, then tachycardia, high blood pressure, diarrhea. This reoccurred i waves over the next week. Also fatique,, muscle and joint pain. for 6 days also had sever headace, numbness in face and lips, spasm of left eyebrow. Mised wek of work, ended up in Emergency room. Had negative covid test. sent home. Was fatiques and dizzy and brain fog for next three weeks. Took a month to feel rigtht.

in first half hour, heat/flush came up the left side of neck and face up to eye. inside of ears felt warm. extreme tinnitus. took Benadryl and slept. after 5 hours, symptoms came back. feels like lower jaw is pulling to right. took more benadryl.

Metallic taste in her mouth. Violent shaking for 11.5 hours and pulled muscles in her stomach and back. Injection site hot. Fingers on that side were white Dizziness. H/A. Vomiting

Severe sudden diarrhea, headache, weakness, taste of smoke with burning sensation. Today unable to do anything, very tired.

Patient reported tingling to tongue. No SOB nor difficulty breathing. Also reported feeling light headed. No antidote nor supportive treatment given. Symptoms resolved within 30 minutes.

COVID tongue began Jan 23, 2021 and is currently continuing. Symptoms whitish tongue, burning , swollen tongue with divots on the sides. I work in a covid icu and had one of the covid intensivist verify what was wrong. Previous report filed on reactions that started on January 21,2020 on this site

lost 22lbs; teeth hurting; can't eat; sores in mouth; cold chills; Headache/it's mainly in the back of her head; Diarrhea; Throwing up/threw up 4 times; low grade temp of 100; This is Spontaneous report from a contactable consumer reporting for self. A 61-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL0140), via an unspecified route of administration in Right arm on 14Jan2021 10:00 at single dose for covid-19 immunisation. Patient received 1st dose of bnt162b2 on 24Dec2020, Lot number: EL0140; She only had a little aches with the first dose. States that she has had Covid before. There were no concomitant medications. She got the 2nd covid vaccine and felt like she got Covid all over again, diarrhea, throwing up, cold chills, and headaches started on 15Jan2021 at around 2:00AM, low grade temp of 100 on 15Jan2021, then she got sores in her mouth and now her teeth hurt. States that maybe it's from the fever. States that she can't eat because it hurts. She lost 22lbs because she couldn't eat. She has been gargling with half warm water and half peroxide. States that she threw up 4 times, but she doesn't even remember how many times she had diarrhea. After she was done throwing up she finally sat down and took her temperature, so it was probably around 4:00-5:00 AM. States that she still has a headache; it's mainly in the back of her head. Outcome of event diarrhea, throwing up, low grade temp of 100, chills was recovered, of headache was recovering, of can't eat and lost 22lbs was unknown, of others was not recovered.

She wore sunglasses in her house because the light bothered her eyes; Eyes felt dry; Loss of vision in right eye; Hole in her retina; Bad headache for 3 days; This is a spontaneous report from a Pfizer Sponsored Program. A contactable consumer reported similar events for 2 patients. This is 1st of 2 report. A 61-year-old female consumer (patient) received 2nd dose of BNT162B2 (Covid Vaccine, lot number: EL1248) on 06Jan2021 at single dose in the right arm for COVID-19 immunisation. Medical history was not reported. Concomitant drug included Multivitamin, Vitamin C, Vitamin D Zinc all from Mar2020 and ongoing. Historical Vaccine was 1st dose of BNT162B2 (Batch/lot number: EK5730) on 18Dec2020 in the right arm. Patient got COVID vaccine and a few hours later or the next day she started getting a hole in her retina and started losing her site in right eye. she went to the doctor as she has a hole in her retina. Again, this may be totally unrelated but she wanted to call and get this reported. She is going to see a retinal specialist this afternoon. After she had her COVID vaccine she had a bad headache for 3 days. She wore sunglasses in her house because the light bothered her eyes. She noticed this on 16Jan2021 because she was looking at paperwork and her eyes felt dry. She blinked a few times and had opened one eye alone, and she noticed that her left eye was fine but the vision in her right was not. This could have been going on longer. She just never closes only one eye. When both are open, her vision is normal. She saw the eye doctor yesterday, and that is when they said she had a hole in her retina. They said she will have to have surgery to close the hole. She knows she is at the right age for this to spontaneously happen, but just in case it is related, she wanted to report it. Outcome of the event Loss of vision in right eye was Not Recovered, for headache was recovered, for other events was unknown. No follow-up attempts are needed. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021046804 same reporter, AE and drug, different patient

Difficulty swallowing, tongue swelling, headache, Epi pen 0.3mg, 25 mg Benadryl Improvement in tongue swelling

Began to have a slight tingling feeling in my bottom lip a few hours after vaccine. Next day, the tingling continued and felt more burning sensation but never severe. However, did contact my primary care provider and they suggested that I take Benadryl to help it. I took it for several days and the tingling/burning feeling stopped completely after about 10 days. I did not have any swelling of lips or tongue but just the tingling/burning sensation.

Tingling upper and lower extremities, tingling left lower lip and cheek, weird feeling in head. Symptoms started February 1 at 6 PM were intermittent until 6 AM February 4. No symptoms until 6 AM February 6, again they were intermittent. Virtual visit with nurse practitioner at MD office February 6 at 11 AM. No symptoms since 6 AM on February 6.

Patient described having a "mild reaction" to first dose Pfizer BioNTech vaccine, and pre-mediated with 50 mg diphenhydramine as well as her morning cetirizine 10 mg before the second dose. Approximately 10 minutes s/p second dose the patient experienced dizziness, facial tingling, anxiety, hard and soft palate numbness, and flushing. She was helped to a stretcher and her BP was 204/94. The patient was taken to the ED for further monitoring. In the ED, she denied any throat swelling, tongue swelling, or difficulty breathing on arrival. She also denied any chest pain and palpitations. She received methylprednisolone 125 mg IV x 1 and a liter of normal saline, underwent observation, then discharged home uneventfully.

From charting for point of care services before EMS transport: Chief Complaint: Immunization Visit: Client received Pfizer Vaccine at 11:30am. At 11:32 am client reports "throat feels a little funny" and Chest tightness. No difficulty breathing reported. Lung sounds clear bilaterally per RN at 11:38am. Pt reports that her throat still feels funny after administration of benadryl by RN. Epi was administered at 11:40am by RN. EMS arrived at 11:42am. Client has is now complaining of jaw pain. Reports shoulder pain ( residual from recent accident). Vital signs obtained by RN Her husband was present when EMS arrived and will follow client to the hospital.

splitting headaches; chronic nausea; Vomiting is explosive and unpredictable; metallic taste in mouth for 3 days.; This is a spontaneous report from a contactable other hcp, the patient. This 61-year-old female patient received BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine) (Lot number: EK5730), dose number 1, via an unspecified route of administration in the right arm on 29Dec2020 at 11:00 (at the age of 61-years-old) as a single dose for COVID-19 immunization. Medical history included type 1 diabetes mellitus from 1974 to an unknown date (T1DM dx 1974) and aortic valve replacement from 1990 and unknown if ongoing (AVR 1990 and 1992). Concomitant medication included insulin (INSULIN), simvastatin (SIMVASTATIN) and lisinopril (LISINOPRIL). 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. The patient was not pregnant at the time of vaccination. On 31Dec2020, the patient experienced metallic taste in mouth for 3 days. On 07Jan2021 at 13:00, the patient experienced splitting headaches, chronic nausea began and vomiting which was explosive and unpredictable. No therapeutic measures were taken as a result of the events. The clinical outcomes of the metallic taste in mouth for 3 days, splitting headaches, vomiting and chronic nausea were not resolved. It was also reported that since the vaccination, the patient had not been tested for COVID-19.

Injection Site Pain, tiredness, headache severe, muscle pain, chills, joint pain, fever, nausea, feeling unwell, cough

AT 3:41PM PATIENT TONGUE FEELS "OFF", HAS HAD FEELING FOR 10 MINUTES BEFORE REPORTING. PATIENT REPORTS FEELING SMALL AMOUNT OF DRAINAGE IN THROAT. ADMINISTERED 50MG OF DYPHENHYDRAMINE, IM, RO AT 3:43PM. PATIENT MONITERED VITALS EVERY 5 MINUTES. AFTER MEDICATION PATIENT REPORTS FEELING DIZZY AND "LOOPY" AT 5:17PM PATIENT COMPLAINS OF TONGUE SWELLING AND BLOOD PRESSURE ELEVATED. EMS CALLED, ARRIVED AT 5:34PM, PT TRANSPORTED TO NORTHSIDE HOSPITAL. FOLLOW UP CALL, NEXT DAY PATIENT STATES SHE WAS GIVEN STEROIDS IN THE ER AND PRESCRIBED AN EPI PEN FOR FUTURE USE.

I received the first vaccination of pfizer at 10:00am Friday, February 12, 2021. I felt fine most of the day, only right arm hurt at the site of the vaccination. Then around 7:00pm at night the right side of my nose went numb, as the night went on, the right side of my mouth was numb. No changes upon waking Saturday morning. As the day went on the numbness subsided on the nose and mouth and moved down onto my chin. Today Sunday, very little numbness on nose and mouth, some on chin. Site of vaccine feels fine.

2nd COVID-19 vaccination on 02-11-2021. NO symptoms with 1st vaccination. I woke up to a fever of 99.8 on 02-12-2021, which gradually escalated to 102 within 2 hours. It remained at 102 for most of day. Finally came down to 101.1 by around 6:00PM. My normal body temperature is low- around 97.6. I also had an odd sensation at the back of my throat- cannot really describe it- sometimes hurt to swallow- but not consistently. Only felt that symptom the day of 02-12-2021. The next morning, my temperature was 99.2. Eventually returning to normal around 3:00 PM that afternoon. I did not take any OTC medications during the course of recovery.

Severe migraine headache with pain behind eyes with uncontrolled tearing, ringing in head, pain and pressure lasting about 12 hours. No treatment. Dull headache with numb forehead lasting several days. Took Advil for 3 days Wheezing and shortness of breath lasting 6 hours and the same symptoms the following day lasting about 6 hours. No treatment Did call the doctor with my reaction and concerns for second dose recommendation.

Mouth and tongue (top and bottom) numb and stinging, facial swelling and red rash - 5 days Fever 101 - 2 days headache - 5 days nausea - still have diarrhea - 6 days Sore and stinging left arm (received vaccine), sore upper and lower back and neck. Felt like I was kicked in those areas - still have Fatigue - 6 days, lessening Toes bright red at the top and are painful, areas on bottom of toe as well - still have

almost like she also had some mild hearing loss; nausea; exacerbation of migraine with paresthesia and tinnitus/ headaches/migraines; exacerbation of migraine with paresthesia and tinnitus; exacerbation of migraine with paresthesia and tinnitus/ increased tinnitus; some abdominal tightness; This is a spontaneous report from a contactable pharmacist (patient herself) via Medical Information team. A 61-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; lot number: EL3302, NDC number/expiration date was unknown), via an unspecified route of administration on the left arm (also reported as upper left arm) on 13Jan2021 at 09:00 at a single dose for COVID-19 immunization; the patient was a healthcare worker and was trying to protect herself. The vaccination facility type was reported as a drive thru site. Relevant medical history included previous neurological problems, which included history of underlying migraine with paresthesia/chronic paresthesia (ongoing) and tinnitus. The patient had no family medical history relevant to the adverse events (AEs). There were no concomitant medications. The patient had no other vaccine received on the same day of the Pfizer suspect or 4 weeks prior. She never had any problems with vaccines in the past. History of all previous immunization with the Pfizer vaccine considered as suspect was reported as none. Initially, the patient was asking if there were any reports of paresthesia, serious neurologic adverse events, tinnitus, hearing loss, or abdominal tightness in the studies for the Pfizer-Biontech Covid-19 vaccine. After the patient received the first dose of the Pfizer-BioNTech COVID-19 vaccine on 13Jan2021, she experienced an exacerbation of migraine with paresthesia and tinnitus. She also reported experiencing some abdominal tightness on an unspecified date in Jan2021. The patient reported she was scheduled for her second dose of the Pfizer COVID-19 vaccine, but had concerns because she was still experiencing tinnitus and it was "almost like she also had some mild hearing loss" on an unspecified date. The patient further reported that she was due for the next dose the following day at the time of the report (03Feb2021). She had previous neurological problems and did not know if this did exacerbate things or not. She had migraines, tinnitus, and paresthesia and was wondering how many other patients with neurological problems reported this and was this a common side effect or adverse event reported. One doctor told her not to get the second dose and another one told her to get it and she wanted to know what she should do. The patient had headaches/migraines on the evening of vaccination on 13Jan2021 that were fairly mild and 3 days after that on 16Jan2021, they got bad and was accompanied with nausea with increased tinnitus. The migraines and nausea had gone, and the chronic paresthesia was the same as she always had, but the tinnitus was a lot louder and worse. The patient also mentioned that her migraines usually go away, but this one had lingered. The AEs did not require any visit to an emergency room or a physician office. There were no investigation assessment. The patient recovered from the event "nausea" on an unspecified date, she was recovering from the event "exacerbation of migraine/ headaches/migraines," she was not recovered from the events "exacerbation of paresthesia and tinnitus/increased tinnitus, while the outcome of the events "almost like she also had some mild hearing loss and some abdominal tightness" was unknown. The reporter assessed the events "migraine, tinnitus, paresthesia, and nausea" as serious, other medically important conditions. The relatedness of drug to the reactions/events "migraine, tinnitus, paresthesia, and nausea" was unknown as per the reporting pharmacist (Method of assessment: Global Introspection).; Sender's Comments: The 61-year-old female had relevant medical history included previous neurological problems. The reported neurological events and partial hearing loss were more likely due to pre-existing conditions, and less likely related to the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE). Event nausea was likely due to the first dose of bnt162b2. The case will be reassessed should additional information become available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics committees and Investigators, as appropriate.

1/7/2021 vaccination 1/9 abcess on tooth; dental pain Following Tuesday, root canal 1/11/2021. Dentist suspected that the vaccine opened avenue of abscess; triggered. 1/10 Saw PCP and following week EKG, Stress test and appt with cardiologist. Cardiologist suspects inflammation to the valve symptoms.

This is a spontaneous report from a contactable pharmacist. A non-pregnant (not pregnant at the time of vaccination) 61-year-old female patient received BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine, lot number: EN5318), intramuscular, first dose on 23Jan2021 09:45 at single dose, for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient was seated in observation area for a 30 minute observation after injection of COVID-19 vaccine on 23Jan2021 09:45. At 10:00, after 5-10 minutes stated she had tingling to tongue and lips. Shaking noted to hands and patient stated she felt numbness to upper extremities with dizziness then felt light headed. Patient transported to first aid room for further assessment and observation. Patient was alert and oriented (A&O) x4, lungs clear to auscultation. Patient also stated she felt like she needed to take a "deep breath". Patient had O2Sat of 95% on room air (RA) and blood pressure (B/p) of 130/80. At 10:16, physician ordered to give patient 12.5mg of diphenhydramine (BENADRYL) liquid oral 1 dose with 16oz of water intake during observation period. Patient was continuously monitored and noted that was able to ambulate at 10:25 to bathroom with assistance but still experiencing dizziness. Patient was monitored for a total of 45 minutes then discharged home. Facility where the most recent COVID-19 vaccine was administered was at a public health clinic/veterans administration facility. Since the vaccination, the patient has not been tested for COVID-19. The outcome of the events was recovered on 23Jan2021 10:30. Case was reported as non-serious.

Thursday February 4th I had Severe Headache, Earache, low grade temp, sore throat then by the Tuesday the 9th I noticed drooping to the right side of my face. Went to the ER and was told it was bells palsy

15 minutes after receiving Pfizer 2nd dose COVID-19 vaccination developed swelling of tongue, stridor and respiratory distress. EPI pen administered right away and employee was transported to ED stat by rapid response team.

metallic taste in mouth; metallic taste in mouth; This is a spontaneous report from a contactable other healthcare professional (patient). A 61-year-old female patient (non-pregnant) received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number= EK4176), via an unspecified route of administration on 19Jan2021 at single dose at right arm for covid-19 immunization. Medical history included T1DM (Type I diabetes mellitus) from 1974, AVR (aortic valve replacement) from 1990 (AVR 1990 and 1992). No known allergies. Concomitant medications included insulin, simvastatin, lisinopril. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, patient had not been tested for COVID-19. Patient previously received first dose of bnt162b2 (lot number= EK5730) via an unspecified route of administration on 29Dec2020 11:00 AM at single dose at right arm for covid-19 immunization, and had metallic taste in mouth on 31Dec2020 for 3 days, chronic nausea began 07Jan2021, vomiting was explosive and unpredictable, and still occurring, splitting headaches. The patient experienced metallic taste in mouth on 19Jan (pending clarification) with outcome of not recovered. The adverse events resulted in neither doctor or other healthcare professional office/clinic visit, nor emergency room/department or urgent care. Patient didn't receive any treatment.

Covid 19 Vaccine screening questionnaire reviewed , administered Covid vaccine; patient developed coughing spells, non productive after 2-3 minutes after the vaccine administration, she states she felt like fainting. Lung sound checked - no wheezing. Pulse Oximetry checked 96%. Observed for 30 mins in the field. Intermittent coughing still noted. Pulse oximetry remained 96%, no shortness of breath or difficulty breathing. After 3 0 mins, patient continue to cough , states she feels tickles in her throat that makes her cough and she has a headache. Patient given Benadryl 25 mg p.o. and monitored for 30 mins. Patient felt better after 25 mins of observation and minimal coughing , pulse oximetry @ 96-98% denies SOB or difficulty breathing . Patient sent home with husband and advised to rest at home and call 911 if she develops SOB or difficulty breathing. Followed up call over the phone at 5: 00 PM , patient states she fell asleep when she went home and no cough , no SOB or difficulty breathing.

Received first COVID vaccination at 3:50pm and 5-10 minutes later began to experience pain and throbbing in jaw and lower molars. pain began moving forward. tongue began to tingle and mouth went numb. Glands were swollen and pain was experienced in both ears, under both eyes and cheek bones. Also experienced pain in the top and back of head.

chills, fever 3-4 hours after vaccine administration injection site pain: took Tylenol 1200mg, helped. Limited range of motion noted on L arm, could not lift arm ROM more than 30 degrees 12 hours after vaccine still had chills, and fever. Then started to itching on both hands, noticed and uncontrollable itching. Took Benadryl 25mg and feel asleep. hives and itching was gone by the time she woke up. Severe fever and body aches 22 hours after vaccine administration. Temperature was 101.8. Throat felt "sore, with some little difficulty swallowing", took Tylenol 1200mg and Vit C 2000mg and Vit D 10,000 IU and Zinc 100mg. Today, 48 hours after vaccine administration, having systemic hives, and eyes are puffy and swollen, R eye more than left, upper lid is swollen. Took Claritin 10mg and Famotidine 20mg. Hives are better but not fully resolved, but itching is persistent. Still discomfort noted in swallowing.

Pain at the injection site was typical for vaccination and was essentially gone by the next day. Headache started within one hour after vaccination and was severe 4 hours after vaccination. Next day morning I woke up with all my face swollen, runny nose, headache, stiff neck, pressure and pain at the base of the skull, pain and edema behind and below both jaws, pain in the right year and dizziness. Face edema and runny nose subsided 3 days after injection. Stiff neck, pressure and pain at the base of the skull, pain and edema behind and below both jaws, pain in the right year persists 7 days after injection. Dizziness and foggy head became worth 7 days after injection.

In the morning of Thursday February 25 at around 6:5 AM, as I was brushing my teeth, the water was leaking out when swishing from side to side. As the day progress, the right side of my mouth was getting number. The next morning Friday February 26, the right side of my face was numb, my speech was swirl, eating and drinking became challenging. I went to the emergency rom at Hospital where the team of doctors diagnosed me with Bell's Palsy. I was given Prednisone and Valtrex for a period of 7 days. Physical therapy as also being advised. The hospital advise me to follow up with my Primary Care Doctor (schedule for Monday March 1st), and to see a neurologist (waiting for an appt). As of today, the right side of my face has lost mobility.

Had chills, nausea and ringing in the head/ears about 4 hours after the first shot. The chills and nausea stopped by the next morning. But the ringing in my head/ears is still going on. It?s driving me crazy. It?s a high pitch buzzing sound that never stops. At times I feel dizzy and nauseous because of it.

Eyes bloodshot; Rash over entire body...arms, legs, abdomen, back, neck; dose number= 1, administration date= 06Jan2021/dose number= 2, administration date=20Jan2021; dose number= 1, administration date= 06Jan2021/dose number= 2, administration date=20Jan2021; This is a spontaneous report from a contactable nurse (patient). A 61-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular at the left arm on 20Jan2021 07:45 at single dose for COVID-19 immunization. Medical history included hypothyroidism. The patient was not pregnant at the time of vaccination. Concomitant medication included thyroid (WP THYROID), methocarbamol, and paracetamol (TYLENOL). The patient has known allergies to cefalexin (KEFLEX) and statins. The patient was previously vaccinated with the first dose of BNT162B2 on 06Jan2021 07:45 at the age of 61-year-old intramuscular at the right arm for COVID-19 immunization. The patient experiences rash over entire body, arms, legs, abdomen, back, neck, not on the face yet and eyes bloodshot; symptoms appeared over 8-hour period beginning at 7 am on 26Jan2021. The patient did not receive any treatment for the events. The outcome of the events rash over entire body and eye bloodshot were not recovered.

she experienced a metallic taste; This is a spontaneous report from a contactable consumer (patient) reported that a 61-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL9262, expiration date: May2021), via an unspecified route of administration on the left arm on 30Jan2021 09:00 at a single dose for Covid-19 immunization. The vaccine was administered at the hospital. The patient medical history was not reported. There were no concomitant medications. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 09Jan2021 for Covid-19 immunization. On 30Jan2021 09:30, she experienced a metallic taste for about 30 minutes after the injection that lasted about an hour with outcome of recovered on 30Jan2021 10:30.

on 01/14.21, The patient had the chills and fatigue. On 1/17/21, The patient developed severe right ear pain and right sore throat. On 1/19/21, developed multiple painful sores on the right side of the hard palate. On 1/20/21, the ulcers in the month got worse. Started on Valtrex. On 1/24/21, the patient felt better but the pain and sore throat returned on the 1/26/21.

Moderate fatigue - unresolved mild headache - unresolved diarrhea - resolved 2/19/2021 joint pain - resolved 2/22/21 increased blood pressure - resolved 2/19/2021 swollen eye lids and upper checks - resolved 2/22/2021

shortness of breath, tingling feeling in lip and face; shortness of breath, tingling feeling in lip and face; shortness of breath, tingling feeling in lip and face; This is a spontaneous report from a contactable other healthcare professional (HCP) who reported for herself. A 61-year-old non-pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) intramuscularly on 20Jan2021 at 14:45 (at the age of 61-years-old) as a single dose in the left arm for COVID-19 immunization. Medical history included restless leg syndrome from an unspecified date and unspecified if ongoing. It was unknown whether the patient was diagnosed with COVID-19 prior to vaccination. Concomitant medications (received within 2 weeks of vaccination) included tretinoin (RETIN A; skin cream), biotin, vitamin D NOS, calcium and multivitamin, all taken for unspecified indications on unspecified dates. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. The patient experienced shortness of breath, tingling feeling in lip and face, all on 20Jan2021, all reported as non-serious. The events did not cause hospitalization. No treatment was received for the events. The clinical outcomes of the events shortness of breath, tingling feeling in lip and face were all unknown. 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.

As soon as injection I got a horrible taste in my mouth then wi seconds my heart rate increased then some shortness of breath, that lasted less then a minute approx 5 minutes later a bad headache started then I felt extremely tired the headache lasted about 5 minutes the tired about 15. Nothing was needed everything got better on its own.

mild persistent headache all symptoms are mild flushed face tired lack of appetite/ food tastes different rash

Ears felt clogged, slight feeling of swelling in throat that lasted about two hours. Did not go to doctor.

itchy eyes, mouth, ears, blisters in mouth, tongue was neon red and cracked, the redness went away in a few hours but other symptoms continued until next day, took 20mg of prednisone next morning instead of usual 10mg

numbness in her lips; swelling in her face; her tongue was feeling funny; her throat was feeling strange; she had itchiness to her right hand; started to develop hives; This is a spontaneous report from a contactable consumer (patient). A 61-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration, on 01Feb2021 at 09:00 (at the age of 61-years-old) at single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) on an unspecified date for COVID-19 immunisation. The patient experienced numbness in her lips, swelling in her face, her tongue was feeling funny, her throat was feeling strange, she had itchiness to her right hand, and started to develop hives on 01Feb2021. The clinical course was reported as follows: Approximately 3 hours after receiving the vaccine, the patient started to experience numbness in her lips, swelling in her face, her tongue was feeling funny, her throat was feeling strange, and she had itchiness to her right hand and started to develop hives. The patient stated that she cannot take diphenhydramine hydrochloride (BENADRYL), but she did take cetirizine hydrochloride (ZYRTEC) to help with the symptoms. The patient was still having symptoms at the time of reporting. Therapeutic measures were taken as a result of all of the events as aforementioned. The clinical outcome of numbness in her lips, swelling in her face, her tongue was feeling funny, her throat was feeling strange, she had itchiness to her right hand, and started to develop hives was not recovered. The batch/lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.

Patient had moderate reaction to COVID-19 first dose vaccination. Tachycardia, lightheadedness, chills, throat discomfort. Patient had improvement with water, O2 and juice. Patient left in wheelchair after 90 minutes of observation with resolution of tachycardia and throat discomfort.. States she had similar reactions to influenza vaccine in past, but did not last that long. We discussed ER evaluation at which patient elected to go home as she had driver and wanted to go home. Patient instructed Benadryl, rest and fluids day of event. 911/ER if worsening symptoms. Patient in agreement to plan.

Immediately after I got the shot, My nose started running and. Lips felt big and tingling. ( MD did not see visible swelling). And roof of mouth was numb, throat felt like it was closing up, Started getting hoarse, chest tightening. MD gave me 25mg Benadryl and after 30 minutes starting relaxing, Coughing up phlegm. My left arm was very sore and swollen like a lemon... Today. My lip feels kind of burning (like pre herpes outbreak). and roof of my my mouth is still numb. I noticed that I lost sense of taste completely!

At 0900 this morning my face next to the right side of my mouth started itching. I immediately felt it swell. I looked in the mirror and could see the left lower part of my face (lower cheek by the edge of my mouth) swell and my right upper lip started to swell. I took a Benadryl (25mg oral tablet) and my roommate drove me to the Emergency Room. That area of my face continued to swell and impacted my lower lip as well. My lips were numb and tingling and I could feel my cheek swell more inside my mouth as it was touching my teeth. I was monitored (vital signs and pulse ox) for 90 minutes and received 20 mg of pepcid oral tablet and 10 mg dexamethasone oral tablet- both 1x only.

Received vaccine 6pm. By 5AM next morning, conjunctivitus in both eyes. No other COVID-19 symptoms or side effects from the vaccine

I lost my sense of taste three days after the shot. So far it has not come back yet a week later. I am noticing that I can taste salt now, but that is about it.

Tongue swelled and then went numb - like novacaine had been shot into it, throat swelling by 6 PM, took a big swig of Benadryl, went to Fire station, transported by ambulance to ER, blood pressure got way too low on ambulance ride, difficulty breathing/taking air in, IV applied - hospital by 6:30 PM, breathing still difficult, blood pressure better until it dropped again, IV given and monitored. Stable and discharged around midnight. Friday - Tuesday - very tired, heavy arms and legs, sore throat and tongue, limited to soft, bland. foods.

Rapid heartbeat, flushing, tingling of whole body like an adrenaline rush, felt like my blood was on fire. Hoarse voice and constant clearing of throat due to production of phlegm in throat. Tingling lips and tongue. This continued all day until I took 10 mg of prednisone. Within 3 hours, all symptoms were gone. Slept well all night. The next day (Wednesday) I felt fine. Slept fine Wednesday night. Thursday morning, all of the above symptoms returned. I took 5 mg prednisone, which didn?t alleviate symptoms so I took an additional 5 mg. I also took 2 Benadryl. Symptoms went away. Slept well Thursday night. Friday morning they returned. I had a doctor?s appointment scheduled (new patient visit) which I canceled as the office told me to go to the ER at the hospital where I got my shot. By the time I got to the ER, my symptoms had subsided. The ER doctor gave me 60 mg of prednisone, 1 famotidine, Benadryl.

1.5 days after vaccine, lost sense of taste and most smells. I had a bad headache that day and slightly less on Saturday. I was told to get a covid test which I did Saturday morning. I received the results of negative on Sunday the 6th. Today is the 10th, one week after the vaccine, and still no taste. I met by phone with my Dr. , and she said to report it as a side effect to the vaccine.

Patient received vaccination at 12:10. At 12:25, patient complained of tongue thickness. EMS called. Difficulty breathing. Developed seizures. Epinephrine 0.3 administered. Seizures continued on/off for approximately 1234. Tongue swelling did improve. Transferred to hospital setting via EMS at 1245.

Begin 4 days after first vaccine on 3/9/2021- First significant increase in thirst; Extreme chills and fever rapidly spiking to 101.5; decrease to about 100 after a few hours and held steady through early morning; decreasing to my normal (97''s) next day; Significant headache from below forward head to left and right side of neck (eustachian tubes and mandibles and lymph nodes) eye pain; vomiting (limited); leg muscle pain/. No injection site reaction 3/11 feel great

I am on infusion for severe psoriatic arthritis, and was doing well. Two days after injection it was as if the effects of my infusions were cancelled. Extreme widespread stiffness, pain, joint swelling and heat, muscle weakness and pain. I also had swollen lower lip and have had an increase in headaches and nausea. Two weeks after the injection I awoke with my right arm swollen, hard, and itchy. The arm and my lips have resolved, but I am still having all the other problems. I have reported these symptoms to both my primary doctor and my rheumatologist.

I noticed a couple of days after my vaccine that my tongue felt like I had burned it on hot food. The feeling has changed some. Now it feels as if my tongue is tingling. I can taste good, but it tastes odd. I have also noticed that salty foods taste saltier and sweet foods taste sweeter.

February 25, 2021 approximately 9:30 am: Approximately 5 minutes after receiving vaccine had a strong medicine taste in throat. Lasted 45 minutes - 1 hour. Approximately 9:55 am slight feeling of throat closing, which lasted about 45 minutes. Approximately 10:00 am headache, which lasted until approximately 4:00 pm, February 26, 2021. Arm soreness evening of February 25, 2021 lasted approximately 2 weeks. February 26, 2021 approximately 6:00 am diarrhea, headache, chills, legs aching, and fatigue, which lasted until until approximately 4:00 pm.

Systemic: Confusion-Severe, Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Mild, Systemic: Flushed / Sweating-Mild, Systemic: Hypotension-Mild, Systemic: Visual Changes/Disturbances-Medium, Systemic: Weakness-Medium

Metallic taste in mouth that subsided the next morning. Sore arm for 3 days Slightly feverish on and off for the first 2 days All of the above were relatively mild

Pt c/o tingling in throat progressing to difficulty swallowing and mid sternal CP. Pt given 180 mg allegra and with in 5 minutes was feeling better. VS stable. Released to home with instructions. BP: 125/71, P=100z, Pox=97% 1215 BP=129/73, P=103, Pox=97% 1225 BP=121/66, P=82, Pox= 99%

Around 12;00pm on 3/13 , I felt muscle aches through back, shoulders, neck. Sore at site of vaccine and Headache. I felt tired and rested around 1:00p.m. Took 1 extra Strength Tylenol. Then started getting chills. Felt like I had swollen lymph node on ride side of throat when swallowing and had some pain going up into my ride ear. These symptoms lasted all evening. I didn't feel like eating dinner so rested and took 2 extra strength Tylenol at 9:00 p.m. and went to bed. Woke up early in morning with bad headache so I took another 2 extra strength Tylenol around 6:00am. I finally started feeling better around 9:00am.

Mild tingling and numbness on right side of face beginning 25 to 30 minutes after getting the vaccine. Right eye began watering later in day. Noticed watering eye after taking 1/2 of a 10mg Zyrtec that evening. This morning, 3/14/2021, the watering right eye continues and the numbness and tingling in right right side of lips continue. The symptom to rest of right side of face appears to have dissipated. The best way to describe it is the feeling to face and lips is it feels similar to the feeling when Novocaine is wearing off.

Developed a rash near my eye after a couple of days rash moved to my face and neck. After the second shot rash covered face, neck and face and eyes would be swollen

C/O of difficulty to swallow saliva and throat dryness after covid -9 vaccine. Vitals taken: B/P 140/80, P79, R18, Ox 98% RA Doctor checked pt's mouth, no swelling. 10 minutes after pt states "I can fee my tongue now, feel better." Pt was observe for 30 more minutes. Pt was rechecked and vitals taken: B/P 138/85, P77. Pt discharged home in stable condition.

Pt states that 5min after vaccination she developed a headache, her nose was tingling about an hour later, she took tylenol and currently 4-5h later her lip is tingling.

Throat closing, SOB, tongue/lips swollen. Evaluated by EMS-Transported to Emergency room/department or urgent care.

Bell's Palsy, right side. Onset 3/10/21. Facial palsy impairing eating/drinking/speaking/blinking/eye closure unable/facial expression droop/unilateral lack of facial movement or facial expression. Reduced salivation.

Ears-ringing, and headaches started after about a week of second vaccine. Still occurring off and on 20 days after vaccine. Not continual and some days worse than others.

1. Cold chills in store, had to use restroom and urinate immediately. 2. Cold chills at home, started to shiver, jaw rattling, immediately had hot tea and wrapped in blanket. 3. Nosebleed, very unusual for me, 7 am. 4. Nosebleed, severe tinnitus, nausea, had to get out of bed and get to restroom, immediate bowel movement, severe dizziness vertigo getting back to bed. Slight tinnitus day after while writing report. Still have low nausea. 5. Sore arm for 4-5 days.

Around noon the following day I started feeling achy and tired. My eyes burn and I have chills. Just feel like I'm coming down with something.

The Covid Pfizer vaccine was injected into my left arm muscle. On March 3, Wednesday, the day of vaccine, immediately after injection, I felt numbness/tingling in lips, upper & lower & inside left of head/brain area, and also brief very sharp pains in my upper body randomly throughout my arms and chest. Intermittent sharp pain in center of chest.- scale 2/10 After the first 15 min, I sat outside the tent, and noticed a numbness in my left leg and foot and sharp pain in my left big toe - (03/21/21 left big toenail showed a light discoloration). Symptoms subsided within an hour, yet a residual minor numbness in my lips, continued, and intermittent sharp pain in center of chest. 2/10 On March 7, Sunday following the vaccine, at 11:00 am I felt definite numbness on the left side of my face. I touched it to determine if I could detect a sensation with my fingers, and I felt the numbness as I touched my face as well. My right side of my face was normal. Residual numbness to left face/head intermittently. including today more noticeable March 22, 2021.

Face Swelling, lips swelling, felt like inside of mouth was thickening. Called doctors office and spoke to oncall doctor. He recommended to take antihistamine. On way home -stopped at gas station and got Benadryl. Took Benadryl twice Saturday and Sunday. Had cold chills and sweating Sunday night. Stomach pain and diarrhea Monday.

Patient DOB 5/16/1959 received 1st dose of Pfizer Lot # ER8730 and was waiting in the 15 minute observation section when she stated that she felt "swelling of her face and tingling of her lips." Blood pressure was 196/98, HR 85, O2 97%, Temp 98.1. Patient was alert and oriented x 4. Patient stated that she was very anxious today and has allergies to dairy and pollen. Patient confirmed that her husband was on the way to pick her up and drive her home. EMT administered 25 mg of Benadryl PO at 12:32 pm. Patient observed for an additional 50 minutes until her husband arrived to pick her up at 1:22 p.m. Patient stated that she was feeling better and was able to walk unassisted with her husband. informed patient to go to ER or call 911 if symptoms worsen.

Patient reported to nurse after receiving first dose of Pfizer that 3-5 minutes later her left side of neck/throat felt tight and tingled. Nurse alerted Doctor and myself to assist patient. We arrived to patient's car in front of garage at 10:55 AM and walked beside car as the husband pulled forward to park. Patient stated she received her vaccine about 10:45 and then as her husband started pulling forward, she told him about her symptoms. Dr. assessed patient and stayed with patient until 11:13AM. Patient left in passenger seat with her husband driving stating that she no longer felt the tightness in her neck or throat.

I woke up about 3am with a fever and freezing to death. I was very lethargic. As the days progressed, I became very weak and wanted to sleep all of the time. I lost my appetite, taste and smell. I was tested for COVID on 1/12 and found out I was positive the next day. I was out of work for 2 weeks and returned to work on 1/25/21. I got an infusion on 1/20 so I can't get my 2nd dose until 90 days after that date.

Immediately: headache, left eye pain, nausea, cold sensation and felt ?weird? but thought it was normal and thought I might feel flying for a bit but that it would wear off so I did not report feeling anything at the clinic. I left the clinic and got in the car to drive home and felt a weird feeling in my throat reminiscent of my esophageal spasm and then it felt like someone had their hand on my throat squeezing my throat and felt like I needed to take deep breaths to expand my lungs. Within a minute or two at most, my lips, tip of my tongue, tip of my nose and face beside my lips and under my cheeks started to tingle and go numb. My insides felt swollen. I had a doctors appointment and went there after picking my son up at home. I reported my feeling to my doctor who prescribed a steroid for 3 days and told me to also take Benadryl or Claritin, which I did. However, today is day 4 after my vaccine and today is the first day my insides don?t hurt.

Severe tinnitus. I had very mild occasional tinnitus before the vaccine. But after the vaccine. it's been constant 24/7 and very loud.

BP dropped to 70/40; seizures; She did fall into a cabinet; bruised up; inflamed; back was on fire; if she moves her head quickly, she can feel like she will have a headache, hangover; could not walk; Trouble walking; Funny taste in mouth; Pain/ felt achy; tingling sensation from head to her to spine/ hands tingling/ it was also in her abdomen area and in her leg; Back pain; Could hardly move; could not stand up; autoimmune response; delayed allergic reaction; tweaky muscle/ pulled a muscle in her back; pain at the top of her head down to her hip; pain at the top of her head down to her hip; having trouble holding her urine; This is a spontaneous report from a contactable consumer (patient). A 61-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID19 VACCINE, Solution for injection, lot number: EL9266), via an unspecified route of administration in the left arm, on 05Mar2021 1:45 PM at a single dose for COVID-19 immunization. The patient did not receive any vaccines within 4 weeks prior to receiving the BNT162B2. Medical history included allergic reaction, autoimmune disease, brain barrier fever, epilepsy, encephalitis and meningitis. She had epilepsy as a child. She gets epilepsy when she gets sick. The last 4 times she got sick she had a seizure. The last seizure was 1 year ago (in 2020). She may have had COVID, but she got really sick and had a seizure. She is not sure if it was COVID or not. If it was the flu, she does not want that again. She had ataxia and ended up in hospital two times but did not stay. Prior to this, she did not go to hospital for 30 years. She was unable to walk, her gait was real bad. The neurological disorder messed her up for a while. Concomitant medications were not reported. It was reported that the patient received the PFIZER-BIONTECH COVID19 VACCINE first dose and experienced autoimmune response. After the vaccine, she had pain and tingling sensation from head to her to spine (05Mar2021), BP dropped to 70/40 (06Mar2021), seizures (06Mar2021), and delayed allergic reaction (Mar2021). She wanted to know if she should take the second dose or not. She also wanted to know if that would be considered the anaphylactic reaction. It was also reported that the patient experienced funny taste in mouth, back pain, hands tingling on 05Mar2021. The patient further explained that when she got the shot, she had a funny taste in her mouth. It started immediately after she got the vaccine and it lasted 30 minutes. She mentioned this to the people at the facility, but they said she was crazy and no one else has mentioned this. She thought they would be interested, but they did not care. About 20 minutes later she had a tingly sensation. It was in the back of her head that developed into a stingy, painful, heat, funny type feeling. It was all the way down to her back. She later further explained the back of her head was tingling (05Mar2021). Like were the cerebellum is to spine. This sensation is still there, but better. After she felt this feeling her back then started hurting. She bent over and her back went out. She felt achy. She already had what she called a tweaky muscle (05Mar2021). She had pulled a muscle in her back, but it was nothing that had caused a problem. After getting the COVID vaccine it triggered an immune response in her body. She started to have pain at the top of her head down to her hip (05Mar2021). She bent over and she could not stand up (05Mar2021). Her husband had to help her put her pants on and sit down due to this. She started to have horrible back pain (05Mar2021). She could hardly move (05Mar2021). She was having trouble walking (05Mar2021). She was having trouble holding her urine (05Mar2021). On Saturday evening (06Mar2021), her blood pressure started dropping and she later had a seizure. After the seizure occurred it seems like everything got better and she did not have any trouble since. It was very scary. She mentioned she was in the bathroom and there was a tub full of water. She had a hard time already getting to the bathroom. She was in a lot of pain. The amount of pain she had she thinks affected her blood pressure. She had pain in the back, middle of her back. It started at her head, back of head, down her spine, came down to her back and hips. She was hurting a lot and having a terribly hard time getting around. She could hardly walk. She was going to the bathroom because she felt like she had to go. Her husband was helping her sit on the toilet. When she stood up it was like her blood pressure dropped, she almost went headfirst in the tub full of water, but her husband caught her, laid her down, and had a seizure. This was a very unnerving feeling. The seizure did not last more than a minute, maybe two at the very most. The seizure occurred probably around 6PM or 7PM. It did not last long at all. She woke up on the floor. She had been sitting and she thought she had fallen off the toilet. However, her husband had to remind her that a few things happened in between. She almost fell in the bathtub and she has glass doors. She mentioned she felt as clarified and confirmed sped up. She did fall into a cabinet and is bruised up from that seizure (06Mar2021). She is sore from the pain from that. Still inflamed (06Mar2021) possibly due to the seizure. Like she has ruminants of what occurred to back of head, cerebellum. Before she had the seizure, her blood pressure had started dropping. It started dropping in the evening around 5PM or 5:30PM. Mentioned she is a little confused about the time onset because she was hurting so much and bad all day. She does not take any pain medication. She has an autoimmune disease and it is difficult for her to take medications. On top of that, if she wanted to take an Aspirin she was told she should not take one. She was informed she was trying to promote an auto-immune response to the vaccine. As the day ran on, she was in a lot of pain. She had been in pain since Friday and was trying to deal with that. The patient further stated her blood pressure is back, no illness. After the seizure her blood pressure went back to normal and at this time it is perfectly fine. The back pain she experienced went from the brain down to her backbone. The pain is gone. It started to go away after the seizure and by Sunday 07Mar2021 it was totally gone. At first it was like she could not walk (05Mar2021). It was like she/her back was on fire (05Mar2021). The patient also mentioned if she moves her head quickly, she can feel like she will have a headache, hangover. She feels it in her back. She feels like she is near recovery, and this is a feeling she does not thing will stay. She further went on to say her hip where she fell is a different story. However, this is associated to a fall and not a vaccine. She was having this problem when she had the vaccine, but the vaccine caused it to be more and extra aggravating. She later added, when she first got home along with head tingling her hands were tingling as well. When her brain and hands were going through this tingling sensation, she started to notice the back trouble and it was also in her abdomen area and in her legs causing trouble walking (05Mar2021). The events did not require a visit to the emergency room or physician office. Outcome of the events trouble walking, could not walk, tingling sensation and hangover was recovering. Outcome of BP dropped to 70/40 was recovered on Mar2021. Outcome of seizures recovered on 06Mar2021. Outcome of funny taste in mouth was recovered on 05Mar2021. Outcome of back pain was recovered on 07Mar2021. Outcome of bruised up was not recovered. Outcome of the remaining events was unknown. The patient provided an unrelated causality between the vaccine and event fall. No follow-up attempts are needed. No further information is expected.; Sender's Comments: Based on the current available information, the event Fall is most likely related to an intercurrent or underlying condition which is not related to the suspected drug.

About 50 minutes after the vaccine was given, my tongue began to swell and I experienced tightness in my throat and chest and shortness of breath. (This was occurring while I was driving myself home from the vaccination site.) I administered my Epipen. And I then drove myself to the Emergency Room, which is near my home. At the ER, I was injected with cortisone, Benadryl, and Pepcid, and had my heart and blood pressure monitored for about 3 hours and then I was released, with a prescription for 50MG Prednisone (1q/day) and 10MG Pepcid (2q/day) x 5 days (for both scripts). I finished the prescriptions, but am still feeling some discomfort in my throat and some dizziness.

Patient came in received second dose Pfizer vaccine at 3:00pm and reported she had burning sensation in top of mouth, throat, chest area at 15:03. Patient stated this reaction had also occured after first dose and lasted 3 days. Patient vitals were 99% O2, pulse 82, BP 122/82, Resp. 18 at time of reaction. Patient has no s/s of shortness of breath, n/v, dizziness, swelling, hives. Patient was given 25mg of PO diphenhydramine and monitored for 30minutes. No increase in symptoms. Patient left with symptoms starting to resolved. Patient educated by provider on site to take famotidine and continue diphenhydramine PO as needed every 4-6 hours. If s/s increase to report to the emergency department.

Pasting clinicians note below: Patient is 61 year old female with hx of anaphylaxis presenting for Covid-19 vaccine, Dose #1. She developed itching in there throat within 30 minute waiting period. She was taken to Rapid Response Room. Symptoms progressed from itchy throat, to congestion in throat/upper chest, clearing her throat, watery eyes. Then dry cough. No nausea, no vomiting, no light headed feeling. No facial swelling No hives. OBJECTIVE: Vitals - 154/97, 105, 100%RA Neck - Supraclavicular mild retractions, end inspiratory stridor CV: tachy, regular, no murmur pulm - diminished breathe sounds throughout, no wheezing. Speaking full sentences. Assessment/ Plan: Anaphylaxis to Covid-19 Vaccine: - emergency responders - epi 0.3 mg IM administered to L mid outer thigh at 9:35 am by me - epi 0.3 mg IM administered to R mid outer thigh at 9:41 am because symptoms not subsiding by me -benadryl 50 mg IM x 1 L deltoid by RN 9:45 am - Itching in throat subsided but still retracting and clearing throat so albuterol 3 puffs given at 9:50 am Vitals stable entire time (see midas report) EMS arrived to transport to local hospital.

Rheumatoid arthritis/Rheumatoid arthritis attack; herpes outbreak- blisters in her mouth; wound on leg started to get worse, leaking a lot of fluid; back is hurting; felt like a tetanus shot in her arm; This is a spontaneous report from a contactable consumer (patient). A 61-year-old female patient received bnt162b2 (BNT162B2, Solution for injection, Batch/Lot Number: EM9809), intramuscular in left arm on 10Feb2021 14:30 at single dose for covid-19 immunization. Medical history included high blood pressure, rheumatoid arthritis and kidney issues. Concomitant medication included insulin. The patient had the first COVID-19 vaccine. She had a lot of issues wrong with her, however she did not have them hit her at the same time. It was currently the 9th day since she had her first shot. About 4 or 5 days into it, the wound on her leg started to get worse. She had rheumatoid arthritis and she had an RA attack. She had herpes, but she did not had an outbreak in a couple of years. She got blisters in her mouth, and this also hit her. She explained everything hit her all at once. She was now on antibiotics for each one of the things. Her doctor figured out that her body just couldn't handle it. She clarified putting the vaccine into her body, she couldnt fight off everything. Like whatever in in the vaccine and how the vaccines works, her body was just not strong enough to fight off everything at the same time. The patient did not went to the emergency room. It was reported that the patient would receive her second dose on 03Mar2021. The outcome of the events was unknown. No follow-up attempts are possible. No further information is expected.

Between 10 and 15 minutes after receiving the vaccine, I felt like someone had thumped me in the chest over my left breast. I tried to breathe deeply, and I started to feel light headed. I didn't tell anyone, I was let go after 15 minutes. I sat in my car about 5 minutes and then decided I was worse. I was weak and shaky and light headed, my top lip was fuzzy feeling. I didn't feel like there was a blockage in my airway but I felt like I was having trouble getting my rib cage to expand so I could breathe. I went back in and was sat down, I was evaluated. Paramedics were called, by time they came I was lightheaded and I was foggy brained. I couldn't respond easily. My BP was 165/99 and my heart rate was 98. my O2 was fine but by that time I felt like I had to work hard to get a deep breath. I was feeling worse quickly. I was taken to the ER in a wheelchair. I was put in a bed and hooked me up to monitors. I was left alone for a while. When the dr came in he checked me out and listen to my lungs. I had a hard time getting my lungs to expand. Doctor ordered a blood sugar test and it was below 100. Chest x-ray, EKG and blood work. He told me later that everything was normal. I was there for 2 hours before I felt like I could go home. I didn't receive any medication. I was able to breathe easier by time I left the hospital. I was thinking more clearly as well. The next day I was still feeling shaky and weak. I went to my PCP on friday and I was feeling normal by then.

Lip Tingling and Minor Swelling started approximately 5 min after shot Tongue Tingling and Minor Swelling started approximately 5 min after shot Blood Pressure increase to over 200/100 - taken approx 10 min after shot and then 15 min after shot, at approx 25 min after shot was down to approximately 160/90

(1) Headache started shortly after injection, mild at first, then moderate, went away 48 hours later (2) Extreme fatigue started 4 hours after injection, improved somewhat 24 hours later, mostly gone 48 hours after injection (3) Tinnitus first noticed 8 hours after injection, mild or intermittent for the next 5 days, then became more noticeable and persistent; has been persistent and nonstop since then. (It has been one week since the injection.)

Had a sudden pounding headache & a super loud buzzing in my ears. The headache lessened & the ear buzzing went down a little bit, but ear buzzing is still pretty loud. The loud ear buzzing has not gotten any better 23 days later!!! My ears are still buzzing now. I am wondering will my 2nd dose of Pfizer Covid vaccine due on 04/01/2021 make my ear buzzing worse?

Tinnitus moderate to severe onset about 24 hours after vaccination. High pitched ringing both ears. Occurred with a low grade fever, chills, and muscle aches. One alleve (naproxen sodium) pill to address symptoms did not impact tinnitus.

Approximately 25 minutes after receiving the vaccine I noticed my eyes were beginning to itch and my throat felt odd and was accompanied by a hoarse voice. I was driving home at that point and considered turning back for medical advice (should have but did not). Over the next few hours itching sensation on my tongue, face including eyes, head and back. Developed just one hive on my eyebrow approx 3 hours after vaccination, and one on my thigh at least six hours after vaccination. The symptoms were not severe but obviously I monitored them. Now 24 hours after the vaccination and still have some itching as described above. Throat is somewhat better. Eyes feel odd more than itchy at this point.

3/26-Caller states her 61 yo F mother had her vaccine 2nd dose yesterday and today at 3 AM developed tooth and ear pain but denies inability to open and close her mouth. Her mom also had multiple episodes of vomiting which have subsided. The caller doesn't have all available information with regards to the patients current medication list for review and or entire PMH.. Caller states that her mom was administered an initial pfizer dose and her second dose was also from pfizer. First dose 3/3/21 EN6199 Second dose 3/25/21 EN6199 Both doses were received on the above dates.

Pt had itchy eyes, coughing and increased dyspnea. She has a hx of allergic reactions and this began much like other reactions she has experienced in the past. She was aware of the change and called for help. She was given benadryl and 125 of solumedrol en route to the ER. Pts SpO2 dropped to 95% and was placed on NC at 4LPM. Pt states her eyes still itch and she feels the need to clear her throat, but no longer feels the shortness of breath.

Lips were red and sunburned like with pain. Following day, fever blisters broke out. (common when my lips get sunburned). Treated with Carmex at onset and they went away in a couple days, fairly quickly.

Dizzy about an hour later. Worked through it. Itching/swelling as in first dose in arm but handled with anti-itch sprays and cremes. In afternoon, nauseated and dry heaves. After 9:00PM, high fever, aches, constant chills throughout the night. Extreme thirst. Fever through the next day and used a COVID sick day. Symptoms gone by morning of 03/27/2021.

Within hours became disoriented, thirsty and achy. Next morning, arm was numb and fingers tingly, Achy, fever, nausea, headache, extreme thirst, disoriented. Extremely sore arm that I couldn't lift to my waistline without extreme pain.. Hard to dress/undress. Never felt so sick in my life!

I had my Pfizer vaccine on March 16, 2021. On March 17th I had a headache, body aches and fatigue which I expected since I had Covid in November 2020. Most of these symptoms only lasted 3 days. After the 3 days I had a continuing headache and started having jaw pain. On March 22nd I started having dizziness and a severe headache with jaw pain, fatigue and nausea. On March 23rd I got up abruptly and felt extremely dizzy and almost passed out. I am having continued sporadic headaches, nausea, dizziness behind my eyes with fatigue and a metal taste in my mouth especially when my mouth is dry. As of March 30th, only side effects lingering are dizziness behind my eyes and nausea

Dizzy; Medicine taste in her mouth; Head and neck pain; Head and neck pain/pressure in the face and back of the neck/pressure in jaw and neck; Pressure in the face and back of the neck/pressure in jaw and neck; Pressure in jaw; Pressure in the face; Heaviness in her legs; Cold symptoms in her chest, almost like bronchitis; Cold symptoms in her chest, almost like bronchitis; Throat started getting scratchy/scratchiness in her throat; Itchy in her ear; Phlegm feeling in her throat; Allergic reaction; Getting twitches and surges/felt surges in her leg, like adrenaline shooting through her with no letting up; Tingling in her mouth near her lip and her foot and then in her hand; Tingling in her mouth near her lip and her foot and then in her hand/jolt in her left leg; Not well/feeling of unwell; Spaciness/doesn't feel like herself/feels off/Is in a fog/fogginess; Her mouth is shaky/shaking; Unsteady; She feels like she has a lot of adrenaline; Felt cold; Muscle weakness; Getting twitches and surges; Laborious to walk; Itchy sensation; This is a spontaneous report from a contactable consumer (patient). A 61-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EN6201; Expiration date was not reported) on the right arm on 08Mar2021 (08:30) as a single dose, with route of administration unspecified, for COVID-19 immunization at the hospital. Medical history included being allergic to sulfa drugs and x-ray dye; and had seasonal allergies. Concomitant medications included paracetamol (TYLENOL) and vitamin D3. The patient previously took doxycycline, and was allergic. On 08Mar2021, the patient had cold symptoms in her chest, almost like bronchitis; throat started getting scratchy/scratchiness in her throat; itchy in her ear; had a medicine taste in her mouth; head and neck pain; pressure in the face and back of the neck/pressure in jaw and neck; heaviness in her legs; and phlegm feeling in her throat. In Mar2021, the patient had an allergic reaction; getting twitches and surges/felt surges in her leg, like adrenaline shooting through her with no letting up; had tingling in her mouth near her lip and her foot and then in her hand; tingling in her mouth near her lip and her foot and then in her hand/jolt in her left leg; not well/feeling of unwell; spaciness, did not feel like herself/had felt off and was in a fog/fogginess; mouth was shaky/shaking; was unsteady; had felt like she has a lot of adrenaline; had felt cold; muscle weakness; was getting twitches and surges; was laborious to walk; and had itchy sensation. On 09Mar2021, the patient was dizzy. The events resulted into physician's office visit. The patient's blood test, electrocardiogram (ECG), electrocardiogram (EKG), "two other panels", metabolic and all tests showed everything was normal on an unspecified date. The outcome of the events was unknown. The patient's second dose of vaccination was scheduled on 29Mar2021.

3/25/21 sore arm, tired achiness, headache, lite headedness-throughout day & night. 3/26/2021 same as previous day. 3/27/2021 at 6:30 am awaken unable to breath.- Both ears felt closed, throat felt closed. Immediately took a Benadryl, put Vicks on neck-throat area, used steamer for moist air through nose. Lasted close to one hour. 3/27/21 most of afternoon & evening extreme tiredness. 3/28/21 morning ok, by afternoon extreme achy tiredness again. 3/29 to present headaches.

Shortly after receiving vaccine experienced phantosmia - smell of perfume or soap. Worked 6 - 11 pm on 3/29/21. Arm very sore at bedtime. Woke up feeling very tired and weak with arm feeling even more sore. No redness or swelling at injection site. Feeling nausea, body aches and cough, called off work on 3/30/21 for 12 - 10 pm shift. Woke up 3/31/21 feeling lethargic with body aches, cough, still smelling perfume and feeling need to suppress cough. Showered around 9 am and noticed rash developing on inside of right thigh and itchiness/rash under right side of jaw. Scheduled to work 5:30 - 10:30 pm this evening. Will attempt to attend work.

Immediate strong metallic taste that has not gone away. High fevers 103, chills and shaking, fatigue, muscle aches and nausea.

Day 2, arm soreness, fatigue, chills half day, metallic taste in mouth, exhaustion, lethargy. Day 3, slight nausea half day, metallic taste in mouth, tiredness.

Ptosis of the left eyelid started on 3/19. Seen by specialist on 3/20 at Hospital. MRI showed inflammation of the left eye socket. No treatment at this time until second vaccine has been administered and two weeks have passed.

10 hours later jaw and chin also feeling funny; Numbing of tongue and lips right away; Numbing of tongue and lips right away; This is a spontaneous report received from a contactable consumer. This consumer (patient) reported for herself that a 61-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) at the age of 61-years, via an unspecified route of administration in left arm at 11:00 on 09Mar2021 at single dose for COVID-19 immunization. Medical history included asthma. Known allergies included nickel, gold, manganese, vanadium. Patient was not pregnant at the time of vaccination. No COVID-19 prior vaccination, no COVID-19 tested post vaccination. Concomitant medications included bupropion hydrochloride (WELLBUTRIN); atomoxetine hydrochloride (STRATTERA); montelukast sodium (SINGULAIR); salbutamol (VENTOLIN). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 09Mar2021 11:00, the patient experienced numbing of tongue and lips right away, 10 hours later jaw and chin also feeling funny. No treatment was received for the adverse events. Outcome of the events was not recovered. Since the vaccination, the patient has not been tested for COVID-19. Information on the lot/batch number is requested.

Feeling of heat in mouth, numbness in mouth, swelling in throat (not severe), difficulty swallowing (not severe), tongue swelling, Day 3 post injection: hives on upper left arm just above elbow, Day 4: headache (severe), numbness/tingling in jaw, neck and face, swelling of lower legs.

patient had a tingly tongue which eventually became swollen and resulted in her not being able to swallow.

pt states her arm felt like it was on fire as the vaccine was being administered. She became very dizzy and had a headache. On 3/16/21 her arm was sore at the injection site. Her throat hurt and when she swallowed she would have a sharp pain right between her eyes. Her left arm became very painful and every time she tried to move it would cause pain in her chest. She had diarrhea, sweating and had 101 fever. On 3/17/21 she had to have someone help her our of bed on this day. She felt like she was going to pass out. She had this feeling on at least 3 occasions. Pt had pain when opening her eyes, trouble breathing and having heart palpitations. She called her cardiologist with her symptoms and was told it was related to taking the vax. She had a televisit w/ PCP and she was sent to have a Covid test which was negative. She was told to drink plenty of fluids and rest. By 3/20/221 pt started feeling better at this time.

Wheezing, severe lung pain with difficulty breathing, swelling inside mouth. Have been able to treat at home with Benadryl, rescue asthma inhaler, and steroids?hydrocortisone that I take for adrenal insufficiency

Initially I reported a definite numbness/ tingling lips & in left side of brain/head immediately following vaccine, plus sharp pains in my body, numbness in my left leg/foot, and a very sharp pain in left big toe that later showed purple under toenail. Then 3/7 I experienced a start of numbness on left side of full face additionally present until today, varying in intensity. It can be intermittent. Now, I wish to also report, I experienced uncontrolled repeated darting eyes, as I would look from one activity to another when focused on a project, and it occurred primarily in evenings. Then eyes would settle on object I was trying to look toward. This has resolved now. I can still feel a slight numbness in left side of face and in brain/head, and lips, and pain in left toe which is still purple under nail. I read online it is recommended to take B12 liquid for cranial nerve inflammation due to Pfizer vaccine. Plus I took Orange Juice with Mango, and Organic Milk to attempt to provide a way to rid body of toxins from vaccine, plus hot baths.

Pfizer-BioNTech Covid Vaccine EUA First vaccine dose was received on Wed 3-31-21. On Thurs 4-1-21 (unsure of exact time and whether it was before or after 24 hours from dose, likely before), I noticed tiny bumps and an uncomfortable feeling along my upper lip, lip was swollen. Bumps are rash-like. On Friday the lightbulb went off and I thought it might be connected to the vaccine. After some online searching I reported it to Pfizer and am now filling out this form. I do not currently have a doctor as my doctor left. I called the practice I had last used but was unable to speak to a doctor or get an appt. (continued below) The rash/swelling/bumps itself is mostly just annoying and not severe but I was concerned it could be a delayed allergic reaction and concerned about whether it is safe to get the second vaccine. I did not seek any treatment other than applying topical chapstick and carmex at home. Today, Sat 4-3 it is somewhat better but not totally resolved.

Canker Sores; Intermittent Headache; Intermittent fatigue; This is a spontaneous report from a contactable consumer (patient). A 61-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, batch/lot number EL3248; expiration date not reported), via an unspecified route (administered on left arm) at the age of 61-years-old on 27Jan2021 02:00 PM as single dose for COVID-19 immunization. Medical history included hypertension and sulfonamide allergy (Allergies: Sulfur-based) both from an unknown date and unknown if ongoing. The patient reported unspecified concomitant medications. Prior to vaccination, the patient has not been diagnosed with COVID-19. The patient didn't receive any other vaccines within 4 weeks prior to COVID vaccine. The patient is not pregnant at the time of vaccination. The patient experienced canker sores, intermittent headache and intermittent fatigue on 27Jan2021 16:00. The events were reported as non-serious. Since the vaccination the patient has not been tested for COVID-19. No treatment was received for the events. The outcome of the events was recovering/resolving. No follow-up attempts are possible. No further information is expected.

ears plugged and ringing; ears plugged and ringing; tongue sore; chills; muscle aches; weakness; joint stiffness; nausea; sharp pains in stomach and breasts; sharp pains in stomach and breasts; tightness in chest; fatigue; dizziness; impaired mental clarity; 102 fever/99 degree fever; This is a spontaneous report from a contactable consumer (patient). A 61-year-old non-pregnant female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration, administered in the left arm on 15Mar2021 at 18:00 (06:00 PM) (Batch/Lot Number: EN6208) at the age of 61-years-old as single dose for COVID-19 immunization; administered to the patient in public health clinic/administration facility. The patient had no other vaccine in four weeks. The patient had no COVID prior to vaccination. The patient's medical history included known allergies (unspecified). The patient's concomitant medications were not reported. The patient previously received the first dose of BNT162B2 in the left arm on 22Feb2021 at 07:30 PM (lot number: EL9266) at the age of 61-years-old for COVID-19 immunization. The patient experienced 102 fever the night of 16Mar2021 (also reported as 16Mar2021 at 06:00 AM) with chills, muscle aches and weakness, joint stiffness, nausea, sharp pains in stomach and breasts, tightness in chest, fatigue, dizziness, and impaired mental clarity. On 17Mar2021, the patient experienced ears plugged and ringing, weakness, tongue sore, and impaired mental clarity. The patient had 99 degree fever during the nights of 17Mar2021 and 18Mar2021 thus far. The patient did not receive treatment for the events. The patient has not been tested for COVID post vaccination. The outcome of the events was recovered with sequelae (reported as recovered with lasting effects).

26 HOURS AFTER RECEIVING THE VACCINE, MY VISION WITH THE LEFT EYE STARTED TO DETERIORATE. THE DOCTOR ON CALL SUSPECTED RETINA DETACHEMENT AND ARRANGED FOR A RETINA SPECIALIST VISIT NEXT MORNING. THE RETINA SPECIALIST DOCTOR CONFIRMED THE RETINA DETACHEMENT AND PERFORMED SURGERY TO REPAIR IT THE SAME EVENING. EMERGENCY SURGERY WAS PERFORMED. I AM STILL RECOVERING (RECOVERY IS ESTIMATED TO TAKE 6 MONTHS), WITH DISTORTED IMAGING FROM LEFT EYE AND DOUBLE VISION.

Chest pains, migraine, difficulty breathing with mask on, out of breath easily,low grade temp, chills and body aches, runny nose ear pain Started with chest pains 4am 3/26 and lasted about 2 1/2 days

itchy throat with no tightness or difficulty breathing. Tingling tongue per patient report. Benadryl 50mg given by mouth @ 1503pm. Pt recovered and was discharged in no distress.

Systemic: Numbness (specify: facial area, extremities)-Mild, Systemic: Tingling (specify: facial area, extemities)-Mild, Additional Details: Patient started with numbness and tingling on her left side of her face after 15 minutes of observation in the store. During the next 30 minutes the numbness moved to her right side of her face and lips. Patient was instructed to contact her PCP after she left the store. Patient was no experiencing any other symptoms.

45 minutes after shot lips tingled and puffed up, roof of mouth became sore , a bit swollen and irritated ,periodic heart palpitations. I took liquid benedryl and after 15-20 minutes symptoms subsided, so I did not use my EPI Pen.

shortly after: dizziness, nauseated, rise in blood pressure, tingly lips/ mouth they sent me to Emergency Room but I did not get seen thinking it would pass nest couple days blood pressure mildly high and then extremely low, dizziness, nausea with vomiting (vomiting started 3 days) and then i stoped eating 6 days later started Zofran to combat the nausea; blood pressure less variable

440, Pt arrives in observation, approx 5 min after receiving vaccine, observed sitting in chair comfortably, no apparent distress, no cough observed at this time, skin appears dry, appropriate skin color, no s/s increased respiratory effort, Smiling playing games on phone, denies any discomfort at this time. 500- Observed pt with intermittent dry cough Pt describes as "just a little tickle", lips pink (mask removed temporaily), talking without difficulty. Denies distress, Offered water, no obvious increased respiratory effort. Pt agrees to continued observation, Offered water, appears to be swallowing without difficulty. 5:05 pt reports "harder to talk without cough" observed increase in frequency of dry cough, pt reports that she wants to continue to be observed, does not want benadryl at this time. Pt agrees to plan that includes, if she feels worse, she will be offered benadryl, she agrees, that if she does receive benadry, she will not attempt to drive herself home.She reports that benadryl "makes me drowsy"She agrees to call family to have them come pick her up. Lead RN at pt;s side. 510- increased frequency in coughing, pt reports that "it's harder to talk without coughing, itchiness in throat increasing" she denies shortness of breath, but reports that she is concerned that she will become short of breath, therefore agrees to 50mg benadryl IM (r deltoid), still awaiting family arrival. Pt reports, "feel hot" No observed increase in respiratory Moved to bench couch(prior to recivng benadryl, , EMT present , vitals taken, bp 148/92,pulse=83, pulse ox 96-98%, pt reports that this BP reading is "higher than usual for me", denies pain except for pain at vaccine injection site, 5:20. No obvious change of status noted, skin remains pink, +cap refill, lungs cta no wheeze herd per EMT. 5:24- pt reports that she is "getting a little drowsy, but feeling better". Cough appears to be less frequent.Pt appears more relaxed, talking without effort, respirations appear to be without effort, relaxed.Conitues to agree not to drive herself home, awaiting her daughter to come get her and drive her home, Encouraged pt to have daughter come up to floor, did discuss with pt, although she is feeling better at this time, if she feels worse, once she is driven home by daughter, she will seek emergent care immediately. Pulse ox 98%, appears to be in no distress. Only occasional cough noted. 5:28, pt reports that she sees her daughter on floor and walks (with normal gait),towards a couple, went to offer to escort pt to car, but she walked away from couple, and left floor without coming back to observation. 5:30, pt observed (from 3rd floor window), talking to another adult woman presumptively her daughter, 5:35, pt observed (from 3rd floor window getting into a different car, by herself, sitting in drivers seat and drives off by herself, driving the car.

High fever for 2 night in a row (in excess of 103), nausea, headache, sore muscles and joints, sore teeth, red inflamed area of vaccination about the size of an orange lasting 5 days., dizziness, unproductive cough, extreme tiredness for 3 days and lingering for 5 days.

Bitter taste in mouth that came on suddenly and distinctly approximately 20 minutes post injection, and persisted for >1 week. Symptom level: mild.

After vaccine given, patient complained of discomfort to throat. Patient felt like heart racing and slight chest heaviness.. O2 sat within normal limits. Taken to ED. HR 122, BP 141/66, O2 sat 98%. Symptoms resolved on own.

Pt reported after her 1st dose 3 weeks prior, approximately 40 minutes after leaving the clinic she felt her tongue swell and throat thick. Reports taking a Benadryl and contacted PCP. Pt presented to clinic on 4/5/21 with paperwork from PCP stating patient to receive 2nd dose of vaccine "benefits outweigh risks." PCP did not recommend premedicating for 2nd dose. After receiving 2nd dose approx 15 minutes later, patient reported feeling of tongue swelling. Patient took her own Benadryl 50mg PO. At 2:28PM, pt reports feeling full throat. Placed on monitor, Pulse Ox 96%, HR 90's, BP 189/119. Pt transported to Emergency Room. Was able to speak clearly on arrival in ED, Dexamethasone 10mg IV push and famotidine 20mg IV Push administered. Patient symptoms resolved, diagnosed with minor vaccine reaction and discharged to home with instructions to f/u with PCP.

Tinnitus, which had almost completely disappeared, is now back and constant 24/7 since my first dose.

Called to car approx 10 min post vaccination where PT reported "my nose and mouth are itchy" "my throat and eye feel itchy". VSS. Offered benadryl po 25mg. PT accepted. 15 min later, pt reported "my throat is tight" "some trouble breathing ". Breath sounds clear bilat. Sao2 = 96 - 99. As precaution, EMS on site consulted. Advised pt that "she looked stable" and gave her options for further obs or d/c home, calling 911 if there was further distress. PT reported feeling better and opted for d/c home. Vital signs stable throughout.

tingly lips with bumps on the inside, itchy skin on scalp, soles of feet, neck & chest, and underpants region. -lasted 9hrs, then started again at 2AM on 04/08/2021 for about 45min. -was on & off for the day on both April 8 & April 9.

About 36 hours after my first dose, I woke up very thirsty and with "gummy," sticky eyes. My moisture-producing glands, particularly my salivary glands were significantly affected and I had, in effect, (drug-induced?) Sjogrens Syndrome. My salivary glands felt uncomfortable, perhaps because they were swollen. The symptoms have diminished somewhat in the past two weeks, but have not resolved. I visited my PCP on 04/02/2021 and she advised to see her again if the symptoms did not continue to resolve on their own. Note that in 2014, I had a similar, but more severe reaction to a single dose of Nitrofurantoin and regained nearly complete salivary gland function after 9-12 months.

Headache, chills, nausea, fever that went higher as day went on, went up to 101 with taking ibuprofen, severe fatigue, could not stay awake more than half hour, fuzzy headed feeling, constant ringing in the ears , day 4 of effects couldn't catch my breath when walking more than 10 feet. Day 6 still have ringing in ears, some fatigue, breathing better but not 100%.

Starting within 30 minutes of shot developed, rash and itchiness all over back. Itchiness in ears, throat and on scalp. Sore throat. Highly elevated BP - 190/100. Was given Benadryl 25mg and sent home. I slept for about 4 hours. Only very minor itching remained for about an additional hour. Minor sore throat continues (4/10/21 10:20 am)

Itchy on left arm and around mouth. Assessed and stood by with epi pen. Symptoms eased and patient returned to normal and released

swelling of tongues and upper inside plate; upper inside palate in her mouth was also kind of swelling; upper lip tingling/numbness and swelling of tongues and upper inside plate; muscle soreness near the injection site; injection site was painful; couldn't move her arm behind her or up and was limited with that arm; This is a spontaneous report from a contactable consumer (patient). A 61-year-old female patient received first dose BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in arm left on 22Mar2021 10:15 (Batch/Lot number was not reported) as single dose for covid-19 immunisation. Medical history included she was in generally good health besides being hard of hearing and she got hit by a car at age 2 and after she got older her HCP said she would be completely deaf by age 60 and she was now classified as being profoundly deaf. There were no concomitant medications. She had never gotten the flu shot in her life. The patient experienced had muscle soreness near the injection site, injection site was painful, couldn't move her arm behind her or up and was limited with that arm on 22Mar2021, numbness and swelling of tongues and upper inside plate, upper inside palate in her mouth was also kind of swelling and upper lip tingling, all on 22Mar2021 19:00.There was no treatment received. She had physician office visit to ask the HCP to see if there was anything she can take before she takes the 2nd dose to prevent this. The clinical course was reported as follows: She had the 1st dose of the Pfizer Vaccine on 22Mar2021 at 10:15am and for the most part where the injection site was and some in the muscle it was very painful and she was told this is very common; the vaccine was given in her left arm into the muscle and the injection site was painful for a while and then the muscle below it felt painful and throughout the day and yesterday she couldn't move her arm behind her or up and was limited with that arm on 22Mar2021. Today the pain was getting better and the muscle and injection site still are kind of sore but she was sure that would get better in time. Around 7:00pm(22Mar2021 19:00) in the evening she had another reaction that was not listed in the severe reactions and that was she had some numbness and swelling in her tongue and then the upper inside palate in her mouth was also kind of swelling and her upper lip was tingling; states this swelling and tingling began on 22Mar2021 and was not ongoing fortunately she slept sitting up and did not want to lie down and suffocate herself; when she woke up at 4:30am the swelling and tingling went away so she does not know what time the symptoms went away because she was asleep. She had no treatment and tries to avoid medicine as much as possible and did not go to the emergency room but following yesterday she went to the walk in clinic last night because she wanted to ask the HCP to see if there was anything she can take before she takes the 2nd dose to prevent this, and the HCP said there is nothing he can do. Case were assessed as non-serious by reporter. Outcome of muscle soreness near the injection site, injection site was painful, couldn't move her arm behind her or up and was limited with that arm was recovering, of other events was recovered in Mar2021. Information on lot/ batch number has been requested.

feels a little dizzy; Noticed her voice is not quite right; feels kind of wierd; significant loss of hearing in right ear; when she eats fruit, she notices blocked feeling in her ear. When she talks she notices an echo in her ear; muscle pain in injection site the first night after her dose; Sore Arm Left; This is a spontaneous report from a contactable consumer (patient). A 61-year-old female patient received first dose bnt162b2 (PFIZER COVID VACCINE), via an unspecified route of administration, administered in Arm Left on 20Mar2021 (Batch/Lot Number: ER2613) as single dose for COVID-19 immunization. There were no medical history and concomitant medications. The patient received first dose of PFIZER COVID VACCINE last Saturday 20Mar2021. On 26Mar2021 the patient reported muscle pain in injection site the first night after her dose but it only lasted one day. Today 26Mar2021 noticed significant loss of hearing in right ear and feels a little dizzy. Noticed her voice was not quite right. She stated she felt kind of weird. When she eats fruit, she notices blocked feeling in her ear. When she talked she noticed an echo in her ear. She stated she was typically healthy. had this been reported and wondering when it will go away. On 29Mar2021 she stated she called last Friday and reported it because she was so frightened that she had lost her hearing in her right ear. She stated that after one day, her hearing half recovered and after two days, her hearing completely recovered. The patient experienced hearing loss in right ear from 26Mar2021 and sore arm left from 20Mar2021. She stated that she was 61, almost 62 and was very healthy, no medications, not sick. She stated her last vaccine that she had was in childhood. She stated that she doesn't get the flu shot and doesn't get the flu, nothing really. She stated that she had this vaccine for other people, for their concern, she was not worried. She stated the first night, she felt muscle pain in her arm and then she forgot about the vaccine, until Friday. She stated she realized when she searched sudden loss of hearing. She stated that it was all gone. She stated she thought should she have the second one, She stated she thinks it was fine. Clarifies that the first morning she noticed it when she got up it was a little weird, She stated she couldn't hear something, so she started searching this and said she better check it out because it said she needed to get treated sooner. She stated she thought what should she do and was in a panic and that was how she went on the internet and make the link. She stated she wanted to let Pfizer know that everything was back to normal. The outcome of event 'significant loss of hearing in right ear' and 'when she eats fruit, she notices blocked feeling in her ear. When she talks she notices an echo in her ear' was recovered on 28Mar2021, of event 'muscle pain in injection site the first night after her dose' and 'Sore Arm Left' and was recovered on 21Mar2021, of other events was recovered on an unspecified date.

Stuffiness in right ear and increased ringing in ear. I have been previously had tinnitus, but has gotten worse after vaccine.

mild headache, itchy nose, runny eye, sneezing- nose bleed the next morning headache, sneezing was over by morning

Patient received her second Pfizer covid vaccine on Tuesday 4/6/21. She said she had been doing yard work before she came to get her vaccine. After she received her vaccine she felt fine. On Tuesday night she started to feel some itchiness. She said the itchiness got worse over the next two days. She talked to her husband and he advised her to take Benadryl so she took two Benadryl. On Wednesday she had some soreness at her injection site. Very early Thursday morning she noticed a golf ball sized knot in her armpit. She said it was sore and if she rubbed it, it felt like it was pushing into her breast. She said it felt like pressure going all the way to her breast bone and along her esophagus. She ended up calling EMS and her blood pressure was up to 181/107 and had a high heart rate. She said she never had any hives but did have some throat, tongue, and lip swelling and said that her throat felt raw. The EMS gave her 2 nitroglycerin tablets and 5 aspirin. She spent Friday and Saturday in the hospital. She said the hospital did all kinds of cardiac tests on her and everything can back clear besides a leaky heart valve. She said she is feeling much better now and that the hospital was not sure if it was a reaction to the vaccine, something else, or a combination of things that caused it.

swelling of lips and under eyes 2 days after second covid vaccine. Patient with hx of dermal injection

Received vaccine on 04/07/2021 at 07:47 AM; Presented at ED on 4/08/2021 at 8:29 am and received prednisone 60 mg and diphenhydramine HCl 50 mg: chest tightness and throat swelling that began yesterday afternoon. She explains that she has h/o anaphylaxis to flu vaccine. She got the first dose of Covid19 vaccine yesterday, she did premedicate with benadryl. She was monitored on site for an hour and felt some left neck pain and jolt of pain down left arm, but it resolved and she went home. Shortly after, she began feeling like she was having asthma attack, wheezing, chest pressure and throat swelling. She used inhaler and took benadryl. Last dose of benadryl at midnight, took Zyrtec D at 7am this morning, last nebulizer and symbicort at 6:30am. She states she still feels chest tightness and throat swelling. She feels like her tongue was very swollen but improved after benadryl. States her voice is different. Feels a little harder to swallow but she is able to drink fluids. She took pantoprazole this morning. States this does not feel like her usual asthma. Rates chest tightness a 4/10 on pain scale, states it feels like something is sitting on chest or squeezing chest. States it does feel a little better in anterior chest now, but she feels it on lateral lower chest still. Denies h/o cardiac issues. Denies h/o MI. No jaw or arm pain at this time. Discharged from ED at 9:27 am and reported to ED at 10:03am on 4/08/2021. Received famotidine 20 mg and discharged home at 1206pm on 4/08/2021 with prednisone, Pepcid, EpiPen

Pt c/o mild blurred vision, "tingly" on head and feeling "jittery." EMS and RN assessed pt. BP was in the 150's/80's. PT states she has a hx of DM, has not eaten yet for the day, has a hx of getting a reaction from Tetanus shot. Blood sugar was 126. Pt was given a snack and water. Reassessed after 10 minutes and pt still "feels the same." After another 15 minutes, Pt and husband decided to leave but recommended to stay and be checked for a few minutes but pt insisted they want to go home. Was advised to go the hospital if symptoms persist. Pt and husband verbalized understanding. Upon leaving, pt had steady gait, denies dizziness and blurred vision at this time.

Horrible headache and eye pain 1 day after second vaccine. On second day, Shingles developed on left forehead and scalp, and in left eye. 14 days PO Valtrex, zirgan opththalmic ointment 12 days, Lyrica, nortriptyline, Tylenol, Tramadol on-going. Still have slight rash with few new blisters everyday, burning/itching/tingling and fatigue.

AFTER ABOUT 45 MINUTES OF RECEIVING THE VACCINE, MY BOTTOM LIP STARTED TO TINGLE. WITHIN A FEW MINUTES OF THAT A HIVE APPEARED RED AND MY LIP STARTED TO SWELL. I TOOK BENADRYL, WHICH SEEMED TO HELP STOP THE SWELLING.

Anxiety thanks to crowds and fleeting initial dis-organization at the vaccine facility. Sore arm the evening of the injection and the next day. Joint/muscle aches and pains nights the 10th and 11th that interrupted sleep; took acetaminophen. Aches during the day and tired the 11th, 12th and 13th (so far). Strange taste in mouth, upset stomach 12th and 13th (so far). Not looking forward to second dose though happy to have started process.

I've had tinnitus since taking my very first dose of Tamiflu on January 15, 2018. Immediately after getting the 1st shot of the Pfizer COVID-19 vaccination, the volume of my tinnitus increased a lot and has maintained that increased volume. It's AWFUL. I'm afraid to take the second shot for fear that it will increase even more.

Numbness and tingling head, face, and neck . Itching inside of nose, eyes. Lasted about 6 hours Took two benadryl and monitored to make sure breathing didn't become impaired.

Metallic taste 2 min later. High blood pressure 5 min later. Swollen lymph mode on collarbone 10 days later.

My tinnitus worsened considerably. Loud high-pitched ringing in ears which I noticed within a day of receiving vaccine.

I went to my eye doctor for my annual exam. They noticed I had a blood vessel break in my retnea so they sent me to a specialist. I didn?t think anything about it until my husband came home from his second shot and his blood vessel had popped in his eye. My husbands you could see right away mine was at the back of my eye and could not be seen. Once I saw his it hit me that it could of been from the shot, too coincidental!

Puffy both eyelids and double vision.; Puffy both eyelids and double vision.; This is a spontaneous report from a contactable consumer (patient). A 61-year-old female patient received the first dose of BNT162B2 (PFIZER- BIONTECH COVID 19, Lot Number: EN6205), via an unspecified route of administration, administered in left arm on 16Mar2021 13:00 (at the age of 61-year-old) as single dose for COVID-19 immunization. The patient is not pregnant. Medical history was none. No known allergies. Concomitant medications included metformin; levothyroxine sodium (SYNTHROID); atorvastatin (LIPITOR) and women one day sl. No other vaccine in four weeks. On 17Mar2021 02:00 AM, the patient experienced puffy both eyelids and double vision. No Covid prior vaccination and not tested with Covid post vaccination. No treatment was received for the events. The outcome of the events was not recovered.

Received shot around 1:10pm, a few hours later around 4pm felt tired. Pain at injection site lasted a few days felt like a bruise. Around 8:30pm lips became bright red, felt like there were sores on the roof of the mouth that were painful and interfered with eating for 3 days after shot ate soft foods, eyes really dry, extremely thirsty for about 2 days after shot. On 4/3/21 around 9pm took a 25mg tablet of Benadryl and that helped a little bit with the symptoms. On 4/13/21, 10 days after the shot, felt extremely fatigued, body and joint aches intense, nauseated, headache lasted a couple of days. By 4/16/21 felt better and was able to go to work in retail.

Loss of breath. Very hard to breathe; Vision degrade; Heart rate increase over 100 BPM; This is a spontaneous report from a contactable consumer, the patient. This 61-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6206) via an unspecified route of administration in the left arm on 12Mar2021 12:30 (at the age of 61-year-old) as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient did not have any allergies to medications, food, or other products. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient had not had symptoms associated with COVID-19 and was not enrolled in the clinical trial. On 13Mar2021 00:45, the patient experienced heart rate increased over 100 BPM, vision degraded, loss of breath and very hard to breath. As a result of the events, a visit was made to the doctor or other healthcare professional office/clinic with the patient's heart rate, blood pressure and oxygen (level) were checked. As of 14Mar2021, the clinical outcomes of the heart rate increased over 100 BPM, vision degraded, loss of breath and very hard to breath were resolved on an unspecified date in Mar2021. The expiration date of the lot number for the vaccine, BNT162b2, was not provided and will be requested during follow-up.

Fatigue 4/16/2021-4/18/2021 Pain on left side of neck and behind ear 4/17/2021, 8:00AM-2:00PM Fog-Brain 4/17/2021, all day Low grade Fever 4/17/2021, 1:00pm-middle of the night when I woke up sweating, 99 degrees during the day time hours Took no fever reducing medications during this time.

My heart flutters; heart spasms; uncalm coming into my dreams viciously, morbidly gross; super watery bowel movement then went into clay like and drier consistency but still dark (I never had stool this dark).; I was dry/ I needed water; room seemed like it was so much further away, my stairs the spindles were larger in size, it was if I was high on something/feeling of peace, calm/high feeling; I was whistling in my breathing/ I had a loud whistle; feeling my eyes and hearing were sharp/ my eyes were changed eventually; had my eyes dilated; felt I like I was getting hemorrhoids/I woke up feeling like I had too much sugar; black stool; constipation; Chills; wanted to vomit; I got shaky; scares; There's a feeling of hardness in my lower abdomen and heart area (Belch); There's a feeling of hardness in my lower abdomen and heart area (Belch); reversed my beta blockers (it keeps it in the 50s) it went to 79; My energy was so much more.; The next day I gained 3.2 pounds then the next day lost 3 pounds; My injection site for the first 2 weeks,I had an itch/ extreme itch; injection site for the first 2 week/there's pain there on touch (no throbbing pain); My tooth broke; movement under my skin/shingles feeling; My skin is extremely dry; This is a spontaneous report from a contactable consumer (patient). A 61-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 11Mar2021 (Batch/Lot number was not reported) as SINGLE DOSE for COVID-19 immunization. It was reported that the patient vision wasn't as good. She also had glasses to read (eyeglass wearer and ongoing) and behind her eyes they were dry one (left) mostly. Concomitant medications included unspecified beta blockers. On 11Mar2021, she got chills on the same day. Right as she got the shot, she wanted to vomit also and got shaky. On 12Mar2021, she woke up with whistling in her breathing for a few minutes then it was done. At the same moment, her eyes were changed eventually. She had mucus in my eyes as her vision wasn't as good and behind her eyes, they were dry one eye (left). So, watching TV wasn't as good and became bothersome. She later noticed, the black in here eye was taken up most of her eye (as if her eyes were dilated). Her eyes and hearing were sharp also now sharp as she was reading better (without my read glasses) and had to turn down the volume in her TV. She also felt like she was getting hemorrhoids for a few days but then it went away. She also had black stool, then constipation (harder stool) eventually went the day right after the shot (12Mar2021). Then around 5pm, she had feeling like she had too much sugar and was dry which she needed water. Once she sat down, her living room door seemed like it was so much further away, stairs the spindles were larger in size, it was if she was high on something. It was different nothing but this injection. She was also experiencing a feeling of peace and calm. As if nothing was wrong, no stress (stressing about something) she couldn't even think of- everything was gone, a calming effect. It was high feeling. The next day (13Mar2021), she had a super watery bowel movement then went into clay like and drier consistency but still dark (she never had stool this dark). In Mar2021, she also stated that there was a movement under her skin like a pre-herpes or a pre-shingles. She mentioned that she knew herpes and the movement under her skin was shingles feeling. Her skin was also extremely dry. On 17Mar2021 (a week after the injection), she woke up to my heart spasm. It was beating real fast (beating like right under her skin), no pain and heart attack but more than a heart flutter. She didn't know whether it was going to beat or stop. She also woke up with a loud whistle (louder than before) out of a dream. She stated that during the day she doesn't get the stressed, but in her dream, it was magnified and woke up in a violent vicious fury. She had 3 nights of this (uncalm coming into my dreams viciously, morbidly gross) started on 14Mar2021. The heart spasms come as a few seconds and goes away but that's happened twice which it scares her. She also stated that there was feeling of hardness in her lower abdomen and heart area (belch) in Mar2021. The injection almost reversed her beta blockers (which keep it in the 50s) it went to 79 (same as it was before she started taking beta blockers) but her blood pressure was normal 121/something (that was a good thing). She also mentioned that her energy was so much more while other people woke up early, cleaning up -would get sleepy and a little tired. But this (injection) gave her energy. Her injection site for the first 2 weeks also had an itch, that would come up (not constant) almost like a yeast infection which had an extreme itch. There's pain was there on touch (no throbbing pain) it took over a week before it was gone. She also mentioned that the chills were off and on for 4 days. The vaccine also did something to her weight as she was expecting to lose weight, but she didn't. One day, she gained 3.2 pounds then the next day lost 3 pounds. Her tooth also broke (but no pain in her tooth) even she had a sensation of her teeth being weak which she could feel it. Her tooth broke eating a tortilla chip and that's weird. She wanted to know if other people had called in with the symptoms that she had experienced. The patient recovered from breath sounds abnormal and constipation on 12Mar2021; cardiospasm, chills and vaccination site pain in Mar2021 while the remaining events were unknown. No follow-up attempts are possible. Information on the lot/batch number cannot be obtained.

tachycardia (avg. 125 bpm); dry mouth; low sodium; low potassium; excruciating headache with light and sound sensitivity/head pounding; light and sound sensitivity; light and sound sensitivity; nausea; lightheadedness; My arm was sore; Felt absolutely terrible; This is a spontaneous report from a contactable consumer (patient). A 61-year-old non-pregnant female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: ER8734), via an unspecified route of administration, administered in left arm on 01Apr2021 13:30 (1:30 pm) as single dose for COVID-19 immunization in a clinic. Medical history included autoimmune hypothyroidism, gastrooesophageal reflux disease and don't tolerate NSAIDs but not allergic all from an unknown date. Concomitant medications included levothyroxine; esomeprazole magnesium (NEXIUM); cetirizine hydrochloride (ZYRTEC ALLERGY); gabapentin; and estradiol (ESTROGEL) all taken for an unspecified indication, start and stop date were not reported. The patient previously took erythromicin and experienced drug intolerance but not allergic on an unspecified date. The patient previously received the first dose of bnt162b2 (lot number: EN6204) on 11Mar2021 1:30 pm administered in left arm for COVID-19 immunization. The patient was not diagnosed with COVID-19 prior to vaccination and has not been tested since the vaccination. On 01Apr2021, it was reported that the patient experienced tachycardia (avg. 125 bpm), dry mouth, low sodium, low potassium, excruciating headache/head pounding, light and sound sensitivity, nausea, lightheadedness, arm was sore, and felt absolutely terrible. The patient was hospitalized for tachycardia (avg. 125 bpm) for 1 day. The events required physician office and emergency room visit. the patient was treated with IV saline, IV anti-nausea, and IV morphine. The patient underwent lab tests and procedures which included blood potassium: low, blood sodium: low, and heart rate: 125 bpm - tachycardia all on 01Apr2021. The outcome of the events was recovered.

auto immune disease oral lichen planus flare x 2 months following vaccine increased size and painful mouth lesions bleeding gums difficulty eating

Six days after my 2nd vaccine I had an anaphylaxis reaction. Out of the blue while I was driving my face started to burn like acid was rubbed on it. It got really hot and turned very bright red. Then my lips began to feel like they had been sunburned badly. Then my forearms both started burning and also turned bright red. I was very anxious. Had two bouts of diarrhea. All this occurred within about a 20 minute time-frame. I chewed up 4 children's Benadryl (50mg) and the redness, burning and anxiousness subsided mostly. My heart rat was still over 100 bpm even after 6 hours. (Usually my HR is 68-70 bpm). I slept for 12 hours and the next day seemed fine. This has occurred two more times since that first time. The 2nd reaction being 5 days after that first one and the 3rd reaction being 5 days after that. Same reaction, same treatment and same outcome.

Sore shoulder for three days-no treatment Bodyaches- for three day-Tylenol, rest, water Headaches- for three day-Tylenol, rest, water Slept all Saturday following, most of Sunday, Some of Monday Insomnia Sunday night about four hours, Monday about two hours. Internal external mouth sores. Still healing from outside sores Brain Fog. Took about three weeks for brain fog to go away from first to second shot. Still have brain fog from second shot which what I am reporting on here.

DAY ONE April 15, 2021. On Thursday April 15th at 10:00 a.m. I received the first dose of the Covid 19 vaccine. They gave me the shot in my left arm. Within about 5 seconds, I started feeling nauseated and light headed like I was going to pass out. I asked to just sit there for awhile because I did not feel stable to stand up and go to the waiting area. I stayed seated for about 1-2 more minutes then the paramedics took me to the Medical area in a wheelchair. The paramedics checked my vitals. My blood pressure was 135 over ?? I don't remember. I told the medic my BP is normally 98/58. She said my BP was elevated. My pulse was in the high 80's. My temperature was 98.6 and my oxygen was 100. I started getting pain and pressure going up the back of my neck, into my head, eyes and ears. It was very painful and throbbing pressure. I felt dizzy and really high. It felt like I was floating on the top of the ceiling and the people were off in a distance. I was really woozy. I then got diarrhea. The nausea continued but I did not throw up. At times my thinking was spacey, so I talked to the paramedic to help me stay grounded. I narrated what was happening in my body. They did a glucose finger prick test because of my spaceyness, but it was normal. It was like my whole system was freaking out. I was there and then not there, feeling like I was floating. These symptoms continued for about 90 minutes and getting worse. The paramedics offered me to go to the hospital, but I thought eventually I would be fine. I did not want to go to the hospital and have a huge medical bill. At around 90 minutes, I started having pain in my heart left side, under my left breast on my left shoulder. The paramedics did an EKG and did not find anything but some irregular heartbeats. The heart beats felt like BA BOOM, then my heart would do a cartwheel. BA BOOM and another cartwheel. At this time, my husband arrived and took me to the hospital emergency room because the pain in my heart was getting worse. I stayed in the hospital emergency room until around 5:00pm on April 15th. They did another EKG and some lab work and did not find anything but low thyroid. I continued to feel drunk, nauseated, pain pressure and throbbing in my head neck, ears and eyes, diarrhea, and like I was High and going to pass out. The chest pain in my heart was off and on. It felt like muscle cramping in my heart, under my left breast and the left shoulder. I also got a pain in my left groin area, then behind my left knee. It was a sharp and throbbing pain for about an hour in each location, but eventually went away. While in the Emergency room, they tried to give me Ativan. I asked what it was for and they said Anxiety. I said I wasn't anxious; I was just having a reaction to my first Covid 19 vaccine. I said I did not want it because my body was already struggling to handle the Covid 19 vaccine. They said the doctor prescribed it. I said I had not seen a doctor, and they said it is protocol. The nurse then came in and wanted to give me a shot for nausea and I said no, I don't want any more chemicals in my body, it is really having a hard time already with the Covid vaccine. I went home, was wiped out, still feeling drunk/woozy/high, also nauseated, diarrhea, very dizzy, had a hard time walking. The pain, throbbing in my head, neck, ears and eyes was still there. By this time, I could not find clear thoughts, and could not make sense of things. I was very agitated and at the same time exhausted and only wanted to sleep. DAY TWO April 16, 2021 I woke up with a smashing head ache, neck ache, back ache and general feeling like Crap. The nausea and diarrhea were still there and had woken me in the middle of the night. I felt like a truck had hit me. I stayed in bed all day and tried to eat and drink as much as I could. I drank a lot of water that day. I felt horrible, but was able to stand without feeling like I was going to fall over. Had trouble finding clear thoughts at times. Still felt out of it and had chest pain off and on. Also had the BA BOOM heart beats and cartwheels in my heart. DAY THREE April 17, 2021 Very similar to day two. I felt weak, nauseated, diarrhea, pain all over, jittery, not able to have clear thoughts at times. It felt like my body was still on RED ALERT!!! I also had very shallow breathing on day 2, 3, 4 and 5. It tired me and I panted just getting up to go to the restroom. I am able to eat fine and keep food down. BA BOOM hear beats and cartwheels in my heart have lessened. DAY FOUR April 18, 2021 I felt a little better and made the mistake of thinking I was getting over the reactions and did too much. Shortness of breath. DAY FIVE April 19, 2021 I feel horrible again, Nausea is really strong as well as the diarrhea. I am feverish, sweaty and shaky. Shortness of Breath. Tight in my chest. I just took my temperature and it is normal, although I am hot, sweaty, feel feverish and shaky. I am exhausted. The headache is still here as well as the pains in my neck, ears and eyes. The aches in my body are still here. I have no energy. A wave of emotions is also here and I am weepy and crying. This is no fun. I am able to eat food OK and drink lots of water to counteract the diarrhea. DAY SIX April 20, 2021 Shortness of breath, very tight in my chest, having to take Benadryl and use my rescue inhaler to keep my breathing open. Feverish, chills, shakey, hot. Temperature 97.0 Blood pressure 90/66 Pulse 70. I feel like crap, just wiped out.

Yellow mucus / vomiting/ diarrhea 15+ / headache/ body ache/ stomach ache / can?t smell / can?t eat / lower back is hurting

At 11:27 AM, Pt states that within approximately 10 minutes of receiving Pfizer vaccine pt c/o tingling ?to roof of her mouth?. She notified RN of symptoms and nurse asked her to open her mouth and observed that tongue was WNL without swelling, speech clear, no respiratory distress. Discussed with Pharmacist and instructed pt to wait another 15 min and to sit close to nurse for observation. RN also asked pt to notify her of any worsening of symptoms and also to not leave site without evaluation of nurse. At 11:42 AM pt stated symptoms were worsening and c/o think tongue, numbness, tingling of lips. Denies any SOB or difficulty breathing. Lungs clear to auscultation posteriorly all lobes.B/P 180/110, Left arm, Pulse ? 100. Pt also c/o blurred vision, numbness across forehead, chest pain and pressure, dizziness and increased tiredness, denies headache and anxiousness. At 11:46 AM 12.5mg liquid Benadryl given p.o. and after consulting with Pharmacist, another 12.5mg Benadryl given at 11:51AM and pt taken to ED via wheelchair. Pt verbalized consent.

severe allergic reaction to the vaccine; sore arm; neck pain; getting lots of saliva; tongue started swelling; rapid breathing, couldn't control her breathing; heart rate it got faster; started getting confused; shaky; wheezing; swelling of her throat; blood pressure dropped; This is a spontaneous report form a contactable consumer reporting for herself. A 61 years old female consumer received the first single dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; NDC number 59267-1000-01) on 29Mar2921 at 14:15, in left upper arm, for COVID-19 immunisation. No other vaccines were given on the same date or within 4 weeks. Medical history included allergic to hamsters (she found out that this one had the Chinese Hamster Ovary cells and she knew she had problems with those things), allergic to prednisone (crazy rash, itching), allergic to a lot of different things, sinus infection. Family history included allergy (the whole family had allergies). Concomitant medications included unspecified antibiotics for sinus infection (but it had cleared up by then) and unspecified allergy shots (but not a vaccine). The patient just wanted to report that she had a severe allergic reaction to the vaccine on 29Mar2021. Symptoms began minutes after getting vaccine. The patient experienced getting lots of saliva started with a couple of minutes of getting the shot, tongue started swelling, rapid breathing, couldn't control her breathing, heart rate it got faster, started getting confused, shaky, wheezing, swelling of her throat, blood pressure dropped, all on 29Mar2021. On 30Mar2021 the patient experienced sore arm and neck pain but she thought that was more of a vaccination saying it was working. Clinical course of the events included the following information: the patient had to stay for a while since she had allergies normally. She started getting lots of saliva and she thought that was her body saying, she did something, not a big deal. Around 15 minutes, she was at a grocery store, she started walking around, her tongue started swelling, rapid breathing, she couldn't control her breathing and heart rate, it got faster. She started getting confused, shaky, it wasn't too good. She made her way back to the place where the injections were done, they were trying to get her to use her epinephrine (EPIPEN). She took a diphenidramine (BENADRYL) while walking around looking for her husband and then took another and was wheezing. She thought BENADRYL would have helped. She should have taken her EPIPEN looking back, she thought BENADRYL would help. They heard wheezing, they contacted the other pharmacist, who contacted EMS then they came and took her to the emergency room on 29Mar2021 in the afternoon. When she was wheeled in, the doctor met her in the hall and he said they could give her a steroid shot. The patient stated she was allergic to prednisone, she got a crazy rash, itching, it's not just prednisone, it's an allergy. She got the shot at 14:15 and she was at the hospital by 15:00. The patient thought she was there for 5 hours and then she was sent home. Her blood pressure dropped. The only one she saw was 114/39 but her husband saw it went even lower than that. At the emergency room, they had the automatic thing strapped on so they watched her until it started going back up again. The vaccine shot was probably the easiest shot she had ever had. She had never had any problems. She did not research it very well in the beginning because she thought they should be good. The patient was told to not get the second vaccine. The events also required physician office visit. Allergic reaction symptoms resolved on 29Mar2021 but the swelling of her throat and heart rate lasted about four days, until 02Apr2021. Neck pain resolved on 01Apr2021. Sore arm resolved on 03Apr2021 or 04Apr2021. Blood pressure dropping resolved on an unspecified date in 2021. Information on the lot/batch number has been requested.

headache, body aches , teeth hurt patient took Tylenol and her Butal acet caff, sumatriptan. Asking if she can take her Ambien?. Advised yes, take medications as prescribed/directed 4/15-Patient returned call, no signs and symptoms at this time. Body aches, headache and teeth pain lasted 2 days after receiving vaccine, has taken Butal acetaminophen caffeiene to relieve symptoms

fever of 101.7, cold, then sweat, resulting in a seizure affecting speech and vision all gray. Ambulance to Hospital.

Patient started complaining of numbness to the right upper quadrant and later developed itchiness throughout body. Patient evaluated by RN and EMS. Patient remained in observation for about 45 mins . Symptoms alleviated and was recommending to drink fluids and take benadryl over the counter at home. Patient then returned as she started developing heavy tongue and numbness to the lips while on her way home. Patient denies any shortness of breath , no chest pain, no dizziness , no nausea. At 1207 pm- Patient was evaluated by Dr. and was advised to administer Benadryl 25 mg IM and advised patient can take another 25 mg of Benadryl PO at home. At 1214pm Paramedic administered 25 mg of Benadryl IM on right arm . 1231pm patient reports feeling better , symptoms have resolved. Patient advised MDs recommendation to take benadryl 25 mg by mouth. Patient advised if symptoms worsen and/or develop shortness of breath contact 911 or go straight to ER.

I received the first dose of Pfizer vaccination #1 on April 8 at 9:15am. Almost immediately the hearing in my right ear started to shut down/muffle. Today is April 22 and the problem persists. After researching online I will not take the second dose, scheduled for April 29 at 12:30pm, for fear of worsened and/or permanent damage.

Patient received 2nd dose of Pfizer COVID-19 vaccine on 4/1/2021. Vaccine given 09:35. She complained of tongue swelling and periorbital swelling. She was evaluated by Doctor and given BEnadryl 25 mg po x1 and Pepcid 20 mg po x1. She was observed for 30 min.

On the 15th day after vaccination with Pfizer vaccine, I got dizzy for a few seconds while laying on my couch. Within a few hour after that I started with loud ringing in my right ear; this happens to be the same side I was vaccinated on. That same night I got a headache and was throwing up. The louder ringing in my ear lasted few about two and a half weeks. Since then is has gradually been subsiding.

Oral allergic reaction. Tingling on lips and roof of mouth 8 minutes after vaccination VS 160/90 HR 91 SPO2 96% on room air; RR 16 Received Benadryl 50mg capsule at 9:08 am

Headaches started 2nd day of 2nd vaccine. About day 8, I began having ear ringing along with headaches. It has been 36 days now and the headaches are still there but not as severe. The ear ringing tho; It is extremely irritating; Headaches started 2nd day of 2nd vaccine. About day 8, I began having ear ringing along with headaches. It has been 36 days now and the headaches are still there but not as severe. The ear ringing tho; This is a spontaneous report from a contactable consumer (patient). This 61- year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE Lot number: ER8733), via an unspecified route of administration, on 01Mar2021 at 12:00 AM (at the age of 61-years-old) as a single dose for COVID-19 vaccination. The facility where COVID-19 vaccine was administered was reported as "other" and anatomically located on the left arm. Historical vaccine included: bnt162b2 (COMIRNATY, Solution for injection, Lot number EL9265,) dose 1 on 08Feb2021, for covid-19 immunization. No allergies to medications, food, or other products. The medical history and concomitant medications were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 02Mar2021, she experienced Headaches started 2nd day of 2nd vaccine. About day 8, I began having ear ringing along with headaches. It has been 36 days now and the headaches are still there but not as severe. The ear ringing thou is still present 24/7. It is extremely irritating and there is nothing i can do to make it better. Treatment was not received for the adverse event. The clinical outcome of the events was not recovered. On 05Apr2021, the patient was tested for COVID-19 via Nasal Swab since having the vaccine, with a negative result. No follow-up attempts are possible. No further information is expected.

On 4/20/2021 client states she began having headaches, leg burning sensations, right eye swelling. Contacted our website and I called and spoke to her. She states eye swelling still present on 4/23/21.

Upper & lower lip swelling , blisters/cold sore on each side of mouth, few bumps on roof of mouth, severely chapped lips. Lip swelling lasted 5 days, bumps on roof of mouth lasted 1 day, chapped lips lasted 2.5 weeks but are still very dry and blisters/cold sores are not as visible but skin at corners of mouth are red and tender and opening mouth to eat causes discomfort

Slight numbness in tongue that lasted several hours beginning within 10 minutes of vaccine along with dizziness; experienced fatigue, nausea, tinnitus, blurry vision in right eye, elevated heart rate, buzzing sensation in back of head, stabbing pains in stomach followed by profuse watery diarrhea. Dizziness and nausea still unabated seven days following vaccination.

Severe joint pain through entire body.; Muscle fatigue; lethargic; Severe headache; Top lip swelled; left eye mild swelling; Temperature of 100°; This is a spontaneous report from a contactable consumer (patient). A non-pregnant 61-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), dose 2 via an unspecified route of administration, administered in the left arm on 17Mar2021 at 14:00 (Batch/Lot number was not reported) at 61-years-old as a single dose for COVID-19 immunization. The patient did not receive any other vaccine within four weeks of the suspect vaccine. The patient was not tested for COVID post vaccination. The patient's medical history was reported as none; no allergies to medications, food, or other products. The patient did not have COVID prior to the vaccination. There were no concomitant medications. The patient previously took bnt162b2 for COVID-19 immunization on 23Feb2021 (Dose number=1; Vaccine location=Left arm; Administration time=13:30; Lot number= Unknown), hyaluronic acid (JUVEDERM) in Jan2019 (location=under left eye), hyaluronic acid (JUVEDERM) (location= top lip) on 02Feb2021. On 23Mar2021 at 05:00, the patient experienced: severe joint pain through entire body, muscle fatigue, lethargic, severe headache, top lip swelled (where she received hyaluronic acid filler on 02Feb2021), left eye mild swelling (at the hyaluronic acid filler injection site from Jan2019), temperature of 100°; all assessed as non-serious. There was no therapeutic measures taken. The clinical outcome of the events was recovering. The batch/lot numbers for the vaccine, bnt162b2, were not provided and will be requested during follow up.

Red blotchy skin within 20 minutes, itching. raised hives. Next 5 days followed by red flushing skin. Itching. Swollen throat and tongue.

when woke up today 4/27/21 at 7am, exhausted, muscle ache, headache, fever 101.3, foggy brain, 2 new symptoms that I didn't get with first vaccine: VERY thirsty, bloodshot eyes

As I was driving home I felt a sensation in my left cheek. I was only tired with mild headache at first, then over days my left sinuses (involving left eye and left cheek) became stuffed up and could not breath through the left nostril. In addition, my left ear ached. Around a week later I developed a sinus infection (left sided). I still have some left sinus, left temoral area and left ear discomfort and only mild stuffiness in the left sinuses (around left eye and left cheek).

I took my temp, which was 100.2; anaphylactic reactions; The neck itching/burning and throat/ear pain got worse; tired; earache; swelling; itching; stinging; peeling; hurt my throat; throat was swelling; couldn't sleep; rash; burning; This is a spontaneous report from a contactable consumer (patient). A 61-years-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm Left on 09Apr2021 09:15 (Batch/Lot Number: EW0158) as SINGLE DOSE for covid-19 immunization. Medical history included Asthma, HBP, High Cholesterol, prediabetes. Known allergies: Penicillin, Sulfa, Peanuts. Concomitant medication(s) included rosuvastatin calcium (CRESTOR) taken for an unspecified indication, start and stop date were not reported; atenolol, chlortalidone (ATENOLOL/CHLORTHALIDONE) taken for an unspecified indication, start and stop date were not reported; metformin (METFORMIN) taken for an unspecified indication, start and stop date were not reported; sertraline hydrochloride (SERTRAL) taken for an unspecified indication, start and stop date were not reported. No other vaccine in four weeks. No covid prior vaccination. No covid tested post vaccination. On 10Apr2021, the patient experienced anaphylactic reactions, tired, earache, swelling, itching, stinging, peeling, hurt my, throat was swelling, couldn't sleep, rash, burning, the neck itching/burning and throat/ear pain got worse. It was reported that 09Apr2021- got her 1st Pfizer COVID shot. Left arm. Felt okay afterward, got a little tired later on. On Sunday, she woke up w/an earache on her left side, which moved down into her neck - near her lymph nodes. Later, her neck started swelling/itching/stinging/feeling warm, and it hurt her throat to swallow anything. She went to get Benadryl and anti-itch creams, but they didn't work. The neck itching/burning and throat/ear pain got worse, and at one point it felt like her throat was swelling and getting narrow, and she wondered if this was one of those anaphylactic reactions. So she took 2 Benadryl, and that seemed to help. That night she couldn't sleep for the neck heat, itching and throat pain. Monday AM (12Apr2021), she took her temp, which was 100.2. She did a Teladoc Zoom so the doc could see the situation, and he said that it could be a severe vaccine reaction, or some kind of infection. He prescribed prednisone & clindimycin. The rash left scars, which are peeling. Ae resulted in: Doctor or other healthcare professional office/clinic visit. AE treatment: Prescription drugs. Outcome of the events was recovering.

at 1200, pt c/o "itching" at injection site "like a bee sting". No hives, swelling noted. Pt stated this is "how I feel when I have an allergy". Stated she "takes benadryl" for this. Observed. At 12290, pt c/o "lower lip feels itchy". Pt requested Benadryl; given 50 mg po Benadryl. At 1245, pt stated she was feeling "better", elected to go home and left vaccination clinic.

Patient left facility after vaccine and had only waited 12 minutes in lobby. Patient states she walked to her car to go home and developed metallic taste in her mouth with nausea and diaphoresis. Patient came back into the clinic. She was placed in the cardiac care chair. Denies any shortness of breath, chest pain, difficulty swallowing or hives. Skin warm but she is diaphoretic. BP 144/70, pulse 71, pulse oximeter 100%. Patient states she still has nausea and feels like vomiting. After 10 minutes, patient transferred to ER at hospital.

61 year old female client received her 1st done of Covid-19 Vaccine by Pfizer on her right arm via IM at 11:20 AM. At 11:25 AM client complained of tingling sensation on her lips. Paramedics and MD on site arrive at the client at 11:28 AM, vitals are BP 168/90, HR 100, O2 98%, RR 17, Pain 0/10. MD gave patient water and educated patient proper breathing technique. At 11:35 AM client reported she feels so much better and she does not feel the tingling sensation on her lips anymore. Client was assisted to her car and was adviced to leave when she feels comfortable already.

passed out; tunnel vision; "jerking movements" of her upper extremities; left arm was tingling/left pinky and ring fingers felt nerve tingling sensations; then the back of her throat had a chemical taste and tingling; then the back of her throat had a chemical taste and tingling; BP was 164/94 while lying down; continued to have pain in her left arm and across the left side of her chest and left-sided back shoulder; continued to have pain in her left arm and across the left side of her chest and left-sided back shoulder; continued to have pain in her left arm and across the left side of her chest and left-sided back shoulder; tongue was tingling and felt swollen with an altered chemical taste for 2 days; tongue was tingling and felt swollen with an altered chemical taste for 2 days; This is a spontaneous report from a contactable consumer (patient). A 61-year-old female patient (not pregnant) received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 1 via an unspecified route of administration, administered in Arm Left on 12Apr2021 11:00 (Lot Number: ER8734) at the age of 61 years old as single dose for covid-19 immunisation. Medical history included Low thyroid, kidney infections, skin rashes, high cholesterol, food sensitivities. Concomitant medications in two weeks included liothyronine sodium (CYTOMEL); levothyroxine; vitamin b complex (VITAMIN B); levoglutamide (L GLUTAMINE). Facility type vaccine was Pharmacy or Drug Store. No other vaccine in four weeks. On 12Apr2021 11:00, within 1st min of vaccine, the patient's left arm was tingling, then the back of her throat had a chemical taste and tingling, then tunnel vision, then that was the last thing she remembered until she heard her partner saying, "Are you ok?" The patient said to her she thought she fell asleep. She was an RN and said that the patient passed out for about 15 seconds and had "jerking movements" of her upper extremities before she woke up. The staff and medic helped the patient to the floor where she rested for 20 min with her legs elevated on chair. BP was 164/94 while lying down, pulse was 74. The patient returned home and continued to have pain in her left arm and across the left side of her chest and left-sided back shoulder for most of the day. Also her left pinky and ring fingers felt nerve tingling sensations for the rest of the day. Her tongue was tingling and felt swollen with an altered chemical taste for 2 days. No treatment received for the events. No covid prior vaccination and no covid tested post vaccination. The outcome of the events was recovering.

severe vertigo; fall down on the floor; nausea; horrible spinning; vomited; dizzy; generalized weakness; brain fog; a little tired; a little off; Fatigue; sore arm; couldn't eat; couldn't open her eyes; nystagmus; couldn't walk at all without help; This is a spontaneous report from a contactable consumer, reporting for herself. A 61-year-old female patient received the second dose of the bnt162b2 (BNT162B2; Lot Number: EN6208; Expiration Date: Jun2021), via an unspecified route of administration in the right arm on 19Mar2021 at 13:30 at a single dose for covid-19 immunisation. Medical history included ongoing celiac disease diagnosed in 2012 and has been gluten free ever since, allergies, and anxiety. Concomitant medications included zolpidem tartrate (AMBIEN) taken for sleep; cetirizine hydrochloride (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) taken for allergies; alprazolam (MANUFACTURER UNKNOWN) taken for anxiety; vitamin d nos (MANUFACTURER UNKNOWN) taken for immune system health; and magnesium (MANUFACTURER UNKNOWN) taken for health. The patient previously received the first dose of the bnt162b2 (Lot number: EN6203) at 61 years of age on 26Feb2021 between 5:15PM and 5:30PM in the left arm at a single dose for covid-19 immunization and the flu vaccine (INFLUENZA) for immunization 15 years ago and experienced arm was sore. There were no other prior vaccinations within 4 weeks. On 19Mar2021, the patient experienced sore arm. On 21Mar2021, the patient experienced a little off, fatigue, brain fog, a little tired. On 31Mar2021, the patient experienced severe vertigo, fall down on the floor, nausea, vomited, horrible spinning, generalized weakness. In 2021, the patient experienced couldn't open her eyes, couldn't eat, nystagmus, could not walk at all without help. On an unknown date, the patient experienced dizzy. The events, severe vertigo, fall down on the floor, nausea, vomited, and horrible spinning, required emergency room and physician office (video) visits. The patient was hospitalized for severe vertigo, fall down on the floor, nausea, vomited, and horrible spinning from 31Mar2021 to 02Apr2021. The clinical course was as follows: the patient received the second dose on 19Mar2021 and she didn't really have any bad side effects, a sore arm, and a little tired on the second day, maybe a little off but was fine. 12 days later she was vacuuming and had severe vertigo, she was down on the floor, just horrible spinning, horrible nausea and laid on floor and vomited all day. Her doctor told her to go to the ER. They did all kinds of tests with unknown results on an unknown date and she could not open her eyes for 2 days, she was so violently spinning with vertigo, they gave her fluids. She went in on Wednesday and by Friday she was a little better, she could open her eyes, still had spinning and vertigo. It was like nystagmus, her eyes were, she just really couldn't open her eyes for the doctor, had generalized weakness and couldn't walk at all without help in the hospital. The only time she moved from one position was to go to the bathroom with assistance. In the ER, she could not get up out of bed the first night they were trying all ways of catharizing her. She could not even get out of the bed with the help, they had to carry her to the CAT scan with negative result on 31Mar2021. She had slightly improved but still had vertigo and she was not vomiting anymore, that was only the first couple days. She was sent home with medications for dizziness and nausea but they didn't do anything. Two weeks later she was still dizzy, had vertigo, it was way better than it was, she can open the windows a little bit but she was basically in a dark room for like the first week and a half. Not violent like it was the first couple of days. The events were further described as: she was a little sore on 19Mar2021, 20Mar2021, 21Mar2021, and maybe the 22Mar2021 her arm was still sore. She clarified the sore arm pretty much ended on the 22Mar2021. She was surprised she felt fine on 19Mar2021 and 20Mar2021 and on the evening of 21Mar2021, in the middle of the night between 20Mar2021 and 21Mar2021 she felt a little off and a little more tired. On 21Mar2021, she didn't feel great, fatigued and brain fog but was fine after that. She began feeling a little off and a little tired early morning on the 21Mar2021. That was pretty much gone by the 22Mar2021. The feeling tired and a little off and the brain fog and fatigue went away 22Mar2021. She vomited constantly, started suddenly and violently and was incapable of moving, all she did was vomit and lay on the floor. It was a complete 360, she was fine vacuuming a minute before and then suddenly got dizzy and went down and could never get up. She had to be taken from upstairs in her house and transported to the hospital. She was not really experiencing the nausea now, she was not completely herself but she can eat, she couldn't eat for the first couple of days and was on IV fluids and once she got out of the hospital was able to eat a little and now eating almost normally. It took a week to eat normally and she couldn't eat holiday dinner on 04Apr2021. From 31Mar2021 to 10Apr2021, every day the nausea has slightly been improving. She was not quite herself and still has vertigo and was making herself eat her meals. She vomited 30 times and in the hospital they gave her an IV to stop that and never vomited in hospital, maybe once in the ER. She confirmed the 31Mar2021 was the last time she vomited. She had not recovered completely from nausea. She used be running around all the time, she would walk 10 miles per week to exercise, yesterday she had a mammogram scheduled and she was just so wiped out for doing something for the first time and had to lie down for the whole rest of the day. She was hospitalized from 31Mar2021 until the evening of 02Apr2021 when they let her out. She was given medication for nausea and dizziness didn't do anything. She was given ondasetron (ZOFRAN), 4 mg and meclizine. Because of her weakness, the patient was checked to see if there was any brain bleed or brain stem problems that would explain the vertigo and did not find anything. The tests were negative for any brain problems on an unknown date. Lab data included: blood levels: low on vitamin d (probably because she was not absorbing nutrients as well) on an unknown date, endoscopy: unknown results on an unknown date, and MRI: negative on 01Apr2021. Therapeutic measures were taken as a result of severe vertigo, fall down on the floor, nausea, horrible spinning, vomited, and dizzy. The clinical outcome of the events, severe vertigo, nausea, generalized weakness, could not open her eyes, nystagmus, could not walk at all without help, was recovering. The clinical outcome of the events, fall down on the floor, horrible spinning, dizzy, was unknown. The clinical outcome of the events, a little off, fatigue, sore arm, brain fog, and a little tired, was recovered on 22Mar2021. The clinical outcome of the event, vomited, was recovered on 31Mar2021. The clinical outcome of the event, could not eat, was recovered in 2021. No follow-up attempts are needed. No further information is expected.

She will be deceased, most likely, if she does.; arms really heavy, can hardly lift them; arms really heavy, can hardly lift them; She feels sick and unwell; face little swollen; chest pain; pressure in chest; ears ringing; Difficulty breathing; Migraine headache; heart palpitations; Chills; nausea; really red face, cheeks; back pain a lot worse; very high fever; This is a spontaneous report from a contactable consumer (patient) A 61-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 1 via an unspecified route of administration, administered in Arm Right on 08Apr2021 (Batch/Lot Number: EL3247) as SINGLE DOSE for covid-19 immunisation . Age at vaccination :61 years. Medical history included ongoing epilepsy (started at 16 years old. Has not had a seizure in years, maybe 20 years) ,herniated disc and chronic back pain from 2003 and ongoing , Heart septal defect (repaired) and seizure disorder.Concomitant medication(s) included carbamazepine (CARBAMAZEPINE)at 200 mg, 1x/day taken for seizure from an unspecified start date and ongoing. The patient experienced "she will be dead, most likely, if she does" on an unspecified date , difficulty breathing on 10Apr2021 with outcome of unknown , very high fever (on 08Apr2021 with outcome of recovering , migraine headache on 10Apr2021 with outcome of recovering , heart palpitations on 10Apr2021 with outcome of not recovered , back pain a lot worse on 08Apr2021 with outcome of not recovered , ears ringing on 10Apr2021 with outcome of recovering , chills on 09Apr2021 with outcome of recovering , nausea on 09Apr2021 with outcome of not recovered , pressure in chest on 10Apr2021 with outcome of not recovered , chest pain on 14Apr2021 with outcome of not recovered , arms really heavy, can hardly lift them (non-serious) on 15Apr2021 with outcome of recovering , really red face, cheeks on 09Apr2021 with outcome of not recovered, face swelling on 14Apr2021 with outcome of not recovered and She feels sick and unwell on 14Apr2021 with outcome of not recovered. Clincal course was reported as follows:On 08Apr2021 she had her vaccine. She is running a fever and has every side effect on the template from the pharmacy. She is not doing good and should probably be in the hospital. She can not drive her self, or have anyone else drive her. She feels really bad and is afraid of a clot. This is from the first shot and she is not getting another. She will be dead, most likely, if she does.She can hardly lift her arms up. She did not see this in list of side effects and doesn't know what that is.She tried to make a claim with Covid compensation number, but was unable to connect with them. Her symptoms started 3 days ago. She did this in case she had to. She read she has to keep her fever down. She just took some Tylenol.She didn't look for few days at the paperwork provided to her after the vaccine. She was seeing side effects and she got nervous, this is why she didn't call earlier.She is having trouble breathing now and has never been so sick. Caller asking how long the side effects last and needs to talk with Medical Information.Her Mother recommended she receive the vaccine and told her of all these people coming across the boarder and that they may bring Covid with them.She had a septal defect repaired in her heart. She doesn't know if there could be something wrong with that, but her doctor and heart doctor said she is fine. They haven't found anything from the testing she had had.Her difficulty breathing is on and off. It started 2-3 days after, and she doesn't know with her heart palpitations and if there could be damage. That's why she called the Covid compensation.The first day, she had a very high fever and headache. She didn't take her temperature, but she knew it was a fever. Today it is not as high as it was, it's not bad.She had a migraine and took something for it and it went away for hours. She took aspirin, Bayer Back and Body, and her fever and headache went away for hours.She experiences heart palpitations. Every time she eats they get worse. She has reported this to her physician. Her Physician said to take Tylenol and gets exercise. She recommended she doesn't lay up and caller thinks she wanted her to go to the hospital. Caller's mother can't drive and her sister is dying of cancer. Caller lives near her mother but she can't drive. She's older and caller can't ask her to do that.Her palpitations are sometimes there.She has a back injury from someone hitting her from behind. It is extreme back pain. It worsens after she gets a vaccine. She gets on the heat pad. She doesn't have anything for it, just some patches.Her ears are not ringing now and might be getting better. She had chills, but they're better today.She had nausea. It's better today. Yesterday, when talking to her doctor caller was advised to exercise. That makes her feel worse. It's not a big thing. She feels sick and unwell.Her face is really red and maybe a little swollen. Her Physician was thorough and she even asked about it, and commented it sure is red.Caller lays in bed and keeps her feet up. She knows she's got to move around, her Physician told her to.Caller is concerned about a blood clot. She is having pressure and pain in her chest. It has been the same. What's new is chest pain yesterday and did not feel bad, but it is noticeable. She hopes it doesn't get worse. What is new is her arms feel really heavy and she can't hardly lift them.Her facial redness worsened with her fever. The Tylenol is working, her fever is going down, but her arms are still heavy, but better.Treatment received for arms really heavy, can hardly lift them and very high fever.Additional information:Vaccination Facility Type: Pharmacy/Drug Store . No COVID Prior Vaccinations

Patient experienced oral swelling 12 hours after her 1st dose of Pfizer. She had symptoms 2 hours after 2nd dose. Took antihistamine and felt better.

Lightheaded, Left eye blurry, palpations, BP 142/88, 100 pulse ox, 82 Heart Rate, 20 respiratory. Emergency response called

3.2.21 chest pain, jaw pain increased heart rate, headache,high blood pressure. I continued to work until 3.5.21 heart rate continued to be high 185 BPM when normally 55- 54 BPM. I went to the emergency room, thought I was having a heart attack, sweats, chest pains, high heart rate and was hospitalized.

I am an employee of a medical facility. After the 2nd Pfizer vaccination, which was administered at the facility, I spent the next day in bed with mild flu like symptoms. I slept most of the day but on the second day I felt fine and went to work. I started noticing a ringing in my left ear upon waking on 2/10/2021. The tinnitus continues at this time. I did test positive for Covid-19 the week of Thanksgiving 2020 and was on Workman's comp for 20 days. I have tried to educate myself on tinnitus and noticed that most information says that there is no cure or real treatment. But after a recent article about those of us who have Tinnitus due to Covid-19 or the Vaccine, I will contact an ENT doctor to see if Steroids might work.

I started to get excessively itching in my both ears and throat; I started to get excessively itching in my both ears and throat; This is a spontaneous report from a contactable consumer (patient) reported for herself. A 61-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left on 19Apr2021 09:58 at 61 years old (Lot Number: EW0164; Expiration Date: 31Aug2021) at single dose for covid-19 immunisation. Medical history included she had to get her glasses to read the handwritten information. The patient's concomitant medications were none. No other vaccines were administered on the same date or within 4 weeks prior to vaccination. Patient received it at 9:58am and stayed there for 15 minutes and went about her day. Everything went fine. Sometimes many hours later, say 6:00 in the evening, she started to get excessively itching in her both ears and throat on 19Apr2021. She didn't even think about getting the vaccine that day or if the reported event had something to do with that. She was talking with someone and they said maybe she shouldn't get the 2nd dose, would the 2nd reaction be more severe? And by the time she went to bed at 11pm it had subsided. The symptoms had subsisted by then. She spoke with her PCP and at first she said maybe she should hold off. Let her call you back and said the more she looked into it was not a severe reaction it wasn't within the first hour and she recommended do get the 2nd one but before she did that, she had 21 days, to refer her to an allergist just in case. Patient asked if there was any information on changing vaccines, like getting the Moderna one for her 2nd dose. She would follow up with an allergist. Stated somebody told her to call her primary care physician and she was wondering if she should get the 2nd dose of the Pfizer COVID Vaccine. The events didn't require a visit to ER or MD office. Caller stated she did not require treatment and the itching in her throat and ears is better. There were no relevant tests. The outcome of the events was recovering. Serious criteria was non-serious. No follow-up attempts are needed. No further information is expected.

I noticed my ears ringing much louder than they usually do. Asked my general doctor and pharmacist if they had heard of any correlation to which they replied they had not. Made appointment with my ENT and he also had not heard of any tinnitus related effects. Had hearing aid evaluation for device with masking but have not made any purchase as of this time.

Started about 3 days after second dose. (First dose was 4/1/21). Constant, low volume hissing/buzzing/whistling in my head. Hard to describe. No other symptoms. It is not painful, just slightly annoying. Has not changed in frequency or intensity as of this reporting. Hopefully it will resolve? I have never had this sensation before other than short term side effect of certain OTC pain meds meds. No hx of tinnitus.

Blurry vision, difficulty focusing eyes. Also happened with the first dose of the vaccine on 4/13/2021 lot #ER8731

Cough; Shortness of Breath; Fatigue, Chills, Muscle or Body Aches, Headaches, New loss of taste or smell, Congestion or Runny Nose, Diarrhea; Vomiting. Prednisone (DELTASONE) 10 mg tablet; Take 2 tablets (20 mg total) by mouth 2 (two) times a day for 4 days-Azithromycin (ZITHROMAX) 250 mg tablet; z pack. 500 mg day one 250 mg day 2-5. -Albuterol HFA (PROVENTIL;VENTOLIN) 90 mcg/actuation inhaler; Inhale 2 puffs every 6 (six) hours as needed for wheezing for up to 7 days.

Immediate excruciating headache and earache, tingling disown my left arm to fingers and nauseated I have continued to be sick since my vaccine Visited my doctor yesterday and was put on methyl prednisone

Tongue numb - Still numb today. I want to know if my tongue will ever recover. Throat swelled. - Took Benadryl. Right arm pain for 4 days. Bad headach for 3 days.

Second vaccine given at 1627. 1700 pt. Stating having tingling lips and feeling shaky. Taken to sit in observation area to sit and VSS BP178/92, HR 92, sat 98%. Benadryl, 25mg PO given with water. VSS 1705 BP191/88, HR 90 and sat 94%. 1710 162/91, 90, 99%, 1715 158/91,93,96%Patient put on cart with knees up and cont. To complain of dizziness and left neck stiffness. 1720 166/83,85HR,99% 1725 154/83, HR85, 99% 1728 157/91, HR 86, 98% 1732 156/94, HR 86, 99% 1737 175/87, HR 86, 99% Took patient into wheelchair, complaining of head spinning 1741 184/72, HR 90, 97% 1747 155/87, HR 90, 98% 1751 187/91, HR 95, 95% Patient was going to attempt to go to car, but continued with dizziness; EMS called. 1756 182/84, HR 97, 99% EMS arrived at 1800; took down history 1800 182/91, HR 99, 99% Patient transferred to cart and taken to hospital. Patient alert/oriented x3, anxious for the entire encounter.

Severe chills, fever, pain at injection site, ears hurt, ears ringing, massive headache, tired, malaise, weakness and sore throat.

Tongue tingling followed by dry mouth Lasted about 4 to 6 hours from onset Note: Dramamine also produces this symptom

After about 5 minutes, lips started to tingle - they then felt swollen and hurt. I had difficulty breathing (mild), and difficulty swallowing. Symptoms increased until about 15 minutes. Then leveled out. They were mild to moderate. I spoke to the EMT (not helpful). I waited 30 minutes and left. Took a Benadryl 25mg tablet (generic) after getting to my car. The symptoms lessened. By the time I got home (30 minutes) the only thing that bothered me was painful lips. That lasted a few hours. My allergist has advised against the 2nd dose.

Respiratory symptoms - Burning pain when inhaling in lower trachea and upper chest. Feeling of weight on upper chest. Breathing was not obstructed. Chills but not fever, hypothermia (97.1 F), body aches, dizziness, spots and floaters in vision, tiredness, slight nausea. Note this related find from internet research: A team of researchers have found that exposure to the SARS-CoV-2 spike protein alone was enough to induce COVID-19-like symptoms, including severe inflammation of the lungs. https://medicalxpress.com/news/2021-04-sars-cov-spike-protein-lung.html Messenger RNA vaccines work by instructing cells to create "spike proteins." These proteins simulate part of the SARS-CoV-2 cell structure and trick the body into believing it's infected with the virus.

This is a spontaneous report from a contactable consumer (patient). A 61-year-old female patient received BNT162B2 (COVID-19 mRNA VACCINE, solution for injection, Lot number: ER0113) via an unspecified route at arm right on 17Apr2021 in the afternoon (around 15:30) (reported as this past Saturday) as a single dose for covid-19 immunisation and diphenhydramine (Lot Number: P122793 and Expiry Date: NOV2023) for two black spots under the site and that part was swollen too, it itches. Medical history and concomitant medications were not reported. The patient received first dose of BNT162B2 (COVID-19 mRNA VACCINE, solution for injection, Lot number: ER8730) via an unspecified route at arm right on 27Mar2021 in the afternoon (around 14:00) as a single dose for covid-19 immunisation with no adverse effects. On Apr2021, patient had experienced the site under where she got it was swollen and hard and it hurt. she put ice on it for the swelling. Patient reported that it started as just one spot which turned black and then she had little black spots everywhere under the spot where the vaccine went in. She had two spots and then those spots turned black and then she has tiny spots like polka dots over her arms and when she woke up next day, she had two black spots under the site and that part was swollen too. She took 2 allergy Diphenhydramine HCl 25 mg antihistamine that morning. They are oozing and she has the little black spots on her left and her right arm, but she had the vaccine in her right arm (further stated that the black spots that are oozing and it was kind of hard under it and under the site. The spots were blacker and more discolored). Patient stated that it itches and that's why she took allergy Diphenhydramine HCl 25 mg antihistamine but that made her drowsy. Patient felt like throat was kind of dry and was feeling hot and had COVID-19 test resulted in everything okay, she didn't have COVID. Patient right deltoid and right below it, maybe 3 fingerbreadths below on the left and right side bilaterally she had blotches that appeared, and they looked red. Next day they looked more like a burn kind, when a darker person gets burned by an iron then the spot gets darker in nature. One of the spots has like a vesicle that was fluid filled kind of like a blister and it was weeping. Overnight this went from blotched to burn-like marks with one vesicles that was oozing and then there are spots dispersed through her body. On her right arm, left arm, and on her right leg as well it was like black spots. Patient does not require to visit emergency room or physician office for the events. Outcome for the events was unknown. No follow-up attempts are needed; information about lot/batch number cannot be obtained.

The soreness in my neck and arm seemed to be the only issues for the first two weeks. Then I began to have dizzy spells. These dizzy spells seem to come and go all day long. The sound going into my ears sounds as if I am under water.

Extreme Tinnitus. One week out and symptoms have not let up. Had mild Tinnitus prior. Now severe. Will not get 2nd shot. Very upset.

slight cough, lips tingling right after shot, then back pain and discomfort, headache 4 hours later, then next morning - extreme fatigue, nausea, then through the day - brain shut down, slept all day, extreme pains throughout body like being stabbed and twisting the knife, convulsion like movements from pain, couldn't eat or drink. Didn't feel better until next morning. That was the worse experience I've ever been through. This was my second vaccine. I reacted to the first vaccine also, but not with such pain.

I have an appointment with an ENT next Monday. The ringing is non-stop. I have to sleep with noise at night so that I can get to sleep.

By 12:50 hands were starting to swell; chest pain; heart palpitations; pulse felt like her heart was racing very hard; non specific interstitial disease in the right lower lobe that could represent atelectasis aspiration organomia; non specific interstitial disease in the right lower lobe that could represent atelectasis aspiration organomia; blood pressure was up; throat felt like it was starting to tighten; eyes itchy; eyes itching much worse; This is a spontaneous report from a contactable consumer (patient). A 61-year-old female patient received BNT162B2 (COMIRANTY; Solution for injection; Lot number and expiration date: unknown), via an unspecified route of administration in left upper arm on 22Apr2021 12:10 (at the age of 61-year-old) as unknown single for COVID-19 immunization. This report was not related to a study or programme. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Adverse events following prior vaccinations was first time had flu shot made her very ill, next year doctor suggested she should just have half of a shot instead of full shot to see if she tolerated it and she was able to tolerate that. She had not any other problems with flu vaccines in general. Some of the other vaccines, she was just supposed to take Benadryl with them because of some of the filler ingredients people put in things. She had previously had the 1 dose shingles vaccine, but she had gotten probably shingles probably a couple of months after that so they encouraged her to get the 2 part shingles vaccine at a later date and told her to do the pre-medicate routine like Benadryl day before, day of and at least 2 days after shingles vaccine doses and if any major problems call for help. She did not have a noticeable problem from the 2 part shingles vaccine. Some of the times depends on what filler ingredients people use. She was allergic to nutmeg which was used as an emollient oil or it's called Myristicin something or other oil; if something has too high a dose of mannitol it can cause a problem. She has a very long list of allergies and high sensitivities; if it was a high enough sensitivity it goes in allergies list, even though it may not be a true allergy. Family has lots of allergies. Regarding prescribed indication additional details: She had 3 doctors who initially advised her to get the vaccine including her primary care physician, oncologist and haematologist; this was because she was a high risk person because of various health issues. Her haematologist 2-3 months ago when she had her last appointment with him he was saying to get the shot and prescribed the epi-pen at that time; no one was having it yet, but he expected she would have some sort of reaction to it not able to be covered by Benadryl alone. Medical history included ongoing platelet disorder Verbatim: Unidentified platelet disorder, Lots of allergies, cardiac murmur, ongoing asthma, osteoarthritis, glucose tolerance impaired, hypoglycaemia slow thyroid and back and neck pain. Concomitant medication(s) included diphenhydramine hydrochloride (BENADRYL) taken for hypersensitivity (50mg taken as needed), cetirizine hydrochloride (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) taken for hypersensitivity (10mg daily), fluticasone propionate, salmeterol xinafoate (ADVAIR) taken for asthma (250/50 twice daily), levothyroxine sodium (SYNTHROID) taken for hypothyroidism (137mcg-1 tablet daily), methylphenidate hydrochloride (RITALIN) (20mg tablet twice daily), salsalate, colestyramine (QUESTRAN LIGHT) (2-500mg tablets 3 times daily), sucralfate (CARAFATE) (1mg tablet 4 times daily-dosage verified with caller as milligrams and captured as provided), loperamide hydrochloride (LOMOTIL [LOPERAMIDE HYDROCHLORIDE]) (2.5/0.25 takes 2 tablets of that 4 times daily), calcium carbonate (CALCIUM OYSTER SHELL [CALCIUM CARBONATE]) (Alternates dose of 500mg and 1000mg on days takes Vitamin D), vitamin c [ascorbic acid] (VITAMIN C [ASCORBIC ACID]) (250 mg), vitamin D (50,000 units every other day taken), vitamin B12 (1mg injection every 14 days), clonazepam (KLONOPIN) (2-1mg tablets at bedtime), montelukast sodium (SINGULAIR) taken for asthma (10mg tablets at bedtime) and cefixime (FLEXERIL [CEFIXIME]) taken for back pain, neck pain (10mg tablets 3 times daily as needed). On 22Apr2021, Onset time: She had a note saying her eyes itchy at 12:20, but they were itching before that because she waited long enough to report it; so onset time was less than 10 minutes when her eyes started itching. Then her pulse; she could feel chest pain; heart palpitations; pulse felt like her heart was racing very hard. They did check her pulse while she was in their initial observation and her pulse was only in the 70s, but oxygenation was at 96%.When at doctors office less than 1 hour before that reading, oxygenation was at 98%.Recorded at 12:30 eyes itching much worse, throat felt like it was starting to tighten, heart felt like it was starting to race. By 12:50 hands were starting to swell. She had already been pre-medicated with Benadryl before this before she went down to get the Pfizer Covid-19 Vaccine, she had Benadryl in her system. She had that same morning with her morning meds had taken Zyrtec and Benadryl in anticipation of getting the possibility of getting the Pfizer Covid-19 Vaccine because she has to pre-medicate for vaccines just in case she starts to react in anyway. History of all previous immunization with the Pfizer vaccine considered as suspect was none. Additional Vaccines was not administered on same date of the Pfizer Suspect. Emergency Room taken from the location where vaccine administered-they gave her Pfizer Covid-19 Vaccine shot had her sit for basic observation then sit for extended observation. In that time period telling them her symptoms were going on, increasing. They gave her another 50mg Benadryl even though she had already had 1 before and then called emergency room, took her down, left her in waiting area even though she had heart and chest palpitations. Physician Office seen prior to event on 20Apr2021, seen after event 27Apr2021. Primary Care Physician didn't hear anything in lungs either visit. Not admitted to hospital; seen in emergency room, theoretically she got treated; however her basic blood pressure and stuff even with what they were doing was higher than when she was triaged in the ER; blood pressure was up and something else,oxygenation level moderately reduced from when she came down to when she was just let go; however her symptoms were worse when she was leaving than when she got there. She knows what they gave her while she was there was IV of normal saline, solumedrol and IV Benadryl. Thinks they later gave her Tylenol tablets. Finally got them to do an EKG because kept saying her chest was getting worse but that was several hours after she was back there even though came there having chest pains. In her opinion this hospital was not taking reaction seriously. Not admitted to hospital even though symptoms were worse and blood pressure higher on discharge, well above her normal levels. Currently trying to get them to explain why they took so long to do anything for her. Finally did a chest x-ray on 22Apr2021:discharge papers say abnormal x-ray and they gave a couple of different possibilities as to what that might be so Primary Care Physician wrote a prescription to get a follow-up chest x-ray to make sure that everything is fine and back to normal and not ongoing or progressing or anything because they gave some strange things: what their impressions were: findings: there is non specific interstitial disease in the right lower lobe that could represent atelectasis aspiration organomia. It says the left lung appears clear; cardiomediastinal silhouette is within normal limits; impression restates non specific right findings there is non specific interstitial disease in the right lower lobe that could represent atelectasis aspiration organomia. This was from front and lateral views of the chest x-ray at 19:00pm 22Apr2021. 2 ECGs: She guesses this is what they call EKG not, relevant point is that in the notes there for the records: Says abnormal ECG compared with blah blah blah, hard to find when exactly they wrote this, trying to get the exact wording for each of the two. Machine results CED, which caller explained is what they call themselves now instead of ER, notes for MD interpretation; one done at 17:53 , other at 21:32. They both say there was slightly different readings, however both say abnormal ECG. One of the wordings that is in both. She had no further details to provide regarding relevant testing/investigations. She had to be in the ER back in the room for several hours before they would do the EKG and that's only because she said I have chest pain and standard procedure is to do an EKG, had been back there for hours, they had done no tests, the only thing they did was basic blood panel, had not done a troponin or heart enzymes test, had not done EKG that's why she knows they were not taking her seriously at all; if someone says chest pains and you don't do anything in the standard protocol they are not taking you seriously. On this Monday, 2 days ago she had gone down to pick up the records from the ER to go to Primary Care Physician appointment 27Apr2021, finally actually got to speak to someone who said they would get back to her on 27Apr2021 to look into why the EKG tests were not done for someone having chest pains. That's one of the first things you do for someone having chest pain, no matter what the source. Frustrated with them because they're still not communicating back, they had not taken her seriously while she was there; unknown if they were actually going to be reporting, as they were still trying to convince her to get the second dose of Pfizer Covid-19 Vaccine. If she reacted to the first dose in first 10 minutes, second dose could be much more of a reaction. With the amount of anti-histamines in her system with Benadryl and Zyrtec and she was still starting to react in under 10 minutes. It's possible to be one of the inactive ingredients but she doesn't see anything in the pamphlet provided that she could identify at first glance as being the culprit to the problem other than 2 possibilities: potassium chloride and other is monobasic potassium phosphate. There is a possibility of her having a reaction to those because she was known to react to certain potassium products; sometimes it was the inactive ingredients. She definitely would have wanted to get the second part of the Pfizer Covid-19 Vaccine series until after she was not getting the medical attention she needed after reaction to the first dose. Because ideally you're supposed to have it at the same location, that just made her very nervous at the prospect of worse reaction at location that did not take her serious the first time. She was a big fan of Pfizer thought they do a great job; she had not known it was a 2 parter, not that it should make much difference. When her Primary Care Physician was saying second dose of Pfizer Covid-19 Vaccine was out of the question and she had been saying to people that she did not think it would be prudent to take the second part, they kept trying to say oh you need to get the second part, talk to so and so so they can convince you to get it, and doctor is going no. She reacted to ringers lactate or lactated ringers whatever the name is, her retired nurse sister sat and watched her getting some ringers lactate prior to surgery for her tear duct and saw her starting to break out in red splotches, patient said she was itching. Action taken in response to the events was drug withdrawn. The outcome of the events was reported as unknown. No follow-up attempts are needed; information about lot/batch number cannot be obtained.

Constant Tinnitus in both years that sounds like a white noise machine or a fan and clogged ears beginning some time in April not precipitated by a cold or infection that I know of. 2nd Vaccine was March 15.

Customer c/o burning sensation in her ears. Code Red called and EMS and nurse responded. BP 159/84, HR 83, O2 97. Customer released and told by EMS if it doesn't go away by the end of the day, go to an urgent care, or call her Dr.

hives on her mucous membranes/got a few hives on shoulder; bumps; then itching inside nostril and other mucous membranes/whole mucous membrane area down there still feels sensitive or irritated or something/burning feeling in mucous membranes, itching and stinging; then itching inside nostril; hives/red flushy skin/itching; touches something like the remote, patient felt very cold; itching on forehead and on back and on shoulder and in other places/itching; flushing; At first had a funny taste in mouth right away; did have diarrhea a lot when first got home; By evening face was flush red; face was probably a little bit puffy; even today every so often where hair touches face is sensitive/All openings to body are sensitive; mucous membrane area down there still feels sensitive or irritated; got goosebumps right away; burning feeling in mucous membranes; stinging; severe allergic reaction; This is a spontaneous report from a contactable consumer (patient) via the medical information team. A 61-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot: ER8736), via an unspecified route of administration in right arm on 28Apr2021 08:15 (at the age of 61-years-old) as 1 st dose, single for covid-19 immunisation. No prior vaccinations (within 4 weeks). No family medical history relevant to the events. No additional vaccines administered on same date of bnt162b2. Medical history included strong reaction to bee stings, allergies/some nuts, allergies/shellfish, allergies to a sulfa drug, allergies, hives, red flushy skin and itching (noted from all allergies that never had anaphylaxis before but gets hives or red flushy skin and itching from some or all of these). There were no concomitant medications. The patient previously took sulfamethoxazole, trimethoprim (BACTRIM) and experienced allergies. The patient received the first dose of bnt162b2 yesterday (on 28Apr2021 at 08:15) and had a reaction to it. The site of the injection for first dose was fine, nothing around the site. On 28Apr2021, the patient experienced at first had a funny taste in mouth right away (vaccination facility said they had never heard that before; gone momentarily after first dose/went away completely); then itching inside nostril and other mucous membranes (within five minutes of receiving the first dose); by evening face was flush red (coloring part was completely gone away); face was probably a little bit puffy; even today every so often where hair touches face is sensitive and will get itchy again; did have diarrhea a lot when first got home (lasted 15-20 minutes and then it was over); right away had itching on forehead and on back and on shoulder and in other places; whole mucous membrane area down there still feels sensitive or irritated or something. All openings to body are sensitive; continued to have burning feeling in mucous membranes, itching and stinging. Skin was really sensitive, when patient felt warm if pushed up sleeves, arm got a little cool and got goosebumps right away. If the patient touches something like the remote, patient felt very cold, skin seemed very sensitive all over. The patient took temperature to see if had a fever, temperature was 98.6, exactly normal, usually runs lower than that but definitely wasn't a fever. The patient left the vaccination facility after half an hour, nothing seemed life threatening. On 29Apr2021, the patient experienced that even today overnight got a few hives on shoulder, back up by shoulder area on one side and noticed the bumps, felt where the bumps were but they are not as big and they were itchy occasionally but not very itchy. (were better now). The events did not require emergency room or physician office visit. The patient stated that it wasn't anaphylactic reaction. The patient have read online that if have a reaction in less than four hours, it was considered severe. The patient was a little concerned when got the shot and was reassured at the vaccination facility that they had not seen anaphylaxis. The patient was wondering if it was okay to get the second dose or should the caller hold off. The patient asked if her symptoms were categorized as a severe allergic reaction (in 2021) and thereby contraindicate her from getting her second dose. The outcome was recovered from taste disorder and diarrhoea on 28Apr2021, from flushing and swelling face on 29Apr2021, from erythema in 2021; recovering from pruritus, piloerection, skin disorder and sensitive skin; not recovered from mucosal pain, burning sensation mucosal, pain, mucosal disorder and nasal pruritus while unknown for the remaining events.

The day (4/25) I received the 2nd vaccine, I was more tired than the first one. On the next day, Monday I felt really tired and little feverish, but no fever. I rested all day. I had vertigo that night I don't remember which side. The next day, Tuesday I was still tired. On Wednesday I felt ok. On Thursday, I felt tired again and when I rested I had vertigo on my right side. Then on Saturday, I was cold before I slept, I wore a sweatshirt to sleep. During the night I started sweating, felt like night sweats. I don't remember when tinnitus got worst. I only remember the vertigo. Currently tinnitus in my right ear is noticeably louder and has been getting me up. I just had vertigo yesterday 5/17 while resting in the afternoon as the night before I did not have enough sleep.

Head & neck all red, itchy; Head & neck all red, itchy; I'm scratching; my left ear was itching super bad; I almost felt like I was sun burned from my neck and head up, my thighs, my abdomen it was like super itchy; she received both her first and second dose; she received both her first and second dose; This is a spontaneous report from a contactable consumer. This 61-year-old (non-pregnant) female consumer (patient) reported that she received both her first and second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number: UNKNOWN) intramuscularly into the right arm on 09Mar2021 15:00 (at the age of 61-year-old) as single dose for COVID-19 immunisation. The patient medical history included hypertension, cancer and overweight. Concomitant medications included Xanax, Synthroid and Estratest (Female hormone). Blood Pressure medication, that was the only prescription she took. On 09Mar2021, she reported that she got her Covid shot about 3O Clock that day and about 8:30 that evening, she kind of itching some and scratching so she was going to bath and her left ear was itching super bad. She was itching and all red and had welch. So, she called her sister who was in the medical field too and that time what was going on and she took a couple of Benadryl and had some and then took a 10 mg of Prednisone and it calmed down but she almost felt like she was sun burned from her neck and head up, her thighs, her abdomen and it was like super itchy. She could not believe how red she was, looked like she have been in the sun. That was it. No investigation assessment done. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. She was treated with Benadry and prednisone. Prior to vaccination, she was not diagnosed with COVID-19 nor had been tested since the vaccination. She has allergies to medications, food or other products. She was a cancer survivor and considered herself a little over-weight, was not obese. Outcome for events was itching and all red was recovering and unknown for rest of the events. Follow-up(10Mar2021): This is a Follow-up spontaneous report from a contactable consumer. This 61-year-old female consumer (patient) reported which included Information related lot/batch number has been requested.; Sender's Comments: Based on the information in the case report and a plausible temporal relationship, A possible causal relationship between reported events and suspect drug BNT162B2 Cannot be excluded The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.

Patient expressed concern that first vaccine she acquired some blurred vision about 2 hours after the vaccine and complained of being tired and slight headache. She was advised at that point to strongly consider following up with her Provider and not getting the booster today. She stated she has a new position in the school system and should get the booster and does not wish to follow up with her PCP. She said she was fine and wanted again to get the vaccine booster. Vaccine booster, Pfizer Lot: ER8727, was given in pts left deltoid at 10:55. Pt tolerated injection well and walked 10 feet to chair in waiting area, where she was visible to me. Around 11:05, this RN called patient's name and approached pt, as she was noted to be staring into space and not responding to audible cue of her name. She could appropriately answer her name but had to be redirected to the question of her last name x 2. She appeared confused to place and time. Her friend, was called to her side as per patient's request. After some coaxing, she was assisted with ambulation to a stretcher in the clinic. At that time she appeared to have an unsteady gait. Her VSs at 1110 were BP-191/109, HR 88, O2 96%. She was able to follow commands with some cuing. She was also able to lift both arms and legs to gravity with moderate strength to resistance. Pupils were equal, reactive and 3mm. She denied any numbness or tingling anywhere, but did complain of a "weird" sensation in her left posterior scalp. No facial droop noted. Her eyes were noted to be blood shot and she stated they had a burning sensation noted. VSs at 1115 BP 169/103. HR 82, O2 95% VSs at 1120 BP 180/95, HR 78, O2 95%, at this time patient was advised of the concern of her elevated blood pressure and that we would continue to monitor for about 10 more minutes to see if it would improve. Cognition now almost back to baseline per friend who was at the patient's side. Patient denied history of high blood pressure in the past, but also states she does not routinely follow up with a Provider. VSs at 1125 BP 192/85. HR 78, O2 94%, at this time patient advised of concern for high blood pressure and associated symptoms she was experiencing and was advised by myself, her friend and Vaccine Clinic RN, to be taken to the ED for a Provider to look at her and a possible evaluation. Pt sat upright on the stretcher and refused to go to the ER. Her friend asked multiple times if she would like a family member to be called and come pick her up if she was going to refuse going to the ER. Patient then stated she was fine and had to go to the bathroom. Pt escorted by myself to bathroom, gait appeared steady and pt no longer starring into space. Pt accompanied to the bathroom. Pt accompanied by friend and myself to waiting area and stated she has an appointment tonight to follow up with a Provider at 1830 for psoriatic arthritis and possible steroids. I asked if I would be able to call and talk to this provider to ensure a better transition of care into the community due to not going to the ER. Pt agreed and came back to sit down with me in the vaccine clinic. Dr. was called and I spoke to him reviewing the aformentioned event to inlcude the patient's VSs. He agreed that when blood pressure initially 191/109 she should've gone to the ER. He then said since the BP was now192/85 that he was okay with her leaving, driving herself back home and seeing him at 1830 tonight, where he would address her hypertention. Pt was then with steady gait and back to baseline, per friend, escorted back to waiting room nd to her car, where she stated she was going to drive directly back to home. Pt was instructed multiple times if she had any sensation of confusion, dizziness, blurred vision to pull her car over and call 911, also if issues once home to go to ER. She verbalized multiple times her understanding of this information and again did not want her sister called to come and pick her up.

Approximately 2 minutes after receiving Pfizer COVID vaccine booster pt c/o dizziness and seeing floaters, was taken to stretcher by vaccination nurse. Spoke with pt who stated she was now experiencing chest discomfort - described as an ache 5-6/10, no diaphoresis noted skin w/d to touch, respirations even and nonlabored, placed into wheelchair and taken directly to the ED. Pt states she has anxiety and a hiatal hernia. Pt experienced anxiety after first vaccination and stayed in vaccine clinic until felt better. Report to ED triage nurse and physician. Dizziness

TIA/Mini stroke; Blood pressure went up to 240/130; Loss of memory; Everything is foggy; Lips and tongue started tingling; Stinging lips; She is not taking the second vaccine. She reported that the card has a reminder to return date to go back in April and states she did not go and is not going to get the 2nd dose; This is a spontaneous report from a contactable consumer (the patient). A 61-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: EN6207), via an unspecified route of administration, administered in left arm on 21Mar2021 10:30 (at the age of 61 years old), 1st dose, single for COVID-19 immunization. Medical history included diabetes and ankle problem from an unknown date and unknown if ongoing, and bariatric sleeve from 2018 to an unknown date. Concomitant medications included all her normal medications and medications for high blood pressure (not specified). The patient reported that she was administered with the first dose of the vaccine on 21Mar2021 and on the same day, her lips and tongue started tingling during the observation period after the administration. The patient also reported a few days later on 02Apr2021 that she had a transient ischemic attack (TIA), which was also described as mini stroke. The patient also reported that she has not been administered the 2nd dose. She is not taking the second vaccine. She reported that the card has a reminder to return date to go back in April and states she did not go and is not going to get the 2nd dose. She also complained since day one on 21Mar2021 about the stinging lips and tingling tongue. She was hospitalized with the mini stroke, she was admitted 02Apr2021 and discharged 04Apr2021. Another thing was loss of memory on 02Apr2021, from the time the ambulance picked her up and took her to the local hospital she recalls that, but she doesn't recall that hospital to being transferred 6-7 hours later. She stated she doesn't recall anything, it's like a blank. She was transferred from one hospital to another and the 1st hospital she recalled getting there, her mom worked there, but she doesn't recall the 6 hours in between or the ambulance ride to a different town. She stated everything is foggy. She still has problems remembering, it's better but she still has problems remembering like if she is talking to somebody and gets sidetracked, she doesn't recall what she was saying. The patient reported that her blood pressure went up to 240/130 on 02Apr2021 when the ambulance picked her up. She reported that since 2018 her blood pressure was always normal until after the vaccination. The patient underwent a heart monitor, brain scan EEG, an MRI and echocardiogram/EKG on an unknown date, with unknown results. The outcome of the events "Stinging lips" and "Lips and tongue started tingling" was recovered on 02Apr2021, and unknown outcome for other events.

After vaccine, 2 hours later my eyes, lips were swollen. They said acute dehydration and my heart started pounding wildly. I went home and took Benadryl the next day I had breathing problems, 3rd day woke up with numb arm and went to ER and developed arm and left numbness and tingling that's still there today. I still have swelling in face and tongue and sores in my mouth and I have to ice myself at bedtime. and still wake up with difficulty breathing. I'm scheduled for an MRI because doctors said it's an adverse event to vaccine and I've also had hives. I will probably go back to ER because I'm having asthma issues again. I checked with my doctor about my medical records to know if I should get the vaccine and was told to get the vaccine. I have left side numbness and that's why I'm getting the MRI to rule out everything.

several days after my second shot I developed tinnitus- I have never had it before. I have not had COVID itself. I had the second shot over a month ago and I still have intermittent tinnitus- at least 50% of the time.

Headaches, chills, tired, no energy, low-grade fever (that has never went away), my eyes hurt and my nose is stuffy. I went to get a COVID test but it was negative.

Tinnitus in both ears, Pulsatile Tinnitus in my Left Ear It has been persistent since 3 days after the 2nd Pfizer shot - all the time- so for 4 weeks plus and ongoing Saw an ENT- CT Scan came out clear Will see TMJ Specialty dentist soon May see a Neurologist for work up over the Pulsatile Tinnitus

14:08, pt presenting with complaint of "lips feel like they are swelling", pt has history of medication allergies & adverse reaction to lidocaine; per EMS S.O., 2-Benadryl-25 mg tables were given. Pt was asked to stay another 30 minutes after taking the Benadryl.

body swelling; Swollen joints; Ulcers in her mouth; Migraine headache; Constant diarrhea; Brain fog; This is a spontaneous report from a contactable consumer reporting for herself. A 61-years-old female patient received the second dose of BNT162B2 Pfizer-BioNTech COVID-19 mRNA Vaccine in Hospital, via an unspecified route of administration, administered in right arm on 20Apr2021 09:00, at 61 years of age, (Batch/Lot number ER8737) as single dose for COVID-19 immunization. Medical history included thyroid disorder from an unknown date and ongoing (she has had it for years), hypertension started about 8 years before this report and ongoing, immunodeficiency from an unknown date and ongoing, her spleen has been removed and she is immune compromised and has had COVID. The patient reported that after the first dose of Pfizer-BioNTech COVID-19 mRNA Vaccine administered on 30Mar2021 at 09:00, she had mild diarrhea, body aches, fever and headaches and she felt she had COVID. The patient's concomitant medications were not reported. In Apr2021 the patient experienced body swelling, assessed as medically significant, swollen joints, ulcers breaking out inside her mouth and a 24 hour migraine headache. Ulcers started about 3 days in from the 2nd dose, they come and go. She keeps them at bay by using Listerine. She understands that whatever is happening in her lower gastrointestinal tract is coming up into her mouth. The patient added she is a neuro-muscular therapist and had an understanding of how her body works. The body swollen started a week after the shot (also reported as immediately after the shot). It continues at the time of the report and it is persisting. The patient stated "she has a little bit of COVID brain". Moreover, the mild diarrhea after the first dose changed to constant diarrhea after the second dose. It is water and with intense cramping and is constant. She reported she is on the BRAT diet. "It won't hold so she is living on Gatorade and white rice". Over the past week, her joints in her hands and in her body have become swollen. Horribly swollen to the point she couldn't get her pants on because her knees and ankles were so swollen. Her hands last week started swelling and the pores around her joints look like blisters. The patient added she has had severe brain fog since an unknown date which was ongoing at the time of the report. The headache has not left as well, the outcome of all the events was unknown at the time of the report. The patient has not been to the Emergency Department or her Physicians office, but was going at the day of the report. No follow-up attempts are needed. No further information is expected.

1. Sore arm for about 2 days. 2. Taste anomalies lasting until the present day (8 weeks). For two days after the vaccine, I had a sweet taste in my mouth, similar to bubble gum. I don't remember exactly, but I think I had had a slight odd taste before the second vaccine, but I don't remember exactly. Over the next 6 weeks, my taste was not normal. It varied, but the most common problems were a bitter after taste, a salty taste (especially when drinking), and a soapy taste. Also, it seemed that the taste sensations right down the middle of my tongue were either gone or lessened. I tasted food better as it filled my mouth to the sides and back. A few examples of what I experienced: my morning coffee tasted vaguely salty; the first glass of water in the morning could bring about a strong bitter flavor (even though upon waking, my mouth tasted neutral); licking my lips was sometimes bubble-gummy, and sometimes a bitter taste mixed in with the salt of my sweat. During its worst times (about 4 weeks after the vaccine), when I first bit into a sandwich or other food, I could taste it only dully, and the taste would get full and better as the food went to the sides and back of my tongue. The worst flavors (also about 4 weeks in) were like what I remember European licorice to be like: a really gross blend of salty and sweet and ???. This would just be in my mouth almost all day. Eating and drinking exacerbated it. I should mention that when I did taste items, they tasted as you would expect, but have the EXTRA salt or bitter flavor superimposed. I tried smelling items independent of taste, and as far as I could tell, my smell was OK. It is now just about 8 weeks past, and I would say my taste is back to about 95 or more % normal. Not perfect. It varies a little day to day. Not 100% this was caused by the vaccine, but it happened in this time frame.

Tinnitus; hearing loss; Gout; Dry heaves; extreme abdominal cramping; Chills/Fever; Chills/Fever; Body Aches; Slept most of the day; Extreme sore arm; Quarter size hard lump X3weeks;; This is a spontaneous report from a contactable consumer (patient). A non-pregnant 61-year-old female patient received BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine), dose 1 via an unspecified route of administration, administered in the left arm, at age 61 years, on 03Feb2021 (Batch/Lot Number: EL9269) as 1st DOSE, SINGLE for COVID-19 immunisation. Relevant medical history includes hypertension, asthma, glaucoma and cataracts, and blood clot from unspecified dates. Prior to vaccination, the patient was diagnosed with COVID-19 on unspecified date. Concomitant medications included chlorthalidone; apixaban (ELIQUIS); losartan; and verapamil, all taken for an unspecified indication, start and stop date were not reported, received within 2 weeks of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient previously received ciprofloxacin (CIPRO) and vancomycin on unspecified dates and experienced known allergies. On 03Feb2021 14:00, the 1st day, patient experienced extreme sore arm; quarter size hard lump X3weeks. On 04Feb2021 14:00, second day, patient experienced chills, fever, body aches, slept most of the day. On 05Feb2021 14:00, third day, patient experienced dry heaves for 2 hours followed by extreme abdominal cramping that required the patient to lay flat for the whole day. On 06Feb2021 14:00, fourth day, patient woke up to gout in his right big toe that lasted for a week. On 08Feb2021 14:00, sixth day, patient had tinnitus in both ears and hearing loss. ENT doctor prescribed oral steroids w/ taper and when that didn't work. Patient went through 4 torturous treatments where ear drum was initially punctured and shot of steroids was inserted through the hole. That didn't work either and around the time of reporting, patient was told that she have permanent hearing loss and the tinnitus has not gone away. She is now looking at needing hearing aids and will not be subjecting herself to the second dose. Hospitalization prolonged was not involved. The adverse event resulted in doctor or other healthcare professional office/clinic visit. Since the vaccination, the patient has not been tested for COVID-19. Facility where the most recent COVID-19 vaccine was administered was at a doctor's office/urgent care. The outcome of the events was not recovered.

Diarrhea; Stomach pain; Stiff neck; Vertigo; Swelling of hands and feet; skin dryness and cuts appeared; skin dryness and cuts appeared; She did not have any smell and taste; She did not have any smell and taste; Fever; Chills; Coughing; Her lymph node glands were swollen between her legs; Right arm was of no use it was so painful it felt like it would break off of the shoulder; Nauseous; Dizzy; Difficulty walking; Exhaustion; The moisture in her skin was almost like it was sucked out and lesions started opening up almost like a papercut; Tachycardia/heart beating out of her chest; This is a spontaneous report from a contactable consumer (patient). A 61-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left on 25Feb2021 11:30 (Batch/Lot Number: EN6198) age at vaccination of 61-years-old at 0.3 ml single for covid-19 immunisation. Medical history included bell's palsy from an unknown date and unknown if ongoing, endometrial cancer from an unknown date and unknown if ongoing, rheumatoid arthritis from an unknown date and unknown if ongoing, drug hypersensitivity from an unknown date and unknown if ongoing (Penicillin allergy), rubber sensitivity from an unknown date and unknown if ongoing, illness from an unknown date and unknown if ongoing (sick for the past 11 years). The patient was not pregnant and was not pregnant at the time of vaccination. Concomitant medications included levofloxacin (LEVOFLOXACIN) taken for an unspecified indication, start and stop date were not reported; levothyroxine (LEVOTHYROXINE) taken for an unspecified indication, start and stop date were not reported; cyclobenzaprine (CYCLOBENZAPRINE) taken for an unspecified indication, start and stop date were not reported. The patient previously took sulfonamide and experienced hypersensitivity, mycin [benzathine benzylpenicillin] and experienced hypersensitivity. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Facility where the most recent COVID-19 vaccine was administered: Hospital. On 25Feb2021 at 1230, she was dizzy, nauseous, vertigo, swelling of hands and feet, tachycardia/heart beating out of her chest, difficulty walking, her right arm was of no use it was so painful it felt like it would break off of the shoulder and her left arm was the arm she got the shot in and it had no reaction at all, she did not have any smell and taste, fever, chills, coughing, her lymph node glands were swollen between her legs and the other weird thing is that the moisture in her skin was almost like it was sucked out and lesions started opening up almost like a papercut, skin dryness and cuts appeared, she could hear the noise of it opening up on fingers it was like a popping, she had a stiff neck and like everyone she had exhaustion. The patient experienced stomach pain and diarrhea on 27Feb2021 those are the things she had and her family won't leave her alone, they think she should get the second injection but she is terrified. She has gotten no help from her doctor. No treatments were given for the events. The patient underwent lab tests and procedures which included sars-cov-2 test negative on 28Nov2020 (Nasal Swab). The patent was not recovered from the events. No follow-up attempts are needed. No further information is expected.

Several weeks after second shot starting hearing ringing in ear when laying down and all during the day. Put off visit to ent thinking it may be water in ear. Just had ent visit, no inner ear fluid but kept questioning any new medications I had taken which was no. He has scheduled me for hearing test to see if any hearing loss. Said may be titanatis? Came home and looked up sudden ringing in ear, and see where it is showing up after second shots in a lot of patients a side effect of COVID shot being reported. Shocked. Pray it goes away. Unbearable to think this is what I will deal with. Also afraid if tied to shot, what do I do about boosters? Do I loose my hearing?

Tinnitus got worse about 10 days after dosage. Feeling like water in ear when touch; Headache; This is a spontaneous report from a contactable Consumer (patient). A 61-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left on 15Feb2021 08:30 (Batch/Lot number was not reported) at the age of 61 years, as single dose for covid-19 immunisation. Medical history included tinnitus from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. The patient previously took z-pak and experienced allergy. On 18Feb2021 16:00 the patient experienced tinnitus that got worse about 10 days after dosage (feeling like water in ear when touch), and headache (Headache off and on for 3 days starting on 3 rd after receiving shot). The patient did not receive treatment. The events were non-serious with outcome of not recovered. No follow-up attempts are possible; Information about lot/batch number cannot be obtained.

Patient reported having itchy tongue at 1450. Denied other symptoms/ side effects. Declined vitals/ medications and preferred to be observed longer. At 1500, client asked for medication. Administered cetrizine 10 mg PO at 1500 and had patient wait extra 30 minutes. At 1530, patient reported itchy tongue had resolved and had no further symptoms/ side effects. Client left clinic at 1530.

Tinnitus in left ear Thought was allergy related so prescribed Methylpred 4mg Pack + Flonase + Claratin but no relief

36% sudden hearing loss in left ear; This is a spontaneous report from a contactable consumer (patient). A 61-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EN6199) via an unspecified route of administration, administered in Arm Left on 12Mar2021 12:00 (at the age of 61-year-old) as 1st dose, single for COVID-19 immunisation. Medical history included allergy to sulfa antibiotics. Patient was not pregnant. Concomitant medications included escitalopram oxalate (LEXAPRO) and levothyroxine (LEVOTHYROXINE); both taken for an unspecified indication. The patient experienced 36% sudden hearing loss in left ear on 18Apr2021. The event resulted in physician office visit and she was currently using a hearing aid. Outcome of event was not recovered. Follow up needed, further information has been requested.

Approx 1 mos after 2nd vaccine, I woke up with pink glossy eyes. I have no history of seasonal allergies and thought that perhaps I had caught something contagious from my husband who had developed bloodshot eyes that calmed to a pink glossy look over the course of a week or two. He is known for seasonal allergies and we thought that something happened during lawn mowing. However, as days went by, I started wondering if we could have caught COVID19 though vaccinated and went to Patient First to be COVID19 tested. The rapid test and PCR test were negative. Dr. also did a rapid strep test (negative). The doctor confirmed my eyes looked irritated and jaundice, but had no suggestion except OTC eye drops. I had tried Refresh eye drops without benefit. I had an upcoming eye exam appt with eye Dr. and so kept it feeling I wouldn't be transmitting something. Dr. acknowledged the discoloration in my eyes but hadn't heard anything related to the vaccine. My husband's eyes, my eyes, and some community friends' eyes are changed and looking glossy, pink, and/or yellowed. I am concerned about the lack of information about this. I am concerned about liver function and anything else that can be contributing to COVID19 vaccine eyes. Someone needs to start paying attention to this. This week I'm notifying Drs. that my situation is calmer but basically unchanged. In making that decision today, I decided to contact vaers as well. Something is going on and I want to know what so that I can understand if there is something or someone that I need to be seeing. My eyes do not itch nor burn but sometimes feel a bit dry so I'm continuing at times with OTC eye drops. My husband is NOT on any of the medications that I am on, my friends are not on any of the medications that I am on. The only thing we have in common regarding this matter is that all of our eyes have a changed appearance. I'm starting to be able to identify many who've had both vaccines by COVID19 pink/jaundice glossy vaccine eyes.

Loss of smell; lost her taste; Diarrhea; This is a spontaneous report from a contactable consumer (patient). A 61-year-old female patient received first dose of BNT162B2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number: EN6207), via an unspecified route of administration, administered in left arm on 15Mar2021 at 10:00 hours as 1st dose, single dose (at the age of 61-year-old) for COVID-19 immunisation. Patient had no medical history (including any illness at time of vaccination). Patient's concomitant medications were not reported. Patient had no prior vaccinations (within 4 weeks). On 15Mar2021 at night, patient lost her taste and smell and had diarrhea. Patient stated that diarrhea stopped at night only and got her taste and smell back today (16Mar2021). Patient declined any treatment for the events. Patient did not get any blood work or diagnostic testing done. Patient had no emergency room and physician office visit. Patient asked if a person was supposed to had side effects after receiving the COVID-19 Vaccine and stated she was scheduled for her second COVID-19 vaccine on 05Apr2021. The outcome of diarrhea was recovered on 15Mar2021 and recovered for rest both the events on 16Mar2021. No follow up attempts are possible. No further information is expected.

Intermittent numbness and itching of the tongue. Resolves without intervention. Still ongoing intermittently for 3 weeks.

Started with an immediate headache after my second shot that lasted for 14 days and then at 14 days I got severe chills, fever that came and went, no appetite, and sleepy for 3 days. Then on May 5th (10 days after my last day of chills and fever) I had chest pains bad enough to visit the emergency room. The pain extended into my neck and jaw and was WORSE when I tried to lay down or lean backwards. I was diagnosed with PERICARDITIS and given anti-inflammatories. The pain subsided in about 24 hours from the onset. I thought it was due to the vaccine but because the timeline was so strange I didn't immediately report. After hearing about the young people that are experiencing the heart issues I felt I had to report. It might be happening to more people in different age groups than is being reported.. I am a very healthy 61 year old female but I do have a history of issues with vaccines. I get sick every time I have ever had a flu shot so I no longer get them. I know this is a different technology so was hoping this wouldn't be the case but I got symptoms after both of my vaccines. The second on was worse than actually getting COVID (which I had and survived easily last Feb...)

This is a spontaneous report from a contactable other health care professional (patient). A 61-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/Lot number and Expiration Date: not reported),via an unspecified route of administration, administered on left leg on 31Jan2021 at 13:00 (reported as 01:00 PM) (at the age of 61 years old) as first dose, single for COVID-19 immunization. The facility where the vaccine was administered was reported to be "other". The patient medical history was not reported. Patient has known allergies with Bupivacaine on an unspecified date. The patient was not pregnant at the time of vaccination and did not receive any other vaccines in 4 weeks. Prior to vaccine the patient was not diagnosed with COVID-19. Concomitant medication included paroxetine hydrochloride (PAXIL [PAROXETINE HYDROCHLORIDE]) taken for an unspecified indication, start and stop date were not reported. The patient experienced ringing in ear on 21Feb2021 at 04:00 (reported as 04:00 AM). No treatment was received for the adverse event. Since vaccination, the patient has not been tested for COVID-19. Outcome of event was not recovered. The patient received the second dose of BNT162B2 (lot number: not reported) via an unspecified route of administration, administered in left arm on 21Feb2021 at 01:15PM, at the age of 61 years old as second dose, single for COVID-19 immunization. No follow-up attempts are possible; information about lot/batch number cannot be obtained.

Cough This is a new problem. The current episode started in the past 7 days (x3 days. Possible covid exposure to covid 2 weeks ago. Had had both covid vaccines. Seen at clinic this week and started on antibiotics for bronchitis. Did not get tested for covid and wants covid test.). The cough is productive of sputum. Associated symptoms include headaches, myalgias, shortness of breath and wheezing. Pertinent negatives include no chest pain, chills, fever or sore throat. Associated symptoms comments: Decrease in taste. N,V,D.. She has tried a beta-agonist inhaler (antibiotics, phenergan) for the symptoms. Her past medical history is significant for COPD. Vomiting This is a new problem. The current episode started in the past 7 days (x3 days). There has been no fever. Associated symptoms include abdominal pain, coughing, diarrhea, headaches and myalgias. Pertinent negatives include no chest pain, chills or fever. Risk factors include ill contacts (No traveling.). Treatments tried: phenergan. The treatment provided mild relief.

Hi. The second pfizer EW0177 injection was given to me on 6/11/21 and the next morning i had a ringing in my right ear and numbness in the left side of my face. Thought i had a stroke called doctor and was sent to emergency rm. The ruled out a stroke but did not know why. I also have a floating black ring in my right eye. I have an eye appt. To see what going on w my eye. Since the first injection my hair is falling out in handfulls. Please contact me with any help with all of this. I am very distraught and concerned.

Bright red rash, intense itching, skin peeled like from bad sunburn - multiple areas. Hives - abdomen, upper back, forearms and hands. Intense extended itching! Facial, eyelid and neck swelling. Fri May 7th (last area that week) - Face and neck also developed bright red rash and itching. As rash decreased skin felt dry and papery. Did peel /exfoliate. Last area to have response.

I started getting sick within a few hours. I got a headache that felt like my brain had exploded, body aches like I had been hit by a bus and nausea to the point of vomiting several times. I was exhausted, unable to eat, had a weird taste in my mouth and my arm was black and blue at injection site with a red rash covering my upper arm. I'm not as sick as I was those 1st 3 days, but my arm and the rash are still going strong and it's not to the touch and itches and feels like it's on fire at times. And like someone used it for boxing practise. Seems to be gradually getting worse rather than better.

Sudden loss of taste 3 months after 2nd vaccine dose. I had started a new supplement (GI Revive) at that time. Stopped taking it and loss of taste persists to this day.

Tingling tongue; Numbness of circle all over my mouth; Numbness is medically up my jaw line/Numbness went like from my chin to top of my head; My tongue like swelling; Tingling back in the tongue; This is a spontaneous report from a contactable consumer or other non hcp (Patient). A 61-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EL3247 and expiration date was reported) second dose via an unspecified route of administration on 27Jan2021 as 2ND DOSE, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number was not reported and expiration date was30Apr2021) first dose via an unspecified route of administration on unspecified date as 1ST DOSE, SINGLE for covid-19 immunisation. On 27Jan2021 evening Patient got a tingling in the tongue, numbness of circle all over my mouth which then it went up my jawline. Patient took a Benadryl but it subsides still there and ended up going to urgent care because of tongue like swelling. And doctor advised to continue with the Benadryl. And that was on Saturday. Further patient added Now yesterday continue Benadryl last Saturday to Monday of this week through February first. And side effects subside, yesterday all sudden I got a tingling back in the tongue. And numbness went like from my chin to top of my head. While patient further questioned what he was supposed to do with side effects. Follow-up attempts are completed. No further information is expected.

nausea , headache, covid like symptoms first five days . On the 7th day lost hearing on left. Very dizzy . Has trouble walking straight.

About 40 minutes after vaccination, started a tingling in the right side of my face tongue and cheek, throat closing, swollen lips and face on right side. Swollen in areas of the right side of my face. I called urgent care who said start Benadryl every for hours. Found I was allergic to polysorbate 80.

On May 10th, I started to feel itchy in my breast area. To took off my clothes and discovered a rash on both breast, on both sides of upper torso. I thought I was have a reaction to peanuts I had eaten. (Note, that I have consumed peanuts before with no issues in the past). By 3:00 pm, The rash & welts was on my stomach, bottom, lower back, groin area, upper thighs, feet, hands. My lips were swolen, My voice changed & my tongue felt swolen. The Doctor at Urgent care gave me a shot of Solumedrol IM -125 mg in my buttock. I instantly felt some relief. I was given a prescription of Prednisone 40 mg for 4 days, told to take Pepcid 20 mg twice a day, Benadryl every 6 hours, Zytrec 10 mg daily for 5 days. I saw my Allergist for an allergy test. She tested me for all nut allergies, eggs. I do not have allergic reaction to nut nor eggs. My Primary care Doctor gave me an Epi pen

On March 31 I woke up and had a hard time breathing. My DR told me to go to the ER immediately so I did. So when I got there, I was put on the bypap and had the respiratory issue, my EKG changed where I had heart problems. My liver enzymes were elevated and my kidney enzymes were elevated. I gained 10 pounds of fluid in three days of being in the ER. I went to intensive care for worsening conditions, ended up having severe migraines and not being able to see correctly. They gave me Benadryl 50mg IV along with epinephrine, all within the first two days. I was in the hospital for a week that I can tell you. Within three weeks later my liver enzymes did go back to normal. I did go to my PCD for follow up, I saw an allergist specialist as well. I couldn't walk correctly, and had a hard time breathing as well. It was like all my organs were affected. Even right now I am still fatigued and I only got the first vaccine, back in March. These all are worsening symptoms as well. I also lost my hair as well. All my nails broke, it was just like, everything happening at once.

This is a spontaneous report received from a contactable consumer, the patient. A 61-years-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6205) via an unspecified route of administration in left arm on 05Mar2021 at 10:15 (at the age of 61-year-old), as a single dose for COVID-19 immunisation. Medical history included high cholesterol. 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. The patient had not received any other vaccines within 4 weeks prior to the COVID vaccine. The patient had received unspecified other medications within two weeks prior to the vaccination. The patient had COVID-19 nasal swab test on 15Mar2021 and resulted negative. On 12Mar2021 at 17:00, the patient experienced an ear ache, headache, tiredness, muscle pain, chills, not feeling well and had high blood pressure. The events resulted in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. It was unknown if the patient received any treatment for the reported events. The clinical outcome of events ear ache, headache, tiredness, muscle pain, chills, feeling unwell and high blood pressure was resolving at the time of this report. No follow-up attempts are needed. No further information is expected.

seeing black moving spots in my right eye; jaw & neck are achy on my right side; jaw & neck are achy on my right side; This is a spontaneous report from a contactable consumer (patient). A 61-year-old non-pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Batch/Lot Number: ER8737), via an unspecified route of administration, administered in arm left on 19Apr2021 at 13:45 (at an age of 61-years-old) as dose1, single for covid-19 immunization. Medical history included hysterectomy on an unspecified date in 2011. Patient was not diagnosed with covid-19 prior to vaccination. Concomitant medications included Calcium (MANUFACTURER UNKNOWN), via an unspecified date on an unspecified date at unknown dose and frequency for unknown indication; levothyroxine, liothyronine (NP THYROID) (MANUFACTURER UNKNOWN), via an unspecified date on an unspecified date at 60 mg, unknown frequency for unknown indication; vitamin d3 (VITAMIN D3) (MANUFACTURER UNKNOWN), via an unspecified date on an unspecified date at unknown dose and frequency for unknown indication; cyanocobalamin (VITAMIN B12 AAA) (MANUFACTURER UNKNOWN), via an unspecified date on an unspecified date at unknown dose and frequency for unknown indication; fish O (MANUFACTURER UNKNOWN), via an unspecified date on an unspecified date at unknown dose and frequency for unknown indication. The patient previously took ampicillin for hypersensitivity and experienced allergy. Patient did not received any other vaccine prior four weeks of vaccination. On 20Apr2021 at 17:00, the patient experienced seeing black moving spots in my right eye since tuesday evening and jaw & neck are achy on my right side. Since vaccination patient not tested for covid-19. No therapeutic measures were taken as a result of the events. The clinical outcome of the seeing black moving spots in my right eye, jaw & neck are achy on my right side were not recovered. Batch/Lot number was obtained. Further information has been requested.

my face swelled up like a balloon, it turned burnt red, it was burning/redness; my face swelled up like a balloon, it turned burnt red, it was burning; My arms swelled up like balloon; Red rash all over my arm; allergic reaction; her face and ears had swollen up like a balloon; her face and ears had swollen up like a balloon; arms were burning and swelling; arms were burning and swelling; had a rash in the arm and neck; This is a spontaneous report from a 61-year-old female contactable consumer (patient). A 61-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Batch/Lot number was not reported) via an unspecified route of administration on 21Mar2021 at 09:30 as 1st dose, single for COVID-19 immunisation. Medical history and concomitant medications were not reported. On 21Mar2021, patient received Pfizer Covid19 vaccine first dose on Sunday at 9:30 a.m. and 2 hours later at around 12 o'clock she experienced that her face and ears had swollen up like a balloon, arms were burning and swelling, had a rash in the arm and neck, they took her to the ER and gave her Epinephrine and Benadryl. Some doctors advised not to get second one and some others advised it was not an allergic reaction and wanted to know if this was an allergic reaction to the vaccine or not. On 09Apr2021 it was reported that her face was red like someone burnt her. It was burning. She was taken by ambulance to the emergency room. Her face was hot, burning, burnt red like she had been in the sun for 4 days, and became red like she had a third-degree sunburn. They took her to the Emergency Room. She developed bilateral arm swelling 5 minutes after the vaccine. She still has a little rash. Her face was a little puffy yesterday but is better today. She only ate in the morning and didn't eat lunch before the vaccine. About 2.5 hours of vaccine administration later her face started swelling, redness, with burning. Both arms started to swell with a rash developing. Caller has seen two providers who said the symptoms were allergic reactions to the vaccine. She also seen two other providers who said it was not a reaction to the vaccine. Caller asking if she should take the second Pfizer Covid 19 vaccine. Patient is confused about getting second dose. It was reported that my arms swelled up like balloon; Red rash all over my arm and just wanted to know if she should get her second shot and asked whether she was getting the second shot on Monday or not. The clinical outcome of the event her face and ears had swollen up like a balloon, arms were burning, and swelling was resolved, the event had a rash in the arm and neck was resolving and rest of the events was unknown.

After first COVID vacc: Shingles outbreak, left side of abdomen and back. Pain/ache/slight itch started 3/19. Rash started 3/20. Rash and pain accelerated 3/22. Doctor confirmation 3/23 and started on acyclovir & gabapentin. 90% cleared up by mid-June. As of 7/1 still not totally resolved (tingling, numbness, sensitivity, rash). After second COVID vacc: Right eye uveitis. tart of symptoms approximately 4/13. Exact date unknown because symptoms were masked by Posterior Vitreous Detachment in right eye, which had started 3/3/21. Symptoms of uveitis: severe inflammation in back of eye, with overall grayish haze, reduction of light contrast, increased light sensitivity, pixilation, overall vision deterioration.

terrible rash / It is spreading and not getting better, it is all over her body, stomach, face.; My eyes started to getting itchy now, this is blinding my eyesight. I can't go to work; itchy and miserable; itchy and miserable; it started on the arm that consumer got the vaccination; This is a spontaneous report from a contactable Consumer (Patient). A 61-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: EWO180) via an unspecified route of administration on an unspecified date (61 years age at the time of vaccination) as dose 2, single for COVID-19 immunization. The patient medical history had chemotherapy and radiation (further not clarified) in the past and high blood pressure. The concomitant medications were not reported. The patient previously received the first dose of the covid vaccine, consumer thought that it was a low dose and felt tired. But nothing really traumatic. It was not so bad. Consumer stated that consumer took the second vaccination, probably now, after eight to nine days, consumer have a terrible series of rash throughout my body. Consumer can't think of anything else it would be coming from and it started on the arm that consumer got the vaccination, and it seems to be travelling around my body and it went from my arm to my stomach to the other side. It's terribly itchy. It is on my face. When probed for the date of first shot: The last one was on June 5th I believe. The first one was on 15May. The second one was on 05Jun and the both was on right date. Consumer had chemotherapy and radiation (further not clarified) in the past and high blood pressure. Maybe it was not approved for people with chemotherapy in the past and radiation. I mean this is pretty miserable and consumer don't want to miss work for it. If this is going, my eyes started to getting itchy now, this is blinding my eyesight. Consumer can't go to work. The outcome of the events was unknown. Follow attempts are needed; Additional information has been requested.

feeling of "like euugh"; tiredness; she probably had the Covid 19 virus; had very little discomfort with the injection; low grade fever 99F; a little cough; frontal lobe headache; sinus issue; scratchy throat; runny nose; head congestion; sinus pressure; ear pain; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 61-year-old female patient received bnt162b2 (BNT162B2 PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot number: EN6199), via unspecified route of administration in arm left on 12Mar2021 at 13:30-14:00 (as reported) (at the age of 61-years-old) as dose 1, single for COVID-19 immunisation. The medical history of the patient included she reported she was in good health. Her blood pressure was borderline and below. She was a little overweight, they tell her she is overweight. She was the type of person who can get the flu shot, no problems. She never had the shingles shot. She does have seasonal allergies and they do happen this time of year. She is going to get checked for arthritis because it runs in her family. She just lost her mother. Her mother had cancer this past year, she didn't die from the cancer. They were secluded at that time. Then the Covid 19 virus came and her family was even more secluded. As far as other allergies, she has an allergy to pollen, and a form of Penicillin. The form of Penicillin she took and had a reaction to was Cephalexin about 25 years ago and she got a rash and itchy hives. She reports that reaction wasn't like she wasn't able to breathe, it was more like what's wrong. The concomitant medications of the patient included calcium and magnesium and multivitamin. The patient did not receive any other vaccines within 4 weeks prior to the covid vaccine. The patient experienced scratchy throat, runny nose, head congestion, sinus pressure, ear pain, low grade fever 99f, a little cough, frontal lobe headache, sinus issue on 12Mar2021 and feeling of like euugh, tiredness, her blood pressure is borderline and below, a little overweight and she probably had the covid 19 virus on an unspecified date. The patient reported that she experienced pretty heavy seasonal allergy-like symptoms. She mentioned that she experienced a scratchy throat 4 hours later, a runny nose, head congestion in the night, sinus pressure, and ear pain due to her head filling with fluid. She also mentioned that she lied down with a general feeling of like euugh and tiredness. She mentioned that this was normal symptoms when she gets seasonal allergies every year but she cannot rule out that this was possibly caused by the vaccine because the timing was just too near her vaccination. As of calling, she was feeling better but still has congestion. She was concerned on getting the 2nd dose because this might happen again to her or maybe worse. She said that people have told her that they did not experience side effects during the 1st dose but had experienced side effects on the 2nd dose. Her symptoms started that night after she received her first Covid 19 vaccine. She went into her normal allergy thing that she gets every year. Clarified she has seasonal allergies that occur every year. She asked some friends and they told her she probably had the Covid 19 virus and she thinks it was more seasonal allergy symptoms. She had head congestion, clear to white mucus, her head was congested. She did have a low grade fever of 99F just one night, the night she received her vaccine. She also had a scratchy throat, the head congestion, a little cough, not the nasty type of mucus. She did not see these symptoms that she was having listed as common side effects. She was asking if these are symptoms we can have. She was getting a little fearful of getting the next Covid 19 vaccine. She does not know what to do. She does not want that anxiety over getting the second Covid 19 vaccine, scheduled to receive it 04Apr2021. she reports she wakes up now and still has a runny nose. She received the Covid 19 vaccine on Friday, 12Mar2021. By Friday night she was totally congested with sinus pressure. She was blowing her nose. It went into her ears, it feels like a whole lot of fluid. It causes ear pain. She still has the symptoms. One night she took Claritin. She's not big on taking medicines. She was still so congested. Every morning she was waking up with it. The scratchy throat started about 3 hours after she received the Covid 19 vaccine. And about 8-10 hours after the vaccine she had a frontal lobe headache, the kind of headache when she gets her seasonal allergies. It's not an allover headache, it's definitely concentrated on her sinuses. Her sinuses feel like they are filling up. It's very much a sinus issue. Feels like the same kind of allergies that she's had for the last 2 years. And it goes into her ears and gives her earache pain. She had very little discomfort with the injection. The patient was not hospitalized. The patient underwent lab tests and procedures which included blood pressure measurement: borderline (her blood pressure is borderline and below) on an unknown date and body temperature increased: 99 fahrenheit on 12Mar2021. Therapeutic measures were taken as a result of AE that included the patient had also taken Tylenol Extra Strength. They were 500mg and she only took one. She took that on 13Mar2021 at 12:00PM. She took maybe a total of 4 Tylenol all together and she felt better so she did not take it anymore. She took them sparingly. Maybe a total of 6 in 2 weeks. The outcome of the events scratchy throat, runny nose, head congestion, sinus pressure, low grade fever 99F, a little cough and frontal lobe headache was reported as resolving and outcome of the events ear pain, feeling of like euugh, tiredness, sinus issue vaccination site discomfort and she probably had the Covid 19 virus was reported as unknown.

Woke up on the morning of May 26, 2021 with complete hearing loss in my right ear. I was experiencing extreme vertigo and collapsed - was taking to Emergency Room. where I was diagnosed with BPPV and had a CT scan which was normal. I was released with a prescription of Prednisone (50 mg) to take for five days with the hope that my hearing would be restored. On June 1 I visited the Emergency Dept. because I still had no hearing in my right ear - I was completely deaf. I was diagnosed almost immediately with Sudden Sensoineural Hearing Loss (SSHL) or "sudden deafness." I was put on 19 days of high-dose steroids, 14 days at 60 mg. then taper off. I visited a specialist at the hospital when I was on Day 13 of the therapy, and he began a series of 4 injections of steroids directly into the ear. I have now completed that series of injections with no change in my hearing.

It did not matter where or how hard the doctor hit here right knee; She has complications with having no taste; She was itching on her right arm, wrists and fingers; She was tomato red from head to toe; Her throat and face was swollen; Her right hand and arm was swollen; She began having vagina spasms. She literally felt like half of a fish was inside of her vagina, and it was flopping around.; Her chest felt heavy; Her right knee had no reflex what so ever.It did not matter where or how hard the doctor hit her right knee, it did not move; The bubble blisters on her wrist; She started getting bubble blisters on her arms, fingers, and over her chest, above her boobs; Her left but cheek, back of leg and knee cap all felt numb, but also felt on fire at the same time. It just really hurt; Excruciating pain in her left butt cheek, back of leg, and knee cap; Her urinary tract started burning. She was peeing, and peeing and peeing. She was using the bathroom a lot; her urinary tract started burning. She was peeing, and peeing and peeing. She was using the bathroom a lot.; This is a spontaneous report from a contactable consumer (patient herself). A 61-year-old female patient (self-reported) received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection), dose 1 via an unspecified route of administration, administered in Arm Right on 01Apr2021 13:00 (Batch/Lot Number: ER8737) as DOSE 1, SINGLE for covid-19 immunisation. Medical history included allergy to shellfish and allergy. Concomitant medication included estrogens conjugated (ESTROGENS CONJUGATED) taken for an unspecified indication, start and stop date were not reported. She received the first dose of the covid vaccine on Thursday, 01Apr2021. She felt fine over the weekend. By Monday evening, 05Apr2021, she started not feeling very good. She received her covid vaccine in her right arm. Around 1:00, her left butt cheek was in excruciating pain, then the pain spread to the back of her leg, and to her knee cap. Her left but cheek, back of leg and kneecap all felt numb, but also felt on fire at the same time. It just really hurt. By 4:00PM, she was hurting so bad, and it moved to her vagina and left leg. It did not bother her right leg. It was only bothering her vagina, butt cheek and left leg. About 16:00 to 16:30, her urinary tract started burning. She was peeing. She was using the bathroom a lot. Her husband came home around 5:30PM and co convinced her to take a hot shower. By 8:00PM, she could not take it anymore. She sent her husband to go get her something for a urinary tract infection. Her husband got her some cranberry juice, and over the counter AZO medication for urinary tract infection. Her back of leg was hurting. She had her husband look at it, but nothing showed up. She did not know that you could not see a blood clot visually. She laid on the sofa and fell asleep. About 1:00, she woke up itching. She was itching on her right arm, wrists and fingers (medically significant). She went to the bathroom, and woke her husband up because from head to toe she was tomato red. She took some Benadryl and went back to her bed. She was still in pain in her left leg, butt cheeks and vagina. She began having vagina spasms. She knows that what she is about to say sounds gross, but she does not know how else to describe it. She literally felt like half of a fish was inside of her vagina, and it was flopping around. She stayed awake and was worried. She was thinking about going to the hospital. She called her doctors on call number, and her they told her to go see her doctor first thing the next morning. Her throat and face were swollen also. She was still red all over. She has shellfish allergies. Her chest felt heavy also. Her doctor looked her over and checked for a urinary tract infection. She took AZO over the counter medication, so the urinary tract infection did not show up. Her tests did grow cultures, but no urinary tract infection showed up. While she was at the doctor, the doctor checked her reflexes. Her left knee had a reflex. Her right knee had no reflex whatsoever. It did not matter where or how hard the doctor hit here right knee. She saw a nurse practitioner, not a doctor. The nurse practitioner did not want to give her a steroid shot. The nurse practitioner wanted her to hold on to as much of the covid vaccine as possible. The nurse practitioner told her to take four Benadryl's a day until her symptoms stopped. She got about 16 minutes from her doctor's office, and she started getting bubble blisters on her arms, fingers, and over her chest, above her boobs. The bubble blisters lasted for two days. Now she has red spots where some of them were. She went to the doctor on a Tuesday. The bubble blisters did not alleviate until Saturday or Sunday. She was told not to get the second dose of the covid vaccine. Her symptoms after the first dose were scary. Her doctor said that she did not have an urinary tract infection, but her sample grew cultures. Her doctor told her that her urinary tract burning had nothing to do with covid. She is an esthetician, she does facials. She knows of three or more people that are her age, in their 60s that have not had a urinary tract infection for the past 25 years. Those people all had a urinary tract infection after getting the covid vaccine. No further information provided. Her symptoms began on Monday, 05Apr2021. Over the weekend, her arm was extremely sore. Excruciating pain in her left butt cheek, back of leg, and kneecap: Her left but cheek, back of leg and knee cap all felt numb, but also felt on fire at the same time. Began on 05Apr2021. It began as a tingle. She knew that it was hurting a lot. At first, she could not pinpoint what it was. The pain moved to her vagina and left leg: Clarifies that it moved down her left leg, over her vagina, to her knee cap. It kept going and stopped at her other leg. She takes Estrogen vaginally. She states that Benadryl helped slow down all of that down. 08Apr2021 through 11Apr2021, she was recuperating. She has complications with having no taste: She does not taste metal, or anything. She feels like she is having trouble cooking, but her husband tells her that her cooking has been wonderful. The food she makes tastes horrible to hear. She feels like her sense of taste is getting a little bit better. Her urinary tract started burning. She was peeing and peeing and peeing. She was using the bathroom a lot: Began about 16:30. She did not have an urinary tract infection, but her sample did grow cultures. She was prescribed Amoxicillin on 07Apr2021. Her symptoms had lessened by 07Apr2021. She does not know if she needed the Amoxicillin. 07Apr2021 through 09Apr2021, she felt so much better. She was itching on her right arm, wrists and fingers: Began about 1:00 on 06Apr2021. She took four Benadryl a day. The itching was annoying to her in certain spots. The itching lasted through 13Apr2021 or 14Apr 2021, she is not sure the end date. She was tomato red from head to toe: Began about 1:00AM on 06Apr2021. It went away 08Apr2021 or 09 Apr 2021. The redness went away the same time as the swelling. Her throat and face was swollen: Began about 1:00 on 06Apr2021. It went away 08Apr2021 or 09Apr2021. Her right hand and arm was swollen: Began about 1:00 on Apr 06 2021. It went away 08Apr2021 or 09Apr 2021. She began having vagina spasms. She literally felt like half of a fish was inside of her vagina, and it was flopping around: Her vagina hurt before she went to sleep. But the spasms did not start until the middle of the night. The spasms lasted all day, for a good ten hours. The vagina spasms have not happened again. Her chest felt heavy: Began about 1:00 on 06Apr2021. Her right knee had no reflex whatsoever. It did not matter where or how hard the doctor hit her right knee, it did not move: Began Tuesday, 06Apr2021. Now she thinks that her knee is just fine. It was just weird. She started getting bubble blisters on her arms, fingers, and over her chest, above her boobs: The bubble blisters lasted for two days. Now she has red spots where some of them were. The bubble blisters lasted until the evening of 07Apr2021. Most of the bubble blisters have went away. The bubble blisters on her wrist went away around 08Apr2021. Indication was she has three children. One of her children is an extreme democrat. Her other two children are democrats. Her democrat daughter did not have anything to do with her if she did not get the covid vaccine. At her age, she could not risk it. She has a lot of junk going on. She is allergic to everything. She has five bulging discs. Her two republican daughters did not want her to get the covid vaccine, they wanted her to wait and see how it affected everyone else. Her democrat daughter was losing it. Outcome of the event She has complications with having no taste was recovering. Outcome of the event It did not matter where or how hard the doctor hit here right knee and Her left but cheek, back of leg and kneecap all felt numb, but also felt on fire at the same time. It just really hurt was unknown. Outcome of the events she began having vagina spasms. She literally felt like half of a fish was inside of her vagina, and it was flopping around was recovered on 06APR2021. She started getting bubble blisters on her arms, fingers, and over her chest, above her boobs was recovered on 07Apr2021. Excruciating pain in her left butt cheek, back of leg, kneecap and Her chest felt heavy and The bubble blisters on her wrist was recovered on 08Apr2021. Her urinary tract started burning. She was peeing and peeing and peeing. She was using the bathroom a lot was recovered on 09Apr2021. Outcome of the other events was recovered on unspecified date in APR2021. Information on Lot/Batch number was available. Additional information has been requested.

lost my sense of smell and taste; lost my sense of smell and taste for 20 minutes; This is a spontaneous report from a contactable consumer, the patient. A 61-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EP6955), via an unspecified route of administration in the left arm on 21Mar2021 at 15:30 (at the age of 61-years-old) as a single dose for COVID-19 immunisation. The patient had no medical history. The patient did not have allergies to medications, food, or other products. The patient did not receive concomitant medications within 2 weeks of 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. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 21Mar2021 at 20:30, about 5 hours after the vaccination, the patient lost her smell and taste for 20 minutes ("luckily it didn't last"). 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 treatment for the reported events lost her smell and taste for 20 minutes. The clinical outcomes of the events lost her smell and taste for 20 minutes were recovered on 21Mar2021 at 20.50. No follow-up attempts are needed. No further information is expected.

Three months after getting my 2nd dose, late in the day on May 31st, I had discomfort in my glands of my throat. It was painful to swallow. Later that night at 2:30am, I experienced a lot of pain in my throat while lying down. I had a temperature over 101 and I was having sinus pressure, nasal discharge, heaviness in my chest, sore throat, and headaches. I called my doctor June 8th and scheduled a telehealth appointment. On June 9th, I spoke to my doctor and they said that I could possibly have the flu with a sinus infection. They prescribed me with an antibiotic.

About 3 hours after the vaccine I was driving and suddenly my vision got blurry; felt tingling in my face; This is a spontaneous report from a contactable consumer, the patient. A 61-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN), via an unspecified route of administration in the right arm on 23Mar2021 at 09:30 hrs (at the age of 61-years-old) as a single dose for COVID-19 immunisation. The patient had no medical history reported. The patient did not have an allergy 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 positive for COVID-19. Concomitant medications included B-12 complex (cyanocobalamin) (MANUFACTURER UNKNOWN), CoQ10 (ubidecarenone) (MANUFACTURER UNKNOWN), multi-vitamins (MANUFACTURER UNKNOWN), vitamin D3 (cholecalciferol) (MANUFACTURER UNKNOWN), turmeric (MANUFACTURER UNKNOWN) all for unknown indications and from an unknown date. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 23Mar2021 at 13:30 (about 3 hours post-vaccination), the patient was driving and suddenly had blurry vision and felt tingling in the face. The tingling sensation lasted 2 seconds for about 2 to 3 hours. The tingling sensation reduced every hour. The event did not result in a doctor or other healthcare professional office/clinic visit, and the emergency room/department or urgent care. The patient did not receive any treatment for the events. The clinical outcome of the events tingling in the face and vision blurred was recovered on an unknown day in Mar2021. Information about lot/batch number cannot be obtained. No further information is expected.

Continued GI symptoms; bloating; no appetite; smells not present or identifiable; Increased back pain; runs; This is a spontaneous report from a contactable consumer (patient). A 61-years-old non pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/Lot Number: EW0162) via an unspecified route of administration, in the left arm on 16Apr2021 12:00 (at age of 61-year-old) as dose 2, single for covid-19 immunisation. Medical history included ongoing (hypertension) HTN, chronic severe l side spinal pain s/p T10-12 laminectomy, fusion and graft from r hip. Had colonoscopy/endoscopy on 27May2021with polyp removal and some gastritis. Although she continued with the symptoms, weight loss, and weird smells. Known allergies were not reported. The patient's concomitant medications were not reported. List of any other medications the patient received within 2 weeks of vaccination was yes but not specified. Historical vaccine included bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/Lot Number: EP7534) via an unspecified route of administration, in the left arm on 23Mar2021 12:45 (at age of 61-year-old) as dose 1, single for covid-19 immunisation. Prior to vaccination patient was not diagnosed with COVID-19. Since the vaccination the patient had been tested for COVID-19. The patient did not receive any vaccines within four weeks prior to the vaccination. On 20Apr2021, the patient experienced continued GI symptoms, bloating, runs, no appetite, smells not present or identifiable. Increased back pain after Feb surgery. Seriousness criteria not reported. Adverse events resulted in doctor or other healthcare professional office/clinic visit. Patient had received treatment for event was increase pain medication and contacted GI docs. Outcome of all events was recovered with sequelae in 2021. Follow-up actions are needed. Further information has been requested

Tingling /Paresthesia hands, feet, face, mouth. stabbing nerve pain in chest, crawling sensation in back, muscle spams and cramping in hands and feet, muscle weakness lower arms and legs, overall weakness, fatigue and lethargy. Also developed UTI feelings, however tests show I do not have a UTI.

Event: Malaise was reported as worsened/ Event: soreness under arm down to wrist was reported as worsened.; She was on another medication for nausea; right tonsil area sore; right tonsil area sore/felt like the right of her throat in the tonsil was swollen; headache; Malaise over my body; swelling is affecting her tongue; aching that goes down her neck, across the shoulder blade and down her arm to the injection site; lymph glands feel tighter in her neck; soreness under arm down to wrist; soreness under arm down to wrist; This is a spontaneous report from a contactable consumer(patient). A 61-year-old female patient received first dose bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: EL9266), dose 1 via an unspecified route of administration, administered in right arm on 08Mar2021 07:20(at the age of 61years) as DOSE 1, SINGLE for covid-19 immunization. Medical history included migraine from an unknown date and unknown if ongoing, ovarian cancer from 1996 to an unknown date, ongoing neuropathy, ongoing complex regional pain syndrome, ongoing dry eye and ongoing fibromyalgia. Years ago she had chemo for ovarian cancer. The chemo triggered migraines. She was on Cisplatin, Bleomycin and VP 16. She was on another medication for nausea. NDC, Lot and Expiry are unknown to caller. She is on disability for several things. She developed migraines, neuropathy, complex regional pain syndrome and severe dry eyes and fibromyalgia after having the chemo and ovarian cancer. Concomitant medications included cisplatin taken for ovarian cancer from an unspecified start date and ongoing; bleomycin taken for ovarian cancer from an unspecified start date and ongoing; etoposide (VP-16) taken for ovarian cancer from an unspecified start date and ongoing. Patient did not receive other vaccination within 4 weeks prior to vaccination no relevant tests were reported patient didn't received other medications. On 08Mar2021 the patient experienced right tonsil area sore right tonsil area sore felt like the right of her throat in the tonsil was swollen, headache, malaise over my body, swelling is affecting her tongue, aching that goes down her neck, across the shoulder blade and down her arm to the injection site, lymph glands feel tighter in her neck, soreness under arm down to wrist, soreness under arm down to wrist , event malaise was reported as worsened event soreness under arm down to wrist was reported as worsened on an unspecified date, she was on another medication for nausea on an unspecified date investigation assessment was not reported. Clinical course of events: Caller received the first dose of the Covid-19 vaccine this morning. On her way home about 30-45 after receiving the vaccine she started feeling like the right side of her throat in her tonsil was swollen. She did not have any breathing problems. She was aching that goes down her neck, across the shoulder blade and down her arm to the injection site. The lymph glands feel tighter in her neck. She has a headache. She feels like she has malaise. She came home and ate. She did not experience any nausea. She did not eat before going to get the vaccine. She asked if this is normal. She did take Tylenol. The swelling seems like it is affecting her tongue. She can tell with her speech. She has a history of neuropathy. She is wondering if this could have hit a nerve. The headache just started in the last hour. She is prone to migraines. When her neck muscles get involved she gets a migraine. They could have accidentally hit a neve. The soreness keeps getting farther down her arm. Therapeutic measures were taken as a result of the events. She was on another medication for nausea. The outcome of the events tonsillar disorder, tonsillar hypertrophy, malaise, swollen tongue, pain, pain in extremity, arthralgia, was not recovered and the outcome of the event headache was recovered and the outcome of the events lymph gland infection, condition aggravated, nausea was unknown. No follow-up attempts are possible; No further information is expected.

Pain in left arm (injection side). Increased difficulty with shoulder movement. Ringing in ears. Ongoing malaise.

sudden sensory hearing loss; This is a spontaneous report from a contactable nurse (patient) from a Pfizer sponsored program. A 61-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE)), first dose via an unspecified route of administration, administered in deltoid left on 16Apr2021 (Lot Number: EW0161; Expiration Date: Jul2021) at the age of 61 years old, as single dose for covid-19 immunisation. Medical history included thyroid, covid-19 from Dec2020. She has no medical history to add. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medication included ongoing levothyroxine sodium taken for thyroid. The patient experienced sudden sensory hearing loss on an unspecified date. She reported she lost her hearing suddenly. The doctor considered it an emergency. It was sudden sensory hearing loss. During that time she had a series of three injections in her ear. She did receive Lidocaine for those injections. She also received Prednisone injections in her ear. She reported it was a virus in her ear and she received three injections and wait and hope that her hearing resolves. She doesn't recall going on 04May2021 for an injection. She provided the dates of her injections as 22Apr2021, 26Apr2021, and 03May2021. The patient and her husband received letters stating that they may have received lidocaine that has been recalled. The date of the letter is 04May2021 which correlates to the time both her and her husband received their second Pfizer Covid-19 vaccine. The patient stated she received their Covid-19 vaccine on 04May2021, and her husband received his on 05May2021 and they both received the lidocaine recall letter. The patient stated the letter stated the recall drug was lidocaine injection and the company is hospira, with a NDC number and recall lot number, along with an expiration date and it stated some vials may contain another drug. The letter from the insurance company also says the Lidocaine vials may contain another drug. The patient stated her husband also had a dentist appointment on 05May2021 and received a lidocaine injection at this appointment. The outcome of the event was not recovered.; Sender's Comments: Based on the available information and known product profile, the causal relationship between the reported hearing loss and the use of BNT162B2 cannot be fully excluded. There is limited information in this case precluding a more meaningful assessment. The case will be assessed further upon receipt of additional information. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.

extreme pain on left sideof neck; pain extended to ear; pain on occasion moved to lower jaw; tenderness in theneck; This is a spontaneous report received from a contactable consumer, the patient. A 61-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN 6205) via an unspecified route of administration in the left arm on 11Mar2021at 12:00 (at the age of 61-years-old), as a single dose for COVID-19 immunisation. Medical history included hashimoto thyroid. Concomitant medications included Levothyroxine sodium (UNITHROID) from an unknown date for unknown indication which was received within 2 weeks of vaccination. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: ER6201) via an unspecified route of administration in the left arm on 18Feb2021 at 16:00 (at the age of 61-years-old), as a single dose for COVID-19 immunisation. The patient had a history of allergy to eggs and corn. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. Since the vaccination, the patient had not been tested for COVID-19. The patient was not diagnosed with COVID-19 prior to vaccination. On 25Mar2021 at 08:30, the patient had experienced extreme pain on left side of her neck, at the base of her skull and was not relieved with ibuprofen. The pain extended to her ear and on occasion moved to her lower jaw. The following day, the pain was only at the base of her skull but on both left and right. By the 3rd day, the pain had moved to the right side primarily and on the 4th day to the right side only, radiating to the right ear, but later in the day back to left centre of her neck. For the entire 4 days, she struggled to use the muscles in her neck at times. At other times she felt she was straining the muscles. Stretching helped, when she could isolate the muscle. At times she found relief with ice or heat, at other times ice or heat caused more distress. she still had tenderness in the neck, but the pain had dissipated. Adverse events resulted in a visit to the doctors or other healthcare professional office/clinic visit. The patient received ibuprofen and treatment from a chiropractor for the reported events. The clinical outcome of the events extreme pain on left side of neck, pain extended to ear, pain on occasion moved to lower jaw and tenderness in the neck was resolving at the time of this report. No follow-up attempts are needed. No further information is expected.

7/11/21 Awakened by a sharp pain in lower right side at 8 am. increasing gastrointestinal upset throughout the day and into the evening along with an unquenchable thirst despite drinking a lot of water. 7/12/21 mid morning began to experience my allergic reaction to ingesting artificial sugar: metallic taste in mouth, very dry mouth, despite drinking water, tingling of mouth and tongue and subsequent swelling. Skin on lips began to peel off with tongue pressure. a second dose of advair was necessary and I was prepared to use rescue inhaler. some of these symptoms subsided around midnight, which is when i noticed a smell in my nose that was very like nail polish remover. 7/13 skin hyper-sensitive to temperature

severe left sided headache near eye; burning sensation throughout my body; severe ringing in ears; This is a spontaneous report from a contactable consumer, the patient. A 61-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8730), via an unspecified route of administration in the left arm on 25Mar2021 at 09:30 (at the age of 61-years-old), as a single dose for COVID-19 immunisation. Medical history included obesity, vertigo, IBS and SVT. The patient did not take any concomitant medications within two weeks of vaccination. The patient was allergic to latex and cayenne pepper. 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 4 weeks prior to the COVID vaccine. On 25Mar2021 at 09:35 (within first 5 minutes post-vaccine), patient experienced burning sensation throughout body which resolved; severe left sided headache near eye on 25Mar2021 at 09:45; and 3 days later, on an unknown date in Mar2021 severe ringing in ears. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive treatment for the reported events. The clinical outcome of the events burning sensation was not resolved (also reported as resolved on an unknown date), while of headache and ringing in ears was not resolved at the time of this report. No follow-up attempts are needed. No further information is expected.

I had a low fever, severe chills, pink eye, tiredness, dry skin, hair loss, sore throat, dizziness, mental fatigue, extra dry lips--lasted 24 hours and required a day off work. I experienced the same symptoms exactly (timing, duration, and severity) after the second dose on 05/21/2021 (also Pfizer, Lot EW 0178) AND after my "immunity day" of 06/04/2021. I was very surprised at the third instance, but my work supervisor, who took the same brand of vaccine with similar timing and at the same Fairgrounds, had the same thing happen.

I've had minor and easily manageable tinnitus in the past, usually not even noticeable. I had been extremely excited to get the vaccine. Unfortunately, about 2 weeks after the 1st Pfizer vaccine, I started having tinnitus very severely. I was desperately trying to find treatments online on Tuesday night April 6 and stumbled across a social media page entitled (Privacy). At the time there were maybe 300 members on that site, which has now been renamed to (Privacy) and has 2,800 members! At that point I knew that that was my issue and decided NOT to get the second shot the next day. It was so severe that I could not risk getting worse. I could not concentrate, could barely sleep, was very tense, etc. After (1) reading that while some people got worse after the second shot, many did not see any change, and (2) since I wanted very badly to be fully vaccinated for ease of travel in the future, and (3) since my tinnitus seemed to improve slightly approximately April 12-16, I went ahead and got the second dose. Since then it got way worse, but then there were better days, too. As I write this on July 16 at around 2:30am, it has been way way worse since approximately July 7th or 8th. The social media page seems to suggest Tinnitus can be affected by diet. I wonder if climate also affects it?? Last week I was in drier climates and I was fine; since my return to my more humid home, it has been the WORST EVER!!

swollen wrists; swollen hands; swollen knees; red hands; severe generalized reaction of significant swelling at all extremities and face; Upset stomach; loose stool; eye burning sensation; skin peeling in both hands; This is a spontaneous report from a contactable consumer, the patient. A 61-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6204) via an unspecified route of administration in the left arm on 10Mar2021 at 14:45 (at the age of 61-year-old) as a single dose for COVID-19 immunisation. The patient had known allergies to some food (beans, pistachios, lactose intolerant), chemicals (in respirators, formol, latex etc), environmental, (dust, pollen, some trees) and medicine (tetracycline). Concomitant medications included claritine (MANUFACTURER UNKNOWN),vitamin C (MANUFACTURER UNKNOWN) and d3 (MANUFACTURER UNKNOWN) since an unknown date for 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 COVID-19 vaccine. The patient experienced red hands, severe generalized reaction of significant swelling at all extremities and face, upset stomach, loose stool, eye burning sensation and skin peeling in both hands on 10Mar2021 at 14:45. The patient experienced swollen wrists, hands and knees after 19 days after the first vaccination on an unknown date. The patient received treatment for the reported events included claritin and benadryl. The events resulted in doctor or other healthcare professional office/clinic visit. The clinical outcome of the events red hands, severe generalized reaction of significant swelling at all extremities and face, upset stomach, loose stool, eye burning sensation, skin peeling in both hands, swollen wrists, hands and knees were not recovered at the time of this report. No follow up attempts are needed. No further information is expected

Tinnitus and partial loss of hearing.; Tinnitus and partial loss of hearing.; This is a spontaneous report from a contactable consumer or other non-healthcare professional (patient). A 61-year-old non-pregnant female patient received first dose of bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; Lot Number: EN6206, Expiry date was not reported), via an unspecified route of administration, administered in left arm on 06Mar2021 11:15 (at the age of at 61-year-old), as single dose, for covid-19 immunization at other facility. The patient's medical history was not reported. The 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. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient has not been tested for COVID-19. Concomitant medications included levothyroxine sodium (SYNTHROID), fluoxetine hydrochloride (PROZAC), bupropion hydrochloride (WELLBUTRIN), oxybutynin, and rosuvastatin calcium (CRESTOR). On 11Mar2021 at 14:00, the patient experienced tinnitus and partial loss of hearing. The events resulted in doctor or other healthcare professional office/clinic visit. The patient received treatment with steroid injection and oral steroids. The outcome of the events tinnitus and partial loss of hearing was not resolved. No follow-up attempts possible. No further information expected. Information on batch/lot number already obtained.

Forehead lips numb; Aches in neck; Aches in shoulders; Forehead lips numb; This is a spontaneous report received from a contactable consumer, the patient. A 61 years-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: ER8732) via an unspecified route administration in the left arm on 25Mar2021 at 14:00 (at the age of 61-year-old) as a single dose, for COVID-19 immunisation. Medical history was not reported. The patient was allergic to naproxen. The concomitant medications included unspecified blood pressure medication, zinc (MANUFACTURER UNKNOWN) and colecalciferol (VITAMIN D3) all taken unknown indication from unknown date. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not tested for COVID-19. On 26Mar2021 at 05:30, the patient experienced forehead lips numb, aches in neck and shoulders. 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 events. The clinical outcome of events forehead lips numb, aches in neck and shoulders were not recovered. No follow-up attempts are possible. No further information is expected.

Ringing in ears; stiff neck; swollen lymph nodes; it is distracting me; This is a spontaneous report from a contactable consumer, the patient. A 61-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: EN6206), via an unspecified route of administration on the right arm on 22Mar2021 at 03:45 (at the age of 61-years-old), as a single dose for COVID-19 immunisation. Medical history included ascending aortic aneurysm. Concomitant medications were not reported. The patient did not have any allergies to medications, food or other products. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 22Mar2021 at 03:45, the patient experienced ringing in ears, stiff neck, swollen lymph nodes and distracting. The patient also reported that ringing started 3 minutes after getting shot and it was distracting her. No therapeutic measures were taken as the result of reported adverse events. The adverse event did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome ringing in ears, stiff neck, swollen lymph nodes and distracting were unknown. No follow-up attempts are needed. No further information is expected.

Tinnitus ringing both ears . Went to my doctors about ringing They told me to get second Vaccine ringing would go away about 6 weeks. Got 2nd vaccine 4/6/21 ringing became worse and my head felt like it wanted to explode.

Site: Swelling at Injection Site-Severe, Systemic: Allergic: Swelling of Face / Eyes / Mouth / Tongue-Medium, Additional Details: patient reports on right arm had swelling as well as right side of face : cheeks, eyes will go to see urgent care

I have had Tinnitus since the age of 22 in my right ear and was able to live with it. After my first injection the tinnitus in creased in tone. But after the second shot the next day it was far worst. My left ear started ringing. The ringing was so loud it was unbearable. Both ears was ringing a different tone. I could not sleep at night, my anxiety increased and I became more depressed.

Approximately 2 days post vaccination individual experienced a sudden onset of headache, felt hot, started sweating then reportedly lost consciousness. During episode bystanders state patients eyes rolled back in her head, she vomited and she urinated on herself. Episode lasted a few seconds and was not followed by a post ictal period. Patient was taken to ER and subsequently admitted for further evaluation.

I can't even see it, my eyes are so bad; I am feeling really achy; This is a spontaneous report from Consumer or other non health professional (patient). A 61-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: 3099, Expiry Date: Unknown), via an unspecified route of administration on arm right on 07Jul2021 (Age at Vaccination: 61 years) as DOSE 1, SINGLE for COVID-19 immunization. The patient medical history was not reported. Other products was reported as no. The patient Concomitant medications were not reported (No, I don't take other medication at all). On 08Jul2021, the patient experienced I am feeling really achy. It was reported that patient stated "Yes, I got shot yesterday and I woke this morning and I am feeling really achy. I know they said that might be some of the side effect, I am just wondering how long it does last?" On an unspecified date, the patient reported that "I can't even see it, my eyes are so bad. I have my glasses on and I can't see it." The outcome of the events was not recovered.

Five weeks after the second dose of the vaccine I had Vertigo. It started after I had the stomach flu or food poisoning. When I returned from the bathroom I could not see and I was very dizzy. I was diagnosed with Benign Paroxysmal Positional Vertigo. I was given some exercises and those helped. It was called the Epley Maneuver. I am still having episodes of positional vertigo if I move suddenly. It has been eight weeks. I have never had any Vertigo before.

Immediately felt dizziness; Lower lip swelling; This is a spontaneous report from a contactable consumer, the patient. A 61-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8737) via an unspecified route of administration in the left arm on 01Apr2021 at 15:15(at the age of 61-year-old) as a single dose for COVID-19 immunisation. Medical history included asthma and COVID-19 on an unknown date in Jun2020. Concomitant medications included lamotrigine (MANUFACTURER UNKNOWN), vitamin d (MANUFACTURER UNKNOWN) and vitamin b12 (MANUFACTURER UNKNOWN) all from an unknown date for an unknown indication. The 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. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 01Apr2021 at 15:15, immediately after the vaccination the patient experienced felt dizziness and lower lip swelling. The events resulted in emergency room/department or urgent care. The patient did not receive any treatment for the reported event. The clinical outcome of the dizziness and lip swelling was recovered on unknown date in Apr2021. No follow-up attempts are needed. No further information is expected.

Numbness and tingling on lips and tongue, fatigue, throat tightening, back of thigh swelling, feverish, and pain. lasted at least 3 days but resolved. All issues completely resolved in a week.

burning on bottom of feet, bottom of hands; pins and needles; numbness on tongue; electric impulses on the top of her toes; tongue she has had burning; This is a spontaneous report from a contactable consumer (the patient). A 61-year-old female patient received first dose of BNT162B2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, solution for injection, Lot number- EWO176, expiration date was unknown) via an unspecified route of administration, in left arm upper shoulder, on 06May2021, (at the age of 61-year-old), dose 1, single, for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Patient had her first shot on 06May2021 and ended up not getting the second because she had weird reactions that have not went away. On 08May2021, patient had burning on bottom of feet, bottom of hands; hands have gotten better and her feet no, pins and needles; it's still there every day, it's persisting; numbness on tongue, also got electric impulses on the top of her toes. Patient clarified that, she has had numbness, pins, and needles, burning on both her hands and feet. On her tongue she has had burning, pins and needles. Her tongue was consistent. Patient called to her internist and he said maybe she shouldn't get the second dose because it sounded like an allergic reaction. No additional vaccines administered on same date of the Pfizer suspect. No other vaccine prior vaccinations within 4 weeks. Patient did not require a visit to emergency room and physician office. Patient did not receive any treatment to the events. Outcome of the events was not recovered. No follow-up attempts are possible. No further information is expected.

After receiving the vaccine a few moments later i instantly started to have this metallic taste in my mouth and that has not gone away since receiving my vaccines. I also was very fatigue the following 3 days after the vaccine. I am a very healthy person and about 2 weeks later I started to feel pain and soreness throughout my body, mostly my joints. It got to the point that I had to visit my chiropractor just to feel a little relief.

Ongoing continuous metallic pasty taste; This is a spontaneous report from a contactable consumer, the patient. A 61-year-old non pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL9262), via an unspecified route of administration in the left arm on 11Feb2021 at 12:00 (at the age of 61-years-old) as a single dose for COVID-19 immunisation. Medical history included seasonal allergies. Concomitant medications included fexofenadine hydrochloride (ALLEGRA), guaifenesin (MUCINEX), montelukast sodium (SINGULAIR) and budesonide (RHINOCORT AQUA NS); all from an unknown date for unknown indication. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: 1384), via an unspecified route of administration in the left arm on 21Jan2021 at 16:00 (at the age of 61-years-old) as a single dose for COVID-19 immunisation and hydrocodone (MANUFACTURER UNKNOWN) on an unknown date for an unspecified indication. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. It was unknown if the patient had been tested for COVID-19 since the vaccination. On 25Feb2021, the patient experienced continuous metallic pasty taste. No therapeutic measures were taken as the result of adverse event. The clinical outcome of continuous metallic pasty taste was not recovered. No follow-up attempts are needed. No further information is expected.

Headache; Rapid heartbeat; Hives on face and neck; Rash on neck; Itchiness; Watery eyes; Extreme dryness on face; Sore arm at injection site; This is a spontaneous report from a contactable consumer, the patient. A 61-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP6955) via an unspecified route of administration in the arm left on 27Mar2021 at 12:00 (at the age of 61-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. The patient did not receive any medication within two weeks of vaccination. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6204) via an unspecified route of administration in the arm left on 05Mar2021 at 14:45 (at the age of 61-years-old) as a single dose for COVID-19 immunisation. The patient was not allergic to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 27Mar2021 at 15:30, the patient experienced headache, rapid heartbeat, hives on face and neck, rash on neck, itchiness, watery eyes, extreme dryness on face and sore arm at injection site. The patient did not receive any treatment for the events. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events headache, rapid heartbeat, hives on face and neck, rash on neck, itchiness, watery eyes, extreme dryness on face and sore arm at injection site were not recovered at the time of this report. No follow-up attempts are needed. No further information is expected.

jaw, gum and teeth pain from 6 pm - continues teeth discoloration noticed 48 hours later - top of teeth are white, bottom of teeth are gray - continues tooth chipping 2 weeks later

Approximately 12 hours after injection, sudden onset headache, went to bed and woke a couple hours later with severe back pain, neck pain, deep muscle ache in legs, low grade fever. 24 hours after injection, some decrease in pain with Tylenol, diarrhea, fatigue, general malaise. Loss of taste, loss of appetite . 48 hours post injection- subsiding muscle aches, other symptoms on going, 72 hours post to present, diarrhea, loss of appetite

Left deltoid was sore initially, then pain progressed upward into left neck up to just under left ear; Left deltoid was sore initially, then pain progressed upward into left neck up to just under left ear; Also felt a little stiffness in that neck area; This is a spontaneous report from a contactable nurse, the patient. A 62-years-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number EH9899) via an unspecified route of administration, in the left arm, on 19Dec2020 at 07:00 AM (at the age of 62-year-old) as a single dose for COVID-19 immunization. Medical history was none. The patient was not pregnant at the time of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medication taken within two weeks of vaccination included fish oil (OMEGA 3 FISH OIL), calcium carbonate, colecalciferol (VITAMIN D 2000). The patient did not receive any other vaccines within four weeks prior to the vaccination. On 20Dec2020, at 08:00 AM, the patient experienced left deltoid was sore initially, then pain progressed upward into left neck up to just under left ear, she also felt a little stiffness in that neck area. The neck pain lasted 24 hours. The events were reported as non-serious. The patient did not receive any treatment for left deltoid was sore initially, then pain progressed upward into left neck up to just under left ear, she also felt a little stiffness in that neck area. The clinical outcome of the events left deltoid was sore initially, then pain progressed upward into left neck up to just under left ear, she also felt a little stiffness in that neck area was recovered. It was also reported that since the vaccination, the patient had not been tested for COVID-19.

6 to 7 minutes after vaccine felt flu like symptoms then could taste medicine. Breathing seemed to slow down, blood pressure went to 140/90 and always have low blood pressure then tongue felt numb. I work at a hospital so they took me to the ER

Five minutes after vaccine patient had itchiness around eyes, itchy throat and mild shortness of breath. Later, patient reported swelling around eyes and lips.

1/2/21- 1/5/21 Fever, chils, arthralgias, swollen throat, nausea, BLURRY VISION, RED eyes, white noise in ears, fatigue lacinating pain ankles, knees ,wrist and finger joints; pain along nerves and vessels fingers with right fourth DIP ulnar side small vessel bleed hematoma 4 cm x 4cm swelling; NO trauma sedenatry Saw Urgent care 1/4/21 -with negative covid 19, strep and flu tests said was repsonse to vaccine Saw primary 1/5/21 Dr hopsital, said probably had covid before and was repsonse to vaccine. 1/6/21; all fingers still swollen no pain most other symptoms improving but TIRED

46 hours after receiving vaccine, experiencing twinges of moderate to severe headache and/or ear pain left side, similar to symptom experienced when I contracted Covid in Mar2020; 46 hours after receiving vaccine, experiencing twinges of moderate to severe headache and/or ear pain left side, similar to symptom experienced when I contracted Covid in Mar2020; This is a spontaneous report from a contactable healthcare professional, the patient. A 62-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot EK5730) solution for injection in the left arm on 30Dec2020 at 13:15 (at the age of 62-years-old) as a single dose for COVID-19 vaccination. The patient was not pregnant at the time of vaccination. Medical history included COVID-19 in Mar2020. Concomitant medications included atorvastatin, colecalciferol (VITAMIN D) and cetirizine. The patient no known allergies to medications, food, or other products. The patient did not receive any other vaccine within 4 weeks prior to the vaccine. Prior to the vaccination, the patient was diagnosed with COVID-19 in Mar2020. On 01Jan2021 at 10:30 (about 46 hours after receiving vaccine), the patient experienced twinges of moderate to severe headache and/or ear pain left side, similar to symptom experienced when I contracted Covid in Mar2020. No treatment was provided for the events ear pain and headache. The outcome of the events ear pain and headache was unknown. Since the vaccination, the patient has not been tested for COVID-19.

10:23pm felt a slight headache and nausea. Left work at 10:43pm since didn't feel good. While on road, my tongue started to tingle and then my lips started to tingle and both sides of face felt numb. This started around 10:50pm? Went to bed and woke up Sat with same tongue, lip tingleling and face numbness. Lips felt very swollen. Felt that way throughout the weekend. On Monday, went back to work place injection area and requested someone talk to me. Nurse practioner came out and spoke to me, asked about balance of facial features, no problem breathing or swallowing and gave me 25mg benadryl to take 3 times a day. Did nothing but make me sleepy. She calls me Tue am and told me to make an appt with PCP. Made phone appt for Wed. Dr calls me Wed am and gives me presciption for 60mg Prednisone to take for a week (at this time symptoms are the same). the first 3 days taking Prednisone the intensity of tingleling seems to lessen day by day. But on 4th day, the symptoms stopped lessening. Finished the meds anyway. Last 3 days, i've also had that mild headache back in addition to the numbness from face traveling up to my ears. Past few days the tingling in tongue isn't confined to just the edges of the tongue. It started with the first 1/4 of whole tongue and is today tingleling in the front half of whole tongue. One good thing so far is the past few days, my lips feel way less swollen and tingleling is lessening. So, riding this out, hoping it will end sometime this year. Will not be getting the second shot. Just so you know.

Confusion, Headache, Myalgia, fatigue, chills Narrative: Felt "loopy" with sharp vision initially. Over 3 day period developed varying degrees of chills, headache, muscle aches. Fatigue on first day.

Early morning Friday 01/08/21, moderate pain at injection site, PO Tylenol 1000mg, @ 0615, heading into work. Then @ 1030 feeling tired, neck & shoulder pain, chills, headache, right ear pain, slight sore throat, PO Motrin, 400mg moderate relief. Total of 30 hrs of recurring symptoms, alternating Tylenol & Motrin throughout. Started to feel better Saturday afternoon 4-4:30p

Patient reports she received the Covid-19 vaccine at 0835. She reports at 0905 symptoms of tingling at the tip of the tongue. No other symptoms, no respiratory distress. SP02 = 99%, P = 75, B/P = 141//85.   0910, tingling of tip of tongue continues but has not increased, no respiratory distress, no other symptoms. SP02 =100%, P = 72, B/P = 132/88. Rapid response team called.   At 0915, tingling of tip of tongue continues but has not increased, no respiratory distress, no other symptoms. SP02 = 100%, P = 74, B/P = 130/83.   At 0920 Rapid Response Team arrived. Care of pt. transferred to RRT. RRT talking with pt. regarding transfer to ED vs. discharge home Patient reports she received the Covid-19 vaccine at 0835. She reports at 0905 symptoms of tingling at the tip of the tongue. No other symptoms, no respiratory distress. SP02 = 99%, P = 75, B/P = 141//85.   0910, tingling of tip of tongue continues but has not increased, no respiratory distress, no other symptoms. SP02 =100%, P = 72, B/P = 132/88. Rapid response team called.   At 0915, tingling of tip of tongue continues but has not increased, no respiratory distress, no other symptoms. SP02 = 100%, P = 74, B/P = 130/83.   At 0920 Rapid Response Team arrived. Care of pt. transferred to RRT. RRT talking with pt. regarding transfer to ED vs. discharge home

Red rash and itching in 4 inch circumference around injection site that lasted 4 days. Sudden onset of runny nose and itching of eyes.

some memory loss; locked jaw/unable to open mouth; her arm hurt; pain went in her jaws; she was really scared; Excruciating pain on left ear; swelling in arm; This is a spontaneous report from a contactable other healthcare professional. A 62-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Batch/lot number: ES1685, Expiry date: 01Mar2021) via intramuscular (left deltoid) on 28Dec2020 at single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. She stated she is very healthy and don't have any medical conditions. She further stated that it was a scary moment, she don't want to take any chances, she was really frightened (28Dec2020). She made a complaint to let know her experience with the vaccine. Her cousin took the vaccine and told her she needed to report these events. The patient stated she experienced side effects after the first dose of the vaccine: Excruciating pain on left ear, locked jaw, her left upper arm was hurting on 28Dec2020. The pain went in her jaws and she was unable to open her mouth on 28Dec2020. She took 2 Benadryl and it relieved her. She saw on television if you experienced any side effects to take Benadryl. She also took Tylenol for the pain. She also had swelling in arm on an unspecified date in Dec2020. She also experienced some memory loss described as short-term memory loss on 30Dec2020. She stayed in bed after the vaccine, she was really scared, and stated she had memory loss and she don't have any memory problems. She was unable to remember if her car was black. She was looking for a white car. She drives a black car. She stayed in bed all day on Tuesday. Patient was asking what will happen if she does not take the second vaccine. The same morning while she was waiting to get the vaccine, a co-worker sent her a video of a woman who had received a COVID vaccine. She does not know which one. The woman experienced Bell's Palsy. The woman was crying and her face was turning side ways. She stated some people were talking negatively about the vaccine. She stated doesn't want her face to be deformed. She stated what are the cons of not taking the second vaccine. Reporter assessed the events as non-serious. Outcome of the events some memory loss and locked jaw/unable to open mouth was recovered on 30Dec2020, outcome of the events excruciating pain on her left ear, pain went in her jaws, her arm was hurt was recovering. Outcome of swelling in arm and she was really scared was unknown.

20 mins later numbness in face a head. Blood vessel popped in right eye. Dizziness feeling out of sorts. Feels like flu shot.

During administration of vaccine pt became dizzy and faint. Pt was able to go to the observation area, waited approximately 15 mins and then reported chest tightness, dizziness, rash and itching on her arms, fast heart rate, watery eyes, runny nose, and throat irritant. Vitals were obtained and pt was requested to wait another 15 mins for monitoring. During monitoring period, patient became to complain of increased throat irritation and new tongue swelling. Response team was contacted. During reassessment patient's symptoms decreased. Team decided patient was stable and did not require transport to the ED. Patient was monitored for another 15-20 minutes with symptoms resolving. Patient was advised to discuss reaction with her PCP prior to getting second dose of the vaccine.

Approximately 20 minutes after vaccine administration, patient reported feeling swelling of throat and tonsils. Patient did sip water and was verbally communicative and was texting on phone with pale, anxious appearance with not obvious shortness of breath noted. 911 was called to Center per vaccine clinic protocol at which ems initiated IV and took patient to ED.

C/O ITCHINESS AROUND MOUTH. OBSERVED X15 MINS. STATES FEEL BETTER AND REFUSED ER EVAL. TOOK BENADRYL AND WENT HOME WITH RELIEF. VITALS STABLE. O2 SAT 98%

Tight sensation in her throat, tongue felt tingling. Temp increased to 99, blood pressure increased to 179/99

Almost immediately after the injection, I noticed a metallic taste. It was mild enough that it did not interfere with the taste of foods or drinks. It was noticeable whenever I had not had anything by mouth for a while. This lasted for 2 to 3, maybe 4, days. Soreness at the injection site, and stiffness of the arm, began the evening after the injection. Warming applications and moving the arm relieved these symptoms. They were gone the next day.

WARM FEELING IN CHEST AND THROAT DENIES ANY DIFFICULY SWALLOWING. HAPPENED 5 MINUTES AFTER INJECT. BP RANGING 140/60, O2 100. OBSERVED FOR 25 MINUTES. SYMPTONS REMAINS THE SAME SENT TO ER FOR FURTHER OBSERVATION.

62 y.o. female who was seen at COVID Vaccine Clinic today for her first dose of the COVID 19 vaccination. She denied any history of previous adverse reactions to vaccines. She was given the Pfizer vaccination in the left deltoid muscle. During her 15 minute waiting period after the injection, the patient began to experience funny taste in her mouth (somewhat metallic like). She denied rash, hives, welts, difficulty breathing, difficulty swallowing, wheezing, throat tightness, hoarseness, stridor, itching, lightheadedness, dizziness, facial swelling, lip swelling and tongue swelling. This provider was notified of patient reaction and she was then assessed in the emergency bay area. Monitored patient for severe reaction symptoms, including but not limited to abdominal pain, blood pressure abnormality , chest pain, collapse, drooling, hypotension, increased swelling, rapid progression of symptoms, respiratory distress, skin changes, tongue swelling and vomiting. ALLERGY REVIEW OF SYSTEMS Previous Reactions: This is patient's first vaccine (Pfizer). Does report previous reaction to influenza vaccine many years ago, states it caused her to get really sick. Objective Vitals Vitals: 01/15/21 0932 BP: (!) 145/83 Pulse: 76 SpO2: 98% Physical Exam Constitutional: General: She is not in acute distress. Appearance: Normal appearance. She is not ill-appearing or diaphoretic. Cardiovascular: Rate and Rhythm: Normal rate. Pulmonary: Effort: Pulmonary effort is normal. No respiratory distress. Neurological: Mental Status: She is alert. Assessment/Plan Treatment included: antihistamines. Follow up response to treatment: good. Patient discharge: Stable to go home and follow up with PCP. Patient doing well upon discharge. Reports some improvement in change in taste prior to discharge/leaving. She was escorted out via wheelchair only due to reports of difficulty ambulating long distances due to being disabled but is otherwise at baseline.

Advised received first covid vaccine 12/21/2020 w/o issues. Received 2nd Pfizer vaccine on 1/11/21. Within minutes her tongue was tingling with sensation of feeling full-felt funny. 30 min later had frontal/jaw headache. 60 min later chills with goose bumps all over while working (works as resp technician at NMCP). While walking to car, her upper arm and front of thighs hurt as if exercised too much. Self treated with Advil and tylenol. --- Next day 1/12 0100am awoke with severe bilateral shoulder joint pain extending to shoulder blades, stabbing abdominal/stomach pain, nausea, urge to vomit. she returned to sleep but awoke 6am with nausea and severe diarrhea and fatigue. She c/o nasal congetion, sinus fullness and severe post nasal drip x 24 hours. S/s persisted and left work early now with severe bilateral ankle pain. She was off Wed/Thursday. Wed 1/13 her shoulder pains eased but now with severe back pain. Wed evening noted tongue swelling sensation again (has pictures) and took oral benadryl and ice chips. She went to sleep. Thursday 1/14 bilateral knee pain/joint with increased nausea again - treated with zofran. Friday 1/15 returned to work, pain in knees made gait wobbly = treated with advil. Notified ID MD and director on tongue swelling and constantly trying to clear throat = sent to ER where treated with oral decadron and M Toradol for pain. She was sent home with prednisone dose pack and compazine. Recommended f/u with HCP for further testing to r/o possibility of a mast cell disorder of familial hypertrytassemia due to her history of multiple allergies/insect allergies--

Vaccine administered at 8:43am; t 8:58, Associate complained that her lips felt tingly. Associate was provided Benedryl 25mg po at 9:05 am; associate verbalized relief of tingling symptoms at 9:30; Assoc was released to home; Vital signs were taken; BP 137/80, 97% Spo2, Heart rate 80; vital signs were obtained after Benedryl administered.

Left sided facial neuropathy, cheek, nose, ear and tingling lips; Left sided facial neuropathy, cheek, nose, ear and tingling lips; This is a spontaneous report from a contactable Other HCP. A 62-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), lot EL3246, intramuscularly on 05Jan2021 16:00 at single dose for covid-19 immunisation. Medical history included arthritis (degenerative arthritis). There were no concomitant medications. Anatomical Location: Arm Left Facility location: Hospital. The patient did not eceived any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced left sided facial neuropathy, cheek, nose, ear and tingling lips on 05Jan2021 16:45 with outcome of not recovered. The action taken was not applicable. No treatment received; Sender's Comments: Based on the information available, a possible contributory role of the suspect products cannot be excluded for the reported events due to temporal association. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators as appropriate.

Left sided facial numbness mildly affecting left lip, cheek and area around left eye. Lasted less than an hour. Continued symptoms 48 hours after vaccine are moderate persistent headache, moderate fatigue. Feeling of not well. taking tylenol.

Loss of taste - things don't taste normal; Loss of taste - things don't taste normal; This is a spontaneous report from a contactable nurse. A 62-years-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), lot number=EK9231, intramuscular in right arm on 07Jan2021 at 08:45 (at the age of 62 years-old) as a single dose for COVID-19 immunization. The vaccine was administered at a hospital. There was no medical history. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medication included duloxetine (DULOXETINE), naproxen (NAPROXEN), ergocalciferol (VIT D). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received medications within 2 weeks of the vaccine. On 08Jan2021, at 9:00, the patient experienced a loss of taste - "things don't taste normal". The patient was not hospitalized for the event nor received treatment. The clinical outcome of the events of loss of taste – things don't taste normal, was not recovered. Since the vaccination, the patient has not been tested for COVID-19.

tongue itching; lips itching; face feels flushed; left hand is tingling or numb (the palm)/left hand that's puffy and tingling; left hand is tingling or numb (the palm)/left hand that's puffy and tingling; left hand is tingling or numb (the palm)/left hand that's puffy and tingling; palm of left hand was itchy; inside of nose; it feels like someone is pinching nose/It's swelling; inside of nose; it feels like someone is pinching nose/It's swelling; face has a rashly feeling; This is a spontaneous report from a contactable consumer reported for self. This 62-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number unknown) via unspecified route of administration on an unspecified date at single dose in left arm for COVID-19 immunisation. The patient medical history and concomitant mediations not provided. The patient reported that she had the vaccine at her work, waited 15 minutes and left the clinic. About 20 minutes then, her tongue was itching, lips were itching; face felt flushed. Face had a rashly feeling. Her left hand was tingling or numb (the palm). Her palm of left hand was tingling and itchy. The inside of nose; it feels like someone is pinching nose. It was swelling. The patient stated "Whenever I get stung by bees, this is how I feel". The patient stated that it was mild. She stated she was having a reaction, but not severe enough maybe it will subside. Her left arm is where she got the injection and it was left hand that was puffy and tingling. The patient stated that she also had N95 mask on and she guess she get that reaction from it. The patient stated that she was just wondering what she should do, if she should just go by some diphenhydramine hydrochloride (BENADRYL). The outcome of events was not reported. Information about lot/batch number has been requested.

Felt itchy and shaky after vaccine. Left after 30 min. She later developed hives and was seen at ED. Per ED notes, approx 1 hour after vaccine, she developed mild erythematous rash over upper chest/ collarbone region. Slightly itchy. She took benadryl PO x 1 with resolution of itching and rash within 1-2 hours. Patient has noted she is needing to clear her throat more often, feeling like it is "a little mucousy". She does not have a frank cough. She denies SOB, chest pain, difficulty breathing, stridor, wheezing or nasal congestion. She does not feel her mouth, lips, face or tongue are swollen. She has no difficulty swallowing. She denies abdominal pain, vomiting, and diarrhea. Denies myalgias, headaches, chills or fevers at this time. Discussed can use additional antihistamine as needed for further rash. Does not need epi IM at this time. Reviewed common side effects for 2nd vaccine to expect in next 24 hours. Reviewed elevated BP and asked to recheck at PCP or next medical visit to monitor for possible hypertension

Patient was given the Pfizer vaccine at 9:27 on 01/21/21. At about 5 minutes post vaccine she was noted to have some throat clearing but denied any concerning symptoms. At 9:40 she began experiencing fluttering in her chest and at 9:41 she was noted to have some chest tightness and wheezing. She was given Benadryl 50 mg oral at 9:42 but then symptoms began to progress and she started to have angioedema of her upper lip and her hands/arms started itching and she was noted to have some early hives. Epipen 0.3 mg was given at 9:45. She continued to have some swelling of her upper lip and chest tightness and soulmedrol 125 mg IM was given at 9:49 and then she was placed on O2 via NC at 2 L. At 9:50 she stated that her throat swelling was starting to improve and her chest tightness and wheezing was getting better. EMS arrived at about 9:51 and report was given and care turned over to them. They left the clinic at 10:00 without further incident.

A little over 12 hours after receiving my 2nd dose at 8:42 am, I woke up at approximately 11:15 pm to find that my tongue and throat were swelling. I immediately took 1 25mg benadryl and went to the Emergency Room (ER). After many questions and examination of my mouth. I was given another benadryl, prednisone, and famotidine. I waited and was observed for approximately 2.5 hours in the ER. At that time it was obvious that the medication was effective and I was comfortable leaving the ER to return home. I had prescriptions for more prednisone and famotidine to take for 5 days. On Wednesday, I felt well enough to go to work at my school, though I did light duty. On Thursday, I was also at school and also attended a physical therapy session and exercise class. I talked at length with my PT about my experience and she could tell that I was feeling good (presumably from the prednisone) and cautioned me about not overdoing things during exercise. I felt like my tongue was beginning to swell and the PT mentioned that my words sounded a bit funny (she was the only one to comment on this). I then went to dinner at my daughters house and began to feel tired from the benadryl. Upon arriving home and getting ready for bed, my husband and I both noticed how flushed my chest and face had become during the day. My throat and tongue were still somewhat swollen and my throat was beginning to hurt. During the day on Thursday, I had registered with the local Covid information website and had received an email stating that I should feel free to call the triage phone number if I needed. At approximately 9:45 pm I called and talked with a nurse who urged me to return to the ER because of the flushing and continued swelling. In the ER I was seen by a different doctor who was concerned not so much about the swelling, but about the white streaks in my throat and had me swabbed for strep throat. That test was negative. He said he had read my chart from Tuesday night and felt that the medication that had been prescribed was appropriate and that he didn't feel anything needed to be changed. He asked about how bad my throat felt and wrote a prescription for Magic Mouthwash and I asked for an EpiPen, which he also prescribed. We arrived home at approximately 12:00 am, but it was still difficult to lie down and sleep. I had already decided that I would not go to school on Friday and stay home and rest. I needed to pick up my prescriptions when the pharmacy opened and I ran a few other errands while I was out, but returned home and slept most of the afternoon. I have not been very energetic this evening, but decided that I wanted to get this form filled out. At approximately 10:00 PM on Friday evening, I hope that I am able to sleep better than I have the last several nights.

Within 10 min after injection had pain in left side of neck and jaw. was given 800mg Ibuprofen and took for a few days. On Jan 6, 2021 supraclavicular swelling occurred near base of neck size of a baseball and lt neck pain. Saw physician on 1/8/21 and have soft tissue swelling

BP at 179/99; Tongue felt tingly; felt a tight sensation in her throat; Temp elevated at 99; This is a spontaneous report from a contactable other HCP. A 62-year-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EZ9231), intramuscular in left arm on 13Jan2021 10:15 at a single dose for COVID-19 immunization. Vaccination was done in a hospital. The patient had no covid-19 prior to vaccination. The patient's medical history and concomitant medications were not reported. The patient previously received the first dose of bnt162b2 on an unknown date COVID-19 immunization. On 13Jan2021 10:15, the patient experienced tongue felt tingly, felt a tight sensation in her throat, temp elevated at 99, BP at 179/99, and HR 62. No hives, no wheezing, and no angioedema. The events recovered on an unknown date in Jan2021. The patient received Benadryl 50 mg as treatment and had ice pack behind neck, laid down for 30 mins. The patient was not tested for COVID-19 post vaccination. Information about batch/lot number has been requested.; Sender's Comments: Based on the time association, the possible contribution of suspect BNT162B2 to the event blood pressure increased 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.

experience funny taste in her mouth (somewhat metallic like); This is a spontaneous report received from a non-contactable other healthcare professional. A 62-year-old female patient received the first dose of BNT162B2 (BNT162B2 PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK9231, expiry date: unknown), via an unspecified route of administration, on an unspecified date, at single dose, for COVID-19 immunization. Medical history included ongoing disability and gait disturbance (difficulty ambulating long distances due to being disabled). The patient's concomitant medications were not reported. During the patient's 15-minute waiting period after the vaccination, the patient began to experience funny taste in her mouth (somewhat metallic like). Treatment included antihistamines (unspecified). The response to treatment was good. The patient was doing well upon discharge/leaving. She was escorted out via wheelchair only due difficulty ambulating long distances due to being disabled but is otherwise at baseline. The outcome of the event was recovering (reported as "reports some improvement in change in taste prior to discharge/leaving"). The reporter assessed this case as non-serious. No follow-up attempts are possible; information about lot/batch number cannot be obtained.

approximately 10 minutes after receiving vaccine patient complained of fullness in throat and difficulty swallowing, also felt tremulous and like heart was racing, some visible swelling of lower lip, initial vitals revealed pulse ox of 99, bp 151/70 and hr of 107, lungs clear without wheezing, no urticaria, given 25mg po Benadryl with gradual resolution of symptoms and normalization of vital signs

approx. 15-20 min after vaccine admin, pt c/o "ha, fatigue", evaluation by EMT, vs 158/86 100, spo2 97, p=101, pt reports that this bp is "normal for her", she remained alert aned oriented, progressed to feeling "flushed from head to waist", at 5:05 pm, pt feels that these s/s r/t "very busy all day,this is the first time I have sat down all day", bp 168/95, 103, spo2 96, cool pack applied to back of neck, pt reports increase in feeling , "flushed", 1720- pt c/o "my neck feels swollen, my jaw hurts", denies shortness of breath, or chest pain, no hives observed on head, or abd, pt agrees to more advanced eval at ER, husband notified, 1730, pt experiences dry heaves, no emesis, bp 179/109, Ambulance called to transport to ER, IV initiated by EMT, 1740, pt to stretcher, with ambulance crew, report given, pt continues to deny shortness of breath, and chest pain, she remains alert and oriented.

Early afternoon - Tiredness- 7-8 pm Fever of 99; Muscle/joint aches/pains; Upset stomach; stuff nose Later in evening - hives Next morning - swollen lip on left side (had derm filler on 1/21/2021) Took Tylenol and Benadryl

I had to get cleared by a allergist prior to getting the vaccine due to my prior history allergy history. I was advised by the allergist to take Allegra an hour before receiving the vaccine. About 10 minutes after receiving the vaccine, I started to throat my started to feel dry and tickling, it felt like it swelling starting from the left side to the center, I started having difficulties swallowing my salvia and any fluid. My blood pressure was checked and it was elevated. I started to have difficulty breathing. They transferred me over to the ER. They gave me IV medicines Benadryl, Prednisone, Pepcid (I think). After 6 hours I was able to go home. Everything went back to normal besides the pain in the left arm at injection site. I had a telemedicine visit today with my primary care physician to follow up.

(Friday)Immediately after the injection-dizziness, vertigo, tunnel vision, blurred vision, pin point pupils, unable to talk, headache, facial and lip numbness, numbness traveled down the right side of my body (side of injection) trembles, weak legs, very weak all over. EMTs were called but I didn't go to the hospital. My son picked me up and took me home because I was unable to drive. On the way I experienced loss of vision and speech for about 5 minutes. When I got home, my legs were so shaky that I had to have help walking. I started getting severe chills that took 3 hours to get warm (2 heavy blankets, space heater, and heating pad). I was very fatigued and felt bad the rest of the day. (Saturday)The next day I had flu-like symptoms; headache, joint aches, chills, nausea, extreme fatigue. Sunday was better but still had to rest most of the day because when I would stay up for over 30 minutes, the symptoms would return. Monday- stomach cramps, headache, fatigue but went to work (30 minutes late due to stomach) and left 30 minutes early.

pressure across chest; eyes were very swollen; flu symptoms; severe aches/ Pain radiated bilaterally up neck, mandibular area, trigeminal and into head; abdominal pain; nausea; Injection site very painful, could not touch; This is a spontaneous report from a contactable nurse reported for herself. This 62 Years old patient (not pregnant) received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via intramuscular on 12Jan2021 13:15 on Arm left at single dose (Lot # EL0142) for covid-19 immunisation. Medical history included hashimoto disease, allergies to maxide. Prior to vaccination, was the patient did not diagnose with COVID-19. Concomitant medications included levothyroxine sodium (SYNTHROID), valsartan, Pravastatin, docusate sodium (COLACE), wool fat (EUCERIN) and Vitamin D Nos. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via intramuscular on 22Dec2020 13:15 on Arm left at single dose (Lot # EK5730) for covid-19 immunisation. The patient woke up 13Jan2021 at 2:00 AM with flu symptoms - severe aches, abdominal pain and nausea. By 13Jan2021 4:30 eyes were very swollen. Slept 14 hours. Next night 14Jan2021 at 1AM, severe arm pain radiating across chest to other armpit - pressure across chest. Pain radiated bilaterally up neck, mandibular area, trigeminal and into head. Injection site very painful - could not touch in Jan2021. As the pain at injection site subsided - so did the symptoms. Events were non serious. No treatments were received. On 15Jan2021, laboratory details included nasal swab which showed negative. Outcome of the events was recovered.

Numbness noted right side of upper mouth /progressed to numbness of mouth/lips; Mild lip swelling; This is a spontaneous report from a contactable nurse (patient). A 62-year-old female nurse (not pregnant) received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number: EL3246) at right arm via an unspecified route of administration on 14Jan2021 16:15 at single dose for COVID-19 immunization. Medical history included none. Concomitant medications included unspecified medications. The patient previously received the first dose of bnt162b2 (lot number: EH9899) at right arm via an unspecified route of administration on 21Dec2020 18:15 at single dose for COVID-19 immunization. The patient experienced numbness noted right side of upper mouth day after 2nd injection on 15Jan2021 16:00. It has progressed to numbness of mouth/lips 5 days post injection. Mild lip swelling on 15Jan2021 16:00. No difficulty breathing etc. Very noticeable with eating and talking in appearance like she have been to the dentist and given novocaine. The adverse events resulted in doctor or other healthcare professional office/clinic visit. It was unknown if treatment received. The reporter considered the events were 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. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient was not pregnant at the time of vaccination. The outcome of the events was not recovered.

Within 15 minutes of receiving the injection, I began with a tingling sensation in my lower lip. Within 3 minutes, the same sensation began in my upper lip. The tingling became more intense and then my lips began to swell. My BP was taken and was 170/100. I was given 25 mg of Benadryl orally and closely monitored for approximately 1 hour. The tingling in the lips and the swelling subsided within 45 minutes to an hour and my BP dropped to 140/82 when I left to go home. The following day, I began to experience fatigue and a headache. The fatigue and headache (which was only slightly relieved with 1000mg. of Acetominophen) lasted for 3 days and then all symptoms completely subsided.

Dizziness; nausea; headache; constant eye and nose drain; constant eye and nose drain; burning eye and nose; burning eye and nose; weakness; tiredness; sore lips and throat; sore lips and throat; sore on tongue; chest tightness; This is a spontaneous report from a contactable consumer reporting for herself. A 62-year-old female patient received the 1st dose of bnt162b2 (BNT162B2) at single dose at left arm on 14Jan2021 11:30 for Covid-19 immunisation, administered at hospital. Medical history included hypertension, high cholesterol, diabetes mellitus, allergies penicillin. Patient was not pregnant at the time of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medication within 2 weeks of vaccination included atenolol (manufacturer unknown), losartan (manufacturer unknown), atorvastatin (manufacturer unknown), hydrochlorothiazid (manufacturer unknown). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 15Jan2021 07:00 the patient experienced dizziness, nausea, headache, constant eye and nose drain, burning eye and nose, weakness, tiredness, sore lips and throat, sore on tongue, chest tightness. The patient underwent lab tests and procedures which included Sars-cov-2 nasal swab test: negative on 19Jan2021. The outcome of all events was not recovered as all ongoing now for 1 week. The events were considered non serious. Information on the lot/batch number has been requested.

101.5 fever for approx. 30 hours; severe headache with light sensitivity for days 1-5; severe headache with light sensitivity for days 1-5; muscle cramps; joint pain; nausea; extreme fatigue lasting several days.; This is a spontaneous report from a contactable Other Health Professional (HCP) (patient). A 62-year-old female patient (pregnant: No) received the second dose of BNT162B2 (COVID-19 MRNA VACCINE BIONTECH, Lot number: EL0140), via unspecified route of administration on left arm on 12Jan2021 at 10:00 AM at single dose for covid-19 immunisation. The relevant medical history included Rheumatoid Arthritis, Asthma, Hypertension, Multiple allergies, Peripheral Neuropathy, degenerative disc disease, known allergies: Sulfa drugs; Tetracycline; Nsaids; Aspirin; Ioxinol; multiple pollens & molds; capsicum, peppers, black tea, black cohosh, and more. Concomitant medications included valsartan (DIOVAN), adalimumab (HUMIRA), leflunomide, hydroxychloroquine phosphate (PLAQUENIL), montelukast sodium (SINGULAIR) and levocetirizine dihydrochloride (XYZAL). The patient previously received first dose of BNT162B2 at the age of 61 years old on 22Dec2020 (first dose, Lot number: EL1283, 03:00 PM, Left arm) for covid-19 immunisation. The patient experienced 101.5 fever for approx. 30 hours; severe headache with light sensitivity for days 1-5; muscle cramps, joint pain, nausea, and extreme fatigue lasting several days on 12Jan2021 at 04:00 PM. No treatment received for the events. No covid prior vaccination and no covid tested post vaccination. The outcome of the events was recovering.

Called PCP, from the note: I got my shot on Jan 19. But last Friday I have been down with a horrible flu. I'm wearing diapers because of uncontrollable diarrhea. I can't leave my sofa to walk over to my desk because I'll be so out of breath. I have a cough that produces a pink or gold Phelm I have dry mouth. I have no appetite I'm so weak and have lost 15 pounds. Don't know what to do. My next Covid is shot is feb 11 Called employer on 2/3/21 but hung up. Tried calling multiple times to follow up. In triage she stated she had a COVID test scheduled and had spoken with her PCP. COVID test through PCP: 2/4/21 She passed away the night of 2/4/21

SENSATION OF BURNING OF TONGUE, LIPDS, THROAT AND NOSE WITH PAIN. EXAM FAIRLY BENIGN, NO OBVIOUS ABNORMALITIES OTHER THAN MILD GLOSSITIS. TREATED WITH ANTIFUNGAL AND ANALGESICS

I have been having ringing in my ears that started on 1/31/21. I have had a slight issue with tinnitus but what I am experiencing right now is considerably worse.

Pt c/o heavy tongue, this RN immediately took the pt for further evaluation. BP 140/90, O2 92%, HR 100, Lung field diminished, HX COPD, pt states she was "joking" pt walked out the building and stated she was feeling better. Supervisor present during the assessment. pt stated getting dry mouth with meds. Pt refused to stay. Instructed to call PCP or go to ER if symptoms worsen. Pt denies SOB or any other symptoms. Stated she was feelin well and walked out as I watched her

Pt. received vaccine at 1805 and Pt. came to RN stating she felt heart racing at 1828. RN took patient to sit in observation area. Asked if any trouble breathing, stated no. RN noted patient with flushed face and red sclera. Patient placed on monitor with HR in 113, oxygen saturation 97% and blood pressure 186/108. Oral benadryl given at 1832 with water. Patient continue on monitor with HR in 107, at saturation 97% and blood pressure 186/103. 911 called at 1835 due to blood pressure issue and cont. flushed. EMT arrived 1842 and took over care. Pt. EKG done by them and then taken to ER at 1900.

Developed typical flu symptoms but developed severe incapacitating migraine/nausea/photofobia/vertigo. Felt feverish but no temp. Severity so bad almost went to ER. Took Imitrex x2 with chest tightness occurring after 2nd dose. Lasted x3 days then pressure on right side of head eye for a month. Elected not to do 2nd shot due to above s/s.

16% loss of hearing; Fullness in ear on the injection side (left); This is a spontaneous report from a contactable consumer. A 62-year-old non-pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL8982), via an unspecified route of administration on 13Jan2021 at 11:30 at a single dose on left arm for COVID-19 immunisation. Medical history included breast cancer, lymphedema (right arm) and asthma from an unknown date and unknown if ongoing. Concomitant medications included montelukast sodium (SINGULAIR). The patient experienced 16% loss of hearing and fullness in ear on the injection side (left) on 14Jan2021 at 17:00. The patient underwent lab tests and procedures which included acoustic stimulation tests: 16 % (16% loss of hearing) on 14Jan2021. Therapeutic measures were taken as a result of 16% loss of hearing and fullness in ear on the injection side (left). The outcome of the events was not recovered.

Woke up one morning w/pain/ache in left lower jaw/back teeth, especially w/opening my mouth. Chewing on back molars hurt. As time went on pain worsened and radiated into my cheek, left eye and left ear. ~ One week later, I saw a dentist; he couldn't say whether it was TMJ or tooth problem, so sent me home w/quick splint to separate my top & bottom teeth at night and some exercises. These didn't help, so ~ a week after that, he gave me antibiotic. No improvement in symptoms until ~ a week after that. I saw pcp, as it felt like something was crawling inside my left ear. Ears were fine; she agreed w/inconclusive answer of dentist - at this point, there was some improvement in my symptoms. She suggested prescription-strength Naproxen for 10 days, which I did. the pain/ache has been mostly gone since completing the Naproxen. For last few weeks, I've been back to normal - no ache/pain/strange sensations in ear at all.

Patient received second dose of Pfizer COVID-19 vaccine today. While in recovery area, patient alerted staff to feeling of swelling in the mouth. Patient was observed sitting in the recovery area in no acute distress, speaking without difficulty, no dyspnea observed. Patient reported feeling of tingling in her mouth/tongue and tingling in the left arm. Patient reported history of reaction to nuts that caused the same sensation in mouth. Denied history of anaphylaxis. Following reaction to nuts, the patient sought care at an Urgent Care facility where they administered benadryl and a steroid. Patient stated she was very nervous to receive this vaccine. I requested for an additional RN to observe patient and assess condition. Second RN assessed patient, discussed recommendation to visit emergency department, and escorted patient to the Emergency Department for treatment.

01/23 Hives began on thigh and progress to arms, torso, underarms and then both thighs. 01/25 Called dr and had a Telemed call with NP on Tues. 01/26. Predisone and Benadryl was prescribed. Thurs. 01/28 Call to let them know that it wasn?t working. I went into the office for one shot of Solumedrol. This help and they were gone. They gave me second dose of Predisone to take in case it came back and to continue the Benadryl. 02/8 Second vaccine. Hives began that night: arms, torso, thighs, hair. Call the Dr. on 02/10 and suggested I go to an allergist. Went to allergist on 02/11 she said to only take one Predisone, Allegra one am and one at noon, then take zertek at nighttime. The Predisone created a major brain fog, I had to stop. Saw the allergist on 2/18, she agreed to get off the Predisone. 02/11 I passed out in the am and when I woke up with vomit running down my face. Still suffering with hives this entire time. 02/17 my face, lips, tongue started to swell and I had chest pain for 90 minutes. My feel swelled and I have hives so bad on my feet I could not walk or put on shoes. 02/20 Woke up with sweat on my chest. My hands were so swollen I had to have my wedding ring was cut off . 02/21 I went to the Urgent Care and received a shot of Solumedrol. They said this should last me for a few days. 02/21 woke up 3 time throughout the night soaked in sweat.

The left side of my face, ear, throat and teeth hurt; The left side of my face, ear, throat and teeth hurt; pain in neck; pain in left shoulder; The shortness of breath lasted over; My lips were tingly; I could feel the end of my nose. My throat was closing/throat closing a little bit; I had pain in my arm; my muscles ached.; The left side of my face, ear, throat and teeth hurt; The left side of my face, ear, throat and teeth hurt; anaphylaxis; allergic reaction to the first dose of the Pfizer COVID 19 vaccine; This is a spontaneous report from a contactable consumer (patient). A 62-year-old female patient received the first dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot/batch number: EN5318), via an unspecified route of administration on 22Jan2021 at 10:30 at single dose in left arm for covid-19 immunization. Medical history included drug allergies from an unknown date. There were no concomitant medications. The patient experienced anaphylaxis on an unspecified date in 2021. The patient had a little bit of an allergic reaction to the first dose of the Pfizer COVID 19 vaccine in 2021, it was not severe enough to use an Epipen. The shortness of breath from 22Jan2021 18:00 lasted over a week. Her lips were tingly from 22Jan2021 14:30, she could feel the end of her nose. Her throat was closing from 22Jan2021 14:30. She had pain in her arm from 22Jan2021 11:00, and her muscles ached from an unspecified date in 2021, the left side of her face, ear, throat and teeth hurt (facial pain from an unspecified date in 2021, ear pain from 22Jan2021 23:00, throat pain from an unspecified date in 2021, tooth pain from 22Jan2021 23:00), pain in left shoulder from 22Jan2021 20:30, pain in neck from 22Jan2021 23:00. She did have to take Benadryl for treatment of shortness of breath. She felt better after 1.5 weeks. The outcome of events anaphylaxis, allergic reaction, muscles ached, Facial pain, Throat pain was unknown, outcome of event pain in arm was resolving, outcome of event tooth pain was resolved on 23Jan2021, outcome of shortness of breath was resolved on 01Feb2021, outcome of other events was resolved on 24Jan2021.

Tongue swelling per patient. No obvious swelling and visualization or wheezing, hives, itching, redness, dyspnea. Advised to be monitored until 9:15am, but patient refused to stay the entire time and left at 8:55 am.

had been having more ear pain / had not had ear pain in awhile /right ear had been hurting her; had been having more ear pain / had not had ear pain in awhile /right ear had been hurting her; Itching on the left side of her tongue; She had a little bit of swelling on the left side of her tongue; Other autoimmune type things going on; This is a spontaneous report from a contactable nurse reporting for herself. This 62 years old female patient received the first single dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot EL3246) on 19Jan2021 at 14:30 (at the age of 62 years old), in left arm, for COVID-19 immunisation. Prior vaccinations (within 4 weeks) or on the same day: none. Medical history included ongoing trigeminal neuralgia (she had nerve issues, clarifying she was diagnosed about 6-1/2 years ago with trigeminal neuralgia that caused right-sided pain in her head and in her right ear), Raynaud's in her hands and feet since she was a kid. The patient previously took a 7-day course of levofloxacin (LEVAQUIN) and after that she had a diagnosis of ongoing erythromelalgia in her hands and feet and permanent ringing in ears, both since 2014, after she took, saying she functioned fine with the permanent ringing in her ears, she had gotten used it. She also felt horrible and had a muscle tear in her right arm a week after taking Levaquin. Concomitant medication included nortriptyline 20 mg capsule once daily (at night), ongoing since about 6-1/2 years ago, for trigeminal neuralgia. On 19Jan2021, 3 hours after vaccination, the patient experienced itching on the left side of her tongue. On the same day she had a little bit of swelling on the left side of her tongue. She took 1 generic 25 mg tablet of diphenhydramine (BENADRYL) at 19:30 and was okay and slept fine. The next day it felt different but it wasn't itching. She had other autoimmune type things going on. Since an unspecified date in Feb2021 the patient had been having more ear pain and usually took medicine for this but had not had ear pain in awhile. The patient said the left side of her tongue itching and swelling was enough to make her concerned. She also said she was concerned that there may be something in the COVID-19 vaccine that will activate her nerve issue since her right ear had been hurting her since Feb2021. She said she thought that maybe the cold weather was causing her right ear pain, but she had been on medication for over 6 years now that had been taking care of her right ear pain. She said she did not want to have the second COVID-19 vaccine injection if it was going to set off her nerve issue. She stated the doctors were thinking that she should get it but staying there and be monitored and not get it on her day off. She would be getting it at the student health center where she worked so she could be monitored and would have access to medical treatment if needed. Relevant tests: none. The events did not require ER visit or physician office visit. Itching on the left side of her tongue resolved on 19Feb2021. Swelling of tongue resolved on 20Feb2021. The other events outcome was unknown.; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the reported event of autoimmune disorder and other events due to temporal relationship. However, the reported events may possibly represent intercurrent 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 autoimmune panel, ANA and ESR, 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.

Cos tongue tingling and possible rash. was taken to ED by RRT. She stated having flushing neck and cheeks, elevated blood pressure 138/115 to 140/73

body ache, head ache, nausea, diarrhea, weakness, muscle pain, moving body pain, food intolerance, thirst, shaking, feeling of crawling out of body. Lasted 3 1/2 days. Last 2 days shaking and crawling out of body feeling was not present. Diarrhea only day 1. Nausea lasted 1 1/2 days. Day 4 no adverse effects remained. Not certain if the above was related to vaccine but timing seemed to match.

Tingling sensation on her fingertips, on the lower part of her face, and chin; Tingling in her tongue and lip; This is a spontaneous report from a contactable nurse (patient). A 62-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number and Expiration Date were not reported), via an unspecified route of administration, on 26Jan2021, at a single dose, for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient previously took the first dose of BNT162B2 for COVID-19 immunization. The patient received the second dose of the COVID-19 vaccine in the morning of 26Jan2021. From that afternoon on (26Jan2021), the patient had tingling in her tongue and lip. The patient did not have this side effect before. The patient was also feeling it on the lower part of her face today (28Jan2021) and is also feeling a tingling sensation on her fingertips. The patient was now (28Jan2021) experiencing a tingling sensation on her tongue, lips, and chin and it doesn't go. The patient wanted to speak with someone to ask if this is a normal side effect or if she should be concerned. The patient was asking what she can do about this. The patient had not recovered from the events. Information about lot number and expiration date for the suspect product will be requested in follow-up attempts.

Onset approx 45 min after injection--swollen eyelids and face, moderate throat constriction and hoarseness, severe fatigue, headache, brain fog for first 20 hrs, then intermittent eyelid and face swelling, hoarseness, fatigue and brain fog for the next 3 days, followed by mast cell activation symptoms of fatigue, puritis, and mild racing heart in the evening for the last two days. For the past 3 years I have been medication free and virtually symptom free. The symptoms of the last few days are consistent with those I had during the years when my MCAD was active. I am concerned that the vaccine has reactivated the hyper-sensitivity of my mast cells.

Double vision Dizzy Elevated Blood Pressure Light sensitivity Fatigue Symptoms lasted for 10 hours, monitored BP, monitored other symptoms (short naps, kept eyes closed as much as possible, minimal light

On day 11 post 2nd vaccination, developed chills, severe headache, fever as high as 100.2. Able to reduce fever with ice packs but fever returned after 8 hours. Had fever from 2/12/21 to 2/18/21. Headache persisted and did not resolve until 2/22/21. Poor appetite and ackward taste in mouth. On 2/16/21, had Rapid Antigen Covid test, results NEGATIVE. Thought symptoms may have been sinus infection, but usual remedies not effective. Headache was like nothing ever experienced before. Symptoms felt very different. Had Covid test on 1/25/21 prior to 2nd vaccination, NEGATIVE. Self isolated after vaccination and worked from home so low risk of exposure. Was not tested for influenza.

Within an hour, I started getting a dry throat and had a dry cough for a few days. A little breathing problem - it was almost like my reaction to bees that I had before - where my throat was closing up but that was just for about an hour. The second day, I had also (three days) of really bad diarrhea.

WITHIN MINUTES OF THE SHOT, FELT LIGHTHEADED & DIZZY. AFTER 40 MINUTES, EXPERIENCED LIP TINGLING, ITCHY/SCRATCHY THROAT, ITCHY SKIN, A COUPLE OF STRAY HIVES. ALL OF THESE SYMPTOMS WERE MILD, AND PASSED AFTER A COUPLE OF HOURS. THE NEXT DAY HAD A VERY BAD HEADACHE. ABOUT 18 HOURS AFTER THE SHOT BECAME ILL WITH FLU-LIKE SYMPTOMS. HEADACHE, CHILLS, MUSCLE ACHES, LOW GRADE FEVER, CHEST TIGHTNESS/PRESSURE, HEAD & CHEST CONGESTION. ALL RESOLVED JUST ABOUT 48 HOURS AFTER THE SHOT.

I received the shot at 11:30, 11:40 tongue started to feel swollen, shortly after lips were tingling, sought medic, was observed for a few minutes then troat started closing and symptoms of bad asthma attack was offered an epi-pen but chose to use my flyp nebulizer with albuterol and was transported to ER. Face started itching(minor). Was able to breathe normally after several minutes in the ER bp was elevated to 144/93 was keep until about 1:20 given prescriptions for Hydrxyzine pamoate 25 mg, famodine 20 mg, prednisone 20 mg and sent home

After getting the vaccine, patient's tongue started to tingle. @1015 diphenydramine 50 mg po x1 lot # 2029906 exp 09/2023

I am submitting this as a supplementary report to the report assigned on March 1, 2021. This is day 10 after the vaccine and my mast cell reactivity symptoms have increased by the day--internal and external swelling, flushing, pruritis, wheezing, tightness in chest, as well as pain and pressure in arm pits, groin, and ears. By late afternoon I am severely fatigued, weak, and foggy-headed. These symptoms are consistent with those I experienced during the twenty years when my mast cell disease was unstable. Through identification of my triggers and avoidance of the same, I have been symptom and medication free for the past three years--until taking the Covid-19 vaccine. It appears that the vaccine has reactivated an excessive degranulation response in my mast cells and that response is getting worse as my body responds to the vaccine. I realize that the percentage of persons who suffer from a condition like mine is small, but I would have appreciated having the information that I am submitting to you when I was weighing the pros and cons of vaccination. I know from the twenty years of navigating this disease that there is nothing that can be done at this point other than taking various H1 and H2 blockers. This vaccine appears to be undoing the hard-won level of stability achieved through years of careful lifestyle management.

Eyes swollen, mostly right eye, but also left eye. Taking Benadryl every 4 hours plus other allergy medicines and asthma medicines to combat allergic reaction. As of 3/8/2021 the left eye is still almost swollen shut - going to doctor office for further treatment options

9 minutes after receiving Pfizer vaccination, while in the recovery area, c/o feeling of throat / tongue swelling, with noted redness in the upper neck region just below the chin. Able to speak without difficulty, denied SOB/pain or dizziness. Vitals were taken, WNL, AA0 x3, received ongoing monitoring. 911 was called as patient continued to c/o throat swelling, called at 1648, arrived @ 1658, patient was assessed, recommended transport to ED to ensure no further progression, patient declined transport, Husband was on seen at all time, agreed not to transport, waiver signed by patient. DC from recovery area @ 1705 w/Husband, ambulating freely and with clear communication/speech.

Seven minutes after receiving the Pfizer Covid 19 vaccine the patient reported having the feeling of being high lasting 10 minutes, elevated heart rate, dizziness and weakness for 1-2 minutes length, blurred vision and "brain fog" lasting for about 24 hours

Inside of body felt like it was on FIRE!! Mouth burning! Heart racing with minimal movement, shortness of breath,

Lips began tingling (similar to when administered novocaine at the dentist) and tightness along jawline to left ear after I left the site, approximately 40 minutes after injection. After about 1 1/2 hour the sensation lessened.

Patient received her second dose of vaccine at 6:40 PM. After the minute observation period, she left the facility en route to her home. When she got to her car, she felt that the base of her tongue was swollen. She returned back to the vaccination center. At 7:05 PM, she was assessed by the post vaccine RN. BP 155/98, HR 103. O2 Sat 98% RA. She continues to verbalize that she feels minor swelling of tongue and "congested" nostrils. 7:15 PM BP 174/112 HR 103 O2 - 97% RA. Patient was also assessed by pharmacy. Epi-pen was not administered. Patient's symptoms were not improving. EMS called to transport patient to hospital for adverse reaction and increased blood pressure. BP 165/102 HR 103. Patient transported to hospital via stretcher.