Pfizer

Sluggish feeling on 1/16/2021; extreme thirst chills, gassy, loose bowel movement - caramel color . Injection site soreness; today 1/18/21 slight headache - Tylenol dose, headache now subsiding; all other symptoms have resolved.

Lowered body temperature 30 min after dose, left hand began to itch approx. 45 minutes, both hands itching & swelling, then feet within hour. Total lose of vision within 90 min followed by fainting approx 10 minutes later. Fainted at check-in desk of emergency room

Reported symptom onset 11:09 of tingling outer lip area and tip of tongue. VS: BP 146/82, pulse 57, Resp 16 at 11:09. Administered 20ml Diphenhydramine Elixer by mouth at 11:16. Reports tingling resolved on tongue and "mostly gone" from lips. Alert after incident, accompanied home by husband.

Patient reports she experienced lip and tongue tingling, "puffy eyebrows" and cheek swelling approximately one hour after receiving the vaccine. Patient reports she is still experiencing swelling under her eyebrows and cheeks at the time of report (01/20/21 at 8:37 pm).

Approximately 1 hour after the shot, I raised a hive on my upper lip. It very quickly (within 2 minutes) got to its maximum size. Not noticeably swollen to an observer, but it felt swollen, red and throbbing. It was not a serious adverse reaction. After about an hour, it was NOT going away, but it was NOT getting worse. I never experienced trouble breathing. The office where I had the shot is "not available" on Friday afternoon, and my personal physician is not in the office on Friday. I was advised by another doctor friend to take benadryl, which I did. While looking at the CDC website, he also advised me that (having had this reaction) I should not receive the second shot.

Joint pain. Subsided they reoccurred with much more intensity. Could barely walk my right knee hut so badly. Other joints can and went but knee just intensified. Today both my eyes are vpred , swollen and stinging

Cough; has a metallic taste in her mouth; This is a spontaneous report from a contactable consumer (patient) reported that a 76-year-old female patient received first dose of bnt162b2 (Pfizer-BioNTech COVID-19 mRNA vaccine, lot number and Expiration Date unknown) via an unspecified route of administration on 04Jan2021 at single dose for covid-19 immunisation. The patient's medical history and concomitant medications was not reported. Patient was getting a cough and has a metallic taste in her mouth in Jan2021. Wanted to know if it was from the vaccine or Covid. The outcome of events was unknown. Information on the lot/batch number has been requested.

Day 1 moderate to severe pain at site and headache treated with Acetaminophen. Extreme sleepiness for 48 hours and slept for most of the day. 2nd Day pain at site and headache continued. Treated with Acetaminophen. Extreme sleepiness slept for most of the day. Sore throat,cough and nasal congestion and drip, and metallic taste in mouth. Loss of appetite. Loss of hearing and appetite. I woke up at night at 1:00 a.m. with severe nasal discharge and had to sit upright for 2 hours till it abated a little. Day 3 Pain at site continued as did nasal congestion and discharge. Loss of appetite and hearing also continued. I still have nasal congestion and discharge on my 3rd week and also the loss of appetite and hearing loss. The loss of hearing has improved very minutely.

Chest tightness; hives on the side of her neck; scratchiness in throat; gums were throbbing; This is a spontaneous report from a contactable pharmacist. A 76-year-old female patient received first dose BNT162B2 (Pfizer BioNTech Covid 19 vaccine, lot number EJ1686, Expire Date: 30Mar2021), intramuscular at Deltoid Left on 15Jan2021 11:08 at the 76 years old at 0.3 mL, single for COVID-19 immunization. The patient medical history included allergies issues with shellfish (allergic reactions), hyperlipidemia and hypertension. The concomitant medications were none. There was no additional vaccines administered on same date of the suspect. The patient was experienced for over 20 minutes with no side effects. After she left on an hour after administration (15Jan2021 12:08), she started feeling scratchiness in throat, her gums were throbbing and chest tightness. She did say she didn't take any Benadryl. She didn't have airway issues, but she did have hives on the side of her neck on 15Jan2021 12:08. She got the shot on 15Jan2021. The side effects started shortly after she left on an hour after administration. Her symptoms were relieved by 15Jan2021 21:30, and she got the shot at 11:08 am. The patient had allergic reactions in the past. She knew what to expect. She got the shot in her Left Deltoid. The reporter had a gut feeling she didn't need to get the second dose. The reporter assessed all the events were not serious. She did not require medical intervention. She did not go to the Emergency room or Physician Office. The patient was not hospitalized, or in the ICU. The Causality was not provided by the reporter. The outcome of the events was recovered on 15Jan2021 21:30.

tested positive; tested positive; being a little tired/she was tired after it; This is a spontaneous report from a contactable consumer (patient). A 76-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL1283, expiry date: 30Apr2021) solution for injection, via an unspecified route of administration on 15Jan2021 at a single dose for Covid-19 immunization. Medical history included hearing aid. There were no concomitant medications. The patient reported she received her first dose on Friday 15Jan2021 and she lost her sense of smell and taste on Sunday 17Jan2021 and she went and got tested today, Monday 18Jan2021 and her rapid test was positive (Covid test). her taste and smell ability disappeared. She stated that yesterday at 3:30PM all of sudden that her taste and smell ability disappeared. Stated that she just had a rapid test done. Stated that she had not felt bad and had no symptoms before the shot. Patient wanted to know if they had any reactions like this. Stated that she will know more when the test comes back, and she will hear shortly. Patient stated that she was tired after it (Jan2021). She was being a little tired. Stated she has a hearing aid which she had prior to getting the vaccine. Outcome of the events lost her sense of smell and taste/her taste and smell ability disappeared were not recovered, while outcome of the other events was unknown. No follow-up activities are needed. No further information is expected.

felt funny; eye lids tender; lips tingled; face was swollen more than before; This is a spontaneous report from a contactable consumer (patient). A 76-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiration date were not reported), via an unspecified route of administration in 18Jan2021 at 15:30 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient reporting on the COVID vaccine and who explained that she had a reaction to the vaccine. She had the vaccine yesterday (18Jan2021) about 03:30 in the afternoon and by the time she got home, within the hour, her lips tingled and she felt funny, and her eye lids tender. There was no one to call by that time and she did not think it was severe enough to go to the ER so she just took a Benadryl and went to bed. The patient woke up and her face was swollen more than before (onset reported as Jan2021). She doesn't think she is at the stage of life threatening, she can still breath, but doesn't know what to do at this point. Should she take more Benadryl or contact her healthcare provider. The patient asked if this makes her ineligible for the second dose. Outcome of the events was unknown. Information about lot/batch number has been requested.

76 yo female with PMHx of CAD s/p CABG 2016, abdominal aortic aneurym, HTN, HLD, Asthma, Diverticulosis, Osteopenia. Presenting to the ED after having Pre-syncope. She reported that today morning she felt nauseated with episode of vomiting, burping and abdominal discomfort after having her lunch meal, headed out to receive her vaccine, she felt well till 10 minutes after the vaccine where a nurse noticed she is pale and less responsive, BP was measured back then and was ~70 ?, the patient reported that she was sitting when that happened, she felt lightheaded, sweating, blurry vision, nauseated. But denies any chest pain, sob, palpitation, weakness or numbness. She was out of balance and feeling weak till she came to the ED where she felt better after IV fluids.

Anaphylaxis symptoms started three day after the shot I started having chills, trembles, sore throat, very high BP, Swelling and numbness on tongue and lips, pain and burning of feet, tingling all over, joint pain,

Within 15-minutes of vaccination, the patient reported a tingling sensation in their tongue. There were no signs of swelling or airway changes. Patient was supervised on-site by EMS.

Rapid heartbeat, shaky, clammy skin, heavy perspiration, nausea, stomach cramps, pain throughout body along with pin and needle feeling mostly on the left side from my foot to the top on my head. Lips felt swollen. Itch in chest, neck with a rash, back legs, mostly all over.

Caller wanted to know if the vaccine would cause a strange odor in her nose/I have an odd odor that I continue to smell in my nose; This is a spontaneous report from a contactable consumer (patient). This 76-years-old female patient received the first dose of BNT162B2 (the covid 19 vaccine Batch/lot number: EL3249) on 18Jan2021 at single dose for covid-19 immunization. Medical history was Diabetic, High Blood pressure, Pain, Heart burn. On 04Jan2020, patient stated became quite ill and that was before COVID was made public. So I thought I had flu but I was sick about for two and a half weeks that I did not get out of bed, could barely move. I couldn't eat, I lose a lot of weight, I lost my sense of smell and taste. I think now I may have COVID. I am getting a smell that is very unusual and it's hard to describe, it's kind of a pungent kind of a smell. I can't really describe it, correct and is there any remedy for it After that I took a COVID test in March and in March it was negative. Then I took another one in August and it was negative. Concomitant drug included Metformin for Diabetic, Lisinopril for High Blood pressure, Tramadol for pain. Patient had a strange odor in her nose from 19Jan2021/20Jan2021, continue to smell in her nose. Outcome of the event was not recovered. Follow-up attempts are completed. No further information is expected.

"Pfizer-Bio-Tech COVID-19 Vaccine EUA" After receiving the Covid-19 vaccine at 12:15 pm client compliant of having tingling lip and tongue symptoms. She stated that she has anxiety and had the same symptoms with the 1st vaccine and received liquid Benadryl. He brought in a note from the allergist that the benefit outweighs the risk and individual should be given vaccine in a controlled environment. 12:15 patient received 25 mg po of Benadryl elixir by mouth 99% Sat's, 156/90,79,20; 12:20 pm v/s 158/92, 56, 20, 99%, 12:25 PM, v/s, 150/90, 56, 18, 99%. Individual was monitor for 30 minutes and stated her can barely felt the tingling in her lips and tongue. Discharge vitals at 12:43 pm 146/92, 58, 18, 98 %.

Patient states she received the COVID-19 vaccine approximately 10:00 A.M. this morning and within minutes after that she noticed a tingling sensation to her tongue and her throat, she then felt her tongue and throat were swelling. She is given intramuscular Benadryl and referred immediately to the emergency room. On arrival to the ER, she states her symptoms are mostly resolving, she denies any swelling in the throat, tongue swelling, shortness of breath, wheezing, abdominal pain, diarrhea, or rash. D/C with cetirizine and recommended follow up with primary care doctor before receiving the second dose of the COVID-19 vaccine.

I have had tinnitus for about 20 years. It was really terrible in the beginning and gradually calmed down and I have been able to control it with diet. After the vaccination, the buzz in my left year became louder, constant, and didn't respond to diet as it has in the past.

Client received Pfizer covid vaccine, and during her observed wait time, she became hot and felt a flush through her body. She also reported tingling in her tongue and throat. She reported itching of her chest, cheeks, and ears. Client was brought back to emergency area, and was assess by nurses. Client did have a prior history of allergy to Iodine and shellfish- but never anaphylaxis. 10:20am, pulse 68, bp 142/83, 98% O2. 10:25am, bp 140/85, still complaining of throat swelling and itching, pulse ox stil 98%. Once client was in a private area, she reported that the flushing and feeling of being hot, had gotten much better. Per Client , her tongue and throat, were not getting worse. Our Medical Director was contacted, and the decision was made to give Benadryl IM. 10:39 pulse 70, O2 95%, . 10:41 am 1ml (50 mg) Benadryl given IM in the right deltoid (lot # 080014, exp. 8/2022). Within a few minutes patient reported that signs and symptoms were better but had not completely gone away. 10:44, respirations 14/minute, O2 94%, patient sat up at this time to help clear some phlem. 10:46 client states tongue feels better. 10:53 am 96% O2, pulse 93. Nurses continued to monitor client, and asked if she felt any worsening of her symptoms to warrant more medication. Client stated she felt a little better and would like to go home. 11:15 am, spoke to Docter again, per his instruction, client was allowed to go home with her sister. Instructed to take more Benadryl in 4 hours if symptoms return. Client was told if anything gets worse than her original symptoms, regarding her airway, tongue, lips, swallowing, she should call 911.

Ringing in ears; This is a spontaneous report from a contactable consumer (patient). A 76-year-old female patient received BNT162B2 (Pfizer-Biontech Covid-19 Vaccine, Lot. EL3246) at single dose, in the left arm, on 25Jan2021, at 04:45 PM, for COVID-19 immunisation. The patient had not received any other vaccines within 4 weeks prior to the BNT162B2 vaccine. Relevant medical history was unknown. No known allergies were reported. The patient had not experienced Covid-19 prior vaccination. Concomitant medications included metoprolol, gabapentin, triamcinolone acetonide (SYMCORT), chlorthalidone and doxepin. On 26Jan2021, the patient experienced ringing in ears. No treatment was received. Clinical outcome of the adverse event was unknown at time of this report. Post the vaccination, the patient has not been tested for COVID-19.

extreme Chills followed by being very Hot and then chills again , headache , teeth hurt , eyes sensitive to light and eye balls aching and still are ,temperature 3rd day morning 100.2 never checked on 2nd day. Shot in the arm hurt 1 st day where a 1st doze shot did not hurt till next day, nausea, weakness all over and joints hurt. I took1/2 of 2 percocets 1half every 3 hours for 12 hours and that helped with headache and teeth..tylenol did not help headache and I never have headaches. I thought I was dying. I spoke to friends who have had 2nd dose and most experienced some but not all and many nothing after 2nd dose.

Woke from sound sleep at 4 am (approximately 14 hours after having the vaccine shot) -- chilled, and every part of body hurt. Went back to bed. 6 am still hurt everywhere, short of breath (oxygen concentration at 90 and sometimes below--thankfully I had oxygen as I sleep with it). Running a temperature of 100., disoriented, heart rate at 115+ and I hurt everywhere. 8 am called Dr. & left call-back. 1 pm tried Dr. again. Told person on telephone and he told Nurse Practitioner. They ordered nose spray because I mentioned I may have a sinus infection as my head hurt, my ears hurt. I continued Tylenol every 6 hours on Friday and Saturday (all day). I was able to get up and do a few things on Saturday. Felt better on Sunday but still weak feeling. Oxygen saturation back to 95-96 and heart rate under 100.

she hasn't been eating like she should; lost eye sight for 5 minutes, everything was grey; could hear her niece, but that her niece sounded far away; very nauseated/wanted to throw up but couldn't; This is a spontaneous report from a contactable consumer, reporting for herself. A 76-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 at the left arm on 29Jan2021 14:00 at a single dose to prevent getting COVID-19. Medical history included cholesterol, high blood pressure, arthritis, medications for her heart, and medication for her stomach. Concomitant medication included amlodipine for high blood pressure and atorvastatin for cholesterol. The patient has been on amlodipine in a good while, 7-8 years and atorvastatin for 5 years. The patient had the COVID shot on Friday, 29Jan2021 at 14:00, and about 4 hours afterward, she had a bad experience. She became very nauseated and lost her sight for 5 minutes. Everything was grey. She was wondering if there is anything she can take afterward. She was scheduled for her next one on 19Feb2021. She was wondering if she will experience the same thing. She has lost about 11 pounds because she has been on a diet. She gave up sugar. After getting the vaccine, she was on her way back. She began to feel very nauseated in the car. Then, all the sudden she wanted to throw up, but couldn't. She couldn't hear her niece or say anything to her. She clarified she could hear her niece, but that her niece sounded far away. She couldn't respond. She rolled the window down to get air in her face. She hadn't eaten. In about 25-30 minutes got better. Since then, she hasn't been eating like she should, so she was still a little nauseated. It has improved though. She got the vaccine in her left arm. Her right arm is mostly metal. She decided to get it because she is over 70 and wanted to prevent getting COVID-19. It was also reported that she was also on an arthritis medication, medications for her heart and a medication for her stomach. She has had no problems with those medications though. The patient underwent lab tests and procedures which included weight: lost on an unspecified date. She has lost about 11 pounds because she has been on a diet. She gave up sugar. The outcome of the events "lost eye sight for 5 minutes, everything was grey", "could hear her niece, but that her niece sounded far away" and "very nauseated/wanted to throw up but couldn't" was recovered on 29Jan2021 while the outcome of all other events was unknown.

UNKNOWN VACCINE BRAND; Subjective swelling of throat, swollen lips, diffuse eythematous rash on trunk and extremities, anxiety; received famotidine, NS, ativan, diphenhydramine, solumedrol

The first night after the vaccine had a headache and woke up with pain near her mouth. The 2nd night, Tuesday, 2/16/21 it got bad, woke up around the same time early morning, had pain on the right quadrant of her upper body, from her ear, eye, throat and down to right under her throat. When she swallows the pain is very severe with difficulty swallowing and that pain radiates to the upper part of her chest. Then on the third night, last night, all the same pain but the headache had disappeared. Today, 2/18/21 she is still having the same symptoms. The hardest thing to deal with is the ear pain in the right ear, and the pain under her right throat area. She has taken one Benadryl at 8:00 AM, and will take another at 8:00 PM. The Benadryl triggers her tinnitus so is limited with that. Her daughter is trying to find OTC medicine for the ear. She has not called her doctor as they are trying to treat it with OTC medicines. For additional information call her daughter: who takes care of all her medical information.

Complained of dizziness, watery eyes, runny nose, and weakness shortly after receiving her second dose of Pfizer. She \ requested to lie down and was escorted to a stretcher. She was provided oral loratidine with slight improvement of symptoms. Approximately 30 minutes after her inoculation her status had not worsened but she requested to be taken to the emergency department. Rapid Response team was notified and assisted her to the ED.

After receiving the vaccine, my daughter took me to my Cardiologist appointment (this was scheduled before I received the vaccine). When I got to my doctor my blood pressure was elevated, it was about 180/88. My blood pressure is never that high. It did go down before I left to 140/84. When we were walking in the elevator after leaving the appointment my gait was unsteady. I felt very weak. I also light headed, and dizzy. It felt like the feeling of the sedation you have receive before having surgery. When we made it home I couldn't even see straight. This lasted about 2 hours. I feel much better today.

Sometime between 1 am and 7am left eye and cheek swelled. Eye mostly shut. Could open a slit. Hot shower compress helped. Only slight swelling by 4 pm.

Immediate itch in the head and arm fifteen minutes after shot along with slight swelling of the lip. Then 2 weeks after 2nd dose the same itch has returned all over the body along with some open rashes on the skin.

at first i was fine and the next morning i noticed my whole bottom lip was swollen. Lasted about 2 days after taking Benadryl.

During monitoring period post Pfizer COVID-19 vaccine, pt states she has mild tongue swelling and tongue numbness. VS: 123/72, Given Benadryl 25mg by mouth. Patient was transferred to: home

Patient reports she got her COVID vaccine around 5:30 P.M. and approximately 20 minutes later developed airway and tongue swelling. EMS arrived and she was given 0.3 mg IM epinephrine, 125 mg solumedrol, 50 mg benadryl, 2.5 mg versed for anxiety. Patient states she is not much better since receiving it, however per EMS she was doing much better.

speech/word finding difficulty ( dysarthria ), Novocain like feeling left perioral area( perioral anesthesia ) , drooling of food occasionally

Left side of face pain including eye inside mouth and throat. Felt like bad sinus infection. Still have some throat pain

4 days after 2nd dose: hives all over my body and swelling of face and eyes. Called Telemedicine at Urgent Care Huntsville Hospital. Was given instructions to take 40 mg of Prednisone first day and taper off, 2-3 doses of antihistamine and Hydrocortisone on welts. Needed to go to ER for IV if face swelling did not go down. Today (second day after call): Face swelling is down but hives are possibly worse (large welts over large portion of body plus on hands and feet and chin)

Patient was here for her 2nd dose vaccine and during her wait time her tongue started to feel funny and swell slightly. Staff was notified as they were talking with her that her voice sounded a little funny and thick. She also started to cough on a regular interval. As staff continued talking with her she stated her throat started to feel funny and tight. Staff notified other healthcare personal and moved her to the private treatment area. She continued to complain of thick tongue and continued to speak different then her baseline. We elected to give 50 mg Benadryl IM. She was also placed on the ECG showing sinus rhythm with O2 stats of 100 % and her blood pressure was 149/61, After the Benadryl, she stated she started to fell somewhat better. After about 10 minutes her tongue started to swell again and when she turned her head to speak to a staff member her airway shut off due to swelling. Staff quickly turned her head back to forward she was able to breath again. She advised that she needed to be transported and was going to get 0.3 epi IM in her left arm. She did state prior to Epi being given she was now also having trouble focusing visually. Dr arrive to assess her and agreed that she needed transported. EMS arrived and care was turned over to Huntertown EMS to transport the patient to Medical Center.

Lower lip swelling that began 2 days after the vaccination. patient is currently being seen in the ER for the same and there is a question as to whether this is allergic in nature vs. infection (but there is no obvious infectious starting source)

After 12 hours, extreme fatigue, headache,tinnitus, chills then joint and muscle pain I took Aleve and was able to sleep off and on during the night. The following morning still had headache and fever. I could not eat breakfast. I took a two-hour nap during the afternoon. Symptoms dissipated slowly by evening.

Within an hour, I felt like I had been hit by a tank; difficulty breathing, dysequilibrium, problems with balance that induced dizziness and vertigo, wobbly gait, extreme weakness, continual tiredness--not refreshed by sleep, difficulty sleeping, insomnia, injection site pain, severe headaches for weeks, eyeball pain, chills, fever, inflammation, joint pain, muscle pain, activity-induced or cognitive exertion muscle fatigue, nausea, swollen lymph nodes, especially in neck, sore throat, difficulty swallowing, cognitive problems -- difficulty with memory, focus, concentration, problems with wordfinding ability, misspeaking; short-term blurry vision; extreme difficulty with body temperature control leading to shaking

10:15- Pt initially c/o left arm numbness sensation, brought back to observation area 10:20- Pt c/o thick throat sensation - Emergency Response Team Called 10:22- Pt c/o increased throat sensation "swelling in back of my tongue and throat" with onset of difficulties breathing- Epinephrine Auto-Injector 0.3mg administered. 10: 26- Emergency Response team arrives 10:28- Pt transported to ER for evaluation

Tinnitus spiked up quite a bit /tinnitus was reported as worsened /her tinnitus increased a great deal. It increased in loudness; arm was sore; stomach ache; upsetting and distressing; This is a spontaneous report from a contactable consumer (patient). A 76-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: EL3247), via an unspecified route of administration at 13:30, on right arm, on 25Jan2021, at single dose for COVID-19 immunisation. The patient relevant medical history included heart condition, she is mostly allergic to antibiotics (She has allergies to several medications; Specific antibiotic names not provided), blood pressure, anxiety, thyroid (thyroid disorder), urinary tract health, I have had tinnitus for 7 years and Bones (bone disorder) and of them were ongoing. The patient concomitant medication included levothyroxine sodium (SYNTHROID) for thyroid disorder and ongoing at 50ug, daily, hydrochlorothiazide tablet for blood pressure and ongoing at 0.25mg (half tablet) once a day, valsartan(DIOVAN) for blood pressure ongoing at 80mg once a day, verapamil for heart issue ongoing at 100mg, metoprolol tartrate for heart, ongoing at 25mg twice a day, alprazolam (XANAX) for anxiety ongoing at 0.25mg, once a day, d-mannose for urinary tract health ongoing at 300mg once a day, vitamin d nos for bones ongoing at 50ug daily, calcium carbonate (CALTRATE) for bones at unknown dose once day, ubidecarenone (COQ10) for heart ongoing at 200mg, magnesium for the heart. It was reported that patient got tinnitus after taking an antibiotic and had for 7 years. After taking the first dose on Monday (25Jan2021), the tinnitus spiked up quite a bit on 27Jan2021 (noticed when she woke up at about 08:00 in the morning). Tinnitus got very much louder, and patient thought that it was from vaccine. Tinnitus increased a great deal. It increased in loudness and was reported as worsened. On an unknown date in Jan2021, the patient arm was sore and got better. The patient also had little bit of a stomach-ache at first and that got better as well on an unknown date in Jan2021. The patient thought that the tinnitus would return to my normal level of loud. The patient reported that it's very upsetting and distressing on an unknown date in Jan2021. The patient was worried about getting the second shot. The patient also stated that had allergic reactions to many drugs and did fine with the vaccine in terms of anaphylaxis. It was reported that prior vaccinations within 4 weeks was none. It was reported that patient had not administered additional vaccines on same date of pfizer suspect administration. The outcome of the events tinnitus spiked up quite a bit /tinnitus was reported as not recovered /her tinnitus increased a great deal. It increased in loudness was not recovered, upsetting and distressing was unknown, stomach-ache and arm was sore was recovering.

head hurt; pain in all of her joints/couldn't move fingers; felt numb; Nauseous; felt unstable; light-headed and dizzy; Sweating; Chills; seemed to not be able to register stuff, she wouldn't necessarily say memory loss, but she couldn't put stuff together; Not hearing correctly; not wanting to eat; She was beginning to feel dehydrated; shaking; equilibrium was off; sleeping for hours; This is a spontaneous report from a contactable consumer (patient). A 76-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL9262, expiry date: 31May2021), via an unspecified route of administration on 29Jan2021 (at the age of 76 years old) at a single dose for covid-19 immunization. Medical history included pre-diabetic, thyroid (disorder), and cholesterol (abnormal). Concomitant medications included levothyroxine from unspecified date to 31Jan2021 as thyroid medication and rosuvastatin for cholesterol. The patient previously took first dose of bnt162b2 (lot number: PFREL1283, expiry date: 30Apr2021) on 08Jan2021 (at the age of 76 years old) at a single dose for covid-19 immunization and experienced Injection arm pain, a little more drowsy than normal, and more tired. On 29Jan2021, the patient experienced sleeping for hours. On 30Jan2021, the patient experienced when she woke up, she thought she was headed for the emergency room (ER) as she had pain in all of her joints. At first, it was only her fingers which lasted for five minutes or so where she couldn't move her fingers, she felt numb, she was very nauseous. she couldn't hold down food, she never threw up though, she felt unstable. If she drank water, she would immediately be going to the bathroom, she was beginning to feel dehydrated. She just couldn't hold it when she had to go to the bathroom. Then, the finger pain went to her joints in her elbows and knees. On 30Jan2021, she was also light-headed and dizzy, she was not wanting to eat, she tried to eat dry toast. She was nauseous in her stomach, but she didn't throw up. She experienced sweating and chills. On late Saturday evening of 30Jan2021, she also had an issue, a very mild case, of not hearing correctly but it was not a ringing in her ear, it was like her equilibrium was off. She ended up putting a little bit of liquid ear drops in her right ear, and that seemed to help it. Right now she feels like she has recovered from everything. When unstable, it didn't seem to last too long, she is in bed most of the time. By the time she got up to eat, she was fine. But then she lapsed into chills and shaking. The patient also experienced she seemed to not be able to register stuff, she wouldn't necessarily say memory loss, but she couldn't put stuff together (30Jan2021). She can remember stuff now and it only lasted that day. On 31Jan2021, her head hurt. Therapeutic measure was taken as a result of the event a very mild case, of not hearing correctly. Outcome of events felt unstable, light-headed and dizzy, memory impairment was recovered on 30Jan2021. Outcome of the events arthralgia, felt numb, nauseous, head hurt, sweating, chills; not hearing correctly, not wanting to eat, dehydration, shaking and equilibrium was off was recovered on 31Jan2021. Outcome of event sleeping for hours was recovering.

Sore arm, extreme fatigue, fever 101.9 and loss of appetite for 2 days following vaccine. aching behind eyes, especially right eye which lingered until about day 7, headache on right side for about last 4 of the 7 days, some discomfort in right armpit and tenderness of right breast nipple. No treatment except fluids and bed rest for first 3 days. By day 6 I felt myself again.

Rash in mouth and throat and shortness of breath on Thursday 3/11/21 around 7 p.m.. Called Covid line and spoke to a RN who recommended that I take Ibuprofen and not to take an antihistamine, and to contact my doctor in the morning. Also to go to the ER if symptoms got worse I took Ibuprofen every 4 hours over night and called my primary care physician in the morning. He sent me to the Urgent Care center since the rash had persisted . The Urgent Care physician prescribed Prednisone and Benadryl. I am taking antihistamines and Ibuprofen for relief of rash and itching. I will follow-up doctor on Monday.

Within 3 minutes of injection I developed a medicinal, metallic taste in my mouth; tingling in my tongue and on my lips; This is a spontaneous report from a contactable consumer herself. A 76-years-old female patient received first dose bnt162b2 (Solution for injection, Pfizer, Lot number:EL3249) via an unspecified route of administration arm left from 27Jan2021 09:30 at single dose for Covid-19 immunization. Medical history included rheumatoid arthritis, and Hypothyroid. Concomitant medication included adalimumab (HUMIRA), levothyroxine sodium (SYNTHROID), montelukast sodium (SINGULAIR), ezetimibe (ZETIA), rosuvastatin calcium (CRESTOR) and calcium. The patient previously took metronidazole (FLAGYL) and experienced allergy. On 27Jan2021, 09:30 AM, within 3 minutes of injection I developed a medicinal, metallic taste in my mouth. In a few more minutes, tingling in my tongue and on my lips and for both events received treatment Benadryl and extra waiting. The outcome o the events recovered in 2021

Approximately a week after vaccination, developed vision problems with blue lights in right eye, followed by deteriorating vision 7 to 10 days after vaccination. 03/09/2021 was diagnosed with central retinal vein occlusion.

half hour after receiving shot tongue and throat swelled up and short of breathe. Throat was sore for few days and short of breathe remained for almost a week It is 12 days and feel better but do not know if I should get second shot

she is not thinking straight; she is able to hear her heartbeat in her ears; having a ringing in her ears; feel tingling, numbness on her tongue, lips and roof of her mouth; feel tingling, numbness on her tongue, lips and roof of her mouth; feel tingling, numbness on her tongue, lips and roof of her mouth; feel tingling, numbness on her tongue, lips and roof of her mouth; She feels fuzzy in her head; This is a spontaneous report from a contactable consumer. A 76-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection lot no: EN5318), intramuscular injection in left arm on 01 Feb 2021 for covid-19 immunisation. the patients' medical history included ongoing high blood pressure and High cholesterol. The patient's historic vaccine included Shingrix for shingles on unspecified date in 2020. The patients Concomitant medication included Amlodipine 5mg tablet once a day orally, Hydrochlorothiazide 12.5mg tablet once a orally, Olmesartan 40mg tablet once a day orally, Meloxicam 7.5mg small tablet orally, three times a week, Preservision Eye Vitamin one soft gel capsule by orally, probiotic two gummies once a day orally, apple cider vinegar gummy two gummies once a day orally for Cholesterol, Citracal + D, calcium and vitamin d supplementation two tablets twice a day orally. on 01 Feb 2021, the patient experienced tingling/ numbness on tongue, lips, and roof of her mouth, felt fuzzy in her head. On 03Feb2021, she experienced Ringing in ears. The outcome of events was not recovered.

Fine after shot and evening; went to bed approximately at 9pm and got so cold, put 3 blankets on and was fine. Got up about 2AM to go to the bathroom; started back to bed; had a bad taste in mouth, so decided to brush my teeth. Started brushing and all of a sudden, felt faint; before I could get the toothbrush back, I fell and my husband rushed over. Said I was out completely; got me awake and back up and went to bed and slept. until 11am. At 3pm when taking a shower, noticed my left shoulder blade was real sore and looked and there were 3 red strips below should blade - no bleeding tho. top R. side of head kinda sore, so must have hit when falling. Went back to bed and slept good. Didn't need to go to the Dr. and am feeling good now. Just rested for a couple days. Had been feeling really good and don't take any prescriptions, so could only think it had to have something to do with the shot. Today is the 4th day and feel good.

EUA Pfizer -BioNTech vaccine 3 days after vaccine, patient complained about facial droop. She saw her PCP who diagnosed her with Bell's Palsy. She was prescribed acyclovir and prednisone. 4 days after the vaccine, she began to feel dry eyes, and difficulty swallowing. She was advised that symptoms will improve with time and steroids and to return to the ED if she experiences voice changed or cannot tolerate liquids.

Took the Pfizer vaccine and within two days, swollen eyes and face. My face has been swollen since then I look like I have chipmunk cheeks, how long will this take before it goes away. It is over a month The eyes are sometimes swollen , but not as much, just bags under my eyes Is there any other suggestions besides ice on face and taking allegro, and benedryl, that will make the swelling go down permantly

2 degree temperature and feeling hot; arm swollen with egg size lump; rash on arm 2inch x 4 inch; extreme fatigue ; red cheeks; and 10 days later JAW HURTING which persists to date

Back hurt a tremendous amount; Lower back, hips, knees, neck pain; Lower back, hips, knees, neck pain; When she would go to move her eyes left or right or up or down it seemed like her eye sockets just hurt to move her eyes.; Very sore, uncomfortable stomach; Exhausted; Chills; Felt like she was having a heart attack; a bit congested; Aches; jaw pain; facial pain; Quite a bit of saliva in her mouth, it filled up quite a lot; sore on the injection site; Bit of a sore arm/left arm pain; This is a spontaneous report from a contactable consumer (patient). A 76-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Right Arm on 02Mar2021 14:26 (Batch/Lot Number: EN619G) as single dose for vaccination. Medical history included joint replacements (specified as 1 hip done in 2007; right knee done in Jan2013; another knee was done in Feb2017; another knee was done in 1986); and in 2011, neck fracture. There were no concomitant medications. The patient had the 1st dose of the PFIZER-BIONTECH COVID-19 VACCINE and on 02Mar2021, she had sore on the injection site, experienced excess saliva production. On 05Mar2021, she experienced chills, feeling of heart attack: left arm pain, jaw pain, facial pain. She is worried to take the 2nd shot as she might have more symptoms on the 2nd dose. On an unspecified date, the patient had lower back, hips, knees, neck pain, eye socket hurts when rolling her eyes, sore stomach, and exhausted. It was also reported as follows: on 02Mar2021 after she got home from being administered the Pfizer-BioNTech COVID-19 Vaccine she had quite a bit of saliva in her mouth, it filled up quite a lot; and a bit of a sore arm for a couple of days but that was about it at that point. On Friday, 05Mar2021 she started getting chills and aches; and felt like she was having a heart attack: her left arm hurt and her left side of face hurt down in her jaw. She was afraid and considered going to the hospital but thought she was going to wait it out see what it is and it passed. She then once again got a lot of saliva in her mouth again. Over the next few days she developed aches that were primarily located in her joint replacements, it seemed like the aches attacked those areas of joint replacements in her hips, knees and where she had a neck fracture. She had a lot of pain and a lot of chills. She was never bedridden, but would lay down because she was exhausted. Her back hurt a tremendous amount. Another thing that happened is her eyes, when she would go to move her eyes left or right or up or down it seemed like her eye sockets just hurt to move her eyes; she did not have a headache; this whole indentation there with her eyes hurt to move them from one side to another. She also had a very sore, uncomfortable stomach; it was not an upset stomach; just seemed very sore, uncomfortable. At first that first part of 05Mar2021 she seemed a bit congested. She is very worried about second dose of Pfizer-BioNTech COVID-19 Vaccine because of the first dose creating all of these difficulties. She does not know what she should be doing. She is scheduled to get her second dose of the Pfizer-BioNTech COVID-19 Vaccine on 24Mar2021 because she is leaving by plane on 29Mar2021. That only gives her like 4-5 days before she leaves and she knows that the other symptoms after the first dose of the Pfizer-BioNTech COVID-19 Vaccine did not start until 3 days later. She is concerned about that, because she is flying to take care of her sister; she is worried about the second dose because she does not like what she experienced with the first dose because she heard that the second dose will be terrible; she is worried about leaving and experiencing those horrible things. She reported that there are no tests/investigations relative to this report to provide. The only thing recently done was having X-rays of her neck on 24Feb2021 because of her neck issues with the fractured neck she had in 2011. Outcome of the events was unknown.

my blood was instead 2.5 to 3, it was 4.9/It should be a range just listen to number 2.5 to 3. My report they showed me that I am 4.9, that is big number. It is like 2 margin over/my blood is too thin; my blood was instead 2.5 to 3, it was 4.9/It should be a range just listen to number 2.5 to 3. My report they showed me that I am 4.9, that is big number. It is like 2 margin over/my blood is too thin; When I go to a surgeon tomorrow because I have wound on my foot from surgery that I had and it is not healing, it is just draining /my body me things don't heal the way they supposed to; She feels weird; her eyes are extra dry; Nervous; This is a spontaneous report from a contactable consumer. This 76-year-old female consumer (patient) reported that she received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number; EL8982, expiry date; May2021), NDC number, UPC number; unknown, covid19 vaccine manufacturer; unspecified intramuscular from 28Jan2021 to 28Jan2021 at single dose on deltoid left (left upper shoulder) for COVID-19 immunisation. Patient medical history included ongoing antiphospholipid syndrome, lupus (Patient medical continuing: Yes, diagnosed around 19 years old), surgery on her feet on 04Dec2020, blood thinner. Concomitant medications included Warfarin (tablet), strength; 6 mg orally from an unspecified date to an unspecified date ongoing at 3 mg (6mg 5 days a week and 3mg two days a week) and then at 3 mg (3mg three days a week and 6mg four days a week) for blood thinner. Laboratory test included INR (International normalised ratio) done on 04Feb2021 with result as (4.9; it is very high). Additional Information for concomitant products Warfarin: Her dose varies, new chart as of todays visit states to take 6mg on Sunday, 6mg on Monday 3mg on Tuesday, 6mg on Wednesday, 3mg on Thursday, 6mg on Friday, and 3mg on Saturday. Patient reported that INR should be a range just listen to number 2.5 to 3. My report they showed me that I am 4.9, that is big number. It is like 2 margin over. When I go to a surgeon tomorrow because I have wound on my foot from surgery that I had and it is not healing, it is just draining. I don't know if one has anything to do with other but I am very suspicious about it because my blood is too thin and my body me things don't heal the way they supposed to. Consumer stated, "I have been hold for almost for 2 hours because what happens I left my number as requested for call back. I got a call back in another 2 minutes. When I press to receive a call it disconnected. So I had to start all over again. So it is been like 2 hours adventure. Firstly I need to say that someone I told to call a second number well disconnect me twice but I have something call a report number that the person I think it has same job title of you. I am not certain but her name is (Name) and she gave me report number. She asked me all the questions, I answered all the her questions including my 28Jan2021 Pfizer injection which was my first injection and I have question referring to my taking Warfarin and wanted to if there was interaction because I went to doctor today to see my blood was instead 2.5 to 3, it was 4.9 which is extremely high and the only thing I have taken, I have done differently was to have my Pfizer injection on 28Jan2021. Consumer stated, "It is already in your system because as I said before I have report number. Should I give the report number. The person I spoke a long time ago that with I have been phone said that she information from my card when you they gave that card for you come like second time for the second dose or booster as I told this call." When probed for if the consumer call the Drug safety earlier: Consumer stated, "That thing I am telling I spoke to someone by the name of (Name). She started asking by same question you did. That is why I am trying to tell you that person already asked me everything and give me report number. She wanted to transfer me because she says it is wrong department. I started here same information again. I have been on phone for far too long for this to be evening. The report number is 'number'. Consumer stated, "Concern is that I have Lupus and I take Warfarin. My INR report does part of what to do when you have lupus. You have blood measure monthly or whatever times that necessary. It is very high. It should be a range just listen to number 2.5 to 3. My report they showed me that I am 4.9, that is big number. It is like 2 margin over. I am trying to find out if the injection had interaction with warfarin that is medication I take. Blood thinner I take because I have lupus with antiphospholipid symptoms. I am trying to find out if the injection had any interaction with warfarin the blood thinner. That is the information I am trying to to get. When I go to a surgeon tomorrow because I have wound on my foot from surgery that I had and it is not healing, it is just draining. I don't know if one has anything to do with other but I am very suspicious about it because my blood is too thin and my body me things don't heal the way they supposed to. The consumer has taken the Pfizer Covid Vaccine: Consumer stated, "That is the first thing I said. I told you and then I am telling about warfarin. I said I wanted to know if the Pfizer vaccine which I took on 28Jan2021 as I said that before if it had conflicting reactions with warfarin. I explained to you I have lupus and I also have antiphospholipid syndrome which cause me to take warfarin medication. I want to know if the Pfizer injection had any negative interaction with warfarin the blood thinner." When consumer informed about Medical Information: Consumer stated, "That person transfer to me before. It was drop. So can you connect me to number. She tried to transfer me and I got nowhere to call just died. If I call I am gonna be on waiting for all over again. I already had experience consumer stated, "I have already been answered all of your questions that is why I have a reference report number that I gave you. I have been answered whole time questions. I answered everything. I just wanna be connected to get somebody because I am tired of being on the phone." Is there a product complaint to report was no. Consumer was provided with the number of Medical Information number and was requested to select option 3, timings as and 8 am to 8 pm Monday to Sundays as per (EST). Investigation Assessment: Yes. She had the first dose of the Pfizer covid19 vaccine on 28Jan2021. She is nervous. She lives with lupus and antiphospholipid syndrome, which means her blood is too thick. She is on a blood thinner, she takes warfarin. She is asking if the vaccine could interfere with warfarin. Today she had her INR checked and it was was 4.9. States a stable reading is between 2 and 3. The only different thing she has had in her body is the vaccine. Reports she is nervous and scared. She had surgery on her feet and she has a wound where a thicker scab came off, states it is draining but not drying out. She was thinking maybe this was due to her her INR being high. She will see the surgeon tomorrow. She put a bandaid on her foot where the open wound on her foot is. The next morning she checked her foot and the bandaid was wet. She put some peroxide on it. She read peroxide is not good for open wounds because it kills good bacteria so she used gauze and placed it over the open wound with tape across it. Last month her warfarin dose was 6 mg 5 days a week and 3mg two days a week. As of today she is to take 3mg three days a week and 6mg four days a week. Warfarin is 6mg tablet that is perforated, clarifies it can be broken in half. She does not think her new regimen that she was given today will bring her INR back in the range between 2 and 3. States her INR has never been that high. She will go back to see the nurse in two weeks to get her INR checked. She sees her patient medical record number listed on the card. She says pardon her grunts and moans because she grunts and moans when she moves since she is 76. She feels weird and her eyes are extra dry in 2021. She is nervous about the area where she had surgery on her feet, she does not want it to get infected. She thinks she had surgery on 04Dec2020 to have arthritis in her toes corrected. Outcome of events was unknown.

Gradual eruption of hives with worsening itching, almost all on the right side of my body, with eventual swelling of my face, mostly on the right side, to the point of nearly closing my right eye.

The patient's daughter called to report her mother developed a swollen tongue the evening after her second covid vaccination. It was mild at first but progressed to the point that it was interfering with the patient's speech. Her breathing was not affected. The swelling did subside some when the patient took allergy medication. I recommended the patient be seen by a doctor, and her daughter agreed, but the patient was not keen on seeking medical care.

1st dose, none Second dose administered 02/18/2021, 11:00 AM 1st 10 days: lymph node swelling of left breast and later, right breast, First evening required a hot pack to reduce pain. Left shoulder was rehabbed from torn rotator cuff over a year ago, now joint pain for 3 weeks, varying in severity Brain fog, fatigue, irritability 3 1/2 weeks Changes in taste but not smell, last 7 days, continuing today 03/29/2021

Pt is presenting today for Shortness of Breath (pt reprted soa, back pain ( due to rehab 2 weeks ago), nausea, stomach pain, bilateral ankle swelling, drainage in back of throat, right ear is clogged), Pt was admitted to hospital for AMS last month, uncertain underlying cause. Over past few days shes gotten more weak, possibly more confused, more back pain, and lost voice, some congestion and ear congestion. Her son is managing medication. She has SOB and nausea too. No vomiting or diarrhea. Symptoms worsening. No sick exposures, 1st covid shot 2 days ago

Tongue Enlargement, tingles around mouth, itchy ears and axillae, shortness of breath - Benadryl 25mg PO given

All of a sudden, at 6pm on Feb 23, 2021, my ever-present tinnitus became dramatically worse - unceasing high hissing whining sound. It has not to date reverted to the way it was before. I did not connect it with the vaccine I had received earlier that day. On March 22, 2021 I read an article about someone who committed suicide b/c of post-COVID tinnitus. Three people commented that their tinnitus worsened after their COVID vaccinations. I checked dates and, sure enough, my tinnitus worsened 4 hrs after my vaccine. I got tinnitus in 2006 and since then have had every vaccination known to man: typhoid, meningitis, Tdap, shingles (Zostavax and 2 Shingrix), pneumonia (Pneumovax and

Day 5 and still have symptoms. Leg spasms like charlie horses from my knees (both replacement knees) up through my thighs to my hips, pretty much 24/7. Chills, loss of apatite and some foods taste strange. have been unable to sleep through the night because of the pain.I do think that the antibiotic did not mix with the second shot even though the medical staff cleared me at the COVID clinic that I could have the shot.

Pfizer-BioN Tech COVID-19 Vaccine EUA: Swelling in mouth/lips, severe itching (all over, especially legs, thighs, back, arms, scalp, eyebrows and in nostrils, sensitivity to sound, elevated blood pressure, swelling in ankles, nausea

Pain in left side of Neck and Ear and both eyes ,Then on the second night the pain moved to the right side of Neck and ear and both eyes,The third day I noticed that the lip is shiffted to the right

Total fatigue and lack of energy; pretty motionless, could take a shower & read but that was about it; sleeplessness; headache; recurring chills; allover muscle & joint pains, nausea, appetite loss -- lost 6 lbs. in 6 days; blurred vision, dizziness. On the 5th day was able to eat cheese sandwich; only chicken noodle soup & crackers & tea & toast prior to that. Finally on the 8th day began to feel normal.

Last injection Jan. 28th. On March 15 I started with sore throat and my husband seemed to have head cold. On Tues. his job told him to get a COVID test. He went in Wed. and the rapid test was positive. I went down hill. I had headache, chills, sore all over, sore throat, coughing, shortness of breath, sore tongue, diarrhea, didn't have fever. Was up Thursday night because of shortness of breath. Called Doctors office and was told to go to walk in clinic and someone would come out and get me. Was seen by PA I think. Not a doctor. They only did a rapid test and it was negative. She didn't do the second test and send it off. I have found two people who had the rapid rest and results were negative that the results s Results sent in from second test came back positive. She prescribed Prednisone which helped. I was sick for over two weeks and still struggling with fatigue, aching , sore throat and shortness of breath.

voracious appetite, about 24 hours after 2nd dose; voracious appetite, about 24 hours after 2nd dose, all food tasted bland; This is a spontaneous report from a contactable consumer (patient itself). A 76-years-old non-pregnant female patient received second dose of BNT162B2(Solution for injection, Lot Number: EL3248 and Expiration date was unknown), via an unspecified route of administration, administered in Arm Left on 01Feb2021 13:00 as SINGLE DOSE for covid-19 immunization .Historical vaccine included first dose of BNT162B2(Solution for injection, Lot Number: EL0142and Expiration date was unknown), via an unspecified route of administration, administered in Arm Left on 11Jan2021 16:30 as SINGLE DOSE for covid-19 immunization. The patient medical history was not reported. Concomitant medication included esomeprazole magnesium (NEXIUM [ESOMEPRAZOLE MAGNESIUM]) 40 mg, daily taken for an unspecified indication, start and stop date were not reported. On 01Feb2021, the patient experienced voracious appetite, about 24 hours after the 2nd dose , all food tasted bland. Seriousness of the events reported as non-serious. The patient had not recovered from the events. No follow-up attempts are possible. No further information is expected.

hearing loss in high frequencies; developed tinnitus; She was very depressed; This is a spontaneous report from a contactable consumer (patient) via Medical information team reported for herself. A 76-years-old female patient received bnt162b2 (BNT162B2, Solution for injection), dose 1 intramuscular, administered in Arm Right on 10Mar2021 09:22 (at the age of 76-years-old) (Batch/Lot Number: EN6206) as SINGLE DOSE for covid-19 immunization. Medical history included immunodeficiency, respiratory disorder, cytogenetic abnormality, endocrine disorder, diabetes mellitus, obesity from an unknown date and unknown if ongoing. There were no concomitant medications. Patient had first shot of vaccine on 10Mar2021 and was due for her second on 01Apr2021. Within 2 days of receiving it, she got Tinnitus and was still experiencing ear ringing. She had already spoke to HCP. She was very depressed that she may have this side effect forever. She asked if anyone else had reported this side effect. She doesn't know if it was a side effect. She was wondering if she should get second shot or will anything worse happen. There was no prescriber. It was either 12Mar2021 or 13Mar2021, that she noticed it. For tinnitus she did not pay a lot of attention until Sunday, so she knew she got it on Saturday, or Friday, unknown time. No ER or physician's office required. She did make an appointment with an ENT and audiologist on 24Mar2021. Patient did not know if it had anything to do with the vaccine. No infection. Somewhat of hearing loss in high frequencies, but she did not need a hearing aid. There were no prior Vaccinations (within 4 weeks) and no lab tests reported. Outcome of event tinnitus was reported as not recovered and outcome of event deafness and depressed mood was unknown.

Patient is here today for her second Pfizer vaccination. She reports that after the first vaccine, she felt very cold and had a sore arm for about 4 days. States that she took a 3-4 hour nap after she got home and the chills improved/resolved. Reports that she received the vaccine at around 10:00 AM. Was in the waiting area and was having some blurring of vision that was "coming in and out" and dizziness. She was taken to the personal observation area to lie down at 10:36 AM. Vital signs monitored. Blood pressure elevated, even though symptoms of blurring vision resolved. At around 10:55 AM, patient sat up on edge of cot. Continues to reports symptoms have resolved. No return of symptoms with standing. Patient walked well without the need of assistance. Husband accompanied her out of facility. Advised that, should blurring of vision reoccur, she should be seen in ED. Advised to schedule a blood pressure recheck with her PCP before the weekend. Patient acknowledged understanding of above information.

Left ear keeps plugging up and interfering with my hearing. Right ear isn't as bad as the left one.n/

BODY ACHES; FEVER; NASTY TASTE; dark urine; backache; heartburn; fatigue; This is a spontaneous report received from a contactable consumer(patient). A 75-years-old female received second dose of BNT162B2 (BNT162B2, formulation: solution for injection, lot no: EL9267), via an unspecified route of administration in Arm Right as SINGLE DOSE for covid-19 immunisation on 12-FEB-2021. Medical history included Diabetes mellitus from an unknown date in 2002 and unknown if ongoing, gastroesophageal reflux disease from 2010 and unknown if ongoing, Gall bladder reflux surgery and blood cholesterol from 2014. Concomitant medication included farxiga (DAPAGLIFLOZIN PROPANEDIOL MONOHYDRATE) 10mg from 2018, esomeprazole sodium (ESOMEPRAZOLE SODIUM) 40 mg, Januvia (SITAGLIPTIN) 100 mg, montelukast (MONTELUKAST)-10 mg, atorvastatin calcium (ATORVASTATIN CALCIUM) 80 mg, hydrochlorothiazide(HYDROCHLOROTHIAZIDE) 12.5 mg. All the drugs are ongoing.On 13Feb2021, patient experienced body aches, fever, nasty taste, dark urine, backache, heartburn, fatigue. There was no treatment due to events. The outcome of events were recovered. No follow-up attempts are needed. No further information is expected.

This is a spontaneous report from a contactable consumer (patient). A 77-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; solution for injection; Lot Number: ER8730) via an unspecified route of administration on 24Mar2021 at 10:30 (at the age of 76-years-old) as a single dose for COVID-19 immunisation. Medical history included ongoing pollen allergy from an unspecified date and ongoing ribs sore from an unspecified date. The patient stated that the pollen was bothering her and that she had been taking Zyrtec in the morning and at night. Medical history (including any illness at time of vaccination) was also reported as none. Family medical history relevant to the event was reported as "her son also had a seizure after the polio vaccine when he was 7 years old". Concomitant medications were not reported. It was reported that the patient denied any medications or medical conditions relevant to symptoms. There were no additional vaccines administered on the same date as the COVID-19 vaccine and there were no prior vaccinations received within 4 weeks of the COVID-19 vaccine. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; solution for injection; Lot Number: EN202) via an unspecified route of administration on 24Feb2021 (at the age of 76-years-old) as a single dose for COVID-19 immunisation. The patient previously received the polio vaccine on an unspecified date for immunization and experienced seizure and the patient previously received the flu shot on an unspecified date (6 years ago) for immunization and 8 hours after the vaccine was achy, sick, in bed for 9 days. Developed bronchitis and coughed so hard she cracked her ribs. Stated her ribs were still sore at times to this day. The patient stated that she would never get another flu shot and that her doctor agreed with her on that decision. On 25Mar2021 the patient experienced headaches, dizziness, dizziness comes and goes but it affects her vision, numb, head feels fuzzy/fuzziness is constant and eyes are crossing. The patient stated that she got her second dose of the vaccine on 24Mar2021. She reported that after her first shot she was fine. She stated that she started having headaches and dizziness the day after her second vaccine and this had lasted for 14 days. It has gone on now for several weeks and was not getting any better. She felt her symptoms went in different degrees at different times of the day. She might go one day without a headache. Today her headache was more like a numbness all around her head. She stated that her headaches come and go, sometimes start when her eyes pop open in the morning or at 10 AM. If she was going to have a headache that day, it usually started by 10 AM and was a full-blown headache. Stated her head always fely fuzzy and woozy and sometimes she felt like her eyes were crossing. She stated that she never got headaches; not since her early 20s. Dizziness continued to come and go, but it affected her vision and she was scared to drive and have a wreck. She reported that the symptoms were driving her bonkers. She also reported that she had to hold onto walls when she walked. The dizziness did not go away even when she laid down. She was dizzy when sitting on the sofa. Her head also felt fuzzy and numb, the fuzziness was constant. She reported that she felt disabled and felt like she was turning 100 instead of 77. She cannot lay in bed all the time and wanted to know how long these symptoms would last. The patient denied any labs, testing or treatment relevant to symptoms. She had not been to the doctor or to the emergency room in relation to these symptoms. She stated that she thought about it at times. She stated that she would have to call an ambulance to take her since she was scared to drive. Yesterday she thought she was not doing so bad and drove to the store. She stated that while in the store, her dizziness had her to where she could hardly pay for her items. Stated that it kind of felt like she was drunk, but she was not drunk. The patient stated that her experience with the polio vaccine made her almost not get the COVID-19 vaccine for fear it would bring on a similar situation. The clinical outcomes of the events headaches, dizziness, dizziness comes and goes but it affects her vision, numb, head feels fuzzy/fuzziness is constant and eyes are crossing were all not recovered/not resolved. No follow-up attempts are needed. No further information is expected.

March 10, 2021 I received my second dose of the Pfizer vaccine and the following day I experienced the predicted side effects of fever, chills, headache, fatigue and lack of appetite, which were all mild and I took Tylenol for the fever. The following day I was fine. After approximately two weeks I noticed there were subtle and unusual changes regarding my appetite, energy level an itchy rash on my back and a runny nose. I didn?t pay much attention to any of these as they weren?t debilitating symptoms, but very unique for me. Then I realized I needed to pay more attention to these symptoms as they were getting more significant, except for the fact I didn?t have a fever. Also my ears felt they were blocked. I thought perhaps because of the feeling of blocked ears I may be getting a sinus infection although I haven?t had one in years. I called the doctor?s office on April 5th and I was told to go to the Urgent Care, which I did. I was examined and given a prescription for a nasal spray, antihistamine and an antibiotic in case symptoms became more severe. It was also suggested that I may want to have a Covid test. I?m not used to taking any medications except for Trazodone, and was reluctant to take what was prescribed because if it was indeed a sinus infection it wasn?t in line with any I?d had years ago. I used the nasal spray for a few days and also the antihistamine. The headache got worse, and would move from one area of my head to another and also down the side of my face and neck. Tylenol didn?t help and Ibuprofen only helped now and again. The headache had a mind of its own. Warm compresses did help. I was in contact through the portal for recommendations from the medical staff.

Left side of face paralysis- eyebrow, eyelid and mouth, pain in left ear. Symptoms left after 2 weeks.

tinnitus; joint pain; headache; extreme fatigue; chills; then fever; This is a spontaneous report from a contactable consumer (patient). A 76-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number: EL9266), via an unspecified route of administration in left arm on 26Feb2021 at 07:15 AM as single dose for COVID-19 immunization. Patient previously took first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number: EL9262), via an unspecified route of administration in left arm on 05Feb2021 at 07:00 AM at single dose for COVID-19 immunization. Medical history included high blood pressure, arthritis. Patient had known allergies. Concomitant medications included lisinopril, calcium, ergocalciferol (VITAMIN D[ERGOCALCIFEROL]), naproxen sodium (ALEVE). The patient was not diagnosed with COVID-19 prior to vaccination. The patient was not tested for COVID-19 since the vaccination. Patient was not pregnant at the time of vaccination. On 26Feb2021 at 08:00 PM, patient experienced headache, extreme fatigue, tinnitus, chills, joint pain, then fever. No treatment was received. The outcome of the event was recovering. No follow-up attempts are possible. No further information is expected.

5/2-Pt reports that she still have ongoing sour taste in her mouth and burning tongue sensations, and especially when she consume something spicy the upper part of her mouth hurts. Her lips also have burning sensations. Pt reports she had been seen by her PCP, ENT and Dentist and was prescribed antibiotic, cream for her lips, and even had her the crowning in her mouth changed out and still none of these provide any relief (pt does not have info on the names of the antibiotic or cream prescribed). Pt reports she had even tried mouthwash for dry mouth and still no relief. Pt reports when she drink water the burning feels less, and when she have candy in her mouth it seems to help with the sour taste. 5/5-Patient returned call and is still experiencing burning of the tongue, it has not subsided and has not decreased in sensation. Patient voiced making an appointment with ENT doctor but unsure of when an appointment will be available. She reports once appointment has been made she will follow up with covid hotline.-JD

Not focusing very well; Totally dizzy and unable to walk very well because of the dizziness; Totally dizzy and unable to walk very well because of the dizziness; Nauseous; This is a spontaneous report from a contactable consumer (patient) for herself. A 76-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 Vaccine, Lot Number: EW0150), dose 1 via an unspecified route of administration, administered in Arm Right on 12Apr2021 13:30 as a single dose for COVID-19 immunization. Medical history included ongoing diabetes mellitus: Diabetic. Concomitant medications included metformin; acetylsalicylic acid (ASPIRIN); calcium carbonate, colecalciferol (VITAMIN D 2000), and Cholesterol Pill, Blood Pressure Pill (unspecified); all taken for an unspecified indication, from an unknown date and ongoing. The patient experienced totally dizzy and unable to walk very well because of the dizziness on 13Apr2021 with outcome of recovered on 14Apr2021, nauseous on 13Apr2021 with outcome of recovered on 14Apr2021, not focusing very well on 15Apr2021 with outcome of not recovered. Treatment included drinks a lot of fluids. The report is not related to a study or programme. She received the vaccine on Monday 12Apr2021 at 13:00. She drank a lot of fluids and ate and went to bed and slept a full 8 hours straight. When she woke up, she was totally dizzy and unable to walk very well because of the dizziness and she had a nauseous feeling, but never vomited. Stated that was on Tuesday and lasted most of the day, sort of subsiding towards evening. When she woke up, she was still dizzy. She was not focusing very well. There was no history of all previous immunization with the Pfizer vaccine considered as suspect. No AE require a visit to Emergency Room or Physician Office. There was AEs following prior vaccinations. No Prior Vaccinations (within 4 weeks). No vaccines were administered on same date of the Pfizer Suspect. No follow-up attempts are needed. No further information is expected.

1/2 hr after receiving dose my throat and tongue swelled up; 1/2 hr after receiving dose my throat and tongue swelled up; My chest started bothering me and I was short of brreathe.; Sore throat; This is a spontaneous report from a contactable consumer (patient). A 76-year-old non-pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number and Expiration date was not reported) via an unspecified route of administration, in right arm on 08Mar2021 10:30 as first dose single for covid-19 immunisation. Medical history included known allergies to various chemicals, foods, red dyes, high blood pressure and AFIB. Concomitant medications included hydrochlorothiazide, lisinopril, apixaban (ELIQUIS), montelukast, duloxetine and metoprolol tartrate all are taken for an unspecified indication, start and stop date were not reported. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. Patient reports a half hour after she left the facility, she started getting a sore throat, then her throat and tongue swelled up. A little later my chest started bothering me and patient was short of breath on 08Mar2021 11:00 AM. Patient states she is getting better very slowly. This lasted all night and started to ease up the next day. patient took some Benadryl and that helped. As per the reporter seriousness criteria reported as medically significant. Patient received treatment that patient took of Benadryl and she has an inhaler. The outcome of the events was recovering. Follow up needed and additional information has been requested.

Runny nose, cough, post-nasal drainage, sneezing, itchy/watery eyes Alka-seltzer plus hot caramel tea with honey

After vaccine on Wednesday three fingers on my right hand went numb and my mouth felt like I had a shot of Novocain, then my tongue had a little tingling. I texted my doctor and he said to go to the ER and they checked me out did EKG, blood work, CAT scan, covid test that was negative and I was admitted. I got an MRI and did other urine test, I was being checked every hour. I was given Plavix and other meds and was told that I had a stroke/TIA.

Cough Fever, unspecified fever cause Loss of taste Loss of smell Nasal congestion Acute nonintractable headache, unspecified headache type

Dry Mouth; This is a spontaneous report from a contactable consumer (patient). A 76-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Left on 17Feb2021 15:45 (03:45 PM) (Batch/Lot Number: EM9809) as 2nd DOSE, SINGLE for covid-19 immunisation. The patient is not pregnant at the time of vaccination. The patient had no other vaccine in four weeks and taking other medications in two weeks (unspecified medications). The patient has no covid prior vaccination and not covid tested post vaccination. Medical history included Osteoporosis, pre-COPD and allergy to dye used in treadmill test all from an unknown date and unknown if ongoing. The patient previously took vicodin and experienced allergies. The patient also previously took bnt162b2 (Lot: EL9262) first dose on 27Jan2021 15:45 (03:45 PM) administered in Arm Left for covid-19 immunisation. It was reported that the patient experienced Dry Mouth on 19Feb2021 12:00 PM. No treatment was given for the reported event. The outcome of the event was not recovered.

Patient complained of blurred vision & dizziness after leaving the observation room. BP 87/58, HR 94, R 18, T 98.6, O2 sat 97%. Patient was given water and crackers. Vitals were rechecked. BP 110/69, HR 93, R 18, O2 sat 95%. Patient stated she was feeling better and was discharged and escorted to family car driven by sister.

very exhausted; sleeping a lot/sleeping all the time; bottom neck area to ache; not able to eat anything; mouth was very dry; achy body and lower back/felt aches and pains; achy body and lower back; went through was some kind of flu; it was hard to sleep at first; kids are watching over her, clean up stuff and doing laundry and all that; Arm hurt; discomfort; feet hurt; she could not walk; felt weak/she could not push herself up, her arm and legs would not push her up; more off balance/balance got worse; could not almost stand up; terrible stomach pains at went up and down her stomach; This is a spontaneous report from a contactable consumer (patient). A 76-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in the left arm, on 26Apr2021 (lot number: ER8731), as 1st dose, single dose, at age 76 years old, for COVID-19 immunisation, at a pharmacy/drug store. The patient medical history and concomitant medications were not reported. Historical vaccine included a flu shot for immunization and experienced hives after. In the evening of 29Apr2021, when the patient was about to go to bed, she experienced terrible stomach pains at went up and down her stomach. She almost called the ambulance. For the next 14 days (dates unspecified), she was very exhausted, was sleeping a lot/sleeping all the time causing the bottom of her neck area to ache, she was not able to eat anything for 2 days (I would just have 'brock' and cheese and crackers something easy), her mouth was very dry she had to keep hydrating, had an achy body and lower back, felt aches and pains, her feet hurt she could not walk, felt weak which made her more off balance/balance got worse (pending clarification) causing her to use a walker just to be careful. The patient stated that what she went through was some kind of flu which knocked her out, she was sleeping all the time and mentioned that it was hard to sleep at first. At one time (unknown date), as she woke up from her nap, she could not push herself up, her arm and legs would not push her up and had to be assisted by her grandson. The patient could not almost stand up. The patient reported that her kids are watching over her, clean up stuff and doing laundry and all that. The patient also experienced discomfort and her arm hurt on an unspecified date. On 13May2021, she had her first real small meal. She stated that she avoided taking medications until she gave in and took Tylenol for "bottom neck area to ache", "achy body and lower back/felt aches and pains", "feet hurt", "arm hurt", and discomfort. She stated, "I was very happy after getting the shot, I felt very good but after some days I felt like I was going to die here, should I call the ambulance, what going on with my stomach, and that's was shocking for me." The patient asked if what she experienced was normal and if she should get the second dose. The patient was recovering from the events (reported as "she was coming out of it"). Follow-up attempts are needed. Further information is expected.

she experienced dizziness; dry cough; Headache; Sneezing; No taste; Nausea; Extremely tired; This is a spontaneous report from a contactable consumer (patient). A 76-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 1 via an unspecified route of administration on 28Jan2021 (Batch/Lot number was not reported), age at vaccination of 76-years-old, as single dose for covid-19 immunisation. The patient medical history was and concomitant medications were not reported. Between the first shot (28Jan2021) and the second shot (on 18Feb2021), the patient experienced dizziness, dry cough, headache, sneezing, no taste, nausea, and was very tired/ extremely tired. Outcome of the events was unknown. No follow-up attempts are possible. No further information is expected.

pt says that she has a tremendous amount of body and muscles aches with extreme fatigue. She already had numbness and tingling throughout her entire body (including lips and face) but became much more severe in April. In the last couple of weeks she has developed rashes on various parts of her body. Pt had appt w/ PCP. She had blood work that was negative and was referred to a Rheumatologist. On 6/3/21 she went to another doctor. She had more blood work. Pt is waiting on results. She also went to see another doctor. She had more blood work and waiting on these results. She has an appt Neurologist. She also had swelling with her gums for a couple of days. She has a very foggy feeling like she is spaced out. She feels like her vision has been impaired. She still feels bad most days saying the her symptoms come and go and she has felt this way since taking the vaccine. She has headache that come and go for the last couple of weeks.

She had high Blood pressure yesterday; Second dose administered on the Left Arm, her arm did hurt a little on 06Feb2021, the day she got this dose; started getting hungry; she was 127lbs, probably because of the swelling, but she is usually 119lbs or 118lbs; swelling under her eyes/eyes started getting swollen; face was swollen; Eye infection; face felt tight; This is a spontaneous report from a contactable consumer (patient). A 76-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot: EM9810; NDC number: Not Provided Expiry Date: Unknown) via an unspecified route of administration on the left arm on 06Feb2021 at 8:31AM (at the age of 76 years), as a 2nd dose, single dose for COVID-19 immunization. The patient medical history included disc protruding (diagnosed before the covid vaccine in Jun2020 or around that, she recalls having several months of MRI's in 2020) and high blood pressure. The patient's concomitant medications included Epidural Shot (Verbatim) for Protruding Disc Patient on 27Jan2021 (she had to go to the doctor in the clinic and get epidural shot in the back at the disc thats protruding). Historical Vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot: EL3249; NDC number: Not Provided, Expiry Date: Unknown) via an unspecified route of administration on the left arm on 16Jan2021 at 12 PM (noon) as 1st dose, single dose (at the age of 76 years) for COVID-19 immunization. Clinical course: She took second dose of Pfizer Covid Vaccine on 06Feb2021, though she had no reaction initially. A week later from vaccination on Feb2021, she then began to notice her eyes started getting swollen couple days after, she then felt like her eyes felt like they were closing, then she saw her whole face was swelling, it looks like she had Chipmunk cheeks. She went to the doctor hoping it would go away, she was prescribed Benadryl and a decongestant as treatment. She takes Benadryl three times a day and the decongestant in the morning and her face is still swollen. It started with the eyes and the bag under the eyes, that was the first thing she noticed. She laughs and though she initially had an eye infection. She just wants to know if there is any other reports of this happening, or how to get rid of it, this has been there since she got her second dose on the 06Feb2021 since like 10Feb2021. After the second vaccine on 06Feb2021 around that time an hour later, she was on the way home and started getting hungry, she thought that was a symptom as well as her arm hurt a bit. She was starving till Monday got up 2AM, 6AM ate all day Sunday and Monday ate all day, as reported "all she knows is she was craving a crab sandwich." Her Eyes swelling started a couple days later and the Face swelling was either the second week or same time, she just recalls looking at the eyes. She recalls telling her son her face felt tight in Feb2021. At the doctors appointment she was 127lbs, probably because of the swelling, but she is usually 119lbs or 118lbs, she is a small girl. The Appointment with the doctor was yesterday (15Mar2021), they prescribed Benadryl. Patient clarified that she was not Prescribed Zyrtec, it was a decongestant but she does not know the name of it. The Druggist however told her she could take another medication also. As reported "The eye swelling and face swelling, at the moment she look like she been drunk, her face is plentiful, she is still swollen, her lids are not bad, but it is ongoing, it has gotten worse because prior she didnt even know it was there and its showing more now. She asked son if he thought she was swollen because she feels tight, over the weekend her face being swollen was noticeable, she is noticing people are pointing it out now." She adds her arm did not hurt with first dose. Second dose administered on the Left Arm, her arm did hurt a little on 06Feb2021, the day she got this dose and the next day (07Feb2021). She thought initially that she didn't have any side effects. She had High blood pressure yesterday (15Mar2021), but that usually goes up and down for her and nothing new. It was reported that, a week later, patient experienced swelling under her eyes, face was swollen, eye infection and face felt tight on Feb2021; hunger and vaccination site pain on 06Feb2021 (reported as the day she got this dose); hypertension on 15Mar2021 (reported as yesterday). Patient would like to know if swelling of the face is a reported side effect from the covid vaccine, how long her side effects from the covid vaccine will last and asking for suggestions on how to get rid of the side effects from the covid vaccine. The outcome of event vaccination site pain was recovered in Feb2021 (duration of event was 2 days), swelling under her eyes, face was swollen was not recovered while outcome of other events was unknown. Follow-up attempts are completed. No further information is expected.

get more blisters in her mouth; progressed to two blisters, one on each arm; This is a spontaneous report from a contactable pharmacist. A 76-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on 19Jan2021 (Batch/Lot number was not reported), at the age of 76-years-old as 1st dose, single; and dose 2 via an unspecified route of administration on 10Feb2021 (Batch/Lot number was not reported) as 2nd dose, single for COVID-19 immunization. Medical history included mucous membrane pemphigus. Historical vaccines included shingles vaccine and pneumonia vaccine on Nov2020 and flu shot on Dec2020; all taken at the age of 76-years-old. The patient's concomitant medications were not reported. The patient received her first shingles vaccine in November as well as pneumonia vaccine. She received Flu shot in December. She waited a month after second dose of product before receiving second dose of Shingrex. She knows vaccines can cause flare up of her historical condition of mucous membrane pemphigus and has been controlled with very low dose dapsone and under control for two years. She stated she started to get more blisters in her mouth and was prescribed dexamethasone wash. Then progressed to two blisters, one on each arm. Referred to her dermatologist who indicated she has seen the condition progress/ in those whose who are fully vaccinated. The outcome of the events was unknown. Information on the lot/batch number has been requested.

Patient received second dose of Covid 19 vaccine at 10:15am. Patient was asked to wait 15 minutes and report any adverse events. She stated she was experiencing blurry vision. Patient was asked to wait another 15 minutes and then she stated she was ok to return home. Called to check on patient at home. Patient stated she still had blurry vision

Heart pounding, palpitations day 3-4. Decreased hearing after shot #2 given on 03/29/2021. Increased joint pain in right hip after second shot. Noticed pain increase about first week of May, 2021.

Do not take the second dose; I will not be able to be fully covered; Started shaking specially my hands; I started to feel very giddy; My tongue started to swell up badly; This is a spontaneous report from a contactable consumer (patient) or other non hcp. A 76-years-old female patient received first dose of bnt162b2 (BNT162B2, Solution for injection, Batch/Lot Number: EP6955), via an unspecified route of administration, administered in Arm Left on an unspecified date as 1st dose, single dose for covid-19 immunisation. The patients medical history and concomitant medications were not reported. She had many vaccines in her lifetime. The Pox vaccine to live in abroad when she was young. Then vaccine to live abroad to work. Then another country and then in another country. She had so many but she never had any reaction to anything. On 22Mar2021, the patient had started shaking specially her hands and then within the first 15 minutes then it was okay and then she started to feel very giddy like she had several glasses of champagne and then her tongue started to swell up badly. The events were considered serious as medically significant events. Patient received Benadryl as treatment for the events. On an unknown date, patient stated that she definitely do not take the second dose. So, she will not be able to be fully covered. It was reported that patients doctor send her to an allergist to see if she should take the second dose. She told that she had even get a the green pass and who knows if she could take anymore vaccine that are created for the mutant strains of this virus. Further, this was a very severe reaction, and she was on the first one not even the second one and its not acceptable. Patient stated that there are people that did not have allergic reaction to anything before in their life. These things nothing, scorpion bite nothing and this was a huge surprise. They need to know this kind of things all this other stuff. It was reported that patient was not experiencing the problem or symptoms. At the time of report, patient was recovering from the events shaking specially my hands, started to feel very giddy and tongue started to swell up badly without hospitalization. The outcome of the event Do not take the second dose; I will not be able to be fully covered was unknown and for other events was recovering. Information about batch/ lot number has been requested.

she lost her sense of taste.; she had a bad UT infection; This is a spontaneous report from a contactable consumer or other non hcp. A 76-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Left on 23Feb2021 (Batch/Lot Number: Pfizer6203) as 2nd dose, single for covid-19 immunisation. Medical history included blood pressure, diabetes type II from an unknown date. Concomitant medication(s) included ATORVASTATIN; acetylsalicylic acid (BAYER ASPIRIN); CLOPIDOGREL 75mg; ubidecarenone (COQ-10); FLUOXETINE; FISH OIL; GABAPENTIN taken for fibromyalgia,METFORMIN taken for diabetes mellitus; PANTOPRAZOLE; PRAMIPEXOLE taken for restless legs syndrome; VALSARTAN taken for blood pressure abnormal,VITAMIN D3; VITAMIN C [ASCORBIC ACID;BIOFLAVONOIDS NOS;HESPERIDIN;MALPIGHIA GLABRA;ROSA CANINA;RUTOSIDE] taken for an unspecified indication, start and stop date were not reported. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On an unspecified date in 2021, the patient experienced she lost her sense of taste and she had a bad UT (urinary tract) infection. Caller stated patient received her first Pfizer Covid-19 vaccination bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Left on 03Feb2021 10:30 (Batch/Lot Number: EL9265) as 1st dose, single for covid-19 immunisation. On 04Feb2021 she lost her sense of taste. Caller stated, and still to this day patient didn't have it. Caller stated she received her second Pfizer Covid-19 vaccine on 23Feb2021. Caller asked, she want to know when will she get her taste back. How long would this last. She still can't taste anything. Is that a side effect and for how long. She went to the doctor yesterday. They said she had a bad UT infection. They gave her a shot. Caller doesn't know the name of the shot she was given. Maybe it was an antibiotic. She did ask the doctor about not being able to taste, but the doctor didn't know. She had asked lots of people and doctors, but no one knows. The patient underwent lab tests and procedures which included weight was 175 or 176 lbs on unknown date. Therapeutic measures were taken as a result of she had a bad UT (urinary tract) infection which include antibiotic. The clinical outcome for event she lost her sense of taste was not recovered while outcome for the event she had a bad UT infection was unknown. No follow-up attempts are possible. No further information is expected.

chills; the glands in her neck, under her chin were swollen and hurt a little; below knee and feet and toes are crampy; Her mouth has been dry and drinking more water; Her body just feels achy; injection site is sore; does not feel well; her tingling in her legs from the knee to the toe; the glands in her neck, under her chin were swollen and hurt a little; sore arm; weight is a little low at the moment; This is a spontaneous report from a contactable consumer reporting for herself. A 76-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot Number EM9810; Expiration date: not reported), dose 1 via an unspecified route of administration, administered in left arm (in the muscle in upper arm) on 03Feb2021 (at the age of 76-years-old) as first dose, single for prevention. The patient's medical history and concomitant medications was none. After receiving the first dose, in the afternoon the patient started experiencing side effects of chills, pain in the injection site, the glands in her neck, under her chin were swollen and hurt a little, a very dry mouth and her tingling in her legs from the knee to the toe. The next day morning sore arm was better, but still experiencing the other side effects. Patient was concerned and would like to know if they were normal. The patient reported that she just got the first dose 03Feb2021 and scheduled for second dose on 24Feb2021. Her weight was a little low at the time of report as she was getting dental work done. Patient went to the site and it did not give anything in terms of if anything happened or what to expect. Patient had chills, and the glands around her neck were swollen. The injection site was sore, but she expected that. Her legs below knees and feet are crampy. Because of her age and lives alone, patient just wanted to know if this was normal. Her mouth was very dry and had been drinking water with lime she squeezed in it. This started after she got vaccinated around 11:00-11:30. Patient just wanted to know what was normal and what was not. She took temperature and does not have a temp 98.1. She just was feeling like she did not feel well. Patient wanted to know if this would pass. The place she got the vaccine, they did not give her any information except the date to return. Patient reported the day before reporting was worse. Her glands were still swollen, but not as bad. Her feet were still crampy and the toes, body just felt achy. Patient would like to know if these symptoms were normal and what the time frame was that she should expect them to continue. Investigation assessments included none. The outcome of the events chills, the glands in her neck, under her chin were swollen and hurt a little, her mouth has been very dry and drinking more water, her body just feels achy, injection site was sore and sore arm was recovering; event of below knee and feet and toes are crampy was not recovered; other events was unknown. Follow-up attempts are completed. No further information is expected.

She has also has dizziness; She is pitching forward like vertigo; The dizziness got much worse this weekend; Memory issues; Confusion; Weakness in her legs; Pain in the back of her head, neck and above the ear and up to her skull; Pain in the back of her head, neck and above the ear and up to her skull; Pain in the back of her head, neck and above the ear and up to her skull; Nausea; Not feeling right, very tired; Not feeling right, very tired; This is a spontaneous report from a contactable consumer. A 76-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection), dose 1 via an unspecified route of administration, administered in arm left on 27Jan2021 16:30 (Batch/Lot number was not reported) (at the age of 76-year-old) as single for covid-19 immunisation. The patient medical history included digestive system, blood thinner, acid, high blood pressure, diverticulitis she went into the hospital in 12Nov2020 or 13Nov2020 for an emergency for diverticulitis and then while she was there, she was sleeping and when she woke up, she had atrial fibrillation. They did the electric shock to get her heart back without sedation and that had an effect on her. Mentions she had another episode of atrial fibrillation about three years before, but it went back on its own. She was also diagnosed with diabetes mellitus at this hospitalization on an unknown date in 2020. Concomitant medications included famotidine for acid at 40mg twice a day via oral, lisinopril at 5 mg via oral for twice a day taken for high blood pressure, metformin at 500 mg daily via oral taken for diabetes mellitus, metoprolol at 25 mg daily via oral taken for blood pressure measurement, lactobacillus acidophilus (PROBIOTIC ACIDOPHILUS [LACTOBACILLUS ACIDOPHILUS]) daily (expiration date: Jul2022, Lot number: WHD204) for digestive system, rivaroxaban (XARELTO) since on an unknown date at 220 mg daily via oral taken for blood thinner. The vaccination facility was a medical centre. The vaccine was not administered at (name) facility. History of all previous immunization with the Pfizer vaccine considered as suspect was none. No additional vaccines administered on same date of the suspect product. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient states she just wanted to report an experience after the vaccine. On 27Jan2021 (Wednesday) she went to the place for vaccination. It went very smoothly, and she didn't feel anything. The patient mentioned that she thought maybe it was her medicine and stopped taking her over the counter probiotic. The patient had problems, so she stopped this a couple of days before for the over-the-counter probiotic she stopped. On an unspecified date, in hindsight she thought some of the effects she was experiencing might be related to the vaccine. She was not sure if she was allergic to her usual medications or not. On 28Jan2021, the patient reports she had a lot of nausea; and not feeling right as in very tired. She didn't connect it to the vaccine. She thought maybe it was her medicine and stopped taking her over the counter probiotic. On 31Jan2021, she reported that weakness in her legs, pain in the back of her head, neck and above the ear and up to her skull. On 01Feb2021, she had worst memory issues and confusion. On an unknown date, she stated that she had had a lot of trouble with confusion doing her check book and questioning things that she did not do usually, and she also has dizziness and feeling like pitching forward like vertigo. On an unspecified date, the patient reported dizziness got much worse this weekend. She was supposed to get the next dose on 17Feb2021. The patient visited physician office. The outcome of the events the dizziness got much worse this weekend, she is pitching forward like vertigo was unknown. The outcome of the events pain in the back of her head, neck and above the ear and up to her skull was resolving whereas other events was not resolved. Follow-up attempts are completed. No further information is expected.

Several days after my second dose I developed double vision. My right eye has moved upward and to the side (strabysmus) and I can?t see without. Patch on that eye. I am seeking care from a neuro-ophthalmologist, hoping to be treated with a newly approved drug, Tepezza.

Swollen lips; Swollen neck; This is a spontaneous report from a contactable consumer, the patient. A 76-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: Unknown) via an unspecified route of administration in the right arm on 20Mar2021 at 14:00 (at the age of 76-years-old) as a single dose for COVID-19 immunisation. The patient's medical history included type 1 diabetes. The patient did not have any allergies to medications, food, or other products. Concomitant medications included NORVASC, LANTUS, lisinopril (MANUFACTURER UNKNOWN) and atorvastatin (MANUFACTURER UNKNOWN). Prior to vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccination. On 21Mar2021 at 08:00, the patient experienced swollen neck and lips. 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 patient did not receive any treatment for the adverse events. The clinical outcome of the swollen neck and lips was not recovered at the time of this report. Information about lot number cannot be obtained. No further information expected.

A raised painful red papule surrounded by inflamed purple tissue on the dorsal surface of the tongue anteriorly along with greatly diminished taste; a raised painful red papule surrounded by inflamed purple tissue on the dorsal surface of the tongue anteriorly along with greatly diminished taste; a raised painful red papule surrounded by inflamed purple tissue on the dorsal surface of the tongue anteriorly along with greatly diminished taste; a raised painful red papule surrounded by inflamed purple tissue on the dorsal surface of the tongue anteriorly along with greatly diminished taste; This is a spontaneous report from a contactable physician. A 76-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot Number: EL9265), intramuscularly, administered in Arm Right on 05Feb2021 at 12:00 (at the age of 76-year-old at vaccination) as a Dose 2, single for COVID-19 immunization. The patient was non-pregnant during vaccination. The patient' medical history included ablation for atrial fibrillation (AFib) from Mar2020, Hypertension, Hypothyroidism, Lymphoedema, Anaphylactic reactions to mango, pistachio, shellfish, glossitis and Glossitis to Sulfa drugs and the patient was inserted with Dual-chamber pacemaker May2021 for 3rd degree heart block. The patient' concomitant medication(s) included cyanocobalamin [B12], bioflavonoids NOS, lecithin, quercetin, ubidecarenone (CO-Q-10 PLUS), colecalciferol (D3), diltiazem, disopyramide, azilsartan kamedoxomil (EDARBI), furosemide (LASIX), levothyroxine sodium (SYNTHROID), hydrochlorothiazide, triamterene (TRIAMTERENE/HCTZ), rivaroxaban (XARELTO) within two weeks covid-19 vaccination. The patient's past medications included levofloxacin (LOVENOX) and Arixtra. The patient had bleeding and swelling because of Lovenox and Arixtra use and allergic to both the drugs. Vaccination facility type was reported as Clinic. The patient was not infected with Covid prior vaccination. The patient was not on any other vaccine in four weeks prior to Covid-19 vaccine. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot Number: EL3248) via unspecified route, administered in Arm Right on 11Jan2021 at 15:30 (at the age of 76-year-old at vaccination) as a Dose 1, single for COVID-19 immunization. On 07Feb2021 at 08:30 PM, the patient had a raised painful red papule surrounded by inflamed purple tissue on the dorsal surface of the tongue anteriorly along with greatly diminished taste. Symptoms started about 55-60 hours after 2nd Covid-19 vaccine injection. Both papule and diminished taste are present and unchanged 72 hours after vaccination. The AE resulted the patient to visit Doctor or other healthcare professional office/clinic visit. The patient was not covid tested post vaccination. The patient had not received any treatment medications for the resulted events. The outcome of the events was not recovered. Follow-up attempts completed. No further information expected.

Stroke. MRI shows small blood clot. in lower back of brain leaving a small blank spot in my vision in upper right

Cellulitis / Cellulitis in her leg; the right eye was sensitive to light; her eyes kept fluttering; It is still draining and is still a little red; It is still draining and is still a little red; right side of the face was swollen; both of her eyes were swollen; This is a spontaneous report from a contactable consumer or other non HCP (patient, self-reporting). A 77-year-old patient of an unspecified age received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: EL9266 and expiration date was not reported), via an unspecified route of administration in arm left on 09Mar2021 at 16:30 (at the age of 76 years) as a dose 2, single for COVID-19 immunisation. infliximab (REMICADE), via an unspecified route of administration from 27Apr2021 (Batch/Lot number was not reported) and ongoing, at unspecified dose for crohn's disease. Patient's medical history included ongoing crohn's disease, She's had it for about 3 years, immune system disorder from an unknown date and unknown if ongoing, She has low immunity, skin cancer from an unknown date and unknown if ongoing, She had skin cancer. The patient's concomitant medications were not reported. The patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: EL9265 and expiration date was not reported), via an unspecified route of administration in arm left on 17Feb2021 as a dose 1, single for COVID-19 immunisation and remicade for crohn's disease. Additional vaccines administered on same date of the Pfizer suspect If applicable, list all vaccines administered on same date with the Pfizer vaccine considered as suspect was none. Any other vaccinations within four weeks prior to the first administration date of the suspect vaccine were and AEs following prior vaccinations were none. It was reported that, Patient who had both doses of the Pfizer COVID Vaccine. She had a birthday yesterday (date unspecified), so she was 77 years old when she experienced the events. She had her 2nd dose on 9Mar2021 and had a Remicade infusion on 27Apr2021. After her infusion, both of her eyes were swollen, the right eye was sensitive to light, her eyes kept fluttering while looking up or bending over, and the right side of the face was swollen. This was constantly happening but is now getting better but not completely over. She mentioned that she talked to several doctors and they think that Remicade, since it lowers the immune system and decreases white blood cell count and the vaccine increases the white blood count, it has interfered with the signals with her eyes. She was also hospitalized from 29May2021 to 2Jun2021 for cellulitis and was given some antibiotics and steroids which she thinks helped with her symptoms. She was asking if this has been reported and if this will happen again on 24Jun2021 for her next Remicade infusion. she was taking Remicade before giving her the vaccine. she had concern, would the vaccine affect the Remicade and cause these reactions. Upon follow up, It was reported that, patient had her second dose of the Covid Vaccine on 09Mar2021, and on 27Apr2021 she had a Remicade infusion. Both of her eyes were swollen, and the right side of her face was a little swollen. She wants to know if it could be an effect of the vaccine and if she will experience this again after her next infusion this June. she comes on the line. Her right eye was the worst. When she looked up it started to go closed. If she goes into a bright light it would go closed and bending over it would go closed. It would keep fluttering, and she would have to go sit down and close her eyes until it settled down. It interfered with her activities, and she didn't feel comfortable driving because she didn't know when it would hit her. Every time she talked to a doctor, they acted like she is crazy. It only seemed after the Remicade that this started happening, and now she was due for another Remicade infusion on 24Jun2021. She had some other health issues earlier this month and was put on antibiotics. The antibiotics seemed to help the eye it is not completely gone but better. She was wondering now if she should get the Remicade on 24Jun2021. She had skin cancer, and when they removed it, she got cellulitis in her leg. She was in the hospital for 3 days. She asked the doctor there and they brushed her off. The last day before she came home the nurse came in and wanted to know if she had her shot. She asked the nurse the same question about the vaccine and Remicade, and the nurse said now they ask people before they get the shot if they are on Remicade. The nurse didn't have anyone that said yes. It was seeming like there is some kind of problem with Remicade and the vaccine. That is why she was a little bit concerned about having it again. Event details Both eyes swollen: They were still swollen. It was reported that, Sometimes her right eye will still go closed. It has gotten better. Right side of face a little swollen: It lasted for at least a month. Cellulitis in her leg: That would have started on 21May2021. She went to the hospital on 29May2021 and came home on 02Jun2021. She doesn't know if it went away. She finished her medication on Wednesday, she took the last of the antibiotics they gave her to take at home. It is still draining and is still a little red. She doesn't think it is quite as red, but it is still draining. It is about the same. Along the way she went to Urgent Care. They put her on steroids that didn't help. A couple weeks after she got an infection and they had her on 3 or 4 different antibiotics. She didn't know if one helped, or it was just the Remicade wearing off. She was on 3 different antibiotics. One was Doxycycline and that didn't help. The other one they gave her to take home was Amox Clav 875, and it was 125mg. She took it 2 times a day for 6 days. Both of the antibiotics she took are in amber colored pharmacy vials. She doesn't remember the name of the steroid that she took. She had her first dose of the Covid vaccine on 17Feb2021 and second dose of the Covid vaccine on 09Mar2021. She has been on Remicade for many years, at least 3 or 4 years. Before that she was taking a pill. The Remicade is an infusion. They mix it up when she comes in. She did not know a dosage. She had gone to the eye doctor, and she did a bunch of bloodwork. The patient underwent lab tests and procedures which included blood test and computerised tomogram with unknown details. She doesn't know what bloodwork she did. She also had a CAT scan of her eyes in the hospital. The patient was hospitalized for cellulitis / cellulitis in her leg (cellulitis) from 29May2021 to 02Jun2021. She was in hospital for 3 days. Events did not require a visit to Emergency Room, but Physician Office visit is required. For her eyes she went to Urgent Care, and they said to make an appointment with an eye doctor. Family Medical History Relevant to the events were none. It was the Product Complaint, Product strength and count size dispensed: Amox Clav 185: 125mg strength. Outcome of the cellulitis / cellulitis in her leg was not recovered, both of her eyes were, the right eye was sensitive to light, her eyes kept fluttering, right side of the face was swollen were recovering. Outcome of it is still draining and is still a little and it is still draining and is still a little red were unknown. Information on the lot/ batch number has been requested.

Tingling in my tongue and lower lip; It is like if you put pepper on your tongue, I am feeling it from the tip of tongue to the sides of my tongue like from the tip you go towards you jawline; It is like burning and it started out as tingling; It feels like it is there and there is something wrong; This is a spontaneous report from a contactable nurse. This 76-year-old female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Batch/Lot Number: EL9265, expiration date was not reported), intramuscularly in right upper arm on 02Mar2021 (age at the time of vaccination was 76-years-old) as single dose for COVID-19 immunization. The patient took the shot at 11.30 yesterday morning, got the shot at around 11:10 AM, the patient was asked to wait for 15 minutes and the patient waited for 25 minutes. The patient's medical history included high blood pressure and it was controlled and taking high blood pressure medication, anxiety. The patient's concomitant medications included the patient take Synthroid and Levothyroxine because the patient had thyroid gland removed years ago (not clarified further) and Sertraline, which was Zoloft (not clarified if consumer was taking Zoloft or Sertraline, hence not captured in tab), 50 mg for anxiety. On an unknown date, the patient would reduce it to a burning, yesterday it was more pronounced, and it continued all night, so the patient didn't sleep flat. The patient was not sure if it will get to anaphylactic or anything, it was like put pepper on tongue, that was best description that the patient can give, it was like if put pepper on tongue, the patient felt it from the tip of tongue to the sides of my tongue like from the tip go towards the jawline and it was not under whole tongue, it was right around it and it was like burning and it started out as tingling and sometimes, it does like it did today morning (on the day of reporting), but it was not a severe tingling but it was felt like it was there and there was something wrong (not clarified appropriately further, hence ongoing not checked). The patient did not received any treatment and was just ready to go hospital if the patient had to just in case but there was nothing. The patient had no breathing problem and nothing at all. The outcome of the event was not resolved. The patient was hesitated to get the second dose. The patient just wanted to report the side effect that did not see in the list and all of the literature. No follow up attempts are possible. No further information is expected.

Room began to spin around while I was sitting in, I was so dizzy that I couldn't open my eyes; couldn't lift my head off the pillow/Extreme dizziness for 7 hours. Unable to function or open eyes.; My lips started tingling slightly and my tongue started tingling slightly; tired a little; This is a spontaneous report from a contactable consumer (patient). This is the clone master case and was report 1 of 2. A 76-years-old non pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: EN6205; Expiration Date: 30Jun2021, UPC, NDC number of Covid 19 vaccine: Unknown), via an unspecified route of administration, administered in left arm on 06Mar2021 at 10:45 (vaccination at the age of 76 years) as DOSE 1, SINGLE for covid-19 immunisation. Medical history included supraventricular tachycardia, slight hypertension and high blood pressure. Concomitant medications included atenolol and menthanenine; the patient received both medications within 2 weeks of vaccination and taken for an unspecified indication, start and stop date were not reported. The patient was allergies to medications, food, or other products includes clindamycin, ampicillin, erythromycin and novocain. Vaccination facility type was reported as hospital. The patient stated, patient received my first shot 06mar2021, Saturday and about 15 minutes after the shot, my lips started tingling slightly and my tongue started tingling slightly so they had me sit there extra 15 minutes that was okay, basically no big deal. The problem came in was, now I got the shot at 10 o'clock in the morning, at 7 o'clock in the evening, the room began to spin around while I was sitting in, at 7:45 PM, was so dizzy that I couldn't open my eyes because every time I open my eyes I felt like I was on a carousel it was just going round and round so my husband helped me to bed, helped during the night, this lasted till 4 o' clock in the morning. My concern is what will happen with the next shot. states she tried to open her eyes and could not open her eyes and it was like she was on a carosel and the room was spinning which lasted until 4:00am the following morning and is now completely resolved. The patient stated she was not too much concerned and heard from people that might have happened with them. The sensation on her tongue and lips after the 1st dose of the Pfizer COVID19 vaccine was very slight in sensation and it was completely resolved and did not last long at all and was resolved within a minute. Caller states she was tired a little bit but at her age that happens and she had a full day yesterday and is going to say that her arm did not bother her after the Pfizer COVID19 Vaccine and other people said that their arms bothered them but she did not have that; She has no other patient information to provide. Event dizziness resulted in Doctor or other healthcare professional office/clinic visit. No treatment received for the adverse event. The patient not had covid prior vaccination and the patient was covid tested post vaccination. Prior and since the vaccination, the patient was not diagnosed with COVID-19. The patient underwent lab tests and procedures which included blood test and covid-19; both were negative on 22Mar2021, and reported as In the last 2 weeks, the patient did go for a Covid test because patient supposed to go for surgery on Wednesday to have, had a problem with bladder, it's kind of dropped down on one side. Outcome of the event My lips started tingling slightly and my tongue started tingling slightly was recovered on 06Mar2021 and other was recovered on 07Mar2021 and event tired a little was unknown. Follow-up attempts are completed. No further information is expected.

hearing loss within 13 days both ears, went for a hearing examination to Dr. on May 18th and bilateral loss of hearing with a stuffy ears which has not gone away. I had never seen him before but he said it was very unusual to have both ears lose hearing the same. Nothing wrong with my ears.

headache; dizziness; fever; chills; Strong stomach pains; nausea; vomiting; distorted taste; new blisters on toes; finger pain; armpit pain; fatigue; brain fog; This is a spontaneous report from a contactable consumer, the patient. A 76-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6208) via an unspecified route of administration in the left arm on 10Mar2021 at 16:00 (at the age of 76-year-old) as a single dose for COVID-19 immunisation. The patient was allergic to sulfa drugs, lidocaine, penicillin and mouthwash. Prior to the vaccination, the patient was diagnosed with COVID-19. Concomitant medications included aspirin (MANUFACTURER UNKNOWN) 325mg one pill per day. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EL9269), via an unspecified route of administration in the left arm on 14Feb2021 at 09:45 (at the age of 75-year-old) as single dose for COVID-19 immunisation. 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 11Mar2021 at 08:00 the patient experienced headache, dizziness, fever, chills, strong stomach pain, nausea, vomiting, distorted taste, new blisters on toes, finger pain, armpit pain, fatigue and brain fog. The patient did not receive any treatment for the events. The clinical outcome of the events headache, dizziness, fever, chills, strong stomach pain, nausea, vomiting, distorted taste, new blisters on toes, finger pain, armpit pain, fatigue and brain fog was recovered with sequela on an unknown date in Mar2021. No follow-up attempts are needed. No further information is expected.

Atrium flutter Blurry right eye Shortness of breath July 4 2021 onset. Still in vestigating. Ruled out stroke, glaucoma, no retina damage. At ER on 5th

Tingling sensation on their lips and tongues; head and room spinning; seizure; The initial case was missing the following minimum criteria: unspecified suspect product. Upon receipt of follow-up information on 07Jul2021, this case now contains all required information to be considered valid. This is a spontaneous report from a contactable consumer. A 76-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/Lot Number: EN6205) via an unspecified route of administration, on 06Mar2021 (at the age of 76 years old) as dose number unknown, single for COVID-19 immunisation. The patient's medical history included allergy to many antibiotics wherein the patient got hives or intense vomiting, and an ongoing high blood pressure. Concomitant medication included an unknown high blood pressure medication. The healthcare professional also said for her to stop taking it because of that sensation she had on her lips and tongue. On 06Mar2021, immediately after the vaccination, it was reported that the patient experienced tongue and lips were tingling. The nurse had the patient stayed for 30 minutes longer until sensation disappeared. The patient was admitted to the hospital and did not receive any treatment for the event. 7 hours later, the patient experienced that her head and room was spinning so intensely she couldn't function or open her eyes. The patient's husband wanted to take her to the hospital, but due to COVID, the patient was afraid to go. The spinning lasted for 7 hours. The patient did go to a neurologist to be sure that she didn't have a tumor, the doctor said that she was fortunate that she didn't have a stroke. The patient had an MRI brain scan to be sure she didn't have any prior issues that may have caused that seizures. She never experienced the dizziness and intense length of time. The outcome of the event "tingling sensation on their lips and tongues" was recovered on 06May2021, vertigo was recovered on unspecified date in Mar2021, while for the remaining event was unknown.

loud ringing in ears like crystal shattering two days after vaccine and continuing to present time..Never had tinnitus prior to this

Saturday evening 1/23/21 after vaccine, just all of a sudden from one moment to the next, left hand was very tingly and tight feeling and could not move very easily. A few minutes later her lip from the center left was also tingling, and then spread to entire left side of her body from head to feet, like her left side feel asleep that tingly feeling and numbness. Began to be worried, called 9-1-1 and the EMT reassured her that she was not having a stroke, and told her that they had heard of it before. Still today, Monday 1/25/21, particularly in her left hand which she is not able to use very much. Did take Ibuprofen but nothing else.

patient reports her upper lip began to get numb, feeling like novacaine from the dentist. no swelling or difficulty breathing. then her eyes began to feel dry and her ears feel "swollen inside" but no pain.

Very Soar Arm and tired first day. Second day, Soar Throat when swallowing, Swollen Eyes in the morning when I woke up, increased blood pressure at times and not as stable when walking. Very Tired. Took Benedryl on second day, one in morning and one at night. Seemed to calm symptoms. Soar Throat lasted two days and much better today (day 3). Left Arm also less soar today and stability when walking seems better...

Burning sensation of lips at 14 min post vaccine folliwed by mildly swollen upper lip. Then started feeling ill and lightheaded so reportedto site nurse/ems. Bp 190/100 which I have never experienced before. Bp on diovan 80 mg typically 110/60; without diovan is 140/80 -90. Given 2 benadryl and monitored and given 2 more. About 60-90 min bp 155/90 and I went home. Took more benadryl and bp 134/80 this morning and have not taken ot for 10 hrs but feel ok. No local rx.

Slight swell in face, lips, cheeks; feeling of tightness; redness in face;, some nasal drainage. Similar to reaction to hot peppers. Took 1 Benadryl tablet. Symptoms subsided over 24-hour period.

Patient had first Pfizer dose for the COVID-19 virus on 1/01/2021. on 1/16/2021 patient was tested positive for COVID. she continues with loss of taste or smell.

Switching vision & lightheadness & felt flushed. vitals obtained; water & juice given. started feeling better, continued to observe & walked with pt & rechecked vitals

experienced allergic reactions; her eyes got red; Her eye lids were red; Her eye lids were red, swollen, and puffy.; Her eye lids were red, swollen, and puffy.; cheeks were bright red; This is a spontaneous report from a contactable nurse (patient) reported that a 77-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: EL3249), via an unspecified route of administration on the left arm on 14Jan2021 14:00 at a single dose for Covid-19 immunization. Medical history included that the patient was diabetic and hypertensive; both were ongoing. Concomitant medications included atenolol taken from 14Jan2021 for blood pressure high; pioglitazone hydrochloride (ACTOS) and ongoing metformin both were taken from an unspecified date for diabetes; ongoing montelukast sodium (SINGULAIR) for history of food and drug allergies and ongoing chlorothiazide for diuretic. It was reported that she had the first dose of the covid vaccine on 14Jan2021 and experienced allergic reactions after she left the facility; they were not life threatening but were not pleasant. She realized how bad it was after she got in the car, removed her mask, and looked at her face. She was concerned about getting the second dose. She even took Benadryl 1 hour before getting the shot and still had a reaction. She clarified her allergic reaction to be as her eyes got red. Her eye lids were red, swollen, and puffy. It looked bad. When she got in the car took her mask of her cheeks were bright red. She sat in the ER parking lot for an hour waiting for it to resolve. It resolved after like an hour and half. After it resolved and went away she went back home. She stated that this allergic reaction is anxiety producing. She gets anxious because she knew what could happen. The outcome of the events was recovered on 14Jan2021.

couldn't sleep; sudden hearing loss; complete hearing loss a few days later/hearing loss in right ear; constant humming in her right ear/getting hissing in my ear; arm felt tender; This is a spontaneous report from a contactable consumer (patient). A 77-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number was either: EL1283, CL1283, or LL1283) on 11Jan2021 at 11:00 at single dose in left arm for COVID-19 immunization. Medical history was none. There were no concomitant medications. Patient previously took pneumonia shot on an unknown date and flu shot in Oct2020 for immunization. Patient got the first dose of the vaccine on 11Jan2021 at 11:00 in the morning. On 11Jan2021 her arm felt tender where the needle went in.On 12Jan2021 late afternoon, she started getting hissing in her ear that was still there and had not gone away at all and she also had a constant humming in her right ear. By 13Jan2021, she still had the humming. She saw an ENT on 13Jan2021 and doctor didn't know if it was correlated to the vaccine or not; doctor took some wax out of her ear and she seemed to get relief from the hissing for about 15 minutes but about 15-20 minutes later the hissing/ humming continued. On 14Jan2021, woke up with complete deafness in right ear. Immediately called ENT doctor and did a hearing test. Patient could not hear and they confirmed she had sudden hearing loss in her right ear on 14Jan2021, she had nothing in her right ear (as reported). They put her on 40 mg a day of Prednisone (20mg tablets) and so far, prednisone hadn't done anything: originally taking prednisone 40mg for four days and was taking two a day; on 16Jan2021 when she was getting no relief and couldn't sleep due to the humming in her ear, she called doctor and was advised to take the 40mg together in the morning, she will take 40mg a day. On 19Jan2021 she took 20mg for four days and then decreased by half again. She was also advised by doctor to take 25mg Benadryl (UPC: 30048284 Lot: SPS023 Exp: Jun2022) at night. They are scheduling her for an MRI in Jan2021.Patient was also scheduled for the second dose on 01Feb2021 and will be on the prednisone until 26Jan2021; she would like to know whether the prednisone will diminish the effectiveness of the vaccine. She also asked if there was a certain amount of time she should wait to restart in case the doctor decided she should not get the second dose; she also wanted to know if she should wait on the second vaccine and maybe start over in two months.She was concerned and wanted to know if she should proceed with the second shot. The patient underwent blood work on an unspecified date to see if she can receive contrast for an MRI. She never had problem with MRI contrast before. Final outcome of the events was reported as unknown.

On the Friday on the 5th, I went to coffee and on the way home it felt like my lip is swelling. I looked and noticed it swollen. It is still swollen as of today. I just sent a message to my doctor. I have taken some allergy medication that I had and some Benadryl.

Pt developed Shingles after vaccination. Notes from call to PCP day after vaccination: "Since yesterday morning after vaccine after she received her covid vaccine, she noted that her right ear hurts. She says that the pain does not feel like it is in the ear but right around the ear, and the bones around the ear. She says it hurts to chew, and the area to the back of her ear has ringing sound. She does not note that the ear is red . When she rubs under the ear she says the area is painful is painful. She does not note a lump or bump under her ear.. She states that the jaw/bone area hurts with the vibration of the conversation." Sore throat and headache, only on right side. Pain progressed to the point of hospitalization, with vesicles erupting on right side of face/ear canal.

"I started to feel strange". "Funny taste in mouth, dizziness, difficulty swallowing, and not thinking clearly, history of reaction to high dose flu shot, HTN

Pain in the jaw, neck, throat, bilateral lymph pain/swelling, sweating, chills, weakness - neck pain, swelling, lymphadenopathy persist now Taking acetaminophen. At home for now. Also adv warm compresses/drinks for comfort. Adv to FU with HCF trouble breathing or if symptoms persist/worsen.

Pt complained of tingling around mouth after injection.Symptoms quickly resolved. VSS 130/61 67, 99% ; observed for 30 minutes. Counseled to call 911 for any symptoms of anaphylaxis

RECEIVED COVID VACCINE 1ST DOSE ON 02/03/21. REPORTED TO ICC ON 2/12/21 FOR HEADACHE, NO TASTE, FATIGUE, AND CONGESTION. REPORTED COVID EXPOSURE 1 WEEK PRIOR. HAD POSITIVE COVID PCR 02/12/21. RECIEVED BAM INFUSION ON 02/12/21.

Patient received 1st dose of Pfizer Covid19 vaccine today at the Health Department at approx 10:56 AM; pfizer lot number EN5318. Patient has history of feeling 'flushed' after paxil, sulfa, flexeril, codeine; no history of anaphylaxis. Patient alerted the guardsman at 11:09AM that she was experiencing swelling and burning on her face and lips. Nursing and medic staff responded and observed swelling over her right eye and cheek. The medic reported a significant increase in swelling from her pre-vaccinated appearance. BP 118/76. EMS already on site. Epi 0.5mg 0.5ml (Lot 339384) administered RD IM and Benadryl 50mg IM LD administered at 11:11 AM. EMS called for 2nd transport vehicle and arrived at 11:23AM and assumed care of patient. Patient transported to hospital. Called patient on 2/11/2021. Patient stated feeling better. Stayed at hospital and was observed for 4 hours. IV and oral Prednisone given. Still has some facial swelling. PCP recommends not getting second dose.

RECEIVED BOTH DOSES OF PFIZER VACCINE. (01/23/21 & 02/13/21) AFTER 1 DAY (02/14/21) WENT TO ICC REPORTING SUDDEN HEARING LOSS IN RT EAR, LIGHT-HEADEDNESS, AND FEELING UNBALANCED. DIAGNOSED WITH HEARING LOSS OF RT EAR AND HYPERTENSION AND INSTRUCTED TO GO TO ER. WENT ER ON 02/14/21 AND WAS DIAGNOSED WITH ACUTE HEARING LOSS OF RT EAR.

02/05/21 6:00PM total exhausion, chills, headache, joint pain, felt like I had the flu. Also, my eyes seem to have new floaters, and I felt strange in my head. 10:00pm the symptoms continued, but when I got in bed I had terrible nauseau so bad that I couldn't sleep. The next morning my symptoms continued but did not worsen, and then I got so dizzy that I was stumbling. This all continued for three days. On 02/09/21 my symptoms subsided, and I felt normal again

Patient presents to ED with hives and lip swelling. Treated with IV diphenhydramine, methylprednisolone, famotidine, and oral cetirizine. Symptoms improved.

Severe virtigo and intractable nausea requiring ER admission. Sxs ameliorated with Ativan, meclizine, Metachlopramide in ER. Persistent sxs of virtigo, decrease hearing, nausea resolving over several days treated with meclizine, ativan, phenergan, Virtigo improved but still persisting when moving quickly or looking up or down Left frontal discomfort and sinus congestion; hearing returned to near baseline after 10d Steroid 5d dose pack and Augmentin started 2/13 Still unsteady (untrustworthy gait), excess fatigue and fatigability, wt loss, head pain Has not had fever

Itching/hives bilateral axilla. Sensation of lump in throat/itching tingling in throat. EMS on site. Patient's Epi-pen used left thigh. EMS started IV in left AC gave fluids and gave 25 mg Benadryl IV. Vitals monitored. Symptoms improved shortly after medication administration. Med unit transported patient to hospital for further evaluation.

Complained of feeling foggy and a weird taste in her mouth after getting the first dose of the vaccine. transferred to ED via wheelchair.

Immediate blurred vision, numbness in extremities, loss of balance within 1 minute. Confusion of surroundings. Tingling in fingers and feet. Swollen tongue within an hour. No sense of time or place. these last about 30 hours.

3-5 mins post 1st dose vaccination on the left arm, patient began having a "funny taste" sensation on her mouth, tongue, and throat. She had dry mouth and numbness in her upper and lower left lip. She was brought over for observation. Vitals were within normal limit. Neurologic exam was normal. She was given Benardryl 25mg one tab and post administration, the "funny taste" sensation in her mouth resolved but the numbness in her her lips remained for another 20 mins. She reported feeling anxious since she had several deaths in the family within one month. She also admitted to feeling a funny taste in her mouth after getting shots. She denies any chest pain, SOB, wheezing, dizziness or nausea. She declined medical transportation to the ER. She was monitored for over an hour. She was advised to follow up with the ER if worsening symptoms of anaphylaxis. She was informed to follow up with her PCP or allergist for further evaluation prior to having her second dose.

Experienced bad taste in my mouth right away, lips felt weird, breathing very raspy, chills, itching on head, ears, arms, headache, swallowing issues, stuffy nose, sinus pressure, extreme fatigue, dry mouth (felt like cotton in my mouth), temperature dropped. Took about five days to feel okay. Took Benadryl (took twice with six hours between doses, took antihistmine, Levocetiriine, used pro air quite often, 20 mg of Prednisone at 2:30 am on the 22 and finally felt relief. Dr.. was informed after I got better.

Lost hearing in my right ear; This is a spontaneous report from a contactable consumer, the patient. A 77-years-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 from in the left arm on 23Jan2021 at 15:00 (at the age of 77-years-old) as a single dose, for COVID-19 vaccination The patient medical history and concomitant medications were not reported. The patient had no known allergies. On 12Feb2021 at 18:00, The patient experienced lost hearing in my right ear (medically significant). No treatment was given for the event. The clinical outcome of the event lost hearing in right ear was not recovered. Information on Lot number was requested.

Notified by patient that she had "an allergic reaction" to her first dose of the vaccine. "It happened a day later, but I don't know if it was the shrimp I had that day. I was flushed and I got welts, so I went to the urgent care. I was prescribed an Epi-pen by my allergist after following up with them. I feel comfortable getting the second dose." Pharmacist and vaccine clinic lead notified. 30 min after dose given, pt states, "My ears are feeling a little itchy." Vital signs @ 1002: BP 175/80 P 69 O2 97% Temp 98.3 F R 12. VS @ 1007: BP 165/79 P 64 O2 98% Temp 98.4 F R 14. 1015 Pt states, "I'm feeling better and my husband is at home to watch me. I think I was just nervous." Pt declines dizziness/lightheadedness upon standing and declines any itching after second set of VS. Educated pt on strict ER precautions. Pt verbalized understanding and was appreciative for visit.

chills, nausea,metallic taste, half an hour after shot felt sick and had chills bad taste in mouth. lasted that day and next day. felt fine after that

patient c/o cotton mouth, felling like a tight airway. Breath sounds diminished bilaterally, expiratory wheezes. Vital signs 136/88-108 (irregular) O2 Sat 95% History of anaphylaxis . O2 sate decreased to 88% Epinephrine 0.3mg IM administered at 3:09pm. Pt states that feeling of tightness EMS notified and patient transported to hospital at 3:25pm

walks with a cane; she has shrunk; tiredness/ extremely tired; vomited twice; lightheadedness/ Very lightheaded; sore throat/ throat is sore; loss of taste/ She has no taste; swollen and puffy mouth/ mouth swollen/puffy; experiencing dry mouth to the point that she cannot talk/ Dry mouth; can hardly talk; This is a spontaneous report from a contactable consumer (patient). A 77-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: EL3249), on the left arm, intramuscularly, on 23Jan2021 at 14:30 at single dose for COVID-19 immunisation. Medical history included mild case of asthma from an unknown date. There were no concomitant medications. No prior vaccinations within 4 weeks. The patient reported that she received her first vaccine a week ago this past Saturday. She didn't feel anything different until 2 days later on 25Jan2021. She became extremely tired and vomited twice, became very lightheaded, has no taste, throat is sore, mouth seems like it is swelling when she wakes up in the morning, her mouth is puffy. Her mouth is getting so dry she can hardly talk. On a unspecified date, the patient reported that she walks with a cane in her own house, she normally doesn't. But since she has had the shot, she has had to use the cane in her own house, she has shrunk. The reporter did not require a visit to a physician's office or emergency room. She mentions she is scheduled for her second vaccine. The patient was vaccinated on an active aging building. The outcome of the events extremely tired and vomited was recovered, for the events very lightheaded, throat is sore, mouth seems like it is swelling/mouth is puffy, mouth is getting so dry she can hardly talk was not recovered, while for the events has no taste, walks with a cane, and has shrunk was unknown.

Ears are messed up; her ears are swollen on the inside; Running a temperature/low-grade fever; Headache; Nervousness; like a chronic ear ache; infection somewhere/earaches which turned out to be infected; This is a spontaneous report from a contactable consumer (patient). A 77-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL1284; expiry date: unknown) , via an unspecified route of administration in the left arm, on 18Jan2021, at a single dose for COVID-19 immunisation. Medical history included ear problems in the past and sick. There were no concomitant medications. The patient had her first COVID shot on 18Jan2021. By Wednesday, two days later (20Jan2021), both ears were messed up, she was running a temperature (also reported as low-grade fever), had a headache, and was very nervous. She went to the doctor and her doctor gave her an antibiotic shot, two steroid shots, and some antibiotic ear drops, which did not work. She then did a home call with the doctor and she provided more steroids, an oral pack, and an oral antibiotic for 5 days. She was still having problems with her ears. Mainly her left ear. It goes from ear to ear. She went to the ENT about the earaches which turned out to be infected, and has subsequently been on two rounds of antibiotics, with persistent symptoms that have gotten better over time. Patient wanted to know if this could relate to the COVID Vaccine. She has never had this happen before, and she has been really sick but not this bad. She has had ear problems in the past, but normally the antibiotic liquid drops clear it up. It was like a chronic ear ache. Her earaches were hurting bad. What she is wondering is if it could be a side effect from the first COVID shot. She clarifies that her ears are swollen on the inside. It was an infection somewhere. The antibiotics and steroids have not healed it up. All of these events were still occurring but come and go. For instance, yesterday she had a low temperature but has not yet had one today. The antibiotic ear drops prescribed were Neopoly HC OTSC 1% OTIC SU. NDC: 24208-635-62. Expiry date: Jun2022. She was unsure what the lot was but also sees: 349111. The oral antibiotics she has is Amoxicillin 875mg/125mcg. These are in a pharmacy vial. Use before: 26Jan2022. She was given two steroid shots. One shorter acting and one longer acting. She was unsure of the names. Oral steroid pack: Manufactured by Pharmaceutical name. Prednisone USP 5mg. REV 1016. 314518. lot: 1150419. Expiry date: Feb2022. She also pre-treated with allergic reaction medications. She goes back to the ENT on Thursday. Patient wanted to know if these had happened to anyone before. Outcome of the event pyrexia was unknown, for events ear swelling, ear pain and ear infection was recovering, while for the other events was not recovered.

She has been able to eat, but nothing taste that great; had a day and a half of diarrhea; She is having chills occasionally; She feels totally exhausted; she has felt so stupid; she doesn't feel well enough; This is a spontaneous report from a contactable consumer (patient). A 77-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL8982), via an unspecified route of administration at left arm on 27Jan2021 13:50 at single dose for COVID-19 immunization. The patient received the vaccine due to her age and she was due for it. Medical history included fractured ankle. Pateint's height was five two and shrinking. She is on (networking site) with people she went to high school with and they are all getting the shot at same time because of their age. They were all saying they have had no side effects and no symptoms. There were no concomitant medications. The patient read the information they gave her after the shot. Now, she knows why she has felt so stupid. It was all the stuff on the list. On 28Jan2021 about 19:00, she had a day and a half of diarrhea and she was having chills occasionally. On 28Jan2021, she felt totally exhausted. A little bit of everything. She was not nauseous. On 29Jan2021, she has been able to eat, but nothing tasted that great. Even when her son got her what she wanted it still did not taste great. She is coming off a fractured ankle and she is going to have cancel therapy because she doesn't feel well enough to do that. She got the first vaccine on 27Jan2021. It will be a week on Wednesday. On Thursday and Friday she had diarrhea. Serious quantity of Pepto Bismol kept that at bay. The exhaustion has only improved a little. It was good for her to get up and move. No additional vaccines administered on same date of the Pfizer suspect. The adverse events did not require a visit to Emergency Room or Physician Office. No prior vaccinations (within 4 weeks). The outcome of the event diarrhea was recovered on 29Jan2021; events chills and exhausted was recovering; event 'she has been able to eat, but nothing taste that great' was not recovered; and unknown outcome for the other events.

I got my first covid 19 injection on Thursday (2/25) at around 11:30 am, and after about 17 minutes later, I began to have some numbness and tingling around my lips. It lasted about 20 minutes and went away, and I've been fine since.

has not smell or taste a lot of the time; has not smell or taste a lot of the time; sight is not clear; flipped out; her blood pressure went up while she was in the Emergency room; panicked; Lightheadedness; Weakness; felt a little tired at that time; atrial fibrillation/started racing/Heartbeats irregular; anxiety; couldn't breathe/shortness of breath/hard time breathing; it was cold outside by her nephew's graveside, but she felt she had to fan herself like she was overheated; her heart rate was flying; scared; she said it was not a migraine headache like she is used to, but more of a mild headache; This is a spontaneous report from a contactable consumer (patient herself). A 77-year-old female patient received BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine, Batch/lot number: EM9801), via an unspecified route of administration on the left arm, first dose on 04Feb2021 (Administered between 9:30-10:00AM) at single dose for COVID-19 immunisation. Medical history included chronic migraines all her life. She said her migraines have let up as she has gotten older. She also had an irregular heart rate before, saying her irregular heart rate started in her adult life. She said she considered herself more of a "carrier" for an irregular heart rate because her irregular heart rate doesn't happen enough for her to think about it. She said she doesn't have an irregular heart rate now. She said her father had a pacemaker & her 2 brothers had heart problems; her oldest brother passed away from his heart problems & her other brother has blood pressure issues. Patient also had mild asthma as an adult. She said she worked at (name) in a dusty environment, and lived near a landfill, where a lot of her neighbors have gotten sick. She said she needs an inhaler for her asthma. She said when she needs the inhaler, she takes 3-4 puffs at a time. She said she doesn't use the inhaler every day and also mentioned that her grandfather had died of a bad asthma attack. No previous immunization with the Pfizer vaccine considered as suspect. No vaccines administered on the same date of vaccine. No prior vaccinations within 4 weeks. There were no concomitant medications. On 13Feb2021, the patient experienced an atrial fibrillation in which she started racing and couldn't breathe. She mentioned that she recently attended a funeral but attributed the symptoms as side effects of the vaccine. She was taken to the Emergency room where she was given cortisone and resolved her symptoms. Patient also further reported she had side effects with the Pfizer COVID-19 Vaccine. She clarified she had her first COVID-19 Vaccine dose on 04Feb2021. She said her side effects happened less than 14 days after getting the COVID-19 Vaccine. Patient thought her side effects from the COVID-19 Vaccine may have been anxiety within. She said her nephew had died of COVID-19, and when she was at his funeral at the graveside, she flipped out while she was at her nephew's funeral, she was not doing good. She said she has a history of chronic migraines, and mild asthma. She said she had to lean against a gravestone because she couldn't breath. She said it was cold outside by her nephew's graveside, but she felt she had to fan herself like she was overheated. She said her heart rate was flying, and she had an irregular heart beat. She said she left her nephew's graveside and went to an urgent care. She said the doctor at the urgent care had done an EKG result abnormal, and told her she needed to go to the Emergency Room right away. She said the doctor had called the paramedics to transport her from the urgent care to the Emergency Room at (Institute name). She said she did not have any pain, but had a hard time breathing. She said she may have been scared because her grandfather had died of a bad asthma attack. She said she has chronic migraines, but what she had at the time was a mild headache, and not a migraine. She said she has not smell or taste a lot of the time. She clarified she has had no smell or taste for a while, saying she would not be able to tell if she got the COVID-19 Virus because of her loss of taste and smell. She said she was tested the Friday before her nephew's funeral and was negative for the COVID-19 Virus. She said she has had a total of four COVID-19 Virus tests before, and all her COVID-19 Virus tests have been negative. She clarified she did not have a COVID-19 Virus test while she was at the ER on Saturday, 13Feb2021. With her nephew's death, getting her COVID-19 Vaccine had left her mind. She said it didn't dawn on her until she settled down, and she thought her high heart rate and irregular heart beat were side effects of the COVID-19 Vaccine. She said she read the paperwork that was given to her at the time she got the COVID-19 Vaccine. She said the side effects listed for the COVID-19 Vaccine is what she had, a very fast heart beat, and it was very hard for her to breath. She said the Emergency Room doctor didn't think to ask her about the COVID-19 Vaccine. She said she panicked when she got to the hospital. She said she didn't even know that someone had drew blood from her. She said someone put a label on her, and told her the label was to show blood was drawn from her. She said when she looked down at the label, she saw an IV access was put in her arm. Additional treatment reported when she was in the Emergency Room, she was given an injection (clarified as IVPB on 13Feb2021) of Diltiazem 120mg at 12:13:50 PM, she said she was given another Diltiazem 5mg injection at the same time. She clarified she was diagnosed in the Emergency Room with Atrial Fibrillation. Patient stated that her blood pressure went up while she was in the Emergency room. She said she was kept in the Emergency Room so she could be monitored up until that evening. She said after the Diltiazem injections were given, her heart rate went down. She said the Emergency Room doctor gave her a prescription for Diltiazem 120mg white capsules, and told her to take the Diltiazem 120mg every day. She said the emergency room doctor told her she could go home, and that she needed to follow-up with her regular doctor. Reported she no longer has the shortness of breath, lightheadedness, or weakness. She said had felt a little tired at that time, as well. Patient also reported that on 22Feb2021 was her first day outside of her house since last Sunday (14Feb2021) and reported she has a slight headache, and her sight is not clear. She said she now feels she has "name" back, clarifying she has recovered completely. She has a follow up with her doctor on 24Feb2021. She is scheduled to take her 2nd dose on 04Mar2021 and is asking if she should take anything before the shot. Vaccination Facility Type was a pharmacy/drug store. Vaccine was not administered at Facility. The outcome of the events was recovered on an unspecified date.

ct reports having fever, body aches, stomach pain with nausea and diarrhea, palpations, rash on her face, vision problems

Patient noted with complaint of feeling a foggy feeling, and having a "weird" taste in her mouth. BP 132/71 P 51 O2 sat 96 on RA. Patient was monitored for 30 minutes with no change in status. Consulted with RN, patient was taken to the ED at 11:57pm.

March 3, 2021-Sore injection site of right arm March 4th- Injection site slightly sore March 5th -sore left calf March 6th- Sore left calf a little more so March 7th- Outside left calf hot to touch & back of calf red and sore. March 8th- Same as above, and I put doterra Deep Blue ointment on it, and it relieved the heat and pain Redness is gone March 9th -Left side of body joints ached. left calf aches/applied Deep blue ointment and a Pain relief ointment . Feels a lot better March 10th- Redness gone, but still feels sore March 11th- Left leg Calf feels a lot better, I put on the ointment again. Deep Blue, and Frank Woods Pain Relief ointment. March 12- Left calf a little sore. No heat . Now my left eye has a light grey spot in it. I can see around it. March 13-Eye's don't feel right. I still have the light gray floater in the left eye.

Severe plantar fasciitis onset first week of February. By February 14, severe bilateral trapezius pain radiating to base of skull and shoulders. Fatigue. Chills. Nausea. Headache. Had repeat PCR Covid test at facility. Negative. Naproxen for approx 10 days of no benefit. Heel pain, shoulder/neck pain, fatigue, chills, nausea and headache continued. Saw FNP BC March 8, 2021. Symptoms continued through March 16.

3/19/2021 Patient was observed post Covid-19 immunization for 30 minutes based on pre-vaccination screening . During the observation period, she experienced an adverse reaction with the following symptoms: patient reported feeling of Swelling of right eye ear. Assessment : Time of assessment . Actions taken: Vitals signs taken @ 1120 BP 180/84, P-73, O2-99%, held in observation for another 15 mins, husband with her, she reports decrease in symptoms, she also she reports that she took homeopathic drops labeled, vaccine related symptom, she also reported experiencing " white coat syndrome', she reports that she takes nothing for BP. There were no vitals filed for this visit. Medications administered: No medication administered. Disposition: Reports no further symptoms of adverse reaction after observation for 30 minutes. Discharged home.with husband

Pt received the second dose of the Pfizer vaccine. The patient waited 15 minutes in the observation area. Once the patient left the building, her husband returned with her within 5 minutes of leaving bc, he noticed her having swelling of her left lower lip and itching in the throat with some difficulty breathing. She was attended to immediately by EMS, PA& physician at the site. Vitals were obtained: blood pressure was elevated at 220/110, PO2 96% pulse 115 BPM. A dose of 50 mg of benadryl was given to the patient orally. Within 10 minutes she felt improvement in her breathing and the swelling in her lip was not as prominent. BP remained elevated 200/100 , transported to hospital for further Tx & observation.

Slurred speech, extreme confusion and disorientation, headache, blurred vision. Symptoms of mild Demetia increased to meditate to severe dementia in a matter of hours.

severe pain emanating from injection site; traveled upward over shoulder; continued up right side of neck; heavy right earache; sore throat; headache forehead and across top of my head; dry heaves; feverish/chills/shivering; feverish/chills/shivering; words mixed up; Felt pain in center chest; congestion across bronchial area and developed upper respiratory congestion temporarily; congestion across bronchial area and developed upper respiratory congestion temporarily; fatigued; had severe coughing spell which included choking and further nausea; had severe coughing spell which included choking and further nausea; severe nausea; Ripple effect across bridge of nose; strong metallic odor and taste within mouth; moving from back of throat and nostrils; it is both painful and difficult to raise my right arm very high; This is a spontaneous report from a contactable consumer, the patient. A 77-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot EN6060, first dose) solution for injection intramuscular in the right arm on 09Mar2021 at 16:00 (at the age of 77-years-old) at single dose for COVID-19 vaccination. The patient was not pregnant at the time of vaccination. Medical history included known allergies: yes. Concomitant medication included vitamins. The patient did not receive any other vaccine within 4 weeks prior to the vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. On 09Mar2021 16:15, the patient had severe coughing spell which included choking and further nausea, ripple effect across bridge of nose, strong metallic odor and taste within mouth moving from back of throat and nostrils, it is both painful and difficult to raise my right arm very high. On 10Mar2021, the patient experienced dry heaves, feverish/chills/shivering, words mixed up, felt pain in center chest, congestion across bronchial area and developed upper respiratory congestion temporarily, fatigued. On 10Mar2021 03:00 the patient had severe pain emanating from injection site traveled upward over shoulder continued up right side of neck heavy right earache, sore throat, headache forehead and across top of my head. Unspecified treatment was provided for the events. The outcome of the events choking, coughing, nausea, ripple effect across bridge of nose, strong metallic odor and taste and smell, severe pain emanating from injection site upward over shoulder continued up right side of neck heavy right earache, sore throat, headache, dry heaves, feverish, chills/shivering, words mixed up, Felt pain in center chest, painful and difficult to raise my right arm very high, fatigued was not recovered. The outcome of the event congestion across bronchial area and developed upper respiratory congestion temporarily was recovering. Since the vaccination, the patient has not been tested for COVID-19.

She has constant spiking of her blood pressure (BP) and lack of sleep/She has been in and out of the hospital for her high BP/admitted to Hospital with 200/103 Bl; she has constant spiking of her blood pressure (BP) and lack of sleep; Racing Pulse; dizziness, blurred vision at times, extreme and constant headaches, tons and tons of pain in her neck". She is "so weak"; she "can hardly speak" and "can hardly function; dizziness, blurred vision at times, extreme and constant headaches, tons and tons of pain in her neck". She is "so weak"; she "can hardly speak" and "can hardly function; dizziness, blurred vision at times, extreme and constant headaches, tons and tons of pain in her neck". She is "so weak"; she "can hardly speak" and "can hardly function; dizziness, blurred vision at times, extreme and constant headaches, tons and tons of pain in her neck". She is "so weak"; she "can hardly speak" and "can hardly function; dizziness, blurred vision at times, extreme and constant headaches, tons and tons of pain in her neck". She is "so weak"; she "can hardly speak" and "can hardly function; This is a spontaneous report from a contactable consumer. A 77-year-old female patient (not pregnant) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number EL9262), via an unspecified route of administration in left arm on 25Jan2021 (vaccination age 77 years) at single dose for COVID-19 immunization. Medical history included: cholesterol, spinal fusion L4/5, stenosis, allergies to medications, food, or other products: kefex, Zithromax, levofloxacin, oxycontin, methylprednisolone, Lisinopril, ezetimibe, Amlodipine. She reported she has constant spiking of her blood pressure (BP) and lack of sleep for 37 days (average 1-3 hours daily), since the vaccination. She described the following: She has experienced "dizziness, blurred vision at times, extreme and constant headaches, tons and tons of pain in her neck". She is "so weak"; she "can hardly speak" and "can hardly function". When she "lays down", her "heart is racing so fast and [her] BP gets so high that it won't let [her] sleep". She feels like her "body is going crazy". She "cannot get more than 2-3 hours of sleep other than 1-2 exceptions". Also, her "BP wakes her from a dead sleep". When she wakes up, she usually "takes a rice [pad] and applies hot and cold to her neck, and she sometimes takes some Tylenol". "Every time [she] wakes up, her BP [readings] are around 152/101 and 160/97. She has been in and out of the hospital for her high BP. After the hospital, she called (Number) because her BP "was off the chart". Her cardiologist ruled out heart issues. She did an "echo, a stress test and EKG". On 01Feb2021 she was admitted to hospital with 200/103 blood pressure. Ruled out cardiovascular & placed on Amlodipine. Now 37 Days later with many visits to doctors, blood pressure remains high. Cardiologist ran stress test & echo with no heart issues. Placed on many Blood Pressure Medications that also created side-affects (urination, flushing, dizziness, extreme headaches); Amlodipine 5 mg, Metoprolol 25 mg, Alprazolam 0.25 mg as needed, Propranol 20 mg. Today, picking up yet another (Hydralazine?) as last-ditch effort. BP daily spikes remain high (160/99 and 175/100). Racing Pulse & BP wakes me out of a dead sleep within 1-2 hours. So weak & constant neck pain that feels like someone is placing pressure around my neck. The blood pressure medication received are the following: Amlodipine from 1Feb2021 until 9Feb2021. She explained it work well to manage her BP but she "could not urinate and had red flashes in [her] face"; therefore, it was stopped by her cardiologist. She was off the BP medication from 9Feb2021 until 17Feb2021. Metoprolol from 18Feb2021 until 25Feb2021, but it didn't work. She explained it was stopped by her doctor because of side effects. Propranolol in combination with Alprazolam as needed for anxiety. She explained she "took 3" of the tablets for anxiety. Hydralazine 25mg which she started yesterday, after seeing her cardiologist. She explained she only got 3 hours of sleep last night. She woke up around 1:30am/2am" her heartrate was at "93" and she put heat and cold on her neck to settle the pain. She specified the headache and pain were so bad it lasted for 1.5 hours, and her BP was 150/93 at 3 am .She added she had a "red and flushed face" and therefore took a "Benadryl at 4am". She explained her BP was down to "125/78", after taking the Benadryl, but got up to "147/90" at 7 am when she attempted to call Pfizer. She explained she has "done [her] due diligence: she consulted HCP, did all the test, she attempted to go for walks and do activities she can tolerate, but her symptoms persist. She added she use to golf and cannot anymore. She explained her symptoms are persisting until this day and her body won't handle it further. She mentioned she knows she is COVID-19 free because when helping take care of her quadriplegic son in the summer, she tested negative. Outcome of events was not recovered.; Sender's Comments: Linked Report(s) : PFIZER INC-2021277006 same patient, different vaccine dose/AE.

numbness at the injection site and swelling; swelling reappeared, and this time it was itchy; numbness at the injection site and swelling; swelling reappeared, and this time it was itchy; Dizzy; little taste in mouth; numbness at the injection site and swelling; swelling reappeared, and this time it was itchy; This is a spontaneous report from a contactable consumer (patient). A 77-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EL3246) via an unspecified route of administration on 21Jan2021 (at the age of 77-years-old) as single dose for protection. There were no medical history and concomitant medications reported. The patient experienced Dizzy, little taste in mouth, numbness at injection area, swelling came back 1 week later, 4 inches and round in shape on 21Jan2021 and itchy in Jan2021. It was reported that the patient got her vaccination on 21Jan2021. When she got it, she felt a little dizzy, and a little taste in her mouth that disappeared. She did experience numbness at the injection area and swelling that disappeared after two days. Then, after one week, the swelling came back. She still has it. It is 4 inches, and round in shape on 28Jan2021. She wants to know if this is life threatening. Her next vaccine is on 12Feb2021. Her height has went down. She got it at the Hospital. She doesn't have a prescribing doctor. She experienced the dizziness and taste in her mouth occurred while in the recovery room, it lasted a couple of hours. The arm numbness and swelling started a few hours later and lasted two days. Right now it is itchy, but she tries not to scratch her arm. The initial injection wasn't itchy when she had the numbness and swelling. It was just numb and swollen the first time. This time, it is itchy and swollen. She got the vaccine because she wants to be safe, for protection. The patient underwent lab tests and procedures which included body height: her height has went down in Jan2021. The outcome of events, dizzy, little taste in mouth on 21Jan2021 and numbness at injection area on 23Jan2021. The outcome of swelling came back 1 week later, 4 inches and round in shape was resolving and was not recovered for event itchy. No follow-up attempts are possible. No further information is expected.

possible Type 3 hypersensitivity (immune complex mediated) to Pfizer - facial swelling, peeling erythematous rash, eye swelling 2-3 weeks after vaccinations (twice).

Strange taste in mouth, sweetish at first, several weeks later metallic. Now (4-7-2021) it's sweet again.

04/07/2021 5:25 am woke up with tight chest and shallow breathing. Immediately took asthma medication. I usually take 2 puffs of Advair and 2 puffs Xopenex an hour or two after waking (daily treatment. I don't wake up with a tight chest. 6:30 a.m. breathing has normalized. Have headache, earache and some nasal drainage.

I started feeling weird in my head, terrible ringing in my ears like 10x's worse than normal, spaced out that I can hardly function, dizziness, misplacing things, disoriented, left eye twitching, vision is more blurry than normal. (patient stated she didn't know if she can live like this because it makes her want to take her life)

fever up to 101 F; itching; severe head and spine pain; severe head and spine pain; Extreme fatigue; Erythematous; Loss of voice; This is a spontaneous report from a contactable consumer, the patient. A 77-year-old non-pregnant female patient received second dose of bnt162b2 (BNT162B2, Solution for injection, Lot Number: EN6201), via an unspecified route of administration in left arm on 12Feb2021 12:30 as single dose for covid-19 immunisation. Medical history included psoriatic arthropathy, basedow's disease, psoriasis. Concomitant medications included levothyroxine sodium (SYNTHROID) (MANUFACTURER UNKNOWN); estrogens conjugated, medroxyprogesterone acetate (PREMPRO) (MANUFACTURER UNKNOWN). The patient previously took fentanyl and experienced drug hypersensitivity and bnt162b2 (product=COVID 19, brand=Pfizer BioNTech, lot number=EL9262, administration date=21Jan2021, administration time=04:00 PM, vaccine location=Left arm, dose number=1). On 13Feb2021 06:30 and experienced fever up to 101 f, itching, severe head and spine pain, severe head and spine pain, extreme fatigue, erythematous. On an unspecified date in Feb2021, patient experienced loss of voice. 18 hours post injection, severe head and spine pain, extreme fatigue, fever up to 101 F persisting 36 hours. Loss of voice 96 hours later, intermittent fever. Erythematous, hot area, raised (size of an orange) with itching in the area persists. On 13Feb2021, the patient underwent lab tests which included body temperature: up to 101 fahrenheit (intermittent fever). The patient did not receive any treatment for the events. The clinical outcomes of the fever up to 101 f, itching, severe head and spine pain, severe head and spine pain, extreme fatigue, erythematous, loss of voice were recovering. No follow-up attempts are possible.

Day after injection my tinnitus shot up to higher level of noise in my head. It now continues at a louder noise and I?m having second thoughts about getting the 2nd dose since it could make the tinnitus even worse.

With both the first and second dose I had a metallic taste in my mouth, worse the second time. Lasted only for a short while.

Patient tested for COVID-19 PCR on 4/10/21; >2 weeks after fully immunized w/ Pfizer on 3/18/21. Patient had cough, myalgia, anosmia, dysgeusia, fatigue. Hospitalized 4/14-4/19/21. Received Remdesivir and monoclonal antibody treatment.

itchy rash; eyes are itchy; blotches on both arms, under arms, some on her breasts, and buttocks, and some on knees and on her elbows; Rash; This is a spontaneous report received from a contactable consumer reported for herself. A 77-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: solution for injection,Lot number: EN6201) via an unspecified route of administration in left arm on 15Feb2021 as single dose for COVID-19 immunization. Patient medical history and Concomitant medications were not reported. No other products or investigation assessment was reported. On 20Feb2021,the patient experienced itchy rash, eyes are itchy, rash, blotches on both arms, under arms, some on her breasts, and buttocks, and some on knees and on her elbows, stated her eyes were itchy and where the rash was itching. Age at time of onset of reaction/event was reported as 81. Stated that she was due for her second dose on 8Mar2021. Reporter wanted to know if the rash will happen again with her second dose. The patient was not recovered from the event. Follow up attempts are completed. No further information is expected.

sudden lost hearing in right ear. waited 1 week to see if cleared up with no change. Instilled debrox routine 4 days as recommended, thought it was a possible wax issue. ( do not typically have ear problems. usually my hearing is excellent. Finally realized this occured just after covid vaccine. Doctor appt to follow

stroke caused by a blood clot; stroke caused by a blood clot; right arm went completely numb; She is tired; shortness of breath; her eyes were blurry; her head felt like somebody put a spike in it on the right side; sore arm; This is a spontaneous report from a contactable consumer. A 77-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Left on 06Feb2021 13:15 (Lot Number: EM9809) (at age of 77-year-old) as single dose for COVID-19 immunisation. Medical history included colitis ulcerative from Oct2020 (dropped weight, she dropped from 127 pounds to 109 pounds) , cardiac disorder, atrial fibrillation, and osteoporosis, all were ongoing. Concomitant medications included carvedilol taken for cardiac disorder, atrial fibrillation from an unspecified start date and ongoing; cyanocobalamin (VITAMIN B12) taken for cardiac disorder from 2018 (reported as has taking it close to 3 years) and ongoing; denosumab (PROLIA) taken for osteoporosis from an unspecified start date and ongoing; ubidecarenone (Q10) taken for cardiac disorder from unknown start date and ongoing; calcium, colecalciferol (CALCIUM + D3) taken for osteoporosis from 2020 (reported as a year ago) and ongoing; influenza vaccine (FLU VACCINE VII) taken for an unspecified indication, start and stop date were not reported, and vitamins NOS (MULTIVITAMIN) from an unspecified start date and ongoing, the patient started taking it when she was a senior in high school and stated because she is not the best eater in the world. There was no prior vaccinations (within 4 weeks). AE(s) following prior vaccinations: The patient stated arm is sore with flu shot and probably did when she was little when she got the loaded shot, the mumps one. She wouldn't remember that because she was little. The patient experienced stroke caused by a blood clot on 20Feb202114:30 with seriousness criteria hospitalization, sore arm on 07Feb2021, and right arm went completely numb, tired, shortness of breath, her eyes were blurry, her head felt like somebody put a spike in it on the right side on an unspecified date. The event stroke caused by a blood clot result in emergency room visit.The patient was hospitalized for stroke caused by a blood clot from 23Feb2021 to 24Feb2021. The patient reported that she received the first dose and she is thankful she got it on 06Feb2021 and the only side effect she had was a sore arm. Stated on 20Feb2021 she had a stroke caused by a blood clot obviously, she ended up in the hospital. She didn't think at the time, doesn't fault the physicians that took care of her. She didn't think it was related and her eldest son thought it was related. The patient stated they thought it was a mild stroke and after they did the C scan the neurosurgeon, while she was lying in the hospital bed, looked at her assistant and said he couldn't believe that she was talking and walking. The patient stated part of it was ignorance on her part, everyone thought it was the left side that numbs, but hers was the right side. Stated she didn't fall, she dropped something and went down to get it and her right arm went completely numb and she couldn't get back up and she tried to push with legs and couldn't get up. Stated all of a sudden her eyes were blurry and then she never gets headaches and her head felt like somebody put a spike in it on the right side, stated it is supposed to affect the left side. stated she has a heart problem. The patient stated she had a sore arm for about a week, lasted for a few days. stated she gets a sore arm with the flu shot. stated when she would roll over to lay on her left side and roll over on that arm it was enough to wake her up. stated it lasted about 5 days. She couldn't figure out why it was lasting so long. Stated the second thing that happened was that she went to her son's home that night for dinner, hadn't told him about it and while she was eating dinner she asked am if she leaning to the left and he said yes, she was and that her words were being slurred and only lasted for about 10 mins. Stated she didn't call and ignorance is unreal with this stuff. She went to urgent care the next day and they didn't call the ambulance. When she went to the doctor on 23 Feb2021 she was sent immediately to Hospital so she could go through the ER and that's when the neurosurgeon became involved. Stated right now her balance isn't quite right but she is driving and she was taking care of herself and they didn't send anyone home to help her. She was not having any problem talking. Stated she was not going to get into this and will beat it and get back to normal. She was tired a lot, which they said it's normal. Stated she was a real dynamite. Stated it is improving slowly, she was extremely tired and not taking her long walk like she was used to and has shortness of breath, she was not trying to over do it. Stated she always gets a sore arm with the flu shot. Stated her pain level is lower than most people. The patient stated the sore arm started late evening but the next day was really hurting and the main thing was rolling over. The patient stated she didn't take anything for her sore arm, she won't even take an aspirin because some of these Advil medications will mix with the heart medications. Stated in the hospital they were giving her medications she had through an IV in her arm but doesn't know what was going through that. Stated they put her on a blood thinner and they were testing the blood thinner through the IV. She was so miserable, she just wanted to go home and get a good nights sleep. Stated they took all kinds of test, checked her oxygen and had to have a certain number before she could go home. The patient received treatment for event stroke caused by a blood clot and not received treatment for sore arm . The outcome of events stroke caused by a blood clot was resolving, of event sore arm was resolved on 12Feb2021, of other events was unknown.

SWOLLEN LYMPH NODES in Right armpit. Still have the swollen lymph nodes today 5/5/2021, almost 2 months. Frightening. Swollen under left eye 3/9/2021 to 3/11/2021. Upper back of both legs painful 3/9/2021. Still have this today 5/5/2021, almost 2 months. Sore at injection site 3/8/2021. Fatigue 3/9/2021.

Right eye pain with tenderness and blistering around the eye. Nose numbness on the right side of nose and around. Top of head sensitive. She went to the ED, which diagnosed shingles and referred her to the eye doctor. Prescribed 10 days of Valcyclovir, erythromycin opthalmic ointment, and prednisolone opthalmic suspension. Symptoms lasted the month of April.

headache; Exhausted; Chills; Joint Pain; achy pain; Flu; Eye floaters; Feeling Strange; Nauseaus; Dizzy; This is a spontaneous report was received from a contactable consumer or other non hcp. A 77-year-old female patient received 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number was not reported) via an unspecified route of administration, administered in arm right on 05Feb2021 14:00 (at the age of 77-year-old) as single dose for COVID-19 immunization. The patient's medical history included digestion problems, ongoing coeliac disease and allergy to gluten. Concomitant medications included vitamin b complex (vitamin b), zinc (zinc), vitamin c [ascorbic acid] (vitamin c [ascorbic acid]), colecalciferol (vitamin d [colecalciferol]), bifidobacterium lactis (Probiotic [bifidobacterium lactis]). The patient was not pregnant at the time of vaccination. The patient had not received other vaccine in four weeks. On 05Feb2021 at 18:00, the patient was exhausted and experienced chills, headache, joint pain started in left ankle, later she had achy pains all over and felt lousy like she had the flu. The patient had new floaters in her eyes and a strange feeling in her head and was also extremely nauseous and dizzy. The patient did not take any treatment. The patient was not tested for covid prior vaccination and post vaccination. The outcome of the events was recovered on an unspecified date in 2021. Follow up attempts are completed. No further information is expected.

April 14 pain in side of face; next day watery eye and rash above eye. Clariton D and advil helpful; April 27th am pain on top of left side of head and face and over eye. Urgent care diagnosis shingles with eye complication; ER tested and then treated me for shingles. One week anti viral with f/u with ophtalmalogist and internist. Antiviral extended one more week and cortisone and triple for eye area. I am still doing the lotion treatment and have gone back to eye doc twice and tomorrow again. Tylenol 3 time a day. I have since come down with a cold but getting over that. It appears pfizer vacine has weakened my immune system for these other diseases.

feeling a little weird; Nauseous; Headaches; blood pressure went up over 220; pulse rate went way up; really ill; memory is a little off right now; felt like I am going to faint; ringing in the ears; dizzy/light headed; a really really sore arm for two days after the vaccine; allergic reaction; This is a spontaneous report from a contactable consumer, the patient. This 77-year-old female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0171), via an unspecified route of administration on 29Apr2021 (at the age of 77-year-old) as a single dose for COVID-19 immunization. Medical history included allergies and sinus headaches which she takes (Excedrin) off and on for years in the past, and high blood pressure. Concomitant medications included atenolol (manufacturer unknown) taken for hypertension, start and stop date were not reported. Past drug history included the patient received a flu shot (unspecified Flu shot) with a mega reaction she was sick for weeks which was at least probably 15-20 years ago So, she never got a flu shot after that and she has never had the flu. On 29Apr2021, the patient had a really really sore arm for two days after the vaccine, dizzy/light headed, felt like I am going to faint, and ringing in the ears. On an unspecified date in 2021, she experienced allergic reaction. On 01May2021, she was really ill, and her blood pressure went up over 220 and pulse rate went way up. On 02May2021, she experienced headaches. On 06May2021, she was feeling a little weird and nauseous. On an unspecified date in May2021, her memory is a little off right now. The clinical course was as follows: the patient reported, "I had a really really sore arm for two days after the vaccine, it's okay now, I couldn't really move it. I feel I may be having a severe allergic reaction to the Pfizer vaccine (Pfizer Covid-19 Vaccine) got on Thursday (29Apr2021) of this past week. I am very light headed, dizzy and felt like I am going to faint, has ringing in the ears, and all that has been going on about a week, since last Thursday (29Apr2021). Then I was really ill last night (01May2021). It started last night when we went to bed around 11 O'clock. I have never had anything like this in my life. My blood pressure was through the roof. With a blood pressure cuff and a stethoscope, her blood pressure went up over 220 which was so high that had never happened before, so I took an extra pill (atenolol 25 mg tablet) last night (01May2021) which helped a little bit but not enough, and I really thought that I was going to pass out and be really sick. Because I thought that it was either having a stroke or a heart attack, my husband had to call ambulance to take me to the hospital last night. The systolic and diastolic and pulse rate went way up. They did chest x-ray, blood work, and urinalysis, and everything came back fine and they could not find anything. They just felt that I was just having a major reaction to the shot so they sent me home. I just got home this morning (02May2021) from having to go to the emergency room. But as soon as we got home, I started with a humongous headache and so I had Excedrin/Tylenol for headaches because I used to get sinus headaches. So, I took that, and it helped a little bit, my headache got a little better. Anyhow, I am much better right now and I am sleeping. But tomorrow it will be the same." Later the patient also reported, "Today (06May2021) I am feeling a little weird with ringing of ears and is light headed sometimes. Because of the light headedness, I feels a little nauseous. But I am a still very nauseous. I feel like I am going to faint again and my blood pressure I think has gone back up. I am trying to keep calm and trying to figure out what is going on. But I am really afraid if I am having a reaction to the vaccine unfortunately. I am dizzy and I do not want to start getting worst again. I guess I will feel better if you tell me that this happens sometimes and what can I do to decrease somehow?" She also stated that she did contact her doctor about this event but she didn't get very far. Her memory is a little off right now because she really has not felt well. She stated that her biggest thing is her blood pressure. She also stated, "The only thing that I am really concerned now is about getting the second shot because I already had the reactions by the first shot. Am I going to face the same thing or even the worse with the second shot?" Treatments were received for her blood pressure went up over 220 and headaches. The clinical outcomes of the event "a really really sore arm for two days after the vaccine" resolved on 01May2021, the event nauseous was not resolved, while the events, allergic reaction, really ill, felt like I am going to faint, pulse rate went way up, ringing in the ears, dizzy/light headed, Headaches, feeling a little weird and memory is a little off right now were unknown.

brain fog, dizziness, strange sensation in sinuses difficulty in concentrating, difficulty focusing eyes when reading, eye events such as "flaters" flashing at outer sdges of eyes, exhaustion and needing more sleep than usual

ear feel like they were popping/ears pop when she swallows; Sore throat; Throat was swollen; fever; diarrhea; chills; This is a spontaneous report from a contactable consumer (patient herself). A 77-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection Batch/Lot number: EL9261, Expiration Date was not reported), via an unspecified route of administration on 25Jan2021 (at the age of 77-year-old) as 1st dose, single for covid-19 immunisation. Medical history included covid-19 from Sep2020 to an unknown date, breast cancer female (Breast cancer with lymph node removal) from 2012 to an unknown date, lymphadenectomy (Breast cancer with lymph node removal), type 2 diabetes mellitus, blood pressure abnormal. Concomitant medications included metformin hcl (METFORMIN HCL, 500mg) taken for type 2 diabetes mellitus from 2006 and ongoing; simvastatin (SIMVASTATIN, 20mg) taken for blood pressure abnormal from an unspecified start date and ongoing. It was reported that, patient got the Pfizer COVID-19 vaccine on 25Jan2021 and on the next day (26Jan2021), she had a fever (101.1F), diarrhea, and chills. It reminded her of her having COIVD-19 back in Sep2021. She said she took some Tylenol and She put compresses on her forehead and neck, then her temperature went down to 99F. She didn't have chills. She did have diarrhea on Tuesday as well, her temperature remained on 99F and caller had no fever since then but on Wednesday (27Jan2021), She was fine on Wednesday. Then on Thursday, her throat was sore. Her throat was still sore when she swallows. She has not had trouble breathing, her throat was swollen and her ear feel like they were popping. Her ears will pop when she swallows. She said it was uncomfortable. It was just annoying. She checks her temp, pulse, and o2 intake every day. They are good. She heard them say something about 3 when they were talking about the dose. She had COVID back in Sep2020. It was a mild case. She had diarrhea and a temp. That was it. She wasn't sure if she could get it again, or if she could carry it and give it to someone. That was why she decided to get it. She also had breast cancer, and her lymph nodes removed in 2012. She was due for her second shot 16Feb2021. She taught school for 32 years. She has a doctor's appointment tomorrow (04Feb2021) and will have some bloodwork done. She said she monitored her pulse (heart rate was on 70s) and oxygen level (94 or 97) and said they were good. She wanted to know recommendations for the second dose considering this AE. The patient underwent lab tests and procedures which included body temperature was 99 on an unspecified date, body temperature was 101.1 on 26Jan2021 , body temperature was 99 on 27Jan2021, heart rate: 70s/good on an unspecified date (She said she monitored her pulse (heart rate was on 70s/She checks her temp, pulse, and o2 intake every day. They are good) , oxygen saturation: 94or 97/good on an unspecified date (oxygen level (94 or 97) and said they were good/She checks her temp, pulse, and o2 intake every day. They are good), sars-cov-2 test: positive on Sep2020. Therapeutic measures were taken as a result of fever (pyrexia). The case was non serious. The outcome for the event fever was recovered on 27Jan2021, for events chills and diarrhoea was recovered on 26Jan2021, not recovered for events ear feel like they were popping/ears pop when she swallows, Sore throat and unknown for other events. Follow-up attempts are completed. No further information is expected

Jaw pain up into eye; lymph nodes in the neck that made her hard to move her head; leg cramps; sleepy; palpitations; My chest has been beating like a 107 and it is normally like in the 70/Fast heart beat; lymph nodes in the neck that made her hard to move her head; I did take a Benadryl for my congestion in the nose and then the eyes and that did not seem to help; I did take a Benadryl for my congestion in the nose and then the eyes and that did not seem to help; My eye started to tear and I went like driving through an allergy attack with the runny eyes and nose; My eye started to tear and I went like driving through an allergy attack with the runny eyes and nose; My eye started to tear and I went like driving through an allergy attack with the runny eyes and nose; My eye started to tear and I went like driving through an allergy attack with the runny eyes and nose; she was sneezing; This is a spontaneous report from a contactable consumer (patient). A 77-year-old female patient received the BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EN6205, Expiry Date; UPC and NDC number: Unknown), via an unspecified route of administration on 26Feb2021 01:00 PM in the right arm at 1ST DOSE, SINGLE for COVID-19 immunisation. Patient's age at vaccination was 77 Years. Medical history reported as, the patient first states that she was medication free, but then clarifies that she does takes a vitamin D that is prescribed by her doctor. She had a lot of allergies when she was very young, she was tested for allergies. Two years ago she didn't think she was sick but her calcium was high, she had 2 parathyroid glands removed and she was stronger than she was before. She takes no pills for it, she has nothing wrong with her, outside of the cancer she had when she was 55 years old. Caller reported that the injection did not hurt for either herself or her husband, and it was wonderful. The patient states that she had no fever or chills from the vaccine, but both the caller and her husband were tired after receiving the vaccine, but caller thought it was from stress. Concomitant medications included colecalciferol (VITAMIN D [COLECALCIFEROL]) taken for an unspecified indication, start and stop date were not reported. Historical Vaccine included an unknown vaccine and patient states as, that back a long time, when she was a youngster, when she was given whatever vaccination is needed to go to school, her arm swelled past her elbow, and she was sick for a few days. Caller does not remember which injection it was, it was whatever injection she had to have to go to school, she was 5 years old. Caller doesn't recall the name of the injection. No prior vaccinations (within 4 weeks). The patient states that she does not take the flu shot or anything like that, ever. Vaccination facility was reported as outside the distribution center in the parking lot. On an unspecified date in Feb2021, the patient experienced My eye started to tear and I went like driving through an allergy attack with the runny eyes and nose, lymph nodes in the neck that made her hard to move her head, I did take a Benadryl for my congestion in the nose and then the eyes and that did not seem to help and she was sneezing; On 26Feb2021, experienced my chest has been beating like a 107 and it is normally like in the 70/Fast heartbeat, sleepy, palpitations; On 01Mar2021, experienced leg cramps; On 03Mar2021, experienced lymph nodes in the neck that made her hard to move her head; On 04Mar2021, experienced Jaw pain up into eye. The report received as, the patient was pleased where she had the injection it didn't have swelling or get red and she does have a history of allergies and her doctor said it was ok to get the shot. The doctor told her, that if she had any eye tearing, nasal drip, or other things like that, to take a Benadryl. Caller waited 12 hours, because her eyes did start to tear, and she was sneezing and so she took a non-drowsy Benadryl, but she waited 12 hours to take the Benadryl, because she didn't want it to interfere. The patient experienced fast heartbeat started in the evening on the same day. Patient also had fast heartbeat yesterday. She reports she had a fast heartbeat; it was in the low 90s, she knows that's not fast for some people, but it was fast for her, and it would come and go like palpitations. Patient does have a machine, her heartbeat was in the 90s, and her chest has been beating like a 107 and it was normally like in the 70s. Caller was in the kitchen when she felt it, so she sat down. The patient reports that she has not experienced the palpitations today. The patient states that she was doing something in the kitchen, she's very active. She normally gets up in the morning and does the breast stroke for 1.5 hours, and patient states that she only got up to the pool once this week, and she didn't stay at the pool long because of the leg cramps. The patient reports she did have a fast heartbeat yesterday. The patient reports that she also started to have a lot of cramps in her legs, which she has never had before in her life. The patient states that 2 days ago, the lymph nodes in her neck must have been swollen, and it hurt so bad last night, she didn't know what to do, she took regular over the counter Tylenol and it did help. The patient states that it's not bothering her today. it's right down the sides of her neck. She looked on the internet for lymph nodes in neck, she knew she had lymph nodes in her neck and it was really, really tight. It was both sides of her neck. It's not as bad today because she couldn't stand it anymore last night so she could take Tylenol. She was to a point sitting in a chair, how could she stretch her neck because it hurt so bad. But this morning she can move it pretty good. She told her husband if it continued that she would go to hospital. She was concerned with if she should get the second shot or not. She was wondering did the first Covid shot cause this. She did take Tylenol this morning, she also reports jaw pain and up into her eyes, that started yesterday, and it has been relieved. She's concerned if she got this with the first shot, could she get it with the second which was scheduled on 19Mar2021, and she was a little doubtful about getting that second shot. The patient states that she was very seriously thinking of not getting the second shot, because she had an awful lot of discomfort with this first shot. The patient states that it wasn't that she was tired, she was just sleepy, she was sleepy on the day she got the vaccine, and then on Saturday, 27Feb2021 she had 3 naps, then on Sunday, 28Feb2021 she had 2-3 naps. Then on Monday, 01Mar2021 she was back to normal. The only things caller was concerned about was if she should get the second shot. She read about not getting the second shot if you had a fast heartbeat. She would call her doctor, but all the doctors are telling people to get the shot. The only reason she got it was because of her husband and his underlying conditions. No specify Antipyretic used around the dates of Vaccination. No relevant tests. The patient underwent lab tests and procedures which included Heartbeat: 107, 90s on 26Feb2021. Outcome of the event lymph nodes in the neck that made her hard to move her head was recovering; events palpitations, jaw pain up into eye recovered on an unknown date; event leg cramps recovered on 03Mar2021 and outcome for remaining events was unknown. No follow-up attempts are possible. No further information was expected.

Benign Essential Blepharospasm; her eyes were red and irritated when she was in for her treatment; her eyes were red and irritated when she was in for her treatment; Her vision was blurry; white circle around the cornea; difficulty swallowing; exhausting; end of her fingers and toes are still hurting and feel frozen; end of her fingers and toes are still hurting and feel frozen; slow abnormal blink. Very slow blink; Neuropathy felt worse; Neuropathy felt worse; Her eyes were extremely sensitive to light./She couldn't open her eyes; muscle spasms in right arm and under right breast and going across her stomach and in legs at times; muscle spasms in right arm and under right breast and going across her stomach and in legs at times; Left arm hurting; This is a spontaneous report from a contactable consumer (patient). A 77-year-old female patient received BNT162B2 (Lot number: EN6201), via an unspecified route of administration, administered in arm left on 19Feb2021 09:30 (at the age of 77-year-old) as 2nd dose, single for COVID-19 immunization. Medical history included multiple myeloma from 2017, fibromyalgia, Raynaud's phenomenon, neuropathy all was ongoing; Bone and blood transplant 3 years ago in 2018, pain, sleep disorder, herpes, cancer, dry eyes, and fungus from the pneumonia. Concomitant medications included ongoing gabapentin, started over 3 and a half years ago (unspecified date) for neuropathy; lorazepam for pain and to sleep; ongoing acyclovir for herpes; ongoing omeprazole (PRILOSEC); ongoing fexofenadine hydrochloride (ALLEGRA); ongoing glucosamine; ongoing cyanocobalamin (VIT B12); ongoing daratumumab taken for cancer treatment; ongoing vitamins; MSN (Did not confirm what MSN was), stuff for bones and for her fibromyalgia. The patient previously received the first dose of (BNT162B2, Lot Number: EL9264) administered in left arm on 29Jan2021 09:30 as single dose for COVID-19 immunization. The patient had a reaction to the second vaccine. The patient experienced left arm hurting on 19Feb2021. She did not feel first one at all. The second one hurt. Arm still hurts when gets up in the morning and reaches for something. She can still feel it. Two (2) days after the second vaccine on 21Feb2021, neuropathy felt worse; her eyes were extremely sensitive to light. She sat inside with shutters closed. She was very sensitive to light. She went outside to walk, wore sunglasses and large brimmed hat. At times she had to stop. She couldn't open her eyes. She felt more on her left side. She had to pull the brim down. She was also getting muscle spasms in right arm and under right breast and going across her stomach and in legs at times. It was more in her arm and stomach areas. She was getting in in legs also. Her eyes are still a little sensitive but not bad. Her doctors wanted her to go off her neuropathy medication. They also talked about replacing the Gabapentin with other medications, but it was explained they all have side effects. She had been taking 2 pills and went down to 1 pill. Neuropathy got worse. They did not think the Gabapentin was part of it. Confirmed with caller that neuropathy medication was Gabapentin. They did not think pill had anything to do with it. Caller stated that she had been on it for at least 4 years. She had been afraid to start on something else. She said everything had something. Caller reported that she has been back on 2 pills of Gabapentin for 3 weeks now. On unspecified date, the end of her fingers and toes are still hurting and feel frozen. At her next appointment, she wanted to know if can go on 3 pills and then cut back. She had it for 4 years, but it got worse. This was under control, the neuropathy, and now all of this threw it out of control. Caller stated that everything calmed down about 9 days later. She had problem with her eyes, she did not have to sit inside in the dark. The neuropathy was there but not quite as painful. After going down to 1 pill of Gabapentin, it got worse. In the past she had dry eyes. She went to 3 different doctors and had different eye drops. They mentioned that her blink was not normal. They put plugs in and for about year, her eyes didn't bother her. At her first appointment, she checked her eyes. She ordered permanent plugs for her eyes for her dry eyes. She had slow abnormal blink on 21Feb2021. Very slow blink. It was causing eyes to be dry. They had suspicion that it was Benign Essential Blepharospasm on unspecified date. She wanted her to stop taking the Gabapentin as side effect is loss of muscle. On unspecified date, her eyes were red and irritated when she was in for her treatment. She was having hard time in there. Her next appointment was 19Mar2021. Caller said her first appointment was 09Mar2021 and she put in plugs. Her vision was blurry. PRIVACY felt she definitely had Benign Essential Blepharospasm. She talked to other doctors and it was agreed this is what she had. The only cure for Benign Essential Blepharospasm is these little Botox injections in her eye. Caller stated on 23Mar2021 she went back. Her eyes were getting worse. She had abnormal blinking problems opening and closing her eyes. She injected Botox on top. Her vision was clear and her blink was back to normal. This only lasted for half an hour. At the visit she saw white circle around the cornea. Caller stated the cure didn't work. Next visit was 30Mar2021. Her eyes were getting worse and worse, mainly only the whites of her eyes were showing. She was having trouble keeping her eyes open. Caller said that a few years ago she got up 3 times in the middle of the night and it took a minute or two to get her eyes open. Her fear was that she couldn't get her eyes open. Caller stated that it was exhausting to keep her eyes open. She got medicine drops to keep her eyes open. 06Apr2021 the white circle around her cornea was getting smaller. It was still blurry. It was burning, but it was a pinch better. She had more control over the muscle. The drops were Apraclonidine ophthalmic drops. At this point her eyes were barely open. Mostly saw whites of eyes. Barely color. Caller stated that she started 2 pills of Gabapentin. On 19Apr2021 white around cornea gone. She had blurry days but also clear ones. They ordered MRI (Magnetic resonance imaging). Her blink was still abnormally slow. When she tried to read or watch TV, it strained her eyes. 02May2021 MRI was done. She saw PRIVACY 03May2021 for treatment and he already had MRI results. MRI normal. They talked about Gabapentin and said he did not believe it was that. Caller says she told him that she had gone back on it. She was getting more muscle control. She continued to use ointment that they had given to her. She told her not to drive. She used the ointment twice daily. It was Erythromycin 5mg. She put in in her eyes twice daily. On 07May2021 appointment PRIVACY said vision was 20/30. It was 20/50 when it was bad. The white circle in her eyes was slightly back. Seeing improvement. On 21May2021 was last appointment. PRIVACY checked her vision and it was 20/25. Caller said she was dancing around. She looked so much better. Her blink was more normal. PRIVACY confirmed that all of the problems were from the second dose. Caller stated that her friend knew a scientist that said that if it was from vaccine, it would take at least 3 months to get normal. It is getting more normal, her eyes. She is driving. Once in awhile it gets a little blurry but mostly pretty clear. It is nothing like before. She could only read one line and texting she knew where it was. She mainly sat around with her eyes closed resting them. Her biggest fear was they would close and not open. Treatment for the events slow abnormal blink, Benign Essential Blepharospasm, her eyes were red and irritated, vision was blurry, white circle around the cornea included Eye plugs, Apraclonidine ophthalmic drops, Botox on eyes, Erythromycin Ointment. She had transplant 3 years ago, bone and blood for Multiple Myeloma. Her doctors researched the chemotherapy she had for the transplant to see if it had anything to do with this. Caller than gave more information regarding the transplant. She had pneumonia. She was supposed to have transplant. There was a shadow on her lung. She had CT scan on unspecified date. She had to cancel her transplant. Something was in the lung. They did a biopsy on her lung (unspecified date). During the biopsy, they pulled her arm down hard. That is when the neuropathy started. She had fungus from the pneumonia. It took 3 months to heal the fungus. Cancer was back up higher than the first time. When it was down low enough, she had the transplant. Caller stated that day or two after blood test for Myasthenia Gravis, she had difficulty swallowing. She looked at internet. She thinks it was just nerves and trying to keep her eyes open. It was exhausting. She called a girl to come stay with her and it went away. When she looked at the internet, she got shook up. The events neuropathy felt worse, extremely sensitive to light, slow abnormal blink, benign essential blepharospasm, her eyes were red and irritated, vision was blurry, white circle around the cornea, muscle spasms in right arm and under right breast and going across her stomach and in legs at times resulted in physician office visit. The patient underwent laboratory test which included Blood test for Myasthenia Gravis in 30Mar2021 with negative result, MRI eyes on 02May2021 with normal result. The outcome of the events neuropathy felt worse, slow abnormal blink, Benign Essential Blepharospasm was not recovered; the events left arm hurting, eyes were extremely sensitive to light was recovering; the outcome of white circle around the cornea recovered on 19Apr2021; and the outcome of the remaining events was unknown.

Head pain; Pain on jaw bone; Pain on both sides of the nose; Pain in neck and shoulders; Froze up her muscles; Physical therapist told her she may have tendinitis in her head/brain; Pain in neck and shoulders; This is a spontaneous report from a contactable consumer (patient). A 77-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection) via an unspecified route of administration on 26Feb2021 (age at vaccination 77-year-old) as 2nd dose, single for covid-19 immunization. Medical history included fall. Patient stated that in the early 2000s she had a fall as a result of an allergic reaction to a prescription medication and hit her head on the kitchen floor and ended up in the hospital after fall, no further information provided by the caller about what prescription medication this was, allergic reaction to a prescription medication and pacemaker. The patient's concomitant medications were not reported. The patient previously took first dose of BNT62B2 for COVID-19 Immunization. Patient stated she had her second dose of the Pfizer Covid 19 Vaccine on 26Feb2021 and had some side effects and she assumes they were from the vaccine. On 27Feb2021, patient experienced head pain and pain on jawbone. Stated she continued to have pain in her head, neck, and shoulders. She went to her primary care and an ear, nose, and throat doctor. Says she had lots of sinus problems, lots of allergies, and was highly sensitive to medications. On an unspecified date in Feb2021, one night, all night, she had pain on both sides of her nose. States she continued to have serious head pain, pain in neck and shoulders, froze up her muscles, she stated the Covid Vaccine froze up her muscles. She said the physical therapist said she possibly has tendinitis in her head and said physical therapy has been helping, it was not just a minor, dull feeling in her head. Patient stated she was in Physical Therapy because they were working on her muscles and said she goes every Tuesday and Thursday. Said they were working on trying to unfreeze her muscles. Patient stated that she sees an allergist once a year. Patient said she wonders if she got an overdose of the vaccine due to her sensitivity, weight, and size. Patient stated she needs someone with technical expertise. Since she has a pacemaker she went and saw her cardiologist to see if there was any impact on her pacemaker. The cardiologist found no changes. She was concerned going forward how much of a risk was she at of getting Covid 19. Patient stated that the ear, nose, and throat doctor did a scan of her sinuses and an x-ray of her head. Patient stated she cannot have an MRI due to her pacemaker. The patient underwent lab tests and procedures which included scan of her sinuses: unknown, scratch test positive: unknown in an unspecified date in 2005, x-ray of her head: unknown. The outcome of the events was unknown. Information on Lot/Batch number has been requested.

Systemic: Chills-Medium, Systemic: Confusion-Mild, Systemic: Dizziness / Lightheadness-Medium, Systemic: Numbness (specify: facial area, extremities)-Medium, Systemic: Shakiness-Medium, Systemic: Tingling (specify: facial area, extemities)-Medium, Additional Details: Patient had faint feeling, chills, temperature normal, blood pressure 164/90 pulse 60. Chief complaint was unusual taste and numbness of lips. Symptoms improved over 30-45 min period

deafness right ear/ lost hearing in right ear; This is a solicited report from a non-Pfizer sponsored program (marketing program name not available) received from a contactable consumer (patient), based on information received by Pfizer(Mfr Control No. 21K-163-3815436-00). A 77-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection) dose 2 intramuscular at age of 77 years on 13Feb2021 10:00 (Batch/Lot number was not reported) as single dose for covid-19 immunisation; adalimumab (HUMIRA, 40 mg/0.8 ml), subcutaneous from 17Jan2021 to 17Jan2021, at 40 mg[(1 in 14 D)], subcutaneous from 29Jan2021 to 29Jan2021, at 40 mg[(1 in 14 D)], subcutaneous from 24Feb2021 (Batch/Lot number was not reported) to an unspecified date, at 40 mg[(1 in 14 D)] for Moderate to severe Rheumatoid Arthritis. Medical history included no tobacco use, abstains from alcohol, allergic reaction.Concomitant medications included insulin detemir (LEVEMIR FLEXPEN); biotin (BIOTIN); acyclovir [aciclovir] (ACYCLOVIR [ACICLOVIR]); alprazolam (ALPRAZOLAM); atenolol (ATENOLOL) ; atorvastatin calcium (LIPITOR [ATORVASTATIN CALCIUM]) ; bupropion hydrochloride (BUPROPION HCL XL) ; clopidogrel bisulfate (PLAVIX) ; famotidine (FAMOTIDINE) ; glipizide (GLIPIZIDE XL) ; losartan potassium (COZAAR) ; mirtazapine (MIRTAZAPINE) ; pioglitazone hydrochloride (ACTOS) ; sodium bicarbonate (SODIUM BICARBONATE) ; sucralfate (SUCRALFATE) ; iron (IRON) ; calcium (CALCIUM) ; vitamin c [ascorbic acid] (VITAMIN C [ASCORBIC ACID]) ; fish oil (FISH OIL) ; coenzyme q10 [ubidecarenone] (COENZYME Q10 [UBIDECARENONE]) ; cyanocobalamin (B 12) ; acetylsalicylic acid (ASPIRIN). The patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection) intramuscular on 23Jan2021 at age of 77 years (Batch/Lot number was not reported) as single dose for covid-19 immunisation. The patient experienced deafness right ear/ lost hearing in right ear since 13Feb2021 18:00. The patient took HUMIRA shot on 17Jan2021. Physician said it was ok to take HUMIRA as long as and did not take it the same day as Covid Vaccine since she had reaction and physician did not able to tell for which shot it might be allergic too if she had a reaction. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. Patient received first dose COVID-19 Vaccine shot on 23Jan2021. She took next Humira on 29Jan2021. On 13Feb2021 around 10 AM, patient took her second COVID-19 Vaccine manufactured by Pfizer. On 13Feb2021 about 6 pm (18:00) or thereabout, she started hearing a ticking in right ear and by the 8 pm hearing was completely gone in the right ear. On 14Feb2021, she went to the immediate care center and was checked for no reason. Then she went to emergency room where she had a CT scan on 14 Feb 2021 for no reason and referred to ENT physician on 17Feb2021. She had a hearing test. She had two steroid injections in ear on 17Feb2021 and 26Feb2021 with no improvement. On 01Mar2021, she had MRI but no explanation was found. She was being fitted with a hearing aid in left and right ear as of 29Apr2021 and was having a little problem adjusting. The patient had lab tests in 2021 with unknown results. The reporter's causality for the event(s) of lost hearing in right ear with Humira 40MG/0.8ML (Adalimumab) was a reasonable possibility/ Possible. AbbVie's opinion is that there is no reasonable possibility that the event of lost hearing in right ear is related to Humira 40 mg/0.8 ml (Adalimumab). Causality with BNT162b2 for Deafness right ear (Deafness unilateral) per reporter was Probable. The action taken in response to the event for adalimumab was unknown. The outcome of the event was not recovered. No follow-up attempts are possible; Information about lot/batch number cannot be obtained.; Sender's Comments: Based on current available information and a temporal association, the causal association between the event and the suspect drug BNT162B2 is assessed as possibly related. Consider also possible contribution from co-suspect drug. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated a 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.

lips felt tingle; tongue dexterity affected; tongue became sensitive to eventoothpaste; tongue felt thickened; Very dry mouth; This is a spontaneous report from a contactable consumer, the patient. A 77-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 04Mar2021 at 11:00 (at the age of 77-years-old), as a single dose for COVID-19 immunisation. Medical history included high blood pressure and cholesterol. Concomitant medication included amlodipine (MANFACTURER UNKNOWN) and simvastatin (MANFACTURER UNKNOWN); both for unknown indications from unknown dates. The patient did not have allergies to medications, food, or other products. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 04Mar2021 at 17:00 (after 4+ hours receiving the first dose), the patient's lips felt tingle and her tongue dexterity affected and tongue became sensitive to even toothpaste, tongue felt "thickened" although no problem in swallowing. The patient also had very dry mouth. The patient took BENADRYL as a therapeutic measure, symptoms persisted but lessened, she was apprehensive about taking second dose. The events did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events lips felt tingle, tongue dexterity affected, tongue became sensitive to even toothpaste, tongue felt thickened and dry mouth was resolving. No follow-up attempts are needed. No further information is expected.

I first lost my nail. It was unusual because there was no trauma to the nail. I was reaching for something across my bed, and I started experiencing radiating pain across my chest as well as pressure. I stayed very still and then it spread through my left arm and up into my shoulder, neck ear and jaw. I remained still and tried breathing the best I could. This lasted a minute or two and then it released and was over. About a month later, I was diagnosed with RSV which ran down into my lungs and soon my blood pressure was going up because my heart was working so hard to breathe. It was over 200/175 which is abnormal for me. I had to end up calling an ambulance because I was having trouble breathing. I was prescribed blood pressure medication, steroids, antibiotics, prednisone and oxygen. I was not allowed to get out of bed, I couldn't walk. They told me it would take baby steps.

Major swell lips; Major swell mouth; This is a spontaneous report from a non-contactable consumer, the patient. A 77-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN), via an unspecified route of administration on 29Mar2021 at 08:15 (at the age of 77-years old) in left arm as a single dose for COVID-19 immunisation. Medical history was reported as unknown. No allergies to medications, food, or other products. Concomitant mediation was reported as unknown. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination the patient was tested for COVID-19 and the result was unknown. On 29Mar2021 at 08:15, the patient experienced lip swelling and mouth swelling. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic treatment received for the events was reported as unknown. The clinical outcome of the events of lip swelling and mouth swelling was not recovered at the time this report. Information about lot/batch number cannot be obtained. No further information is expected.

It felt like it was kind of closing; reflux; swelling under her upper lip; swelling of her throat; This is a spontaneous report from a contactable consumer or other non health care professional from a Pfizer-sponsored program . A 78 year old female patient received bnt162b2 (PFIZER-BIONTECH mRNA COVID-19 VACCINE, solution for injection, Lot Number: EL0140 ), dose 1 via an unspecified route of administration, administered in Arm Left on 07Jan2021 13:00 (Age at vaccination: 77 years) as 1ST DOSE, SINGLE for covid-19 immunisation. Medical history included she has a lot of food a lot of food allergies including nuts, and seeds. She was very allergic to poppy seeds and would like to know if any ingredients have been derived from poppy seeds. Patient did not received prior vaccination in 4 weeks. There were no concomitant medications. The patient experienced swelling of her throat and swelling under her upper lip in Jan2021. Patient reported, it felt like it was kind of closing, reflux, on an unspecified date. within 24-48 hours felt a little feeling of swelling of her throat. It felt like it was kind of closing. She got an EMT Scope and they saw that her throat was swollen. They thought that it was because of reflux and gave her reflux medications which did not help. ENT said her throat was swollen and she has some swelling under her upper lip. She thinks it was something to do with the vaccination. Then she received the second 28Jan2021 13:00PM in the right arm. After the second dose she continued to feel like her throat was swollen and her upper lip underneath feels swollen. Adds you can't see it but if you lift up her lip you can see it was swollen. She saw an ENT and an allergist who confirmed everything. It was further reported that after 1 month she finished the 2 doses of Pfizer covid-19 vaccine, she stated that she received the 1st dose last 07Jan2021 and started feeling like there's a pressure on the back of her throat, since she was feeling that she visited a physician and telling her that it's just a reflux. but since she was feeling that her throat was closing she started taking medication for reflux. (3 weeks) and she noticed that she's swelling/tingling in her upper interior lips. but she was advised that there's no medical intervention but until now she had all the reactions after 1 month. The outcome of throat is swollen and swelling under her upper lip was not recovered. The outcome of the rest of the events was unknown. No follow up attempts are possible. No further information is expected

her memory was kind of worse; swelling in the face, forehead, eyebrows and she feels it moving; swollen over her eyebrows, over eyes and lips; This is a spontaneous report from a contactable consumer (patient). A 77-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 03Jun2021 (at the age of 77-year-old) as DOSE 1, SINGLE for covid-19 immunisation. Medical history included diabetes mellitus (she is a diabetic on an insulin pump), breast cancer, kidney disease and patient had unknown allergy (she was allergic to something but cannot provide what it is specifically). The concomitant medications of patient were not reported. Patient stated that her face was swollen up, wondering if this is a symptom. She just got the last one, it swelled up with the first one, but she didn't call, this is the second one. Caller stated that her face swelled up the second or third day after the first shot. She stated that she got her both doses on 03Jun2021 (1st dose) and 24Jun2021 (2nd dose). Caller declared that her face has swollen up after her 1st dose and has persisted since the 2nd dose. It was swollen over her eyebrows, over eyes and lips. She also noticed it moved from one side to the other in a matter of hours. She knows she was allergic to something but cannot provide what it is specifically. Caller informed the vaccination site that she has serious case of diabetes, allergy, kidney problems and had cancer. Caller mentioned that she was questioned if she does have the cancer again. However, the vaccinator proceeded with her shot. Another thing she noticed was her memory was kind of worse. That started after, she noticed more after the shot, the first shot. She stated seems like it was improving, as soon as she found out what was wrong, as soon as she was alerted, she was not remembering too good. After the first dose of the vaccine on 03Jun2021, she experienced swelling in the face, forehead, eyebrows and she feels it moving. The doctor wanted to do biopsy of it. Caller stated that she was scheduled for biopsy today (29Jun2021) and wanted to know if that is too soon, with not even been a week since she had the COVID shot. Caller wanted to know if more than 1 vial can be used to give the vaccine as she thinks that more than 1 vial of the Pfizer covid vaccine was used to give her shot. She was asking if Pfizer use two vials with the vaccine because she saw them use two vials and wanted to know if something is mixed with that. Seriousness was reported as no. The outcome of event memory impairment was recovering and for rest of the events outcome was unknown. Information on Lot/Batch number has been requested.

Itching; Tongue redness; Tongue swelling; This is a spontaneous report from a contactable consumer (patient). A 77-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EL1283 and Expiration Date not reported) dose 1 via an unspecified route of administration on 04Feb2021 as DOSE 1, SINGLE for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient received historical vaccine of flu shot (no details provided) in September. The patient has no known allergies. The patient received the first dose of the COVID-19 vaccine a week ago and had a reaction of itching and the tip of her tongue got a little red and a bit swollen. She says she was scheduled to take the next dose of the vaccine on the 25th of this month and had some concerns. She said that the reason she called was she wanted to make sure it was ok for her to take second dose. She said she already talked to her doctor who told her to call Pfizer. The patient told that, the itching was probably for 12 hours. The patient said that, the tongue redness and being a bit swollen did not last long, she came home and had lunch and drank a lot of water. She said that the itching stayed until almost the next day and her tongue was better. She said she was concerned and went to her doctor. The patient received treatment with Benadryl one time at night, UPC: Unknown and product did not have a barcode on it and it was small tablet size and Diphenhydramine HCI 25mg said it as antihistamine on the label, with EXP Dec2021 and LOT SEF004 and took one by mouth one time. The outcome of events was unknown. Follow-up attempts are completed. No further information is expected.

Loss of taste and smell starting after second vaccine and continuing until now. She was unable to smell burning food.

loss of appetite; loss of taste; headaches; fatigue; This is a spontaneous report received from a contactable consumer or other non hcp (patients son). This consumer reported for mother. A 78-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/lot number was not reported) (age at vaccination was reported as 77 years) via an unspecified route of administration on an unspecified date in 2021 (Batch/Lot number not reported) as single dose for covid-19 immunization. Patient's Medical History including any illness at time of vaccination was reported as none. The patient's concomitant medications were not reported. The patient experienced loss of appetite, loss of taste, headaches, fatigue on an unspecified date. Additional context reported as report that his 78-year-old mother experienced side effects after administration of the fist dose of Pfizer Covid-19 Vaccine. The patient has already gone to the physician for the management of the symptoms. The patient was dosed with first dose of Pfizer Covid-19 Vaccine less than 2 weeks ago but does not have the actual date of administration or the Pfizer Covid-19 Vaccine Lot and things like that. The patient underwent lab tests and procedures which included chest x-ray: not have pneumonia on 09Jul2021. She does not have pneumonia. The clinical outcome of the events was not recovered. Information on the lot/batch number has been requested

A few days after her second COVID vaccination, she developed severe tinnitus, cognitive impairment, difficulty with speech and language

Elevated blood pressure; swelling in mouth/lips; Nausea; Sensitivity to sound; Severe itching (all over, especially legs, thighs back, arms, scalp, eyebrows and in nostrils); This is a spontaneous report from a contactable consumer, the patient. A 77-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: 0140), via an unspecified route of administration in the left arm on 20Jan2021 at 10:00 (at the age of 77-years-old), as a single dose for COVID-19 immunisation. Medical history included spinal stenosis, degenerative disc disease, arthritis, sciatica, high blood pressure, diabetes, high cholesterol, pollen allergy, dust allergy, ragweed allergy, carageenan allergy and fruit allergy (tomatoes). Concomitant medications included morphine sulfate (MANUFACTURER UNKNOWN), amlodipine (MANUFACTURER UNKNOWN) and metoprolol succinate (MANUFACTURER UNKNOWN); all from unknown dates for unknown indications. The patient previously took simvastatin on unknown date for an unspecified indication and experienced drug allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 20Jan2021 at 22:00, the patient experienced swelling in mouth/lips, severe itching (all over, especially legs, thighs back, arms, scalp, eyebrows and in nostrils), nausea, sensitivity to sound and elevated blood pressure. It was unknown if therapeutic measures were taken as a result of the reported events. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events swelling in mouth/lips, severe itching (all over, especially legs, thighs back, arms, scalp, eyebrows and in nostrils), nausea, sensitivity to sound and elevated blood pressure were resolved on an unknown date in 2021. No follow-up attempts are needed. No further information is expected.

PATIENT REPORTS APPROXIMATELY 5-10 MINUTES AFTER RECEIVING VACCINE TO LEFT ARM THAT "MY HEAD FELT WEIRD AND I GOT A PAIN TO MY LEFT EAR FOR A SPLIT SECOND." SHE REPORTS IT CAME AND LEFT VERY QUICKLY. UNABLE TO DESCRIBE WHAT THE HEAD FELT LIKE OTHER THAN WEIRD. REPORTED FEELING COMPLETELY NORMAL AFTER OCCURANCE

Patient reports feeling flushed and lips/tongue tingling. Physical examination in the emergency department noted as normal. Patient given diphenhydramine 25 mg orally with resolution of symptoms.

Patient reports feeling flushed and lips/tongue tingling. Patient transported to the emergency department for evaluation. Physical exam noted as normal and no tongue or lip swelling. Patient administered 25 mg diphenhydramine orally and observed for 2 hours.

began to ache 2 pm of day of vacination, could not sleep. shooting pain ears, hands, head, much worse than 1st shot

18:10 Pt. reports to observation nurse throbbing (R) eye stabbing pain, (R) sided headache. 10 minutes post vaccine. EMS evaluation. B/P 125/71, HR 88, 99% Sat O2, 2 hours post prandial BG 149. (R) sided headache and (R) sided eye pain worsens, pt. agree to transport to local area hospital.

Around 3PM about 7 hours later of shot The left side injection / problem left side of Face from cheek bone to jaw line redness , puffiness plus skin irritation chaffing . her left side of lip she complained of slight numbness it was suggested that if irritation take Tylenol which we did two over 4 hours before bed around 1AM took one Advil she was restless to go to sleep fearful finally around 3AM tired enough to fall asleep About 11AM called my niece Nurse Hospital she said take Benadryl but speak to DOCTOR First he said same thing did for about 4 days Swelling and Redness went down numbness lower lip still slight their now about 10 days later acceptable feeling still wondering why??

1040 The patient received the COVID vaccine. At 1055 the patient began to complain of a dry scratchy throat. Zyrtec 20 mg given per MD. Patient monitored for another 45 minutes. Patient reported feeling better. Symptoms resolved. Discharged home per MD

Patient complained of difficulty swallowing, tingling feeling in her tongue. She initatally took 50 mg of benedryl, and after 15 more minutes, she continued to have the same symptoms, and in addition was breathing more labored, was having a harder time swallowing, and complaining of feeling dizzy and a headache. She then received an Epi Pen, was placed on oxygen, used her Xopenex inhaler, and EMS was called. She was then transferred to the ED for continued monitoring.

TEN DAYS AFTER RECEIVING THE FIRST VACCINE, LOST SENSE OF TASTE, ON FEBRUARY 2, RECOVERED TASTES TO FOOD, I REALIZED AS I ATE AN ORANGE AND THEN TEA, ON FEBRUARY 5TH, IT STARTED TO DISAPPEAR AGAIN. AT NO POINT HAVE I LOST SENSE OF SMELL.

This 78-year-old female has a history of allergic reactions to ciprofloxacin and latex. She received a COVID-19 vaccine this morning at approximately 11 AM. In a matter of minutes after receiving the vaccine she developed tingling to the left side of her lower lip as well as some pressure in her tongue and behind her eyes. She reported a sensation like her face was swelling. She denies difficulty breathing, difficulty swallowing. There is been no nausea or vomiting. She was observed in the vaccine area, and then ultimately referred to the emergency department after approximately 40 minutes of symptoms. No chest pain or chest pressure. No rash.

double vision, little dizzy, headache - yesterday had her 2nd vaccine SYMPTOMS DURATION: 2 days. Patient states she got her first COVID vaccine on 2/5/21 and had a slight headache but no other symptoms. Today, she was sitting the car when she started to have double vision. She reports dizziness/lightheadedness that is moderate. Patient states the double vision isn't everything but random things and at random times today. Denies dehydration, fever, or injection site abnormalities. No headache today. Reports that last week at her PCP's office her BP was slightly elevated and she thinks her BP may be elevated right now but does not have a cuff with her to check. Went to the Emergency Department on 2.6.21 - admitted overnight until the 7th. DETAILS OF HOSPITAL STAY: DX: Diplopia [H53.2] Blurred vision, bilateral [H53.8] HOSPITAL COURSE: 1. Double vision post COVID vaccine. Unclear etiology or if related to vaccine reaction. Resolved. CVA ruled out. Could be migraine associated. Advised patient to talk to PCP about migraine prophylaxis and see ophthalmology as outpatient. 2. HTN 3. HLD Advised patient not to drive till cleared by ophthalmology Inpatient workup included myasthenia gravis panel which is still pending The patient is a 78-year-old right-handed woman who received her first Pfizer COVID vaccination February 5. This morning she developed double vision. Images were horizontal she does not know if they were binocular or monocular. She saw couple with 1 child and it appeared that they had 2 children. She looked at her son and saw 2 heads on 1 body. She saw 2 traffic lights. Each time she saw diplopia, it lasted for maybe 1 minute, and after blinking it went away. The double vision was not associated with headache, facial numbness or weakness, numbness or weakness in her extremities, speech change or imbalance. She recovered from each episode. She has had torn retina twice in each eye. Those were each associated with flashes of light in floaters. She did not have a fever today. She has never had double vision before. Review of systems: She admits to a history of headaches. She said she had catamenial headaches and sinus headaches.

Approximately 30 minutes after injection patient presented to the emergency department with mild facial swelling. Both cheeks and around her lips feel a little swollen. Denies trouble breathing or swelling in her tongue or intraoral area. Patient treated with diphenhydramine, prednisone and famotidine. Symptoms resolved.

Approx 5 min after injection complained of lip swelling. Denied any sob or throat tightness. Resp even/nonlabored. Speaks full sentences. Doctor notified. VO given for Benadryl 50 mg IM. Benadryl 50 mg given in L glute and patient was taken to Urgent Care for evaluation Doctor. Taken to Urgent Care via wheelchair for evaluation. Symptoms improving upon arrival and report given to Doctor and LVN.

A little weak at bedtime (Saturday) Next morning Strong toothache upper back left teeth, slight swelling/itching lower left side of mouth/chin area (Sunday) Pain all day (Monday) Feels like teeth are in a vice, swelling left side of roof of mouth

Flashes of lights in my eyes, burning pain in my legs, my ankles were on fire. Totally fatigued, could hardly walk and had to walk with a cane and hold onto wall. Just plain pain all over, I felt nauseated but never threw up. I took anti-nausea pills and pain pills.

severe headache lasted almost 3 days High blood pressure with a racing heart on the third day I received a prescription from my cardioligist the next I lost my sense of taste as of 02/02/2021 (11 days) my taste has not returned

Few minutes post vaccination, after moving to observation area via wheelchair, the patient complained of dizziness. She took glucose tabs she had brought with her. Staff wheeled her to Triage # 1. Her eyes rolled back in her head and she lost consciousness. Staff (paramedics on site) transferred her to gurney and started compressions. AED placed, V- Fib was rhythm, Shock # 1 given, CPR resumed. Shocked again. Fire truck and additional EMT arrived on site and took over care. Epinephrine was given 3 times via intra-osseous route, Amiodarone given intra-osseous route. Additional defibrillation with on site AED for a total of 6-7 times. Patient had good chest rise with ambu-bag, no airway obstruction or peri-oral edema noted. Code called at 12:40 PM.

Pt received the vaccine and had a breakout inside the mouth. 5-6 pronounced bumps that appeared on the same side as the injection and they lasted for a few hours and they just went away.

Patient reports being in her usual state of good health when she presented for COVID19 Vaccination. She reports onset of diplopia without other symptom approximately 45 minutes after vaccination. Later that night she notes onset of full L eye ptosis which resulted in resolution of the diplopia. She was evaluated by ophthalmology the next day, 2/11, and was referred to the ER where she had a brain CT with no acute changes and unremarkable labs. Treatment with Plavix 75mg was initiated. She was evaluated in my office on 2/16 for persistent ptosis of her L eye and her exam is consistent with isolated third nerve palsy. Diabetes and lipid levels are at target.

My Mom had an an allergic reaction four hours after receiving her first dose of the Pfizer Covid 19 vaccine. Her face swelled up and became red....worse on the right side than the left...her eyes were swollen as well. It lasted this way for four days....it is a little better now, but her face is still a little swollen (seven days after shot). She had a headache on and off and felt tired (which we understand is not an allergic reaction, but rather an immune response). Her family physician suggested taking antihistamines before her second shot. Needless to say, we are apprehensive about what the outcome from the second shot will be like for her.

Had CoVid vaccine #1 1/22/21 - felt fine. 2/5/21, eyes became swollen and red - called her eye Dr, who met her after hours at his clinic and diagnosed with shingles. She does not remember ever having chicken pox but states she might have forgotten. She called MC to inform us she could not return 2/11/21 for her second vaccination d/t the shingles. We also had a second person vaccinated the same day that also called with shingles so decision was made to enter this variance report.

1. Immediately had very unpleasant metallic taste in mouth. 2. Five to ten minutes after injection had very severe headache. After returning to car, took 2 extra strength (500 mg) rapid release Tylenol. Headache lasted 5/6 hours. 3. Soreness around injection site for 2 1/2 days.

Double vision; the way she talked she kind of had slurred speech; mouth was dry; she had Bell's Palsy/ Droop in her lip/mouth; her eye was still watering; puffiness around her eye; This is a spontaneous report from a contactable consumer (patient). A 78-year-old female patient received first dose of bnt162b2 (manufacture unknown, Lot Number: 9264), intramuscularly in left arm on 29Jan2021 14:55 at 0.3 ml, single for COVID-19 immunization. Medical history included non-hodgkin's lymphoma from Jul2019 and ongoing (The first time she was diagnosed was Jul2019. She then went into remission and then got the cancer back, she doesn't know when. She knows they started treating it as the cancer had returned in Aug 2020), watering eyes from an unknown date and unknown if ongoing (Her eye was watering before the injection. She knows her eye was watering before she received the vaccine), chemotherapy from an unknown date and unknown if ongoing (she is a cancer patient on chemotherapy), fever blister from an unknown date and unknown if ongoing. There were no concomitant medications. The patient experienced she had bell's palsy and she does not know if she got this from the covid shot or not but she still has the droopy lip which apparently that can last a while. on 02Feb2021, droop in her lip/mouth on 02Feb2021, her eye was still watering on 02Feb2021, there was a little puffing around the eye/ puffiness around her eye on 02Feb2021, double vision on an unspecified date, the way she talked she kind of had slurred speech on an unspecified date. Caller was calling about the Pfizer COVID 19 vaccine. She said on Friday 29Jan2021 she had the first shot at about 12:30. Her eye started watering in the morning Thursday the day before and she maybe assumed she was getting a cold in her eye but it was really runny and she got the shot. She was a cancer patient on chemo and she went to the doctor because she was supposed to get her chemo. That Tuesday morning she had a droopy lip on the right side and her eye was still watering, there was a little puffing around the eye and the way she talked she kind of had slurred speech so she thought stroke but she was going to get her chemo in an hour or 2 so she when they checked her she told them what happened, she was seeing the PA that day so she left and came back 10 minutes later and said she had talked to the doctor, they were not going to give chemo today and told her she had Bell's Palsy and she does not know if she got this from the COVID shot or not but she still has the droopy lip which apparently that can last a while. This was her first shot so as a cancer patient on chemo should be getting the second shot 21Feb. She was concerned about taking that when she already has Bell's Palsy now, what else would it cause and then if she does not get it would she be 50 % protected. The doctor seemed to say she thought it was from the vaccine, but caller does not know because the eye watering began the day or 2 prior to getting the vaccine. Product details: She does not have the vaccine card right with her and she was using a walker to get up and down and so she was not able to provide NDC lot expiration right now. It would be available if needed at a later time. Indication: doctor said she should have it because she has no immune system. They don't know what to do they are just following what they told her and they were scared to death. The caller states she was a cancer patient on chemotherapy. She received her first Pfizer COVID-19 injection on Friday, 29Jan2021. Prior to the vaccine, her eye had been watering Thursday or Friday morning before she had shot, it was just her right eye. On Tuesday, 02Feb2021, she developed a droop in her mouth and puffiness around her eye and so forth. Caller clarified it was just on the right side and with her right eye. She also has double vision in her right eye. She got up in the morning on 02Feb2021, and her husband was in the other room and told her that she sounded funny. She explained to her husband her mouth was dry and she was kind of slurring her speech. Her husband came into the room she was in and said, "huh, your lip was drooping". Since it was in the morning and she had no other symptoms besides the talking funny and the puffiness around her eye, she didn't take it as a stroke. She figured she would just until she went to her chemotherapy appointment she had the same day, 02Feb2021. She went into her appointment and showed the person and gave her information on what happened. The person wanted an MRI of the brain to make sure she didn't have cancer there or cancer anywhere else up in that area and also that she didn't have a stroke. She confirms the MRI was fine, both were negative for any signs of this. She was told she developed bell's palsy. She has a drooping lip. The caller was concerned about her second shot. She wants to know should she getting the second vaccine, because the person at the (institution name) office (where she receives her chemotherapy) believes the bell's palsy came from the COVID-19 vaccine. She was supposed to have chemotherapy that day (02Feb2021), but they wouldn't give it to her then, but she did have it done yesterday. Caller explains she has no NDC, Lot number or expiration date for the chemotherapy she receives. She isn't given any stuff with any numbers and she gets numerous medications. Patient's Medical History (including any illness at time of vaccination): Her eye was watering before the injection. She knows her eye was watering before she received the vaccine because as she was sitting waiting to receive her injection, she remembers wiping her eye and thinking to herself, "I wish this eye would quit watering". Caller states she had a fever blister, but she was not quite sure about when this appeared. She doesn't know if she had developed the fever blister before or the next day after receiving the vaccine, she was not quite sure. The any events were not required a visit to Emergency Room. She went to the Oncology Office for her chemotherapy appointment. No Prior Vaccinations (within 4 weeks). Caller had the MRI (magnetic resonance imaging) on 02Feb2021 showed she didn't have a stroke and no cancer of the brain. The patient underwent lab tests and procedures which included magnetic resonance imaging: negative on 02Feb2021 Negative for stroke and/or cancer. The outcome of events was unknown. No follow-up attempts are possible. No further information is expected.

At location, she felt fine during 15min wait At 3:30-4:30 Zoom call, she looked good, but said she wasn?t feeling great & was concerned due to chills & 4days headaches after 1st dose At 8:30pm she called with chills, 3 layers of clothes & bedwarmer on... said her teeth chattered & was trying to drink warm water to heat from the inside (hydration w/o cold water; said no more coffee) At 11:00pm she texted chills were over, she was expecting aches ?but would be asleep during them?... good attitude at the time At 2:19am she called, had fallen & couldn?t get up, said she called a friend to come help her ... said she?d tried to get up, but legs were numb... said she was dizzy when she fell, total dry mouth & had reached for water, but it spilled when she knocked into things when she fell. She wondered if she should call Fire Dept (but wasn?t making total sense). Her friend came, tried to help, but I think she decided to call 911 for help getting her up & wants EMTs to check her out. **She had fallen during Covid, went to ER & they gave fluids & she was ?good? for a week, but then dizzy & severe lethargy, same friend took her to ER & she was admitted (negative covid test at that point), but very large PE, thus heparin & then Eliquis (Dec 2020).

Waited 15 minutes after receiving the vaccine; went to car and when driving home about 30 minutes later my face and lips on the left side of my face went numb. The vaccine was placed in my left arm. The numbness lasted about 2 hours and then went away.

Awakened by severe leg cramps in both legs, upper and lower, front and back. Pain so intense it? brought tears to my eyes and I woke my husband with my moaning. It lasted about 15-20 minutes. I have never had muscle cramping like this before or since.

hearing totally gone/complete hearing loss in left ear; tinnitus in ears and feeling of pressure; tinnitus in ears and feeling of pressure; Didn't make a real issue out of it and thought it was just congestion; This is a spontaneous report from a contactable consumer. A 78-year-old female consumer received first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 20Jan2021 in left arm at 11:15 at single dose for COVID-19 immunisation at the age of 78-year-old. Lot number was E18982. Medical history and concomitant medications were unknown. Historical vaccination included flu in Jan2021 for immunization. On 08Feb2021, the patient woke up with complete hearing loss in left ear, hearing totally gone, tinnitus in ears and feeling of pressure. In Feb2021, the patient did not make a real issue out of it and thought it was just congestion. On 08Fb2021, the patient saw ENT. On 08Feb2021, the patient performed a hearing test: complete hearing loss. On unknown date, blood work was performed, and the results were unknown. The patient did not recover from woke up with complete hearing loss in left ear/ hearing totally gone, tinnitus in ears and feeling of pressure, the outcome of nasal congestion was unknown.

10 minutes after receiving COVID vaccine dose #2 complained of mild tongue tingling with no associated symptoms. Blood pressure 109/71. HR 68. Patient given 25 mg of Benadryl with good effect. Monitored for 30 minutes and was sent home in no distress. Called patient home to check her status, patient reported feeling well and safe.

she has a hearing problem; Constant chills; Cramps; Diarrhea; Nausea; This is a spontaneous report from a contactable consumer (patient). A 78-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot number: EL3248) via an unspecified route of administration on 25Jan2021 10:30 on the left arm at a single dose for COVID-19 immunization. The patient had no medical history. There were no concomitant medications. The patient stated that she did not experience any problems until 27Jan2021 around noon, in which she started experiencing chills, cramps, and diarrhea all afternoon. She would like to know if these reactions have been reported and if they continue to persist, can she take something like Imodium. She didn't have any effect at all from it on Monday or Tuesday, and at noon on 27Jan2021, she had nausea and constant chills and diarrhea, she doesn't think this was a side effect, but wanted to check and see. She was not terribly ill, just uncomfortable, is this something she should be reporting? Stated she has a hearing problem, wished for DSU agent to speak slower. Nausea: was off and on all the time since noon today, it is better, the main thing is diarrhea, and the nausea is connected Constant chills: improving, it came and went all afternoon, she doesn't know if it has gone away, she thinks it is still here, but she is not constantly bothered, it has been periodically since noon today. Diarrhea: better since she has nothing left; nothing was getting worse, she was reporting it because she thought it may be a side effect. Outcome of the events constant chills and nausea was recovering, diarrhea was recovered on an unspecified date while unknown for the other events.

I gave the patient her first COVID vaccination today at approximately 10:30am. After about 30 minutes, she reported tingling lips and a puffy tongue but no trouble breathing. After consulting with our clinical pharmacists, I gave her 50mg IM Benadryl and observed her for another hour. Her vitals were stable. She felt like the Benadryl helped (tingling gone, tongue felt achy), and no other symptoms appeared. She went home with instructions to call the ED with concerns if she developed signs of anaphylaxis, and to take more Benadryl if any tingling/itching occurred. I spoke with her at 7pm this evening and she reports her symptoms have mostly resolved (still a bit of an achy tongue).

the vision in my right eye became blurry; This is a spontaneous report from a contactable consumer (patient herself). A 78-year-old female patient received her second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: el9262), via an unspecified route of administration in the left arm on 26Jan2021 09:00 at a single dose for COVID-19 immunization. The patient had no relevant medical history and no known allergies. Concomitant medication included metoprolol succinate (TOPROL 25 mg) received within 2 weeks of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. She previously received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: el3246), via an unspecified route of administration in the left arm on 05Jan2021 11:30 for COVID-19 immunization. The patient was not diagnosed with COVID-19 prior to vaccination. She was not pregnant. The patient experienced "the vision in my right eye became blurry" on 26Jan2021 09:15. The patient reported that the event was "still is" as date of the report. The event was reported as non-serious and resulted in doctor or other healthcare professional office/clinic visit. The outcome of the events was not recovered. The patient had not been tested for COVID-19 since the vaccination.

Slight feeling of swelling within the mouth; This is a spontaneous report from a contactable consumer (patient). A 78-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration in the right arm, on 01Feb2021 at 11:00 (at the age of 78-years-old) at a single dose for COVID-19 immunisation. Medical history included high blood pressure, indolent follicular lymphoma (not under treatment, but being watched), and allergy to cat dander. The patient was not pregnant at the time of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient's concomitant medications were not reported. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) on 11Jan2021 (at the age of 78-years-old), in the right arm, for COVID-19 immunisation and erythromycin estolate (ILOSONE) as an antibiotic and experienced allergy. The patient experienced slight feeling of swelling within the mouth on 01Feb2021 at 11:30. The event was reported as non-serious. It was reported that the patient felt the swelling in the mouth after the 15 minute wait. The patient did not receive treatment for the event. The clinical outcome of slight feeling of swelling within the mouth was recovered on an unspecified date. It was also reported that since the vaccination, the patient had not been tested for COVID-19. The batch/lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.

Excessive shivering/shaking; weakening of lower legs; spiked high temp during the night into the next day. 102, finally lowered 48 hours later. Nausea; massive headache; complete body pain in muscles and joints, including jaws and eye sockets. exhaustion, fast hearbeat; no injection site swelling or pain. Reecovery within 72 hours, fatigue and nausea for another 12 hours more or less. I do feel it was worth it.

Pfizer-BioNTech COVID- 19 Vaccine EUA: During the post-vaccination observation period, vaccine recipient experience an allergic reaction. They developed headache and throat closing. They were treated by EMS on site with diphenhydramine and methylprednisolone. They were transported to emergency department at Regional Medical Center. They reported itching, swelling, and tingling around the mouth. During reexamination, the patient?s symptoms did not recur and they were discharged to home. Registered 03/03/2021 3:00 PM, Discharged 03/03/2021 6:13 PM.

Guillian Barre reaction (difficulty walking, difficultyusing hands- small motor skills; difficulty speaking; began on 2/7/21 and continued to worsen until hospitalization on 2/24/21 and 5 plasmapheresis treatments. While hospitalized patient has developed double vision.

Patient stated she started feeling tingling on her lips, 10 minutes after getting vaccinated. At 12:42 pm patient stated tingling is going away on its own. At 12:57 pm, patient stated she feels ok and wants to go home.

Extreme fatigue, lightheaded and dizziness, extreme joint pain, vision blurryness and sore eyes, starting Wednesday March 3rd and continuing through today Monday, March 8th. Also beginning Friday, March 5th woke up with right arm swollen just below the elbow. Not sure if any of this is related to the Covid shot or having other problems. Just noticed that my vaccine card shows Lot #EN6202 but the letter sent says Lot #EL9263, for the 2nd dose.

Numbness in calves, pain in calf muscles, varying from slight to severe; slight numbness on occasion in arms and mouth area. This has not gone away. It is not debilitating. I had the same reaction to a flu shot several years ago. This lasted about 1 1/2 years, then slowly went away.

Eyes swollen; lids puffy and red, red circles around each eye; lids puffy and red, red circles around each eye; yellow jaundice look below each eye in a little pouch filled with fluid; itchy eyes; skin on eye lids peeled off; yellow jaundice look below each eye in a little pouch filled with fluid (this jaundice look with pouch disappeared within 5 -6 days from receiving 1st shot).; This is a spontaneous report from a contactable female other healthcare professional reported for herself that 78-year-old female patient received first dose bnt162b2 (Solution for injection, pfizer (Batch/Lot Number: EL9265)) via an unspecified route of administration, administered in Arm Left on 28Jan2021, 16:45 as single dose for covid-19 immunisation. Medical history included myocardial infarction from 2014 to an unknown date In good health - Heart Attack 2014 , drug hypersensitivity from an unknown date and unknown if ongoing known_allergies: Sulfa drugs. The patient historical vaccine bnt162b2 (Solution for injection) on 28Jan2021 Start Date/Time: [Pfizer Lot EN6198] 19Feb2021 09:45 AM, left arm for covid-19 immunisation. Facility most recent COVID-19 vaccine was administeredin Doctor's office/urgent care. The patient was not received any other vaccines within 4 weeks prior to the COVID vaccine. On 01Feb2021 07:00 AM, Eyes swollen, lids puffy and red, red circles around each eye, itchy eyes, skin on eye lids peeled off, yellow jaundice look below each eye in a little pouch filled with fluid (this jaundice look with pouch disappeared within 5 -6 days from receiving 1st shot). Other eye condition remains. The event Yellow ocular coloring was recovered in 2021 and other events not recovered.

Lightheadedness; tired; aches in her hands; corner of her eye and around it was itching really bad; started hurting and felt strained; started itching in her body; Headache; muscle aches; Nausea; Chills; This is spontaneous report from a 78-Year-old Female consumer reported for herself that she received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/lot number: EL9269), via an unspecified route of administration on 02Feb2021 at single dose for covid-19 immunization on arm left. The patient relevant medical history and concurrent conditions included cataracts from 2005 with ongoing, macular degeneration from 2012 with ongoing, arthritis from an unknown date and ongoing and fingers and both hands that had knots since 2010. The patient stated that she had nausea, chills, headache, and muscle aches on 02Feb2021, and on 03Feb2021, she had lightheadedness, tired, and aches in her hands where she has arthritis and all at once that the corner of her eye and around it was itching really bad and she touched it to relieve the itch and they started hurting and felt strained. The patient got Systane over the counter eye drops that she had and held hot compresses to it. She reported that it lasted for a few hours and she had cataracts and a little macular. The patient started itching in her body at 7:30 and took Benadryl and went to bed and it went away. She was concerned with second vaccine as she got through the nausea and everything else, but her eyes scared her. The patient received treatment medication for nausea and took Tylenol for Arthritis and muscle aches. The patient had an x-ray 3 years ago for her back and was diagnosed for unknown results. The outcome of the events nausea, aches in her hands, corner of her eye and around it was itching really bad, started hurting and felt strained and started itching in her body was resolved on 03feb2020, whereas the events chills, lightheadedness, tired, headache and muscle aches were resolved on 04Feb2021.

Tinnitus started approx 4 days after the 2nd vaccine dose administered and had progressively gotten louder over several weeks slightly lessening in loudness at this time

metallic taste in mouth and nausea. Was asked to wait an extra 15 minutes and give pretzels and water. Felt a little better and wnt home. Nausea continued for 5days u with discomfort at the pit of my stomach, then I started with multiple bowel movements for the past 3 days.

Patient has had prior left stapes in 1990s. Her hearing has been stable. She got her 2nd Pfizer vaccine on Feb 1 and around the same time or shortly after she noticed her hearing has worsened mainly in the right ear.

she woke up dizzy; it was like everything was moving or shaking just a little bit, and it would drive someone crazy; her eyes felt like they were burning out of the sockets; she was tired the next morning; she felt like she was floating out of the room, her head tingled, she tingled from the top of her head to the bottom of feet; she was nauseated; temperature of 103; she broke out in a terrible sweat; she was weak as water; light headedness; high blood pressure; This is a spontaneous report from a contactable consumer via Medical information centre. A 78-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EL8982) via an unspecified route of administration on 27Jan2021 14:00 as single dose for covid-19 immunisation. Medical history and concomitant medications was not reported. On 27Jan2021 20:00 the patient experienced light headedness, she broke out in a terrible sweat, she was weak as water. On 27Jan2021 the patient experienced high blood pressure. On 28Jan2021 her eyes felt like they were burning out of the sockets, she was tired the next morning, she felt like she was floating out of the room, her head tingled, she tingled from the top of her head to the bottom of feet, she was nauseated, temperature of 103 (pyrexia). On 05Feb2021 she woke up dizzy and it was like everything was moving or shaking just a little bit, and it would drive someone crazy. The event high blood pressure was considered as serious (Medical significant). It was reported that she had the Pfizer COVID shot 2 weeks ago today. She had severe reaction to the shot, she didn't have it immediately she got the shot on 27Jan2021 and at 2 pm and at about 8 pm she was sweeping the floor and she broke out in a terrible sweat and after that she was weak as water and then started feeling lightheaded and her blood pressure was going up, she put cold rags on her head. She did not take temperature but she did take her blood pressure and it was like 198/something, she said she noted at 8:30 she took it again and it was 180/98 she started drinking water she thought she might be dehydrated and finally by 9:45 she got it down 148/58, she slept that night felt pretty good but she was tired the next morning, about 4 o'clock that afternoon the second day she felt wonderful she went to sleep at about 10 o'clock, but when the clock was striking midnight it woke her up and she felt like she was floating out of the room, her head tingled, she tingled from the top of her head to the bottom of feet she was lightheaded her eyes felt like they were burning out of the sockets, she was nauseated when she stood up so she took Tums and that took care of the nausea. She came in and took her blood pressure and that is when it was 194/90 the second time, she has a Rely On arm band and it said 205/98 and then she took it again and it said 235/117. She called the medic and he told her he thought she had a false reading but her temperature was 103 and before he left her blood pressure come down 180/70. Her heart rate was 86 the medic got ready to go her temperature came down to 102.2. On 05Feb2021 which was last Friday she woke up dizzy and light headed and but it was like everything was moving or shaking just a little bit, and it would drive someone crazy .On Saturday she took 3 Motrin that morning and Amlodipine 5 mg and 20 gm Omeprazole and she also takes 1 24 HR Allegra with Fexafenadine and her temperature was normal that day, all day it has been normal. On Sunday at lunch time she got light headed and was floating again and she checked her blood pressure and it was 183/77.She stated that her doctor recommended to get the second dose if she have no more side effects She plan on getting the second dose next Wednesday. Therapeutic measures were taken as a result of high blood pressure, she was nauseated and temperature of 103. The outcome of the events was unknown.

Patient stated her tongue, lips and eye lids were swelling. Patient had children's liquid Benadryl with her and immediate started drinking the Benadryl. Patient was assessed by the NP and also by her PCP while in the office. Patient was advised that she needed to go to the ER via ambulance, she refused. She was observed for an additional 30 min. with no further symptoms. Vitals were taken again before she left the office. Patient was contacted again via phone at 3:00 pm to check on her, she stated she was home and doing well. She contacted the after hours service at 6:37pm stating she was continuing to have swelling when the Benadryl wears off. Patient was advised by the after hours provider to go directly to the ER and explained the risk of airway swelling during the night. Pt. verbalized understanding. Pt. was seen in the ER on 3/26/21 in the ER for allergic reaction was discharged the same day with instructions to follow up with her PCP.

Swelling on her right ear; Symptoms of the flu/side effects like the flu; Diarrhea/bad diarrhea; Urinating like crazy/had to urinate non-stop; Sick; Swelling on her right eyelid; Pain down her neck; Everything was swollen, her one eyelid and the outside of her ear then down her neck on the right side; This is a spontaneous report from a contactable consumer (patient). A 78-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EL1283, Expiry date: unknown) via an unspecified route of administration, administered in Right Arm on 19Jan2021 (at the age of 78-years-old) at a single dose for covid-19 immunisation. Medical history included mastectomy (she had a mastectomy before, so she has no lymph nodes, she doesn't let them touch her left arm. She says this was done 26 years ago when she was 52), arthritis (she has bad arthritis in her back), Blood pressure high (she takes a high blood pressure medication), High cholesterol (she takes a high cholesterol medication) and eye surgeries (she has had all kinds of eye surgeries before this). The patient's concomitant medications were not reported. The patient experienced swelling on her right ear, symptoms of the flu/side effects like the flu, diarrhea/bad diarrhea, urinating like crazy/had to urinate non-stop, sick, swelling on her right eyelid, pain down her neck, everything was swollen, her one eyelid and the outside of her ear then down her neck on the right side on an unspecified date in 2021. The patient stated that she had a lot of side effects and she talked to her doctor who said to go ahead and get the second dose. She says she had no fever, but had all the rest of the side effects, such as swelling of her neck, ear, and eye, which all went away fast. She says she was sick almost 4 days, and her doctor said side effects shouldn't last that long, so she called to get advice about whether to get second shot or not. She says her appointment for her second shot is the 09Feb2021, she would like to know if it is safe for her to get. She says her side effects started in the evening, the swelling of her right ear didn't last, it went away. She says during the night she woke up and had to urinate non-stop that started that night a day later. She says that lasted the next day, then the day after, until Saturday she felt better. She says she had all side effects like the flu, then later bad diarrhea too. She says she finally took something for diarrhea (no further information provided about this) and took Tylenol. she doesn't see the expiration on that bottle, she thinks it is good for 2021. She says that she doesn't see too good. She clarifies that they Tylenol she had took before, with no issues, and her not seeing too good had nothing do with the vaccine, she has had all kinds of eye surgeries before this. She says her right ear was swollen, everything was swollen, her one eyelid and the outside of her ear then down her neck on the right side. She says that the pain started about a day later Pfizer COVID-19 vaccine. Caller says that she called her doctor today, that was the first time she did that, she was trying to wait and see, and her doctor said normally side effects don't last that long, so he has her worried. She says if she does not take the vaccine she will not be protected, but if she does, she may have worse side effects. Therapeutic measures were taken as a result of diarrhea/bad diarrhea. The patient recovered from the event swelling on her right ear on an unspecified date in 2021, outcome of the event Urinating like crazy/had to urinate non-stop was recovering, while outcome of other events was unknown.

her immune system since has not been the same and has been very deprived; her immune system since has not been the same and has been very deprived; wasn't feeling right; Dizzy; weak and very disoriented; weak and very disoriented; did not feel good; terrible headache and laid down right away; things started spinning/head spinning; Nauseous; Flu like symptoms; Flushed; very cold; chills; very cold; chills; Pain in arm; rapid heart beat; anxious; like something was going to happen; bathroom a couple times and felt week with the flu like symptoms, they were very bad; did eat something later yesterday, but food was flat tasting; didn't taste right; This is a spontaneous report from a contactable consumer (patient). A 78-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: EL9262, Expiration date: Unknown) via intramuscular route of administration in left arm on 28Jan2021 10:00 as SINGLE DOSE for COVID-19 immunization in the clinic. Medical history included neoplasm malignant, chemotherapy, radiotherapy, immune system disorder (her immune system since has not been the same and has been very deprived) from an unknown date and unknown if ongoing. Concomitant medications included bee venom for arthropod sting. The patient experienced wasn't feeling right , dizzy, weak and very disoriented, did not feel good, terrible headache and laid down right away, things started spinning/head spinning, nauseous, flu like symptoms, flushed, very cold, chills, pain in arm, rapid heart beat, anxious, like something was going to happen, bathroom a couple times and felt week with the flu like symptoms, they were very bad, did eat something later yesterday, but food was flat tasting, didn't taste right on 28Jan2021 and her immune system since has not been the same and has been very deprived on an unspecified date. the first Covid shot yesterday at 10:00. They had her to sit for 15 minutes to make sure she was okay to walk. About 7-8 minutes she noticed she wasn't feeling right, dizzy, weak and very disoriented. She got up and didn't want to create a scene and started walking through the clinic and stopped to ask the receptionist to call her husband in the car. There was so many people so she just kept walking and luckily was able to get to car and told her husband she did not feel good. By then she had a terrible headache and when she got home she laid down right away. Then things started spinning and she was very nauseous and is aware that these things can happen with the vaccine. Had flu like symptoms like she never had before, but this was worse. She did not have a fever, but was flushed and very cold, chills. Her arm was not hurting until about 9pm and during the night she had a rapid heart beat, but not really. Was very anxious like something was going to happen and she tried to calm herself by taking deep breaths but does not know if that worked. Finally, after 3 hours she was able to go to sleep and did go to the bathroom a couple times and felt week with the flu like symptoms, they were very bad. When she got up today she was 60-65% better. She did eat something later yesterday and had thought the nausea was because she hadn't eaten all day long. The food was flat tasting and she know she has that whenever she has the flu where nothing tastes right. She clarifies she has that anyway since 16 years ago she had cancer and a strong dose of chemotherapy and radiation and her immune system since has not been the same and has been very deprived. Whenever she gets sick she gets deathly sick and has to be watched or she may have to get hospitalized due to weakened immune system. States some people say that the second dose is worse, is that true or is it the same feeling. If she feels like that with the second dose she may not get it. No further details provided. Mentions as the day goes on she comes around more. Has to get her glasses to see card given. No other vaccines given that day or 4 weeks prior. No problems with vaccines in past. The outcome of event her immune system since has not been the same and has been very deprived was unknown and other events were not recovered. No follow-up attempts are possible. No further information is expected.

Pt has allergic reaction w/ her 1st dose. She was in the middle of her graded COVID-19 Challenge (dose 2) under a physician's supervision. Pt just received 0.03ml (10% ) of full dose. Pt then started experiencing increased mucus in her throat, clearing of throat, and states that her ears feel weird about 11 minutes later. Her Vitals at this time were 168/78, 85 HR, 14Resp, 100% Spo2. 5 minutes later another set of vital signs were taken at 152/84, 86 HR, 16 resp, 95% Spo2. EPi 0.3 mg was administered immediately. Pt states that her throat feels better about 3 minutes later, but her chest still feels irritated. Her Spo2 was up to 100% at this time. Pt then stated that she is starting to feel shortness breath after using the bathroom. Pt is then transferred directly to the ER .

Pt developed palpitations, headache, dizziness and nausea after receiving vaccine. BP 192/81, repeat 206/86. HR decreased from 106 to 90; regular rhythm and rate. O2sat 99 RA. Lungs CTA. Denies chest pressure, tightness, sob. Also reported throat discomfort; benadryl 25 mg po x1 given. Sent to ER.

Persistent Dry Mouth after dose 1 Oral Candidiasis (yeast tongue) after dose 2 (02/21/2021) Took Clotrimazole lozenges 5 per day for 2 weeks Needed refill prescription of Clotrimazole still on it . Some relief but not gone. Gastric reflux-

pt states that she has sore left arm. Pt has metal screws and plates in her left ankle and later that night after getting the vax she got severe shooting pain in left ankle. This pain lasted about 15 or 20 minutes. Today 4/7/2021 about 11 AM she started feeling like she has an exposed nerve in her mouth. She said the pain traveled through her mouth, to her ear, then to her head. She says it is now numb and tingling. She has a rod in her femur to her hip and so far has not had any pain in that location. Pt says called her PCP and she was instructed to take Tylenol or go to the ER if her pain persist.

Acute headache radiating to neck and right shoulder and right eye. Acute hypertension with hypertensive crisis BP 223/113 needing Emergency department admission. Following this ED visit the the BP had been uncontrolled with ongoing headaches and right sided neck pain radiating to the right eye/head through March and in April have improved. During this time had #2 Pfizer vaccine 2/12/21 and had experienced arm pain and headache as well as a spike in her BPs as well as right sided neck pain radiating to her right eye

About 5 or 4 days ago my scalp towards the top of the head hurt while going to sleep on my back. I assume that I probably scratched my head while shampooing my hair. Then next day my right eye started to bother me. I thought I had bumped my eye while trying to clean the discharge I have in the mornings with q-tips. But finally it got worse until it hurt me. So I went to the ophtlamologist today who according to his diagnosis I had shingles. I just got an antiviral medication for the next seven days and drops to help clean my eyelids. This is so bothersome, sometimes while trying to read I see blurry.

my tongue & the roof of my mouth started burning; my tongue & the roof of my mouth started burning; My tong also swelled enough that I bite the side of my tongue at night; This is a spontaneous report from a contactable consumer (patient). A 78-years-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: EN9581) second dose via an unspecified route of administration, administered in left arm on 19Feb2021 13:45 as SINGLE DOSE for covid-19 immunisation. Medical history included burning tongue reaction when prescribed Zoloft, Buspiron, Effexor, so immediately stopped and burning subsided within 24 hours and also get a burning tongue reaction to walnuts and fresh pineapple, all from an unknown date and unknown if ongoing. Patient did not test positive for Covid prior to or post vaccination. Concomitant medications included ATORVASTIN, GABAPENTIN and METHENAMINE. On 27Jan2021 at 11:30 AM patient received first dose of Bnt162b2 (lot number=EL9265 in left arm). On 19Feb2021 after receiving 2nd vaccine shot patient stated that my tongue and the roof of my mouth started burning. My tongue also swelled enough that I bite the side of my tongue at night, enough to break the skin of my tongue. It has been 6 days since the 2nd shot and the burning has not diminished. Almost impossible to sleep at night. Doctor gave some prednisone yesterday to see if the auto immune reaction would diminish. The burning did not diminish. The patient was very fearful to take a booster shot in 6 months and no one was able to assure her. Patient was given Prednisone and lidocaine rinse as therapeutic measure for the events. Outcome of the events was not recovered.

nerve pain in face; Tooth pain; severe nerve pain left ankle/nerve pain in mouth/pain in her legs/pain in the calf; Numbness. It affects my face and head. Anything that goes to your brain.; feels numbness/feels it in her eye too; Deep pain.; trigeminal neuralgia; severe damage in both legs; tingling; This is a spontaneous report received from a contactable consumer (patient). A 78-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Left on 05Apr2021, at the age of 78-year-old, (Lot Number: EW0150) as single dose for covid-19 immunisation. Medical history included ongoing Allergies. The patient had allergies to ciprofloxacin (CIPRO), clindamycin, amoxicillin, penicillin, sulfamethoxazole; trimethoprim (BACTRIM), cefalexin monohydrate (KEFLEX), clarithromycin (MACROBID), levofloxacin (LEVAQUIN), valsartan (DIOVAN) (blood pressure med). Some of them allergic and can never take. Some have minor effects like itching or rashes, allergic reaction to dairy, the enzyme, not the lactose. The patient had bloodwork 2 weeks before the vaccine (in Mar2021) to see if there were any antibodies. Stated that she not only had the short test and the long test but that she went for the blood test that showed no antibodies and was told she could take the shot. Stated that she has taken blood pressure medicine every day since she was 29. No prior vaccinations within 4 weeks. No AEs following prior vaccinations, no family medical history, no relevant tests. Stated that she had an accident that promoted a lot of her nerve damage. No history of all previously immunizations, no additional vaccines administered on same date. The patient had plates and screws. Rod attaches to her hip. Metal Clips in shoulders. Severe spinal stenosis. Rotator cuff operation. Arthritis and a scar in her arm. Concomitant medications included levothyroxine sodium (SYNTHROID) been taking more than 15 years for thyroid, start and stop date were not reported; ongoing hydrochlorothiazide taken for an unspecified indication, start was not reported and stated that this is a water pill that she takes as part of her program; ongoing amlodipine besilate (NORVASC) taken for an unspecified indication, has been taking since age 29; ongoing budesonide (NASOCORT) taken for allergies, Stated that she did take on the day she received the vaccine. Have a lot of pollen down here; ongoing hydrocortisone taken for an unspecified indication, start was not reported, Only takes half of that, takes 2.5mg. Doctor thinks it doesn't do anything, that it's like taking 3 Advil and Has been taking on and off only at night did not take it Monday night. ongoing Coreg -Has been taking since age 29. Ongoing desloratadine (CLARINEX) for allergies, ongoing Vitamin D nos and states she takes either 1000 or 2000 in liquid form for unspecified indication; ongoing Magnesium (Powdered drink mix) for unspecified indication and ongoing ascorbic acid (VITAMIN C) for an unspecified indication. The patient experienced severe nerve pain left ankle on 06Apr2021 (it happened later that night, after 2 or 3 in the morning, so it was 06Apr2021), nerve pain in mouth and face on 07Apr2021, Had plates and screws, so knows the difference between hurting and nerve pain. She experiences pain constantly every day. This was severe nerve pain. Stated that just the ankle was severe. Stated that when she woke up, she already felt pain in her legs. States that she also had pain in the calf but didn't pay much attention because the pain was mostly in her ankle. States that it was where the metal was and went on for about 15 or 20 minutes. States that it has subsided. None treatment received. The patient experienced tooth pain and states that this started today (07Apr2021) around 10:30 or 11:00 this morning. States that all of a sudden felt an exposed nerve in the tooth, like the worst toothache you've ever had. States that it was pretty devastating and nerve pain really hurts a lot. States that she knows you don't have to have exposed nerve to know. States that it started on her face on the left side, the way neuralgia starts and goes to the eye, all on the left side, same side as the shot. States that it was weird to her. The patient was told by her doctor to take Tylenol but she did not take it because it really doesn't work. States that she can't feel everywhere. States that she would like to know what is going on and she still feels numbness (in Apr2021). States that her face is not numb but feels numb-ish, and can't even explain it. States that she feels it in her eye too. States that it feels better now then when she first noticed it. States that she will take something eventually if it keeps up. Caller states that when getting the shot, she told the man that she already had a scar in the right arm from a full rotator cuff. States that she is leery of the shot. The patient had numbness. It affects my face and head. Anything that goes to your brain on an unspecified date. She wanted to know if any metal in their body metal ankle screws in place 47 years. Rod attaches to her hip. Metal Clips in shoulders. Trigeminal neuralgia. Nerve that goes to face. Severe spinal stenosis. Vaccine in left arm. Rotator cuff operation. Talked to HCP. He is going to leave it up. She just don't want to experience a bad reaction. Deep pain. Eye and Face. Left arm. Did not affect the rod. Affected all the nerves on the left side. Supposed to get the shot the 26th. Now this to her face. It makes she think do she want that shot to her brain. That's what makes she wonder. HCP told to take Tylenol 500mg or go to ER. She chose not to go to ER. Asking if this adverse event has been reported and if she should receive second dose. States that she had the vaccine on Monday 05Apr2021, on that night. States that are several things wrong with her and she questioned everyone about taking it. States that she did report today (07Apr2021) about her recent experience. Is not sure whether she wants to take the second shot. States that she has severe damage in both legs. States that she has trigeminal neuralgia. States that she has middle ankle screws and plates that she has had for 47 years on her left side. She have arthritis. On the right side, from the femur to the hip, she has a rod attached there. Has severe spinal stenosis and has long lasting problems. States that this is why she was worried about taking the shot. States that all of her doctors said to really take it because she is 78 years old, so she took it. States that Monday night (05Apr2021), she got the shot in the left side of her body. States that the person giving her the shot noticed a scar in her arm in the muscle area. States that she had one of many operations on that shoulder, including the rotator cuff. States that he asked her if there was any metal in there and she stated that there probably is metal in there, or clips, does not know for sure if metal. States that he went ahead and gave the shot. States that on Monday at about 2 or 3, she woke up with severe nerve pain in that ankle area. States that she has had other things long enough to know that the nerves were affected. States that it subsided after 15 minutes or so. Today (07Apr2021), got up and felt like an exposed nerve in her mouth, then from her face to her brain. States that she put heat on it, states that she knows things to do and knows that it is not exposed nerve. States that right now it is acting up a little and feels like exposed nerve and a little tingling and numb (in Apr2021). Caller states that she figured they didn't find anything about people who have metal in their body. States that she does not take meds for nerve damage because she chooses not to. States that they are rough medications. States she is kind of leery about taking the second shot. The events did not require emergency room and physician's office. The outcome of the event severe nerve pain was recovered on 06Apr2021; the outcome of the event nerve pain in face was recovering; of the other events was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained.

Adverse events: unstable, too dizzy to walk, through-up, double vision. Treatment: wait for the symptoms to pass.. The symptoms have lessened but are still with me.

hurting on right side of face, in and around R ear; hurting on right side of face, in and around R ear; severe headache; nausea; vomiting; severe dizziness; All over body rash; This is a spontaneous report from a contactable consumer or other non hcp. A 78-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 Right on 23Jan2021 08:00 (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunisation. Medical history included high BP, hx of blood clots/CAD, covid-19 from 10Dec2020 to an unknown date. Concomitant medications included warfarin sodium (COUMADIN); and atorvastatin calcium (STATIN [ATORVASTATIN CALCIUM]); both taken for unspecified indications, start and stop dates were not reported. On 26Jan2021, 12:00 AM, 3 days later started hurting on right side of face, in and around R ear, severe headache/nausea/vomiting & severe dizziness. All over body rash occurred. 10 days later and lasted 3 weeks. The patient received treatment for the events: antibiotic/anti nausea/MRI/CT. The patient was hospitalized for five days for the events. The outcome of the events was not recovered. The patient underwent lab tests and procedures which included computerised tomogram: unknown results on an unspecified date, magnetic resonance imaging: unknown results on an unspecified date. The patient has not been COVID tested post vaccination. Information on the lot/batch number has been requested.

Loss of voice; Asthma; her voice became extremely hoarse; This is a spontaneous report from a contactable nurse. A 78-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration on 16Mar2021 09:15 (Batch/Lot Number: EN6207) as single dose for COVID-19 immunization. Family history included sore arm. Concomitant medications included fluticasone furoate, vilanterol trifenatate (BREO ELLIPTA) taken for an unspecified indication, start and stop date were not reported. The patient previously took BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 (lot number: EN6198) on 23Feb2021 in the right arm for COVID-19 immunization. About 3-4 days after (as reported), her voice became extremely hoarse, in which she lost a voice for 3 weeks. She mentioned that she was diagnosed with Asthma on 23Mar2021 and was started with a Breo Ellipta inhaler. The Breo had a listed side effect of hoarseness of voice in which she started a week after receiving the vaccine, to which her hoarseness became worse. She mentioned that according to the paperwork she received from Pfizer, hoarseness of the voice was also listed as a side effect. She consulted with her Pulmonologist who determined that the inhaler was working pretty well and would like to continue her on it and wanted to see if the hoarseness is still there by May. As of calling, she already has some of her voice back, but the hoarseness was still continuing, which gets worse in the afternoon or evening. She would like to know if this has been reported and for how long it will last. She had the injection/vaccine and hoarseness started about a week before she started on the Breo Ellipta inhaler (NDC: 01730859-10 Lot: UL4F Expiration: 10/2022 Dose: 100mcg/25mcg). She stated they both can cause the same thing with hoarseness. She clarified that when she lost her voice, it was just above a whisper. It had gotten progressively worse since it started a week prior. It lasted almost 3 weeks. Now she has started to get her voice back, but still has the hoarseness and this was as good as her voice gets, it gets worse in the afternoon and by 2:00 P.M. it was back down to no voice. She went down to see the pulmonary specialist and prescribed her 2 different inhalers. The specialist said it was an unusual hoarseness, but he couldn't tell what one it was from. The patient clarified she experienced the hoarseness first from the Pfizer Covid Vaccine after the second vaccine, and then a week later she started on the Breo Ellipta, and the hoarseness got worse. The doctor wants to wait until 19May2021 and see if she still has the hoarseness and then he might switch, but it was working so well, he didn't want to switch her yet. The patient was prescribed Breo Ellipta and Albuterol but she hasn't used the Albuterol. The patient reported that she considers the event as medically significant because hoarseness can cause cancer and she doesn't want it to get worse. No other vaccines administered on the same date of the BNT162B2 and no prior vaccination. The event hoarseness started on 18Mar2021 and loss of voice on 23Mar2021. The events did not require a visit to the emergency room. The outcome of the event hoarseness was not recovered, Loss of voice recovered on 13Apr2021 and asthma was unknown. The events hoarseness and loss of voice was reported as serious-medically significant. Follow attempts are possible. Further information is expected.; 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 serious events Hoarse voice and Loss of voice 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.

tongue tingling, light headed, Benadryl given BP 142/78, P 85, R 12, Pulse Ox 100% Was able to drive to sisters house after recovery

Sore tongue with acute sensitivity at tip. First geographic tongue noted by dentist on 2/15/21, followed a few days later by onset of acute sensitivity at tip and right side with cuts and pustules. Now on the left side and tip. Both physician and dentist seen since onset. Vitamin B recommended. Now taking One A Day - Women's 50+ to no effect.

muscle and joint aches; muscle and joint aches; teeth and bones hurt; teeth and bones hurt; chills; weakness; I can hardly walk right now; This is a spontaneous report from a contactable consumer (patient) via Medical information team. A 78-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number: Unknown) via unspecified route of administration on an unspecified date (4 weeks and 2 days after the first dose) (at the age of 78-year) as single dose for COVID-19 immunization. The patient medical history included lumber stenosis. The patient concomitant medications were not reported. Previously patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number: unknown) via unspecified route of administration on unspecified date as single dose for COVID-19 immunization. On an unspecified date, patient felt awful with muscle and joint aches, teeth and bones hurt, chills, weakness. She stated that she could hardly walk right now and could not get over to her primary care physician. The patient informed that she received a steroid injection of some kind on her back for lumbar stenosis 2 weeks and 2 days after the first dose of the vaccine. The outcome of the events was unknown. No follow-up attempts are needed; information about lot/batch number cannot be obtained.

burning sensation in throat; mouth with a very metallic taste; mild taste distortion; fever; chills; aches; This is a spontaneous report from a contactable consumer (patient). A 78-years-old non pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection, Lot Number: EK9231) via an unspecified route of administration in left arm on 21Jan2021 at 17:00 as single dose for COVID-19 immunization. Medical history included CKD2, CAD, HBP, and Diastolic Congestive heart failure. The patient had allergies to medications, food, or other products Demerol, all statins was reported. Concomitant medications included Sertraline hydrochloride, valsartan, Ranexa, and Fenofibrate. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. It was reported that App. 30 min. (21Jan2021 17:30) Post shot, had burning sensation in throat and mouth with a very metallic taste. Metallic taste lasted about day and a half. After that it cleared somewhat, but still have mild taste distortion. About day three did develop some fever, chills, and aches which lasted about three days. Treatment was not received for the adverse events. The events were considered as non-serious. The outcome of events was recovering.

1422: Pt reports "ringing in ears and throat tightness" 1422- Pt taken to ER for further evaluation

The patient called in around 1:00 pm on 5/25/21 to report symptoms after vaccine. She said that she had pain in the right side of neck and in the back of the head and felt dizzy after the 15 minute wait when she stood up to leave after receiving her vaccine. She said that she felt tired later and slept well all nigh. At 6 am she said that she had cramps in calves, legs, and arms. At 9:30 am she woke up and felt tired and had a strange sensation in the back of the neck and numbness in the mouth and jaw. She said she is feeling a little better now.

Shortness of breath, extremely tired, chills. nausea, feeling unwell, lymph nodes, allergic reaction such as rash, extreme itching, swelling of face, loss of taste and smell, severe congestion upon awakening. PCP is out of town entire month of June. Sick of being sick. Must be remedy to all of this! Am not recommending to my friends. I should have never had second vaccination.

tested positive for COVID-19/tested positive for covid 19 virus after receiving covid 19 vaccine; flu like symptoms; achy body; high temperature; there was throat involvement; very, very ill/sick; This is a spontaneous report via Pfizer-sponsored program and medical information team from a contactable consumer (patient). A 78-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EL9266) via an unspecified route of administration, administered in left arm on 25Feb2021 as 1st dose, single for COVID-19 immunization. Medical history included thyroid disorder, ongoing incontinence. Concomitant medications included mirabegron (MYRBETRIQ) for Incontinence. Patient previously years ago took flu vaccine and she had feel sick with flu, she did have flu symptoms. No Prior Vaccinations (within 4 weeks). On Sunday (28Feb2021), she became very, very ill with flu like symptoms, she had an achy body, she had high temperature, there was throat involvement. She had those symptoms until Monday (01Mar2021) and was feeling better on Tuesday (02Mar2021). On Wednesday (03Mar2021), she had a COVID-19 test and it tested positive for COVID-19/ tested positive for covid 19 virus. She thought she was having a reaction to the shot when she got sick. Yesterday was her last day of self-isolation. She has not had another test, she was senior. She was scheduled for her second dose of the vaccine a week from now from tomorrow (19Mar2021) and she wanted to know if she should have the second shot or she has to undergo an antibody test since she got COVID after the first dose. The outcome of tested positive for COVID-19/tested positive for covid 19 virus after receiving covid 19 vaccine was unknown; for illness recovered on 28Feb2021, flu like symptoms recovered on 02Mar2021, while for others was recovering. No follow-up attempts are possible. No further information is expected.

First dose: Redness in her eyes; First dose: Couldn't focus; First dose: Pressure behind left eye; Vertigo; This is a spontaneous report from a contactable consumer (patient). A 78-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot number: EL3248), via an unspecified route of administration, administered in left arm on 30Jan2021 at 14:30 (at the age of 78-year-old) as 1ST DOSE, SINGLE DOSE for covid-19 immunisation. The patient's medical history included ongoing glaucoma (had it for 7 years), ongoing hypothyroid (started 7 years ago). It took her 5 years to find the right doctor and the right medication. It took a while to balance it off. She has been okay the last 2 years with the right medication; asthma from 1969(controls her allergies, so it did not turn into asthma), ongoing high blood pressure (had it all her life), allergy to glycerin and ongoing vertigo (started way before she had the vaccine). Concomitant medications included ongoing irbesartan (AVAPRO) for high blood pressure (She just went back to it about a year ago because it was doing really good then her blood pressure spiked up) and ongoing levothyroxine sodium (TIROSINT SOL) for hypothyroidism for 3 years. The patient previously took flu shot and then had the flu and got pneumonia. On an unknown date, couple of days after the first dose the patient experienced redness in her eyes, about a week or 2 after the vaccination the patient couldn't focus. On 06Feb2021, the patient had pressure behind left eye and vertigo (vertigo). There were no relevant tests done. She was being treated for vertigo, but the vertigo was basically gone though she was seeing a physical therapist. The vertigo started way before she had the vaccine. The patient visited physician's office for the adverse events. The Patient did not go to the emergency room. The patient should have gone to the hospital, but she was afraid to be around people with Covid. She did not get vaccines at all because she fears having a reaction. The last vaccine she had in 2006 made her so sick she got pneumonia. It was for the flu, and she got the flu. The patient did not have any vaccination within four weeks prior to the first administration date of the suspect vaccine. The patient thought it was important for her to take the vaccine which it took her awhile to talk herself into it because of her previous experience with adverse reactions. She took levothyroxine sodium solution because the patient was allergic to so many things. The first one they gave her was a gel capsule and it caused an itching reaction. The patient is allergic to glycerine and could not take capsules that have a glycerine encasement. The first one they gave her was a gel capsule and it caused an itching reaction. She was allergic to the preservative in eye drops. She did not know if the Covid vaccine had any preservative, she did not think it did. She looked it up and did not see anything she was allergic to. The patient had a long list of allergies. Her family all has high blood pressure and allergies. The outcome of the event vertigo was recovered on an unknown date, for redness in her eyes was not recovering while unknown for rest of the event. Additional details unable to be obtained.

her tongue felt burned; her mouth was burning; her throat was burning; acid reflux; everything was still burning; This is a spontaneous report from a contactable consumer (patient) via Medical Information Team. A 78-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration on 25Feb2021 (at the age of 78-years-old) (Batch/Lot number was not reported) as 1st dose, single for COVID-19 immunization. Medical history included macular degeneration. The patient's concomitant medications were not reported. Historical vaccine included tetanus vaccine on an unspecified date for immunisation. She got her first dose of the Pfizer Covid 19 vaccine on 25Feb2021 and thought she was having a reaction. She called her doctor and he said go get some Benadryl to make sure your throat doesn't get swollen. She went out and bought Benadryl and she took the Benadryl every six hours. Her doctor said don't get the second dose of the Covid 19 vaccine because these side effects she had are a warning and the second dose might not be helpful for her. The patient reported that she stayed at the facility that gave her the Covid 19 vaccine for 20 minutes and her husband was waiting for her. When she was driving away from the facility her tongue felt burned and then her mouth was burning and then her throat was burning on an unspecified date. She does have acid reflux but this wasn't like any acid reflux she's ever had. She got home and she drank some cool water but everything was still burning. By then it was almost supper time so she took 20 mg of Pepcid. Her mouth burned throughout her meal. She called her doctor again and he asked her if her mouth was swollen and she told him she didn't know. She took more Benadryl. One of her daughter's told her that the Covid 19 virus was so bad that she should get her second dose of the Covid 19 vaccine no matter how bad her reaction was. Her doctor told her not to get the second Covid 19 vaccine. She assumed it was a done deal. She wasn't going to get the second dose. She was supposed to get her second dose on 17Mar2021. She had gone to the doctor a couple times and each time he told her, do not get the second Covid 19 vaccine. He showed her the Pfizer Covid 19 vaccine print out with side effects. When her mouth started burning after she got the first Covid 19 vaccine her husband did ask her if she wanted to turn around and go back to the facility where she got the vaccine but she told him no. Now she's missed her second Covid 19 vaccine on 17Mar2021 because she thought that what her doctor told her was the final word. She was afraid to get the second Covid 19 vaccine and she wants to listen to her doctor because he knows what's best. During this Covid 19 virus time she was also diagnosed with Macular Degeneration. That's keeping her from driving and she's lost even more of her independence. She's heard if she gets the Covid 19 virus it can attack her eyes. Every time she hears the words fully vaccinated it makes her want to cry. She's worried that people won't want to be near her because she's not fully vaccinated. Her husband had both of his Covid 19 vaccines and he had no side effects. Her husband gets every vaccine on the market and never has any side effects. As far as she's concerned she feels like a pariah because no one will want to be around her because she's not fully vaccinated. Therapeutic measures were taken as a result of all events. The outcome of the events was unknown. Information about lot/batch number has been requested. Follow-up (02Jun2021): No follow-up attempts are completed; information about lot/batch number cannot be obtained.

She got her vaccine, and within a day or two she had a feeling that her mouth was pulling sensation, and has had shingles in the paste. She started using lip balm, and it would loosen up at the beginning. Then, it started getting worse after a couple of days, and started circling her mouth. On 3/5/21 she had a crust around her mouth and went to a doctor and said that she had psoriasis or eczema and told her that she could not treat it. She has a band-aide on her face from the biopsy and has a picture for that. She went to her for 4/5 visits and gave her a hydrocortisone cream and a cold tar treatment, and it stopped for about a week. The cold tar burned to put it on her face, but was doing it, then that stopped. She had an APT on 4/30/21 that she cancelled. Then within the last 7 days it has recurred again. She then went on 6/3/21 to Dr., which was a referral from her PCP, Dermatologist. She demanded her records and he has marked off COVID screen and shingles in a circle and to FU in one month. He has sent her to have patch testing, and to go see a Dr. She informed the doctor of what she has been using for the rash, and he sent her to the other doctor. She has a crack on her nose, and the cream made that area sore. She has had shingles twice in the past. The only place that she has the rash is on her neck upward, her face and seems to be moving to her forehead. The other day it was on the side, and now has moved to the entire forehead. She wears wigs due to the alopecia and seems to be moving up under the wig. She has scaly skin, and crusty skin. He did not diagnose her with shingles, but had it written on his form. She asked if she had shingles and he told her that the Pfizer one had some symptoms of shingles. She has tried eliminating foods, using other problems, and has been taking Benadryl and it's not helping the reaction. He told her to go home and wash her face and not to be put anything on it and that it might go away on it's own, but she has had it for 3 months now. She was very slight near the eyes. Her right eye has had two detached retina and a cataract repair as well, and is worried that if it goes into her eye that she will be blind. The rash is on both sides of her face not one sided. She has put cocoa butter cream on her lips and it seems to be helping her, but was told not to use it. Told her to wash her face frequently and has an APT in a month to have the patch biopsy.

Tingling in arms and legs; red, swollen ear lobe; rosacea; This is a spontaneous report from a contactable consumer (Patient). A 78-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/Lot Number: EN620U), dose 1 via an unspecified route of administration, in left arm on 04Mar2021 11:30 (at the age of 78-year-old) as 1st dose, single dose for covid-19 immunisation. Facility type reported hospital. Medical history included breast cancer. Prior to vaccination patient was not diagnosed with COVID-19. Since the vaccination the patient had not been tested for COVID-19. Known allergies reported to dairy, gluten. Concomitant medications included levothyroxine sodium (SYNTHROID), monascus purpureus (RED YEAST RICE), probiotics, vitamin D [vitamin D nos]. The patient did not receive any vaccines within four weeks prior to the vaccination. On 04Mar2021 at 15:00, the patient experienced tingling in arms and legs, red, swollen ear lobe and rosacea. The patient received treatment of benadryl for events. The outcome of events was recovering. No follow-up attempts are possible. No further information is expected.

tooth ache; Teeth was loose; pain and aggravation; This is a spontaneous report from a contactable consumer (patient). A 78-year-old female patient received first dose of bnt162b2 (BNT162B2; Lot number was not reported), via an unspecified route of administration on an unspecified date (at 78 years) as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Patient was going for her 2nd shot on 12Mar2021. 2 days had a tooth ache (Mar2021) but last night seemed to stop. She did not have any tooth ache for years. Teeth was loose and had pain and aggravation (Mar2021). On 12Mar2021 she felt better, took ibuprofen on 10Mar2021 but not on 12Mar2021. Patient asked if she can get the shot. Final outcome was unknown. No follow-up attempts are needed; information about lot/batch number cannot be obtained.

Lips tingling/Tongue started to tingle; Face red which felt like swollen; Face red which felt like swollen; Her face "felt tight"; This is a spontaneous report from a contactable consumer (patient). A 78-years-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 26Jan2021 14:00 (Batch/Lot number was not reported) as 1st dose, Single Dose for Covid-19 immunisation. Medical history included Von willebrand's disease Von Willebrand syndrome and Glanzmann's disease and allergies. Family history included bleeding disorder. She was poisoned by pesticides and formaldehyde years ago and they burned her entire respiratory system. There were no concomitant medications. The patient never had a reaction to a vaccine. No vaccines administered on same Date of the Pfizer suspect. No prior vaccinations were given within 4 weeks and no adverse events following prior vaccinations. On an unspecified date of Feb2021, the patient experienced lips tingling, face red which felt like swollen, tongue started to tingle, her face felt tight. The events lasted about 1- 2 hours. Patient wanted to know; can she take a Benadryl before the vaccine. The second dose is due on 16Feb2021 so the first dose was 3 weeks before that one was due. After getting the shot, her lips started to tingle, tongue started to tingle, and her face felt real tight. When the nurse came out to check on her, she was told by the nurse her face was really red. The nurse was going to get an EpiPen and wanted to call EMS. The reporter states she told her to just give her a Benadryl, she normally has them in her car but had run out. Patient stated she was allergic to everything. Anything coming in contact with her respiratory system such as hair spray, scents, any chemical causes her problems. The patient explained that she was re-reading the information about telling the vaccination provider about medication conditions including allergies and bleeding disorder, both of which she has. She was concerned about getting the second dose. She wants to know if the first dose will offer any protection. She had the first dose of the covid shot on 26Jan2021. She started feeling funny. The patient called the nurse and reports her lips were tingling and her tongue was starting to tingle. Her face was really red. Her face felt like it had pressure like it was blowing up but it did not feel swollen, it was tomato red. The patient queried if she does not get the second dose what will that do. She knows there needs to be given a certain amount of time between the doses. She heard on the tv that it can be given up to 45 days and still be effective. She heard all kinds of information, she heard that someone should get the second dose within 28 days and the paperwork states something different. Asked if her reaction will be worse with second shot. She was supposed to go back on 16Feb2021 for the second dose. Patient stated she took Benadryl after her reaction from the vaccine. She wanted to know if this affects the vaccine. Patient mentioned the fact sheet states that patients should tell the vaccination provider if they have a bleeding disorder or are on a blood thinner. She states she has a bleeding disorder. Therapeutic measures were taken as a result of the events. She took a Benadryl for treatment. The outcome of the event was resolved on an unspecified date of Feb2021. Information on the lot/batch number has been requested. Follow-up attempts completed. No further information expected.

Still itching spots plus left eye is itchy, dry and red; Still itching spots plus left eye is itchy, dry and red; Still itching spots plus left eye is itchy, dry and red; BP was high; high heart rate & MAP; high heart rate & MAP; tired; left side of throat felt swollen; feelings of being "out of sorts"; Small patch of itchy rash just under left arm, itchy stomach, left leg also itchy on varicose veins; Mild nausea; Arm soreness at vaccination site; This is a spontaneous report from a contactable consumer. A 78-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: EN6208), via an unspecified route of administration, administered in left arm on 14Mar2021 13:15 (at the age of 78 years old) as 2nd dose, 0.3 mL single for covid-19 immunization. Medical history included thyroid nodules, mild macular degeneration, postmenopausal syndrome, high blood pressure (HBP), total hysterectomy w/oophorectomy, gallbladder removal, appendectomy, allergy to penicillin, allergy to contrast dye, allergy to adhesives, and hard of hearing (HOH). Concomitant medications included valsartan (DIOVAN); famotidine (FAMO); pravastatin; estrogens conjugated (PREMARIN); levothyroxine sodium (SYNTHROID); and vitamin D3, all taken for an unspecified indication, start and stop date were not reported. The patient previously took nitrofurantoin (MACRODANTIN), clarithromycin (CLARITIN) and experienced drug drug allergy from both; also previously received the first dose of BNT162B2 (Lot number: EN6201), on 14Feb2021, 13:00, administered in left arm, for COVID-19 immunization. On 14Mar2021 late same day, the patient experienced mild nausea which lasted less than an hour, arm soreness vaccination site. On evening of 15Mar2021, a small patch of itchy rash just under left arm, itchy stomach, left leg also itchy on varicose veins. Upon waking on 16Mar2021 the patient was still itching spots plus left eye was itchy, dry and red; with a bit of nausea, BP was high, no fever, high heart rate and mean arterial pressure (MAP), was tired, left side of throat felt swollen, feelings of being "out of sorts", and her arm no longer hurts at all. The patient took Benadryl and Aleve and all seem better at the moment. She stated she would describe her symptoms as mild although somewhat scary especially the increase in blood pressure and MAP. Her oxygen was normal at 95-97. The patient was recovering from the events.

my bottom lip has a little puffiness on it; I have a tingling on my lips/ My lip is so tingly; the bottom lips is little swollen; This is a spontaneous report from a contactable consumer (patient). A 78-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/Lot number: EW0172, Expiration Date: not reported), via an unspecified route of administration on 13May2021 (at the age of 78 years old) as second dose, single for COVID-19 immunisation. Medical history included hypertension from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. The patient previously received the first dose of BNT162B2 (lot number: EP7533), via an unspecified route of administration on 20Apr2021 (at the age of 78 years old) as single dose for COVID-19 immunisation. On 13May2021, when the patient got home after having the second shot of BNT162B2, the patient experienced that her lips was so tingly and the bottom lips was little swollen. On 14May2021, it looked like the patient's bottom lip has a little puffiness on it. Treatment was received in response with the events which included diphenhydramine (BENADRYL, 25mg) about 4 doses about over the night (as reported). Outcome of all events was not recovered. No follow-up attempts are possible. No further information is expected.

severe rash/worsened considerably; severe itching; dizziness; swollen tongue; tight throat; even bothering my eyes; This is a spontaneous report from a contactable consumer (patient). A 78-years-old non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, lot number was not reported), via an unspecified route of administration on 18Feb2021 (at the age of 78-years-old) as a single dose for COVID-19 immunisation. The patient's medical history included rheumatoid arthritis, neuropathy, heart disease, starts and stop date was not reported for all and patient was allergic with sulfa. The patient's concomitant medication(s) included prednisone; gabapentine and unspecified blood pressure medicine, all are taken within two weeks of vaccination. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, lot number was not reported, patient was 78-year-old at the time of vaccination), via an unspecified route of administration in left arm on 25Jan2021 at 03:00 pm as a single dose for COVID-19 immunisation. Patient previously took simvastatin and had allergies. On 24Feb2021 at 12:00, the patient experienced severe rash and worsened considerably, severe itching, dizziness, swollen tongue, tight throat, even bothering my eyes. Patient received treatment with benadryl then Zyrtec for all events. Patient not received other vaccine in four weeks of vaccination. Patient visited doctor office/clinic visit for the events. Patient had not covid prior vaccination and not tested covid post vaccination. The final outcome of all events was recovering. No follow-up attempts are possible; information about lot/batch number cannot been obtained.

Pain in the shoulder; Hurt when I take a deep breath (lasted for days), pain radiated around my breast in the front.; Hurt when I take a deep breath (lasted for days), pain radiated around my breast in the front.; The "pain in the hip and there was also pain in the big toe- 'in the very core of toes' and next 2 toes/foot pain; And arms hurting/arm was really sore; She was sleepy tired; She was sleepy tired; Had tingling on the lips; A sore on my tongue; Felt like I got stabbed in the butt/hip and butt was hurting; Hip joint was hurting; This is a spontaneous report from a contactable consumer (patient). A 78-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number was reported as FW0179 or EW0179, Expiry Date and NDC number are unknown), via an unspecified route of administration, administered in Left deltoid on 27May2021 at the age of 78-years-old as 1st dose, single dose for covid-19 immunisation. Medical history included asthma, osteoarthritis, hypertension from an unspecified date. It was reported that patient has food allergies, drug allergies, and environmental allergies. The patient had tingling on the lips and stated that she had experienced this before when she gets exposed to chemicals with a very strong aroma that her body didn't like. Concomitant medications included losartan (LOSARTAN), hydrochlorothiazide (HYDROCHLORZIDE), simvastatin (SIMVASTATIN), fluticasone furoate, vilanterol trifenatate (BREO ELLIPTA) taken for unspecified indication, on unspecified date. The Caller reported having possible side effects after the first dose. She said that she has a lot of allergies and was asked to stay for 30 minutes and nothing happened. She went home (10 minutes from site), and she had tingling on the lips, right away on 27May2021. She stated that she had experienced this before when she gets exposed to chemicals with a very strong aroma that her body did not like. she knows that is an allergic reaction. She also reported a sore on her tongue (not sure if from vaccine), felt like I got stabbed in the butt, hip joint was hurting on 27May2021, and arms hurting. The next day on 28May2021, she stated that her arm was really sore and that she was sleepy tired. Her arm hurt and she had pain all day and was sleepy. The caller knows that being sleepy and the pain in the arm is normal. On the third day, 29May2021, she said that the pain in the hip and there was also pain in her big toe- 'in the very core of toes' and the two toes next to it. The next day on 30May2021, she didn't feel the toe pains but still felt sleepy and tired. That Wednesday, 02Jun2021, she had pain in her shoulder when she took in a deep breath. This went on so the caller went to the doctor and had an x-ray on Thursday. She was prompted to consult because of "pain in the shoulder" she said it hurt when she takes a deep breath (lasted for days), pain radiated around my breast in the front. Her shoulder wasn't hurting that bad, but it was still there until Friday. The pain was in her shoulder blade and it went to the front near her breast. She went to the chiropractor on friday, and he said he thought it was from the vaccine. Upon checking up with Doctor with an x-ray, Doctor confirmed that he couldn't see anything; nothing to indicate pericarditis. In addition to this, she mentioned that the nurse practitioner also experienced the toe pains (Age and Gender not provided). On the next day on 03Jun2021, she set an appointment with her chiropractor, and confirmed these side effects were from the vaccine. It was reported that age at time of onset of reaction/event was 78. Does the caller wait to a take the vaccine. Does the caller not even take the second dose. Her hip hurting was like a jab. Her foot pain woke her up in the middle of the night. She received her first dose on 27May2021. She was scheduled for her second dose on 16Jun2021. She was worried and has her reservations about getting the second dose because she had a reaction. She asked if it would make a difference to wait for getting the second shot; "is it better if I wait between vaccine one and two" She has heard that people get adverse events after the second dose. The patient underwent lab tests and procedures which included chest x-ray: normal on the same week that she received the shot on an unspecified date in 2021, the nurse practitioner said the chest x-ray was unremarkable and x-ray: normal on an unspecified date in 2021. Reporter seriousness for events was unspecified. The outcome of the event had tingling on the lips was recovered on an unspecified date in 2021 and for Felt like I got stabbed in the butt/hip and butt was hurting, Hip joint was hurting, arms hurting/arm was really sore was not recovered while for other events was unknown.

Tinnitus (severe). Hearing loud pounding noises 24/7. Can't sleep. ENT doctor > Ear exam was normal, hearing test was normal, brain catscan was normal. Tinnitus began on March 30, 2021 and continued with no end in sight. Been suffering for 3 months.

This is a spontaneous report received from a contactable consumer or other non hcp. A 78-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/lot number: EM9809) via intramuscular route of administration in left arm on 05Feb2021 at 09:45 (age at vaccination 78 years old) as single dose for COVID-19 immunization. Medical history included cardiac disorder from an unknown date and unknown if ongoing Mother had heart issues, but she is passed away, ongoing panic attack the caller said that she has only had like 2 panic attacks in her life. She said that on 30Dec2021 she had a panic attack on the day of the vaccine, she had a light one on the way to get the injection, she said that she had COVID-19 previously and was diagnosed 05Jan2021 and was cleared so she took the vaccine, ongoing fatigue She said that her tiredness started during when she had COVID-19, but stated that she understands it was a symptom post COVID-19, ongoing gait disturbance She said that she may have been wobbly on her feet since she had COVID-19, but has gotten worse since the injection. There were no concomitant medications. On 05Feb2021 the patient experienced panic attack, her heart was racing/heart was racing to 132, unstable and wobbly on her feet, extremely tired and on unspecified date in February 2021 she said she feels like her eyesight has gotten worse, unstable and wobbly on her feet was reported as worsened/extremely tired was reported as worsened/she said she feels like her eyesight has gotten worse/and got very worse after vaccination. with outcome of unknown. The patient underwent lab tests and procedures which included electrocardiogram fine in 2021. The clinical outcome of the event panic attack, her heart was racing/heart was racing to 132 were recovered and unstable and wobbly on her feet, extremely tired were not recovered other events were unknown. Follow-up attempts are completed. No further information is expected.

I had itchiness and swelling around my eye. I thought it was a bug bite but it kept getting worse. Eventually, I had a rash around my eyes, my forehead, my hair. I went to the urgent care where they prescribed me an antiviral. The antiviral seems to be slowing things down. I am also now experiencing a crawling sensation throughout my body. It feels as if a bug crawling on me. This is something new that I have never experienced before.

She thinks she has a sinus or allergy related ear infection; She thinks she has a sinus or allergy related ear infection; She thinks she has a sinus or allergy related ear infection; Ear feels plugged up; This is a spontaneous initial report from a Pfizer sponsored program . This consumer (patient) reported for herself that. A 78-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: ER8734), dose 1 via an unspecified route of administration on 13Apr2021 09:30 as 1ST DOSE, SINGLE for covid-19 immunisation. Medical history included ongoing hypertension (She was probably diagnosed 40 years ago with high blood pressure), ongoing thyroid disorder (She was probably diagnosed 45 years ago or longer with her thyroid issue), ongoing hip surgery (She had hip surgery two months ago). There were no concomitant medications. No Investigation Assessment. No Additional Vaccines Administered on Same Date of the Pfizer Suspect. No Prior Vaccinations within 4 weeks. No Patients Medical History including any illness at time of vaccination. Family Medical History Relevant to AE(s): NO whole family has allergies. No Relevant Tests. The patient experienced she thinks she has a sinus or allergy related ear infection, and ear feels plugged up on 03May2021. It was reported that the caller is scheduled to get the second dose of the vaccine on 07May2021. She thinks she has a sinus or allergy related ear infection, but she is not sure. She was taking Coricidin, a cough and cold medication with high blood pressure. She stated she has high blood pressure. She took this yesterday morning at 9:30 AM and she did not take any more because she thought it might affect the shot. She stated she won't restart it until after the shot. She stated she is feeling better but does not know if this medication will affect the vaccine. It was reported that She was calling to see if she needed to stop this medication before getting her second dose. Confirmed caller has already stopped the medication. It was reported that she has had the ear infection for last four or 5 days, and she did not get it right after she had the shot. It was reported that she guesses it won't bother her, but it might bother him regarding contacting her physician. She never went to the doctor, or that she doesn't know if it is an ear infection or sinus drainage. She states her ear just feel plugged up. It was reported that it is not as bad as it was. She states she took 4 of those pills (Coricidine) and she got better but she still has the ear infection. She had to stop the pills because they could interfere with, COVID vaccine, and could not read the information on the box without glasses nor could she locate the NDC number on the box. Reporter seriousness for events: Unspecified. Patient was not visited Emergency Room or Physician Office for events. The outcome of events was recovering. No follow-up attempts are needed. No further information is expected.

Systemic: Allergic: Itch (specify: facial area, extremeties)-Severe, Systemic: Allergic: Swelling of Face / Eyes / Mouth / Tongue-Severe, Systemic: Body Aches Generalized-Medium, Systemic: Exhaustion / Lethargy-Severe, Systemic: Flushed / Sweating-Severe, Systemic: Neurological Disorder (diagnosed by MD)-Severe, Systemic: Numbness (specify: facial area, extremities)-Severe, Systemic: Seizure-Severe, Systemic: Tingling (specify: facial area, extemities)-Severe

Patient started to have trouble breathing around February 10th. She also complained that she couldn't swallow very well since the 2nd vaccine on February 2nd. On February 12 she called in a panic. Her lips were swollen and then her tongue started to swell. I took her to the ER where they sent us to a large hospital. They ran all sorts of test. Blood work, CT Scan, ultra sound. No one could tell me why this was happening. They gave her antibiotics and steroids and the following morning on February 13th she was discharged. The next morning on February 14, patient called me again in a panic. She couldn't breath and couldn't swallow. Her lips, tongue, and under her chin were swollen, hot, and hard as a rock. I rushed to get her and took her back to the hospital. She was in the ER for about 8 hours where she was almost intubated as her airway was close to closing off. She was moved up to the ICU that day and stayed in the the ICU until February 19th. During that time, they ran all the same tests, blood work, CT Scan, ultrasound and no one could tell me why my mom was having this reaction. After we returned home I received a call from the ICU doctor who was checking on her as they had more patients come in with the same symptoms post covid - vaccine. She advised to file this reaction with all the information I had and told me that patient was not to get the booster if one was required later.

Eye issue of excessive tearing and redness; Eye issue of excessive tearing and redness; itching eyes; This is a spontaneous report from a contactable consumer (patient). A 78-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported, expiry date: unknown), dose 2 via an unspecified route of administration on 02Feb2021 as dose 2, single for covid-19 immunisation. Medical history included ongoing macular degeneration. Historical vaccine of BNT162B2 for Covid-19 immunization as 12Jan2021 at the age of 78-year. Concomitant medications included varicella zoster vaccine rge (cho) (SHINGRIX). She clarified that she had regular eye care due to macular degeneration, and she also had the Shingrix vaccine in that general time period of 2 weeks between any other vaccine doses. The patient experienced eye issue of excessive tearing and redness, itching eyes in 2021. She received second dose of Pfizer Covid-19 Vaccine in Feb and this been going on since. Caller clarified that her last name was (withheld), as provided by inbound transfer agent. She clarified that she has been administered both doses of the Pfizer Covid-19 Vaccine, with her second dose being administered in Feb2021. She clarified that she has had an eye issue of excessive tearing and redness for several months that may or may not have something to do with the Pfizer Covid-19 Vaccine. She clarified that she was not sure of exactly when this event started but it was in the ballpark of after she got the second dose of the Pfizer Covid-19 Vaccine. She called to ask if there have been any reports of this effect with the Pfizer Covid-19 Vaccine. Consumer on the line who did not want to file a report, but wants to know if this has been reported before as she was experiencing red and itching eyes. She has received both doses of the Pfizer COVID-19 Vaccine. She is 78 years old and her birthday is tomorrow. She received the first dose, on 12Jan2021 and the second dose on 02Feb2021. Transfer agent stated she informed the caller this was not listed as a side effect. Transfer agent stated the caller was looking to see if anyone at all, like in the history has reported this allergy. Informed transfer agent in this department did not have anything to speak to regarding events. Transfer agent stated she tried to inform the caller of this, but she was not having that either. Therefore, was trying to transfer to safety department to see if we could help. After transfer, caller clarified event details. She stated she is having redness in the eyes and excessive tearing. She was under treatment and has macular degeneration. She goes to the specialist once a month and is seeing other specialist to determine what the issue is. She is currently using a lot of drops. She was calling because she wanted to know if this was a possible reaction to the COVID-19 Vaccine, if other people are having eye issue. She declined to continue with safety report, because she did not want to report as event because she feels it could also be a million other things. It could be her carpet or shampoo. She stated she has spoken to several different departments. At first she was speaking with a Medical department that said they do not handle COVID and then she was transferred to the Medical department that handles COVID and all they could tell her was it was not on the list of reactions. Caller stated, even though it's not listed on their list of reactions she wants to know if it has been reported at all before. She declined transfer back to Medical Information as she was told by them only have information on actual side effects. They don't know about things before it reaches a certain threshold. She stated she was informed the safety department captures the AE reports and they are the ones who could tell. After placing the caller on hold, caller then questioned about the vaccine booster. She stated she was happy to get the vaccine, she is grateful and feels that it saved her life. She wanted to know the recommendations on the booster and the projected timeline of when should get it as she is coming up on having had the vaccine for six months now and wants it before it is wore out. The outcome of events was not recovered. Information about lot/batch number has been requested.

Tinnitus; This is a spontaneous report from a contactable consumer, the patient. A 78-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6201) via an unspecified route of administration in the left arm on 23Feb2021 at 16:00 (at the age of 78-year-old) as a single dose for COVID-19 immunisation. Medical history included glaucoma. The patient did not receive any medication within two weeks of vaccination. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EL9264) via an unspecified route in left arm on 02Feb2021 at 16:30 as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 23Feb2021 at 16:00, post second vaccination, the patient experienced tinnitus which persisted since then. The patient did not receive any treatment for the event. The clinical outcome of the event tinnitus was not resolved at the time of this report. No follow-up attempts are needed. No further information is expected.

This is a spontaneous report from a contactable consumer, the patient. A 78-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL3247) via an unspecified route of administration in the right arm on 23Jan2021 at 09:30 (at the age of 78-years-old) and received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL9266) via an unspecified route of administration in the right arm on 13Feb2021 at 09:30 (at the age of 78-years-old); as a single dose for COVID-19 immunisation. Medical history included laryngopharyngeal reflux disease (LPRD), irritable bowel syndrome (IBS), Raynaud's disease and fibromyalgia. The patient had unspecified allergies to medications, food, or other products. The patient received unspecified medications within two 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 four weeks prior to the vaccination. On 02Feb2021 at 07:00, 10 days after first vaccine, the patient developed tinnitus, which she never had before. The event resulted in doctor or other healthcare professional office/clinic visit. The patient did not receive any treatment for the reported event. The clinical outcome of the event tinnitus was not recovered at the time of report. No follow-up attempts are needed. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021384484 Same reporter/ drug/ event for different patients

pain under right arm pit; very stiff neck; pain radiating into ear; pains radiating down right arm, chest and back; pains radiating down right arm, chest and back; nausea; Vomiting; severe chest and back pains on right; severe chest and back pains on right; This is a spontaneous report from a contactable Other Health Professional (patient). A 79-year-old female patient (not pregnant at the time of vaccination) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EH9899), via an unspecified route of administration in right arm on 18Dec2020 08:30 at single dose for covid-19 immunization. The COVID-19 vaccine was administered at Hospital. The patient medical history was not reported. Concomitant medication in two weeks included citalopram, levothyroxine, atorvastatin, anastrozol. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 3rd day (21Dec2020), the patient experienced severe chest and back pains on right at time of 12:30 AM. On 4th day (22Dec2020) pains radiating down right arm, chest and back, nausea and vomiting. On 5th day (23Dec2020) pain under right arm pit, very stiff neck, pain radiating into ear. Temperature was normal. On 6th day (24Dec2020) most symptoms dissipated. On 7th day (25Dec2020) almost back to normal. No treatment received for the events. Prior to vaccination, it was unknown if the patient was diagnosed with COVID-19 and since the vaccination, the patient was not been tested for COVID-19. The outcome of events was recovered in Dec2020.

Verbalize at 1:02 pm feeling light headache, blurred vision like vertigo. He was evaluated by Fire Rescue and released home feeling better at 1:05 pm.

Approximately 15 minutes following the first dose vaccination the patient began to complain of sudden onset bilateral blurred vision at at distance. Patient denies any additional neurological symptoms. Patient brought to the ED for evaluation.

Approximately 15 minutes following the administration of first dose vaccination the patient began complaining of sudden onset bilateral blurred vision at distance. Patient denies any additional neurological complaints. Patient brought to the emergency department.

WITHIN 5 MINUTES AFTER VACCINATION :SWOLLEN LIPS,DIFFICULTY SWALLOWING ,SENSATION OF THROAT CLOSURE, DI FUSE RASH (ARMS ,LEGS ,BACK) ,SWOLLEN NOSE AND FACE AREA AROUND.

I am blurry and it's sort of a vision thing where I can't see everything quite right, it's blurry; A little bit of brain fog not quite thinking everything correctly; Sometimes it feels like my legs aren't quite there; My senses aren't quite right; This is a spontaneous report from a contactable consumer (patient). A 79-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number: EL3246), on 07Jan2021 at SINGLE DOSE on upper left arm for COVID-19 immunisation. The patient medical history and the concomitant medications were not reported. The patient was blurry and it's sort of a vision thing where she can't see everything quite right, it's blurry and a little bit of brain fog not quite thinking everything correctly and sometimes it feels like her legs aren't quite there like her senses aren't quite right. Treatment was no.

Patient presented to hospital 1 day following vaccination with slurred speech, left sided weakness, and left gaze preference concerning for acute neurologic injury.

Chest palpitations, thickness of tongue. Medic administered epinephrine injection and benadryl though IV in arm in tent on site. Taken by ambulance to hospital and observed for over 4 hours.

urine issues/kept going to the bathroom to urinate; upset stomach; diarrhea; felt like she was going to faint, pass out at any second; dizziness; Had a funny taste in her mouth; felt very weird, strange; This is a spontaneous report from a contactable consumer (patient). This consumer reported same events for two patients (one is patient self). This is the first of two reports. This 79-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL1284), via an unspecified route of administration to right arm on 13Jan2021 15:00 at single dose for COVID-19 immunization. Medical history included allergies to Sulfas, Penicilins, and Avelox, Sulfa or Penicillin allergies since she was a child and had the Avelox allergies about 15-16 years ago. None concomitant medications. Patient did not receive any other vaccines that day or 4 weeks prior. Did get the original Shingles vaccine about 3 years ago and then they came out with the new one and she got the first dose of that and believes she had a reaction to that one, thinks it was a rash. Also had the flu shot and she usually gets sick with it, but didn't with this last one. Thinks her body is just delicate. No vaccines administered on same date. Patient had the Pfizer BioNTech vaccine on 13Jan2021 15:00 and she was fine. She had a reaction the following day (on 14Jan2021). At 11am the next day she got very dizzy and felt like she was going to faint, pass out at any second. Used cold compresses and drank water and took deep breaths, but she didn't pass out. She had a funny taste in her mouth. Then from that time until about 7pm she had urine issues and kept going to the bathroom to urinate and had diarrhea and upset stomach. Patient felt like she was out of her body, felt very weird, strange. Doctor stated she maybe had a reaction to the vaccine and recommended for her to take Tylenol. She didn't take it until right before going to bed. She was able to sleep on 14th night. Woke up the next morning and was fine. She didn't see any of these reactions listed and that happened. Patient explained to a friend of the reactions and the friend mentions that she also had a friend who had the vaccine and had the same exact reactions, everything. Everything improved and stopped the next morning she was fine, on the 15th. No Emergency Room or Physician Office visit. The events outcome was recovered on 15Jan2021. It was just a span of time and she has to assume that it was the vaccine since she has never had that before. Patient does not know if she should blame the vaccine because she also has a lot of allergies to a lot of antibiotics and does not know what caused her reactions.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021065869 Same reporter/ vaccine/ AEs, different patient

Severe vertigo; pressure in the ears; eye nystagmus drastically worsened; Strong intense pressure in the head (not a headache); Fatigue

79 yo female with past medical history only significant for endovascular coiling of cerebral aneurysms over 30 years ago presenting with fevers, fatigue, weakness, noise sensitivity, myalgias,and tremors. She exercises regularly and has become so weak that she cannot climb stairs. Neurological exam revealed hyperreflexia, subtle proximal muscle weakness, the presence of a startle reflex and rooting reflex, clonus, and a positive Babinski. Infectious work up has been negative, autoimmune evaluation is underway. Inpatient neurology consultation has been obtained, she was given a trial of diazepam for stiff person syndrome and started on daily IVIG on 2/3/2021 for a 5 day course. She continues to have an elevated CRP, a mild transaminitis, and mild thrombocytopenia. The ESR dropped from 44 to 20 with hydration. She has had no cognitive changes. No headache, visual changes, jaw pain. We are unable to obtain MRI given the presence of these coils which are not MRI compatible. Encephalitis immune antibodies are pending, myositis panel, MOG antibodies ADEM are pending, GAD65 antibody pending.

This vaccine clinic was held at the Center in on 1/23/21 and hosted by the Hospital.. Vaccine administered at 1340 by LPN. Patient with immediate c/o of feeling light headed, hot all over, flushed. Patient stated she felt better but at 1357 c/o of itching all over body and tongue swelling. Epinephrine pen administered at 1358 by LPN. Emergency services contacted. Patient transported to ER at approximately 1410.

pt stated that she had a little head ache and was achy and tired on day of vax. On 2/7/21 pt woke up and had pressure in her right eye. She went to her Retina Specialist and was given a shot since in the eye it was hemorrhaging. Pt will go back in 4 weeks for FU and another shot.

About 30 minutes after the shot, sudden very weird feeling, visual distortion, confusion, disoriented (now believe was sudden drop in blood pressure), followed by mouth feeling odd, tongue felt too big, difficult to swallow, followed by sensation of intense heat. This all lasted about 5-10 minutes. Resolved on its own. Felt a little shaken but OK afterwards.

Immediate taste sensation and then swelling of tongue w/o any change in breathing, some sense of tongue soreness and hyperemia remains

I recieved the shot on 2/5/2021 on 2/8/2021 I was off balance all day. I would run into walls and doors. As I went down the steps of my home I couldn't stop at the bottom. I ran into the door and it stopped me. I was this way all day. When I got up the next morning on 2/9/2021 I was o'k until around 9:00 then my tongue got sore and my mouth got all coated. My whole mouth was coated. Around 10:00 my tongue swelled. This lasted all day. The next morning I was fine.

Client reports developing shingles after vaccination on right side of face and has right eye involvement. Client reports started with runny nose and watery eyes on 2-1-2021. Was recommended to get COVID-19 testing which was completed on 2-2-2021 and results returned negative. Client was given prescriptions for amoxicillin and prednisone dose pack on 2-2-2021 by COVID testing site practitioner. Client then developed nausea, vomiting and diarrhea after starting amoxicillin and stopped taking it. She spoke with her MD who placed her on another ATB, which she has not taken. On 2-4-2021, she went to the ER as recommended by her PCP for dehydration. The ER noted eye swelling and that she had increased eye pressure after running some tests. She saw her eye doctor on 2-5-2021 and is scheduled for an MRI and MRA on 2-11-2021 and will follow-up with eye doctor on 2-12-2021 as well.

45 minutes after injection the left side of my face became numb to half of my tongue BP was higher than normal 177/97! Numbness lasted about 45 minutes! BP was back to normal the next morning! 2/9/2021

Weird taste; extremely tired; other_vaccine_same_date_vaccine_date=28Jan2021; other_vaccine_same_date_vaccine_date=28Jan2021; This is a spontaneous report from a contactable consumer who reported for the patient. A 79-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 28Jan2021 14:30 at single dose for COVID-19 immunisation. The patient was vaccinated at Health facility. Age at vaccination was 79 years. On the same date (28Jan2021) the patient receive another Pfizer vaccine for immunization. It was reported the patient receive other Pfizer vaccines within 4 weeks prior to the COVID vaccine in Jan2021. On 28Jan2021 at 17:15 the patient experienced weird taste and was extremely tired. No treatment was received for the adverse events. The events had resolved in Jan2021. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, has not been tested for COVID-19. Information on the lot/batch number has been requested.

On 2-8-21, she had the chills, and on 2-9-21, she developed double-vision which has continued. Documentation double-vision still present on 2/12/21. Patient sought treatment in the emergency department 2/12/21 dx. Binocular vision disorder with diplopia .

4 seizure type episodes (including shaking, eyes rolling back for about 15-30 seconds long) after being moved out of bed - lasted 4 days Fever up to 102.5 - lasted 5 days Could not stand - 8 days Body aches - 8 days Could not walk - 9 days Weakness - on going since vaccine Shaking - on going since vaccine

Developed itching and redness all over body. Eyes itchy and developed hemorrhage; Jaw pain. Patient had COVID-19 a few months ago.

injection site and arm pain; tiredness; muscle pain; joint pain; feeling unwell; metallic taste in mouth

sinus infection; cannot see out of her right eye; sick; terrible terrible splitting headache on her right temple; can't sleep; pressure behind her right eye; head is all fuzzy; mind isn't good; throat hurts; jaw hurts; little off balance; she walks she falls into things; she walks she falls into things; can't see things hardly in her right eye; pain; This is a spontaneous report from a contactable consumer (patient). A 79-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; lot number and expiration date were not reported), via an unspecified route of administration on 04Feb2021 at single dose for Covid-19 immunization. The patient's medical history was not reported. Concomitant medication included atenolol for blood thinner. The patient previously took first dose of bnt162b2 for Covid-19 immunization and experienced no adverse event. The patient stated that she received the second dose of the vaccine on 04Feb2021 and has been sick ever since. She has a terrible terrible splitting headache on her right temple and can't sleep and was having so much pressure behind her right eye. She stated she can't even lay her head on a pillow. She stated she had no reaction to the first shot but this time her head is all fuzzy, her mind wasn't good and when she sets things down she can't remember where they are. The second shot was really giving her a fit. Her throat hurts, jaw hurts, head hurts, and feels like she is running a temperature. She is a little off balance, when she walks she falls into things because she can't see things hardly in her right eye. She stated she can't put up with the pain any longer, it is terrible behind her temple and eye. She thought it was a sinus infection but now she thinks it was from the shot. She stated she almost had a wreck today because she cannot see out of her right eye because of the shot. She hit a telephone thing and almost wrecked 3 or 4 times. She tried to get tested for Covid but she didn't have an appointment and she cannot go to work until she finds out about the virus. She was going to get tested tomorrow but was going to have to call the rescue squad because she can't drive and she was not putting her son through this if she has the virus. The patient asked if she was allergic to the second shot or if these were normal symptoms. She asked what she should do. She stated she takes Atenolol, a blood thinner, and thyroid medicine. She stated she was taking Tylenol but it doesn't help any and nothing seems to help. All the events occurred on Feb2021. Outcome of all the events was unknown. Information on the lot/batch number has been requested.

79 yr old caller had first vaccine yesterday at 1425 (pfizer) late in the afternoon she had chills and pain in arm, mouth was sour. she hasnt been taking her potassium on large amount of diuretics for kidney and heart. she is on 2.5 mg eloquis. today she stayed in bed this am her temp was 100. an hour ago it was 101.3 adv apap for fever if ok with your medical situation, sx are normal for vaccine. ok to go for dr next week if f/u is needed. these sx are not contagious.

Shot was on 2/15. No adverse until about 9 pm on 2/19 when started having. Neuropathy in feet, legs and mouth started to burn. This burning and tingling has happened every night since. Was hoping would clear up on its own. Had some neuropathy before but nothing like this. Went to Dr on 3/1. This was first appointment. I could get. He did number of tests should hear from them soon. At the present time of typing this I have some tingling and burning and numbness. But is extremely bad at night

tingling lips, itchy red cheeks - on the way home Saturday muscle aches from neck to ankles - during the night Saturday to Sunday stuffy nose, dry cough, fatigue, chills (no fever), nausea, sore arm - Sunday and Monday on third day the only thing remaining are chills sought no treatment

headache, tingling in throat and tongue, sneezing, fatigue, burning sensation in knees, memory issues

Lost part of my vision and it only lasted for three to four minutes; mini stroke/ TIA; This is a spontaneous report from a contactable consumer (patient). A 79-year-old female patient received bnt162b2(Pfizer-BioNTech COVID-19 Vaccine, Lot number: EL9284, Expiration date: 31May2021), via an unspecified route of administration at the left arm on 11Feb2021 14:00 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On 11Feb2021 7pm, patient went to get something to open the can of soup but when she went into the pantry, she lost part of her vision and it only lasted for three to four minutes. The patient's daughter who is a neurologist thought it was the mini stroke or TIA (Feb2021). The doctor was setting up the sonogram for her arteries and her neck and also for her heart and said she might have to rely on a pacemaker. The outcome of the events was unknown.

Had a Herpes Simplex virus that was dormant unless I get excited; Got the vaccine; First reaction was a numbing on left side of my face and my eye, my jaw and then my left arm was tingling; Got the vaccine; First reaction was a numbing on left side of my face and my eye, my jaw and then my left arm was tingling; Developed a taste of metal in my mouth; Had a very salty taste along with the metal taste in my mouth; Mouth became dry; Developed a taste of metal in my mouth; Had a very salty taste along with the metal taste in my mouth; Mouth became dry; Developed a taste of metal in my mouth; Had a very salty taste along with the metal taste in my mouth; Mouth became dry; My heart felt like rush; Started to get an ache in my left eye, pressure in my eye and feeling just kind of bumped out; Started to get an ache in my left eye, pressure in my eye and feeling just kind of bumped out; Have Covid tongue; symptoms got progressively worse; feeling just kind of bumped out; This is a spontaneous report from a consumer (the patient). A 79-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EM9809), via an unspecified route of administration on 10Feb2021 (at the age of 79-years) as a single dose for COVID-19 immunization. Medical history included cholesterol. Concomitant medication included rosuvastatin calcium (CRESTOR). The patient previously took Aspirin (e.c.) about 10-15 years ago and experienced anaphylactic reaction, Lyrica about 10-15 years ago for neuralgia and experienced hypersensitivity. The patient reported that on 10Feb2021, she got the vaccine. When she first obtained the vaccine, she was put in a holding situation in regards to having any reaction. She was sitting there about 10-15 minutes, and the first reaction was a numbing on left side of her face and her eye, her jaw and then her left arm was tingling, then she developed a taste of metal in her mouth; had a very salty taste along with the metal taste in her mouth; her mouth became dry. Her heart felt like rush. The "EMT" guy was there, he watched her. So, she sat there for a while. She went home and her symptoms got progressively worse. It was almost an immediate reaction. She started to get an ache in her left eye/pressure in her eye, and feeling just kind of bumped out. Immediately, after she got the vaccine, she had a very salty taste along with the metal taste in my mouth. When I came home, my mouth became dry. The patient reported that she still have a salty taste in her mouth and have "Covid tongue". The patient also reported that she had a herpes simplex virus that was dormant unless she get excited and it has been down for a long period of time. The patient reported that "I am afraid to take my second dose". The patient did not receive treatment for the events. She stated " I just thought it would go away". The clinical outcome of the event salty taste in her mouth was not recovered. The clinical outcome of the remaining events was unknown.

Patient presented with bilateral ptosis and weakness in the jaw while chewing that progressively gets worse as the day goes on. Patient was prescribed pyridostigmine bromide 60 mg with improvement of symptoms. Patient is following up with neurology.

Patient reported 1st dose gave her jaw tingling on her way home after her 15 minute obs. She states on arriving home it had dissappeared. Today we agreed with charge nurse we would keep her additional 15 minutes. As first dose at the 15 min mark she reported tingling in jaw at 20 minutes she reported the tip of her tongue was tingling. She states some times when eating hard candies she has the same sensation with her tongue. At 10:14 she states vaccine side effects have resolved bp 156/86 HR 80 OX 100 % We agreed she would stay 15 minutes longer. We discussed any oral itching of throat itching any airway sensations she will seek medical attention.

Pt. felt mouth numb and had a headache in observation line. Paramedic assessed her until pt. symptoms subsided. Paramedics released her to leave.

Shocking and immediate onset of painful sensation on right side of face.- similar to feeling when shots given for dental work begin to wear off. Tingling pain from hairline to mid throat, from behind ear to right side of nose. areas of numbness, , noticeable swelling of lymph node under right chin. Painful to swallow, painful to open mouth, pain in jaw like having a really bad tooth ache. this is nine days. I had a titanium tooth implant in the last six months. Painful to chew food - eat soups, ice creams, soft food like bananas.

sore throat, followed by headache and right ear pain. Nausea and fever of 101.0 on March 8th, in addition to previous symptoms. In the emergency department on March 11th with complete right facial droop consistent with Bell's palsy; this has persisted as of today, also with evidence of right serous otitis media

Had mild tinnitus from time to time, tinnitus resurfaced and became much worse, constant and almost intolerable.

Patient tested positive for COVID-19 after being fully vaccinated. Symptoms started on 3/18 with runny nose, sore throat, cough and minor loss of smell

Patient stated "lips feeling numb and thirsty". RN and EMT were called for evaluation and called onsite EMS. Pt was evaluated by onsite EMS, pulse 75 bpm. Pt released bt EMS at 11:05AM.

This is a spontaneous report from a contactable consumer (patient). A 79-year-old female patient received BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine; lot number and expiry date were unknown), via an unspecified route of administration on 09Feb2021 (at the age of 79-years) as a single dose for COVID-19 immunization; and liraglutide (VICTOZA), via an unspecified route of administration from 10Feb2021 to an unspecified date at unknown dose, weekly for an unspecified indication. The patient's medical history and concomitant medications were not reported. It was reported that everything was going fine until she had her COVID-19 vaccine on 09Feb2021, and then on 10Feb2021 she had the liraglutide injection. That's when everything went wrong and had to be hospitalized. She is losing her magnesium and her potassium. She had diarrhea, hadn't eaten in 5 weeks, was throwing up, and lost weight. She just can't eat, everything tasted so bland. She is getting better now though. The action taken for liraglutide was unknown. The outcome of the events was recovering. No follow-up attempts are possible; information about the lot number cannot be obtained.

prothrombin time was 16.2 seconds (standard: 11.9-14.5 seconds); Pfizer vaccine caused the bleeding around the eye/bleeding under her eye; Black eye/left eye was black. It is a purple eggplant in color.; This is a spontaneous report received from a contactable consumer (patient). A 79-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN6200, expiry date: 30Jun2021), via an unspecified route of administration in the right arm, on 28Feb2021 10:20, as single dose, for Covid protection, at the hospital. Medical history included atrial fibrillation and ablation. Concomitant medication included apixaban (ELIQUIS) taken for atrial fibrillation and to prevent stroke from 2019. The patient did not have prior vaccinations within 4 weeks. It was reported that the patient received the first dose of COVID-19 vaccine on 28Feb2021 and was scheduled to get the second dose on 21Mar2021 (Sunday). On 12Mar2021, her left eye was black, it was a purple eggplant in color. She wondered if she needed to tell the doctor and remembered her mother had blood vessel that burst. The patient clarified that it was to the side of her eye and not in her eye. It was bleeding under her eye. The nurse wanted the patient to stay so she could do some research. The nurse told her that the Pfizer vaccine caused the bleeding around the eye. The patient didn't want to have the second dose of the vaccine. She was told that she needed to report it. The nurse also told her that she needed to have her blood levels checked and that she does not need to take the second dose until she gets her blood levels checked. She went to her doctor's office but her primary care doctor and the other doctor were on vacation. She was seen by the nurse practitioner. The nurse practitioner told her that she had to take the second shot and she might have to come off the blood thinner. She underwent blood work on an unspecified date with unknown results. She was told that the nurse practitioner has to study up on this and might have to come off of the blood thinner in order to get the second dose. She has been on blood thinner since 2019 after having an ablation. She has done wonderful. She is on this to prevent a stroke. She is on Eliquis. She is thankful for it. She has gone in and out of atrial fibrillation while taking Eliquis. The patient didn't want to take a chance on the second dose of the vaccine in case of hemorrhaging and was scared to take the second dose. Her blood clotting time was checked on 17Mar2021 and her prothrombin time was 16.2 seconds (standard: 11.9-14.5 seconds). She was hoping that Pfizer could advise her on taking the second dose. She thinks she will cancel her appointment for 21Mar2021. She is afraid to have the vaccine. The outcome of the events "Pfizer vaccine caused the bleeding around the eye/bleeding under her eye" and "Black eye/left eye was black. It is a purple eggplant in color" was not recovered; and "prothrombin time was 16.2 seconds (standard: 11.9-14.5 seconds)" was unknown.

I had a delayed response to Covid 19 vaccine by one week, March 13th 2021. I had a bright red rash on hand, thighs, buttocks, with small blisters in between fingers and inside upper and lower lips. Also, had hives, welts, and swelling of these areas. Severe itching that did not subside. On March 14th I went to urgent care, by Tuesday March 16th it was worse, went to see Doctor and she increased Pepcid and prednisone dosage that I was given at urgent care. She increased my Zyrtec that I was taking from home and added Singulair. She did labs at this time. I was much better the week of March 21st and advised to see an allergist. Saw him on March 23rd, and he advised no more vaccines until her could test me. So far, April 1st there is no Pfizer vaccine available for test. I'm making another virtual appointment for April 20th.

Went into A Fib; Went into A Fib; thirsty; This is a spontaneous report from a contactable consumer (patient). A 79-year-old non-pregnant female patient received her second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EP6955) at the age of 79-years-old, via an unspecified route of administration in left arm on 19Mar2021 at 11:00 at single dose for COVID-19 immunization. Medical history included allergies to penicillin, arthritis, and episodic atrial fibrillation (AFib) in which she had 3 episodes in the last two years. The patient has no COVID prior to vaccination. Concomitant medications included apixaban (ELIQUIS), diltiazem, colecalciferol (VITAMIN D), and bifidobacterium lactis (PROBIOTIC). The patient has no other vaccine in four weeks. The patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN6200) at the age of 79-years-old, via an unspecified route of administration in left arm on 22Feb2021 at 11:00 at single dose for COVID-19 immunization. The facility the vaccine was administered was public health clinic/veterans administration facility. The patient went into AFib on 19Mar2021 at 23:45, 12 hours after receiving the dose (as reported). She was told to drink plenty of liquids following the shot, which she did because she was so thirsty. The patient was in AFib for about 18 hours until it resolved into sinus rhythm. She wondered if there was any association with the vaccine and heart rhythm. The patient did not receive any treatment for the event "went into A Fib". She was not tested with COVID post vaccination. The outcome of the event "went into A Fib" was recovered on 20Mar2021 at 17:45 and unknown for the other event.

couldn't walk straight; use a cane; Guillain-Barre syndrome; left knee and left hip were so painful; equilibrium was totally off; tired; pink blotches and a red rash on her legs; pink blotches and a red rash on her legs; didn't feel good; her legs started burning; her eyes were bloodshot with dark circles; This is a spontaneous report received from a contactable female consumer (patient). A 79-years-old female patient received bnt162b2 (PFIZER-BIONTECH mRNA COVID-19 VACCINE, Solution for injection), dose 1 via an unspecified route of administration, administered in Arm Right on 11Feb2021 09:45 (Batch/Lot Number: EL1283) as SINGLE DOSE for covid-19 immunisation. The patient did not have any allergies to medications, food or other products. The patient did not have any relevant medical history. Concomitant medications includes: Plavix (CLOPIDOGREL BISULFATE) 75mg, once a day, Oral, Losartan 100mg, 1/day, Oral for blood pressure high, toprol XL (METOPROLOL SUCCINATE) 50mg, 1/day, Oral for Blood pressure high, ezetimibe (ZETIA) 10mg, once a day for , Oral for High cholesterol. Vitamin C (ASCORBIC ACID) 1000mg, 1/day, Oral. Omega 3 1000mg, 1/day, Oral, taking for 2 years. Vitamin D 1000IU, 1/day, Oral, taking for 6 months. Multivitamin dose unknown, 1/day, Oral. Aspirin (ACETYLSALICYLIC ACID) 81mg, 1/day, Oral. All the Concomitant medications started dates was unspecified. It was reported that Consumer states she got the first dose 11Feb2021 of the Pfizer COVID 19 vaccine at 0945AM in the right arm. Adds she had no reaction the first day. Then about three days later (14Feb2021), she noticed pink blotches and a red rash on her legs; and she didn't feel good. About five days later she called the doctor who did a blood test. No results known. The doctor put her on Prednisone and she took three doses and on Feb2021 her legs started burning so she stopped. Adds she doesn't think it had anything to dowith the Prednisone; it was the vaccine. Reports she started to have balance and coordination problems, on 25Feb2021 her left knee and left hip were so painful that she had to use a cane and could not walk straight and her equilibrium was totally off so that she was she was walking into the wall. Mentions that on 17Feb2021 she was tired, on Feb2021 other eyes were bloodshot with dark circles. Mentions she did lots of research on her phone and decided that all of her symptoms seem to relate to GBS, Guillain-Barre syndrome. Clarifies she does not know if she has GBS. She has been to the doctor again and they are telling her not to get the second dose of the shot. Mentions that pretty much everything cleared up by 1Mar2021. Additional information includes plavix was used for head and neck blockage, taking for 10 years, Losartan patient took off the water pill portion HTZ part of months ago, toprol XL taking for 13 years. Zetia taking for 8 years. Vitamin C patient taking for her immune system, taking for 3 years. Omega 3 taking for 2 years. Vitamin D was taking for 6 months. Multivitamin. Aspirin patient taking for taking for keep blood flowing since 14 years. Outcome of the events didn't feel good, couldn't walk straight and use a cane and Guillain-Barre syndrome was unknown. Outcome of the events left knee and left hip were so painful, equilibrium was totally off and recovered on 01Mar2021. Outcome of the event her legs started burning was recovered on Feb2021. Outcome of the events her eyes were bloodshot with dark circles on 04Mar2021. Additional Information has been requested/ Additional information on lot/batch number has been requested.

1 week upon completion of vaccination series, pt started having balance issues and new onset tinnitus, which is persistent

Within five minutes of receiving the first vaccine, my mom had body aches, and her hands became sweaty. Within a couple of hours, she developed a fever that lasted 24 hours. The body aches remained, and her knees swelled seven days after the vaccine. Yesterday, she received the second vaccine, my mom's pain throughout her body is worse. She also has pain in her jaw and her left eye.

sore tongue; This is spontaneous report received from a contactable consumer (patient). A 79-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: EL3248, Expiry date: Unknown), via an unspecified route of administration on 15Jan2021 at single dose for COVID-19 immunization. The patient's medical history included she had a lot of wax and dry skin and her ear was compacted. Concomitant medications of patient were not reported. On an unspecified date patient experienced sore tongue. She states after her 1st dose 15Jan2021 she got a sore tongue, her tongue got sore and she thought it may have been something that she ate, it was nothing drastic it stayed sore. Outcome of event was unknown. No follow-up attempts are possible. Information about lot/batch number cannot be obtained.

thrush on her tongue; cold sore; pulsing in her right ear; States she had a lot of wax; dry skin; earache; This is a spontaneous report from a contactable consumer(Patient). A 79-years-old female patient received second dose of bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: EL9261), via an unspecified route of administration on 05Feb2021 as SINGLE DOSE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date, It was stated that after the 2nd dose about 2 days later the patient had experienced got thrush on her tongue, she has never had thrush in her life and her doctor prescribed her a swish in her mouth for 4 days, 4 times a day. on the 5th day she got a pulsing in her right ear that started, and she still has that and it seems like just today it may be getting a little dimmer and not as bad and then she had cold sores and has been prescribed with NYSTATIN 1000, she was 79 years old and is healthy. she walks every day for an hour, doesn't take any medications, states her ear doctor wants to do a scan of her head and throat. The patient wanted to know if there are other complaints about ear complaints after getting the shot. And she had also stated that she had a lot of wax and dry skin and her ear was compacted in that right ear. The patient also experienced thrush on her tongue (oral candidiasis), cold sore (oral herpes), pulsing in her right ear (tinnitus), states she had a lot of wax and dry skin and her ear was compacted in that right ear (excessive cerumen production) , states she had a lot of wax and dry skin and her ear was compacted in that right ear (dry skin) , earache (ear pain). The outcome of the events was unknown. No follow-up attempts are needed. No further information is expected

Onset of chills, fever, deep ache in bones of face, jaw, neck, upper arms, chest and back. Restlessness, pain in base of tongue, extreme dry mouth, stuffy nose. Unable to sleep all night due to pain. Treatment so far, two Tylenol this AM. Outcome not yet determined.

hallucinations; Headache; chills; fever; sweats; diarrhea; got ill/not feeling well; Pain behind eyes and neck and shoulders; Pain behind eyes and neck and shoulders; Pain behind eyes and neck and shoulders; muscle pain; vomiting; she got the 2nd dose of the vaccine last 02Apr2021, she got the first vaccine last 24Mar2021; she got the 2nd dose of the vaccine last 02Apr2021, she got the first vaccine last 24Mar2021; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer (patient) reported that a 79-year-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration on 02Apr2021 as SINGLE DOSE for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. Historical vaccine includes first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) on 24Mar2021. On 02Apr2021, the patient experienced hallucinations, headache, chills, fever, sweats, diarrhea, got ill, pain behind eyes and neck and shoulders, muscle pain, and vomiting. The patient was hospitalized for all events for 4 days. The patient further stated that after 3 hours getting the vaccine she experienced a terrible adverse event like headache, muscle pain, diarrhea, vomiting and chills, she contacted her doctor and she was advised to call the ambulance and go to the hospital but since she was designated next to the isolation of COVID patients she decided to go home after getting the saline that will help her to increase the potassium, she mentioned that until now she was experiencing hallucinations and severe headache and she was not feeling well. The patient also stated that she got the first vaccine last 24Mar2021 (less than 21 days interval). The patient mentioned that she had taken diarrhea medications and antibiotics after the 2nd dose. Therapeutic measures were taken as a result of hallucinations, headache, sweats, diarrhea, got ill, pain behind eyes and neck and shoulders, muscle pain, and vomiting. The outcome of all events was unknown. Information on lot number/batch number has been requested.

Mouth inside cheeks inside lip area., raw thicker,, slight burning on left side corner of the lips and inside left side to upper. Worst started April 30 with immediate swelling including change in throat. Took Hydroxizine. The throat got better aware of inside mouth swollen.

Swelling of my tongue and throat. The second and third days I was unable to stand or walk without assistance and was extremely tired and also had memory lapses.

On the 3 rd day after pt received her first shot. She started getting symptoms of Bells Palsy on the Right side of her face. Eye and mouth drooping. On 4/25/2021 she still has some drooping and her Right hand eye is blurry.

shortness of breath; experienced white and pink bumps on her face around her lips; experienced white and pink bumps on her face around her lips; she experienced aches and pain in her joints; blurred vision on and off; This is a spontaneous report from a non-contactable consumer (patient). A 80-years-old-female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number was not reported), via an unspecified route of administration on 23Feb2021 (79-years-old) as 1st dose, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. It was reported that patient did not have her medications, but she did state that she has had several Botox injections in the area on her face where she experienced the reaction. The 2nd day after the first dose of the vaccine (24Feb2021) she experienced white and pink bumps on her face around her lips. She also had some shortness of breath and called 911. She was admitted to the hospital. The ruled out COVID infection and Pneumonia. On the 3rd day while hospitalized she experienced aches and pain in her joints. She was discharged after 3 days. Her symptoms have subsided. She is only complaining on some blurred vision on and off. She received her first dose on 23Feb2021. Her Doctor told her she should not get the 2nd dose. Therapeutic measures were taken as a result of shortness of breath, experienced white and pink bumps on her face around her lips, she experienced aches and pain in her joints. The outcome of event she experienced aches and pain in her joints was recovering, while other events was unknown. It was reported that patient had several Botox injections in the area on her face where she experienced the reaction. No follow-up attempts are possible; information about lot/batch number cannot be obtained.

tired; cold; head was in a fog; Staggering; Diarrhea; ears were ringing; arm was sore; body ache; neck was painful; back of head pain; This is a spontaneous report from a contactable consumer (Patient). A 79-year old female consumer reported that she received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number EL0140, Expiration Date Mar2021) into the left arm on 11Feb2021 at 4:00pm (at the age of 79-years-old) at single dose for COVID-19 immunization. Concomitant drugs included ciclosporin (RESTASIS) twice daily both eyes taken for dry eye; bimatoprost (LUMIGAN) one daily both eyes taken for glaucoma for 5-6 years, vitamin B complex 1 daily taken as supplement for 15-20 years; colecalciferol (D3) 2 daily during the winter and 1 daily in the summer taken as supplement for 3-4 years. She use to get a lot of sore throats. Her doctor suggested she take vitamins. Some that she took didn't help. On 11Feb2021 the patient experienced arm was sore not recovered, body ache recovered on 13Feb2021 and on 12Feb2021 she experienced tired recovered on 13Feb2021, cold recovered on 12Feb2021, head was in a fog not recovered, staggering recovered on 13Feb2021, ears were ringing recovered on 13Feb2021, Diarrhea recovered on 12Feb2021. Further reported the back of her head and neck was painful that was gone by 13Feb2021. Her arm was sore if she lays on it she can feel it. Unable to answer outcome of event for being tired,if she sits long enough she falls asleep. Her head still feels tender. She is no longer staggering. She feels comfortable going up and down stairs. The next dose is scheduled for 04Mar2021. She is considering not taking the second dose.

feeling the half of her face swollen, thick and numb; feeling the half of her face swollen, thick and numb; feeling the half of her face swollen, thick and numb; the tip of the tongue tingling and sore.; the tip of the tongue tingling and sore.; This is a spontaneous report from a contactable consumer (patient). A 79-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Batch/Lot number and expiration date was not reported), via an unspecified route of administration on 27Jan2021 (age at vaccination 79-year-old) as 1st dose, single for covid-19 immunisation. Medical history included allergy related with sinusitis from an unknown date and its ongoing. Concomitant medication included prednisone (PREDNISONE) taken for sinusitis, start and stop date were not reported. The patient reported that she was administered with the first dose of the Pfizer's COVID-19 vaccine on 27Jan2021 (Wednesday) and a few hours after the administration of the vaccine she started feeling the half of her face swollen, thick and numb and the tip of the tongue tingling and sore. The patient reported that she took Prednisone that she had in her house and was previously indicated for the management of an allergy related with sinusitis. The patient reported that she has taken 3 doses of Prednisone, one each 24 hours. Patient asked for information about if her symptoms could be related with the administration of the Pfizer's COVID-19 vaccine. The outcome of the events was reported as unknown. Information on the Batch/Lot number has been requested Follow-up attempts are completed. No further information is expected.

a few little chills; I started shaking violently from chills; severe muscle pains all through my back; severe muscle pains all through my back; my knee joints hurt; severe headache; had fever.; unsteady; dizziness; everything was so severe. I've never have shaken that bad; nausea; sick; taste problems; I thought maybe I had this COVID because I was sick; feeling a little chilly; This is a spontaneous report from a contactable other health care professional. A 79-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection; Lot Number: EN6198) at the vaccination age of 79-year via an unspecified route of administration on 05Mar2021 as single dose for COVID-19 immunization. Patient historical vaccine includes first dose of BNT162B2; LOT number: EL9269 ,which was administered on 12Feb2021 for COVID-19 immunization. Medical history included neuropathy peripheral and hypertension. Concomitant medications included, lisinopril taken for hypertension, gabapentin taken for neuropathy peripheral, levothyroxine and dicyclomine. On an unspecified date, the patient experienced I thought maybe I had this covid because I was sick; I had the taste problems and the doctor lately did a test on me to see if I still have the antibodies and I did not. so, he said no, it does not look like you had it; a few little chills; I started shaking violently from chills; severe muscle pains all through my back; severe muscle pains all through my back; my knee joints hurt; severe headache; had fever; unsteady; dizziness; everything was so severe. I've never have shaken that bad; nausea; sick and taste problems. On 05Mar2021 09:00 PM patient was feeling a little chilly. On an unspecified date the patient underwent lab tests and procedures which included blood thyroid stimulating hormone: unknown results, sars-cov-2 test: negative. The seriousness of all the event was reported as non-serious. The clinical outcome of the events was unknown. No follow-up attempts are possible. No further information expected.

Adverse event: ears "clogged up" i.e. filled with fluid. A common allergic reaction with me. Lasted several hours. Going away after a few hours.

eyes really burning and watering, she almost could not see; eyes really burning and watering, she almost could not see; she almost could not see for a few minutes; Tiredness; excruciating pain in all 10 fingers, just to the area that connects to the hand, nothing in her palm or hand; red mark about the size of a quarter at injection site; couldn't move her fingers; This is a spontaneous report from a contactable Nurse. A 79-year-old female patient received first dose of BNT162B2 (Formulation: Solution for injection; Batch/Lot Number: EW0150; Expiration Date: 31Jul2021), dose 1 intramuscular, administered in Arm Left upper on 24May2021 11:30 AM (at the age of 79-year-old), as 1st dose, 0.3 ML single dose, for COVID-19 immunization. Medical history included first pulmonary embolism in 2007; second in 2017 Went to hospital 23Jan2017, left hospital 5 days later. Patient has allergy to aspirin from Dec1982 to ongoing. (Patient Had headache, took Aspirin in 20 minutes had severe reaction-like never seen. Did not go to hospital, never felt throat closing off, coughing, trouble breathing. Skin felt on fire inside and out, took everything off, ice cold shower, skin beet red felt on fire all over, skin looked like elephant skin, wavy; Neighbor nurse gave her liquid Benadryl she drank. Within 15 minutes everything started to clear up, never been near Aspirin again). Patient has allergy to Advil from 1985 To Ongoing. (Had Severe reaction. Did not go to hospital, never felt throat closing off, coughing or trouble breathing. Couple years later had new job picked up fever from little kids coming in. Took Advil had reaction started the same way as with Aspirin, but she had Benadryl at home and able to catch it in time. Never taken again). Patient has allergic to other things, has environmental allergies. She kept Benadryl in her purse. Patient had Gall bladder surgery from 1985 to Unspecified date. (When had gall bladder taken out, they gave her Percodan and Percocet in hospital, had reaction of rash so they had to take her off Percodan and Percocet and give her Benadryl). Patient had Titanium filter in place from 24Jan2017 to ongoing. On 23Jan2017, patient was hospitalized because she could not breathe with pulmonary embolism, they put titanium filter in place probably after midnight so on 24Jan2017. Patient had lumbar stenosis with pinched nerve from 49 years of being a nurse. A few years ago, she had 2 procedures where they would inject long-acting unknown product, she guesses Cortisone but did not know the name of the product she guesses Cortisone but does not know the name of the product. On her right hand the numbness was still there. Patient underwent EMG test and a couple weeks later he told her he thought she has carpel tunnel. The concomitant medications include Eliquis taken for pulmonary embolisms (2.5 mg, 2x/day) from unspecified date of Jan2017 to ongoing. Synthroid taken for thyroid problem from unspecified date to unspecified date. Eliquis has to be a pretty powerful drug; don't know about Pfizer Covid Vaccines, wondered if something interacted because excruciating pain in all 10 fingers, just to the area that connects to the hand, nothing in her palm or hand and couldn't move her fingers took a little over 4 days after Pfizer Covid Vaccine for onset. The patient previously took (years ago) hepatitis vaccine, shingles vaccine, pneumonia vaccine, no reactions to those; she was very cautious did not leave the office too soon after vaccines. She never got flu shot; when she was first in nurses training, she had a reaction to the flu vaccine in like 1960 and was in the emergency room. This retired Registered Nurse was the patient who called regarding her first dose of Pfizer Covid Vaccine. She reported tiredness; eyes really burning and watering, she almost could not see; excruciating pain in all 10 fingers, just to the area that connects to the hand, nothing in her palm or hand; She couldn't move her fingers. She also mentioned red mark about the size of a quarter at injection site. She reported she had absolutely no symptoms, nothing after the Pfizer Covid Vaccine other than tiredness, feeling kind of tired, that's about it. On27May2021 in the afternoon she had onset of her eyes really burning and watering, she almost could not see for a few minutes. She washed her eyes out, and the burning and watering went away after she washed them. She had no make-up on, no eye make-up on for a few days at that time. Otherwise, everything was ok. She went to bed last night and during the night she woke up with excruciating pain in all 10 fingers, just to the area that connects to the hand, nothing in her palm or hand. She couldn't move her fingers for maybe a minute or two. Eventually she was able to move her fingers a little, then more and more and the event stopped, she kind of went back to normal and fell asleep. A couple of hours later she had the same event reoccur, just down to the hand, all 10 fingers, couldn't move them for a few minutes and then after that she could, they seemed to be ok, and she fell asleep again. Whether event started 27May2021 or 28May2021 is unknown, unknown onset times. She has been fined all day. She has written checks out, made meals, coffee, washed and dressed herself, had no other problems. At her age it was hard to tell when the tiredness started regarding time of onset. Thinks in the evening of 24May2021 she felt onset, tired and the next day on 25May2021 she had a couple episodes where her arms felt really heavy just for a short time maybe 30 seconds and then the episodes went away and she just felt tired. 26May2021 she noticed she was not as tired, and yesterday and today improved, feeling pretty good. Seriousness of all the events was not specified by reporter. The outcome of the events eyes really burning and watering, she almost could not see for a few minutes was recovered on 27May2021. Time of onset: late morning, probably about 11:00-11:30 really burned, then eyes started to really, really water. She was familiar with her house so she held onto furniture to get to the bathroom and as soon as she rinsed her eyes out event never happened again. Her eyes are not bothering her.The outcome of excruciating pain in all 10 fingers, just to the area that connects to the hand, nothing in her palm or hand and couldn't move her fingers was resolved on an unspecified date in 2021. The outcome of the event tiredness and red mark about the size of a quarter at injection site was recovering. Follow up attempts are completed. No further information is expected.; Sender's Comments: Based on close temporal association the causal association between the reported event she almost could not see for a few minutes with the usage of the vaccine BNT162B2 cannot be excluded. The contributory effect of the patient's medical history and concomitant medications also need to be considered. The case will be reassessed should the 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 RAs, Ethics Committees, and Investigators, as appropriate.

Blurry Vision; This is a spontaneous report from a contactable consumer, the patient. A 79-year-old female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6204) via an unspecified route of administration in the right arm on 16Mar2021 at 10:45 (at the age of 79-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medications were not reported. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN5318) via an unspecified route of administration on right arm on an 19Feb2021 at 14:00 as a single dose for COVID-19 immunisation. On 17Mar2021 at 12:00, the patient experienced blurry vision. The patient did not receive any treatment for the reported event. The clinical outcome of the blurry vision was resolved on an unspecified date in 2021. No follow-up attempts are needed. No further information is expected

This is a spontaneous report from a contactable consumer (patient). A 79-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection; Lot number: unknown) via unspecified route of administration in arm left on 06Mar2021at 11:00 (at the age of 79-year-old) as single dose for COVID-19 immunization. Medical history of the patient included high blood pressure, sinus issues. Family Medical History included that her daughter has had reaction to medications, she had flu vaccine and she ended up in the emergency department, she had trouble breathing. Concomitant medications included atenolol started a long time ago taken for high blood pressure. Patient previously used clindamycin as in her age she occasionally breaks. Patient previously received flu vaccine in 2009 for immunization and had a reaction. She had the Flu vaccine for many years and the one she had trouble with was a vaccine without preservatives. On 06Mar2021, seven hours after receiving first dose of vaccination, in the evening patient noticed that her mouth started to burn, accidentally pinched her arm and the pain was more than expected and it left a bruise. On 12Mar2021, patient experienced sinus issues. On 20Mar2021, patient experienced that her legs were heavy and felt like they were weighted, which made it difficult for her to walk. On 22Mar2021, patient experienced burning pain on her lower lips, specifically in the space between the lip and the teeth. There was also burning pain in the face, in the arm and her neck-chest area, which caused great mental distress, a huge emotional toll, specifically being upset and devastated, lack of sleep, and weight lost due to lost of appetite with 5 pounds being lost within 2 weeks of these side effects. On an unspecified date in 2021, patient experienced hypersensitivity reaction. Patient stated that when she was changing her outfit she accidentally pinched her arm and the pain was more than expected and it left a bruise. About 7 hours after, she noticed that her mouth started to burn. She mentioned that she also had pineapple that day and was not sure if it was caused by the vaccine. On the 09Mar2021, she consulted a nurse practitioner who said that the burning may have been caused by the Pineapple. On 10Mar2021, she consulted her allergologist and got tested for a pineapple allergy. The results came in on 15Mar2021 and they came back negative for the allergy, but her allergologist mentioned that pineapple can still irritate the mouth. On 18Mar2021, she consulted with her Primary in which she was given magic mouthwash that made it worse. She was made to continue her benadryl and aspirin spray. On 20Mar2021, that Saturday night, as she was walking, she felt that her legs were heavy and felt like they were weighted, which made it difficult for her to walk. It lasted for about 20-30 minutes before subsiding. Last Monday, 22Mar2021 she really started to notice the burning pain on her lower lips, specifically in the space between the lip and the teeth. There was also burning pain in the face, in the arm and her neck-chest area. She described it as not constant but comes and goes. On 25Mar2021, she consulted with her primary again in which she was recommended not to get the 2nd dose of the vaccine and her side effects lean to a more neurologic cause. The doctor mentioned that the vaccine was still too new. These side effects has caused great mental distress, a huge emotional toll, specifically being upset and devastated, lack of sleep, and weight lost due to lost of appetite with 5 pounds being lost within 2 weeks of these side effects. She said that has not been fun. it has been horrible, and she would choose dying over this burning sensation in the mouth. Patient visited physician Office, 3 times and allergist did it virtually. Reportedly, after eating dinner she was eating pineapple from a can. She had the can and tried it. She had not had pineapple in a long time. While sitting in her recliner, she experienced her mouth burning. She added that began about an hour and a half after eating the pineapple and it has lasted for approximately 2 weeks. It was not constant all the time. She did not know at the time if the burning in the mouth was related to the pineapple. Caller added they thought it was the pineapple causing this. Last Sunday, the caller indicated that it was leaving and going away. Caller saw her new primary medical doctor on 09Mar2021. The Nurse Practitioner said it was probably the pineapple, She started her on Benadryl. Manufacturer was unknown to caller. Caller took 2 tablets on 09Mar2021 and stopped taking it on 10Mar2021. She restarted taking the Benadryl on about 14Mar2021. Caller stated she was primarily calling and asking because on Monday, 22Mar2021 she started having burning in her face and had burning in her arm. Caller reported the burning in her arm was not from the vaccine and she thought it was caused by her blood pressure cuff. Caller took her own blood pressure. Burning was better today, she still had burning in her arm. She took Zyrtec as instructed by her physician twice a day. She took a half tablet on 10Mar2021 through 13Mar2021. She was taking half a tablet in the morning and a half tablet at bedtime. Caller added that the Zyrtec made her feel unsteady and it made her sleepy. She did not tolerate it. Dose was 10mg. She has recovered completely from unsteady and being sleepy with Zyrtec. Caller took Tylenol because she was having sinus issues. She did not have the manufacturer, she took it on 12 and 20, two times. Its 325mg, by mouth, the regular strength. Caller saw an allergist on 10Mar2021 who tested her for pineapple allergy. The Allergist called on 15Mar2021 and reported she was not allergic to pineapple. Allergy was also tested for egg white, milk, wheat, corn, peanut, soybean, potato, yeast, and tomato. All resulted as negative. Benadryl: took 2 times in 09Mar2021. Caller restarted Benadryl and took it on 14Mar2021-17Mar2021. These days she only took it in the evening. She took 25 mg at night. Then she took Flonase, twice, on the 17th and 18th. Its over the counter. Lot number: TE8G, caller doesnt have box to provide UPC, stated there was another number of 0140592, expiry Mar2021. Dose was 27.5mcg per spray, spray into each nostril. When providing strength, states writing was so small for her to see. Gets a magnifying glass to confirm strength, states it's with her age. The doctor also suggested for the caller to try Afrin spray on 18Mar2021. Caller started it on 20Mar2021 and used it only once. She didnt like it. Caller said at her age she occasionally breaks out and uses Clindamycin for that. Dermatologist has her using Clindamycin 1 per cent pledgets. Applied twice to face once daily, She stopped 20Mar2021. Given Magic Mouthwash, which was in a pharmacy bottle, she took it once on 18Mar2021, but stopped. It was 5-10ml swish and spit. It made things worse and did not improve it. The doctor forgot to give her a measuring cup, and caller thought she told her a teaspoon. Caller added she tried using a warm cloth on her sinus area and her skin felt like a sunburn. The cloth left a red area around her cheek. Then this Sunday, after using the pledgets, went for a walk, next day noticed her face was really burned, not just face, her neck, arms, but she was not exposed, but had a burning pain, and she still continued to have it. She asked the dermatologist if this could be caused from the Clindamycin. The dermatologist told her no. She took a walk on Saturday and did not know if she was dehydrated. She felt like there were weights on her feet as she walked. It lasted 30 minutes. The burning in mouth started 7 hours after the first dose and it had improved. Therapeutic measures taken in response to the events included Benadryl, Zyrtec, Tylenol, Flonase, Afrin spray, clindamycin, magic mouthwash. Outcome of the events "mouth started to burn/burning in mouth" and "sinus issues" were ongoing-not recovered and for all other events were unknown at the time of report. Information on Lot/Batch number has been requested.

felt sick/sick as a dog; feeling nauseous; threw up like crazy; funny feeling around her head/Feeling really funny; face usually gets red when her blood pressure is high and it she is not red at this time; vertigo; blood pressure/ up to 210/110 mmHg; not walking well; funny feeling around her head/Feeling really funny; felt chills/Chills; Felt yucky; her balance was not quite right; felt the really funny feeling going up her throat; Her heart rate has been wanting to be a little higher than usual; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 79-years-old female patient received bnt162b2 (PFIZER- BIONTECH COVID- 19 VACCINE, Solution for injection) via an unspecified route of administration, administered in Arm Left on 30Jan2021(at the age of 79-years-old) (Batch/Lot Number: EL1283) as 2ND DOSE, SINGLE for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. Prior Vaccinations (within 4 weeks) If applicable, list any other vaccinations within four weeks prior to the first administration date of the suspect vaccine(s) was none. Family medical history relevant to AE(s) was none and she is getting close to obesity if she keeps eating like this. The patient previously took first dose of bnt162b2 on 11Jan2021, (Lot Number: EK9231, Expiry Date: Unknown, this is not on the CDC vaccine record card) via Injection administered in Arm Left for covid-19 immunisation and experienced Left arm was real sore after first dose injection. The historical vaccine included shingles vaccine. The patient experienced blood pressure/ up to 210/110 mmHg on 20Feb2021 felt chills/chills on 31Jan2021, felt yucky on 31Jan2021, not walking well on 20Feb2021 , felt sick/sick as a dog on 20Feb2021, feeling nauseous on 20Feb2021, threw up like crazy on 20Feb2021, funny feeling around her head/feeling really funny on 20Feb2021, face usually gets red when her blood pressure is high and it she is not red at this time on 20Feb2021, vertigo on 20Feb2021, felt the really funny feeling going up her throat on an unspecified date in 2021, her heart rate has been wanting to be a little higher than usual on an unspecified date in 2021 and her balance was not quite right on an unspecified date in 2021. The patient underwent lab tests and procedures which included blood pressure measurement: 220/110 mmHg (normal value: 120/80) on 20Feb2021, computerised tomogram: doctor mentioned 3 little places on 20Feb2021, electrocardiogram: unknown results on 20Feb2021, heart rate: little higher than usual on an unspecified date in 2021, laboratory test: unknown results on 20Feb2021. Patient received both dose of the Pfizer covid vaccine on 11Jan2021 and 30Jan2021. On the next day after the 2nd dose, she felt chills. On 20Feb2021, she started not walking well, thought she would fall. All of a sudden, she felt sick and threw up like crazy while she was visiting her daughter for the day. The firefighters came to take her blood pressure and it was up to 210/110 mmHg. They advised her to go to the ER. After several hours, she was given blood pressure and nausea pills. They mentioned vertigo. She says it got okay. However, 2 weeks ago, she started to have a funny feeling around her head. Not dizzy but her face usually gets red when her blood pressure high and she was not red at that time. It was again reported that the day after she was administered the second dose of Pfizer-BioNTech COVID-19 Vaccine she had chills and felt yucky that day. She also reported feeling really funny since 20Feb2021. She was asked for further information on events related to Pfizer-BioNTech COVID-19 Vaccine. She was at her daughter and noticed her balance was not quite right. She started feeling really funny so just lay down there for a little bit. When she did get up after about 15 minutes she started feeling nauseous. She got to the bathroom really fast and threw up like crazy. She did not have her blood pressure cuff with her so her daughter called the fire department and took her down there real fast. At the fire station they took her blood pressure which was 210/110 mmHg, so they suggested she head to the emergency room so she did. She was under observation in the emergency room, but not admitted to the hospital. The doctor mentioned vertigo somewhere along the way before she left the emergency room. She just kind of brushed the vertigo off until she was reading about that the Pfizer-BioNTech COVID-19 Vaccine can cause vertigo. She guesses vertigo was what caused these events because she had been sick as a dog. When they got her on the bed and rolled her back she felt like she was going 90 miles per hour and by the time they got her back on the bed she was throwing up again-but this time and the initial onset of throwing up was the only times she threw up. They gave her something after probably 5-6 hours, blood pressure medicine and nausea medicine and she got ok and left there. Her heart rate has been wanting to be a little higher than usual. About 2 weeks ago she was just sitting on the couch and noticed especially when she would turn her head she still feels really funny; not dizzy, dizzy; she was walking ok; but the really funny feeling keeps hitting her continuously. During call when she sat back down she felt the really funny feeling going up her throat. It was just the weirdest thing, she wishes she had a word to really explain what the really funny feeling was but she does not. She has not checked her blood pressure for a while because she has been holding for a while for this department, so her blood pressure could be up a little bit, but she stated event was worse right now than it has been. Regarding testing/investigations while in the emergency room they did a CT head scan, lab tests, and an EKG. CT head scan results, the doctor mentioned 3 little places but when she talked to her doctor he said that was really just nothing to worry about with age; he said they will check it in 6 months and make sure areas are not growing. Caller has no further information to provide regarding lab tests or EKG results, they did not mention anything. Therapeutic measures were taken as a result of blood pressure/ up to 210/110 mmHg and feeling nauseous. The outcome of the events, felt chills/Chills , Felt yucky, her balance was not quite right, felt sick/sick as a dog, threw up like crazy, face usually gets red when her blood pressure is high and it she is not red at this time, felt the really funny feeling going up her throat, Her heart rate has been wanting to be a little higher than usual was reported as unknown, not walking well, feeling nauseous and vertigo was reported as recovering, funny feeling around her head/Feeling really funny and blood pressure/ up to 210/110 mmHg was reported as not resolved. No follow-up attempts are possible. No further information is expected.

full blown tinnitus; some ringing in my ear on and off; not much sleep; ear felt full; sore, painful glands neck & base of skull; woke with night sweats; mild arm soreness; This is a spontaneous report from a contactable consumer or other non-health care professional (patient). A 79-year-old non-pregnant female patient received bnt162b2 (BNT162B2 PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot number: EN6205), via an unspecified route of administration, in arm right on 26Feb2021 at 17:30 (at the age of 79-years-old) as dose 2, single for covid-19 immunisation. The medical history of the patient included High blood pressure - controlled (hypertension) from an unknown date and unknown if ongoing. The concomitant medications of the patient included levothyroxine sodium (SYNTHROID), losartan, verapamil, colecalciferol (D3) taken for an unspecified indication, start and stop dates were not reported and tumeric. The past drug history of the patient included allergy to penicillin. The patient previously received first dose of BNT162B2(solution for injection, Batch/Lot number: EL9269), via an unspecified route of administration, in arm right on 03Feb2021 at 06:45 PM (at the age of 79-years-old) for COVID-19 immunisation. 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 not been tested with covid-19. The patient experienced mild arm soreness on 27Feb2021 at 21:30, woke with night sweats and sore, painful glands neck & base of skull on 10Mar2021 at 21:30, ear felt full on 12Mar2021 at 21:30, some ringing in my ear on and off and not much sleep on 14Mar2021 at 21:30 and full blown tinnitus on 15Mar2021 at 21:30. The reporter stated that she called her doctor she said there was nothing to be done for it and also stated that tinnitus 24/7; glands sore; ear still wonky (technical term). The events did not result in death or Life threatening or caused/prolonged hospitalization or disabling/incapacitating or congenital anomaly/birth defect. The events are reported as non-serious by the reporter. No treatment was received. The outcome of the events was reported as not resolved. Follow-Up (28Jun2021): Follow-up attempts are completed. No further information is expected.

Mouth around lips and cheek, followed by palette red sores,followed by swollen face,eyes blistering around eyes,burning itchy peeling rash neck,chest,around ears,burning itchy rash fingers to shoulder. On going progressive to present date. Prednisone finally prescribed at Hospital emergency. 40 mg. Per day for 5 days. Dr. is lowering the dosage. The first three weeks are prescribed 40 then 20 on going to 20 and an appointment July 22 to decide on the dosage to continue. I have photos documenting every horrible symptom. I was advised to do that.

she is losing her vision completely; patient's vision went blurry after the first vaccine/few days later the patient took the second dose of the vaccine and its 3 months and no vision came back; vision became distorted; This is a spontaneous report from a contactable consumer (patient and her husband). A 79-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in left arm on 23Feb2021 (Lot Number: EN6201; Expiration Date: 30Jun2021) as single dose; dose 2 via an unspecified route of administration on 25Mar2021 (Lot Number: ER8727) as single dose, both at the age of 79-years-old for covid-19 immunisation. The patient medical history was none. The patient's concomitant medications were none. The patient had both doses of the Pfizer covid vaccine. After the first dose she complained of visual disturbance which affected her sight, she was losing her vision on 27Feb2021 which went away after 1 month. Patient proceeded to take the second dose, and since has had the same visual disturbance from the previous dose, but this time it has not gone away. The patient received the first dose on 23Feb2021 and on 27Feb2021 the patients vision became distorted. Reporter stated she has seen 3 specialists and was now calling to find out if this side effect has been reported. The patient had been seeing an Ophthalmologist. Then about 20Mar2021 or 21Mar2021, the patient was on bromfenac sodium (PROLENSA), which was like an ibuprofen for the eye, her vision came back. A few days later the patient took the second dose of the vaccine and its 3 months and no vision came back. The patients vision has worsened since March. The patients vision went blurry on 27Feb2021 after the first vaccine and now she was losing her vision completely. The reporter wanted to know what he can do to keep the patient from going blind. Outcome of the events was not recovered.

I had an eye event which was later diagnosed as an optical migraine. One half of my vision was filled with colorful geometric shapes. I also saw large black "blobs" floating through my vision for a while. It lasted for about 1 hour and then gradually cleared up with only black specs recurring.

Lips burn and mouth swelled Benadryl 25 mg 1 every 8 hours starting on 01/08/2021 @ 7:00pm x 4 doses; and then took another one at 10:30am on 01/11/2021 after her mouth started swelling again

CoVid -19 vaccine given at 1 pm. At 1:15 pm patient calling for help. Assisted by staff. Symptoms reported "tongue feel little tingling." Given Benadryl 25 mg p.o.. No difficulty swallowing, No difficulty breathing, No rashes or any symptoms presented. Immediate relief felt after being observed for 5 min. Stated " imagining thing" "nervous" "completely normal now."

pt had already waited 15 minutes after receiving her vaccine and reported to RN before exiting building that she felt as though her bottom lip was swollen. She also c/o the tip of her tongue being slightly itchy. As she was describing symptoms to RN, pt stated that her throat was getting scratchy. pt denies difficulty breathing/respiratory distress, headache, nausea. Pt states she "feels ok and does not want to stay". RN asked to see pt's lip and tongue. Tongue was pink, moist. Bottom lip without swelling.

PT called to hospital today 01/26/21 reporting 2 hours after vaccine developed HA, Throat and jaw discomfort, denied SOB, called 919 . Pain subsided at that time and she did not seek ER care, but called reporting "severe side effects"

2 hours post vaccination nurse noticed angioedema in 1 eye and puffiness in the other eye. Nursing staff gave 25mg of Benadryl and used a cold compress. Swelling went down quickly and patient is doing well.

perioral numbness and tingling 15-25 min after vaccination. epi-pen administered 25-30 min after vaccination.

Dizziness, lightheadedness, sweating, diaphoretic. Patient is diabetic, had high BP, dizziness, loss of hearing, tunnel vision, emotional/crying. Patient was given juice, observation done, vital signs monitored, glucose checked, pulse ox checked. Patient improved after interventions. Patient verbalized feeling better and was discharged to home/self care with husband @ 1:15PM.

patient reported a metallic taste in mouth but no other symptoms, around 9:46 (11 minutes after onset) the metallic taste was resolving

Within 15-minutes of vaccination, the patient reported dizziness and a heartburn sensation in her chest. EMS noted orthostatic hypotension in the field, systolic was in the 130s when sitting with a rapid drop to the 70s upon standing. Patient was transported to emergency department. In the ED, the patient reported having a dry mouth and having not eaten breakfast. Patient was administered IV fluids and noted improvement. Labs were unremarkable. Diagnosed with orthostatic hypotension secondary to dehydration, vasovagal episode, and GERD.

PATIENT STATED THAT AFTER 3 HOURS OF RECEIVING THE FIRST DOSE OF THE COVID-19 VACCINE, HER LEFT EYE BECAME RED AND PART OF HER CHEECK BECAME SWOLLEN, PT STATED THAT SHE TOOK BENADRYL AND IBUPROFEN. DIDN'T SEEK MEDICAL ATTENTION.

Amyloidosis; felt a sweep over her stomach up her body and up to her head; Eyes swollen; hands hurt; sharp pings up and down legs; This is a spontaneous report from a contactable consumer (patient). An 80-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK9231), via an unspecified route of administration on the left arm on 16Jan2021 13:45 at a single dose for COVID-19 immunization. Medical history included ongoing diabetic and previously took the flu shot one time and started having right arm pain across her chest over to the left side right after getting it. So she don't take it anymore and takes a bunch of herbs. The patient's concomitant medications were not reported. The patient reported that she has a disease, amyloidosis on an unspecified date, where there is a build up of protein in the body. She didn't know that there is protein in the shot and doesn't know the affects it has with her condition. She found out the day after getting the first Pfizer C-19 (clarified as COVID-19) shot that there was protein in it. The patient wanted to know the affects it has with her condition and if it will affect her getting the second dose and if it covers the new virus and booster shot. The patient got the vaccine on 16Jan2021 and found out about the protein in it the next day when it came across her phone. The patient received it at a school, where they vaccinated 1,169 residents. They text her to inform her she could get the vaccine. They also have the health department there. No other vaccines given that day or 4 weeks prior. On an unspecified date in Jan2021, the patient took 1 Tylenol about 15:00 that afternoon and seated herself in the chair about 17:45, then she felt a sweep over her stomach up her body and up to her head. She stood up and walked around to see if she was going to faint and she did not faint. She walked through the house and nothing else happened. The patient mentioned that her eyes have been swollen and her hands hurt, that's where the protein build up comes in the body. Has pings up and down her legs, they are sharp pings that lasted through on to Tuesday. She took 1 Advil to help and as of yesterday (as reported) no pings. Her hands still hurt, because this condition forms chains in the body and the chains are around the hands like carpel tunnel. The protein normally should leave the body and with this condition it doesn't and it leaves chains. When she was diagnosed with it they took a spot off the ankle to test it, the Dermatologist did and sent it off. No further details provided. Wants to know the affects of her getting the second shot. No further details provided. The outcome of the events amyloidosis and hands hurt was not recovered, the events felt a sweep over her stomach up her body and up to her head and sharp pings up and down legs was recovering, and the event eyes swollen was unknown.

gray spot on forehead; face felt hot and flushed; Face red; was tired and wiped out; Eyes were red bloodshot; face was burning and burned bright red/her face feeling sunburned/ face got really like the worst sunburn; This is a spontaneous report from a contactable consumer (patient). An 80-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Batch/lot: EL8982) intramuscular in right arm on 22Jan2021 at 13:00 at single dose for COVID-19 immunization. Medical history included Gastroparesis from 2016 and ongoing, ongoing Osteoarthritis (diagnosed about 10 to 20 years before), acid reflux (esophageal), blood pressure, osteoporosis, arthritis, anxiety, high cholesterol, stomach problems, allergies and pretty bad sinus problems/sinus trouble in the winter, leg cramps at night, allergic to all kind of bites. Patient previously took shingles vaccine as immunization and she had had a small reaction, she had a patch of shingles break out around her arm at the site of injection site. Concomitant medication included ongoing omeprazole for Gastroparesis, ongoing erythromycin, ongoing aluminum hydroxide/magnesium carbonate (GAVISCON) for acid reflux (esophageal), ongoing calcium for Osteoporosis, ongoing losartan for Blood pressure, ongoing acetaminophen for arthritis, ongoing spironolactone as diuretic, ongoing tramadol for Osteoarthritis, vitamin C [ascorbic acid] as general supplementation, ongoing alprazolam for Anxiety, ongoing doxazosin for high blood pressure, ongoing fenofibrate for High cholesterol, ongoing vitamin b complex (B-COMPLEX) as general supplementation, ongoing bisoprolol for high blood pressure, ongoing magnesium good for heart recommended by cardiologist, ongoing biotin for hair and nails, ongoing zinc as immunity booster, ongoing montelukast sodium for allergies and pretty bad sinus problems/sinus trouble in the winter, ongoing levocetirizine dihydrochloride (XYZAL) for allergies, ongoing cyclobenzaprine for leg cramps at night as muscle relaxer, ongoing macrogol 3350 (MIRALAX) as laxative and ongoing "CVS brand multivitamin at one tablet once a day oral as general supplementation" (as reported).The patient experienced face felt hot and flushed and face red on 24Jan2021; gray spot on forehead on 25Jan2021; was tired and wiped out, eyes were red bloodshot, face was burning and burned bright red face feeling sunburned in Jan2021.Events were described as follows: patient received the first dose of the vaccine on 22Jan2021 and she had a few mild symptoms. She did not feel really good for a day or two but it was nothing that alarmed her, she was tired and wiped out. She always took a shower since she had arthritis and it get gets her joints going. On 24Jan2021 after she got out of the shower, her face felt hot and it was red. She didn't think too much about it and it went away pretty soon. She did not connect it with the vaccine. On 25Jan2021 she took a little longer shower and the same thing happened, but it was 10 or 12 times worse in regards to her face feeling hot and was red. She was drying off and getting dressed and reported her face felt funny and it was really hot. When she looked at it was bright red like she had the worst sunburn, it felt like a sunburn. Her face was red and eyes were red bloodshot and it lasted about half an hour; her face got real flushed like a real bright sunburn and her face was burning and burned bright red. She started putting on cold wet wash cloths to help cool her face down and when it the wash cloths got warm, she would wet it again to cool her face down some more. She was alarmed but about 30 minutes later it started lightening up a bit and pretty soon it was back to normal. Her face felt different in the afternoon, it was a little red. She worked out in yard and last summer she got an insect bite on her forehead that turned gray, it was the size of silver dollar. After the hot flush thing this morning, that gray spot came back. Her doctor said it might take a while for it to go away. Her face felt warm like it has been sunburned. Her throat was dry since she has been waiting on the phone for an hour. Her face feeling sunburned/hot was about 95% gone, barely there. Her face getting red started on 24Jan2021 morning and it was almost gone. Treatment included ponds face cream and it was very soothing. Patient just wanted to know what to do about this flushing of her face and if it was dangerous what she can do. She would like to know if she should be worried about this, it only happened when she took a shower. She was asking if there was anything she can do before she can get the second injection, so it does not happen again or what to do if it does happen again. Final outcome of tired and wiped out, eyes were red bloodshot and face was burning and burned bright red/her face feeling sunburned/ face got really like the worst sunburn was unknown; outcome of the other events was not recovered.

The night after receiving dose 1 of the vaccine, she didn't want to eat dinner, was starting to spit up saliva, and noted a new headache, and asked her daughter to sleep with her that night considering she was feeling poorly. She was restless all night, and then at ~5am her L arm began to twitch; she was still alert at this time but didn't realize her arm was moving. Shortly after this she lost consciousness, her eyes rolled back in her head, and she developed a frank GTC seizure. Her daughter called an ambulance, and by the time she was on the way to the hospital, she was awake and alert again. At the hospital, she was initially talking and able to answer most questions appropriately. She was noted to be afebrile, hemodynamically stable, without an O2 requirement, though with tachycardia to the 110s. She was found to have a leukocytosis to ~16, thrombocytosis to ~550, and LDH elevated in the 600s. Over the following day, her mental status declined and she became agitated and disoriented to place/time. CT chest revealed b/l multifocal pneumonia, for which she was started on pip-tazo. She underwent MRI brain (DWI sequence only) which did not reveal any obvious CVA. LP was performed on 1/29 at ~10PM; as far as we can tell, she had only received pip-tazo for antibiotics at this point. CSF studies revealed 220 WBCs (14% PMNs, 76% lymphs, 10% monos), 14 RBCs, Glu 59, Prot 145; GS 2+ WBCs, no orgs; india ink stain negative; Cx pending at time of transfer. Given concern for bacterial or viral meningoencephalitis she was transitioned to vancomycin/ceftriaxone/acyclovir. Patient was then transferred to another Hospital for further management. Micro was all negative or pending at the time of transfer. Shortly after admission to hospital she was intubated. Spine MRI was notable for longitudinally extensive transverse myelitis. All infectious workup has been negative with just two more pending studies for tuberculosis; autoantibody panel pending. She is now able to follow commands with eyes and mouth, but has not been able to move her arms or legs. We do not have high suspicion that this syndrome is related to the vaccine, given that progressive neurological symptoms started the week before vaccine, but thought it prudent to report given the time course.

Patient had episode of intense right eye pain as well as hypertension 170'2/110's with no previous history of HTN.

complains for numbness and tingling of tongue, lips and thick tongue. 60mg Allegra given, observed, all vitals within normal limits. Patient stated her tongue and lips are better, still with "thick tongue" but also complains for funny feeling in back of throat. 911 called to transport to ER for observation/treatment.

RECEIVED BOTH DOSES OF PFIZER COVID-19 VACCINES ON 01/27/21 & 02/17/21. REPORTED TO ICC ON 02/21/21 WITH EAR PAIN AND DAIGNOSED OTHER NON-RECURRENT ACUTE NONSUPPURATIVE OF LEFT EAR AND BILATERAL IMPACTED CERUMEN.

injection site inflamation redness around injection about the size of a quarter, itchy with raised bumps, tin taste in mouth, irrated tongue. severe tiredness. sore arm.

Asthma attack began about 20 minutes after injection, with throat tightening, slight mouth swelling sensation and immediate wheezing which grew progressively worse. I had my inhalers (Levalbuterol and Flovent) with me, used Levalbuterol at the direction of medical people who surrounded me after I reported wheezing. They gave me a Benadryl, then brought a wheel chair and sent me directly to the ER. I was there about 3 hours during which I had a heart monitor, a "breathing treatment" by a respiratory therapist, and DUONEB, famotidine (PEPCID), and (DELTASONE). I was given a 3 day Rx for 20 mg. of prednisone, and released. My lungs felt "twitchy" the next day and my voice was muted, but was well otherwise. The only "normal" side effect I had was some soreness at the injection site for a couple of days, with some light sensitivity there for a few weeks.

0920, reporteed thickness in back of tonge,c/o trouble swollowing, able to drink water, 126/72, hr83, 02 sat 96% RA, rr 16 Called rapid response, NP assessed and rec ER, pt refused. 0940 Benedry 50 mg po given. Refused ER again, Agrreded to monitor until 11am Checked out At 11:10. Denied other symptoms.

Pfizer-BioNTech COVID-19 Vaccine EUA: five days after vaccination patient presented to emergency department with left-sided facial droop, right gaze preference, and left hemi-paresis. Patient diagnosed with right middle cerebral artery occlusion, likely thrombotic etiology, admitted to hospital, and underwent thrombectomy and recanalization with symptom improvement. Discharged to home improved, stable, with vital signs within normal ranges two days after arrival to emergency department.

Patient reported tongue was tingling and felt "thick". She said she could "taste" the vaccine and had ringing in her ears.

38 hours after vaccine was given, patient awoke to a heart attack...says it felt like someone punched her between the shoulder blades and kept their fist there, pain then radiated down both arms to the elbows - more substantial on the rt side, pain also radiated up to the back of her jaw.

She did not feel good; Eyes were blurry/ she felt pressure in them; Bad head cold; she couldn't bend over; Aches all over; Back pain; Eyes were blurry/ she felt pressure in them; This is a spontaneous report from a contactable consumer from a Pfizer sponsored program. An 80-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EJ1687), via an unspecified route of administration on the left arm, at the age of 80 years, on 29Jan2021 17:00 at a SINGLE DOSE for covid-19 immunisation. Medical history included cataract, arthritis and seasonal allergy from an unknown date and unknown if ongoing. There were no concomitant medications.The patient stated that a couple of times she did not feel good and got very sore and could not bend over to pick things up and her eyes blurred up. After she got the shot, she gradually noticed aches all over and back pain. It was stated it hurt really bad in her back on the right side on the bone and she used the heating pad on it. Then the next day she was stiffer than ever and she couldn't bend over. She added her eyes were blurry, they felt like she had a cold in them, and she felt pressure in them. She added she always has this problem with her eyes but it got a little worse after the shot. All of that has gotten better now. It was stated they are telling her the second dose was worse and she was unsure about getting the second dose. Also mentioned they were saying you can wait a little longer and she was unsure if maybe she should wait. She wanted to ask about getting the second dose. She added she was scheduled to receive the second dose of the vaccine on 19Feb2021. The patient said it was right sided back pain. She said she applied heading pad and took ibuprofen. She also experienced "eye pressure" and "blurry eyes", "how you feel when you have a bad head cold". She said, "I have allergies-seasonal, so this isn't new to me". Therapeutic measures were taken as a result of back pain (back pain). The outcome of the events did not feel good, eyes were blurry/ she felt pressure in them and bad head cold was unknown while other events were recovered on 31Jan2021.

Second dose adverse events: Extremely horrid headache, chills and low grade fever, fatigue, sore arm. Slept almost all day and all night of the second day. Second dose-second day: Headache almost gone but very sore eyes, the arm was better, fatigue lingers, and noticeably breathless. Later but don't remember exact day; Rt jaw bone by the ear sore; hard to open my mouth to eat. This side had the Bells Palsy in 1996.

Thumping in ears; swelling in face; straight mouth unable to move; This is a spontaneous report from a contactable consumer (patient). An 80-year-old non-pregnant female patient received 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in the right arm on 29Jan2021 09:00 at a single dose for COVID-19 immunisation. The patient has no medical history. Concomitant medication included acetylsalicylic acid (ASPIRIN BAYER) and vitamin D [vitamin D nos]. The patient experienced thumping in ears while in observation room and had swelling in face with a straight mouth unable to move on 30Jan2021 23:30. Outcome of events was unknown. The adverse events resulted in emergency room/department or urgent care. No treatment was given for the events. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Events assessed as non-serious. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. Information on the lot/batch number has been requested.

Nausea, severe headache, pain in left leg, mouth has copper taste, cramping on the third day after vaccine. Never reached out for treatment.

choking experience; throat tickled; dizziness; bowel movements all afternoon which is a common allergic reaction; bowel movements all afternoon which is a common allergic reaction; Her heart started to pound/a rapid heartbeat; her ears started to ring (a pounding in her ears); had pressure in her jaw, chest, head, ears, and allover; high adrenal stimulance; excreted 1 cup of urine more than what she usually does; high pressure; dehydrated; couldn't sleep; This is a spontaneous report from a contactable consumer (patient). An 80-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: EN6202), via an unspecified route of administration, administered in Arm Right on 01Mar2021 13:30 (at 80 years old) as single dose for covid-19 immunisation. Medical history included irritable bowel syndrome, allergic to gluten, lecithin, and other barky parts of plants, high pressure, she did not hear very well, left breast surgery, skin cancer. She had a small skin cancer taken off each of her legs, one removed in Jan2020 and one removed in Feb2020. They are all healed up and they are fine, it was not the bad kind. There were no concomitant medications. The patient experienced choking experience in which her throat tickled, and dizziness, dehydrated, her heart started to pound (a rapid heartbeat), her ears started to ring (a pounding in her ears), she had pressure in her jaw, chest, head, ears, and allover, she had high pressure, excreted 1 cup of urine more than what she usually does, couldn't sleep due to high adrenal stimulance, bowel movements all afternoon which is a common allergic reaction all on 01Mar2021 with outcome of unknown. Clinical course was reported as follows. She mentioned that she was fine for 20-30 minutes to an hour after she got home. That afternoon, she noticed that her bowel movement was regular, constant, and repeating which was not normal and would typically indicate SIBO (Small intestine bowel overflow) in which the colon empties everything. She mentioned that this was indicative of her gluten allergy. She reported having had bowel movements all afternoon which is a common allergic reaction she has to plants like lectin and gluten especially due to the irritable bowel system-her whole bowel system will empty and she will have to replace 2 days worth of food. With this event starting 01Mar2021 her bowels just kept emptying and emptying. During dinner while she was eating and watching tv, her heart started to pound (a rapid heartbeat), her ears started to ring (a pounding in her ears), she had pressure in her jaw, chest, head, ears, and allover, she had high pressure, and a choking episode in which her throat tickled, and dizziness that she couldn't get up. She took hot water for the tickling sensation and took one aspirin for the other symptoms, but she still did not feel very well. She went to bed at 9pm but couldn't sleep due to high adrenal stimulance, she only slept like 2-3 hours long which she can get from Novocaine with her teeth. She got up 3 times and excreted a cup of urine per time. In the morning, she woke up and excreted 1 cup of urine more than what she usually does. She got herself weighed and had a weight of 109lbs versus the normal 122lbs which indicated that she was really dehydrated so she took her fluids and ate breakfast. Other than this, she mentioned that she got up today and felt fine and feels that in 2 days she will be fine. She felt pretty good and she was going to run but did not dare burn any more calories or fluids so she is sitting still and taking it easy. Regarding outcome of event she reported the pounding pressure like high blood pressure are better, fine# she had a normal breakfast# she can get around and do whatever she needs around the house except she needs now to spend the day recouping from the dehydration so she needs pay attention to what she eats and drinks. She mentions that she runs 3-4 miles a day and tries to be active for her age. She is asking if she can take the 2nd dose in 3 weeks. She is unsure if this is an allergic reaction or something psychological. The outcome of the event was reported as recovering.

Patient reported for 2nd dose in the Pfizer-BioNTech series. Upon review of patient's consent form, an allergy was noted for the first dose. The patient reported that she experienced swelling of her mouth, tongue, and lips that started at some point overnight the night of her first dose. It was discovered when she woke up the next day. Patient stated she did not receive treatment, and that the swelling went down after approximately 3 days. Due to the reaction we recommended she not complete her vaccine series at this time and consult with her physician.

blood pressure went from normal to 190; feeling her chest tight; couldn't breathe; black spot in her eyes; just a tightness in her throat; sugar is very high; This is a spontaneous report from a contactable nurse (patient). An 80-year-old female patient received bnt162b2 (BNT162B2, Solution for injection), via an unspecified route of administration on 02Mar2021 (Batch/Lot Number: EN9809; Expiration Date: 30Jun2021) as a single dose for COVID-19 immunization. Medical history included diabetic, asthma, allergy, sugar, and thyroid (disorder). The patient also stated that she has a lot of allergies. She was allergic to bees and allergic to bunch of things and many more things. She had her thyroid removed. Concomitant medications included levothyroxine (LEVOTHYROXINE, 100 ug) taken for thyroid (disorder), start and stop date were not reported; metformin (METFORMIN, 100 mg) taken for her sugar, start and stop date were not reported; hydrochlorothiazide (HYDROCHLOROTHIAZIDE, 12.5 pill), taken as diuretic, start and stop date were not reported. The patient reported that she had a very bad reaction from the vaccine, which was 20 minutes her blood pressure went from normal to 190 and she started feeling her chest tight and couldn't breathe (all on 02Mar2021). She also had a black spot in her eyes (02Mar2021). The patient reported that the events started the minute after she got the shot. She was sent to the hospital on 02Mar2021. When she was in the hospital, her blood pressure went up to 244, it is the highest. Her chest was going to have an asthma attack but she didn't develop an asthma attack it was just a tightness in her throat (02Mar2021). She was a day and half in the hospital, trying to get her blood pressure down which went down somehow that she still have over 200 blood pressure. When paraphrased the above concern she stated, "Yeah absolutely want to know what kind of result or what kind of the side effect you are going to have." The patient also stated at the time of report, "I still have my blood pressure is still 200 and my sugar is very high too (unspecified date in Mar2021), is that part of the after effect of the vaccine because I didn't have that before." The patient was hospitalized from 02Mar2021 to 04Mar2021. Therapeutic measures were taken as a result of blood pressure went from normal to 190 (hypertension) and couldn't breathe. The patient stated her doctor put her in the double medicine for the blood pressure. When probed for if patient was still experiencing issue, she stated "No, as soon as I came home I took Benadryl". The patient reported that her breathing improved as soon as she took Benadryl and her chest is probably clear now. As treatment, they gave her blood pressure pills. They gave her Pravastatin 20 mg. Outcome of the event blood pressure went from normal to 190 and sugar is very high was not recovered. Outcome of couldn't breathe was recovering. Outcome of the other events was unknown.; Sender's Comments: Based on the available information, the known safety profile and the temporal association of BNT162B2 administration to the events, a possible contribution of the drug to the 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 appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.

Systemic: Allergic: Difficulty Breathing-Medium, Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Medium, Systemic: Allergic: Swelling of Face / Eyes / Mouth / Tongue-Medium, Systemic: Chills-Medium, Systemic: Shakiness-Medium, Additional Details: Patient reported allergy to flu vaccine, asked for reaction and she did not report anaphylactic symptoms. Patient told that we will watch over her after receiving the vaccine. About 5 minutes later, swelling on back of the neck reported and gave Benadryl 25mg. Later reported difficulty swallowing and administered 1 dose of 0.3mg epinephrine. Daughter called 911, after arrival patient reported feeling better but still taken to ER. Daughter said she felt better at ER.

On Saturday, February 13, I began to experience severe headaches for a week, and then excruciating pain in my temples and under my chin when biting into a sandwich and chewing food. On February 23, I visited my Dr. and he said he could not give me anything for the pain because it would affect the antibodies. On March 2, I visited my internist, Dr. He did a SED test and found excessive inflammation. On Saturday, March 6, I woke up with lost vision. Was sent for an MRI at the Hospital. Entered the Hospital that night and was given 1 gram of IV solumedrol for 4 days. Biopsy was positive for GCA. I am on100 mg of Prednizone daily and have been referred to a neuroopthalmologist.

Headache, chest pressure (3/10), tongue tingling. BPs 139/75 (pulse 63), 129/64 (pulse 64). O2 sats 96%. Taken to the ED.

9:20 patient complains of burning of tongue radiating down throat, denies chest pain, tightness, tingling, or difficulty swallowing. 9:44 blood pressure elevated, patient was sent home with daughter. 10:02 patient was given Benadryl 25mg x 1 dose. Patient ate food and at 10:18 reports lip swelling and burning. 10:20 patient was given dexamethasone 4mg x 1 dose and Pepcid 20mg x 1 dose. 11:28 patient verbalized improvement of symptoms, patient was advised to continue with Benadryl 25mg every 8 hours x 1-2 days and to follow up with her primary care provider the next day.

high blood pressure , dizziness , blurred vision , nausea saw doctor , was in hospital 4/15-contacted the patient , patient has been feeing much better for some time , no issues now

very ill and had to be taken to hospital; terrible pains all over; dehydrated; headache; feeling like something was choking her in mouth; coughing real hard; it was breathing and it was like somebody has cranky paper in hand which screaming up that's what breath sounded like; joint pain; patient was like fainting; panicked; allergic reaction/face swollen up; and lymph node was swelling up; white lumps on lip; some white patches on face/couple of patches around mouth; white lips; Short of breath; sore around mouth; face swollen up; pneumonia; This is a spontaneous report from a contactable consumer (patient). An 80-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on 23Feb2021 (Batch/Lot Number: EN6200; Expiration Date: 06May2021) as single dose for covid-19 immunisation. Medical history included insomnia from an unknown date and unknown if ongoing. Patient weight was 155 now. Patient was overweight because this eating and eating. Feeling inactive, not going out so patient gained a lot of weight. Patient took blood pressure medication and for heart some basically and patient didn't sleep well, so patient took Alprazolam to relax to sleep, but patient was an insomniac but that was basically problem. The patient's concomitant medication included isosorbide. Patient had the first Pfizer shot and wasn't even sore or anything, patient was so happy but that about 4 or 5 hours later about maybe 5 o'Clock, patient had allergic reaction and started to feel a sensation in lip and when she looked in the mirror, what was all that on lip and one side on lip it had turned white and it had lump was extended along lip line, lymph node was swelling up and patient had white lumps on lip which still had but it was going down and some white patches on face. Nothing happened on the 24Feb2021. Patient thought it was the 25Feb2021 that was when all trouble started. Patient felt like nightmare because she started feeling like something was choking her in mouth and next minute patient started coughing, coughing real hard and that was terrible cough then after this strange voice and patient realized it was breathing and it was like somebody has cranky paper in hand which screaming up that's what breath sounded like. Patient start to get out of bed and then waken to kitchen, patient had terrible headache, joint pain, pain all over from head to foot and patient was certainly dehydrated. She had no water in at all, she was like don't know something come over and felt like she was sort of leaving the world, patient was like fainting, and panicked. Patient had terrible pains all over and felt like patient was dying, patient was going to die. Patient said she need an ambulance, patient was very ill and had to be taken to hospital. They came within a few minutes, they started questioning about what was happening and they put patient to the emergency room and well they test patient for Covid as well naturally. It was negative, they did it 2 times and it was negative. When they took patient to one of the room in fact patient was frightened because they didn't told patient it was negative. Patient said she got the virus, they said not but patient had to take the oxygen as it's surge to scan on lungs. They said patient had allergic reaction to the vaccine. Patient was supposed to have it but at the same time there was the variant, doctor said patient was 70% covered, didn't have it but patient want to just check the status was with a person like her was allergic. Patient had shots in face and patient did tell them that she had all sorts of things on face. Now patient still had the white lips and couple of patches around mouth and naturally patient was worried like what to do. The patient didn't take the second shot because she was too nervous. Patient went hospitalization on the 25Feb2021 very early, and was relieved on 27Feb2021 (not sure). Reason of Hospitalization: On the University hospital. They put down to the Pfizer injection but that was older happens to patient, they infused patient with antibiotic they gave pills. Patient said she won't be able breath with them and that was what they did, they 'reflect' her, they said patient had pneumonia which she did not have (Further clarification was unknown). Early the next morning they put patient down 2' o'clock in the morning. Patient wanted to go home, they said patient can't as she had very bad infection in lungs which was completely untrue. The next morning (the same morning early), patient was okay because the pains and everything was gone but she believe the medication they put patient on that caused to short of breath and patient said please don't give her the medication and they did. They only give generic medicine in the hospital and patient took brand name. On 26Feb2021 patient actually called the doctor for all results and she told nothing, patient didn't get the result. Anyway they took patient off one medication, they didn't give it to her and this medication you can not get off of it and through that patient had a headache the whole of the day and the whole day on the 26Feb2021 patient was suffering with very bad headache and kept asking for the medication they said they would give to the patient. Finally the doctor gave only to the aspirin and paracetamol (TYLENOL) that both the same and in the end patient husband have to go and get the pill because they still hadn't given it to patient all day long. Patient said to doctor because she was breathing hard and she said the doctor did this to her by giving these pills that don't agree with her. She told she can not take this medication, anyway the doctor said to patient husband go home and get her medication, and he said so now you are medicating yourself. By the next day patient was ready, she was breathing normally and was ready to go home but late afternoon they said patient should go home but she still had those white patches but they were not as prominent as what they were. Patient whole lip turn white, whatever they did, whatever they gave, patient had sore around mouth and face swollen up. Patient didn't know whether she was allergic to the medicine or what but her face, it looked like she had, patient was fine anyway couldn't get an appointment with GP to the Wednesday (unspecified week) but it free appointment on the Tuesday and patient went in and showed him what it looked like. He said it should return to normal within 2 weeks and it but still face like normally excepted lips. Outcome of events pain, short of breath was recovered in 2021, and outcome of other events was unknown. Date of second shot was 17Mar2021, it was reported patient had got the both shot of covid vaccine.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021404239 similar report from same reporter

First shot reactions: I woke up I was in so much pain over my whole body. I was sobbing. I was told I could take ibuprofen, so I did , it helped relieve some of the body aches. But the headache on the left side continued for 4 days. I stayed in bed for 4 days. The second shot, I got a horrible headache within the fifteen minutes, I told the staff I had a horrible headache but they said to go home anyway. This was March 10th. I went home and was in bed for 2 days. Since then I have a sick headache on left side, and blurred vision, the fatigue is terrible and I am dizzy, I don?t feel like I have my balance. I?ve been to 4 specialists since then with numerous tests, but no one has an answer.

I had an allergic reaction to the Pfizer Covid vaccine; I fell; Passed Out Without Warning and Hit her Face on the Tile Floor; Busted Mouth; Stitches in Mouth; Right Knee Very Sore /Left Shoulder Very Sore and Can't Use It; Black Left Eye; states it was black, blue, purple, green and yellow; Tiredness; Left Hand Pinky Sore; This is a spontaneous report from a contactable consumer (patient). An 80-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), second dose via an unspecified route of administration, administered in Arm Right on 11Mar2021 14:00 at age of 80-year-old (Batch/lot Number: EN6205) at single dose for COVID-19 immunization. The vaccine was not administered at Military Facility. Medical history included she has hearing aides but it is hard to hear or understand sometimes. There were no concomitant medications. Prior Vaccinations (within 4 weeks) was the first dose of Pfizer COVID Vaccine (Batch/lot number: EL9267) on 18Feb2021 at age of 80-year-old administered in right arm and no adverse events following prior vaccinations. The patient reported she had an allergic reaction to the Pfizer COVID vaccine, she fell on 11Mar2021, not fainted. On 11Mar2021, the patient passed out without warning and hit her face on the tile floor, experienced busted mouth/stitches in mouth, right knee and left shoulder were very sore, black left eye/it was black, blue, purple, green and yellow, tiredness, left hand pinky sore. The patient was calling about the Pfizer COVID Second Shot; verified Pfizer COVID Vaccine. Her second shot was on 11Mar2021 and on the same day she passed out without any warning whatsoever, and she hit the tile floor and ended up in the hospital for five days. She passed out and didn't remember falling or feeling anything before falling. The patient also has a primary physician, but she had been seeing the plastic surgeon for this. The patient asked what does she do if she needs to get a booster. It scared her to death if she would have to take another shot. The patient asked (name) to hand her a pair of glasses to read the plastic surgeons name. She stated the printing is so small on there. She was supposed to see the doctor on 19Apr2021, but she didn't feel good enough to go see the doctor. For busted Mouth, they put in 3 layers of stitches. The stiches have been giving her a fit because sometimes they come undone and hang down. She had to go back into him and get them cut out twice, and she had another one from last night (18Apr2021). It is very sore. States the stiches inside the lip have not resolved and it was still hard. One part of her lip is soft and one part is hard. It was all hard in the beginning. The stitches on the inside are supposed to dissolve. For right Knee it was very sore and she can't hardly use it. For left shoulder it is very sore and she can't hardly use it. It made it awkward to get in and out of bed when she can't use her left arm or her right knee. Her left shoulder was really bothering her and she may have to go have some more work done. It has been popping and went in and out of the joint. That would be back with her primary doctor. Sore pinky on left hand had recovered it didn't stay that long. Black left eye, it was black and blue purple green and yellow. It cleared up in the last couple of days. She was lucky she didn't break the bone around her eye. Treatment included stitches, hospitalization, given antibiotics and blood clotting shots so she didn't get blood clots, she had 3 of those in her belly. She wasn't allowed to get out of the bed when she was in the hospital. She had a terrible experience in the hospital. For the event onset time, it was at 20:00, they drove home from (place name), which is an hour and something, and they stopped at (place name), came home and set outside and she said she had to go lay down because she was tired. She woke up an hour and half to 2 hours later, got out of bed, sat on side, stood up and got herself together and walked to bottom of bed and went out flat. The events required a visit to emergency room and physician office. For emergency room visit, it was reported on 11Mar2021 at (hospital name); the patient should've called redacted number but didn't, they drove in. The patient was hospitalized from 11Mar2021 to 16Mar2021 at (hospital name). The outcome of passed out, tiredness were resolved on 11Mar2021, outcome of 'black left eye/it was black, blue, purple, green and yellow' was resolved on 17Apr2021, outcome of left hand pinky sore was resolved in 2021, the outcome of fell, allergic reaction to the Pfizer COVID vaccine were unknow, outcome of busted mouth, right knee/left shoulder very sore were not resolved.

I got my first shot on 1/5/2021. I had no adverse effects from the first shot. Three weeks later I got my second shot on 1/26/2021. Three days after that, on 1/29/2021, I became quite ill. I had sudden onset of total body weakness, I was unable to sleep for 4 days, I developed a constant frontal headache, I felt like my body was electrified, my eyes started twitching and feeling like my eyelids were being pulled, my face felt like it was being pulled on one side, my nose became runny and hasn't stopped. To this day I have no energy and am not like my old self before the shot. I have gone downhill incredibly fast. My doctors don't know what to do with me and I don't think things are going to get better. My day to day life is a struggle. I have no energy to do things. One of the only things I have not had is a fever. My eye doctor told me he thinks I had a GROSS IMMUNE SYSTEM REACTION to the vaccine. 0 I would appreciate it if there is anything you can do to help me. Thank you,

The morning after Mom's first dose of the Pfizer shot, Dad woke up and found Mom lying on the floor next to the bed. Mom said, "I can't move my arm." Dad called paramedics who checked her. They said her vital signs were normal and left. On 2/9/21 in the morning my da awoke to see that Mom had large amounts of bubbly saliva pouring from her mouth onto her pillow. Dad called paramedics, who said this was a diabetic reaction. Mom had NEVER had anything happen like this before. Mom was very sleepy, could not be aroused, and made only gurgling noises. She was admitted to the hospital for care and therapy. She pulled her own IV out. Mom had to be restrained in the hospital and sedated, due to confusion and worsening dementia. By 2/18 when we spoke by phone mom's speech was abnormally slow and very repetitive. "I'm very tired today" was spoken many times. In morning time mom was able to follow basic conversation. Not so later in the day. Mom came home from rehab on 2/26/21. She was able to walk steadily and independently at home after her therapy. After a week or so, Mom began hitting the in-home caregiver. Dad's presence would calm her. In a short time Mom seemed not to know dad anymore, and would hit him and the caregiver when they helped her. She also pulled all covers off the bed and pulled clothes out of the closet, throwing them all over the room during the night. Mom was usually walking around the house during each night. On 4/16/21 Mom and dad were napping sitting up on the couch in the morning. Mom fell forward and hit her head on the hearth. Dad and caregiver gave first aid and called paramedics, who took her to the ER. Mom came home on 4/17/21. On 4/18/21 Mom pulled her catheter out in the early morning. In the afternoon Mom's appearance was concerning, so Dad called paramedics. They said that Mom's BP had dropped very low and took her to the ER. Mom was combative the next day in the hospital. Dr. adjusted her medications periodically to ensure that mom's care would be manageable when she would eventually be sent home. Minimal therapy was done due to dementia. By 5/3/21 doctor said that Mom is bed bound and needing total care. Her blood sugar spiked high despite special diet. Staff waiting for insulin order from doctor. 5/4/21 Doctor called Dad to say that Mom had died during the night.

she had just a slight smell but it was so horrible; This is a spontaneous report from a contactable nurse (patient). A 80-year-old female patient received bnt162b2, via an unspecified route of administration, administered in Right Deltoid on 22Jan2021 (Lot Number: EK9231) as 1st dose, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. She had the first one 22Jan2021 and after that (22Jan2021) she had just a slight smell but it was so horrible. She thought that it was the blanket on the bed and she had passed it off a little bit. When she had her first shot she had mild side effects and then the next morning she could eat a little bit. After her first COVID vaccine she only had the horrible smell. That episode was short and by the next morning she didn't have the smell anymore. The event was reported as medically significant. The outcome of the event was recovered on 23Jan2021. The reporter considered the causality was related.; Sender's Comments: As there is limited information in the case provided, the causal association between the event parosmia and the suspect drug BNT162B2 cannot be excluded. The case will be reassessed once new information is available. The impact of this report on the benefit/risk profile of the Pfizer 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.

minor hallucinations; metallic taste; horrible smell that she experiences in which it makes her not want to eat or drink; chills; joint pain; tissue tender; This is a spontaneous report from a contactable nurse (patient). An 80-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: EN9581), via an unspecified route of administration, administered in deltoid right on 12Feb2021 (at the age of 80-years-old) as unknown, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient previously received the first dose of BNT162B2 on 22Jan2021 for COVID-19 immunisation. The reporter stated that since then (having both doses of the vaccine), she has been to the emergency room 4 different times experiencing side effects. She has a metallic taste and horrible smell that she experienced in which it made her not want to eat or drink. She has minor hallucinations, chills, joint pain, and her tissue is tender. Her joint pain has improved. Then stated, "I'm afraid I'm going to die from it." She asked if anyone has reported these reactions previously and what should she do about them. Her family physician's nurse looked up a study in which 11% of the patients were experiencing a metallic taste. Also stated, "This is very discouraging and depressing." The outcome of the event joint pain was recovering while of the rest was unknown.; Sender's Comments: A possible contribution role of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) to the onset of minor hallucinations cannot be excluded due to temporal relationship. 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.

First dose March 24, second dose April 14. About a week later developed facial swelling. Was seen by her primary MD and given antibiotics for presumed facial cellulitis (clindamycin and cephalexin). The facial swelling improved but then her right eye became red with worsened vision (3 days prior to presenting to ophthalmology). Exam found new onset of inflammation of the conjunctiva and all internal structures (panophthalmitis). She is a long-time patient at the eye clinic since 1993 and has never had inflammation in either eye prior to this episode. There is no other explanation for the sudden presentation of an acute inflammatory condition.

Complete unilateral hearing loss right ear; This is a spontaneous report from a contactable nurse. An 80-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), in Feb2021 (Lot not reported) as 1 st dose, single then on 18Mar2021 (Lot not reported) as 2 nd dose, single; both intramuscular (at the age of 80-years-old) for covid-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, patient was not diagnosed with COVID-19 and since vaccination, patient was not tested for COVID-19. Medical history included neoplasm malignant. The patient's concomitant medications were not reported. The reported adverse event was complete unilateral hearing loss right ear on 27Mar2021. The event resulted in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. Treatment received were PET-scan (in 2021), MRI (in 2021), hearing test (in 2021), antibiotics and prednisone. The outcome of the event was recovered with sequel in 2021. Information on the lot/batch number has been requested.; Sender's Comments: Based on the information currently available a causal relationship between event unilateral hearing loss right ear and BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) cannot be completely excluded. The case will be reevaluated should additional information become available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.

Burning of mouth, lips, difficulty breathing. Lips swelled, cracked and peeled. Inside of mouth no longer burning , Swelling in lips has gone down, they have been peeling for days. Lips are red, still sore, but I'm hoping they are done peeling. I really don't feel I can handle another shot of this vaccine. I think I may have to cancel the second shot. I don't know what is it it, everyone keeps telling me it has no penicillin or sulfa drugs in it, but the symptoms are the same. The only difference is my hands haven't cracked and peeled along with my lips and mouth. I've had these problems since last tuesday night and am taking Benadryl trying to get some relief from it still. Please let me know if you have any solutions to prevent this.

chills/terrible chills; throat raspy was with a dry mouth; throat raspy was with a dry mouth; headache; "red puffed up" fingers/her finger tips got red and she had swollen red hands; "red puffed up" fingers; muscles hurting; allergic reaction to the vaccine; This is a spontaneous report from a contactable consumer via a medical information team. An 80-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; Batch/Lot Number: EL1283; Expiration Date: 30Apr2021), via an unspecified route of administration, administered in Arm Left on 22Jan2021 10:00 as SINGLE DOSE for COVID-19 immunization. Medical history included breast cancer survive (diagnosed in 2008), Allergies: latex, Allergies: sulfa. There were no concomitant medications. The patient previously took ciprofloxacin [CIPRO] and experienced Allergies, influenza vaccine (FLU VACCINE VII) (flu shot) for immunization and experienced no adverse event. The patient experienced headache on 22Jan2021 10:10, "red puffed up" fingers/her finger tips got red and she had swollen red hands on 22Jan2021 10:10, "red puffed up" fingers on 22Jan2021 10:10, chills/terrible chills on 22Jan2021 11:00, throat raspy was with a dry mouth on 22Jan2021 10:20, muscles hurting on 22Jan2021. It was reported on the COVID vaccine that the patient got the first shot on 22Jan2021 and was sent an email that her second dose was scheduled for 05Feb2021, was that ok. It was also noted when she got the first vaccine they held her up at the location because she has allergies. After getting the shot, her finger tips got red, her throat got raspy, and she got a headache. When she got home she had terrible chills and her muscles hurt. It was clarified that her finger tips got red and she had swollen red hands- this started 10 minutes after the injection was given and continued on and off for about a week. Throat raspy was with a dry mouth- this started 20 minutes after getting the shot and lasted about a week and a half. Headache - this started 10 minutes after getting the shot and lasted 3-4 days. Terrible chills- this started about an hour after getting the shot and lasted about 5 hours. Muscles hurting- this started that day and lasted 2 days. She reports she went to the emergency room 2 days later on 24Jan2021 and was given an antihistamine and told to take 2 Benadryl before the second shot. Since she was told she had an allergic reaction to the vaccine she was nervous about getting the second shot, what should she do. The outcome of the events headache, "red puffed up" fingers/her finger tips got red and she had swollen red hands, "red puffed up" fingers, throat raspy was with a dry mouth and allergic reaction to the vaccine was recovered on an unspecified date in 2021 and the events chills/terrible chills was recovered on 22Jan2021 16:00, muscles hurting was recovered on 24Jan2021. Follow-up attempts are completed. No further information is expected.

Swelling and peeling of lips, peeling and soreness inside mouth, Diarrhea, upset stomach ache, dizziness

Headache; Sever pain behind left ear; Stiff neck/ Neck stiff and behind left ear it hurt; just in the back of the neck; started bother me; cold made it worse; This is a spontaneous report from a contactable consumer (Patient, self-reported). A 80-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: EN6198), dose 1 via an unspecified route of administration on 26Feb2021 (80-years-old at the time of vacciantion) as 1ST DOSE, SINGLE for covid-19 immunisation; paracetamol (TYLENOL), via an unspecified route of administration from an unspecified date (Batch/Lot Number: SLA071) to an unspecified date, as 500mg for an unspecified indication. Medical history included High Blood Pressure and glaucoma. Concomitant medications included clopidogrel bisulfate 75mg (patient stated, that is the blood thinner. It's generic is clopidogrel bisulfate, that's the blood thinner); perindopril erbumine 8mg (This is the generic of Aceon); amlodipine besylate 5mg (Patient take its Generic of Norvasc); timolol maleate 5mg (take eye drops for glaucoma. Patient take twice a day from 50 years). Reportedly, patient had vaccine shot Friday, I am taking Tylenol. Sever pain behind left ear. Can I take ibuprofen. Stiff neck going on five days. I've been using heat. I don't have the chills, nausea, joint pain. her husband was 82. Not on walker/canes. Tylenol doesn't affect, it doesn't do anything for me but they tell not to take Ibuprofen because of the virus. Reason for no lot number of Tylenol: patient stated, I don't have that on here. On 26Feb2021, the patient experienced sever pain behind left ear, stiff neck/ neck stiff and behind left ear it hurt; just in the back of the neck; started bother me; cold made it worse, on an unspecified date headache. Therapeutic measures were taken as a result of sever pain behind left ear, stiff neck/ neck stiff and behind left ear it hurt; just in the back of the neck; started bother me; cold made it worse, headache. Outcome of the events was not recovered. Additional Context: Patient stated, I just talk to you and we got hung up. When probed for the concern, consumer stated, I would like to know if I am taking a reaction to the vaccine shot. I got it on Friday the 26th. I had a, my neck start getting stiff on Wednesday and Thursday, Friday it wasn't, it went away but now I got the only thing side effect really I got is just stiff neck, now while when I came home (incomplete sentence), stiff neck, my neck is stiff and behind the left ear it hurt but headache and all that, I don't get a headache. It is just in the back of the neck. I don't have a fever, I don't get nauseous. I don't get any of the symptoms only that I have stiff neck. Consumer stated, I want to know really. What could I do about it? I put cold on it (treatment) and it made it worse. The "phone" (not clarified) says put heat on it that what's I have been doing and Tylenol doesn't affect, it doesn't do anything for me but they tell you not to take Ibuprofen (Ibuprofen captured conservatively) because of the virus you know. When probed for Email address, consumer stated, I don't have one. Consumer stated, I took it (first dose) on 26 and I am supposed to take on the 19th (second dose). When probed for vaccine expiration date, consumer stated, It doesn't show the expiration date. When probed for Tylenol LOT# and expiration date, consumer stated, I don't have that on here. It has my birth date and it has the day I took it was 26Feb2021 and I just gave you the other number that was on here. The other number is I was supposed to take it on 19Mar21. That's the only number I got. When probed for start date of the problem, consumer stated, The night at 26th (Feb2021) is when it really started bother me. I was fine all day long until late that night. When probed still having the problems, consumer stated, Yes. When probed to confirm treatment, consumer stated, Tylenol, cold and heat. Cold made it worse so I put heat on it. Description of complaint: Tylenol doesn't do anything for her. Patient wants to know what to do and how long will it last. patient had a stiff neck. She had it a few days prior to getting the vaccine. It went away. On Friday night after getting the vaccine she had a tremendous pain in her neck that went down in the shoulder. They want her to take Tylenol. She has been drinking extra water. Tylenol doesn't do anything for her, only Ibuprofen. She tried using a cold water bottle. No follow-up attempts are possible. No further information is expected. Follow-up (02Mar2021): This is a follow-up spontaneous report from a contactable consumer reported that: patient details (weight, height), medical history, suspect product details (start date, lot number), concomitant drugs, events.

Patient only had faint faint bruising at her eye.; Patient's right eye became swollen; Looked like she had a black eye; She looked in the mirror and saw that her eye was a mess; This is a spontaneous report from a contactable nurse. This nurse reported for a 80-year-old female patient that an 80-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection. Batch/Lot number, NDC number, expiry date; unknown), Reason for no lot number: of Pfizer covid vaccine: Other: Reporter does not have patient's patient record card. Is Pfizer covid vaccine a Pfizer product; Unspecified, Pfizer covid vaccine manufacturer; Unspecified, dose 2 via an intramuscular route of administration on 20Apr2021 (at the age of 80-years-old) as 2nd single dose for COVID-19 immunization (because of patient's family). Vaccination facility type was clinic. Patient's medical and concomitant medication (Prior Vaccinations (within 4 weeks): None) history were not reported. Family history was reported as none. Laboratory tests included CBC, INR, PT, WBC and unspecified labs done on an unspecified date with results as normal. Historical vaccine included first dose of BNT162B2, lot number, expiry date; unknown), time of vaccination, anatomical location of the vaccine administered; not provided on an unspecified date for covid-19 immunization. Reporter stated that when patient got her first dose of the Pfizer Covid 19 vaccine within 24 hr while brushing her teeth she started spitting out blood from end of Mar2021 to an unspecified date (not serious). Consulted her dentist and as per consumer "no abscess, so no cause or no reason for the bleeding. The bleeding also stopped." After her second dose, her right eye were swollen that made it look like a black eye. Asked consumer if patient has bleeding disorder to taking anticoagulant. She said no. Asking if we have any other reports just like this. Response: Told the consumer we don't have reports just like these and will be escalating her request. She wants to be contacted via email. Reporter is a Nurse Practitioner. Reporter is calling about the Pfizer covid vaccine. Reporter is calling on behalf of a patient who she seen today. Patient had an adverse reaction to the vaccine. Patient did not realize that she had a reaction to the covid vaccine. After the first dose of the covid vaccine, patient went home and within 24 hours, she was brushing her teeth and was spitting out a lot of blood. Patient went to the dentist and got a dental exam, the dentist said everything looked normal. The bleeding stopped, and the patient was fine. The patient waited three to four weeks between the first dose of the covid vaccine, and the second dose of the covid vaccine. After the second dose of the covid vaccine, patient's right eye became swollen, and looked like she had a black eye. This kind of happened so soon after patient received the second dose of the covid vaccine. Patient went to the emergency room, a eye doctor, and a hematologist. Everything ruled out negative. Everyone is thinking that this was a reaction to the covid vaccine. Reporter is wondering if anyone else has been having these symptoms. Reporter gave consent to contact patient directly if Pfizer has any follow up questions. Reporters first visit with patient was over the phone on 07May2021. Reporter saw patient today in person. Reporter thinks that patient received the first dose of the covid vaccine four weeks prior to the second dose of the covid vaccine. Confirmed this began after the first dose of the covid vaccine and reporter does know exact dates. Patient received the second dose of the covid vaccine on 20Apr2021. Patient woke up at 4:00 AM to go to the bathroom. Whenever patient went to the bathroom, she looked in the mirror and saw that her eye was a mess. Patient had no headache, or anything. After the second dose of the covid vaccine, patient had to go to the emergency room. Patient went to the emergency room on 21Apr2021. Patient showed reporter a picture of her eye. Reporter stated that it was quite swollen and black, and looked like patient got punched in the eye. Today, at patient office visit, patient only had faint faint bruising at her eye. Seriousness criteria: Not provided. Indication: Because of patient's family. Patient's adult children wanted her to get it so they could come and visit her. Causality: Reporter ruled out a lot of stuff. Patient went to see an oncologist. Reporter is still waiting to get access to those files. Reporter is going to call oncologist's office today. Reporter knows that they checked patient's PT and INR, and both were normal. Patient's WBC was normal. Patient's CBC was normal. The oncologist hematologist also ordered some labs, and they were all normal. Verbatim event relatedness to pfizer-biontech covid-19 vaccine was reported as related. The outcome of events eye swelling and eye contusion was recovering and for others was unknown. Information on the lot/batch number has been requested.

Reduced consciousness; Pain and swelling in the arm where she received the shot; Pain and swelling in the arm where she received the shot; Slight fever; Chills; Heart rhythms; Tiredness; Sudden severe headache; Imbalance; Trouble walking; Dizziness; Vertigo; Slight vision changes; Confusion; Numbness or weakness of one side of her leg; Numbness or weakness of one side of her leg; This is a spontaneous report from a contactable consumer (patient). A non-pregnant 80-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: ELO9269), via an unspecified route of administration in right arm, on 10Feb2021 at 14:15 (at the age of 80 years), as first dose, single dose, for COVID-19 immunization. The patient's medical history included stroke (few years ago), multiple hip transplants, and rheumatoid arthritis (for 35 years). The patient's concomitant medications included apixaban (ELIQUIS) and metoprolol tartrate. The patient had no known allergies. The patient was not diagnosed with COVID-19 prior vaccination. No other vaccine was administered in four weeks. The vaccine was administered in a clinic. On 11Feb2021 at 16:45 PM, normal side effects felt are pain and swelling in the arm where she received the shot. In addition, the patient may have a slight fever, chills, heart rhythms, tiredness, headache, and imbalance (trouble walking) on 11Feb2021 at 16:45 PM. On the patient's first two days (starting on 11Feb2021 at 16:45 PM), the patient experienced dizziness or vertigo, slight vision changes, sudden severe headache, confusion or reduced consciousness, and numbness or weakness of one side of her leg. It was unknown if treatment was given for the adverse events. The patient had not been tested for COVID-19 post vaccination. The patient recovered from "Sudden severe headache", "Dizziness", "Vertigo", "Slight vision changes", "Confusion", "Reduced consciousness", and "Numbness or weakness of one side of her leg" in Feb2021; and from the other events in 2021. No follow up attempts are possible. No further information is expected.

May 14th, 2021- I got up in the morning and had double vision, during he day it got worse, until I had severe double vision, went to doctor, diagnosed with 6th nerve palsy, which is a nerve issue in the left eye, there has been NO improvement in this new symptom. I had previously reported 7th nerve palsy, but that has improved.

Chills, low fever, nausea, sneezing, runny nose, diarrhea, aching, weakness, unclear thinking, metallic smell and taste- severe at times, slurred speech

Felt weak; Dry throat; States she has noticed she has been burping a lot and coughing harder.; States she has noticed she has been burping a lot and coughing harder.; She has a dry cough and when she coughs hard she gags until almost vomiting/ she has had some coughing where she coughs until she feels like she has to throw up; she has been having shortness of breath that started when she got the first dose of the Pfizer COVID vaccine on 27Jan2021; Chills; she just felt tired was all; pain at the injection site in her right arm so she took Tylenol that morning; This is a spontaneous report from a contactable nurse (patient). A 80-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: EL9265) dose 1 via intramuscular route of administration in Arm Right on 27Jan2021 at 13:30(at the age of 80 years old) as single for COVID-19 immunisation. Medical history was none. There were no concomitant medications. Patient had no other vaccines on the same day as the COVID vaccine. The patient experienced as, she has been having shortness of breath that started when she got the first dose of the pfizer covid vaccine, chills, she just felt tired was all, pain at the injection site in her right arm so she took tylenol that morning on 27Jan2021, felt weak on 07Feb2021, she has noticed she has been burping a lot and coughing harder, she has a dry cough and when she coughs hard she gags until almost vomiting/ she has had some coughing where she coughs until she feels like she has to throw up, and dry throat on an unspecified date on Feb2021. Therapeutic measures were taken as a result of she just felt tired was all and pain at the injection site in her right arm so she took tylenol that morning. The patient underwent lab tests and procedures which included weight: 145-147 on an unspecified date. Therapeutic measures were taken as a result of she just felt tired was all and pain at the injection site in her right arm so she took tylenol that morning. Outcome of the event shortness of breath and chills were recovered and unknown for rest events. Information about batch/lot number has been requested. Follow-up attempts are completed. No further information is expected.

on her right arm she experienced Bursitis or swelling on her elbow/Olecranon bursitis/Popeye's Bursitis; on her right arm she experienced Bursitis or swelling on her elbow.; hard of hearing; This is a spontaneous report from a contactable consumer (patient). A 80-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/Lot Number: EL9264; Expiration Date: 30May2021) via an unspecified route of administration, in right arm on 08Feb2021 (at the age of 80-year-old) as a single dose for covid-19 immunisation. The patient had no medical history and concomitant medications. Patient did not receive any other vaccines on the day of vaccination. On 08Feb2021, the patient got her first dose at her right arm and she experienced popeye's bursitis or olecranon bursitis/ Bursitis or swelling on her elbow. Patient stated that she was also hard of hearing on an unspecified date in 2021. Patient confirmed that the bursitis was located in her right arm. Patient was wondering if there was a connection, if the vaccine could have caused it as she had never had anything like that before. The outcome of the events was unknown. Follow-up attempts completed. No further information expected.

Two weeks after Dose #2, I had 3 days of hives, my tinnitus reappeared after being gone several years, I got plantar fasciitis in my left foot (which after two months, I found online the cure is turmeric...took two a day for a week, and the plantar fasciitis was gone), got full-body sweats (unpredictable...they just come w/out warning). I have vax brain fog also.

Finger tip swollen, red; Raspy throat; The initial case was missing the following minimum criteria: as there is no indication that the consumer experienced an event under BNT162B2. Upon receipt of follow-up information on (11Jun2021), this case now contains all required information to be considered valid. This is a spontaneous report from a contactable consumer (patient) reported similar events for three patients. This is the first of three reports. A 80-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for Injection, Batch/Lot number was not reported), via intramuscular route of administration, administered in arm on 12Feb2021 12:30 (at the age of 80-year-old) at a 2nd dose, single dose for COVID-19 immunization. The patient medical history included she has allergies, allergies to latex, sulfa; patient is a breast cancer survive, diagnosed on an unspecified date in 2008 (survivor 13 years), mastectomy from on an unspecified date in 2008. The patient concomitant medication included diphenhydramine hydrochloride (BENADRYL) via oral route from 22Jan2021 to 23Jan2021 and 02Feb2021 to 03Feb2021. The patient previously took first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for Injection, Batch/Lot number: EL1283, Expiration date: 30Apr2021), via intramuscular of administration, administered in arm left on 22Jan2021 10:00 AM (at the age of 80-year-old) at a 1st dose, single dose for COVID-19 immunization and experienced headache, her finger tips got red and she had swollen red hands, red puffed up, chills/terrible chills, throat raspy was with a dry mouth, muscles hurting. Duration of reaction was 21 days. Events were recovered on an unspecified date in 2021. Patient previously took flu shot prior vaccinations (within 4 weeks), Cipro and experienced allergies to cipro. The patient experienced finger tip swollen, red; 5 minutes after it raspy throat on 12Feb2021 10:00. Patient said she, her husband and her sister received the 1st dose of the Pfizer-BioNTech Covid-19 Vaccine last 22Jan2021 and was scheduled to receive the 2nd dose 2 weeks after the 1st dose. Patient got the first shot on 22Jan2021 and was sent an email that her second dose is scheduled for 05Feb2021. Patient had an allergic reaction to the vaccine she is nervous about getting the second shot. Outcome of the events was unknown. Follow-up attempts completed. No further information needed.; Sender's Comments: Linked Report(s) :PFIZER INC-2021128085 same reporter/vaccine and different patients.;PFIZER INC-2021128086 same reporter/vaccine and different patients.;PFIZER INC-2021128086 same reporter/drug/AE and different patient

Systemic: dysgeusia-Severe, Systemic: Nausea-Severe, Systemic: Vomiting-Severe, Additional Details: dysgeusia at onset followed by vomiting 3 days pater precipitating a trip to er and subsequent rx for ondansetron

Saw throat; I had no voice for 12 days.; Voice came back hoarse; This is a spontaneous report received from a contactable consumer, the patient. An 80-year-old non-pregnant female patient received an unspecified dose number of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN), via an unspecified route of administration in the left arm on 04Feb2021 at 15:30 (at the age of 80-years-old), as a single dose for COVID-19 immunisation. Medical history included COPD (chronic obstructive pulmonary disease), heart disorder. The patient had a history of known allergies. The patient had received unspecified concomitant medications within two weeks of vaccination. The patient did not receive any other vaccines within four weeks, prior to the COVID-19 vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 04Feb2021, the patient experienced saw throat. It was reported that the patient had a saw throat for 4 days then she had no voice for 12 days. The patient's voice came back hoarse and was still that way. The event resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measure taken included speech therapy. The clinical outcome of the event saw throat and hoarse voice was not resolved while that of loss of voice was resolved on an unknown date. No follow-up attempts are possible; information about lot number cannot be obtained.

developing itchiness, a little redness at the left breast a little below the waistline, itching in the scalp and the right eye; developing itchiness, a little redness at the left breast a little below the waistline, itching in the scalp and the right eye; itching in the scalp and the right eye; This is a spontaneous report from a contactable consumer (patient). An 80-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: EL3302 and Expiration date: unknown), via an unknown route of administration, administered in left arm close to shoulder on 01Feb2021 around 02:30 (at the age of 80-years-old) as dose 1, single for covid-19 immunisation. Medical history included allergy unspecified from an unknown date. There were no concomitant medications. The patient previously took clonidine 0.1 mg, hydralazine 10 mg, cipro (ciprofloxacin) and sulfa for blood pressure abnormal and had itching. Patient also took spironolactone tablets for blood pressure abnormal and had a little rash of bumps under the skin on her right arm. On 01Feb2021, she received covid vaccine probably about 02:30. When she got home, about 2.5 hours later at 05:00, she started itching somewhat, a little redness at the left breast a little below the waistline, itching in the scalp and the right eye. There was nothing she could see in those places. She went ahead and called the pharmacist. The pharmacist told her to take Benadryl, so she took one 25 mg liquigel. It took the itch away. She went to bed and decided it had subsided. She decided to go ahead and take one more through for the night. When she woke up in the morning, she didn't have a problem. She was wondering if she should be concerned for the second shot. She didn't have a prescribing doctor. She got the invite to get it. It was gone through the night. Therapeutic measures were taken as a result of developing itchiness, a little redness at the left breast a little below the waistline, itching in the scalp and the right eye. Outcome of events was recovered on 02Feb2021.

both forearms ache; chest felt heavy; lips swelled; eyelids drooped; hands were weaker than usual; whole right side was weak; she could not eat; could not digest food; Lost weight; she got continual heartburn and burped throughout the day after she ate; felt burning; Her stomach was knotted, she could feel her stomach closing up on her; Her stool was mush for the whole three months, it finally got to droplets that turned to mush.; it affected her digestive system and her release of the stools.; Her forehead was very much wrinkled; has a lot of food intolerances and it is not new that she is intolerant; This is a spontaneous report from a contactable consumer or other non hcp. An 80-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number: EN6205), via an unspecified route of administration, administered in Arm Left on 01Mar2021 (at the age of 80-years-old) as dose 2, single for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. She does not take pills. She takes vitamins but states that does not count. The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number: EL9262) via unspecified route of administration, administered in Arm left on 08Feb2021, in the morning around 9:30 or 10am (at the age of 80-years-old) as dose 1, single for covid-19 immunisation. It was reported that she thinks she should report the difficulty she had with the vaccine since it was not the usual adverse reactions and it was extended. She went to doctor several times. She was wanted to know how to deal with it. Clarifies she does not have a question since this was no longer part of her system. She woke up every morning between 05:30 and 07:00 am and was awoken by both forearms aching. Then it got to where the right forearm ache was worse than the left. Sometimes she felt burning. Her chest felt heavy. Her lips swelled. Her eyelids drooped; left eyelid drooped more than the right eyelid. Her whole right side was weak. When she wrote her right hand was weaker than usual. The worst reaction was that she could not eat, she could not digest food, her digestion was completely off. When she went to doctor, she weighed 92 pounds since she got continual heartburn and burped throughout the day after she ate, and this continued for hours. She had to make special food for herself since she could not digest/ eat most food. She ate fish, bread, and potato. She could not digest anything heavy. Her stomach was knotted, she could feel her stomach closing up on her. She was fearful of eating. Her stool was mush for the whole three months, it finally got to droplets that turned to mush. The main thing as she said, it affected her digestive system and her release of the stools. She lost 8 to 10 pounds. She kept a diary of her food and feelings for months. Her forehead was very much wrinkled, she has wrinkles anyways since she was old, but she had wrinkles in her wrinkles. She had a lot of food intolerances and it was not new that she was intolerant. Her body had many intolerances such chocolate, lactose, nuts, and some medications. She cannot eat anything with any chemicals such as msg and yellow food dye. She cannot eat deli meat since it contains some chemical. At first, she didn't realize it and did not know what was going on with her body, she noticed the side effects mentioned above more after the second dose which was given on 01Mar2021. It took three and half months and finally went it all went away, recovered completely. The patient was recovered from all the events on an unspecified date. No follow-up attempts required. No further information expected.

Lip swelling; Burning lips; Blood pressure elevated; Burning of tongue radiating down throat; This is a spontaneous report from a contactable other health care professional, the pharmacist. A 80-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6206) via intramuscular route of administration in the left arm on 15Mar2021 (at the age of 80-year-old) as a single dose for COVID-19 immunisation. Medical history included hypertension, hyperlipidemia and penicillin allergy. The patient previously received codeine (MANUFACTURER UNKNOWN), vicodin (MANUFACTURER UNKNOWN) on an unspecified date for an unknown indication and experienced drug allergy. It was unknownif the patient was diagnosed with COVID-19, prior to the vaccination. Since the vaccination, it was unknown if the patient had been tested for COVID-19. It was reported that the patient did not received any other vaccines within 4 weeks prior to the COVID vaccine. On 15Mar2021 at 09:20, the patient complained of burning of tongue radiating down throat, denies chest pain, tightness, tingling, or difficulty swallowing. On 15Mar2021 at 9:44, the patient blood pressure was elevated and the patient was sent home with daughter. On 15Mar2021 at 10:18, the patient experienced lip swelling and burning, it was reported that the patient ate food. It was reported that on 15Mar2021 at 11:28, the patient verbalized improvement of symptoms. Therapeutic measures were taken as a result of reported adverse events burning of tongue radiating down throat, blood pressure was elevated, lip swelling and burning included treatment with BENADRYL 25mg, once daily, dexamethasone (MANUFACTURER UNKNOWN) 4mg once daily, peptic (MANUFACTURER UNKNOWN) 20mg once daily. It was stated that the patient was advised to continue with BENADRYL 25mg every 8 hours once a day for2 days and to follow up with her primary care provider the next day. 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 burning of tongue radiating down throat, blood pressure was elevated, lip swelling and burning were recovering at the time of this report. No follow-up attempts are needed. No further information is expected.

This is a spontaneous report from a contactable consumer (patient). An 80-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 2 via an unspecified route of administration on 18Mar2021 (at the age of 80-years-old) (Batch/Lot number was not reported) as single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration on 25Feb2021 (at the age of 80-years-old) (Batch/Lot number was not reported) for COVID-19 immunisation and had pain in her arm. The patient reported that she had first shot on 25Feb2021 and followed the procedure 21 days later and received second shot on 18Mar2021 after the first shot. When probed for second shot vaccination timings, consumer stated, "her second shot was on "319" (Further not clarified). On 19Mar2021, she woke up and her teeth were killing her like she slept she was fine but in the morning she had terrible toothache and she was taking care of her teeth, she had Flu like symptoms her eyes puffed up, swelled and runny nose, she went to a Dermatologist Doctor and she gave her some medicine to take swelling down, she had severe leg cramps and could hardly barely walk. She was trying to find out if she could have blood clot, she could have everything, she went to funeral and she had to leave early, she left and fly back Home, it disturbed her, it could be from Pfizer shot. She was 80 years old and she was not be able to, she should be hardly be able to function. Consumer stated, she was in pain and on pain medication, she was in terrible pain because her legs and back hurting so much. Her eyes swelled up badly. When probed for any laboratory test, consumer stated, she had pain today, she walks 3 miles a day, today she probably walked a mile and it was painful. She went Dermatologist for her eyes. Consumer stated, she went to a Dermatologist to see why her face is swallowed up. She would like to be followed up, what she was to do with her pain, she was like crippled, she was in pain all the time, she would like to know Pfizer to tell her what medication she needs to take. She did not know, the Doctor knows what to give. She needs them to recommend what they are giving to other people those are having these severe reactions. Consumer stated, she had two Pfizer shots (both doses) and she had a severe adverse effect. Now it was difficult she had severe pain in her legs. she walks 3 miles a day. she had her eyes swell as well, she went to a Dermatologist. She walks to her Doctor after the severe pain from the Pfizer shot, he gave her some pain treatment Tramadol and "Ibuprofen" (not clarified) besides the fact that it will help. She started to walk, she sneeze a lot, swelled up like her eyes swelled up and she had sticky stuff that was for 9 days, no apparent reason then she went to the Dermatologist. She had severe swelling then she had her teeth ache, for eye condition and skin she went to Dermatologist and he gave her "Hydrocortisone" (name not clarified) several days for two weeks and her teeth have no pain in her teeth. She woke up this morning and felt cry it was painful and she don't know what to do about this adverse effect. she wanted to ask to Pfizer people to get medicine. The caller has had severe adverse effects after receiving the Pfizer Covid 19 Vaccine. The caller could barely use her legs, the legs were in severe pain. The caller was a person that walked and exercised, walked 3 miles a day. The caller could barely get around, and up and down in the morning is hell. The caller was so weak and the legs hurt so bad. The other effect was the caller's eyes swelled up and ran sticky oozy stuff. The caller went to the dermatologist and was given cortisone and after 14-15 days that cleared up, it was white. The caller went to her doctor about the pain in her legs. The caller was taking Tramadol and Ibuprofen and they were not a lot of help. The doctor said it will run its course. The caller asked how long it will be and the doctor said the good news is it will go away and that is about all the doctor would say. In the mean time, the caller was in severe pain and is asking what can be taken for the legs. The caller states she had been in severe pain since February. The caller states if she is not going to get any help why this was not put on the news report. All it is go get another shot. No reports on how it may have these adverse effects. Another thing is the caller goes to bed at night fine and wakes up in the morning with jaws and teeth killing the caller. The caller had excellent dental work. The caller's eyes still run, continually run. The caller states she specially asked what the caller can get for some relief from the pain or is the patient to call the rest of her life. The caller states she could walk. The caller said Pfizer doesn't report a thing, no side effects, everybody is shut up on tv. The caller thinks the side effects, percentages and dangers for the elderly like the caller and the young, young children should be told. The caller states she did talk to her doctor and he gave the caller tramadol (50mg, Expiration date: 12Jul2022) and Ibuprofen (Expiration date: 21Jun2022). Outcome of the event toothache was recovered in 2021; eye discharge was not recovered; other events was unknown. Information about the Lot/batch number has been requested.

I received my vaccine at 10:39 a.m. About 8:30 p.m. I started to feel arm soreness at the site of injection. About an hour later (9:45 pm) I started to feel numbness around my mouth. When I got up the next morning (today) within one hour the numbness returned all around my mouth and lips.

fast heartbeat, dizziness and it took about 45 minutes to feel better. Had a bad taste in her mouth received Gatorade. On Saturday I felt nausea and just not feeling good and terrible taste in her mouth. Denies any shortness of breath during this entire time. Needed to eat to make her stomach to feel better, chills. injection site sore. Sunday felt better and Monday was almost normal and Tuesday no complaints.

Watery drainage from her right eye; Nose feels full; congestion; Phlegm; Fever blister on her tongue (sore blister on the right side of her tongue); sores on her tongue; Feels a little weird; Dizzy or dizziness like vertigo (funny feeling like vertigo); Headache; Slept hard - she never sleeps that much; Drinking a lot of water; Fever; feverish; This is a spontaneous report from a contactable nurse (patient). An 81-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EL1284, Expiration Date: 30Apr2021), via an unspecified route of administration, on 11Jan2021 at 09:00, at a single dose, for COVID-19 immunization. The patient's medical history included colitis and diverticulitis (chronic; diagnosed years ago); and allergies. The patient's concomitant medications included chlordiazepoxide/ clidinium bromide (LIBRAX) for colitis, omeprazole (PROTONIX), levocabastine hydrochloride (ZYRTEC) for allergies, and cyanocobalamin (VITAMIN B12) for colitis. The patient previously took the first dose of BNT162B2 (Lot Number: EH9899, Expiration Date: 31Mar2021) on 21Dec2020 for COVID-19 immunization and experienced a little sore on site; and varicella zoster vaccine (SHINGLES VACCINE) for immunization and it hurt and she got blisters at the injection side. The patient just got her second shot on Monday (11Jan2021) at 9 in morning. After a couple of hours (11 AM), the patient feels a little weird, dizzy or dizziness like vertigo (funny feeling like vertigo), and headache. That night, the patient took ibuprofen (MOTRIN) and paracetamol (TLENOL) and she just slept hard - she never sleeps that much, she is drinking a lot of water. The patient also had a fever that night and received treatment for this. On Tuesday (12Jan2021), the patient was okay but, in the evening, she started feeling feverish and has a fever blister on her tongue (sore blister on the right side of her tongue). The patient never had a fever blister before. Last night (13Jan2021), the patient was a little feverish, still has the sores on her tongue and she was having watery drainage from her right eye and her nose feels full; congestion and phlegm. The patient wanted to know if she should go to work tomorrow but was encouraged to reach out to a health care professional for medical advice. The patient asked health employee and they told her to call the company. Got the vaccine from work at a center. The patient recovered from "Dizzy or dizziness like vertigo (funny feeling like vertigo)" in Jan2021. The outcome of "Feels a little weird", "Headache", "Slept hard - she never sleeps that much", and "Drinking a lot of water" was unknown. The patient had not recovered from the remaining events.

developed herpes voster-pain behind the right ear and neck with rash and up into the head started on 1/26/21 and still present on 2/1-rash appears to be crusted over on 2/1/21

Starred to get blurred vision like a migraine; Fever/temperature was 99.8 then later that day it was 103; Sweat some during sleep, which was pretty normal; No sleep; This is a spontaneous report from a contactable Consumer (patient). An 81-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number: EL1284; Expiry Date: 30Apr2021) on 14Jan2021 at SINGLE DOSE in the right arm for covid-19 immunisation, so she did not get the virus. Medical history included Inflammatory bowel disease. There were no concomitant medications. she was allergic to Sulfa. She had no sleep the first night on 14Jan2021. The next day on 15Jan2021 she had a fever. Her temperature was 99.8 then later that day it was 103. She took an Aspirin. Friday night on 15Jan2021, she slept alright but sweat some, which was pretty normal. Saturday morning on 16Jan2021, her temperature was fine but she starred to get blurred vision like a migraine. She took another Aspirin and it went away. Later that day her temperature was normal at 97.2. She was a pretty active person. After she had the shot around 8 AM-10 AM in the morning, at 12 or 1230 she went out and took down her Christmas lights and she thought she felt good so she was going to trim her plants and she wondered if that had anything to do with her adverse events. Her arm did not hurt or anything. She is wondering if her activity had anything to do with disrupting the medicine? She was using that arm a lot, she probably should not have done it. She will not do it again. The outcome of Starred to get blurred vision like a migraine was recovered on 16Jan2021, of other events were recovered on 15Jan2021.

Dizzy; Headache; Joint pain; Fever; Injection site swelling; heartbeat would accelerate for a few seconds; Chills; off balance; throwing up; she could not drive and was half delirious; I am not feeling good; sneezing; has no energy; her bowel movement was little dab and then again another little dab; if she does not blow her nose, it feels like something is going down the back of her throat; She still has a punchy feeling; she does not have her peripheral vision right; Her arm felt like a boil where they gave her the shot.; Her arm is still is sore; This is a spontaneous report from a contactable consumer (patient). An 81-year-old female patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EL8982, Expiry Date of Pfizer covid vaccine: May2021), intramuscular injection in left shoulder on 21Jan2021 13:00 at single dose as preventative, since she did not want to get COVID again/there was a new strain of COVID that was easier to catch. Medical history included ongoing high blood pressure diagnosed about 5 to 7 years ago, ongoing high cholesterol diagnosed about 5 to 7 years ago, thyroid disorder, Supplementation, for bones, COVID-19 from Nov2020 to Dec2020: She had COVID in Nov2020 till the end of Dec2020, and she was getting better. Concomitant medication included ongoing metoprolol tartrate for high blood pressure, ongoing simvastatin for cholesterol, ongoing levothyroxine for thyroid, ongoing colecalciferol (VITAMIN D) as Supplementation, for bones. The patient experienced chills, off balance, dizzy, headache, joint pain, fever, injection site swelling, heartbeat would accelerate for a few seconds on 21Jan2021, throwing up in Jan2021. The patient spent that whole night getting up and down and going to bathroom for bowel movement, and her bowel movement was little dab and then again another little dab. She was throwing up by 3am or 4am that night, she threw up twice and reports it was like bubbles. Her side effects started Thursday night. She experienced chills, joint pain, fever, injection site swelling, her heartbeat every so often would accelerate for a few seconds. She dizzy and off balance when she would get up to go the bathroom. Since then she still had sneezing and she was blowing her nose, and if she did not blow her nose, it felt like something was going down the back of her throat. She wanted to ask how long she would experience the side effects and how many people had a problem with the first dose. She still had a punchy feeling, had no energy. She could lay down and fall asleep at almost anytime. Height: about 5'2'', she jokingly stated she was shrinking monthly. Her chills started Thursday night and by Saturday morning they were completely gone. When she tried to turn a corner and reported she did not have her peripheral vision right since she kept running into door frames. She was a little better, sometimes she could walk a straight line and sometimes she veers. Headache was ongoing. She did not have it today, it was not a severe headache, it was more irritating than severe. Her arm felt like a boil where they gave her the shot. Her fever went away Saturday night or Sunday morning. She felt like she was not in her own mind, like she was drifting, so time lines for side effects are hard to recall. Her arm was still was sore. Heartbeat would accelerate for a few seconds was occasionally still happening, it happened last night. She called the hospital (facility where it was received) back the next morning and she was told she could come if she wanted to but it was suggested to stay home and sleep it off. She told them she could not drive and was half delirious, she was told she could call an ambulance to come get her. She confirms she did not call ambulance or go to the hospital. When querying indication, she was told there was a new strain of COVID that was easier to catch. The outcome of events chills was recovered on 23Jan2021, vomiting was recovered on 22Jan2021, joint pain was recovered on 24Jan2021, fever recovered in Jan2021. The outcome of events balance impaired NOS, dizzy, vaccination site swelling, Peripheral vision defective was recovering. The outcome of event headache, sneezing, feeling of total lack of energy, feeling abnormal, sleep excessive and pain in arm was not recovered. The outcome of rest events was unknown.

allergy like symptoms; Excessive sneezing; Eyes itching; Throat not closing up; This is a spontaneous report from a contactable consumer (patient). An 81-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number unknown), via an unspecified route of administration in the left arm on 20Jan2021 23:30 at a single dose for COVID-19 immunization. The patient's medical history included hypertension and seasonal allergy. The patient was not pregnant at the time of vaccination. The patient was not diagnosed with COVID-19 prior to vaccination and had not been tested for COVID-19 since the vaccination. Concomitant medications were not reported. It's winter and patient have self-isolated for 2 1/2 months. On22Jan2021, the patient experienced allergy like symptoms such as excessive sneezing, eyes itching, and throat not closing up. Throat not closing up and sneezing lessened with nasal spray. The patient did not receive treatment for the rest of the events. She didn't checked her temperature. Outcome of the events was not recovered. Information about lot/batch number has been requested.

Swollen tongue. Swollen neck glands. Headache, Racing heart. Blood pressure went to 190/95 Occurred after I arrived home. Called Fire Department. I was still able to talk and breath so they did not use Epi pen. Stayed with me because of BP concern. Offered to bring me to Hospital. Said to take Benydryl if symtoms began anew and to call them back and they would take me ER but as day progressed, symptoms subsided somewhat. Higher BP readings continue and my PCP prescribed mild BP RX..

Approximately 75 minutes after vaccine had significant shortness of breath, extreme fatigue (difficulty walking to the bathroom). Over the next week and a half, blood pressure and heart rate swung widely (outside of normal range). Heart rate periodically dropped down into 30-40 range. Experienced whiteouts.

My blood/glucose level was abnormally high for two days following the vaccine My diabetes symptoms were more prevalent( thirst, frequent urination, dry mouth, diarrhea)

Sensorineural sudden hearing loss. Treated with Prednisone for 10 days. Hearing returned to normal. Physician will monitor in 3 months.

check her own self with her hand and it was like she put her hand on a stove; Allergic reaction; felt bad after taking the first dose-flu like symptoms /achy like flu symptoms; had high fever/feverish; urine became yellowish-brown; had a little diarrhea symptoms; get sick; vomiting; has a really bitter taste, or no taste in her mouth/ her mouth still has that nasty, old bitter taste that does not go away with brushed teeth; has a really bitter taste, or no taste in her mouth/ her mouth still has that nasty, old bitter taste that does not go away with brushed teeth; This is a spontaneous report from a contactable consumer (patient) via a Pfizer-sponsored program Pfizer First Connect. An 81-year-old female patient received her first dose of bnt162b2 (BNT162B2 reported as PFIZER COVID-19 VACCINE; manufacturer reported as Pfizer-Wyeth; lot number: EL1283; expiration date: unknown), via an unspecified route of administration left arm on 21Jan2021 12:30 at 0.3 mL, single dose for covid-19 immunization. Medical history included arthritis in back; always had diarrhea because she had cancer and is unable to control her bowels. They tell her she has a lot of fiber in her food; but she can't control it; if she eats vegetables then she knows what's happening; but she always tries to take Imodium A-D before eating vegetables. She mentioned to them if she did not eat vegetables all she could eat is meat and cheese; doctor told her she was borderline diabetic, so she has wanted to keep up with that. The doctor was not worried about it; ongoing acid reflux; pain; and ongoing high blood pressure. Concomitant medication included ongoing omeprazole for acid reflux, ongoing amlodipine for high blood pressure, naproxen for arthritis in back, caffeine, codeine phosphate, paracetamol (ACETAMINOPHEN WITH CODEINE) for pain, loperamide hydrochloride (IMODIUM A-D) for diarrhea. The patient has not received any other vaccinations within four weeks prior to the first administration of the covid-19 vaccine. Vaccinations reported as she has gotten flu shots and pneumonia shot and has never had any adverse events, reactions or problems with those; nothing. The reporter mentioned that she got her first dose of the vaccine in a clinic on 21Jan2021 and aware that the second dose will be on 16Feb2021. The patient reported that she felt bad after taking the first dose-flu like symptoms on 23Jan2021 at 8:00 and had high fever Saturday (23Jan2021), urine became yellowish-brown and wants to know more information. The patient guesses she is having an allergic reaction on 23Jan2021 at 8:00 and asked for further information about the allergic reaction relative to the vaccine. On Saturday (23Jan2021), she was feeling good. She got up, went to store, came back and had little diarrhea symptoms then she began to get sick, feverish. She added that then the vomiting, then achy like flu symptoms. She still feels feverish, she has a really bitter taste, or no taste in her mouth really but it's going away. To her it seems like the worst part is over. She almost called 911 but then did not want to go the hospital because of all the people with COVID in the hospital. The next day on 24Jan2021, when she woke up, she was not as fevered. She can check her own self with her hand and it was like she put her hand on a stove. She went to sleep and the next morning (24Jan2021), she was not as feverish; her mouth still has that nasty, old bitter taste that does not go away with brushed teeth. She feels better today (unspecified date). She mentioned that the second dose is scheduled to be administered 16Feb2021, but she really does not want to go get that if she feels like this. She had blood work for her sugar done on 21Jan2021 because she is borderline diabetic, but results are unknown, have not had any results yet. The outcome of the events was recovering.

muscle and joint pain; wanting to faint/dizziness; blurry eyes; sweating; unable to sleep the whole night as a result of lots of pain in her wrist and hand but especially thumb/wrist on the right side; unable to sleep the whole night as a result of lots of pain in her wrist and hand but especially thumb/wrist on the right side/she was having pain on her wrist/joint pain; unable to sleep the whole night as a result of lots of pain in her wrist and hand but especially thumb/wrist on the right side; swelling in her hand and was hardly able to bend her fingers; swelling in her hand and was hardly able to bend her fingers; wrist was swollen; itchiness, numbness and tingling in her fingers on the right side; itchiness, numbness and tingling in her fingers on the right side; itchiness, numbness and tingling in her fingers on the right side; This is a spontaneous report from a contactable consumer (patient). An 81-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EN5318), via an unspecified route of administration on 06Feb2021 15:00 at single dose at left arm for covid-19 immunisation. Medical history included wrist had arthritis (pain). There were no concomitant medications. Patient height was a little less than 5. She used to be over 5 but she shrunk. Her weight used to be at 226 lbs, it came up to 230. This year (2021) it went up because, its her, she ate too much and she did not obey the rules. Patient received Pfizer vaccine on 06Feb2021 afternoon at 300 pm in her left arm and that night developed itchiness, numbness and tingling in her fingers on the right side. Last night (07Feb2021) she unable to sleep the whole night as a result of lots of pain in her wrist and hand but especially thumb/wrist on the right side. she also reported swelling in her hand and was hardly able to bend her fingers. She tried to bend her fingers and she can but her wrist was swollen, it was less right now but she still had the pain. She applied muscle relaxant (unclear if topical) and took paracetamol (TYLENOL) and massaged her hand with warm water and then for the second time she used the muscle relaxation. She hadn't taken paracetamol yet she was waiting 4 hours but the pain was still there, it was a little bit less. Not sure if it her arthritis or side effects from vaccine but believes it was from the vaccine. Stated she used to have the same problem with her wrist arthritis (pain). Also reported that she experienced additional side effects on 08Feb2021 which lasted about 5 minutes then went away: blurry eyes; wanting to faint; dizziness, sweating (whole body started to be like sweaty). Asking for information on muscle and joint pain after the vaccine and recommendations on what to do. So far she didn't know what it was, and if it was a side effect of the arthritis, because once in a while that happens but when it happened it went away right away but this time her wrist pain was there still there. Patient sat down and now she was stretching her leg, she sat down on the chair and its gone she had no more problems. Patient said her right hand, she was very slow writing. She said at least she can write her hand was going back to a routine but she was in a lot of pain. Outcome of event wanting to faint/dizziness, blurry eyes, sweating was recovered on 08Feb2021, and outcome of other events was unknown.

Patient received second dose of Pfizer vaccine. Both patient and her daughter went to the car to wait. Was approached by security as daughter returned to the center stating her mother was having a reaction. I went to the car & assessed patient. Patient c/o numbness/tingling along the left side of her face and head. Significant tremors and shortness of breath noted at the time. Daughter went and secured wheelchair & we brought the patient back into the vaccine clinic. VS at 1340: BP: 164/65, PO2: 88% on 3L, HR: 60 Patient reported anxiety prior to coming in for vaccine. VS at 1347: BP: 184/82, PO2: 94% on 3L, HR: 60. Patient states numbness/tingling increasing; reporting circumoral tingling/numbness. 25mg Benadryl given. VS at 1355: BP: 233/102, PO2: 92% on 3L, HR: 60 Discussed with Pharmacist. EMTs called for transport to ED per patient's request. Observed in ED and d/c home with no further treatment in stable condition.

RECIEVED SHOT ON THE 22., FELT FINE THAT DAY. NEXT DAY TOWARD EVENING I FELT UNWELL, NO APPETITE. RESTED HAD A LITTLE CEREAL BEFORE I WENT TO BED. TOKE SOME TYLENOL, SLEPT WELL, FELT GREAT NEXT DAY AND AGAIN LATE AFTERNOON FELT SICKLY, MY LEFT JAW FELT SORE, NOTICED WHEN I WANTED TO EAT IT HURT TO OPEN MY JAW, VERY PAINFUL WHEN I NEEDED TO JAWN, WAS HUNGRY AND TRIED TO EAT A BANANA WHICH I WAS ABLE TO EAT BY LIKE SCRAPING THE FRUIT WITH MY TEETH. SINCE THEN THE PAIN LESSENED TODDAY I STILL HAVE PAIN WHEN I OPEN MY MOUTH WIDE, I FEEL IT IS GETTING BETTER DAILY AND SINCE I HAVE ONLY THE OTHER SIDEEFECT OF HAVING NOW AND THEN HOTFLASHES , I THINK I WILL BE FINE AGAIN IN A COUPLE OF DAYS.

patient developed unexplained diplopia and vertigo; extensive diagnostic workup including mris and LP. Felt to have aseptic meningitis with vestibular neuronitis

Tongue tingly lower; inside of upper and lower lips swelled; itch on palm of hands, bottom of feet and thighs and face; This is a spontaneous report from a contactable 81-year-old female consumer reported for herself that she received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot En5318) single dose on 04Feb2021 at 14:30 at right arm for COVID-19 immunisation. Medical history included osteoporosis, reflux, spinal stenosis and macular degeneration, asthma, hypertension. The patient had known allergies. Concomitant drugs included Atenolol, calcium, fish oil, cyanocobalamin (B12), loratadine, tocopherol (VIT E). The patient had tongue tingly lower and inside of upper and lower lips swelled, itch on palm of hands, bottom of feet and thighs and face on 04Feb2021 at 14:30. The event resulted in doctor or other healthcare professional office/clinic visit. The patient received steroid injection and diphenhydramine hydrochloride (BENADRYL) as treatment. The event was reported non-serious. Patient recovered from the event with lasting effects.

30 minutes after receiving 1st dose, headache set in and my tongue and the inside of my mouth starting itching. Arrived home 15 min later. Immediately took a Benadryl. Suspected I was having an allergic reaction. It stopped the itching. A Tylenol stopped the headache. A 2nd headache set in later in the afternoon. Another Tylenol stopped it

About 10 min post vaccination, patient reported "tingling in the mouth and lips" and "tightness in the throat". Patients vitals were taken and within normal limits. Patient was then monitored one-on-one and reported slight difficulty breathing about 10 min later. Patient was given diphenhydramine 25mg PO x 1 dose. Patients vitals were taken again 10 min later and were within normal limits. Patient reported improvement of symptoms and was monitored for an additional 15 minutes.

She went to the living room and fell and couldn't get up; She went to the living room and fell and couldn't get up; tiredness; She has a sore throat and fever blisters on her mouth; lost almost 18 pounds in the last week with all this stuff; severe headache; muscle pain in the back of her neck and back; She has a sore throat and fever blisters on her mouth; violent chills; sick with diarrhea; Dry heaves; This is a spontaneous report from a contactable Consumer. An 81-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number and expiry date not reported) via an unspecified route of administration to left arm on 25Jan2021 at single dose for covid-19 immunization. Medical history included Crohn's disease and Type II Diabetes. The patient experienced sick with diarrhea on Jan2021, dry heaves on Jan2021, she went to the living room and fell and couldn't get up on 27Jan2021, tiredness on Jan2021, she has a sore throat and fever blisters on her mouth on Jan2021, lost almost 18 pounds in the last week with all this stuff on Jan2021, severe headache on Jan2021, muscle pain in the back of her neck and back on Jan2021, violent chills on Jan2021. The patient underwent lab tests and procedures which included weight: lost almost 18 lbs on an unspecified date (lost almost 18 pounds in the last week with all this stuff). She received the first dose of the vaccine a week ago on Monday. For two days she was absolutely normal and fine. The night of the second day she had fallen asleep on the couch and when she woke up it was midnight. She knew immediately she was going to be sick with diarrhea. She had dry heaves. She never vomited. The dry heaves were longer than she has had in her life. The diarrhea kept going and going. She went to the living room and fell and couldn't get up. She is 80 years old (as reported). She has never had that happen before. She slept on the floor until six in the morning. When she woke up she managed to get up. She had so many of these side effects. She has tiredness, severe headache, muscle pain in the back of her neck and back, violent chills. She has never had chills so violent before. She has a sore throat and fever blisters on her mouth. There must be 9 or 10 of them. It is a never ending list. She has lost almost 18 pounds in the last week with all this stuff. The symptoms have not stopped. Outcome of the events was not recovered

3/02 As the vaccine was given in my left arm, I felt it travel down inside my arm and toward my hand. i waited at Pharmacy for 20 minutes with no reaction. I returned home and within the hour I began to feel "very tired' and lay down in my bed. Within minutes, my left thump had spasms and painful cramping and "froze" I massaged my thump for about 5 minutes and the pain subsided. I then had painful cramping in my left calf and then the entire leg which then followed by Muscle pain and cramping in both legs. I was told that I should exercise, so I went for a long walk. When I returned home, i felt even worse so I went back to bed. Headaches began. I had flu-like symptoms (chills and discomfort) I covered my self with two blankets and drank lots of water and took an Aleve.which upset my stomach. 3/03 (the next morning), my usual sinus stuffiness was Gone! and I could breathe better than i have in a long time (by days end my sinusitis had returned) and so had my headache. Today 3/04 I still feel exhausted and I have swelling, puffs under my eyes (not usual) and occasional headaches. My Left Arm (area of the inoculation) Has Never Been Painful!!!!!!

She is experiencing an Allergic reaction, rash; little coughing spell; Itching eyes/My eyes started itching; Multiple hives all around her right eye; Wheezing; didn't feel comfortable; her upper lip became puffy/bottom lip began to swell; This is a spontaneous report from a contactable nurse (patient) via Medical Information Team. An 81-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number: EN6201), intramuscular at upper left arm on 21Feb2021 at 08:30 at SINGLE DOSE for COVID-19 immunisation. The patient had no prior vaccination within 4 weeks. The patient had no additional vaccines administered on same date of bnt162b2. Medical history included seasonal asthma, allergy to class A antihistamines that started in her 20s, facial & peripheral edema, blood pressure abnormal, and celiac disease. The patient had known allergy to Benadryl and when she takes it she gets peripheral and facial edema, lip swelling, top and bottom, hives around her whole right eye. The patient also has an allergy to Class A antihistamines that started in her 20s. She said the allergy started with Seldane & Claritin. She said she had giant hives with Claritin. She said she was told there were 2 classes of antihistamines & she couldn't use the Class A antihistamines. She said she previously reported her Seldane, Claritin & Benadryl allergies, saying she has facial & peripheral edema. She said she only uses the Class B antihistamine Cimetidine now. Concomitant medications included metoprolol, omeprazole, and pravastatin. On an unspecified date, the patient was experiencing an allergic reaction, rash. On 21Feb2021, the patient experienced "her upper lip became puffy/bottom lip began to swell," multiple hives all around her right eye, wheezing, and didn't feel comfortable. On 21Feb2021 at 14:00 (reported as about 2PM), the patient experienced "Itching eyes/My eyes started itching." On 21Feb2021 at 21:00 (reported as 9PM), the patient experienced little coughing spell. The reporter considered the events swelling lips, itching eyes, multiple hives all around her right eye, and wheezing as serious medically significant. The patient further reported that she felt fine after the shot, her arm was not sore, nothing. She said her arm was fine, and she had no problems, whatsoever, after receiving the COVID-19 Vaccine. She said she has had some weird allergic reactions in the past, but no anaphylaxis. About 12:00 to 12:30 PM (also reported as around midday), the patient's lip felt puffy. She said she had ate an apple and thought maybe something was on the skin of the apple. She said then her bottom lip began to swell, so she took 3 Cimetidine (NDC Number: 49035-820-72, lot number: 9AE2576A, expiry date: Dec2020). The patient stated that she was allergic to what she believe are class A antihistamines as they gave her facial and peripheral edema including Benadryl and everything on the list. About 2PM, the patient's eyes felt itchy, she took allergy eye drops (eye drops seasonal relief with tetrahydrozoline HCL 0.05% and zinc sulfate 0.25%. She said the product packaging reads it soothes eyes, and she said the eye drops worked. Lot number: AC8K275, expiration date: Sep2021). She said when she looked in the mirror, she saw a large hive on her eye (clarified as multiple hives all around her right eye). And about 4PM, she realized that her lips felt puffy, so she repeated the Cimetidine, it kept them from getting worse. At 7PM, her eye felt worse. She had this real hive that surrounded her right eye, she took a picture so she could report it to the doctor. The patient have an appointment on Wednesday. At 7:30PM, the patient's lips were puffy, she repeated the Cimetidine again and took of the 200 mg, she takes 3 at a time, she mentioned she could take 4, but she takes 3. She said she took more Cimetidine at 8:30PM, and talked to a pharmacist, who told her to call Pfizer to report her reaction. She said she attempted to call Pfizer last night, but it was too late, clarifying Pfizer Medical Information was already closed for the day. The patient also reported that she had a little coughing spell at about 9PM, so she stayed up with her husband till 10PM because she didn't feel comfortable. The patient told her husband to wake her up every once in a while. The patient felt a little wheezy, she used both of her inhalers, she could hear the wheezing, she used the serevent diskus (Serevent Diskus 50 mcg Inhaler. She said she has been using the Serevent Diskus Inhaler for seasonal allergies for years and the inhaler works. She said she occasionally uses the Serevent Diskus for colds during the winter. She said she realized she was wheezing last night and thought she should use the Serevent Diskus. NDC Number: 0173-0521-00, Lot Number: VV3E, Expiration Date: Sep2021) and Flovent (Flovent HFA 110mcg Inhaler, NDC Number: 0170719-20, Lot Number: C47A, Expiration Date: Jul2021). That seemed to be okay, she went to bed, and had a good night no problems. She said she woke up this morning and felt better. She said she sounds a little gunky this morning, clarifying that was somewhat typical for her. The patient further reported that she got up at 6:30AM, she took a shower, she was having a rebound reaction, and wheezing, so she took 3 more Cimetidine and repeated the inhalers. She clarified while her symptoms worsened after the hot shower this morning, her symptoms are much less than yesterday (21Feb2021), saying she was aware of her symptoms today, and paying attention to them. She said her lips became puffy, and she was wheezy after the hot shower. She said she took Cimetidine and her inhalers again this morning to treat the rebound reaction. She decided to repeat again at about quarter to 10AM, she repeated again trying to keep it under control. In the meantime, she spoke to her doctors office, and they just said keep doing what she's doing, and if she get real bad, call 911 or go to emergency room (ER). The patient have an appointment, the patient's big concern was that she probably shouldn't get the second COVID shot. She read on (website), that there was a very rare, mild anaphylactic reactions. What caught her eye was that this takes place about 4 hours after the dose. This was when her symptoms began, lucky her. Her whole life has been allergy related. The patient don't know if celiac disease has anything with this. The patient wanted to know whether or not there was some way to take the shot without killing herself. She said she was not having breathing difficulty, she was just wheezy. She said she repeated the Cimetidine about a half hour before she called Pfizer today. She said she called her doctor's office this morning, and her doctor said for her to keep treating her symptoms as she had been doing. She said her doctor told her to call an ambulance or go to the emergency room if her symptoms happen to get worse. She said she read online that skin anaphylaxis (hives, itching, and swelling of the eyes, face, lips and throat) can occur with the COVID-19 Vaccine. She clarified she read the information about the COVID-19 Vaccine at (Website name). She said she read skin anaphylaxis was extremely rare and less than 1% of the population has the allergy, and those individuals should not get the COVID-19 Vaccine. She said she was upset because what she read probably means she can't get the second COVID-19 Vaccine shot. She said she read the skin anaphylaxis appears within 4 hours after getting vaccinated with the COVID-19 Vaccine. She said her symptoms occurred in almost the same amount of time as to what she read about a skin anaphylaxis reaction to the COVID-19 Vaccine. She said she has a regular check-up on Wednesday (24Feb2021) with her doctor, and will speak further to her doctor about getting the second COVID-19 Vaccine. The reporter considered the events lip felt puffy, eyes started itching, hives, and wheezing as serious medically significant. The patient had no emergency visit. The patient had no relevant tests done. Therapeutic measures were taken as a result of the events swelling lips, itching eyes, multiple hives all around her right eye, and wheezing. The patient had not yet recovered from the events swelling lips, itching eyes, multiple hives all around her right eye, and wheezing while outcome of the events rash, little coughing spell, and didn't feel comfortable was unknown. The reporter considered the events swelling lips, itching eyes, hives, and wheezing as related to bnt162b2.; 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.

gained about 3 pounds now; The next day, her cheeks, face, and the part under her chin became swollen/her body also became swollen; she feels something in her throat which she can't describe; she feels something in her throat which she can't describe; her vision on her good eye became a little depleted; inside of her lips was swollen; This is a spontaneous report from a contactable consumer. This 81-year-old Female consumer reported for herself that she received the first dose of (PFIZER-BIONTECH COVID-19 VACCINE, Lot number unknown) at single dose on 27Jan2021 for COVID-19 immunisation. Relevant history included food allergy. Relevant concomitant drug was unknown. The patient received her 1st dose on 27Jan2021 and stated that she was feeling fine for about 10 minutes and when she got back home which was not very far from the vaccination site, she noticed that the inside of her lips was swollen. She mentioned that this was not strange for her since she was mostly allergic to food but usually it was the outer portion of her lips that became swollen and not the inner portion. The next day, her cheeks, face, and the part under her chin became swollen and she felt something in her throat which she could describe. She also noticed that her vision on her good eye became a little depleted which got her a little concerned and her body also became swollen and stated that she already gained about 3 pounds now. She wanted to know if anyone had reported the same reaction she had and if it was recommended for her to get the 2nd dose or not. Outcome of events was unknown. The information on the LOT/Batch number has been requested

No side effects in 30 minute waiting period and none on day of injection--some mild itching began night of injection. Day after, Saturday, itching intensified, throat tightened (muscular feeling); and tongue began to become sore, and began to show redness on sides. Bad enough that I finally took a 4-6 hour dose of Benadryl, and slept afternoon. Felt better when I woke up but when effects of Benadryl wore off, the tongue swelling intensified and frightened me. Decided against emergency call on weekend and took Benadryl (4-6 hour) about 8 or 9 Pm and next morning (about 5 or 6AM) noted that I felt okay and tongue had become pink not red though still some swelling on the sides of tongue. Had no strong adverse effects after first dose, some chills in the evening and arm swelling/pain that resolved by 3AM.

tired; rash from shoulder to elbow; Eyes heavy; feels under the weather; low energy level; slept for 3 days; This 81- year-old female patient contactable consumer received the second dose BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE lot EL9262), via an unspecified route of administration, on 28Jan2021 at 11:30 (at the age of 81-years-old) as a single dose for COVID-19 immunization, left arm in the muscle. The facility where COVID-19 vaccine was administered was at a clinic. Historical Vaccine included first dose of BNT162B2 on 07Jan2021 (lot EI3246), for COVID-19 immunization, left arm at the same site between 11:30-12:00. The patient's concomitant medications included medications for years for thyroid and cholesterol. The medical history included: diagnosed allergies, compromised immune status, respiratory illness, genetic / chromosomal abnormalities, endocrine abnormalities (including diabetes) and obesity: Allergic to Sulfa, years ago and she got a rash. States she is very healthy. She has had no other vaccines in the past 4 weeks. She stated she has had a low energy level, heavy eyes (31Jan2021) and has been tired for nearly two weeks now. She still feels under the weather (31Jan2021). She had a rash from shoulder to elbow (31Jan2021) and was sleeping for 3 days(28Jan2021) without getting up much. For 3 days she was out and it got better, but she would go to bed (as reported) and back to bed. She is usually a very active person. Like yesterday, she had to go out. She is not one to fuss over anything. She went out and today, is a bit better. She is getting better every day. The outcome of the events low energy level and tired was unknown; rash, slept for 3 days, Eyes heavy, and feels under the weather was recovering.

A week after the first dose, I experience Tintinis. I thought my hot water heat was amiss because I heard a gurgling sound like water rushing through the pipes. I have heard a loud rushing sound and also a sound of high frequency. The sound seem to rotate in a random order. Today. I am experiencing a loud rushing sound.

Came to the emergency room. she woke up from the sleep, she was noticing increased secretions, she was short of breath and was wheezing. She called EMS, when EMS came her pulse ox was 56%, she was placed on CPAP and oxygen, pulse ox went up to 82%. Patient was placed on BiPAP in the emergency room Severe mitral regurgitation, class IV CHF symptoms despite medical therapy for her volume overload. Was transferred to larger hospital due to severity

Frequent arrhythmias; 20 point systolic BP rise; sense of oppression in breathing; vertigo on arising; brain fog; night sweating with normal temp; burning feet; trembling hands; weak muscles; fatigue; audible pulse in ears; This is a spontaneous report from a contactable consumer (patient). An 81-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot: EN6200), via an unspecified route of administration administered in left arm on 19Feb2021 18:00 (at the age of 81-years-old) as single dose for covid-19 immunisation. The patient was not pregnant at the time of vaccination. The reported facility type was a hospital. No other vaccine in four weeks. The patient did not have covid prior vaccination and was not covid tested post vaccination. Medical history included Hashimotos Thyroiditis, irritable bowel syndrome (IBS), food and seasonal allergies, allergies Iodine isotope contrast, latex, cows milk protein. Concomitant medications included levothyroxine sodium (SYNTHROID); amlodipine and spironolactone. The patient previously took paracetamol (TYLENOL) and thiomersal and experienced allergies from these drugs. The patient experienced frequent arrhythmias day after; several days of 20 point systolic BP rise; audible pulse in ears; sense of danger; sense of oppression in breathing; vertigo on arising; brain fog; night sweating with normal temp; burning feet; trembling hands; weak muscles; fatigue all on 20Feb2021 at 13:00. After 20 days (in Mar2021), all has abated but muscle weakness and fatigue. Unwilling to risk the booster. There was no treatment for the events. The outcome of the events muscular weakness and fatigue was not recovered while for the remaining events was recovered with sequelae in Mar2021.

break in rash/rash in mouth and throat; sore throat; dizzy; weak; felt like sleeping all the time; pain in her arm; blood clot in right leg; couldn't walk; veins are swollen; right knee got swollen; ear ache; felt like burning/ sore in her mouth like she was burned; sore in her mouth like she was burned; nausea; headache; slight fever; This is a spontaneous report from a contactable consumer (patient). An 81-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration in right arm on 09Mar2021 (Lot Number: EL9266) at single dose for covid-19 immunization. Medical history included arthritis, respiratory issues, allergies, Eczema of the nipples and breast, arthroscopic surgeries, she lost her voice. Caller stated she exercised everyday, she did yoga. Caller reported the last 2 years she hadn't been able to climb the mountain on the stairs. Caller states she didn't catch a cold, she was fine, she was very active. She was good except arthritic conditions, she has had arthroscopic surgeries, that was a side effect of that. Caller reporting she was a first responder and had some respiratory issues. Caller stated she had some allergies, if with dust or smoke, her throat constricts, it was just small, like her throat. She cannot be around that. She got once in a while, when she got in a rush. Caller stated before the vaccine, she had eczema in her nipples, on her breast. Caller stated she never got sick, besides the rash she got once in a while. Caller states but she was very healthy otherwise, no medication, no smoking, no drinking. Caller stated she was from 9/11, this was what happened with her voice once in a while, she lost her voice. Caller stated she had had some respiratory issues and allergies and so on. Caller stated she was here for 56 years and her mother died of old age so she was not sure. There were no concomitant medications. The patient previously took advil. Caller stated she used to take Advil when she went to the gym and had problems but she hasn't taken Advil for a while. She didn't take meds. Caller stated she didn't drink or smoke because what it did was it gave you a release. Caller stated she was not taking none, she was pushing through and hoping it will heal itself. The patient experienced blood clot in right leg on 26Mar2021, break in rash on an unspecified date, headache on 09Mar2021, slight fever on 09Mar2021, veins are swollen on 12Mar2021, right knee got swollen on 12Mar2021, sore throat on an unspecified date, ear ache on 10Mar2021, nausea on 09Mar2021, rash in mouth and throat on an unspecified date, felt like burning/ sore in her mouth like she was burned on 10Mar2021, sore in her mouth like she was burned on 10Mar2021, dizzy on an unspecified date, weak on an unspecified date, felt like sleeping all the time on an unspecified date, couldn't walk on 12Mar2021, pain in her arm on an unspecified date. Was a first responder, sometimes break in rash once in a while. Got Pfizer 1st vaccine 09Mar, was scared to have difficulty breathing however had headache, slight fever, right knee and veins were swollen, sore throat, ear ache, nausea, rash in mouth and throat also felt like burning also was dizzy and weak and felt like sleeping all the time. Caller stated she was told by her doctor to take the shot on 09Mar2021. Caller stated she had headache, slight fever, then her head was ok the fever was gone but the headache persisted as of today. Caller stated she still had headache and ear ache and her knee got swollen, her right knee. Caller stated for a few days she couldn't walk. Caller reported she has arthritic conditions in knees, she exercises everyday and no problem, but she couldn't walk for a few days. Caller states now she is able to walk on something, but the veins in the knee were still there and she didn't know. Caller stated she was due for second next on Tuesday and she was wondering what to do. Caller stated she was honestly worried about this reaction after the first shot. Caller stated she was told the 2nd had a worse reaction, so she was really weary and worried. Caller stated she only slept 5 hours at night, but now she wanted to sleep all the time. Caller stated she had such a headache and earache. Caller stated it made her nauseous, like in a sea or something. She stated she didn't know how to explain. She didn't vomit like when you were nauseous, it wasn't that feeling. Caller stated it was just lingering like when you were in the ocean. Caller reported headache has gotten better. It has gotten worse and then gotten better. Caller stated the earache was so painful and was still there. Caller reported she got it during the day and when she lied down, but the severity had subsided. Caller stated she didn't measure fever. She wanted to say after that, her mouth was sore after fever from the heat or from the vaccination. Caller stated her mouth was still today, still sensitive. Caller reported it was like her throat and her mouth was so sore like a burn. Caller reported her headache was mostly on the left side, but went to the right side too. Caller reported she could feel it in her eye, it hurt and her ear hurt. Caller reported her sore throat, the upper part, was still sensitive. Caller stated she couldn't swallow, but it was clear, her mouth was clear, only the upper top she would say. Caller stated it's 99% gone, its healing. Nauseous, like in a sea, its not like she has it all day long- nauseous- maybe once a day, nothing severely like what she had for a few things. The patient had a pain in her arm and she had that symptom one night and the following day she had nothing. Her arm was cooperative. Since she had been diagnosed with a blood clot. She saw her doctor on Friday and was recommended that she took some medications. She continued to have headache which she reported, though not as bad. She also reported that she had a sore mouth and earache. She was still fighting symptoms and didn't know what to do with the blood clot. She was scared to take the blood thinner Eliquis and that she will have side effects that it will do her harm she felt Eliquis will do her harm if she received the second dose of the vaccine or takes Eliquis. She was supposed to 20mg daily which she felt will kill her given her body was not healed from receiving the first dose of the Covid-19 vaccine. There was no prior vaccinations within 4 weeks. She was prescribed Eliquis Film-coated tablet (Lot Number: ABN4449S, Expiry date: Feb2023) 20mg daily for blood clot but had not started because she felt it will kill her was scared to take the second dose of the vaccine. The patient underwent lab tests and procedures which included Sonogram: blood clot in right on 26Mar2021. Therapeutic measures were taken as a result of blood clot in right leg. There was Physician Office Visit for all events. The outcome of the event blood clot in right leg, veins are swollen, right knee got swollen, couldn't walk was not recovered, of event slight fever was recovered on 10Mar2021, pain in her arm was recovered, of event ear ache, nausea, felt like burning/ sore in her mouth like she was burned, sore in her mouth like she was burned was recovering, of other events was unknown.

Woke up on 4/10 (day after administration) with bone and muscle aches, blurry vision, headache that felt like it was in eyes on both side. Also had hot sweats during the night. Took tylenol and drank a lot of water, as advised, at vaccine facility. Treated with bed rest; All symptoms resolved on Mon 4/12

double vision; This is a spontaneous report from a contactable consumer (patient's daughter). An 81-year-old female patient received BNT162B2(Pfizer-BioNTech COVID-19 mRNA vaccine), dose 2 via an unspecified route of administration, at age 81 years, administered in the arm on 09Mar2021 16:00 (Batch/Lot Number: EP6955) as single dose for COVID-19 immunization. Medical history included ongoing chronic obstructive pulmonary disease (COPD) diagnosed from an unspecified date about 2 years ago but reporter was sure she had it before that. Patient did not have prior vaccinations within 4 weeks. There were no concomitant medications. Patient historically took the first dose of BNT162B2 (Lot: EL3302) on 09Feb2021 at around 12:00, at age 81 years on the arm for COVID-19 immunisation. Patient had a reaction to Pfizer's COVID vaccine where double vision happened 2- 3 days after her second vaccination, but clarified that it was on 11Mar2021. The patient did not initially mentioned double vision to reporter herself, patient told her daughter last Saturday that she had been having double vision but reporter did not find out about it until later. The reporter took her to the doctor regarding the double vision and the doctor sent the patient to the hospital emergency room for double vision on 15Mar2021. Patient was not admitted to the hospital, was kept under observation in the emergency room where she had testing performed. While in the emergency room the patient had a CAT scan, and MRI and bloodwork and all of those tests results came back clear on 15Mar2021. The patient was released home from the emergency room after probably about 5-6 hours. The reporter just thought the double vision seems to be a little suspect being that she had had the Pfizer-BioNTech COVID-19 Vaccines and they have nothing else to attribute the event to. The vaccine was not administered at military facility. Outcome was not recovered at the time of reporting. Case was reported as non-serious.

Patient describes long standing fever that persisted for 30 days. They experienced body chills. They stated they ended up with the influenza A/B virus after getting the vaccine (tested 2 weeks after & verified positive for A/B at hospital per patient). Patient states they lost their sense of taste and smell. They state it caused their hands to turn blue.

Tinnitus began within a week of first Pfizer injection. Seemed a bit better, comes and gets a bit better, never leaves after 2nd injection, both ears affected...

Dry tongue; For the past 3 days the Tingling was worse; Tingling on [her] tongue/tinging on the tongue; Dry mouth; This is a spontaneous report from a contactable consumer (patient). An 81-years-old female patient received first dose of BNT162B2 (Solution for injection, Batch/Lot number: EL9262, Expiry Date: Unknown) via an unspecified route of administration on left arm on 24Jan2021 at 12:15 as single dose for covid-19 immunisation. Medical history included monoclonal gammopathy, high blood pressure and cholesterol. Concomitant medications included Losartan and Metoprolol for high blood pressure and Lipitor for cholesterol which is under control with medication. Patient experienced dry mouth on 24Jan2021, tingling tongue on 26Jan2021. For the past 3 days the tingling was worse, then this morning it's better and dry mouth is about the same. Patient asked if her experience was a reported side effect of the vaccine. She replied she already spoke with HCP. She also asked if she could take Benadryl for the tingling on her tongue. She then indirectly questioned if she should receive the second dose of the vaccine after her reaction to the first dose. Patient also stated her second dose of the Pfizer-BioNTech COVID-19 vaccine is scheduled on 12Feb2021, 19 days after the first dose. She asked is 19 days too early to receive the second dose of the Pfizer-BioNTech COVID-19 vaccine. She is concerned because that is only 19 days. She is not sure if that's okay. Patient declined to write down Pfizer websites stating that she is not tech savvy as she is 81 years old, she prefers talking to someone. Outcome for Dry mouth was not recovered and recovering for tingling tongue. Patient enquired about the timing of the second dose of the Pfizer-BioNTech COVID-19 vaccine.

Twenty minutes after the shot, hissing developed in my ears. There is pressure in my ears. These symptoms arrived after the vaccine , were not present before the vaccine.

6 days following vaccine patient had blurred vision and collapsed; refused transport to hospital from EMS; 10 days after vaccine, patient suffered what was deemed to be a TIA but actually found to be an ischemic stroke. Was speaking and was to be released to at home rehab; 1.5 days later suffered what appeared to be a stroke but brain MRI showed no change. She now has C3 nerve involvement not related to the stroke and, speech and movement issues. Cause undetermined.

81 year-old female patient in otherwise good heath received her first dose of BNT162b2 (Pfizer-BioNTech COVID-19 Vaccine), administered in right arm on 02/02/2021 (Lot Number EL9264) for COVID-19 immunization. Concomitant medications include: Losartan and Atenolol. Vaccine was administered at approximately 5:00 pm at a drive through location. The vaccination was administered by the County Health Department. Shortly after receiving the vaccine (but while still at the facility), patient started experiencing a bulging of the right eyelid. Patient did not immediately recognize that this may have been related to the vaccination. Over the next several days, patient started experiencing additional symptoms including drooping of right side of face, drooping of right eyelid, difficulty closing right eyelid and weakness on the right side of the face. This was unusual and on 02/10/2021, patient contacted her primary care physician who referred her immediately to Emergency Department for evaluation. The following tests and procedures were performed by the ER: Basic Metabolic Panel, CBC Hemogram, Troponin, eGFR and CT Head w/o Contrast (reason facial drooping). Diagnosis: Bell's Palsy, Adult. On 2/11/21, patient had a follow-up with primary care physician. On 02/11/2021, the patient received prednisone (10 mg once daily for 5 days) as treatment for the Bell's Palsy. The reported events required visit to Emergency Room on 02/10/2021 with follow-up at Physician's office on 02/11/2021. Reporting is delayed because patient understood that the adverse event had already been reported. At a later date, patient requested a copy of the adverse event report for her records but learned that the adverse event actually had not been reported. Report is being filed by a contactable family member.

Profuse Vomiting; chills; dryness; This is a spontaneous report from a contactable Nurse. A 81-year-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Solution for injection; Lot Number: Unknown; Expiry Date: Unknown) dose 1 intramuscular, administered in Arm Left on 06Feb2021 16:00 as SINGLE DOSE for COVID19 immunization. Medical history included If covid prior vaccination: Yes. Concomitant medications included apixaban (ELIQUIS); propranolol; chlorthalidone; pravastatin sodium for an unspecified indication. The patient did not receive any other vaccines within 4 weeks. The patient was diagnosed with COVID-19 prior to vaccination. The patient was not tested positive post vaccination. The patient experienced on 06Feb2021 16:00 profuse vomiting, chills, dryness. The patient did not receive any treatment for adverse event. The outcome of the events were unknown.

feeling a bit achy; her arms hurting; having a little cough; earache; she is stressed out; This is a spontaneous report received from a contactable nurse and a consumer (patient). An 81-year-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration on an unspecified date at 81 years old (Batch/Lot number was not reported) at single dose for covid-19 immunisation. The patient's medical history was not reported. The patient's concomitant medications included tofacitinib citrate (XELJANZ) from Feb2021 and ongoing. Patient reported feeling a bit achy and her arms hurting after taking her first dose of the covid-19 vaccine. Patient also reported having a little cough and ear ache. Patient stated this happened when she was stressed out. The adverse events were non-serious. The outcome of the events was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained.

Patient experienced tinnitus starting one week after first dose and intensified after second and persisting tinnitus.

ears went dead with no sound to be heard, went to walk felt like could not control body, was swaying all over the place, and really sick. sick to stomach when stroke started happening, weaknesses everywhere could not stand up or get up in bed. Started throwing bike up really bad , dizziness happening, spilled out both ends of body, speech little slurred, stroke was happening. Got to hospital still felt dizzy for at least 3 days, throwing up lasted several hours. Zoned out in hospital for awhile but not while stroke was happening, in intensive care for 2 full days, in hospital for 3 days then transferred to rehab in hospital. Left side was affected both arm and leg and slurry speech. Little weakness in right arm. Home from rehab 2 weeks later. Still having issues with leg.

ED to Hosp-Admission Discharged 4/6/2021 - 4/9/2021 (3 days) Last attending ? Treatment team Acute hypoxemic respiratory failure due to COVID-19 (CMS/HCC) Principal problem Discharge Summary Internal Medicine Discharge Summary Hospitalist Medicine Admission Date: 4/6/2021 Length of Stay: 3 Days Discharge Date: 4/9/2021 Admission Diagnosis Hospital Problems POA * (Principal) Acute hypoxemic respiratory failure due to COVID-19 (CMS/HCC) Yes Type 2 diabetes mellitus (CMS/HCC) Yes Obesity Yes Hypothyroidism Yes Chronic combined systolic and diastolic heart failure (CMS/HCC) Yes Benign essential hypertension Yes 81-year-old female presented to the hospital with a complaint of fever and cough COVID-19 - now saturating well on room air and Afebrile Complaining of sore throat and difficulty in swallowing- now resolving Back pain improving Episode of diaphoresis and blurry vision -now resolved Home Or Self Care CODE STATUS: DNR (Do Not Resuscitate) Active Issues Requiring Follow-up Follow-up with PCP for further care as outpatient. Test Results Pending at Discharge Pending Labs Order Current Status Blood culture- 2 SETS Preliminary result Blood culture- 2 SETS Preliminary result Hospital Course HPI: See H&P Hospital Course: Patient presented to the hospital with a complaint of fever and cough. She was admitted for COVID-19 with respiratory failure. Since she was saturating below 94%, she was started on remdesivir on admission. Oxygen was given for supportive care. She received albuterol inhaler, Mucinex, Tessalon Perles and Decadron. In addition she complained of some sore throat and received Chloraseptic spray along with lozenges. She had an episode of diaphoresis and change in vision during the hospitalization. There were no events on the monitor and the CT of the head was negative. The symptoms resolved. She also complained of insomnia back pain for which he received melatonin and Lidoderm patch respectively. She is feeling much better and has been saturating well on room air above 95% for the past 2 days. I will continue with the albuterol inhaler, Decadron and Mucinex as outpatient for few more days. She is asked to follow-up with her PCP for further care as outpatient. ED to Hosp-Admission Discharged 4/13/2021 - 4/16/2021 (3 days) Last attending ? Treatment team Weakness Principal problem Discharge Summary (Physician) ? ? Internal Medicine Discharge Summary Hospitalist Medicine Admission Date: 4/13/2021 Length of Stay: 1 Days Discharge Date: 4/16/2021 Admission Diagnosis Hospital Problems POA Type 2 diabetes mellitus (CMS/HCC) Yes Hypothyroidism Yes Hyperlipidemia due to type 2 diabetes mellitus (CMS/HCC) Yes Gastroesophageal reflux disease Yes Problem List Resolved POA Resolved Problems Acute hypoxemic respiratory failure due to COVID-19 (CMS/HCC) 4/17/2021 Yes * (Principal) Weakness 4/17/2021 Yes Generalized weakness 4/17/2021 Yes Home Under Care Of Organized Home Health Service CODE STATUS: Prior Active Issues Requiring Follow-up Test Results Pending at Discharge Hospital Course HPI: See H&P admit report. Hospital Course: Patient was admitted secondary to weakness and hypoxia she recently did have a bout of COVID-19 and had been discharged home and has been set up for remote outpatient monitoring as per protocol. She returns for ongoing weakness. Patient was continued on Decadron and was seen by physical therapy and Occupational Therapy. The patient slowly continued to improve and was now back to baseline functioning. She may be discharged home and follow-up with PCP as advised as she is no longer on oxygen. She is to complete the dexamethasone dose as she had previously been taking to complete a course. Home health had been previously set up at her previous admission.

Patient complained of "weird feeling in neck and jaw and lips tingling." Nurse administered Diphenhydramine 25mg by mouth at 0945 RN contacted Dr. Patient was advised to contact medical provider for follow up. Patient observed for 15 minute increments after administration of Diphenhydramine 25mg. patient stated that she was better.

swelling of lower lip and other parts of face; swelling of lower lip and other parts of face; This is a spontaneous report received from a contactable consumer or other non hcp. A 81-years-old non pregnant female patient received bnt162b2 (BNT162B2), via an unspecified route of administration in Arm Left on 19Jan2021 10:00 (Batch/Lot Number: ELI283) as single dose for covid-19 immunisation. The patient medical history included hypertension, arthritis, vertigo from an unknown date and unknown if ongoing. The patient had allergies to medications, food, or other products with Codeine, Z-pak, some Sulfa drugs. The patient concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously took codeine and, zithromax z-pack and experienced drug hypersensitivity. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient experienced swelling of lower lip and, swelling of face on 20Jan2021 03:00 primarily noticeable to me and others who know me. Otherwise, not particularly noticeable .The patient visited Emergency room/department or urgent care for the event.Outcome of the event unknown. Follow-up attempts completed. No further information expected.

Cough Pt states been sick for 1-2 wks, can't eat, no taste, fatigue, diarrhea, slight headaches, cough. Had 2nd covid shot 4/29/21. ? Diarrhea ? Fatigue Patient is a 81 y.o. female HPI Pt presents with concerns of possible Covid 19. Pt reports the following symptoms that started 10 days ago. Sinus pain and pressure No Fever/ chills Yes Headache Yes Body aches No Cough Yes Sob No Sore throat No Nausea/ vomiting/ diarrhea. Yes Loss of taste or smell Yes Medications used:Yes Tolerating fluids:Yes Tolerating. solids:Yes Smoke exposure:No Exposed to someone who tested positive for COVID 19: Yes History of asthma, bronchitis, pneumonia. yes Patient felt sick before receiving her second COVID 19 vaccine on 4/29. She states her and her husband were also exposed to someone at church who tested positive x 5 days ago and they were not wearing masks. She does use her rescue inhaler as needed for her cough. ED to Hosp-Admission Discharged 5/5/2021 - 5/17/2021 (12 days) Hospital MD Last attending ? Treatment team Pneumonia due to COVID-19 virus Principal problem Discharge Summary MD (Physician) ? ? Internal Medicine Discharge Summary Hospitalist Medicine Patient: Date: 5/17/2021 DOB: Admission Date: 5/5/2021 PCP: DO Length of Stay: 10 Days Discharging provider: MD Discharge Date: 5/17/2021 Admission Diagnosis Medical Problems Hospital Problems POA * (Principal) Pneumonia due to COVID-19 virus Yes Asthma without status asthmaticus Yes Systemic lupus erythematosus (CMS/HCC) Yes Overview Signed 12/1/2020 7:46 AM by LPN Note: Document: 08/22/19 - Consults Rheumatology - Paroxysmal atrial fibrillation Yes Atrial fibrillation with RVR Yes Esophageal stricture Yes

blood shot eye/Blood shot eye on same side that she got vaccine; This is a spontaneous report from a contactable consumer reporting for herself.. A 81-years-old female patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration, administered in Arm Right on 08May2021 (Batch/Lot Number: EW0168) as single dose for covid-19 immunisation . Medical history included ongoing gastrooesophageal reflux disease , hypertension , ongoing anxiety. The patient received the first dose of BNT 162B2 vaccine on 27Mar2021 and experienced a fall. Concomitant medications included omeprazole (OMEPRAZOLE) taken for gastrooesophageal reflux disease from an unspecified start date and ongoing. The patient experienced blood shot eye/blood shot eye on same side that she got vaccine on 11May2021 with outcome of not recovered. Follow up information has been requested.

Equilibrium affected; I could not hear; I woke up with pressure in both of my ears; Deaf in my right ear; arm soreness; This is a spontaneous report received from a contactable Nurse (patient). An 81-years-old female patient received bnt162b2 (BNT162B2, solution for injection, Batch/Lot Number: TR2613; Expiration Date: 31Jul2021), dose 1 via an unspecified route of administration, administered in left arm on 21Apr2021 at 09:00 as 1st DOSE, SINGLE for covid-19 immunization. Medical history included atrial tachycardia (From: 2015 To: Unspecified), macular degeneration diagnosed about 3-5 years ago, low thyroid hormone seems like she's had forever, high cholesterol just beyond normal has had for years, latex allergy since the 1980's, banana, avocado, and kiwi allergy (states all are interrelated because they are cousins to the rubber tree plant and also healthcare personnel allergic to latex can and may develop a cross allergy to psyllium which is Metamucil), Psyllium allergy (states she had an anaphylactic reaction to a metapower bar in 2015. About 7 minutes after eating the bar, she went into a severe reaction and ended up in the emergency room and stayed overnight. thankfully was at work). Reported having shingles vaccination in 2014 and had shingles 2-3 weeks later, can't remember details. States it was a mild case. NDC, lot, expiry unknown. She stated every flu shot she received, she has gotten the flu and only takes periodically. States she retired in 2017 and had to take in 2016 and 2015, she would have lost her job if she didn't take. It had been 5-10 years before that, and another 5-10 years before that. States she stays away from the flu shot. Concomitant medications included metoprolol ER from Jan 2016 for atrial tachycardia, SYNTHROID started about 15 years ago for low thyroid hormone, Simvastatin ongoing, started about a year ago for cholesterol slightly elevated, OCUVITE PreserVision(Ongoing) taking about 3 years for macular degeneration age related has not changed or gotten worse in 3 years, baby aspirin started Jan 2016 (Ongoing) as cardiologist thought it would be a good idea, Vitamin D3: taking for 3 years (ongoing) for bone health, calcium with magnesium been taking a long time. 5-10 years to prevent osteoporosis (ongoing), glucosamine chondroitin taking since late 1990s. about 20 years for joint health (ongoing), multivitamin taking since 1995 or 1996. about 25 years for general health, vitamin C about 3 years ago started with the Ocuvite (eye doctor though it was a good idea to take together. On April 28th2021 patient could not hear. She was deaf in right ear and the day before on April 27 it was like she woke up with pressure in both ears. It sounded like hell like she was in the airplane and by yawning she could not relieve the pressure and went to the doctor and was under treatment with steroids and antivirals and still deaf in right ear." She confirmed pressure is gone, but still deaf and under medical treatment with otolaryngology. She was kind of tossing whether to get the vaccine or not. First went to family doctor to see, didn't think she had an ear infection because no pain and was hoping maybe she would have wax in her ear, but ears were clean and no wax. So they sent her to an ear specialist and they did hearing test and she has pretty severe hearing loss in that ear. So she was still being treated. First the doctor put her on valacyclovir and methylprednisone for about 7 days and then that didn't seem to do anything and now she's getting dexamethasone injections into her middle ear. States she is due for one about lunch time. Pressure in both ears: patient reported has subsided, but then confirms it is a lasting effect comes and goes a little bit. Left ear is pretty much clear but right ear still has pressure and cannot hear and has not subsided. On an unknown date her equilibrium affected and stated has gotten slightly better, minuscule. Patient added she's pretty healthy and moves about, gardens takes care of business, goes to exercise class twice a week now partially participates because she gets dizzy from moving her head. Patient was treated with Valacyclovir: 1 gram tablet every 6 or 8 hours, states can't remember. Started 05MAY2021 for 7 days. Caller confirmed it did not help and she threw bottle away. Methylprednisone: 4 mg tablet by mouth started dose at every 4 or 5 hours, dose was a decreasing frequency of dose over 7 days. Confirmed she threw package away. Stated cortisone decreases irritation and inflammation. And Valacyclovir is an antiviral. Started dexamethasone injections last Thursday, 20 May 2021. Is scheduled to receive a dose today, will skip next week, and then one the following week, and then one the following week after that, states it is a series of four doses and then if that doesn't help she will have an MRI. Airborne: started taking about one week ago after first dexamethasone injection through tympanic membrane into middle ear. Relevant Tests: Hearing Test (Date: 05MAY2021)Result: pretty severe hearing loss in right ear, Test: Ear exam (Date: 03MAY2021; 05MAY2021) Result: Normal. Outcome for pain in extremity was recovered, for ear discomfort and deafness it was resolving, for hypoacusis and. equilibrium affected it was unknown. Reporter seriousness for pressure in both ears and equilibrium affected: Medically significant, Deafness right ear: Disabling, Arm soreness: non-serious Reporter causality: deafness in right ear: Causality: strong suspicion it's related to the vaccine, maybe not necessarily the vaccine itself, but her immune system reaction to the vaccine. Causality for pressure in both ear, arm soreness and equilibrium: related; 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 events such as deafness,balance disorder and ear discomfort cannot be totally excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.

My teeth were sore/teeth were so sore she felt like she had abscessed teeth on lower jaw: Medically significant; Inflamed gums; Abscessed teeth on her lower jaw; some kind of side reaction; My gums and the roof of my mouth (Incomplete sentence)/my gums were so raw, I couldn't brush my teeth; My mouth became all inflamed; I have a very hard time hearing you; Equilibrium affected; But I am still deaf in my right ear; This is a spontaneous report from a contactable Nurse (patient). An 81-year-old female nurse received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for Injection, Batch/Lot Number: EW0169; Expiration Date: 31Aug2021), via an unspecified route of administration, administered in arm left on 12May2021 20:00 (at the age of 81-year-old) at a 2nd dose, single for COVID-19 immunization. Medical history included macular degeneration (diagnosed about 3-5 years ago), low thyroid hormone (seems like she's had forever), high cholesterol just beyond normal (has had for years), banana, avocado, and kiwi allergy (stated all are interrelated because they are cousins to the rubber tree plant. Also, healthcare personnel allergic to latex can and may develop a cross allergy to psyllium which is metamucil); psyllium allergy (patient had an anaphylactic reaction to a metapower bar in 2015. About 7 minutes after eating the bar, she went into a severe reaction and ended up in the emergency room and stayed overnight), flu (every flu shot she received, she has gotten the flu and only takes periodically. She had to take in 2016 and 2015. It had been 5-10 years before that, and another 5-10 years before that), latex allergy (since the 1980's), shingles (having shingles vaccination in 2014 and had shingles 2-3 weeks later, can't remember details. Stated it was a mild case. Patient gets the shingles vaccine and gets the shingles, gets the flu vaccine and gets the flu), atrial tachycardia from 2015 to an unknown date, anaphylactic reaction to a metapower bar from 2015 to an unknown date (about 7 minutes after eating the bar, she went into a severe reaction). Concomitant medications included levothyroxine tablet at a dose of 50 ug, 1x/day, vitamin B complex and akurit (not clarified hence not captured in tab). The patient previously took first dose of BNT162B2 (Batch/Lot Number: TR2613; Expiration Date: 31Jul2021), administered in arm left on 21Apr2021 09:00 for COVID-19 immunization and experienced deaf in my right ear, I woke up with pressure in both of my ears, I could not hear and arm soreness. The patient drug history included synthroid from an unknown date to ongoing (started about 15 years ago) for low thyroid hormone, simvastatin from an unknown date to ongoing (started about a year ago) for cholesterol is slightly elevated, ocuvite preservision from an unknown date to ongoing (taking about 3 years. Macular degeneration has not changed or gotten worse in 3 years) for macular degeneration age related, vitamin D3 (taking for 3 years) for bone health from an unspecified date to ongoing, calcium with magnesium (it has calcium citrate. Been taking a long time. 5-10 years) to prevent osteoporosis, glucosamine chondroitin (taking since late 1990s. About 20 years) for joint health from an unspecified date to ongoing, vitamin C (about 3 years ago. started with the Ocuvite. Eye doctor though it was a good idea to take together), multivitamin (taking since 1995 or 1996. about 25 years) for general health; metoprolol ER for atrial tachycardia from Jan2016 to an unspecified date, baby aspirin from Jan2016 to ongoing (81 mg daily, cardiologist thought it would be a good idea). The patient reported, she received first Pfizer vaccine on 21Apr2021 and equilibrium affected and on 28Apr2021 she could not hear in her right ear and the day before on 27Apr2021 it was like she woke up with pressure in both of her ears. It sounded like heck like she was in the airplane and by yawning she could not relieve the pressure and went to the doctor and was under treatment with steroids and antivirals and she was still deaf in her right ear. She got second vaccine on 12May2021 and on 16May2021 and 17May2021 her gums and the roof of my mouth became all inflamed and her teeth were so sore she felt like she had an abscessed tooth. My gums were so raw, couldn't brush my teeth. So she gargle with some peroxide and some saline and then her teeth were sore like you have an abscess teeth on lower jaw. And then that went away within two days. Pressure in both ears has subsided, but then confirms it is a lasting effect comes and goes a little bit from 27Apr2021 to ongoing. First the doctor put her on valacyclovir and methylprednisone 4 mg tablet by mouth started dose at every 4 or 5 hours, dose was a decreasing frequency of dose over 7 days. Started 05May2021 for 7 days. And then last week he started me on the dexamethasone injections through tympanic membrane into her middle ear last Thursday, 20May2021. Is scheduled to receive a dose today, will skip next week, and then one the following week, and then one the following week after that, states it is a series of four doses and then if that doesn't help, she will have an MRI. States cortisone decreases irritation and inflammation. Adds she is pretty healthy and moves about, gardens takes care of business, goes to exercise class twice a week now partially participates because she gets dizzy from moving her head. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Outcome of the events I am still deaf in my right ear, I have a very hard time hearing you was not recovered; equilibrium affected, some kind of side reaction was unknown; my teeth were sore/teeth were so sore she felt like she had abscessed teeth on lower jaw, inflamed gums, abscessed teeth on her lower jaw, my gums and the roof of my mouth (incomplete sentence)/my gums were so raw, I couldn't brush my teeth, my mouth became all inflamed was recovered on an unspecified date in 2021. Information on lot/batch number was available. Additional information has been requested.; Sender's Comments: Based on temporal association, the causal relationship between BNT162B2 and the events, unilateral deafness, non infective gingivitis, tooth abcess, toothache, balance disorder cannot be completely ruled out. The impact of this report on 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, Ethic committees, and Investigators, as appropriate

slept all day, very tired; mouth and throat was dry; mouth and throat was dry; problems with stomach, like hurting; stomach felt warm; could taste shot; Felt terrible; This is a spontaneous report from a contactable consumer (patient). An 81-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, in right arm on 06Mar2021 at 09:15 (Batch/Lot Number: EN6200) at the age of 81-year-old as second dose single for COVID-19 immunisation. Medical history included ongoing restless legs syndrome, sinus and nose run. She takes a blood pressure medicine and she has restless leg syndrome that she takes a medicine for. She had a regular check up in Dec2020. Historical vaccine includes BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot EL9269), via an unspecified route of administration, on 13Feb2021 at the age of 81-year-old, as first dose single, for COVID-19 immunization and the patient experienced no adverse events. On 06Mar2021 at 17:30 the patient experienced problems with stomach, like hurting, stomach felt warm, could taste shot and on 07Mar2021 experienced slept all day, very tired, mouth and throat was dry. The patient reported when they gave her the shot she tasted it and then about 17:30 on 06Mar2021 she started having problems with her stomach. Her stomach started hurting. Then it felt like when you put your hand on your stomach like putting your hand on your head for a fever that it felt warm. She felt terrible. On 07Mar2021 she slept all day and she didn't feel like going to work on 08Mar2021 and she's not one that misses work. She only weighs less than 85 pounds, she did not know if her weight had something to do with that. Her husband took the COVID-19 vaccine and he didn't have any side effects. She told her doctor that she wasn't going to get the COVID-19 vaccine until he did. And he got it. It's not like her to sleep all day. She reported her mouth was dry as it could be, like she had cotton in her mouth. She's never sick, she doesn't miss days at work. Is there anything she can take? Her daughter had said people do get sick and it lasts about 24 hours and then they feel better. She took aspirin clarified as Dollar General Pain Relief 500mg, she took 3 at one time. She takes Dollar General Pain Relief when she has a bad headache. She doesn't usually have headaches. She reports the Dollar General Pain Relief did help. Expired 2019 she didn't even see that, that's how much she doesn't use them. She sees AO561 on bottle. She usually does and goes and goes, she's usually doing something. She woke up on 07Mar2021 and her mouth was dry, she has sinus, but her nose usually runs. Clarified nose did has not run since getting the COVID-19 vaccine. Her stomach was better on 08Mar2021 but her throat was still dry. At least her stomach was not hurting. She felt better last night (07Mar2021). She's feeling better and decided take one more day off to not overdo it. She reported that her stomach felt real warm like her stomach had a fever but she did not have a fever and her stomach is fine now. The events did not require emergency room visit or physician office visit. Outcome of mouth and throat was dry was not recovered, outcome of problems with stomach, like hurting and stomach felt warm was recovered in Mar2021, felt terrible was recovering, while outcome of other events was unknown. No follow-up attempts are possible. No further information is expected.

Bleeding of eyes; Bruising of leg; This is a spontaneous report from a Pfizer sponsored program. A contactable female consumer (patient daughter) reported that a 81-year-old (same age at vaccination) female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection) via unspecified route of administration on Feb2021 as single dose for COVID-19 immunization. Caller stated that her mother received the first Pfizer covid vaccine in February and had large bruising that showed up on one leg, then she received the second dose and large bruising showed up on her other leg. while her mother was at her eye appointment, she started bleeding from her eye. Caller stated her mother was now being seen by a haematologist for a bleeding disorder. Caller stated her mother was very active and doesn't take medication for anything, no blood thinners, no heart medications. Outcome of both the events was unknown. Information on the lot/batch number has been requested.

she is bleeding into the eye and that to her is just, it keeps getting worse; thrombo; elevated potassium; had bruising in the other leg; doctor did PTT, confirmed as PTT, and it was elevated; This is a spontaneous report from a contactable consumer (patient). An 81-year-old non pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; formulation: Solution for injection, Lot Number, Expiry date UNKNOWN), via an unspecified route of administration at left arm on an unknown date in Feb2021 (at the age of 81 years old) as a single dose for COVID 19 immunisation. Medical history was not reported. The patient received the medications within 2 weeks of vaccination was Asperin. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; formulation: Solution for injection, Lot Number, Expiry date UNKNOWN), via an unspecified route of administration on an unknown date in Feb2021 experienced adverse events such as large bruising on one leg, after the next dose, bruising on the other leg. She has bruising on both lower limbs, a bleeding disorder. She bled from her eye at the ophthalmologists office. On an unspecified date patient second one, then had bruising in the other leg. She went to the hematologist, and to the doctor. The doctor did PTT, confirmed as PTT, and it was elevated. Reported added that patient also had an elevated potassium. She states this was like what you would get if patient were taking warfarin. it was very concerning now, not only does she have bruising in the leg, but she was bleeding into the eye and that to her was just, it keeps getting worse. She has nothing else to add to that report except that her mom has an elevated PTT, TPTT and states she does not know, it was thrombo. At 81, her mom walks around an hour a day, does aerobics. She was not seeing a hematologist and she was concerned. If she cut herself, she would bleed out. The fact she was bleeding into the eyeball, she has to google the acronym but it was basically clotting issues it was resulting in. No additional details provided; Reporter did not know the name of the elevated test. Information about lot/batch number has been requested.

Feeling unwell; Nausea; stomach upset; sinuses are bad; tiredness; muscle pain; Dizziness; possible ear infection; This is a spontaneous report from a contactable consumer (patient). An 81-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for Injection, Lot number: EN6208, Expiration date: Jun2021), via an unspecified route on an 10Mar2021 and first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for Injection, Lot number: EL9266, Expiration date: 31May2021) via an unspecified route on an 17Feb2021, both as a single dose for covid-19 immunization. Medical history included thyroid and blood pressure. Concomitant medication included lisinopril taking for about 4-5 years and levothyroxine taking may be for 15 years for thyroid. On an unknown date after receiving the first dose, patient experienced stomach upset, nausea, sinuses, tiredness, muscle pain and dizziness. She feels so unwell that she went to the emergency room after the first Pfizer Covid vaccine administered on 17Feb2021 for feeling so unwell. They could not find anything wrong, hence not admitted her. She had improved some but was not really good when she went for the second dose on 10Mar2021. Therapeutic measures taken as a result of the events included antibiotics after the first dose for sinuses and possible ear infection and treated with amoxicillin Clav 875/125mg tablet, dosage two times a day for 21 days, came in an orange colour. The clinical outcome of the events was still experiencing the same side effects after the second dose. No follow-up attempts are needed. No further information is expected.

Shortness of breath; dizziness; numb tongue; This is a spontaneous report from a contactable consumer (patient). This 81-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot Number: EN6199), dose 1 via an unspecified route of administration in Right arm on 05Mar2021 at 01:00PM (at the age of 81 years) as single dose for COVID-19 immunization. The patient's medical history included known allergies to the Opioids. Concomitant medications taken within two weeks included, Gabapentin 300 mg, paracetamol (TYLENOL 500), Acetylsalicylic Acid (ASPIRIN) 81mg, all were received for an unknown indication from an unspecified date and unknown if ongoing. The patient did not receive any vaccine within 4 weeks prior to the suspect vaccine. She did not have Covid prior vaccination. On 05Mar2021 at 01:15 PM patient experienced, Shortness of breath, dizziness and numb tongue. Patient received treatment for the events. She had not been tested for covid post vaccination. Outcome of all the events were recovered. No follow-up attempts are possible. No further information is expected.

Started losing my voice; I can't clear my throat. It sounds scratchy. It has stayed like that. I spoke to my Nurse about it (in home nurse). She said it was "COVID voice." I am now trying to use some local honey (1 T in my coffee) and that doesn't help. I am going to see Ears, nose and throat doctor soon. I still work in real estate and need my voice to be clear. It's hard to push the air through.

The clicking of the bone is a situation; Left brother's house about 2100, doesn't even remember driving away; The caller states or passed out or what the heck ever is going on with the caller's brain; The second dose Pfizer Covid 19 Vaccine was given in the right arm and had the bad side effect of excruciating pain 3.5 hours later and the pain was for some reason was in left arm.; In the evening, after done driving around doing shopping on that Saturday, 15MAY2021, did not know she fell asleep on the couch with the radio on; Had wobbly ankles, knees and hips; Had blurry eyes; Tiredness; After receiving the second dose Pfizer Covid 19 Vaccine, was what thought was a blood clot coming from the nasal area; It was extreme pain. It has not done anything but stayed in the muscle occasionally; This is a spontaneous report from a contactable consumer. This 81-year-old female consumer (patient) reported for herself. An 81-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: EW0176, Expiration date: 20Aug2021), via intramuscular, administered in right arm on 15May2021 (at the age of 81-year-old) as DOSE 2, SINGLE for COVID-19 immunization. Patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: EW0164, Expiration date: 20Aug2021), via intramuscular, administered in right arm on 24Apr2021 at 12:15 or 12:30 (at the age of 81-year-old) as DOSE 1, SINGLE. The patient medical history includes Pneumonia cryptococcal (Dormant Lung disease cryptococcus), Osteopenia, Pancreatic disorder, Crohn's disease and Colectomy (2002), Cancer, Diabetes mellitus and Polyp, aphasia and seizures (1996). Dormant Lung disease cryptcoccus, this comes from pigeons, bats and birds poo flying in the air. With allergies the caller breathed it in on some far at the time in year 2000. Checked every year since year 2000. Gastroenterologist after many undisclosed solution for drastic weight loss since year 2018, now several tests have determined the caller's pancreas and stomach are not cooperating with each other. The caller has many issues with what the Gastroenterologist are doing with the caller, she feels like a Guinea pig. Concomitant medications include PANCREATIN (CREON) for Pancreatic disorder, AMITRIPTYLINE for Cerebral disorder and CYANOCOBALAMIN (B12-VITAMIIN). The patient was taking concomitant products creon because stomach and pancreas not cooperating with each other. In relation back up to brain thing drug for that is Amitriptyline. Began taking probably 12 years ago, 10 years ago at least. B12 was taking for memory, began taking probably 4 years ago courtesy of all the testing the general physician had done. The caller states she was lacking in so much and will be on this for the rest of life. Amitriptyline was supposed to take 10mg pill twice a day but don't take twice a day. Caller is getting antsy about putting too many chemicals in the body. When the caller is crying again will take more amitriptyline. So far just upset about current Pfizer situation. Only member to have Crohn's disease and intestines removed. Gall bladder, caller has not gotten. Cancer, diabetes and polyps in family history. On 15May2021, after the vaccination, the patient experienced bad side effects of excruciating pain 3.5 hours later and the pain was for some reason was in left arm. This arm pain lasted off and on for two days. It was extreme pain. It has not done anything but stayed in the muscle occasionally, and the shoulder joint was picking occasionally, on the left and the caller still had the clicking. The pain was a normal like grade of 2 to 3 type pain at the time of this report. Whenever the caller twinges the pain happens on its own. Patient also experienced wobbly ankles, knees and hips. The caller's walking was terrible, caller states this is just persisting but at a lower level. The caller is concerned because she is a fracture risk person because of osteopenia. Patient experienced blurry eyes and tiredness. The caller usually gets blurry eyes when the caller is not hydrated enough because of loss of weight and the ileostomy bag itself is free flowing so the caller's retention is not good to begin with. The caller clarifies the infectious disease doctor when the caller was reviewed in April, prior to receiving the Pfizer Covid Vaccines, knew the caller was under weight and severely effected because the caller wears an ileostomy bag due to Chron's disease and intestines being removed twice. The caller's absorption is not normal to begin with. When the doctor's office authorized the caller to get the Pfizer Covid 19 Vaccine in the first place it was within a 20 minute response time and nobody evidently checked the caller's chart prior to approving the caller to get this serious serious of Pfizer Covid Vaccines. Which is why the caller is so annoyed. The patient fell asleep on the couch with the radio on. The caller woke up to her surprise not knowing that she had even gone to sleep for a God knows unknown period. The caller continued to listen to all her favorite shows on the Saturday night radio and it happened again, the caller doesn't know the time it was the caller fell asleep again, patient also states that she passed out or what the heck ever is going on with the caller's brain. Patient also experienced tiredness, she states she delivered the grocers and unloaded the groceries and was really wiped out. She also experienced impaired driving ability that on the way back from her brothers house she doesn't even remember driving away at about 21:00. She states God knows how many minutes later in the caller's driveway sitting at the steering wheel of the caller's car. The caller has no recollection of what transpired in the 12 miles from the brother's house to the caller's house. Patient also experienced blood clot coming from the nasal area on 15May2021. It was a tiny blood clot, not normal, red from end to end. A hair, two or three like hair from the head coming out of the left nostril when the caller blew her nose. Tiny, red tipped white, no pain, no drip, nothing except naturally what came out when the caller blew her nose, hardly. caller states this went away and didn't last at all. on 16May2021, the next day with pain in the arm was off and on. On 17May2021 patient called the doctor's office and listed all of her side effects and passed the message to whatever nurse on duty and the nurse consults the doctor. The caller had been told to do the report to Pfizer for anything wrong. Also, the caller went to the Urgent Care, they told the caller she could not get her B12 shot for memory. The caller states her memory is not too good at the present time. The event blood clot from nose assessed as serious. The patient underwent lab test includes loss of wight 97 lbs at the time of vaccine. The outcome of the event thrombosis was recovered on 15May2021. The outcome of the events loss of consciousness, Somnolence, Joint stiffness, Blurry vision, Fatigue, impaired driving ability and Bone disorder was unknown and The outcome of the event pain in arm and myalgia was recovering.

The patient presents for "body is burning", eyes burning, burning urination, muscle aches, sinus drainage. Describes back pain as 10/10.

after first vaccination about midnight, I rolled on to right arm and it hurt really bad, next day I took Acetaminophen and I noticed my lip was swollen, it went down 5 hours and yesterday 1/21/2021 flu symptoms started. Experienced fatigue, weird body ached and pains in strange locations pain in top left top of foot, left hip, back and chills and fever 101.9 and cheeks were flushed. woke up this morning and all aches and pains were gone.

Patient observed for 15 minutes, then went to her car with her daughter, then started having slurred speech, right eye twitching and right hand clenching.

touched the back of her ear, it was tender and very sore; feeling very tender on the gland; Lymphatic glands, those were the ones that got swollen; Headache; Neck was hurting; swollen; Neck was hurting; swollen; dryness, felt it on lips; This is a spontaneous report from a contactable consumer (patient). An 82-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on14Jan2021 at a single dose for COVID-19 immunization. Medical history included arthritis on clavicle, thorax and lumbar. The patient had concomitant medications (unspecified). The patient wanted to report the reactions occurred on 14Jan2021 for the vaccine she got; she got a headache, couple of hours later, her neck was hurting. So, she asked somebody that was with her to check and told her that it was swollen. She also had dryness, felt it on lips. The patient touched her neck and it hurts. It did hurt and it was swollen, the neck. They gave her Tylenol and Benadryl. So, it does help her sleep but the next day, she was not so much hurting. Just had headache. On 17Jan2021, when she touched the back of her ear, it was tender and very sore. It was not as bad as it was. The first day (14Jan2021), she was feeling very tender on the gland. Those were not swollen. Lymphatic glands, those were the ones that got swollen on 14Jan2021. She would like you to know the main cause, they looked and told her it is normal for the lymphatic glands to get swollen after the vaccine. So, the patient guessed that is what she got but she still had a lot of soreness in the back of her neck. Outcome of the event events headache and neck pain was not recovered while unknown for other events. Information on the Lot/Batch number has been requested.

Patient reported sensation of lip tingling 13 minutes after vaccine administration. Symptoms resolved with minutes after removing her mask and drinking water. Patient was observed for 30 minutes with no new or worsening symptoms. She remained well appearing throughout observation.

Approximately 4 days post-vaccination, pt developed L periorbital pain. The pain worsened over subsequent days and she also developed L eye swelling and mild decrease in vision 5 days post vaccination. She saw her primary care physician on 2/10/21. Eye exam showed mild L periorbital edema without erythema, warmth, induration, bilateral eyes PERRL, EOMI, conjunctivae clear, no photosensitivity on exam. Temporal arteries with palpable pulses and nontender. She was referred to an optometrist who on slit lamp exam diagnosed anterior uveitis, mild in severity.

Swelling, pain, redness, left neck to ear. Temperature 99.0 F. Pain increased with eating. symptoms wax and wane. Primary physician not in office but nurse advised me to see Dentist.

fatigue, fever, chills, sharp pain behind eyes, ears, throughout head. generalized severe body aches.

About 3 hours after shot I got diarrhea and it was bad. Pain in arm, dizziness and loss taste and i have not gotten back yet, joint pain, tiredness, fever. I have been so thirsty i have been drinking a ton of water. i had all the symptoms of covid . I had covid in November and symptoms were worse .

10:05 am Pt received vaccine and was seated in observation area. Pt alert, interacting with staff and other pts. 10:15am Pt appears asleep, rouses with touch and when spoken to. Observation area nurse notified, provided pt with bottle of water and helped her take a drink. Nurse then notified pharmacist who came to pt's side. Pt given 25 mg benadryl caplet. Able to swallow it, needed assistance for holding water bottle. Pt breathing regular, pulse regular and easily palpable. 10:25 Pt increasingly lethargic. Nurse and pharmacist with pt. Lips and tongue slowly swelling, responsiveness decreasing. Pharmacist called 911. 10:30am Pt's daughter administered epipen 30mg, L outer thigh. Swelling of lips and tongue quickly resolving. Pt lethargy increasing. Increasingly slow to open eyes and respond to questions. Pulse and breathing continue regular. EMS arrived on scene approx 10:35-10:40. BP 80/60, NSR, pulses palpable, pupils reactive, able to answer questions but slow to respond and weak voice. Pt transferred to Medical Center. In ER pt given IV solumedrol, IV fluids, CXR, EKG. Awake and oriented, arms shaking, weak, requires assistance to stand, intermittently drowsy. Admitted for observation. 3/3/21 pt preparing for discharge, BP extremely high. Pt given metoprolol, BP increased, tachycardia increased, pt very drowsy. Continued to monitor, given Lisinopril, bp decreasing. Pt feeling much stronger, alert, interacting with staff and daughter. Discharged home.

Severe headache, very low blood pressure and blood sugar , dizziness , fatigue that cause fall. Body aches , low grade fever abs coughing and none stop running nose abs very dry throat

Covid Vaccine Chronology March 8 ? 16, 2020: Hospitalized with Covid-19 Virus. Health largely restored to previous level February 25, 2021: Received first dose of Pfizer Covid Vaccine and noted a small red spot and small bump on the arm at the injection site February 26, 2021: Noted the following symptoms; Took Tylenol ? Arm swelling with the bump getting painful and redness expanding ? Very weak and body aching ? Chills and fever ? Headache and nausea February 27, 2021: Noted these symptoms: Took Tylenol ? Felt like I had the virus all over again with every bone aching ? Headache with fever of 100.5. ? Chills with shaking ? Loss of appetite ? Swelling in the arm growing larger with the bump feeling hard and more painful February 28, 2021: Noted these symptoms: ? Stomach hurt and thirsty took some Tums and drank water to relieve it ? Arm very red swollen and painful from shoulder to elbow. Pain in the bump close to level 10. Took pictures ? Still limited appetite ? Body aches ? Night sweats March 1, 2021: Noted these symptoms ? Arm still red, swollen and painful but area away from the bump becoming itchy tried ice but not very helpful ? Chills, fever and body aches dissipating ? Night sweats ? Thirsty ? Able to take a short walk outside March 2, 2021: Noted these symptoms: ? Woke up drenched in sweat ? Still very thirsty ? Labored breathing when we took a walk ? Tried heat and cold on arm which was still painful but the pain level had come down between 8 and 9 ? Saw Dr. who prescribed Traumeel to reduce the redness and swelling in my arm and told me she would do more research but at this point not to take the second dose of the vaccine after hearing my symptoms March 3, 2021: Noted these changes ? Arm still swollen and red with the bump still painful but closer to a 6 or 7. ? Saw my chiropractor, who gently massaged my body back into alignment and showed me some massages for my arm ? Was able to take a walk and the breathing was improved

hearing loss in left ear; tinnitus; This is a spontaneous report from a contactable consumer (patient). A 82-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) (lot number/expiration date: unknown), on 24Feb2021 (at the age of 82 years old) as a single dose in the left arm for COVID-19 immunization. Relevant medical history included known allergies: Keflex. Historical vaccine included: first dose of BNT162B2 lot number=en9581, administration date=03Feb2021 at 02:00 PM, Right arm. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included warfarin sodium (WARFIN), Spironolactone, Torsemide. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 26Feb2021at 14:00 AM, the patient experienced Hearing loss in left ear, and tinnitus. No treatment was received for the events hearing loss in left ear and tinnitus. The outcome of the events hearing loss in left ear and tinnitus was not recovered. 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.

A few days after I received my 2nd vaccine dose on 24Feb2021, I lost hearing in my right ear; extremely light headed; nausea; This is a spontaneous report from a contactable consumer (patient). An 82-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot EN6202), via an unspecified route of administration, administered in left arm on 24Feb2021 at single dose for Covid-19 immunisation. Medical history included hydrocephalus condition-corrected with surgery also wear hearing aides, and seasonal allergies on occasion. The patient was not pregnant. The patient had no known allergies. Concomitant medications included omeprazole (PROTONIX) and simvastatin (ZOCOR). The patient received first dose of bnt162b2 on 03Feb2021 for Covid-19 immunisation and experienced lightheaded and lost hearing in left ear. A few days after she received her 2nd vaccine dose, she lost hearing in her right ear and have become extremely lightheaded and somewhat nausea in 2021. The events resulted in doctor or other healthcare professional office/clinic visit. The patient did not have Covid prior vaccination and was not Covid tested post vaccination. Outcome of events was not recovered.

lost the hearing in her left ear; became light headed; This is a spontaneous report from a contactable consumer (patient herself). An 82-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; lot number: EL9269, expiration date was unknown), via an unspecified route of administration, administered in the left arm on 03Feb2021 at 15:45 as a single dose for COVID-19 immunization. The vaccine facility type was reported as "other." Relevant medical history included hydrocephalus condition, which was corrected with surgery and for which the patient was also wearing hearing aides; all from an unknown date and unknown if ongoing. The patient had no known allergies; however, she had seasonal allergies on occasion from an unknown date and unknown if ongoing. Concomitant medications included omeprazole (PROTONIX) and simvastatin (ZOCOR); both taken for an unspecified indication, start and stop date were not reported. 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. The patient was not tested for COVID post vaccination. Right after the patient received her first vaccine dose (while at the clinic) on 03Feb2021 at 15:45, she became light headed. The next day, on 04Feb2021, she lost the hearing in her left ear. The adverse events (AE) resulted in a doctor or other healthcare professional office/clinic visit. It was unknown if the patient received any treatment for the events. The patient was not recovered from the events.

Got her vaccine, came home drove herself, had no problem whatsoever, felt perfectly fine during the day. She then went out, got lunch, brought it home, nothing about the day was out of the ordinary other than the vaccination. She often stays up too late and watches TV in her recliner and falls asleep. She guesses she didn't put things away properly, and the next thing that she remembers was going into the bathroom to get ready for bed, extremely cold evening. She then remembers when she went to hang up fuzzy robe up in the bathroom on a hanger on the doorway, and when she reached up just at that moment she felt herself falling/passing out. She does not remember the moments before or after the event. She fell over her bathtub that was in the doorway, and remembers the pain of hitting the tub. The next thing she remembers is like she was in a dream, and remembers thinking that she had to call her son as she knew she was in trouble. She does not remember dialing his # at that point, but her memory tells her that she told him that she needed him. She was told that was her 2nd call and she does not remember that. She remembers thinking at some point that she was coming in and out of consciousness, and remembers her son didn't come. She called 9-1-1 and remembers talking to somebody and telling them that she could not get up. She answered that she had her door unlocked and remembers that, and apparently told them that she could not stand up. She remembers crawling, possibly to the front door to unlock it. She also remembers telling the 9-1-1 person to tell the sirens off when they get to the neighborhood. They came and took her to the hospital, but doesn't remember that but then suddenly felt like she was freezing, and asking for a blanket, and asked if somebody opened a door. She does not remember the ride to the hospital, going out of her house, just being so cold she was hurting. She doesn't remember anything whatsoever of being in the ER, running tests. They apparently did 2 CAT scans and 2 MRI's, with and without contrast on both. The ER report said that when they got her that she was having extreme chills, and in a stroke-like condition, she could not see and she could not move her body. No tests indicated that she had a stroke. She doesn't think any of them knew that she had the vaccine, they only knew she was a heart patient, and looking for the stroke by doing typical stroke tests. She apparently had called her son first and told him that she was going crazy, and he called his sister, and then she called him again and said that she needed help, and didn't understand what she was talking about. She had no temperature she was told when they took her to the hospital. At some point she then started to spike her fever, which went up to 103. The next clear memory she has is that she woke up on Sunday in the hospital in a pool of sweat after her fever had broken. She also has a memory that she woke up and somebody was touching her in her privates, and there was somebody trying to catheterize her. At first she didn't understand why and then had a vague memory of trying to get a bedpan under her, and decided to catheterize her. She then back to sleep and woke up on Sunday and was completely waking up then and saw her son sitting there. All memories other than this was vague and in and out. After she was awake on Monday they came and did an EEG of her brain, it was normal. She then was given speech therapy on Sunday afternoon, had 10 questions, and answered 9 of them, but on one of them she told them that she could not do that, and did it the next day again and was able to complete that test. When she fell and hit the bathtub she did hurt her arm from her elbow to halfway toward her wrist. Then they discharged her home with someone with her 24 hours a day and could not drive or use the stairs until she had been seen by her family doctor in a week or two to make that she was safe. She had home health care coming in and PT had been coming as well. She had home health still as of yesterday 3/25/21, and PT discharged her as of yesterday. She has been by herself, and is OK to use the stairs and driving again. She has one more home health nurse visit for them to sign off and say that she is now OK. She did get her 2nd vaccine, and she had minor issues, a weird feeling in her head for 12 hours, but nothing bad enough to take something for it. It was a little uncomfortable and out of the norm for about a day, and at one point the next afternoon was making a sandwich and had something that went through her body and felt like she was going to pass out and got into her recliner. She laid down for about 15-20 minutes, it passed and she has been fine. She had somebody stay with her for 24 hours and has done well since. She is convinced that this reaction did come from the vaccine, and that the first vaccine can cause adverse reactions, and that she does live alone and never occurred to her that she needed somebody to stay with her, and now she is afraid to be alone.

Severe ringing in ears was followed by burning sensation starting in abdomen, then to legs and then to upper body. This happens every night about one hour after sleep. I have no fever. But I feel like I am in an oven. Subsides about one hour later but extreme tinnitus continues. During the day I feel hot but not the same intensity of the nightly attacks. Never had this before. I had a second shot on 2/26 and on that night it was very severe. Still suffering to this date. Primary doctor does not know what I have. Blood work negative except for two positive Ana antibody tests.

overwhelming feeling of dizziness/she felt the sudden urge to faint and then became so dizzy that she had to lie down on the couch; very weak; very tired; she has slept a lot; she felt the sudden urge to faint; unable to visually focus, if she closed her eyes and she opened one eye it would be blurry and the people on TV were sliding off the screen and everything was sliding away; pain behind her left eye into her head; she tried to get up to go to the bathroom the room was spinning; an inner ear problem or problems with the "crystals in her ear"; When she got up, she couldn't put her two feet on the floor out of bed without leaning towards the left; This is a spontaneous report from a contactable consumer (patient). An 82-years-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EN6200) via an unspecified route of administration, administered in Arm Left on 01Mar2021 11:00 as SINGLE DOSE for covid-19 immunisation, at 82 years old. Medical history included history of a stroke from an unknown date (previous history of a stroke 19 months ago). There were no concomitant medications. The patient previously received BNT162B2(Lot# EW5318) on 07Feb2021, at 82 years old for COVID-19 immunization and experienced no adverse event (no reaction). Other historical vaccine included Flu shot (influenza vaccine) on an unspecified date and experienced almost killed her. The patient reported no reaction and no problems (no pain, no nausea, no anything) from the second dose until the evening of 08Mar2021 when she was in her kitchen cooking and chopping vegetables, she felt the sudden urge to faint and then became so dizzy that she had to lie down on the couch. She had an overwhelming feeling of dizziness. A feeling like she wanted to faint, and she never faints. Her daughter got her to the sofa. She couldn't get off the couch. The room spun unbelievably. Everything spun. She went to bed and when she woke up, she felt worse. She states that the dizziness was worse, she was unable to visually focus, if she closed her eyes and she opened one eye it would be blurry and the people on TV were sliding off the screen and everything was sliding away, and she had pain behind her left eye into her head. When she tried to get up to go to the bathroom the room was spinning. It lasted through the next day (09Mar2021). When she got up, she couldn't put her two feet on the floor out of bed without leaning towards the left. She didn't fall. It was so bad she had to grab onto things to walk. During that day they brought her downstairs and she stayed on the sofa and it just got worse. Her daughter had her call her primary care doctor and he said that if her neurologist had heard any of what had happened, then go to the emergency room, to which is where she was 19 months ago with her stroke. She spent the 11Mar2021 and 12Mar2021 in hospital (due to dizziness). They couldn't find anything. She had not had a new stroke. She had every test known to man. They did a full neurological work up including an MRI, CT Scan, carotid artery studies and checked everything and could not find the cause of her extreme dizziness. They did confirm that she did not have a stroke. The told her that she could potentially have an inner ear problem or problems with the "crystals in her ear" which could be causing her dizziness, however, they could not positively identify the cause of her problem. They found evidence of her previous stoke. When they were sending her home, it says on her discharge paperwork, they were going to put her in a vestibular clinic. It has to do with crystals in her ear. She was still dizzy and still walking with a walker which she hasn't had to use in 19 months since her stroke. And she has slept a lot, the night she was discharged on 12Mar2021 and the following day. On 14Mar2021 she woke up a little bit. But on 15Mar2021, she is very tired and very weak and still very dizzy. The dizziness is not the room revolving kind. She is taking an anti dizzy pill. She has to see her doctor tomorrow morning, her neurologist at hospital. The dizziness is still persisting but not as bad and she can jump up and walk and do things with the walker. Regarding tests done at the hospital, she came out with shining colors apparently. All tests came through fine. There was no evidence of stroke, her blood pressure, triglycerides, fluids or liquids, everything tested perfect. When querying if she had gone to her physician's office, she reported she had a morning call with her doctor on a phone appointment and he sent her straight to the hospital. She is still dizzy and walking with a walker which she has not had to use in 19 months. She states that doing a lot of hand-eye coordination exercises at home. She has the television on to check her vision which seems to be returning to normal. She stated, "I just don't know where to go from here." She stated that she has a follow up appointment the following day with her neurologist. She wanted to know if this side effect has been reported and how long she can expect to feel this way. The patient underwent lab tests and procedures on Mar2021 which included blood pressure, triglyceride, fluids or liquids: tested perfect; and CAT scan, EKG had unknown results. On 11Mar2021, CT Scan: unknown results (could not find the cause of her extreme dizziness. They did confirm that she did not have a stroke/they could not positively identify the cause of her problem); MRI: unknown results (could not find the cause of her extreme dizziness. They did confirm that she did not have a stroke/they could not positively identify the cause of her problem). Therapeutic measures were taken as a result of overwhelming feeling of dizziness and unable to visually focus. Outcome of the event dizziness was not recovered; outcome of the event unable to visually focus (visual disturbance) was recovered on an unspecified date in Mar2021; while room was spinning (spinning sensation) was recovered on 09Mar2021, while unknown for the other events.

Symptoms started around 3/30/21, after her second COVID vaccine. Presented to ED with evidence zoster in the V1 distribution of the ophthalmic nerve. Rash on the face was classic for zoster and involved swelling of her eyelids. Started patient on treatment for zoster infection. On acyclovir 10mg/kg q8h.

COVID Vaccine I got my #2 Pfizer last Tuesday Apr 6....no problem at all with #1. The vaccination was in my LEFT arm, and the 1st day or so I didn't really have anything but tiredness. But the last few days have been very painful. I developed swelling on the RIGHT side of my face starting at the temple. That progressed down to the ear area the next few days and was quite painful. Since Saturday my tongue, lips, gums became swollen resulting in barely being able to swallow. Also rash developed and is getting worse. Additionally I ache all over and feel like a very bad case of the flu. I tried Tylenol Extra Strength in the beginning, but that seemed to only ease the pain for about an hour. Now I'm using Advil, which helps for several hours. Is there anything I can do to get relief. This is the 8th day....and it seems to be getting worse instead of better.

Called in to assess patient. Per daughter, " she was feeling jittery and had blurred vision earlier but she said she's feeling better now ". Patient denied dizziness/ headaches/ shortness of breath. BP noted to be elevated at 230/93, HR = 100, SaO2 = 98%. Rechecked after a few minutes still elevated. BP = 223/105, HR = 93. Seen by nurse practitioner on duty with instructions to take patient to urgent care if BP is still above 180 systolic. Patient taken to the urgent care reception accompanied by daughter. Warm hand off to RN on duty. Last V/S prior to transfer - BP = 230/80, HR = 81. No distress or discomfort.

Large hemorrhagic stroke with severe headache & throwing up. Not sure when it actually happened but found her on bathroom floor when I woke up. Transported to local hospital & transported to Neuro icu at major hospital. Now in nursing home with rehab. Unable to assist yet with much therapy. Impaired vision, can't feed herself or sit unattended. Very groggy & sleepy. Never lost consciousness.

This all happened after the second shot I felt nothing except a sore arm after the first shot. I immediately felt dizzy and nauseous. Nausea continued for days--intermittently for 3 weeks. Severe headache, muscle and joint pains, fatigue. Very very cold the fist night. slight fever. In the morning my nightgown was soaking wet. Headache persisted for a few days. Eventually loss of tast but that returned. The only thing that persists is intermittent fatigue and nausea.

Pt sitting for her 15 minute post vaccine period. At end of 15 minutes she was noted to become less responsive and slump in her chair. Speech not clear, could not keep eyes open. Appeared pale and clammy. Lightly retching but did not vomit. With 2 assist were able to get patient to wheechair and then to gurney nearby. BP immediately taken - it was ~ 165/80. Pulse = 70. Pulse ox = 94%. Her color remained somewhat pale. Pt able to talk more clear and state she is a diabetic and requests glucose check. We called a "first responder". Glucose machine arrived and her glucose was noted to be 287. She notes it has been "very up and down lately" and recently made changes in her insulin/med regimen. She states she did eat breakfast and took both her long and short acting insulin. She did eat a cracker and then after ~ 20 minutes wanted to sit up. She sat up and appeared improved but not 100%. Her BP sitting up was ~ 125/70. Pulse remained 70. She then stood up to get into wheelchair but once in wheelchair began to become less responsive again and appeared more pale. She was then put back on gurney with assist of 3 and taken to ER. Per ER note, she did have some vomiting and dizziness. Her BP was initially 222/99. BP improved to 1178/84. She was given meclizine and rested. She felt improved and able to ambulate, and was dc'd from ER.

could not open her mouth almost like lockjaw; could not chew; face was hot and puffy; face was hot and puffy; might have some fever; This is a spontaneous report from a contactable consumer (Patient himself). An 82-year-old male received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot/Batch number: Unknown, ExpirationDate: Unknown) on 30Mar2021 via unspecified route of administration at SINGLE DOSE for COVID-19 Immunization. The patients medical history and concomitant medications were not reported. The patient stated the next morning she could not open her mouth, could not chew, face was hot and puffy, might have some fever also. She took a couple of Aleve, and it went away after couple of days. The patient stated she didn't know for sure if it was related to the Covid-19 vaccine or not. The day that she got the Covid-19 vaccine, later provided as 30Mar2021, she felt fine and never had a sore arm or fever. It was reported that it was almost like lockjaw, that she couldn't brush her teeth or chew. The patient reported that later in the day, the side of her face was all hot and might have been swollen and she took ibuprofen and that the inability to open her mouth went away in a couple of days. The reporter assessed the events as non-serious. The patient reported that she went to the chiropractor a couple of days later and the chiropractor said that he had heard about patients experiencing lockjaw after receiving the Covid-19 vaccine and she looked on Pfizer's website and the AE she experienced was not listed as a side effect. She is just a little concerned as she is scheduled to receive her second dose of the Covid-19 vaccine next week on 20Apr2021. She is afraid that the lockjaw might come back and might be worse. She is just curious if she is the only one that experienced the inability to open her mouth. The patient reported she does not know anyone that had this reaction and it is not listed as a side effect on Pfizer's website. The outcome of the event was recovered. No follow-up attempts are needed; information about lot/batch number cannot be obtained.

chills; fever; achy joints; headache; metallic taste; loss of appetite/lost appetite/no appetite; very weak; tired; uncontrollable teeth chattering; This is a spontaneous report from a contactable consumer (patient). An 82-year-old non-pregnant female patient (patient was not pregnant at the time of vaccination) received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EL 9266), via an unspecified route of administration, administered in Arm Left on 15Feb2021 (at the age of 82-years-old) at a single dose for covid-19 immunisation. Medical history included Hashimoto disease and known allergies: penicillin. Concomitant medications patient received in two weeks included nebivolol hydrochloride (BYSTOLIC); rosuvastatin calcium (CRESTOR); levothyroxine. The patient previously took first dose of BNT162B2 (Lot number: EN-5318) on 25Jan2021 at 02:15 PM in the left arm at a single dose for covid-19 immunisation. On 20Jan2021 at 09:00 PM, the patient experienced chills, fever, achy joints, headache, metallic taste, loss of appetite which lasted for 2 days. On the 5th day after vaccine, I lost appetite again felt very weak and tired all day and by evening I spiked a fever 102.2 with uncontrollable teeth chattering. The same occurred 6th day, metal taste, no appetite, fever 101.2. Today is 7th day, still no appetite and temp are normal. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. No treatment was received for the adverse events. The patient underwent lab tests and procedures which included body temperature: 102.2 on 20Feb2021, 101.2 on 21Feb2021 and normal on 22Feb2021. The patient was recovering from all the events.

Two days after vaccine I started with pain in my jaw joint down my neck into both arms that lasted 2 minutes, then it came back in a couple hours and now it's still coming and going. It's more in my right arm and I cannot lift my arm when it's happening and it leaves me weak, trembling and in a cold sweat and sometimes I'm real hot. In February I went to the hospital and 4 doctors looked at me, I stayed there one day overnight . I kind of think that I was given the whole vial of the vaccine and want to know how long will it take for it to wear off, I watched them draw up the vaccine and they gave me everything in the vial. I think I got the whole vial.

difficulty hearing; headache; pain in neck/shoulder area; pain in neck/shoulder area; unusual severe pressure around upper rib cage increasing over two days; This is a spontaneous report from a contactable consumer (patient). An 82-years-old non-pregnant female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number was not reported), via an unspecified route of administration, administered in Arm Right on an unknown date in Feb2021 at 15:45 as single dose for COVID-19 immunization. Patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number was not reported), via an unspecified route of administration, administered on an unknown date in Jan2021 at 03:45 PM, as single dose for COVID-19 immunization. The patient medical history was not reported. The concomitant medications included furosemide (LASIX [FUROSEMIDE]) and omeprazole (PROTONIX [OMEPRAZOLE]). The patient had reported allergy with shingles vaccine. Patient not received other vaccines within 4 weeks prior to the COVID vaccine. The patient not tested for COVID-19 since the vaccination. On 07Feb2021 at 09:00 the patient experienced difficulty hearing, headache, pain in neck/shoulder area and unusual severe pressure around upper rib cage increasing over two days. The outcome of event was recovered on an unknown date in 2021. No treatment received for the adverse event. Information on the lot/batch number has been requested.

Itching/her shoulder started to itch like crazy/ Was itching so bad like a mosquito bite; Has a little fever; Rash/rash is hot and has a temperature in it/Rash was a week later and was weird; Itching began 25Jan2021 at night at injection site; felt like an anxiety attack; Metal taste in mouth; Funny feeling in chest; This is a spontaneous report from a contactable consumer (patient). A 82-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection), via an unspecified route of administration on 19Jan2021 at 17:30 (Batch/Lot number was not reported) as 1st dose, single for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient received flu shot and experienced shoulder pain, she received first week in Oct2020 at one of the grocery stores, she doesn't remember doing that the last year or before. On 19Jan2021, the patient had metal taste in her mouth and a funny feeling in her chest that felt like an anxiety attack. The next day was fine. The patient was not anxious prior to COVID-19 Vaccine, lasted for a couple seconds and then was gone. It was minor and was not short of breath or anything.On 25Jan2021, the patient had rash and week later 26Jan2021, her shoulder started to itch like crazy. didn't look at it until the next day. Looked in mirror and noticed a rash. Has a little fever, rash was still there and can see the rash around where the point of the needle went in. The patient did not know if that was important.On 27Jan2021 took a picture of the rash and was still there. Feels there was a temperature in the rash, but it was not hurting. Stated the rash site has a fever in it. Rash looked unhappy but took a long time to look unhappy. On day of reporting, patient noticed the rash was hot and has a temperature in it. It was not big and red but was still there. Surprising that rash appeared a week later. The patient did not go through primary care to receive COVID-19 Vaccine. Lab test included mammogram, CAT scan, and testing done at the hospital. A week later rash was weird and was itching so bad like a mosquito bite and was scratching and rubbing it, didn't look in the mirror. The patient doesn't know if rash was there when it started itching. Next day was when she noticed the rash. Stated rashes can itch if they are the allergic type of reaction. Thought it was very strange. On 19Jan2021, the outcome of event anxiety attack, metal taste in her mouth and a funny feeling in her chest was recovered and outcome of other events was unknown. Follow-up (16Apr2021): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.

Dizzy, head pressure, increased sleepiness, headache, nausea, congestion, ringing in ears, chest pain

Pain in her jaws down to her arm and she cannot even lift it.; Pain in her jaws down to her arm and she cannot even lift it.; Pain in her jaws down to her arm and she cannot even lift it.; This is a spontaneous report received from a contactable consumer (patient). A 82-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration on 18Feb2021 (Batch/Lot Number: EL9269) at the age of 82-years-old as single dose for covid-19 immunization. Medical history included heart attack when she was 25 years old. The patient's concomitant medications were not reported. The patient previously received first dose of BNT162B2 on an unknown date for covid-19 immunization. Patient had called about a reaction to the second vaccine on 18Feb2021 and she was still having side effects. Wanted to know if this was a time released drug and how long can she expect the side effects to last. Stated that she has pain in her jaws down to her arm and she cannot even lift it. Stated that it was really bad in her right arm. Wanted to know when she got a pain really bad was there anything that she can do to lessen it and when can she expect it to end. Was wondering if she was given more than the recommended dose. Wanted to know how many doses were in a vial. Wanted to know what would be the side effects if she were given more than the recommended dose or when it will end. Stated that she was in the hospital overnight and they did tests. Was told that she was having a reaction to the vaccine that they thought would not last long but has continued to last. Stated that the hospital did a temporary report. Stated that she had a report completed with Pfizer today. The outcome of the events was not recovered.

Patient was admitted to referring hospital on 5/24/21 for tongue swelling . Per chart review, patient's husband reported spontaneous bruising of right arm and swelling after received 2nd dose of COVID vaccine, which eventually came down. Repeat swelling occurred about 2 weeks prior to index admission, and was started on antibiotic for suspected cellulitis (cephalexin). Also reports of spontaneous brusing, as well as one episode of bleeding/oozing. At the ED, blood work revealed low hemoglobin (5.6) and PT 14.3, PTT >120. She was nasally intubated for airway protection. She was transferred to our institution on 5/25/21 for hematology work up and evaluation. Hematology evaluation is highly suspicious for acquired factor VIII inhibitor, and later confirmed with laboratory tests. She received recombinant factor VIII replacement (Obizur) as well as Emicizumab, as well as rituxamab for treatment acquired factor VIII inhibitor. Patient current still hospitalized.

swelling and tingling on upper lip, right side; swelling and tingling on upper lip, right side; Slight swelling on roof of mouth on right side.; This is a spontaneous report from a contactable consumer or other non hcp. An 82-years-old female non pregnant patient received first dose of bnt162b2 (BNT162B2(PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection, Batch/Lot Number: En6206) via an unspecified route of administration, administered in arm left on 06Mar2021 11:00 (Facility type Vaccine: Hospital) as first dose, single for COVID-19 immunization. The patient was not pregnant at the time of vaccination. The patient had no known allergies. Medical history included tachycardia. Concomitant medications included aspirin (ASPIRIN [ACETYLSALICYLIC ACID]) and digoxin (DIGOXIN). The patient did not receive any other vaccine in four weeks. Prior to vaccination patient was not diagnosed with COVID. Post vaccination patient did not test for COVID. It was reported that, about 11:30 AM slight swelling and tingling on upper lip, right side and slight swelling on roof of mouth on right side. This report is being created at 4:55 and took Benadryl at 4:30 on the advice of pharmacist and effects are still ongoing. The patient received treatment for the events. The outcome of the events was recovering. No follow-up attempts are possible. No further information is expected.

Developed pulsatile tinnitus right ear after first shot; This is a spontaneous report from a contactable consumer (patient). An 82-year-old female patient received first dose of bnt162b2 (BNT162B2), via an unspecified route of administration, administered in left arm on 06Feb2021 10:30, at the age of 82-years-old, (Lot Number: EL9581) as SINGLE DOSE for covid-19 immunisation. Medical history included artificial mitral valve. Patient has no known allergies. The patient is not pregnant at the time of vaccination. The patient did not have COVID-19 prior vaccination. On 16Feb2021, patient developed pulsatile tinnitus right ear after first shot. The patient went to the doctor for tinnitus, had MRI and CAT scan. All tests were negative. Right side got better after several days. No treatment was received for the event. The patient was not tested for COVID-19 post vaccination. The outcome of the event was recovered. No follow-up attempts are needed. No further information is expected.

Patient reported pain on left side of neck and a visual disturbance. Vital signs obtained: At 1400: 230/115 pulse, 140 pulse ox of 92% on room air. The medic was called. At 1415 BP 260/120 apical pulse of 180. At 1430 BP 266/118. The patient was transported.

Sharp shooting pain in right ear Noticed mfufled like sound reception in right ear (got second vaccionation shot in right arm) This has lasted since 3/11/2021 and finally saw ENT and had CT scan to see if neuroma and/or tumor in brain or inner ear NEGATIVE FOR BOTH Had hearing test and right ear has severe hearing loss.

Severe headaches, pain in body, night sweats, weakness in legs, tiredness, lumps throughout body, ringing in ears, unbalanced when walking

The day after the second shot i had a low grade temperature of 99.3, Severe muscle aches, and very tired. I began to have huge amounts of blood mucus, spitting it up and choking on it. Was given a sinus infection amoxicillin antibiotic and musilix and nasal sprays. 2 weeks The heavy blood mucus traveled into my eustachian tubes, imparing my hearing and making me off balance...3 weeks. Experienced sever headahce for a week and went to ER for Ct scan . No stroke or anyerism . Then the heavy bloody mucus went into my bronchi and lungs causing shortness of breath and weakness...given a pneumonia antiibiotic . I am currently on a prescription for Prednisone ( on the refill) and improving slightly but still weak and tired and shortness of breath. Still having shortness of breath (6/26/21_ and very tired. Cannot perform all my daily functions like taking a walk . I am able to prepare meals. adverse reaction still exits 2/25/21 - 6/26/21

had previous shortness of breath but got much worse after vaccination, heaviness in chest, extreme fatigue and weakness, wheezing in chest, fuzzy eyesight, can't focus eyes, feels as if eyes are going cross-eyed, muscle weakness, trouble walking, previously had headaches but more frequent and worse since vaccination

Tingling lips; nose and cheeks tingling; Chest tightness; This is a spontaneous report from a contactable consumer (patient). An 82-year-old female patient received bnt162b2 (PFIZER-BIONTECH mRNA COVID-19 VACCINE, solution for injection, Batch/Lot Number: EN6206), dose 1 via an unspecified route of administration, administered in arm right on 28Feb2021 (at the age of 82-year-old) administered at approximately 13:30-13:45 (at the age of 82-year-old) as dose 1, single for COVID-19 immunisation. She did not have prior vaccinations in 4 weeks. Medical history included multiple allergies. she had allergies to Penicillin and Sulfa, since in her 40s. Concomitant medications included (procaine hydrochloride) NOVOCAIN taken for an unspecified indication from 24Feb2021 to an unspecified stop date. She had dental work on Wednesday, 24Feb2021, that included a shot of Novocain. She said she wondered if the Novocain shot had anything to do with the COVID-19 Vaccine causing the tingling in her lips, nose and cheeks, since everything she experienced on 28Feb2021 happened in her face area. She did not have the Novocain dose, NDC, Lot, and Expiration Date. The patient previously took codeine experienced drug allergies. She said her second COVID-19 Vaccine was a couple days before the recommended 21 days between COVID-19 Vaccine doses. The patient experienced tingling lips, nose and cheeks tingling, chest tightness on 28Feb2021 at 22:00. She clarified the tingling in her cheeks was higher up around her cheek bones. She said her cheek tingling was not as strong as the tingling in her lips and nose. She had allergies, and was scared, so she went to the emergency room. She clarified her lips, nose, and cheeks tingling started approximately 5 hours after she received her first COVID-19 Vaccine shot. She said she went to the emergency room about 5 hours after the tingling started, at 22:00 (28Feb2021). Treatment was reported as she was given 1 intramuscular shot of Benadryl while she was in the emergency room. She said she did not know the Benadryl dose or the Benadryl NDC, Lot, and Expiration Date. She clarified the intramuscular Benadryl shot did not effect her lip, nose and cheek tingling at all. She said she was wondering if she should get the second COVID-19 Vaccine shot. She was discharged home from the emergency room after about 2 hours. She said she was given a prescription for oral Benadryl 25mg by mouth, four times a day, as needed, for itching and allergies (30 tablets). She said she did not fill the Benadryl 25mg tablet prescription because she did not think the Benadryl prescription was necessary. she also had felt a little tightening in the center of her upper chest area, towards her throat. She said the chest tightening was very slight, so much so, that she thought the chest tightening maybe her imagination. She said the slight chest tightening went away sooner than her lip, nose, and cheek tingling. The tingling in her lips, nose, and cheeks was much less by the next morning (01Mar2021) and was completely gone by noon (01Mar2021). She said she called her dentist on 01Mar2021 to ask if he thought the Novocain could have contributed to her lips, nose, and cheeks tingling. She said her dentist told her he didn't think the Novocain had anything to do with the tingling she experienced after getting the COVID-19 Vaccine. She said she had Novocain in the past, and Novocain had never caused her to have a reaction. The second COVID-19 Vaccine dose was scheduled for 19Mar2021. The outcome of the event was recovered on 01Mar2021 No follow-up attempts are possible. No further information is expected.

slight hearing loss; I started with ringing in my ears; unable to sleep; This is a spontaneous report from a contactable consumer (patient). An 82-year-old-female consumer (no pregnant) received the second dose of BNT162B2 via an unspecified route of administration on the left arm on 26Mar2021 at 02:00 PM (Lot Number: ER8732) at the age of 82-year-old as single dose for COVID-19 immunization. Medical history included history of high blood pressure. The patient previously received the first dose of BNT162B2 via an unspecified route of administration on the left arm on 05Mar2021 at 02:00 PM (Lot Number: EN6204) at the age of 82-year-old as single dose for COVID-19 immunization and no reaction on previous exposure to drug. The patient previously took Percocet (PERCOCET [OXYCODONE HYDROCHLORIDE; OXYCODONE TEREPHTHALATE; PARACETAMOL]) used for unknown indication and experienced drug allergy and took codeine used for an unknown indication and experienced drug allergy. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received BP Medications within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 03Apr2021 at 08:00 AM, the patient started with ringing in ears (head) that had never stopped since that day. The patient unable to sleep since that day due to the constant noise. The patient had been to primary care Dr. and also an ENT Dr. The patient not deaf but do had slight hearing loss. The events all result in doctor or other healthcare professional office/clinic visit and the events of hearing loss and ringing in ears also result in disability permanent damage. The treatment was received with Steroids x 10 days. The outcome of event was not recovered.

Severe headache for 24 hours. Severe Double, Blurry Vision. Did not need glasses before the vaccines but now needs glasses with prisms. After the second shot my eyes got much much worse. The Vision problem is still affecting me.

Blurred eyes; Weak; Blood pressure and heart rate off the wall; Blood pressure and heart rate off the wall; Swelling of the face; Mouth was swollen, just her face and her lips were real swollen; Mouth was swollen, just her face and her lips were real swollen; Tiredness; Had a bowel movement, it was white-looking and smelled like a chemical; Urinating cloudy and with a chemical smell; her eyes were so foggy; Running from nose; Coughing; Having trouble thinking; This is a spontaneous report received from a contactable consumer or other non hcp. A 82-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/lot number was not reported; Expiration Date: Feb2022) via an unspecified route of administration in Arm Right on 05Mar2021 13:20 (age at vaccination 82years old) as single dose for covid-19 immunisation. Medical history included ongoing blood pressure measurement. The patient's concomitant medications were not reported. The patient experienced running from nose, coughing, her eyes were so foggy, urinating cloudy and with a chemical smell on 05Mar2021, blood pressure and heart rate off the wall, swelling of the face, mouth was swollen, just her face and her lips were real swollen, weak, tiredness, had a bowel movement, it was white-looking and smelled like a chemical on 06Mar2021, having trouble thinking on Mar2021, blurred eyes on an unspecified date. She has never reported the side effects that she had, and her daughter told her should have done that. She found her papers and now she is 82 and she got her first shot on 05Mar2021. Patient reported as she felt fine then she got up to leave and her nose started running and it was just like water was pouring out and she made it up to the front and had Kleenexes in her pocket, then started coughing violently, her nose was running violently and trying to come out of her mouth, and she sat down on the chair there and she thought it will pass. she walked out to look for the person that took her out there and she saw exactly where they parked, and her eyes were so foggy she could hardly even see the car. She felt okay then the next day, she got up and her mouth was swollen, just her face and her lips were real swollen. However, her whole face was swollen. she didn't read the side effects to it and thought oh well, it's just some-thing. The next day her blood pressure was going off the wall, her heart rate was horrible, she called the doctor, they wanted her to go to the hospital. The doctor told her to take Benadryl, and Benadryl bothers her, and she said that made her worse. It made her worse. She further clarified made her worse as, it made her heart worse, dizzy and lethargic and she was already tired anyway. she would have been better off not taking it. Her heart rate, which is always normal or very good, and it was like it was going ninety miles an hour. she would get it to slow down then it would feel like it was going 90 miles an hour for a few days then she was really weak and her mind, which at her age she has a very good mind, they tested that, she was having trouble thinking. she guesses she would call it foggy. she wanted to sit down and pay bills, but she couldn't even concentrate. Her question is she had the first shot but now she's afraid to get the second shot because of what it did the first time around. she's afraid it will do double; they say it's a worse reaction. The card that she had, she said that her nose was running so bad, she shoved the card in her purse and looked in her purse later and she can't even find that card. She will say she can't get the flu shot because in the past, she had a very bad reaction from the flu shot, she was questioning whether to get this vaccine or not. It wasn't a live vaccine. she is scared to death of the virus and her kids wanted her to get it now, hurry, hurry, and she thought she would try it. Since she has reactions to suspect product, she's concerned about getting the second one. That was 10 years or more that she had the bad reaction. She is a person that her body is very sensitive. Her doctor has trouble getting medicines she can take. She has a bad back, she has tired every painkiller there is and she can't take any of them, they are worse than the pain. She has trouble seeing too. She keeps every-thing up, they don't give as many papers and it changes every week. She doesn't know how the people in the medical profession can take it, she imagines they change things on them overnight. She has macular. She couldn't understand with that shot why she could see whenever she went in and after she got the shot then everything was fogged when she came outside, but she knows it still wasn't as bad as getting the virus. She's still weak, but she's gotten better. They said she could leave, her nose started running and she started coughing. The girl said is she okay and thought she was, and she made it out then started coughing violently and that water was almost drowning her. She sat down in the chair, and it finally calmed down and got in the car, kept wiping that water with paper towels in her car and coughing and by the time she got home it was slowed down. She is more tired than usual, and her eyes haven't cleared up as good as they should. She doesn't know what that happened, it just came out of there and thought well god what has happened to her eyes. She has an appointment with the Optometrist at the end of April. Another thing she forgot, they are going to think she's looney, she started urinating that evening and she thought, this is not good, something was going on with her kidneys, because it was cloudy-like and had a chemical smell and then the next morning, she still smelled the same thing and her bowels were the same way, just smelled this chemical. That evening her urine was like that and the next morning she noticed it was like that into the next day, whatever was in there had to come out and then her urine and things cleared up. Started on 05Mar2021, that evening, when she urinated before she went to bed it was cloudy and had this chemical smell, maybe it was something she ate or something. The next morning, she urinated a lot and it was cloudy and the bowel movement, it was white-looking and smelled like the chemical and cleared up. She has recovered completely after whatever was in there got out the next day. She states she was okay after she did all that, she cleared up. The clinical outcome of the event blurred eyes was unknown, another events week, her eyes were so foggy, having trouble thinking, tiredness was recovering, and event running from nose, coughing recovered on 05Mar2021, blood pressure and heart rate off the wall was recovered on 09Mar2021, swelling of the face, mouth was swollen, just her face and her lips were real swollen was recovered on an unspecified date Mar2021, urinating cloudy and with a chemical smell and had a bowel movement, it was white-looking and smelled like a chemical was recovered on 06Mar2021. Therapeutic measures were taken as a result of swelling of the face (swelling face), mouth was swollen, just her face and her lips were real swollen (mouth swelling), mouth was swollen, just her face and her lips were real swollen (lip swelling). Information on Lot/Batch number was available. Additional information has been requested. Follow-up (05Jul2021): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected. No follow-up attempts are possible, information about lot/batch number cannot be obtained.

Tinnitus Tremors Diaphoresis Sob Epipen given, paramedics called, sx resolved 20 minutes after sx onset

At approximately 11:09 am, patient began complaining of dizziness, headache, blurry vision and nausea. Patient states that she had a headache on arrival and took her bp meds this morning. Patient released by EMS to home with friend on site.

had trouble breathing; toung was greatly swolen; This is a spontaneous report from a contactable consumer (patient) reported that an 83-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3246, expiration date: not reported), via an unspecified route of administration in the left arm on 11Jan2021 09:30 at a single dose for COVID-19 immunization. Medical history included very mild chronic obstructive pulmonary disease (COPD) from an unknown date. Concomitant medications included sertraline, temazepam, levothyroxine and pravastatin. It was reported that on 11Jan2021, the patient had injection at 9:30 am then at 6 pm, had trouble breathing and tongue was greatly swollen (reported as "toung was greatly swolen"). The patient called ambulance and went to emergency room/department or urgent care. As treatment, the patient received saline IV, banophen and prednisone. The outcome of the events was not recovered.

Patient left the clinic after 15 minute observation. 5 minutes later called and reported facial and lip swelling. No other c/o's. Instructed patient to go to ER. Arrived at ER 5 minutes later. Symptom improved and resolved to bassline without intervention. Patient left ER after 15 minutes with no intervention.

swollen lips; tightening of her neck was more intense after receiving the vaccine, it felt like the left half of her throat was tightening; tightening of her neck was more intense after receiving the vaccine, it felt like the left half of her throat was tightening; tightening of her neck was more intense after receiving the vaccine, it felt like the left half of her throat was tightening; chills and shaking; chills and shaking; red dot on the inside of her throat; she took the Benadryl thinking it was an allergic reaction; swelling on left side where the nodule was removed; burning sensation in her left arm; ear pain; nausea; This is a spontaneous report from a contactable consumer (patient). An 83-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), intramuscular on Left deltoid (upper left arm) on 13Jan2021 14:00 at single dose to prevent COVID. Medical history included sulfa drug reaction, high blood pressure diagnosed in 1970s or 1980s (States she was in the hospital in the 70s or 80s. She has high blood pressure which has been difficult to control, she is seeing a cardiologist and he is content with her blood pressure readings, her diastolic is normal), incontinence, thyroid nodule surgery a year ago (2020), thyroid nodule, ten operations in the last 3 years, tightening in her neck repeatedly since her thyroid nodule surgery, scratchy throat problems since a week prior to getting the vaccine (from Jan2021) and post nasal drip and she has had that for years and when they operated nothing worked. The patient's concomitant medications were not reported. The patient previously took cipro where she could not breathe. She does not have lot, ndc or expiration date to provide for any of the medications mentioned that she had a reaction to. She took the Asiatic flu shot in 1958 (as reported), she had a reaction and high fever, weak and pale. This occurred when she was 19 years old. She took the Pfizer covid 19 shot last Wednesday. She stated that it could be her but she got a few of the reported side effects. What she found most important was that she had swollen lips that started about an hour after receiving the vaccine. Last night (13Jan2021) she got the chills and was shaking during the night. She had mild chills in the last few days, during the night she was shaking from the chills but it may have been cold at night, reporting the chills have subsided but she can feel it a little bit. In Jan2021, she felt a burning sensation in her left arm which lasted about two minutes. She got a piercing earache in her left ear for about two minutes and then it went away. She experienced nausea within two minutes, but she ate the ginger candy she had in her purse and her nausea went away. She could have something else too since she has a red dot on the inside of her throat. She did not see it was red before last night (13Jan2021). She took Benadryl on Wednesday afternoon after she called the doctor's office, she took the Benadryl thinking it was an allergic reaction, her swollen lips seemed like it was improved but now it was minor. She has had the tightening in her neck repeatedly since her thyroid nodule surgery but she felt the tightening of her neck was more intense after receiving the vaccine, it felt like the left half of her throat was tightening, it is sort of still ongoing but states it has sort of improved. Patient also mentioned swelling on left side where the nodule was removed. She was asking if she should get the second dose. She has an appointment for her second dose. She has never had much problems till she was 80. Her husband tested negative for covid and she tested negative in Aug2020 prior to one of her surgeries. Patient stated that she is 83 but she is biologically younger. She felt pretty good normally. The events did not require emergency room visit or physician office visit. No prior vaccinations (within 4 weeks). The outcome of the events burning sensation in her left arm, ear pain and nausea was recovered in Jan2021; Swollen lips, tightening of her neck was more intense after receiving the vaccine, it felt like the left half of her throat was tightening, chills was recovering; and unknown for the other events. Information about batch/lot number has been requested.

Two days after injection noted swelling to lips not both at the same time but goes back and forth between the two, then two days later noted fever blister on bottom lip and tongue felt sensitive. These sx have continued off and on.

First day following vaccine, very tired. some blurred vision the next few days. on fourth day following vaccination, blurred vision, unstable walking felt like having Vertigo. Today the 16th, all adverse symptoms are gone

Left jaw visible swelling, and perceived left side of tongue and left side of throat "felt swollen"; this occurred at 2 am, 17 hours post vaccination, and again a week later at 11 pm at night; both times symptoms did not impared breathing or swallowing and resolved after taking Benadryl, sipping water, and gargling with salt water

Adverse events experienced and are they still occurring now: -double vision (MRI done last week and everything seemed normal) What happened as a result of the adverse event? went to her pcp and did various check ups and everything was normal, doctor still recommended her to get her vision done also went to the eye doctor and they told her she doesnt have anything abnormal

Sever swollen hives on face, head, neck, and torso. Itching. Went to ER, they gave a injection of dose of Pepsid and told her to take claritin and pepcid daily. Said it should clear up. She has been doing that now her eyes are itching and body again, plus has a sever sore throat now.

We did not immediately recognize a connection between hearing loss and vaccine. next day??? we noticed drastic drop in her hearing..I had to speak loudly, almost shouting.. Local ear doctors were not taking new patients so we did nothing.. wait and see! we are 99% sure vaccine was cause of hearing loss...hope it is not long lasting...we approach our second shots on 03/05/2021 with some trepidation. (there has been no change in her hearing to date..

after I got my first shot, I noticed once in a while I couldn't taste anything; This is a spontaneous report from a contactable consumer (patient). An 83-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; batch/lot number and expiration date unknown), via an unspecified route of administration on 08Jan2021 at a single dose for covid-19 immunisation (because they want everybody to have the vaccine and age). The patient has no medical history and concomitant medications. After the patient got her first shot, she noticed once in a while that she couldn't taste anything but that wasn't all the time. The patient stated that they want everybody to have the vaccine and age. And they started with the older people which that is her, she was 83 so that's the reason she was getting it. It was not a prescription; in her town, they are giving them free. So, the patient did not have to have a prescription. They went by age. The outcome of the event was unknown. Information about Lot/Batch has been requested.

she was not feeling well/she just has not felt good, just have felt blah; just can't taste anything; pain in her arm; Injection site did have a little pain; Tiredness; Muscle pain; This is a spontaneous report from a contactable consumer (patient herself). An 83-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EL9262), via an unspecified route of administration, on 28Jan2021, at single dose, for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number unknown) on 08Jan2021 for covid-19 immunization and experienced couldn't taste anything. The patient called about the vaccine as she was having some effects. She stated she got the first shot on 08Jan2021 and, last 28Jan2021 she got the second shot. She informed she was given a "paper" to tell her of the effects that one might possibly have when getting the shot, and then she checked all of those. On 30Jan2021, 2 days after the shot, she was not feeling well. She stated her injection site did have a little pain on Jan2021, but it was okay, it went away the next day. She also had on Jan2021 some tiredness and muscle pain which was on there; other than that, she just has not felt good, just have felt blah. She informed that her lymph nodes were not swollen, and she has not been nauseated or have had any of these things written on the paper. She also informed having read on the paper that "the people with Covid-19 and it gave the symptoms of people with COVID 19 and one of them was loss of taste, and smell was okay". She then added that after she got her first shot, she noticed once in a while she couldn't taste anything but that wasn't all the time. But now, since she got the second shot, it seemed like all day yesterday, 30Jan2021, and this morning also, that she just can't taste anything. Then she stated "So, my problem is, would that be a result of the shot?" She stated she was feeling a little bit better today other than that, her mouth - she can't taste anything. Also, yesterday, she took an extra strength Tylenol every 4 hours to try to help with the pain in her arm on Jan2021; but she has not taken any today. She was just trying to help her arm feel better. The outcome of the event injection site did have a little pain was recovered on Jan2021. The outcome of the event she was not feeling well/she just has not felt good, just have felt blah was recovering. The outcome of the event just can't taste anything was not recovered. While the outcome of all other remaining events was unknown.

Pounding in head; Heart pounding; Elevated BP; bouncing off the walls, and going from side-to-side when she tried to walk; oxygen saturation level kept dropping; shaking; cold; Weakness; Tiredness; Throat tightness; Dry mouth; This is a spontaneous report initial from a contactable nurse and follow up from a Pfizer-sponsored program. This Nurse (patient) reported for self that the 83-year-old female patient received first dose of bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN6200), via an unspecified route of administration on 17Feb2021 09:30AM on right arm at single dose for covid-19 immunization. Medical history included rheumatoid arthritis from an unknown date and unknown if ongoing Reported she was diagnosed with Rheumatoid Arthritis about 10 years ago, fibromyalgia from an unknown date and unknown if ongoing and stated when the doctor couldn't figure out what was causing her pain, the doctor said she had Fibromyalgia, carotid endarterectomy from 2014, pain in extremity from an unknown date and unknown if ongoing She said she has rheumatoid arthritis, and has had terrible leg pain for a long time. Family Medical History Relevant to AE(s) was not provided. Concomitant medication included cortisone (CORTISONE) for Pain in leg from 10Feb2021 and stated her doctor gave her a Cortisone shot in her right knee to help with her right leg pain. Reported she received a Cortisone shot in her right knee on Wednesday, 10Feb2021. She said the doctor gave her the Cortisone shot in her right knee to see if it would help her right leg pain. She said she has a problem with Cortisone, clarifying the Cortisone keeps her awake. She said the doctor wanted her to have another Cortisone shot in 3 months, and she is not going to take the Cortisone shot because she doesn't like how the Cortisone makes her feel. The patient experienced pounding in head (hospitalization, medically significant), heart pounding (hospitalization, medically significant), elevated bp (hospitalization, medically significant), bouncing off the walls, and going from side-to-side when she tried to walk (hospitalization, medically significant), dry mouth (medically significant) all on 17Feb2021 with outcome of recovering, throat tightness (medically significant) on 18Feb2021 with outcome of recovering, weakness (medically significant) on 19Feb2021 with outcome of not recovered, tiredness (medically significant) on 19Feb2021 with outcome of not recovered, oxygen saturation level kept dropping on an unspecified date with outcome of unknown, shaking on an unspecified date with outcome of unknown , cold on an unspecified date with outcome of unknown. He experienced terrible pain in the leg after the 1st dose and took a marijuana cookie and she was rushed to the ER because she was shaking and cold. The patient was hospitalized for events pounding in head, heart pounding, elevated bp and bouncing off the walls, and going from side-to-side when she tried to walk from 17Feb2021 to 18Feb2021. The nurse states that "I told her up until a Month ago, she was taking care of a huge house and husband that is blind. I've been having the pain in my legs for over a month, doppler was done, and I had an injection in my knee with cortisone, I won't do that again, it keeps me awake at night. There is no diagnosis yet on the pain, have an orthopedic appointment coming up. Caller states, I got the first Pfizer vaccine shot on Wednesday at 9:30 am in right arm. Never so much have felt it. or have not felt anything else since. My friend talked me into eating a marijuana cookie about 5pm that day, and at 6 or 6:30pm, I started feeling terrible, my head was feeling terrible, my heart was pounding, I could hardly walk, my mouth was dry as a bone. we called paramedics, we found out on Friday before the shot that I have a right bundle block. Woke up 4:30 in the morning the Friday before with chest pain. EKG found right bundle block, my blood pressure was 245/105, that night in the ER, they got my blood pressure down and sent me home. Wednesday, I had the covid shot in right arm, at 9:30am, that day about 4:30 - 5:00 had the cookie thing, about 6pm, had to call the paramedics, they kept me in the hospital overnight. because my oxygen saturation kept dropping, down in the 86% or 89%, I don't know. Gave me breathing treatments, CT scan for blood clots in lungs was done, Doppler for blood clots in legs, and a HgbA1C. They did an echo of my chest. I don't know all of the results yet. Even yesterday, in the hospital I felt better, but feel week and tired, while walking the hall in the hospital my Blood pressure went up a little bit. I told the nurse, my head feels like this when my blood pressure is up. They sent me home last night. Today, I am feeling okay. My mouth is still a little dry, got a little better yesterday. My legs are still killing me, I have an appointment with my Cardiologist and Rheumatologist, I have Rheumatoid Arthritis. My question is , the doctor didn't know if it was from the cookie or from the vaccine. I am wondering if I should get the second vaccine." She stated she never had a sore arm after getting the COVID-19 Vaccine. She said she did something stupid after she received the COVID-19 Vaccine. She said she has rheumatoid arthritis, and has had terrible leg pain for a long time. She said her friend talked her into having a cookie that had marijuana in it. She said her leg pain was so severe at the time, she took the cookie with marijuana in it around 4:30PM-5:30PM on 17Feb2021. She said at 7:00PM she was bouncing off the wall (clarified as unsteady, and going from side-to-side when she tried to walk), her head was pounding, her heart was pounding, she was dizzy and shaky. She said she went to the hospital emergency room. She said the hospital kept her overnight because her oxygen saturation level kept dropping. She said she got home from the hospital last night (18Feb2021), clarifying she was discharged from the hospital at 6:00PM. She said she noticed her mouth was very dry when she went to the hospital on 17Feb2021, and her mouth continued to stay very dry all night. Caller asked if she should get the second COVID-19 Vaccine shot after experiencing what she did after receiving the first COVID-19 Vaccine. Reported her leg pain became severe about a month ago, clarifying she has had leg pain for a long time. Reported her blood pressure was up while she was at the hospital, clarifying she had one blood pressure reading of 145/82 that she recalls. She said her blood pressure is pretty normal, and she takes blood pressure medications. She said she believes her heart rate was up too, but was unsure what her heart rate was. Reported a couple days before receiving her first Pfizer COVID-19 Vaccine, she went to her doctor on 12Feb2021 because she was having severe chest pain. She said her doctor did an EKG and told her she had a right bundle branch block. She said her doctor sent her to the hospital Emergency Room. She said while she was in the Emergency Room she had an extremely high blood pressure of 245/105. She said she came home from the Emergency Room on 12Feb2021, and had a couple spells, but was OK. She said she was OK when she went to get her first COVID-19 Vaccine shot on Wednesday, 17Feb2021. Reported she had difficulty reading her COVID-19 Vaccine Immunization Card. She said the Pfizer COVID-19 Vaccine Lot Number looked like EN6200, and there was no NDC Number, or Expiration Date listed on the card. Reported she had blood work done at the hospital. No further details provided. Treatment included she was given Albuterol breathing treatments while in the hospital, along with some other things that she can't remember. Reported she believes her symptoms were medically significant because she was nervous from recently being to the Emergency Room for her severe chest pain a few days before. Reported she did not think her symptoms were from the COVID-19 Vaccine. She said she thought the cookie with marijuana in it caused her symptoms because the symptoms happened about 1-1/2 to 2 hours after she had the cookie with marijuana in it. Reported she feels very weak and tired. Reported yesterday (18Feb2021) while she was in the hospital, her head felt like it was going to explode when the hospital staff tried walking her around. She said she asked the hospital staff to check her blood pressure because her head will feel like that when her blood pressure is up. She said when the hospital staff checked her blood pressure, her blood pressure was elevated. Reported the pain in her legs is driving her crazy, so she called for an appointment with an orthopedist today. Reported she is feeling better, but is still experiencing a tightness in her throat. She clarified she felt the throat tightness on Wednesday, 17Feb2021. She said she has no problem swallowing or eating, but her throat feels tight. Vaccination Facility Type was Hospital. History of all previous immunization with the Pfizer vaccine considered as suspect (or patient age at first and subsequent immunizations if dates of birth or immunizations are not available) was none. Additional Vaccines Administered on Same Date of the Pfizer Suspect was None. AE(s) required a visit to: Emergency Room (admitted to hospital), no Physician Office. Prior Vaccinations (within 4 weeks) was none.; Sender's Comments: The 83-year-old female patient had medical history included rheumatoid arthritis, fibromyalgia and carotid endarterectomy, and was on multiple concomitant drugs. Considering temporal relationship, a possible contribution role of vaccination with BNT162B2 to the onset of the reported events, cannot be completely 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.

she is short of hearing; losing her breathe; This is a spontaneous report from a contactable consumer (patient) from a Pfizer sponsored program. An 83-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number: unknown) via an unspecified route of administration on 29Jan2021 at single dose for COVID-19 immunization. The patient's medical history included: Stage 3 lung cancer, radioactive therapy on 25Dec2020 to 31Dec2020 (Also reported as 2-days prior to her 1st vaccine shot, the nurse gave her 2 radioactive therapy and the last one was 31Dec2020), immune therapy on 01Jan2021 (7 weeks' worth received all in 7 days), and steroid therapy on December 2020 and Jan2021. The patient had terrible reaction from the immune therapy on an unspecified date which include all the skin of her mouth had ulcers, had such sickness, diarrhea, a rash all over the face, had headaches, was so fatigued, no energy and could not get out of bed. Patient felt better in the past few days. Other medical history included had a bad fall, two broken ribs and needed hip replacement surgery from unspecified dates. She lives alone and received 700 units a day of steroids for 10-days last December. Family history included lung cancer runs in her family (sister and brother died of lung cancer, other sister got it too). Patient stated her doctor called her in 2 days before and stated her next step was immune therapy, she has had massive doses of radioactive before, she had 7 weeks of that in 10 days, and had an extreme reaction from that, the last one was 31Dec2020. Concomitant medications were not reported. The patient stated she refused her immune therapy, as she wanted the vaccine. It was put down as she did not want it. The patient reported that nurse there then said she was going to be put on unspecified steroid, which she never had before. Her friend picked up the prescription and, without reading everything, and she usually does, she took two of them. It said take all 6 that evening, but she took 2 then read and it said not to take with any vaccine. She stated that the nurse knew how she stressed she wanted the vaccine, and so she had the COVID vaccine. She just had the two steroids, and she said she wanted to wait until Mar2021 until she considered getting immune therapy, but the nurse booked her for 26Feb2021, and she had her second vaccine from Pfizer scheduled on 19Feb2021 one week apart. She asked if that is too soon, and does she need to put off immune therapy again. She read it is 2-3 weeks between, she wanted to have this verified. Patient stated she supposed to take 6 steroids then 5 and so on. She took 2 pills then as she was reading information regarding the vaccine, she did not take anymore. Last week is when she took the two steroids, she won't take them. She called a pharmacist, who said do not take them. The doctor's office, the nurse, gave them, after she told them she would have the vaccine. She stated she was furious, but she was getting this all the way down the line. She put the steroids away, she said she was not taking them, she talked to someone in the medical field and told her how she felt, and she agreed. Patient asked if it will be ok to have the immune therapy at that time and soon after getting the vaccine if it would be effective. She mentioned that at her age she is more concerned that she gets that vaccine and she wants to delay having the immune therapy until March given the horrible reaction she had before. She tried and tried to have this conversation with her doctors, but she does not have all that technology and they are only offering remote appointments. Patient stated that she had no problems from the first dose of the vaccine stating she did not even feel the needle. She has been exactly an hour on the phone. The patient stated that she was losing her breathe after speaking at this time during the call on 05Feb2021. She also stated she is short of hearing (onset date unknown). Outcome of the events was unknown. Information on the lot/batch number has been requested.

Pt complained of swelling in tongue and itching in tongue, mostly on L side. Given 25 mg PO benadryl with symptoms resolving prior to leaving

Within 15-minutes of vaccination, the patient reported lightheadedness, nausea, and dry mouth. EMS evaluated the patient on-site. The patient stated they were currently taking Augmentin for a UTI. Patient was hypertensive (162/82) with a FSBG of 84 mg/dl. EKG demonstrated NSR, rate 99bpm, no ST elevation. EMS administered 250mL IV saline en-route to Emergency Department. In the ED, the patient reported lightheadedness, nausea, dry mouth, left arm injection site pain, and feeling like her throat was closing. Patient remained slightly hypertensive (144/81). Physician administered 1L IV saline bolus and 10mg IV Decadron. The patient was discharged with diagnoses of Dizziness and Vaccination reaction.

Starting approximately one week after the first dose of vaccine, my mother began suffering what she describes as "episodes" of chest pain, neck pain (front and back), pain going down her arms, pain up into her jaw that are very sudden onset and cause her to have to lay down and rest until the episode is over. Timing of these episodes are random, but seem to occur when she first gets up in the morning or after she takes a shower or has been active. They lasts between 3 and 7 minutes and then completely resolve. She has never had any similar symptoms. She reports that these episodes occur between 4-6 times during the course of 24 hours.

her nerves pounding all throughout her body/the nerves in her whole body were just aggravated; she was a little shake and kind of weak; a headache; a stiff neck/Her neck felt stiff; Heart beating really fast/Her heart was pounding she could hear it in her ears; a blood pressure of 174/78/Her blood pressure was 174/78; she was a little shake and kind of weak; her head felt heavy; her whole body felt heavy; She had ringing in her ears; This is a spontaneous report from a contactable consumer (patient). An 83 years old female patient received 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EN6202), via an unspecified route of administration on 02Mar2021 at age of 83 years old at single dose for covid-19 immunisation. Medical history included hip surgery a few months ago and she was still kind of stiff and sore. Concomitant medications included lisinopril at low dose 10 mg once daily taken for blood pressure abnormal about 10 years ago; clopidogrel bisulfate (PLAVIX) taken for transient ischaemic attack from 2012 (she believed it was a around that time); acetylsalicylic acid (ASPIRIN LOW) at low dose (she began taking this before the Lisinopril so it has been several years).The patient mentioned that she received her 1st dose of the vaccine on 02Mar2021 and everything was fine that day and the day after. At late in the day on 04Mar2021, she experienced a lot of problems which she mentioned was the worst experience in her life. She was 99% sure it was from the vaccine because she didn't experience anything like that before getting the vaccine. She mentioned that she experienced side effects all night like her heart beating really fast, a headache, a stiff neck, her nerves pounding all throughout her body, and a blood pressure of 174/78. She mentioned that it was the worst she's felt so far as compared to going to the ER, as she's experienced before. She did not go to the ER as she could not drive herself and she was living alone. She mentioned that she better the next day although it was not totally gone, she was a little shake and kind of weak. As of calling, she said that she was feeling okay and better than yesterday (07Mar2021) in which the effects were still present. She mentioned that it was horrible, very scary, she was very ill, very uncomfortable, really bad, and didn't want to go through that again. She didn't know if she would make it through the night. She was asking for what to do and asking if there needed to be an adjustment for her dose because she was a very small person. She didn't want to have the 2nd shot if she went through that again. It was the worst experience of her life. She was not sure what to do now about her second shot. She had the first shot 02Mar2021 and everything was fine, 03Mar2021 she was okay but on 04Mar2021 she had, by night time, she had a lot of scary things that had never happened to her before. Her heart was pounding she could hear it in her ears. Her head, her neck felt stiff and her head felt heavy, her whole body felt heavy and like the nerves in her whole body were just aggravated, it was hard to explain. She had ringing in her ears. Her blood pressure was 174/78 and she was just afraid to have the second shot, it was scary, it was really bad. She was wondering if the amount of the vaccine was too much for her. She confirmed it was the evening 04Mar2021 when all this began. She said all of this was pretty well recovered at this point. She said the day after that happened, she was shaky but today (08Mar2021) she was fine. She did not know what it would be medications they are looking for but she was on normal medicine for old people she guesses. This was so bad that she really was not going to take the second dose unless they can tell her if she should or that they should give her less or something like that. The outcome of events was recovered in Mar2021.

severe sudden onset hearing loss; This is a spontaneous report from a contactable consumer. This consumer reported similar events for two patients. This is the first of two reports. An 83-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in arm on 30Jan2021 10:00 (lot number: EN5318; Expiration Date: May2021) as a single dose (at the age of 83-years-old) for covid-19 immunisation. Medical history included a little discomfort in her hands and arthritis both from an unknown date. Concomitant medication included paracetamol (TYLENOL ARTHRITIS) taken for a little discomfort in her hands and arthritis, start and stop date were not reported. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EH9899, expiry date: Mar2021) on 09Jan2021 (at the age of 83-years-old) for covid-19 immunisation and flu (at the age of 83-years-old) for flu vaccine on an unspecified date in 2020. It was reported that two weeks later (19Feb2021), she had developed severe sudden onset hearing loss. The hearing loss occurred in both ears and that it has basically stayed the same. They have gone to the ENT and already had steroid injections. The patient was also prescribed Valtrex. The patient had finished the 10 day course of Valtrex that was prescribed just in case there were any viral or fungal issues causing the hearing loss. The patient has had 3 hearing tests performed and there has been no improvement in her hearing. The patient was scheduled for her 4th hearing test this week on 22Mar2021. The patient has had 3 rounds of steroid injections into her ears. The patient underwent lab tests and procedures which included hearing test: unknown result on 01Mar2021, hearing test: not improving, unchanged on 08Mar2021 and 15Mar2021 and magnetic resonance imaging: normal on 12Mar2021. The outcome of the event was not recovered.; Sender's Comments: Linked Report(s) : 2021315404 Same reporter/vaccine/event, but different patient

Total lost of vision in the left eye for about one minute; This spontaneous report from a contactable consumer reporting for herself An 83-year old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) on 30Mar2021 at 09:00 at single dose via an unspecified route of administration on left arm for COVID-19 immunization. Relevant medical history was not reported. Concomitant medications included unspecified antidepressants and levothytoxine. On 30Mar2021 on 15:30 the patient experienced total lost of vision in the left eye for about one minute. The patient recovered from the event on 30Mar2021. Information on the lot/batch number has been requested. Follow up attempts are needed.

She had buzzing in her ear or tinnitus; lost her balance; The dizziness started on the morning of 14Feb2021 and has continued and worsened since then and getting to the point where its getting dangerous and inconvenient; This is a spontaneous report from a contactable consumer. This consumer reported for an 83-ear-old female patient that received second dose of bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 13Feb2021 (Batch/Lot Number: EN6201) as single dose for covid-19 immunisation. Medical history included ongoing Hashimoto's thyroiditis and She says she has had this since the 1970's, she was diagnosed in the 1970's but she had it long before that, they finally figured out what it was, ongoing tremor and she says she has had this for about 10 years, her brother has it, her sister has it, her mom has it, it is called familiar tremors. Concomitant medication(s) included ongoing levothyroxine sodium (LEVOTHYROXINE SODIUM) at 125 mcg once a day for Hashimoto's thyroiditis She says this is Synthroid, she has been taking it for years, She was diagnosed with Hashimoto's thyroiditis in 1970, but she's had it all her life; ongoing metoprolol tartrate (METOPROLOL TARTRATE) at 25 mg, once a day for tremor and She says its a heart medication but she takes for tremors, she has been taking it for a long time; ongoing nitroglycerin (NITROGLYCERIN) precautionary because she was having chest pain from 22Nov2019 and she says she has never had to use it, ongoing cobamamide (VITAMIN B12 [COBAMAMIDE]) and she says she has been taking this for a long time, it has green tea, coQ10, B vitamins in it for energy and ongoing Vitamin D3 and she says she has been taking this for a long time for energy. The patient previously took first dose of bnt162b2 for covid-19 immunisation. The patient experienced the dizziness started on the morning of 14feb2021 and has continued and worsened since then and getting to the point where its getting dangerous and inconvenient on 14Feb2021 with outcome of not recovered , lost her balance on 15Feb2021 with outcome of unknown, she had buzzing in her ear or tinnitus on an unspecified date with outcome of unknown. The clinical course was reported as follows: Dizziness - is this normal and how long will it last? Upon further discussion, patient stated that she got her second dose of the Pfizer Covid 19 vaccine on 13Feb2021. The dizziness started on the morning of 14Feb2021 and has continued and worsened since then and getting to the point where its getting dangerous and inconvenient. The other day, she lost her balance when going down the steps and almost fell. Her doctor suggested the Epley maneuver which she has been using for the past 2 weeks and it is not helping at all. She had buzzing in her ear or tinnitus (onset not reported). Her doctor has referred her to an ENT specialist for further evaluation. Discussed per Pfizer-BioNTech COVID-19 Vaccine EUA PI (LAB-1457-7.0, Revised: 06 April 2021) Adverse Reactions section (nothing found on dizziness, vertigo, tinnitus) and per attached CONS documents and VR re: 'dizziness and weakness' as part of possible allergic reaction, noting no specific information on duration as it may vary by individual. Referred to HCP for further discussion/guidance, based on medical history. Investigation Assessment: No Additional Context: The caller is calling about the COVID vaccine, Pfizer. She says she had her last vaccine on 13FEB2021 and got dizzy and it's not going away. She says she has seen her doctor, he suggested using the Epley maneuver but it its not helping any. She said that she is ondering if the Pfizer Vaccine is causing the dizziness? She is wondering if this is something she should be worried about it. Contact Details: She says she was a medical transcriptionist for many many years and a medical secretary. She does not have an email address. HCP: Caller does not have a full address or email to provide. Products: She reads EN6201, Pfizer EN6201. She says her first dose was on 23JAN2021 and reads EL8982 for that one. No expiry date for the first dose. History: She says it is hard for her to get around, she is so dizzy. She says she has nitroglycerin because she had chest pain back in 2019. She says her doctor is sending her to an ear specialist. VACCINE SUPPLEMENTAL FORM Pfizer Suspect Vaccine and Vaccination Details Time the Vaccination Was Given: 10:15 in the morning Anatomical Location of Administration of Pfizer vaccine considered as suspect: left arm Vaccination Facility Type hospital. No Vaccine Administered at Military Facility. No additional Vaccines Administered on Same Date of the Pfizer Suspect. AE(s) require a visit to no Emergency Room but Physician Office. Saw her primary doctor, she called and told him about it, her appointment was for this past Friday but he had her come in that day. She does not remember which day. She says she put up with the dizziness, it got worse. Prior Vaccinations (within 4 weeks): No. She says she needs to get a lot of vaccines, she is behind in a lot of this, she just hasn't done it yet. AE(s) following prior vaccinations: No She says she has had reaction to 3 medications. Sulfa, she says the reaction was low blood pressure. Celebrex, she says the reaction was severe chest pain, she thought she was having a heart attack, she went to the ER they thought she was having a heart attack. Codeine, she says the reaction was an extremely low blood pressure, all her vitals dropped really low, dangerously low. She says there was another one she can't remember, her reaction was she broke out in real bright red hives. Family Medical History Relevant to AE(s) She says her mother had cancer and died of cancer and her husband died of cancer. She is wondering if this is something she should be worried about it, if this is a normal side effect and is it going to last much longer because it is terrible. No follow-up attempts are needed. Information on the lot/batch number cannot be obtained.

Patient described brain fog. Tinnitus progressing to hearing crickets and then hearing the ocean. Patient broke out in shingles, this time affecting the eye and losing partial eye sight (had visit with eye doctor recently). Has follow up regarding tinnitus with healthcare provider soon. First Shingrix dose was November 13, 2020.

Pain in right thigh; Pain moved down leg into knee and calf; Pain moved to right foot, felt like stone bruise when walking; Pain moved to left foot and leg; gums bleeding; very tired, no energy. Had 2 steroid shots; went to Podiatrist for Plantar Fascia; He detected possible blood clot.

gas; balance problems; dizziness; sensitivity to being enclosed inside warm rooms (above 66 degrees); sleeplessness; anxiety; inability to sit still; dehydration; loss of appetite; frequent urination; sensitivity to noise; This is a spontaneous report from a contactable consumer. A 83-years-old non pregnant female pa-tient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection. Lot Number: EN9263, Expiration date: Unknown), dose 1 via an unspecified route of administration, in right arm on 05Feb2021 at 14:30 (at the age of 83-years-old) as single dose for COVID-19 immun-isation and the patient received second dose of BNT162B2 (Solution for injection, Lot Number: EL6203, Expiration date: Unknown), via an unspecified route of administration, in right arm on 25Feb2021 at 11:15 AM (at the age of 83-years-old) as single dose for COVID-19 immunization. The patient medical history included arthritis and spinal stenosis. The Patient received concomitant medications in two weeks which included phytosterols nos and chondroitin sulfate sodium, glucosa-mine hydrochloride, multi-vitamins. Patient did not receive any other vaccine within four weeks. Patient was not diagnosed with COVID, prior vaccination. Patient has not been tested for COVID, post vaccination. The patient had no known allergies. The patient had experienced gas, balance problems, dizziness, sensitivity to being enclosed inside warm rooms (above 66 degrees), sleeplessness, anxiety, inability to sit still, dehydration, loss of appetite, frequent urination and sensitivity to noise on 06Feb2021 at 19:00. There has not been any pain at the injection site or anywhere else on her body. No treatment received for events. The patient went to physician or other healthcare professional of-fice/clinic visit, Emergency room/department or urgent care due to events. The patient underwent lab tests and procedures which included nasal swab test on 05Feb2021 and 25Feb2021 result was nega-tive. The outcome of all events was not recovered. No follow-up attempts are needed; information about lot/batch number cannot be obtained.

Cranial Nerve VII Palsy; Double Vision requiring an eye patch on one eye so that I can see single objects; Medial drifting of left eye. Inability of left eye to move laterally past midline.; This is a spontaneous report from a contactable consumer (patient). An 83-year-old female patient received the first dose of BNT162B2 (PFIZER COVID-19 VACCINE, lot number: ER8733), at the age of 83 years old, in right arm on 30Apr2021 at single dose for covid-19 immunisation (The patient also received the second dose of BNT162B2 (lot number: EW0169), at the age of 83 years old, on 30Apr2021 at single dose for covid-19 immunisation, pending clarification). The patient was not diagnosed with covid-19 prior to vaccination. Concomitant medications included levothyroxine sodium (SYNTHROID) and omeprazole. The patient did not receive any other vaccines within 4 weeks prior to vaccination. The patient experienced cranial nerve VII palsy on Apr2021. On Apr2021, double vision requiring an eye patch on one eye so that she can see single objects, medial drifting of left eye and inability of left eye to move laterally past midline. The patient was hospitalized for the events for 4 days. The patient was unknown if she was tested for covid-19 since the vaccination. Therapeutic measures were taken as a result of events and included treatment with prednisone. The outcome of events was not recovered. No follow-up attempts are possible. No further information is expected.

eyes were showing bright silver snowflakes; severe abdominal pain; diarrhea; vomited3x in 15 min; This is a spontaneous report from a contactable consumer (patient). A 83-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6201), via an unspecified route of administration, administered in arm left on 24Feb2021 14:00 (at the age of 83-years-old) as 1st dose, single for COVID-19 immunisation. Medical history included high blood pressure, kidney stones (controlled), penicillin allergy, allergy to antibiotics, allergy to trees, allergy to grass and sulfa and cataracts and surg to replace retina 6 years ago (as reported). Concomitant medications included simvastatin, metoprolol, amlodipinum, lisinopril and paracetamol (TYLENOL),all taken for an unspecified indication, start and stop date were not reported. On 25Feb2021 15:00 the patient experienced severe abdominal pain followed by diarrhea and vomited 3x in 15 min. On 26Feb2021 16:30 the patient had eye problem: she was not able to see because her eyes were showing bright silver snowflakes. Lasted about 15 minutes. Tearing and water made it go away. The patient did not received treatment for the other events. The patient did not have COVID prior vaccination and she was not tested post vaccination. The events were resolved on an unspecified date. No follow-up attempts are possible. No further information is expected.

downward spiral after 2nd vaccine; high blood pressure; extreme back pain; swelled feet; pain was arthritis; vomiting a lot; very weak; sodium was low; arm is blue; vision is decreasing; This is a spontaneous report from a contactable consumer (Patient's daughter) communicated to a Pfizer Colleague. An 83-years-old female patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration on 10Mar2021 (Batch/Lot Number: EN6206) as 2ND DOSE, SINGLE, vaccinated at the age of 83 years old for covid-19 immunisation. Patient received the first dose of bnt162b2 (lot number: EN6201, at the age of 83 years old) on 17Feb2021. The patient medical history was not reported. The patient's concomitant medications were not reported. Patient had no previous health issues, then from 12Mar2021 downward spiral after 2nd vaccine. Within days of shot, on 12Mar2021 had high blood pressure(178/86) extreme back pain, swelled feet. Dr then said pain was arthritis and presribed blood pressure med for high bp. Pt was getting worse and in a couple of weeks ago she was vomiting a lot and was very week. Went to ER and was kept overnight. Was told sodium was low and she was sent home. Now her arm is blue and her vision is decreasing. Reporter reported her mother never had any health issues prior to getting vaccine. Events feeling abnormal, hypertension, back pain, swelled feet, pain was arthritis, vomiting, very weak and sodium was low resulted in Doctor or other healthcare professional office/clinic visit and Emergency room/department or urgent care and hospitalized. Outcome of events was not recovered.

Loss of voice, difficulty swallowing, rapid muscle mass deterioration, eventual death on 5/21/2021 from acute respiratory failure, and slight pneumonia.

Received Pfizer vaccines on 1/29/21, 2/19/21; tested positive for COVID-19 by PCR on 7/13/21. Symptoms of cough, loss of taste, unknown onset date. Will receive monoclonal antibodies.

Pain in chest; Lightheadedness; Chills; Fever; Splitting headache; Fatigue; Nauseated; Eyes were watering; Pain in lymph nodes in neck when touched; Loss of appetite; Felt like heart was going to go through her head; Heart was racing; Felt like her throat was closing up a little bit; This is a spontaneous report from a contactable consumer (Patient). A 83-years-old female patient received second dose of bnt162b2 (BNT162B2, PFIZER-BIOTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: EN6198), via an unspecified route of administration, administered in Arm Left on 02Mar2021 13:00 (age at vaccination: 83-yesr-old) as single dose for covid-19 immunization. (Vaccination facility: Clinic). Medical history included bursitis, arthritis, High blood pressure, High cholesterol all from an unknown date and unknown if ongoing, body aches many years at least from 10 years ago. Concomitant medication included ubidecarenone (COQ-10) taken for myalgia (started shortly after she started taking the cholesterol medication and she found out she was having body aches many years at least 10 years ago), acetylsalicylic acid (ASPIRIN CHILDREN) taken for cardiac disorder (started since long time ago probably 15 years or better), LISINOPRIL taken for blood pressure measurement (stated since many years), SIMVASTATIN taken for blood cholesterol increased (from same time as the lisinopril, at least 10 many years). Vaccine not Administered at Facility. It was reported that patient stated she and her husband received their second dose of the Covid shot clarified to be the Pfizer Covid 19 vaccine. She stated that she got almost every symptom on the list. Later that both she and her husband experienced fatigue. reported that she broke her hip a few years ago and that her husband told her that she did better after breaking hip than after receiving the Covid 19 vaccine. She reported that she does not usually experience any side effects after vaccinations stating that she normally sails right through the flu shot. She stated she just retired from a full time job in the first part of February, and if she had still been working she wouldnt have been able to go to work. Patient reported that within 12 hours of receiving the Covid-19 vaccine she was woke up in middle of night around 2 AM with her heart was racing she felt like she was going to have a heart attack, and reported that it felt like heart was going through the top of her head. She stated that she used a breathing method that she uses when she feels her blood pressure is increased to calm herself down and that she can usually bring herself down within a few seconds. She stated it could have been her heart or her blood pressure that she felt like she was speeding. She also reported that she was running a fever had chills pain and a splitting headache. She stated that within 48 hours the worst had passed. headache improved after the first night but that for a few days after she would get a shot up the back of her neck into her head. She reported that it was quickly resolve on its own. fatigue was worse after the second dose and they are both still experiencing fatigue. She was stated that she feels that the fatigue has improved but at the time of the call she stated that she felt like she could lay down and take a nap. She stated that the fatigue could also be related to her age. She is still having some lightheadedness if she stands up too quickly, she has to take a moment to balance herself before she proceeds, this was began after receiving the Covid 19 vaccine. She stated she was Felt like her throat was closing up a little bit, she did not feel that it was emergent or life threatening that she thought it was related to her swollen lymph nodes. she noticed pain around her breasts when she put her bra on mostly on the left side. She stated that she believed that it was lymph nodes in her chest that were causing the discomfort. She was unsure of when it began because she was down for 48 hours and stated that she noticed the pain around 05 Mar 2021. She reported that the pain gradually diminished. She stated that it didnt bother her, she was noticed it when getting dressed. She stated she was just slightly nauseated but that she didnt throw up or anything. She stated that her stomach felt a little queasy or upset, but that it wasn't anything serious. Caller stated that the nausea resolved a few days later around 06Mar2021 or 07Mar2021. Reported that the watering eyes have cleared up. She stated that it resolved quickly maybe a day or two after they began on 04 or 05Mar2021. She also reported had Pain in lymph nodes of neck she felt around her throat and felt like her lymph nodes were inflamed, they were painful to touch. She stated that the pain gradually diminished. Loss of appetite occurred in the same time frame as the nausea. She stated that she was hungry but her stomach just didnt feel like it had the room for food. She reported that the loss of appetite resolved a few days later around 06 or 07Mar2021. Received treatment with Tylenol she stated during the 48 hours after symptoms began she stayed in bed and slept. She reported that she was get up to get a drink or take Tylenol just a couple a day and was drank water. She reported that she drank lots of fluids. She stated that she was get up would take something and then go right back to sleep. Tylenol helped a little bit Tylenol doesn't do a whole lot but it's better than nothing. Adverse event not resulted in Physician Office visit or ER visit. The outcome for the event Fatigue and Lightheadedness was resolving, for events Loss of appetite, Eyes were watering, Nauseated outcome was resolved on Mar2021, for events Felt like heart was going to go through her head, Heart was racing outcome was reported as resolved on 03Mar2021 and for events Fever, Chills, Splitting headache, Felt like her throat was closing up a little bit outcome was resolved on 05Mar2021, and for remaining events outcome was resolved on unspecified date. Follow-up attempts are completed. No further information expected.

This is a spontaneous report received from a contactable consumer, the patient. An 83-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6200) via unspecified route of administration in the left arm on 16Feb2021 at 09:30 hours (at the age of 83-years- old) as a single dose for COVID-19 immunisation. Medical history included Macular degeneration (mild), glaucoma, epstein barr, vestibular neuritis, benign paroxysmal positional vertigo(BPPV), claustrophobia from unspecified date. The patient was allergic to penicillin, epinephrine, procaine (NOVOCAINE), narcotic related codeine, erythromycin and allergic to shrimp. Concomitant medication included rosuvastatin (MANUFACTURER UNKNOWN), tafluprost (ZIOPTAN), ascorbic acid; tocopheryl acetate; zinc; xantofyl; zeanthin (AREDS), D3(MANUFACTURER UNKNOWN) and sambucus nigra (ELDERBERRY) from an unspecified date for unknown indication. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EL9262) via an unspecified route of administration in the left arm on 26Jan2021 at 08:30 hours (at the age of 83-years-old) as a single dose for COVID-19 immunisation. 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 vaccine within 4 weeks prior to the COVID vaccine. On 13Mar2021, at 01:30 hours, the patient awakened at middle of the night with sudden loud tinnitus. Panic attack was experienced, had claustrophobia anyway so exacerbated the issue. The event resulted in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient received anti- anxiety prescription as treatment for the events. The patient went to physical therapy facility for balance and ear crystal treatment and it was continuing at the time of this report. The patient was under evaluation. The clinical outcome of the event panic attack and tinnitus was recovering at the time of this report. No follow-up attempts are needed. No further information is expected.

Pain in chest; Bursitis; High blood pressure; High cholesterol; stomach felt a little queasy or upset; Lightheadedness; Loss of appetite; Felt like her throat was closing up a little bit; Eyes were watering; Pain in lymph nodes in neck when touched; NAUSEATED; Fatigue; Felt like heart was going to go through her head; Heart was racing; fever; Chills; Splitting headache; This is a spontaneous report from a contactable consumer or other non-health care professional. An 83-years-old female patient received bnt162b2 (BNT162B2 PFIZER-BIONTECH COVID-19 MRNA VACCINE; Solution for injection (Batch/Lot Number: EM98089, Expiration date: Unknown), dose 2 via an unspecified route of administration in Arm Left on 02Mar2021 at 13:00 as dose 2, single for covid-19 immunisation. The patient medical history included bursitis, arthritis Verbatim: Arthritis, hypertension, ongoing blood cholesterol increased. The patient also received first dose on bnt162b2 (BNT162B2 PFIZER-BIONTECH COVID-19 MRNA VACCINE; Solution for injection) via an unspecified route of administration on 09Feb2021 as dose 1, singe for covid-19 immunisation. The patient concomitant medications included ubidecarenone (coq-10) taken for myalgia, start and stop date were not reported; acetylsalicylic acid (aspirin children) taken for an unspecified indication, start and stop date were not reported; lisinopril (lisinopril) taken for blood pressure measurement, start and stop date were not reported; simvastatin (simvastatin) taken for blood cholesterol increased, The patient did not receive any other vaccine in four weeks. Prior to vaccination patient was not diagnosed with COVID. Caller reported that within 12 hours of receiving the Covid-19 vaccine, she woke up in middle of night around 2 AM with her heart racing, she felt like she was going to have a heart attack and reported that it felt like heart was going through the top of her head. She stated that she used a breathing method that she uses when she feels her blood pressure is increased to calm herself down and that she can usually bring herself down within a few seconds. Caller reported that it could have been her heart or her blood pressure, that she felt like she was speeding. Caller reported that she was running a fever, had chills, pain, and a splitting headache. She stated that within 48 hours the worst had passed. Caller stated that the headache improved after the first night, but that for a few days after she would get a shot up the back of her neck into her head. She reported that it would quickly resolve on its own and also that both she and her husband experienced fatigue after receiving the first dose of the Covid-19 vaccine, but that the fatigue was worse after the second dose and they are both still experiencing fatigue. Caller stated that she feels that the fatigue has improved, but at the time of the call she stated that she felt like she could lay down and take a nap. She stated that the fatigue could also be related to her age. she was still having some light-headedness if she stands up too quickly. She reported that she has to take a moment to balance herself before she proceeds. She stated that this began after receiving the Covid-19 vaccine. Felt like her throat was closing up a little bit: Caller reported that she did not feel that it was emergent or life threatening, that she thought it was related to her swollen lymph nodes. Caller reported that she noticed pain around her breasts when she put her bra on, mostly on the left side. She stated that she believed that it was lymph nodes in her chest that were causing the discomfort. Caller stated she is unsure of when it began because she was down for 48 hours and stated that she noticed the pain around 05Mar2021. She reported that the pain gradually diminished. She stated that it didn't bother her, that she just happened to notice it when getting dressed. she was just slightly nauseated but that she didn't throw up or anything. She stated that her stomach felt a little queasy or upset, but that it wasn't anything serious. Caller stated that the nausea resolved a few days later, around 06Mar2021 or 07Mar2021, went along with throat feeling like it was closing up. Caller reported that the watering eyes have cleared up. She stated that it resolved quickly, maybe a day or two after they began on 04 or 05Mar2021. she felt around her throat and felt like her lymph nodes were inflamed, they were painful to touch. She stated that the pain gradually diminished. Caller reported that the loss of appetite occurred in the same time frame as the nausea. She stated that she was hungry, but her stomach just didn't feel like it had the room for food. She reported that the loss of appetite resolved a few days later, around 06 or 07Mar2021. Caller reported that during the 48 hours after symptoms began, she stayed in bed and slept. She reported that she would get up to get a drink or take Tylenol, just a couple a day, and would drink water. She reported that she drank lots of fluids. She stated that she would get up, would take something, and then go right back to sleep. Tylenol helped a little bit, Tylenol did not do a whole lot, but it's better than nothing. Tylenol: UPC/lot/expiry not provided. Caller stated that she was not supposed to take ibuprofen, saying the reason was something to do with blood pressure or something. She reported that if the AEs she experienced had gotten severe, she would have called her doctor and had them check it out or at least asked advice. She stated that because symptoms began resolving after 48 hours, she thought it was ok. She reported that she is going to the doctor in May for a routine check-up, and they will inform her if anything has changed. The outcome of events was fatigue was resolving and outcome of other events Felt like heart was going to go through her head, fever, Chills, Splitting headache, Felt like her throat was closing up a little bit was resolved on 05Mar2021, Heart was racing on 03-MAR-2021. Outcome of events Loss of appetite, Lightheadedness, Eyes were watering, Pain in lymph nodes in neck when touched, High cholesterol, stomach felt a little queasy or upset on an unspecified date. Outcome of Bursitis, High blood pressure was not recovered. No follow-up attempts are possible; information about lot/batch number cannot been obtained.

she experience a burning sensation that right side where she got the injection, the sensation went up her neck and into her throat.; She states that she had an odd taste in her mouth, but it was not metallic, just a funny taste in her mouth; Her stomach cramped up a little bit as well.; muscle pain in the back of her neck that did last for a couple of days; A little bit of pain in the left breast; Pain in arm; She states that a couple dats after taking the vaccine she got up to walk (she walks with a walker when she is able to, other wise she uses a power chair) the pain in her hip wasn't there.; This is a spontaneous report from a contactable consumer (patient) or other non HCP via Medical Information Team. A 83-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot Number: EN0186, Expiration date: unknown), dose 1, via an intramuscular route of administration, administered in Arm Right on 23Jun2021, (at the age of 83-year-old), as dose 1, single for covid-19 immunisation. Patient medical history included ongoing Arthritis (she had arthritis as a teenager but did not know it. She reported that she was diagnosed with arthritis years ago in her late 40's), ongoing Heart condition (she has a heart murmur and she believes that she was born with it),ongoing High cholesterol (she was diagnosed with high cholesterol many years ago and she cannot remember when), ongoing Hypoglycemia (she was diagnosed years ago), ongoing Macular degeneration (the macular degeneration began years ago and that is why she is now legally blind), ongoing Asthma (she was diagnosed years ago and it goes along with the allergies), Cancer (she reported that she had cancer surgery on her left breast), Diverticulitis, lumpectomy in the late 1990s, Covid-19, ongoing Osteoporosis (she was diagnosed with osteoporosis years ago), Colon resection in the 2000's and guesstimate around 2011. Patient reported that her last surgery was for diverticulitis in the 2000's, she wants to guestimate around 2011. She reported that her diverticulitis has been pretty good since the surgery. She reported that once in a while she has a little discomfort. She reported that she was not sure if the diverticulitis was causing the pain in her hip area as that is where the colon resection was done. She reported that she was not sure if was arthritis or osteoporosis or the other stuff. Family Medical History Relevant to AE(s) was none. She has allergies to strong odors and stuff like that and some foods like berries, strawberries, and chocolate cause her to break out in pimples and a rash and allergy to pollock, the fish. She has allergy to unspecified medications caused her to break out with hives really bad. She had most allergies to NSAIDs medications. The patient concomitant medications were not reported. The patient historical drugs included Lescol, Zocor, Lobid, Lipitor, Celebrex, salicylate, Darvocet, clarithromycin, erythromycin, Lyrica, Crestor, Zoloft, Zyrtec, Vicodin, Limbrel, and Vioxx and experienced allergies. She reported that she carries a list with her of her medication allergies so that she is not prescribed anything she is allergic to. Additional Vaccines Administered on Same Date of the Pfizer Suspect was none. Prior Vaccinations (within 4 weeks) was none. AE(s) following prior vaccinations was none. On 23Jun2021, within the first 5 minutes of receiving the Covid-19 vaccine, the patient experienced a burning sensation that right side where she got the injection, the sensation went up into her neck and throat, felt odd taste, Her stomach cramped up a little bit as well, muscle pain in the back of her neck that did last for a couple of days, A little bit of pain in the left breast and Pain in arm and Pain in left hip is not there within a day or day and a half of receiving the Covid-19 vaccine, She states that a couple days after taking the vaccine she got up to walk (she walks with a walker when she is able to, other wise she uses a power chair on an unspecified date in Jun2021. The clinical course of the events as follows: She reported that within 10 minutes while waiting, she first experienced a burning sensation on the right side where she got the Covid-19 vaccine injection. Caller reported that the burning sensation went up into her neck and throat, also felt an odd taste that she could not distinguish, not a metallic taste, but kind of a funny feeling with her throat, an odd feeling, she reported that a couple of minutes later, she felt cramping in her stomach and later on in the afternoon, a couple hours later, she had real severe muscle pain in the back of her neck, severe muscle pain in the back of her neck lasted quite a while, for a couple of days, pain in her arm developed the evening of 23Jun2021 and she felt it for a day and a half. She stated that they say that the arm pain was normal but the other things she was not quite sure about. she did feel a little bit of pain in her left breast, she had cancer surgery on her left breast and that the pain was probably in the lymph node area. Caller inquired if these are just normal side effects for people to get and not to worry about the second Covid-19 injection. She reported that the burning sensation, odd taste in her mouth, and funny feeling in her throat only stayed a little while. Muscle pain in back of neck lasted 2-3 days, little bit of pain in the left breast lasted 2-3 days, cramping in stomach lasted a couple of days. Pain in left hip is not there: she reported that she has a lot of senior problems and one of them is that she has arthritis from head to toe. Caller reported that in her left knee and hip on the inside of the hip area, she has severe pain. She reported that she has minimal walking ability and uses a wheelchair but uses a walker in the house when she has good days. She reported that within a day or day and a half of receiving the Covid-19 vaccine, she got up to walk to the kitchen and the pain in her left hip was not there and reported that it was really weird, and she was grateful of course, but her left hip is still ok. She reported that when she was on her feet and walking, she does not have the severe pain that used to put her off her feet. She reported that when she was laying down in bed and stretching, she feels severe pain, but walking around it's better. She reported that the pain in her left hip was not there when she was walking and that used to be when it was the worst. She reported that her second dose of the Covid-19 vaccine would be due for 14Jul2021. She reported that she knows that the vaccine is still experimental and that there are side effects, but it was better to take chances on the Covid-19 vaccine than to get Covid. She reported that one of her distant family members that got Covid got really sick, and they were young. She reported that she just wanted to make sure that these side effects would not prevent her from getting the second dose of the Covid-19 vaccine. She reported that the side effects were not severe but were annoying. The events did not require a visit to Emergency Room and Physician Office. Relevant Tests were none. No Investigation Assessment was done. she said that she had not heard of those side effects and it was nothing severe and not to worry. She reported that the girl instructed her that if she did have an allergy, she had to wait 6 hours to take an allergy pill. the outcome of the events burning sensation that right side where she got the injection, the sensation went up her neck and into her throat, felt odd taste was resolved on 23Jun2021, the outcome of events Cramping in stomach, muscle pain in the back of her neck that did last for a couple of days, little bit of pain in the left breast and Pain in arm was resolved on an unspecified date in Jun2021, while outcome of other events were unknown.

Pt developed heavy chest and SOB sensation with pain behind her left ear. All self resolved after approx 10 mins.

Pt received COVID 19 Vaccine today. Approx. 10 mins after administration, pt reported "I feel chills and tingling lips." Pt reports, "I ate a full breakfast at 1030 today" No h/o DM. NO shortness of breath NO CP (pain 0/10) NO dizziness NO Nausea/Vomiting No vision changes No itching or hives reported or observed. At 1245, pt states, "my tongue feels tingly and my lips feel numb. I feel like I have a lump in my throat." See VS flowsheet for vitals during monitoring period. PMH reported: COPD MEDS reported: Amlodipine, Gabapentin, Nortriptyline, Levothyroxine 1300: Maryam, ED Charge RN called for report and patient needing to be transferred for higher level of care post COVID 19 vaccine. 1310 approx.: HarmPt received COVID 19 Vaccine today. Approx. 10 mins after administration, pt reported "I feel chills and tingling lips." Pt reports, "I ate a full breakfast at 1030 today" No h/o DM. NO shortness of breath NO CP (pain 0/10) NO dizziness NO Nausea/Vomiting No vision changes No itching or hives reported or observed. At 1245, pt states, "my tongue feels tingly and my lips feel numb. I feel like I have a lump in my throat." See VS flowsheet for vitals during monitoring period. PMH reported: COPD MEDS reported: Amlodipine, Gabapentin, Nortriptyline, Levothyroxine 1300: Maryam, ED Charge RN called for report and patient needing to be transferred for higher level of care post COVID 19 vaccine. 1310 approx.: Harmony, RN from ED came to safely transport pt to ED. No family at bedside. Pt a good historian w/ stable VS when transported to ED. RN from ED came to safely transport pt to ED. No family at bedside. Pt a good historian w/ stable VS when transported to ED.

Hard of hearing; hurts a little bit sometimes and it was red; over weight; where the shot was, it kind of hurts; This is a spontaneous report from a contactable consumer reported for self. This 84-Year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 15Jan2021 at single dose for covid-19 immunisation. Medical history included ulcer, allergy, cholesterol, vertigo, cancer. Concomitant products included omeprazole at 40 mg for Ulcer, spironolactone at 25 mg for water pill, montelukast at 10 mg, 1x/day (in the morning) for allergy, simvastatin at 40 mg, 1x/day (in the evening) for cholesterol and piracetam (MECLIVIN) 25 mg, 2x/day one in the morning and one at night for Vertigo. The patient was hard of hearing, needed hearing aid and didn't have them. And wanted to say that when the patient got the vaccine, Friday morning (15Jan2021) and it was outstanding, talk about being organized it was superb. The patient had Pfizer Vaccine Friday morning, and today (17Jan2021) where the shot was, it kind of hurts. And the patient reading the paper that they gave the patient and had redness, it's red and it says you might have side effects, but those are the only side effects the patient had. This hurts a little bit sometimes and it was red. The patient was over weight. Lab data included Height: around 5'2. Outcome of the event hurts a little bit sometimes and it was red was recovering. Outcome of other events was unknown. Information on Lot/batch number has been requested.

Received vaccine 7:30 PM Monday, began feeling tinging in lower lip Tuesday, did not notice any symptoms Wednesday, Thursday 11:00 AM noticed drooping left side of face, couldn't smile on left side, eye drooping, difficult to close left eye. Transported to ER by ambulance at 11:30 AM. Diagnosed with Bell's Palsy. Released from ER to home.

Approximately 15 minutes after receiving vaccination, patient complained of burning and itching of her tongue. No tongue swelling or any other symptoms at all. After 45 minutes of observation, her symptoms were starting to abate. No treatment other than water was given. BP was notably elevated at 178/88, pulse 66.

Reports mouth tingling sensation, denies any other symptoms, VSS, alert and oriented, speaking in full sentences, ambulating without difficulty, MD ordered PO Benadryl 25 mg, administered, patient recovered and ready for discharge

blindness in one eye; delirium; Weakness; This is a spontaneous report from a contactable consumer. An 84-year-old female patient received bnt162b2 (Pfizer-BioNTech COVID-19 mRNA vaccine), via an unspecified route of administration in the left arm on 03Feb2021 11:15 at a single dose for covid-19 immunization. Medical history included congestive heart failure, diabetes, glaucoma, breast cancer survivor, high blood pressure and allergies. The patient has unspecified concomitant medications. On 03Feb2021 21:30, the patient experienced blindness in one eye, weakness and delirium. The patient did not receive treatment for the events. The events were assessed serious, disability. The patient has not tested positive to covid prior vaccination. The outcome of the events was not recovered. Information on Lot/Batch has been requested.

Dry mouth, unable to resolve by drinking water, gargling, swishing with olive oil. Continues over one month after initial dose.

Client describes a metallic taste after the first dose. She still is experiencing the metallic taste. She denies a change in medication or diet. Doctor instructed her to call an ENT. The nurse at the ENT office stated it was from the COVID vaccination.

2/23 - PT awoke at 0230 w/altered mental status, generalized weakness, severe headache, nausea and fever. T 101.2, PERL, BP 120/82, HR 88 regular, RR 18. Grips/Pushes equal/weak. A&O x2 (A&O x 4 baseline). ABDM soft, non tender. Breath sounds clear bilaterally. 1100 IV NS 1L, 30 mg Toradol IV given. Temp 99.2-102.0 variable throughout the day. Severe HA. Tylenol and Motrin alternated q 4hr. 2/24 Severe Headache, pt reports disturbances in her visual field. A&O x3. weakness/malaise continues. Motrin & Tylenol - LABS 2/25 Severe Headache, with altered visual fields.- CT HEAD 2/26 Same as above. 2/27 Same as above. Urgent Care for Flu & COVID Testing. Both Neg 2/28 Headache managed with Celebrex, 12 hrs relief, then 200mg Motrin 3/1 Same as above. Retinal specialist for consult and Fluorescien Angiography - WNL 3/2-3/5 Headache and visual field changes continue. Pt states "do not feel myself"

Patient reported losing her "taste buds" and also did not feel hungry and was tired around 3 days after her second dose of the Pfizer-BioNTech COVID-19 vaccination. Patient said this has now resolved but did not state exactly when it resolved.

restless; tired; head hurt; arm hurts; body aches; cold chills; couldnot sleep; tongue burning; This is a spontaneous report from a contactable consumer (Patient's daughter). A 84-year-old 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 28Jan2021 19:00 (at the age of 84-years-old) as a single dose for COVID-19 immunization). Medical history included diabetes mellitus and arthritis from 20 years. Concomitant medication included ibuprofen (ADVIL [IBUPROFEN]) at a dose of 200 mg as needed. The patient did not receive any other vaccines within four weeks prior to the vaccination. On an unspecifie date consumer stated her mom got the first shot of the Pfizer COVID 19 vaccine 28Jan2021 at 19:00PM in the right arm. After the shot she was fine but during the night her head hurt, she had body aches and cold chills, she was tired but she couldnot sleep because she was so restless and her tongue was burning up and she couldnot feel it. Clarified she can feel her tongue and it feels really hot. It was questioned that this a side effect of the vaccine. She was scheduled to receive the second dose of the vaccine on 18Feb2021. Added her mother took two Advil before the shot getting the shot because she was anxious and worried about the side effects. It was reported that the events couldnot sleep, tongue burning and tired were worsened. Outcome of the event cold chills was recovering and not recovered for other events. Information on the lot/batch number has been requested.

A few days after receiving my second vaccine shot I lost my hearing. it was mostly in my right ear . Went to Dr he gave me Afrin for 3 nights, flonaze during day and claritin. After one week no improvement. Went back and was given predzone for 10 days and went for a hearing test. Test showed way below normal both ears. Now have an appointment with an ENT specialist next week. Ears seem to build up with pressure and noise and cause lightheadedness.

She had swollen lips the day after and was treated with Benadryl. She was ok Saturday afternoon. Then on Sunday night @ 1030 pm she got hives all over body. Taking Claratin and Calamine Lotion as per doctor.

Patient reports experiencing the muscle soreness in the L deltoid muscle along with some general fatigue. She also informs you that she had ?loss of vision in her right eye? that developed 1-2 days after she received the injection, but her vision returned to normal in about 24 hours

toothache; This is a spontaneous report from a contactable consumer, the patient. An 84-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; lot number: EL3302) via unspecified route of administration in the left arm on 28Jan2021 09:00 AM as a single dose for covid-19 immunization. The patients medical history was not reported. The patient had no known allergies. Prior to vaccination, the patient was not diagnosed with COVID 19. Since the vaccination, the patient had not been tested for COVID 19. Concomitant medications included metoprolol succinate at 25 mg with unknown frequency, calcium and multi-vitamins. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously received first dose of bnt162b2 in the left arm on 07Jan2021 10:30 AM as a single dose for Covid-19 immunization (Lot number: EJ1686). In 2 days patient started having a toothache. It kept getting worse. Monday morning patient called the dentist and saw him on thursday, he took X-rays for abscess with unknown results, on an unknown date. There was none. Could be bite, no that wasn't it either. Then she figured it out. It was still sore to the touch then go back in 2 was. Will see what he says. There was a program with dentists talking about a side effect of shot and then patient knew that was the problem. Patient elbow was the same way, couldn't touch it for a couple of day it was so sore. The patient received treatment for the event. The outcome of the event was recovering.

ringing in her ears; Blood pressure went up; This is a spontaneous report from a contactable consumer (patient). An 84-year-old female patient received her second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date were unknown) at the age of 84-years-old, via an unspecified route of administration on 19Feb2021 at 11:30 at single dose for COVID-19 immunization. Medical history included high blood pressure diagnosed 3-5 years ago and ongoing and blood clots (reported as blood thinner) from an unspecified date and ongoing. Concomitant medications included rivaroxaban (XARELTO) from 2020 and ongoing as blood thinner, metoprolol from 2018 and ongoing for high blood pressure, amiodarone from 2020 and ongoing for high blood pressure, and ongoing normal supplement. The patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL9263) at the age of 84-years-old, via an unspecified route of administration in left arm on 22Jan2021 at single dose for COVID-19 immunization. On 19Feb2021 at 15:30, four hours after the second dose of the COVID vaccine, the patient started having ringing in her ears and it has not gone away. It was like a truck in her head, she felt like she was losing her mind, it was driving her insane. She could not live like this; it was the worst thing in the world. Her blood pressure went up. She went to the ER for the ringing in ears and had to stay for 2 days at the hospital because they saw a blip on her EKG and it turned out to be nothing. She was hospitalized from 19Feb2021 to 21Feb2021. She has seen 3 doctors. One of them recommend a stress test which was done on 2021 and it was ok. She went to the doctor's office and they thought she had fluid, but it was not there; the neurologist said there was nothing they could do. With regards to treatment for ringing in hears, first, she stated nothing, she did not know what to do. She has gone to 3 doctors and one of them prescribed prednisone but that did not help. She had to take an MRI yesterday (25Mar2021) because they wanted to make sure her brain was okay, and it was all normal. The outcome of the event ear ringing was not recovered and unknown for all other events. Information on the lot/batch number has been requested.

Patient started experiencing stabbing pain out side of her ear. no other side effect. Has not taking anything for pain. Pain started on Sunday evening and re-occur every 20 seconds until now as time of report. I recommend pt to contact her physician asap

Pt presented with acute onset of right vision loss. She was seen by ophthamology and diagnosed with central retinal artery occlusion. She had to be changed to warfarin as this clot developed while she was already on eliquis. She still has some vision loss.

acute sense of smell; nose is swelling; This is a spontaneous report received from a contactable 84-year-old female nurse (patient). An 84-year-old female patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Left on 25Feb2021 (Lot Number: EN6206) as SINGLE DOSE for covid-19 immunisation. Medical history included ongoing asthma from 2019 and ongoing. Concomitant medications included albuterol [salbutamol] taken for wheezing from an unspecified start date and ongoing; beclometasone dipropionate (QVAR, lot number: ASR72A, expiration date: Sep2021) taken for shortness of breath from Aug2019 and ongoing; oxygen using this for sleep from 2012 and ongoing. The patient experienced acute sense of smell and nose is swelling on 25Feb2021. Also on an unspecified date, the patient stated she has shrunk from 5 feet 5 1/4 inches to now 5 feet 2 inches. The events parosmia and nasal edema was assessed as medically significant by the reporter. Outcome of the event body height decreased was unknown while outcome of the remaining events was recovered on 25Feb2021. Follow up attempts are needed. Further information is expected.; 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 drug is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.

terrible thirst; Fever 100.3; achy pain everywhere; no energy; chills; This is a spontaneous report received from a contactable consumer (Patient). A 84-years-old female patient received second dose of bnt162b2 (BNT162B2, Solution for injection, Batch/Lot Number: EL9261), via an unspecified route of administration, administered in Arm Left on 10Feb2021 at 14:00 as single dose for COVID-19 immunization. Medical history included atrial fibrillation and drug hypersensitivity. The patient's concomitant medications were not reported. On 10Feb2021 at 22:00 patient experienced terrible thirst, fever 100.3, achy pain everywhere, no energy and chills. The patient underwent lab tests and procedures which included body temperature as 100.3 on an unspecified date. Treatment received with aspirin and loads of fluids. The outcome of the events was recovered.

Got tremendous pain in my right ear; it was outside of the ear; pain was really bad; This is a spontaneous report from a contactable consumer. A 84-year-old female patient received the first dose of BNT162B2 (COMIRNATY, PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EW0151 and expiry date: unknown), via an unspecified route on 10Apr2021 (at the age of 84-year-old) as single dose on left arm for COVID-19 immunization. Relevant medical history included blood pressure. Concomitant medication included lisinopril (5 mg every morning), amlodipine (10 mg), simvastatin (10 mg), Vitamin D, calcium and alendronate sodium (once in a week), and temazepam. On an 11Apr2021 (Sunday), the patient had tremendous pain in her right ear, and it was outside of the ear not the inside and persisted for every '20 seconds'. She also stated the pain was bad. In 1 to 10 pain scale, it was 8 and it persisted for whole day. On the same date, night the patient received treatment with paracetamol (Tylenol) and it calm down a little bit. The patient was wondering that if same thing will happen, when she will take her next shot. The patient stated that she did not have a computer. Outcome of the events was unknown. No follow-up attempts are needed. No further information is expected.

Tiredness; left ear ache; This is a spontaneous report from a contactable consumer (patient's daughter). An 84-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in arm right on 20Apr2021 14:00 at the age of 84-years-old (Batch/Lot Number: Not Provided) as single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient had the vaccine yesterday on 20Apr2021 and was having side effects. She wanted to go over the side effects and what to do. It was for the Pfizer Coronavirus vaccine. Stated that this was her first dose. Stated that she was sleeping, having tiredness and ear ache in Apr2021. Stated that she got the vaccine at 2pm. Stated that she looked at list of symptoms and has never had ear aches. Wanted to know if ear aches was part of it and what to do about it. Stated that the ear ache was for her left ear. Stated that she received the vaccine on the right. The outcome of the events was unknown. No follow-up attempts are needed. No further information is expected.

1. Close exposure to COVID: Requesting COVID test. No respiratory symptoms. Afebrile, stable, nontoxic. COVID PCR obtained. Chief Complaint(s): Chief Complaint Patient presents with ? Dizziness TEAM NOTES: Pt is here today for dizziness. ASSESSMENT and PLAN: 1. COVID-19 2. Acute suppurative otitis media of both ears without spontaneous rupture of tympanic membranes, recurrence not specified 3. Acute pansinusitis, recurrence not specified 4. Dizziness Patient Instructions In addition to COVID you have a bilateral ear infection and sinus infection. Start taking amoxicillin as directed, continue to completion. I would recommend a probiotic pill or yogurt (like "Activia" or "live active cultures") 2 hours after antibiotic. If not any better in the next 3-5 days or starts to get worse please return the office for evaluation. Start taking plain mucinex/Robitussin (not DM) every 12 hours. Take with plenty of water. Continue flonase. Please call with questions.

About 15 to 20 min. (when Pharmacist was notified) after her shot, the patient reported in Spanish, through her daughter, numbness around the mouth. The Pharmacist had advised her to sit and wait 30 min. after the shot, due to her anaphylaxis history from multiple things. The Pharmacist monitored her and she continued to report itching on the forearm where she got the shot (not around the site) and slight shortness of breath. The patient never appeared to be in distress. As the symptoms continued, the Pharmacist decided, though an Epipen was ready to use, to call 911. Paramedics arrived within 5 to 7 min., questioned her, took her BP, Oxygen level and listened to her breathing (all were good). She said she was feeling better and said "no" when they asked her if she wanted to go to the hospital. The paramedics stayed with her about 10 minutes longer and she left with her family. She did not receive any Epipen or Benadryl (is allergic to it) but wanted to take a box of Claritin 10 mg with her (said it always helps). The paramedic told her Claritin will not help anaphylaxis (for future). The patient was advised to contact her physician because she probably would be at high risk for a second Covid vaccine.

having difficulty breathing because of her tongue; tongue started burning about 2 hours after receiving the vaccine; tongue as "burning up" and painful; body aches; arm pain; This is a spontaneous report from a contactable consumer (patient's child). An 84-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number and expiration was not reported), via an unspecified route of administration on 28Jan2021 as first dose, single for an Covid-19 immunization (At the age of 84 years). The patient medical history and concomitant medications were not reported. On 28Jan2021 (yesterday), the patient received the first dose of the Pfizer COVID-19 vaccine, and noticed her tongue started burning about 2 hours after receiving the vaccine. On 28Jan2021, she was also experiencing body aches and arm pain. The patient described her tongue as "burning up" and painful and she was having difficulty breathing (start: 28Jan2021) because of her tongue. The reporter was taking her mother to the hospital now (29Jan2021). The outcome for all the events was unknown. Information on the lot/batch number has been requested. Follow-up attempts are completed. No further information is expected.

Slight change in taste bud; This is a spontaneous report from a contactable consumer. An 84-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, batch/lot number: EL9261, expiration date and NDC number were not reported) via an unspecified route of administration on 25Jan2021 at 11:40 in right arm as a single dose for COVID-19 immunization. The patient took the COVID vaccine because she had COPD and was a cancer survivor. The patient's medical history (including any illness at time of vaccination) included blood disorder. Family medical history relevant to adverse event and Investigation assessment was not reported. No other prior vaccination (within 4 weeks) and no additional vaccines were administered on same date of the Pfizer suspect. The patient did not experience any adverse event prior vaccination. There was no history of previous immunization with the Pfizer vaccine considered as suspect. Concomitant medication included hydroxycarbamide (HYDROXYUREA) 500mg tablets by mouth twice daily taken for blood disorder, start and stop date were not reported. The chemo pill started may be 4 years ago, when it was discovered she had blood problem. As per the description, it was reported that the patient had Pfizer shot, later clarified as COVID vaccine on last Monday 25Jan2021. On 4th day, 29Jan2021 at 08:10, she woke up in morning and had a slight change in taste bud, not as sharp as it was, she still had her sense of smell. There was no emergency room or physician office visit. She will get her second dose on 15Feb2021. There were no relevant tests reported. The outcome of all events was recovering/resolving. Follow-up attempts are completed. No further information was expected.

a little over 30 days post vaccine - patient experienced "stroke like event" that took her to overnight stay in hospital - this patient had no history of elderly illness except for well managed diabetes - from first Covid shot April 19 to current, patient has had a seizure, an extreme reaction to codeine, and a stroke like event - patient now exhibits mild to moderate short term memory loss - patient has had 4 CT scans and 1 MRI

Received Pfizer vaccines on 2/19/21, 3/16/21. Tested positive for COVID-19 on 7/10/21. Symptoms began on 7/6/21 w/ cough, dysgeusia, fatigue. Hospitalized on 7/13/21; transferred to ICU on 7/22/21. Patient expired on 7/25/21 due to pneumonia d/t COVID-19. Patient was intubated; given dexamethasone 6 mg x9 d, 5 day course of remdesivir, one dose of tocilizumab for COVID pneumonia. PMH significant for past medical history significant for pulmonary sarcoidosis, on prednisone 5 mg daily; immune thrombocytopenic purpura, on rituximab.

Resident reported loose stool, not feeling well, resident complaint of lost taste. Hospitalization on 01/14/2020.

Client verbalized tingling of the lips after receiving the vaccine. Client evaluated by onsite Sheriff Fire Rescue. Client released to go home at 11:25 am by Fire Rescue after symptoms resolved.

Patient received that vaccine at 1130 at 1142 patient noted she was having a flush feeling her her face, tingling in her tongue. No noted swelling to lips, tongue, face, no breathing events. Patient was administered Benadryl 50mg IM and was brought for continuous monitoring in our clinic. She noticed relief in flushing within 2 mins of injection and tongue tingling within 5 minutes. It was approximately 30 minutes after Benadryl injection she had improvement with her lip tingling. Patient was monitored in total in clinic for 1 hour prior to be discharged home, no other administration of medications needed. All symptoms resolved prior to discharge by provider.

Pin prick feeling in right scalp, 1/23. pink patches on forehead, painful feeling in right eye, swelling eyelid. much soreness on forehead and six inches into scalp during the next two days. small blisters developing, diagnosis - Shingles

Pt is a 85 year old female who had her 1st dose of Pfizer today. Approximately 30 minutes after having the vaccination, she was sitting in her chair getting ready to leave observation area when she complained of a dry throat with no other associated symptoms. Patient was assesed and released via the process. Patient had symptoms decrease in severity during assesment. Additionally a full set of vital signs were obtained. Refer to POD 1's patient care report for further details.

Seizure - onset approximately 1 hour after vaccination administration. No medical history of seizures. Duration estimated 3 min - myoclonic head jerking, eyes rolled back, cyanosis

2/1/21 2:30pm Pt c/o tongue numb, difficulty speaking. Noted facial drooping & reddened watery Lt eye. Emergency room diagnosed Pt with shingles/Bells Palsy.

Tingling, numbness of lips, sensation of swelling in left side of throat without difficulty swallowing,, elevated BP, no shortness of breath, O2, P wnl. Benadryl 25 mg PO given and tolerated, flushing of face and still sensation of lt throat swelling, called EMS to transport to ED

Patient reports lower lip feels tingly and puffy, denies other symptoms. Given Benadryl 25 mg PO per MD. Approx 20 min later reports feet feel tingly, provider ordered another dose of Benadryl 25 mg PO. Symptoms subsided and MD cleared for discharge. Friend will drive patient home.

I got the vaccine at 8 AM that morning and I was fine until about 5PM and I got very cold. I was freezing. I had a chill. I checked my temperature and it was around 99-100. During the night I woke up with a bad chill, I was really cold and I was shaking really bad. I checked my temperature and it was 102. Tuesday I checked my temperature all day it never went over 102. I took Ibuprofen all the day, no more then 4 tablets. I took a nap in the afternoon for about 2 hours and I when I woke up I was really cold and I was freezing and shaking. I was so cold my teeth were chattering. My mouth was very dry, I tried to drank a sip of water, which made me nauseous and I throw up slightly. My husband was concerned because he couldn't get me warm and he called our son. Our son came over, and asked do I know who he is and I responded no. I have reconciliation of my son coming over or my husband calling our son over to come check on me. My son immediately to called 911, EMS arrived and they transported me to hospital. I do not remember any of this, I didn't become appear until I was stretcher , at that point I became aware and knew the answers to the questions being asked but I couldn't respond. I remember hearing the EMT say to turn the air on, I was burning up and had a temperature of 105. I was transported to Medical Center. They run a lot of tests and they were trying to get my fever down. Sometime late that night they were finally able to my temperature down. I was released about 10 AM on Wednesday morning. I have been fine since then. The doctors who all seen me in the ER all said they have not seen anything like this.

Client stated blurry vision. Checked her frequently (every 5 minutes approx.) Spouse claimed she also has macular vision. Did not clear completely. She was adamant about going home. b/p 170/82 Spouse stated that she is very anxious and b/p increases with her anxiety. Kept for 50 minutes to monitor

Pfizer-BioNTech COVID-19 Vaccine EUA Patient received her second dose of the Pfizer COVID vaccination and felt some heaviness in her chest and tingling in the lips shortly afterward. Patient had some similar symptoms on the first vaccination, but felt better following Zyrtec administration. Her symptoms today were persistent despite receiving Zyrtec so she was sent to the emergency room for evaluation. On evaluation, patient reports feeling little bit off as well as some nasal stuffiness. Patient was observed in the emergency department for over an hour without developing any new or worsening symptoms. Patient was discharged home

Had a hard time getting sleep; My left eye got seriously inflamed/ left eye became extremely red, inflamed; Eye was red, and still swollen/ left eye became extremely red, inflamed; Eye was red, and still swollen; Painful/ Eye is still sore/still having the pain in it but not intense; This is a spontaneous report from a contactable consumer (patient). An 85-years-old female patient started to receive bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EN5318), via an unspecified route of administration on 29Jan2021 at 01:15 at single dose for to protect me against COVID. Medical history included blood pressure and muscular degeneration in eye. Concomitant medication included hydrocodone (trade name not reported) for blood pressure. The patient experienced my left eye got seriously inflamed/ left eye became extremely red, inflamed, eye was red, and still swollen/ left eye became extremely red, inflamed, eye was red, and still swollen, painful/ eye is still sore/still having the pain in it but not intense on 29Jan2021 and had a hard time getting sleep on an unspecified date. Outcome of the events eye was red, and still swollen and painful/ eye is still sore/still having the pain in it but not intense was not recovered and other events were unknown.

2/14/21-Immediately after 1st covid vaccine experienced pressure sensation in chest and breast. Great on the right side, went up to the back to neck. The shock sensation went over the top of the head onto face with tingling bilateral. Resolved on 3/3/21. 3/3/21- Severe vertigo-hospitalized for 3 days. On day 1 of vertigo sudden hearing loss.

Client states about 4-6 hrs after her first Pfizer covid vaccine on her L arm , she developed raised red welts and then small blisters began to develope, which spread down her arm. She also added a few days later her vision became very blurred, her vision did come back to normal. She states on 02/14/2021, she returned to receive her second Pfizer Covid vaccine. She states she did tell the nurse and showed the rash on the L arm. The nurse consulted with other nurses at the clinic and it was decided to provide the vaccine on the other arm, which the client agreed to. She states a few hours later the red raised welts appeared on the her right arm and begin to spread down her arm. She states the red raised welts began to spread over her body including her legs, feet, and buttocks. The blistery rash then began to spred over her breasts, stomach and back. She did consult Dr. and was placed on prednisone. She states she has received the treatment for about 4 weeks

hard of hearing; Headache and then I had muscle aches/Achy and headachy; Headache and then I had muscle aches/Achy and headachy; Little bit of discomfort; Kind of stiff; Trouble in seeing; Used to be 5'7" but now I am 5'4"; she noticed bright red bleeding in her urine when she emptied her bladder; I just had a taint little bit till the day when I got it and then the next day I went to the bathroom to empty my bladder again and I had bright red bleeding again with some blood clots in it; Skin dry; slept a lot; she felt tired and so rotten; mild low-grade fever; body aches and pains; This is a spontaneous report from a contactable consumer (patient herself). An 85-year-old female patient received her second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EM9810) via an unspecified route of administration on 25Feb2021, 11:00 am as a single dose for COVID-19 immunisation. Medical history included hypertension, stroke, heart attack, COVID-19 in Aug2020 (actually had COVID this summer in August, had the mild case), and emergency surgery in Aug2020. Concomitant medications included ajmaline (CARDIA), isosorbide, and levothyroxine sodium (SYNTHROID) taken for cardiac disorder; and losartan. The patient her first dose on 04Feb2021 and experienced headaches, muscle aches and pains, chills, other flu-like symptoms, heart conditions, and sensitivity to eggs. She mentioned that this was normal and nothing unusual. She received her second dose on 25Feb2021 at 11:00 am. She was still kind of stiff but was okay. The next day on 26Feb2021 at 11:00 am, she noticed bright red bleeding in her urine when she emptied her bladder. After a few hours it faded. On the next day on 27Feb2021, she experienced the bright red bleeding in the urine again. The red blood did not hurt and patient was achy and headachy, "you know muscles." So, that kind of happened and it just kind of eased off. She slept a lot because she felt tired and so rotten from Friday, Saturday, Sunday after getting the shot. She also had a mild low-grade fever, headaches, and body aches and pains which she considered normal. Patient was hard of hearing and did not have a bright red bleeding, just had a taint little bit till the day when she got it and then the next day, she went to the bathroom to empty her bladder again and had bright red bleeding again with some blood clots in it. Then she did not really have that much the rest of the day and since then it seems to be clear. She did have a little bit of discomfort and her skin was dry. She have never had that experience before so she was just not sure was that connected with that shot? She wanted to know if there were any other patients that have had that. Patient also stated, "I have a bit trouble in seeing. So, I am going to have my magnifying glass" when asked about the product details. She will be getting her annual check up on 24Mar2021 so she will also check with her doctor. She mentions that she doesn't take that much flu-shots because she is sensitive to eggs. Her urine seems to be clear as of the time of report. She wants to know if the bright red bleeding in the urine has been reported. Patient stated, "I used to be 5'7" but now I am 5'4". I think I am weighing about 158 now. I am sorry like I said because of my hearing and with a language difference a little bit. I was having a trouble hearing you." The patient did not have treatment for the events. Outcome of the events was unknown.

Due to history of allergic reactions, patient waited a full 30 minutes after receiving vaccine. However, shortly after getting in her car she experienced a feeling that her throat and tongue were swelling. Epinephrine administered and patient transported by EMS to hospital in area. patient states she left hospital at 5 pm on 3/26/21.

My sugar have been crazy/my blood sugar is continually 195 to 240, well the worst was 294; vomited twice/threw-up; exhausted; shivering; malaise/I didn't feel well; I threw-up; I did not need eat the rest of the day; Hard of hearing; This is a spontaneous report received from a contactable nurse (patient herself). An 85-year-old female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection and Lot Number: EL1283) via an unspecified route of administration in the right arm on 04Feb2021 at 18:30 (at the age of 85-year-old) as single dose for COVID-19 immunization and Insulin via an unspecified route of administration on an unspecified date at an unspecified dose for an unspecified indication. Medical history included Diabetic, Cardiac, unstable gait, hypothyroid and Known allergies: PCN (penicillin). Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Concomitant medications included levothyroxine sodium (LEVOTHYROXIN) and furosemide. Patient historical vaccine included first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN5318), via an unspecified route of administration in the left arm on 14Jan2021 at 18:45 for COVID-19 immunization. On 05Feb2021 at 9:30, the patient experienced shivering, malaise, vomited twice and exhausted. On 06Feb2021 patient was reported that her sugar has been crazy, she has hardly even eating because she doesn't feel well; her blood sugar is continually 195 to 240, well the worst was 294, that's not me usually my high at night is 166 or 157, she threw-up; she did not need eat the rest of the day, she doesn't feel comfortable this way; yesterday she didn't feel well the day before she didn't feel well and hard of hearing. Patient stated that "on the 5th the next day she did not feel well, she ate almost a soft-boiled egg in the morning with a slice of toast and she threw that up and she did not need eat the rest of the day and her blood sugar went up to 294 which she never had that high." Patient reported as "that night (07Feb2021), when she went to the bed 3 or 4 hours after she ate it was 294. She took 15 units of insulin and in the morning, it was 137 which is unusually high for her. That night it was 230 before she went to bed the next morning after 15 units of insulin it was 195 in the morning 7:53 in the morning and then at 9:50 last night she went to bed early it was 240 this morning after 17 units of went insulin it was 198. She checked it contour and it was 211. The patient did not receive any treatment for the events. Action taken for the insulin with respect to the events was unknown. The clinical outcome of the events shivering, exhausted was recovering, malaise, vomited twice, blood sugar abnormal, did not need eat the rest of the day was not recovered and hard of hearing was unknown.; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the Blood glucose abnormal and other reported 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 fasting plasma glucose at baseline, 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.

drooping of her face; swelling on her face; under her eyes it was sticky and hot/some areas on her face feel hot; under her eyes it was sticky and hot/some areas on her face feel hot; This is a spontaneous report from a non-contactable consumer. An 85-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: ER8727), dose 2 via an unspecified route of administration, administered in Arm Left on 24Mar2021 14:15 (at the age of 85years) as single dose for Covid-19 immunization. The patient received the first dose of BNT162B2 on 03Mar2021 in the left arm (unspecified route) for Covid-19 immunization. The patient's medical history was reported as none. Concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. It was reported that the patient had the second dose on Wednesday (24Mar2021) and four days later (as reported) (on 28Mar2021) she has swelling on her face and drooping of her face on the left side. It was further reported that it seems to be getting better today (31Mar2021); the drooping is almost all gone but some areas on her face feel hot; under her eyes it was sticky and hot. The reported asked if it was normal, or should the patient see the doctor. The patient was given Tylenol and she seems better. The outcome of events was recovering. Follow-up attempts are completed. No further information is expected.

Following adm of 1st Pfizer vaccine, she developed double vision the next day. This has persisted since. She has brief periods in the morning when her vision seems normal, but then her vision blurs, is doubled, and at times is transposed (what is on the right is seen on the left). She also has a pain in her right eye that occurs occasionally. She denies headache and nausea.

Lot of blisters inside my mouth and I was just miserable. I wasn't able to eat for three days, It was really difficult; Lot of blisters inside my mouth and I was just miserable. I wasn't able to eat for three days, It was really difficult; Lot of blisters inside my mouth and I was just miserable. I wasn't able to eat for three days, It was really difficult; My blood pressure was of some concern; I was so sick; mouth is full of sores; it's was an antibiotic, it's Clindamycin I didn't take it because my daughter who is in medical field thinks it probably a viral infection not bacterial.; it's was an antibiotic, it's Clindamycin I didn't take it because my daughter who is in medical field thinks it probably a viral infection not bacterial.; This is a spontaneous report from a contactable other Nurse (Patient). An 85-years-old female patient received bnt162b2 (Pfizer-Biontech Covid-19 Vaccine, Formulation: solution for injection, Lot Number: EN6201) via intramuscular route of administration in left arm on an unspecified date as 2ND DOSE, SINGLE for covid-19 immunization. The patient medical history included hypertension and atrial fibrillation. The patient's historical vaccine included bnt162b2 (Lot number: EL3247) with pain in extremity as reaction. Concomitant medications included alprazolam (ALPRAZOLAM), apixaban (ELIQUIS) taken for atrial fibrillation, furosemide (FUROSEMIDE), losartan (LOSARTAN) and propranolol (PROPRANOLOL). The patient was a retired nurse and stated that her first injection was just perfect, little it of a sore arm and that was all. She started that the injection that she got a week prior for the second injection she was okay until the next day, and then she got a lot of blisters inside her mouth and she was just miserable. She wasn't able to eat for three days. It was really difficult and she just wanted to know if anyone else had that kind of symptoms. She was sure had troubles with that. She stated she was so sick, yesterday at a clinic and her biggest problem was her mouth was full of sores. They did take her blood work and said it was ok. Her blood pressure was of some concern. The patient stated that they gave her four different things. They gave her Ondanse, lidocaine for pain and Valacyclovir. She did not take Valacyclovir as it was an antibiotic. She did not take clindamycin because her daughter, who is in medical field thought it probably was a viral infection and not bacterial. The outcome of the events was unknown. Follow-up (12MAY2021): Follow-up attempts completed. No further information expected.

Funny feeling in her lips; felt funny; Funny feeling in her lips; felt funny; This is a spontaneous report from a contactable consumer or other non health care professional (patient) reported in response to Non-health care professional letter sent in cross referenced case. An 85-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: Solution for injection, lot number and expiration date not reported), via an unspecified route of administration in an unspecified anatomical location on 27Jan2021 (at the age of 85-year-old) as single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. On an unspecified date in 2021, the patient experienced same reaction as first shot: funny feeling in her lips; felt funny. Patient took benadryl as treatment for the events. Symptoms disappeared in about 5 min, fine afterwards. The outcome of evens was resolved on an unspecified date in 2021. Follow-up (13May2021): Follow-up attempts completed. No further information expected.

She had a few spots all over her body but they went away; losing her sense of taste; It was kind of strange. It was not the metallic taste that people reported.; she has "some sort of hives" or little spots on her body; it was an allergy to something; itchy; It was a lump, little lump.; caller said it hurt.; She has a Micro Pacemaker inside; This is a spontaneous report from a contactable consumer (patient). A 85-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number: EN6201), dose 2 via an unspecified route of administration, administered in arm Left on 16Feb2021 14:00 (age at age 85-year-old) as dose 2, single for COVID-19 immunization. Medical history included could not sleep after husband died, diverticulitis and UTI (urinary tract infection) and ongoing low hematocrit, heart Afib (atrial fibrillation), polymyalgia rheumatica, cholesterol, seasonal allergies, glaucoma, maybe addicted to Alprazolam, GERD (gastroesophageal reflux disease), pacemaker. Concomitant medications included ongoing ferrous sulfate (SLOW FE, Tablet) for dietary supplement (hematocrit was low and now fine but kidney doctor said to continue it. Was taking 4 per day and now taking 1. Was taking this before she got the shot. It does not say the dose) from an unspecified start date and ongoing; metoprolol (MANUFACTURER UNKNOWN) for Heart Afib; apixaban (MANUFACTURER UNKNOWN) for blood thinner (been taking for several years) from an unspecified start date and ongoing; prednisone (MANUFACTURER UNKNOWN) for polymyalgia rheumatica (been taking for maybe about 20 years) from an unspecified start date and ongoing; pitavastatin calcium (LIVALO) for cholesterol (been on for a long time) from an unspecified start date and ongoing; torasemide (MANUFACTURER UNKNOWN) for diuretic (been on for a long time) from an unspecified start date and ongoing; potassium chloride (MANUFACTURER UNKNOWN) for lose potassium with diuretic from an unspecified start date and ongoing; cetirizine hydrochloride (ZYRTEC) for seasonal allergies (been on for long time) from an unspecified start date and ongoing; alprazolam (MANUFACTURER UNKNOWN) for sleep (Caller stated if she said it was called Xanax, it was not, it was alprazolam. After husband died, she could not sleep. She had been taking all along. She thought maybe she was addicted to it now) from an unspecified start date and ongoing; rabeprazole sodium (ACIPHEX) for GERD (been on for a long time) from an unspecified start date and ongoing; methenamine (MANUFACTURER UNKNOWN) for UTI (been on it for about 1 to 2 years) from an unspecified start date and ongoing; ascorbic acid (VITAMIIN C) for UTI (been on it for about 1 to 2 years) from an unspecified start date and ongoing; acetylsalicylic acid (ASPIRIN) for heart to prevent stroke from an unspecified start date and ongoing; brinzolamide (MANUFACTURER UNKNOWN) for glaucoma from an unspecified start date and ongoing; timolol (MANUFACTURER UNKNOWN) for glaucoma, start and stop date were not reported; latanoprost (XALATAN) for glaucoma from an unspecified start date and ongoing; netarsudil mesilate (RHOPRESSA, Eye drops) for glaucoma from an unspecified start date and ongoing. Caller stated that she was on 4 different eye drops for Glaucoma. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: EL9263), dose 1 administered in arm left on 26Jan2021 14:00 for COVID-19 immunization. The patient did not receive any other vaccine prior to COVID-19 Vaccine. The patient did not experience any adverse events prior to COVID-19 Vaccine. Vaccination Facility Type was University. Also reported something that looked like hives. She did not get hives until maybe not even a month later. That does not coincide with the report got if they were reporting it shortly after. Caller stated that she had Covid tests done. She had the rapid and regular tests done. Both were negative. This happened after she had her shots. Caller stated that the spots might have started a couple of months ago. It might have been the end of April or the beginning of May. Then she said that might be it was earlier in April. It took a long time for them to go away. It left a mark. One of them kind of acted up the other day. Caller was trying to think of something she did or ate. She came to no conclusion. Caller said the spot was on top of her leg. She could still feel it. On 2021, the patient reported that she received both doses of the Pfizer COVID-19 vaccine and a month after the second dose, she started losing her sense of taste. She also stated that she had seen an ENT and an allergist, and that the caller (patient) also reported she had some sort of hives or little spots on her body, but the doctor did not think it was hives. Caller stated, would like to know if this was a common side effect, if anyone else had reported and was it going to go away and if it was and when. she liked to taste some good food once in a while. Caller stated her symptoms were this first of all, she could taste when she first taste something. She did not get the full effect but a pretty good taste but then it gets milder and milder as she continue to taste. Caller questioned if it was a common side effect. Also asking were there other people that reported this. It was not the metallic taste that people reported. She did not experience that. She was wondering if the vaccine caused that. Her doctor said it was not hives and that it was an allergy to something. No one could tell her. She had a few spots all over her body, but they went away. One spot that she had seemed to be itchy again. She said she was not supposed to have salt. She used mustard. She had a sandwich for lunch with mayonnaise, relish, ham, cheese, and lettuce. It was not too bad. She said she knew it had been tastier. Caller stated that if she ate a cookie something that was nice and sweet, she could taste pretty much the first bite, but as she ate more, it would get milder and milder. Caller stated that she had no problem with smell. She said it was an insidious thing. She did not know when it happened. It was less than a month after 16Feb2021 when she had the second shot. They told her to go to Neurologist. She went to the Neurologist. He told her he did not think it was anything bad. He wanted an MRI to make sure it was not brain tumor. Caller said that she had a Micro Pacemaker inside. Caller said that taste had worsened. Coffee did not taste right, and it went on from there. Caller said the spot was on top of her leg. She could still feel it. It was a lump, little lump (on an unknown date). It did not seem to be itchy anymore. The adverse event requires to visit at Physician Office. Treatment medication for the event she has some sort of hives or little spots on her body was hydrocortisone cream. The patient underwent lab tests and procedures which included Rapid Covid Test: negative on 2021. The outcome of all the events was unknown. No follow up attempts are needed. No further information is expected.

headaches; muscle aches; pains; chills; other flu-like symptoms; Hard of hearing; Kind of stiff; Little bit of discomfort; Trouble in seeing; I just had a taint little bit till the day when I got it and then the next day I went to the bathroom to empty my bladder again and I had bright red bleeding again with some blood clots in it.; Skin dry; This is a spontaneous report from a contactable consumer or other non-HCP (patient). An 85-years-old female received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: Unknown), via an unspecified route of administration on 04Feb2021 (age at the time of vaccination 85-years-old), as single dose for COVID-19 immunization. The patient's medical history included Hypertension, Stroke, Heart attack, and on an unspecified date Aug2020, Covid-19, I actually had a mild case of COVID. The patient's concomitant medication included Isosorbide, Losartan, and Cartia Xt (Diltiazem Hydrochloride). On an unspecified date, the patient experienced headaches, muscle aches, pains, chills, other flu-like symptoms, Hard of hearing, Kind of stiff, Little bit of discomfort, Trouble in seeing, I just had a taint little bit till the day when I got it and then the next day I went to the bathroom to empty my bladder again and I had bright red bleeding again with some blood clots in it, and Skin dry. On an unspecified date Aug2020, the patient underwent lab tests and procedures which included Covid-19: positive, I actually had a mild case of COVID. The outcome for all the events was unknown. No follow-up attempts are needed. No further information is expected.

Resident became rigid with eyes crossing and rolling back in her head. She was unresponsive and became limp. Pulse Ox decreased to low 80's. She came to and then was agitated throughout the day.

Congestive cough; Weakness; didn't have an appetite; legs felt stiff, or almost frozen; Severe muscle weakness/extreme weakness was only in her mother's lower body; tremendous fatigue/Tiredness; Couldn't walk; This is a spontaneous report from contactable consumers. An 86-year-old female patient (mother) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration at left arm on 12Jan2021 10:15 at single dose for COVID-19 immunization. Medical history included ongoing chronic obstructive pulmonary disease (COPD) for years; COVID-19 Virus from 23Apr2020 to an unknown date, patient was not on a vent or in the ICU but did receive plasma as part of her COVID-19 Virus treatment; ongoing cough. Caller's grandmother had Multiple Sclerosis. There were no concomitant medications. The patient received her first Pfizer COVID-19 Vaccine dose, and had significant side effects. Patient weight was 175 lbs as provided by caller, who stated her mother recently moved into an independent living facility, and gained weight because the facility has a really good pastry chef. Patient height, reported her mother shrunk, and was 5'5-1/2". Reported her mother couldn't walk after receiving the first dose. She said her mother was not able to walk the next morning, 13Jan2021. The caller stated she had to spend 3 days with her mother, after her mother received her first COVID-19 Vaccine dose on 12Jan2021. Reported she thought initially what her mother was experiencing was either neurological or muscular. She said it was like her mother's brain wanted her to move, but her mother's legs wouldn't move. She said her mother needed to use a walker and have someone hold her from behind. She said now, at a week later, her mother still was not back to normal. She clarified her mother needed a walker to maneuver around, but didn't need someone holding her from behind. Reported she assumed her mother may have had tiredness, weakness, severe muscle weakness from receiving the first COVID-19 Vaccine dose. She clarified if her mother wasn't able to walk after receiving the first COVID-19 Vaccine dose, then what her mother had was the epitome of weakness, and the weakness was only in her mother's lower body. She said her mother had tremendous fatigue on days 2, 3, and 4 after receiving the first dose. She said her mother was able to function as of 19Jan2021, but her mother couldn't keep her eyes open during that time period. Reported her mother developed a congestive cough. She said her mother's cough was not continual, but persisting. She stated her mother said the cough was there before she had her first dose of the COVID-19 Vaccine. The caller stated she disagreed with her mother. She said her mother has COPD, but her mother was not a cougher. She said her mother's cough now, reminded her of the cough her mother had when her mother had the COVID-19 Virus in 2020. She clarified her mother was tested on 23Apr2020 for the COVID-19 Virus, and diagnosed positive for the virus on 24Apr2020. The caller said she was perplexed by her mother's cough, and her mother will be seeing her doctor this Thursday, 21Jan2021. She said she gave her mother some Robitussin for the cough. She said her mother's cough was not persistent, but the cough was still there. She said her mother's cough was not constant, but her mother's cough was congested. She said she didn't know when her mother's cough started. She said she thought giving her mother the Robitussin doses was kind of insignificant, because her mother did not have a constant cough, where she needed to take the Robitussin. She said her mother didn't even use half of a normal sized Robitussin bottle. Caller stated she did not have the Robitussin UPC, Lot, and Expiration Date. Reported her mother has an annual lung x-ray and MRI, clarifying she believed her mother had both within the past 3 months. Reported her mother was concerned about receiving the second COVID-19 Vaccine dose. She said she told her mother that it was better to get the second dose of the COVID-19 Vaccine than to get the COVID-19 Virus again. Reported her mother had asked her primary care doctor if she should get the COVID-19 Vaccine, and her doctor told her absolutely. She said her doctor told her she needed to take the COVID-19 Vaccine even if she had the plasma treatment with the COVID-19 Virus in Apr2020. Reported she planned to stay with her mother after her mother received the second COVID-19 Vaccine dose. She said she didn't anticipate her mother having a reaction after the first COVID-19 Vaccine dose because people said most reactions are happening after getting the second COVID-19 Vaccine dose. She said now people are reporting having reactions after the first COVID-19 Vaccine dose. Reported she thought her mother's side effect after having the COVID-19 Vaccine to be unusual, since most people say it feels like they have the flu, or they are tired, or they have a headache. Reported her mother not to be able to walk wasn't that her mother was not walking, but that her mother's foot wouldn't move. She said mother not walking was either neurologic or muscular, unless that is what extreme weakness is. She said she wondered if others have experienced what her mother has. She said if her mother was experiencing just extreme weakness, the extreme weakness was only in her mother's lower body, not in her upper body. She said her mother didn't have an appetite, but her mother was not too weak to put a spoon to her mouth. She said her mother couldn't move her legs, and her mother said her legs felt stiff, or almost frozen. She said if her mother had extreme weakness, and couldn't walk, what did that mean. She said if a person is really tired, the person can still move and get out of bed. She said her mother said she was really, really tired, and couldn't move. The caller said her mother said she couldn't move, and it took her mother 20 minutes to get her legs over the side of the bed. She said her mother not being able to move her legs could be extreme weakness, but observing her mother first hand, she said it looked like her mother not being able to move her legs was neurologic. She said her mother was strong in character and body, and her mother would do everything she could in her body to move, but it was like her mother's brain said "go", and her body said "not now". The outcome of the event Congestive cough was not recovered, of the other events was unknown. Information on the lot/batch number has been requested.

A metallic type taste in the mouth followed by numbness of the tongue starting from back of the tongue and progressing to entire tongue. Pt was moved to first aid room where v/s and ecg monitoring were started. The numbness never progressed to swelling, scratchiness, or anything else. No further treatment was provided and symptoms resolved on their own within 15-20 minutes. Pt did not feel further evaluation was necessary.

Patient had no discomfort following vaccination until 2 days later on 2/5. She began to have extreme pain, a hard knot, and redness at the injection site. On 2/6, she had diarrhea, altered vision in the right eye. and "face hung down" Symptoms lasted about 36 hours. By Monday 2/8/2021, symptoms were completely resolved with no residual effect.

Less than 24 hours after receiving 2nd dose of vaccine, resident developed symptoms of fever (101.7F), body aches, peri-orbital fluid in right eye, right eyelid ptosis with mild facial droop, tongue deviates to the right.

Patient reported tongue sensation after 15 minutes of observation. No evidence of facial swelling or tongue edema on exam. She denied throat tightness/itching, shortness of breath, or worsening symptoms. She declined to stay beyond 15 minute interval as she stated she was feeling anxious. Reviewed s/sx anaphylaxis, advised her to call 911 if these occur. She remained well appearing and was speaking clearly in full sentences throughout observation.

Left sided numbness, tingling of face, arm and leg. Loss of hearing in left ear. Called 911. Air rescue to Hospital. Workup labs, CT, MRI and carotid ultrasound. Symptoms resolved 5 hours.

Blisters in my mouth, my tongue; Blisters in my mouth, my tongue; Hadn't have any other symptoms except I had not been feeling right that I had been feeling real bad.; All blistered and swollen ; whole mouth is sore and my tongue is blistered; Big blotch, not at the injection site but below it, it was red, swollen and itchy; All blistered and swollen ; whole mouth is sore and my tongue is blistered; All blistered and swollen ; whole mouth is sore and my tongue is blistered; Tongue is tightening; I think that was a symptom of Covid, called Covid tongue; This is a spontaneous report from a contactable consumer (patient). An 86-year- old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EN5318 and expiration date not provided), via an unspecified route of administration second dose on 26Jan2021 at single dose for Covid-19 immunization. The patient's medical history included High Blood Pressure. The patient's concomitant medication included amlodipine, alendronate sodium, hydrochlorothiazide, levothyroxine, losartan for Hypertension, and simvastatin. The patient historical vaccine includes BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EL0142 and expiration date not provided) first dose on 05Jan2021. It was reported that patient had the second dose 5 days ago on 26Jan2021 and three days after the patient got the vaccine on 29Jan2021 the patient experienced got all these blisters in my mouth, my tongue and everything, top of my tongue is tightening. The patient wonder if that was a type of reaction from the vaccine. The patient think that was a symptoms of Covid, called Covid tongue. The patient did not know if she should go to the doctor or thought that it was just a reaction. It was still on, it was 5 days now and it was still all blistered and swollen. The whole mouth was sore and patient tongue was blistered. The patient did not have any other symptoms except the patient had not been feeling right that I had been feeling real bad. The patient had a real big blotch, not at the injection site but below it, it was red, swollen and itchy but other than that I have nothing and I just know for sure I hadn't heard of anything that there had been a reaction from the vaccine. The patient wanted was wondering if these reaction was from the vaccine or you think I should go, get tested? The events Oral mucosal blistering, Tongue blistering, Oral pain, Swollen tongue, Mouth swelling, and Tongue disorder was treated with mouth wash. The outcome of the events was unknown.

light-headed, dry mouth, nausea, dizziness, abnormal sensation in tongue, anxiety & hypertensive 197/96 post vaccine administration. Transported to ED, observed and symptoms resolved discharged to home. - history of anaphylaxis to shellfish and PCN, IV contrast dye allergy history

Starts around 4 pm. Lot of pain right side of face like: 1. toothache, whole jaw aches 2. neck arthritis 3. sinus infection 4. ear infection all at the same time. Strong pain all through right side of face, sometimes up through eye. Worse lying down. Cause? Dental exam complete mouth x-rays indicated no problems with any teeth. Saw Dr. 3/3/2021, was checked for ear, sinus infections, felt all around my neck, no problems. Prescribed gabapentin, told to continue the Tylenol Arthritis I had been taking on my own. Symptoms continue today, only right side of face, head, temple area, sometimes up through right eye, teeth on right side ache. Only take the Tylenol once a day since that is all that I need it. More painful if I lie down in bed at night so sit upright until pain is gone; then sleep through the night. No problem all during the day when I?m up and around doing whatever. . .no pain then. Someone in my dental office has the same symptoms along with Bells Palsy, was told by her doctor it's from the Covid shot and could last 3 months? Pharmacist also told me filling the gabapentin for several others with same symptoms (I live in a small town).

In the afternoon after getting the vaccine she was eating an ice cream bar and had a time trying to eat it, it did not go down and it did not go down. She ate dinner and at 10:30 she had terrible burning that went through to her back, had shortness of breath like she could not catch her breath. Her daughter took her to the ER as the pain was so severe she thought she was having a heart attack. In the ER they ran a bunch of tests, did an EKG and took blood, she did not have a heart attack. She was admitted and monitored her. She did have a chest x-ray in the ER as well Nothing showed blood clots in her lungs, nothing in her lungs, but she still had the SOB and the pain went away. She thinks they may have given her some medicine and the pain was gone, but she still was shortness and still is today 3/19/21. She has an appointment next week to have an echocardiogram. She has had check ups with the cardiologist and her PCP since coming home from the hospital. Her PCP gave her an inhaler to use but she has not used it. She did not have any reaction to the injection site itself. Ever since this has happened has had no appetite, brain fog, shortness of breath, fatigue and nothing sounds good to eat She can taste okay, but nothing tastes good to her. She said she doesn't think she can handle this much longer, it's been over a month.

Woke up with the right eye whiteness covered with blood. 10 days to heal. This occurred the day after receiving the second dose - March 8. On March 24, lost vision in the right eye for about a half an hour.

had worsening vision loss in her eye; had worsening vision loss in her eye; This is a spontaneous report from a contactable consumer (patient) based on the information received by Pfizer. An 86-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number unknown) dose 2 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for covid-19 immunisation; pyrimethamine (Tablet, Lot Number: AM0737A; Expiration Date: 31Jul2022) via an unspecified route of administration from an unspecified date and ongoing at 25 mg once daily for toxoplasmosis retinitis. Medical history included toxoplasmosis retinitis (eye infection toxoplasmal), vision loss (Blindness), and an allergy to sulfa medications. Concomitant products were not reported. On an unspecified date, the patient had a second dose of the Covid vaccine. On an unspecified date in Feb2021 (over the last month of 01Mar2021), after starting the products, the patient had worsening vision loss (visual impairment) in her eye within one month of receipt of the second dose of the COVID-19 vaccine. The patient felt the only thing that was new was she had just received the second dose of the Covid vaccine. As of 01Mar2021, the statuses of treatment with pyrimethamine and the worsening of vision loss in her eye were ongoing. An association with pyrimethamine cannot be ruled out. However, the event is confounded by toxoplasmosis retinitis, vision loss, and receipt of the COVID-19 vaccine, which the reporter notes was the only new occurrence. The action taken in response to the events for pyrimethamine was dose not changed. Therapeutic measures were taken as a result of had worsening vision loss in her eye. The outcome of the events was unknown. The reported was considered as other serious (important medical events). No follow-up attempts are needed; information about lot/batch number cannot be obtained.

After vaccination began to experience itching and swelling of hands, arms, chest, back, and face which continued for almost two weeks; After vaccination began to experience itching and swelling of hands, arms, chest, back, and face which continued for almost two weeks; After vaccination began to experience itching and swelling of hands, arms, chest, back, and face which continued for almost two weeks; The symptoms progressed to redness swelling of the face, including swelling around the eyes; After vaccination began to experience itching and swelling of hands, arms, chest, back, and face which continued for almost two weeks; The symptoms progressed to redness swelling of the face, including swelling around the eyes; slight dehydration.; This is a spontaneous report from a contactable 86-year-old female non-pregnant patient (nurse) received first dose BNT162B2 (Solution for injection, lot number: EL3247, COVID 19, brand: Pfizer) on 19Jan2021 12:30 PM on Arm Left for COVID-19 Immunization. Patient medical history included Hypetension, mitral valve prolapse, cornea transplants both eyes, Allergies: sulfa. Concomitant medications included metoprolol, furosemide (LASIX), KCL, losartan, apixaban (ELIQUIS), cefalexin (KEFLEX). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. After vaccination began to experience itching and swelling of hands, arms, chest, back, and face which continued for almost two weeks even after taking an antihistamine, Allegra after the 3rd day of onset of symptoms on 21Jan2021. The symptoms progressed to redness swelling of the face, including swelling around the eyes on 21Jan2021. No shortness of breath. Went to physician on 05Feb2021 who prescribed lab work and chest X-ray to rule out SVC syndrome; chest X-ray was normal. Lab work was normal. With exception of slight dehydration on 21Jan2021. He gave her a shot of steroids and a prednisone dosing pack as well as ointment for the arms and hands which were still red and itching on that day. Redness of face was much improved within 24 hours and most facial swelling resolved by 08Feb2021. The physician did advise her not to take the second COVID shot. He do have photographs of the reaction on her face, arms and hands. No Seriousness criteria reported. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. Outcome of events was recovering.; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the reported events due to temporal relationship. Clinical presentation is suggestive of allergic reaction. There is limited information provided in this report. This case will be reassessed upon receipt of follow-up 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.

Pt has a history of dementia. She reported numerous symptoms including feeling lightheaded, body aches, "puffy face, tongue and throat." Denied SOB, rash, CP or other symptoms. There were no objective abnormal findings on exam. BP 130/80, HR 67, 98%. The pt noted that she felt improved after several minutes. EMS services and ER evaluation were offered but the son declined and elected to take her home. He believed that symptoms were related to anxiety.

Patient reports mild soreness in her left arm after receiving the vaccine. Reports mild fatigue but this was expected due to pharmacy consultation prior to administration. She states she experienced vision loss in her right eye that developed a day or two after receiving the shot. Vision returned in about 24 hours.

Patient reports mild soreness in her left arm after she received the vaccine. She reports mild fatigue but this was expected due to pharmacy consultation prior to vaccine administration. Reports experiencing vision loss 1-2 days after getting the shot. Vision returned to normal after 1 day.

Body Rash. Both upper arms, lower back, back of legs, mouth. Significant itching and discomfort. Right upper arm developed Cellulitis. Treatment - Cephalexin 500mg, Triamcinolone acetonide 0.025% cream, hydrOXYzine 50mg.

Patient received 2nd Pfizer vaccine. 5 minutes after injection patient had complaints of feeling pressure behind her eyes and feeling "fuzzy". Patient was accompanied by her daughter who came to the nurse at the end of the 15 minutes wait time to report the symptoms. When nurse talked to patient she states that the "fuzziness" went away but still had some pressure behind her eyes. Nurse had patient stay an additional 10 minutes. When patient left clinic she was feeling better.

New onset seropositive (acetylcholine receptor antibody positive) myasthenia gravis, symtpoms included ptosis, diplopia, fatigue, proximal muscle weakness, symptoms starting 2-3 weeks after intitial vaccination date.

TWO DAYS AFTER FIRST VACCINE - TONGUE TURNED BLACK. LASTED FOR OVER A WEEK 3 DAYS AFTER SECOND VACCINE - TONGUE TURNED BLACK. STILL HAVE SOMME BLACK SPOTS AS OF TODAY.

Pt started with "burning" to her eyes about 10 min after the vaccine. RN noticed swelling to bilateral eyes. Pt also stated "burning in my throat". airway was patient, denied shortness of breath. did state a history of allergic reactions to the flu shot. after discussion with the pt and an assessment with a nurse practitioner it was decided to take the pt to the ER. 911 was called and the pt transported.

Severe headache later feel like I had relate to my teeth ache; Severe headache later feel like I had relate to my teeth ache; I got the funny hot kind, shoot through my whole body; This is a spontaneous report from a contactable consumer (patient). An 86-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: EN6200), via an unspecified route of administration on 26Feb2021 (age at vaccination 86-year-old) at single dose for covid-19 immunization. The patient medical history was not reported. Concomitant medication included diltiazem. It was stated, "patient got her first Covid shot yesterday (clarified as 26Feb2021) afternoon and last night, on an unspecified date in 2021, she got had a severe headache later feel like she had relate to her teeth ache, but then later in the, patient got the funny hot kind, shoot through her whole body, it was like when she had up her surgery, when they put dye (further not clarified) in her she feel hot and now that she get it few times, the 4 o clock this morning and she got it again and now what she had all and got it in her back, was this severe allergies or otherwise she was okay." When paraphrased the concern, consumer confirmed the same and stated, "Yes, you are correct its shooting hot like it was hard to explain that it get real kind of hot and it was going through her whole body, not all the time." It was stated, "she was on medications for Blood pressure." The outcome of events was unknown. Follow-up attempts completed. No further information expected.

This is a spontaneous report from a contactable consumer (patient). An 86-year-old female patient received first dose of BNT162B2 (lot number: EW0191) on 29May2021 (at age of 86-year-old) on left arm at single dose for COVID-19 immunization. Medical history included ongoing Asthma, ongoing degenerative osteoarthritis, ongoing Stent, COVID-19 from 15Jan2021, diarrhea. Concomitant medications included paracetamol (TYLENOL) 500 mg tablet for pain. The patient previously took Plavix from unspecified date and ongoing. Caller states she is calling about the immunization, says she got it last Saturday in the afternoon (39May2021). She felt alright on Saturday, but from Sunday (30May2021) on, she began to have problems. Caller states she has advanced, degenerative osteoarthritis, and says it has been storming in Indiana this week. Caller states she has been in terrible pain, says she usually doesn't complain, and has been living with pain for years. Caller says she has to be pretty bad to complain. Sunday was really miserable with the arthritis. Caller says she is telling Pfizer not because she expects Pfizer to do anything with it, but says maybe she can help someone else who calls in because obviously she survived and the pain has gotten better through the week. Caller says Monday was another bad day, and she finally just had to give up and leave everything where it was and just go in the bed because she was hurting so bad. She clarifies she had to give up, says she tried to stay up but had to go back to bed because of the pain. Caller states her symptoms were an elevated temperature, which was a low grade one and still has it today, and she had GI symptoms. Caller states she and her grandson were running parallel, says they were both exposed at the same time, and both came down at the same day, and their symptoms were the same except her grandson does not have arthritis. Caller states they had a low grade temp, GI problems where they were not exactly nauseated, but it was kind of like a hunt. Some things went in their stomach and her stomach felt a little better with food in it, and then the problem was the diarrhea. Her and her grandson both had diarrhea and both slept quite a lot. Caller states she slept the clock around a couple of days. Caller stated both her and her grandson were hazy, mentally. The caller states she was surprised because her grandson is a very sharp young man, and he was sort of numb. When attempting to verify the details above and if her grandson also received the vaccine at the same time she did, the caller clarifies she is confusing things. She was talking about when they both had the COVID virus about the 15Jan. Caller says they were both exposed and came down with it the same day, says they ran parallel for 3-4 weeks. Caller confirms she is the only calling about herself today having received the vaccine. Caller states she is about 140 lbs, says she hasn't been very active lately. Caller states she received her vaccine at noon, says she was supposed to be there at 11, got lost getting there, waited in line, and then was ready at noon. Caller states they made her wait awhile longer because of her reactions to medications, says she waited a half of an hour. Caller states because felt it was wise for her to take the COVID-19 vaccine in lieu of her medical history with asthma, a stent, things like that. Caller says the doctors said it was wise for her to take it even though she had had the virus. She trusts , and has been with the doctor for 30 years, says she started with him when he first started his practice, says she trusts him, he's excellent, so when he said she should take it, she said ok. Caller states she didn't want to. Causality: Caller states she is inclined to think pain is related to the vaccine, but she is not going to say positively it was related, but it certainly is a coincidence. Caller states what she felt was that whatever was in the vaccine sort of irritated the irritation in her back and hips and leg and everything. Caller says they had some stormy weather this week and that always makes arthritis worse, but something caused the low grade fever. Caller states she is kind of assuming it's the COVID-19 vaccine. To be honest, she is kind of scared of the second dose so that's why she changed her appointment until the day after Father's day. Father's day will be the first time to see her entire family since the virus. Caller says her second dose was scheduled for the day before Father's day, but after the week she has had, she's going to get the immunization afterwards so she gets to see everybody. Caller then states she does feel the low-grade fever, and pain she was feeling, and the GI upset, were related to the vaccine. The GI upset was kind of a milder version of what she had when she had the virus. Caller states both she and her grandson had the GI upset when they had the virus. Caller says he wouldn't eat for awhile, but she got him to eat what she was eating because she figured out what her stomach would tolerate. Her and her grandson both had diarrhea and that was the bothersome part of it. After the vaccine, the caller did a lot of sleeping, says sleeping didn't last as long with the vaccine as it did with the virus. Caller says it was just a feeling of tiredness and she felt kind of blah. She really felt kind of stupid, it was hard to think- she doesn't know whether it was because she slept so much or what. Caller states she does not take strong pain medications for her arthritis because she has a stent and is on Plavix 24/7. She was told two years ago there is an incidence of internal bleeding for people who take arthritis medication and those who have a stent and are on a blood thinner 24/7. Caller states she was given the option of either taking a chance or not to take the pain medication. Caller says she didn't take the chance and opted not to take the pain medication. Caller says she only takes Tylenol extra strength, she does not use anything else. Caller says it can't be a pain medication that made her sleepy and stuff. Terrible pain: Caller states that one day, she just gave up and went to bed because she hurt so bad. She is not sure she would say the pain is disabling. The pain began on Sunday. She was a mess when she woke up. She clarifies she might have been up through the night to go to the bathroom and was miserable. Sunday was miserable, and Monday was a miserable day. Elevated temperature: Caller states fever began in the night, says she can't remember whether it was Sunday night or during the day on Sunday, says she's not exactly sure when. When probed for the seriousness, she said the significance might be due to the immunization. She confirms the fever is getting better, she felt better yesterday. Caller says today her eyes are burning. She took her temperature earlier and it was up, and her temperature is still up. Caller states because she takes Tylenol morning and evening, before she goes to bed, says it helps the pain somewhat. Caller says the first part of the week, Monday and Tuesday, the Tylenol might have taken the edge off. Extra Strength Tylenol: 500 tablets per bottle, 500 mg per tablet. Caller states the NDC:3014256190. Caller says she doesn't see a lot number, but there is a number underneath the expiration date: 9EE2582B.Exp: Feb 2021. Caller states the pain today is about the same that it always is, says she's pretty much in pain all the time, says it's something she has to live with. Caller states about the only time she is pain free is when she's in bed and has relaxed and taken a dose of Tylenol and it has taken effect. Caller states after she gets up in the morning and starts moving around, she starts having pain. Sometimes she has pain early in the morning, depends on what she does, like run the sweeper or when she's getting groceries. Caller states getting her groceries are one of the worst things, and she will have more pain the next morning. GI upset symptoms: Caller says she's pretty sure it started Sunday or just right away after that. Caller says it's a strange feeling, it's kind of a queasy, hungry feeling, it's a weird feeling. Caller says she puts a little food down there and it helps. Caller says she's been eating a lot of crackers, wheat thins, and ginger snaps. Caller says she has eaten and is pretty comfortable, says she would say it's getting better. Caller states she thinks in general, she is getting better- it's not perfect, but she is getting better. Caller states the reason she called is, for instance, her daughter in law, the mother of her grandson, was tending to think his symptoms from the virus were psychological and so forth. Her daughter in law is sort of that way, and she thinks everybody's else pain is psychological but hers. Caller states she came to her grandson's defense and fixed him up three care packages over a month with food that her stomach would tolerate- like crackers, ginger snaps, powdered chicken noodle soup, not canned, and oddly enough canned green beans, just plain old green beans, nothing on them- she didn't even have to warm them. Caller says her stomach tolerated them. Also, baked beans helped, she needed protein in there, says she tolerated baked beans and so did her grandson. Caller can't say everything she put in the care package, but tea was one thing, and another thing was cocoa. Caller says she got a generic mix. She mentions she tried some others, but they were not that good which was also because her taste doesn't enjoy food. Caller states this cocoa was good and was the generic brand. She gave her grandson a couple of cans of that because she drank that every evening when she took her medicine and ate crackers with her medicine before bed, and it was kind of soothing to her stomach. She knows it sounds weird, but it worked. Her GI upset she would consider medically significant because there was definitely a tie up. She explains it wasn't disabling and she doesn't consider it serious. She explains it was annoying, especially when she had the diarrhea. Unable to determine if caller was referring to vaccine symptoms or virus symptoms. Tiredness: She states she would consider the tiredness medically significant because she would sit down and she would get sleepy and then she did all this sleeping. Caller states it wasn't serious. She states the whole thing about this virus is kind of annoying because it was just bad enough it kept her from functioning normally and kept her feeling kind of lousy. Caller states she is feeling better, says it's improving. Hard to think: Caller states she would also consider this medically significant. She wouldn't have driven, says she wasn't sharp enough to drive or do anything important. Caller states today she is a little tired, but her temperature is up- it all goes in together. Attempted to clarify symptoms of the vaccine with caller. Caller states one thing she wants to tell Pfizer about her grandson is about the mental fog. The caller and her son were very afraid her grandson had that because her grandson was just a blob sitting there. He has been depressed because his parents are in a custody battle, so she doesn't know what part that played in it. Caller says she was concerned about him. He is 15 and he is very intelligent, but his grades went to Ds and Fs. Caller says her son got ahold of the high school counselor and the mother wouldn't do anything about it. The high school counselor got in on it, her son got on it, then they got someone got on it. Caller says they got her grandson through the work he was behind on, says he was behind for the whole thing. His mother didn't encourage him to do any school work. Maybe it wouldn't have done any good, maybe he was too far gone to do any work. Caller says they were concerned about the mental fog. She says her grandson is coming out of that and becoming his old self again. Caller says he is very intelligent and inquisitive, and he was just a blob for a long time. Medications: Caller stated she has been taking Plavix since 2008. She clarifies she started taking the Plavix because of her stent. She was on brand Plavix for a while and at one point she was switched to generic and she is on the generic 24/7. Tried to confirm with caller the generic name, but the call disconnected. Outbound call,was placed on 04Jun2021 at 3:24pm and was unsuccessful. Placed second outbound call, on 04Jun2021 at 3:25pm and was unsuccessful. The outcome of the events was unknown. The causality was reported as related. The seriousness was reported as medically significant.

Eyes roll back and she looked like she passed out and then she looked like she started having a seizure. Then she stiffened and would not respond. This lasted for about 2 minutes. Then for 10 minutes after she felt very drained and disoriented.

Experiencing a heaviness in her chest; jaw pain; like she is freezing outside; she could barely walk with her walker; severe nausea; shaking from head to toe/having tremble; felt like burning up inside; Weakness; Has zero appetite; Anxiety.; This is a spontaneous report from a contactable consumer (daughter). This consumer reported for an 86-year-old female patient that: An 86-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Lot Number: ER8735), via an unspecified route of administration, administered in Arm Right on 27Apr2021 at 11:00 (at the age of 86 year) as single dose for covid-19 immunisation. Medical history included Chronic hives from an unknown date and unknown if ongoing, ongoing Unspecified reactions, ongoing Unspecified medication allergies and patient had a prior fall where she suffered a broken ankle. Concomitant medication(s) included dupilumab (DUPIXENT) taken for eczema from Sep2020 and ongoing and latanoprost (LATANOPROST) taken for glaucoma from an unspecified start date and ongoing. Patient historical vaccine includes shingles vaccine for immunization and within 48 hours, the patient broke out in severe eczema from head to toe and first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Batch/Lot Number: EP7533), via unspecified route of administration on Right arm for Covid-19 immunization and experienced no adverse event. She had Called on behalf of her mother who was 86 years old. Mother received the second dose of the Pfizer BioNTech Covid-19 vaccine last 27Apr2021, within 24 hours, mother experienced severe nausea with shaking from head to toe and felt like burning up inside. The weekend after the second dose, the mother experienced heaviness in the chest and jaw pain and was brought to the ER. Full cardiac work up was done, and results were fine. Doctors said this may be due to anxiety. Mother had CT abdomen, an endo scan, and blood works but they were all fine. Mother continues to weaken, having tremble and is nauseous. These symptoms would come and go. Mother was in the ER twice this past week and they could not find anything. Nausea got worse. It would come back strong around 3:30 in the morning. Caller wanted to know if these were reported with the Pfizer Covid-19 vaccine and if there was anything they could do further. Mother was taken to different doctors and tests were done but no findings. caller mentioned that the symptoms happened right after the shot. She reported that the patient has been seeing an infectious diseases doctor as during her lifetime, the patient has always had chronic hives. Caller reported that the patient has reactions to many things and is allergic to many medications. She reported that that weekend it got so severe, the patient was experiencing a heaviness in her chest and jaw pain. She reported that they thought the heaviness in the patient's chest and jaw pain might be cardiac, so the patient was taken to the emergency room. She reported that the patient stayed 2 nights in the hospital. Caller reported that the patient's heart was ruled out and her bloodwork came back ok. Caller reported that the hospital physicians thought that the heaviness and jaw pain could be anxiety and prescribed anxiety medication for the patient. She reported that the patient went to her primary care physician after leaving the hospital. Caller reported that the patient got worse and was experiencing nausea more and more. She reported that the patient's physician ordered an endoscopy and brain scan to rule out everything medically. Caller reported that the patient's physician informed her that her blood pressure was fine, her bloodwork was fine, and that all of her test results were normal. She reported that the patient just continues to weaken and trembles and burns up. Caller reported that the patient was so severely nauseous but never throws up. She reported that they are just at their wits end and do not know where to turn. Caller inquired if anyone else was calling with these side effects and if there was anything they can do. She reported that the patient went from being just fine, on no medications, to this. Caller reported that everyone keeps saying they do not know what was wrong with the patient. Caller reported that the patient's physician keeps saying that maybe it is anxiety, but the patient has been on the anxiety medications for 6 weeks and there are no signs of improvement. She reported that she does not want the patient to take the anxiety medications if they are not helping. The patient has been taking the generics for Lexapro and Xanax, escitalopram and alprazolam, for 6 weeks and has shown no improvement. Product strength and count size dispensed: Escitalopram 5 mg; dispensed in pharmacy bottle Alprazolam 0.25 mg; dispensed in pharmacy bottle Additional lot numbers: Caller unable to provide product lot numbers as they were dispensed in a pharmacy bottle. Caller reported that the Escitalopram was manufactured by Accord and the Alprazolam was manufactured by Sandoz. She reported that the patient was started on 5 mg of Lexapro, but the dose has been increased to 10 mg. Caller reported that the patient was taking two 5 mg tablets. Severe nausea: Caller reported that the patient's nausea has worsened. Caller reported that the patient initially would experience nausea for a couple of hours then it would ease. Caller reported that the last 10 days, the patient's nausea is almost all the time. Caller reported that the patient gets a couple good hours maybe before going to bed and that is it. Caller reported that the patient wakes up with severe nausea around 3:30 in the morning like clockwork. Shaking from head to toe: Caller reported that the patients shaking comes and goes. Caller reported that the patients shaking was definitely worse in the morning when she was the weakest or if she was getting a bad bout of it, like the nausea comes on stronger. Burning up inside: Caller reported that the patient feels like she is freezing outside when she was burning up inside. Heaviness in chest: Caller reported that the patient experiences heaviness in her chest when she gets episodes where the nausea and burning up inside, freezing outside come on. Caller reported that the patient does not always have the heaviness in her chest. Weakness: Caller reported that they took the patient to the emergency room a second time because she could barely walk with her walker. Jaw pain: Caller reported that the patients jaw pain comes and goes. Has zero appetite: Caller reported that they have to force the patient to eat. The patient underwent lab tests and procedures which included abdominal x-ray: normal on Apr2021, blood pressure measurement: fine on Apr2021, blood test: normal on 30Apr2021, cardiac function test: normal on 30Apr2021 results were fine computerised tomogram abdomen: all fine on Apr2021, endometriosis: all fine on Apr2021, endoscopy: normal on May2021 and scan brain: normal on May2021. Patient was visited to emergency room and physician's office for the events Jaw pain, heaviness in chest, nausea and weakness. Patient was hospitalized for the events experiencing a heaviness in her chest and jaw pain from 30Apr2021 to 02May2021. Therapeutic measures were taken as a result of the events with Escitalopram and Alprazolam. The outcome of the event's severe nausea, shaking from head to toe, felt like burning up inside, jaw pain, Weakness, has zero appetite, anxiety was not recovered and experiencing a heaviness in her chest, she could barely walk with her walker, like she is freezing outside and she could barely walk with her walker was unknown. Information on Lot/Batch number has been requested.

Patient being monitored after vaccine developed swollen uvula and heavy lip 20 minutes after administration. Patient given benadryl with relief and evaluated by nurse practioner.

The caller has a hard time seeing so I am not 100% sure that she read the lot number correctly to me. My arm hurt me really bad and my armpit hurt really bad. This started a couple of hours after receiving the injection. This lasted about 2 days. I noticed the red spots (bright red and flat) about noon on Friday. They are still there and have not changed since then.

Patient has been under Hospice services for almost a year. She began to demonstrate a large amount of oral secretions on 1/10/21 at 2130. She was suctioned and a Rapid COVID-19 test was performed, which was negative. The COVID-19 Rapid test was repeated on 1/11/21 and was positive. Oxygen saturation was noted to be 78% on 1/12/21, and oxygen was initiated at 1133 at 3L per nasal cannula. Oxygen was increased to 4L at 1635 d/t shortness of breath. On 1/15/21 @ 0645 patient was unresponsive and without vital signs. Orders were for DNR and CPR was not initiated.

About half an hour of vaccination, patient complaint of numbness of lips and tongue felt cotton dry. Patient stated that she has had reaction to bee sting before, but the reaction was immediate. I gave patient 2 tablets of 25mg Benadryl and kelp an eye on her. She felt fine after half an hour of observation. She then went to her room.

Patient reports tongue swelling/tingling the day after receiving the vaccine. Patient reports that her tongue swelled/tingled for about 2-3 days after receiving the vaccine, but has fully improved 4 days after receiving the vaccine. Patient used hydrogen peroxide mouth gargle but otherwise did not take any other medication to relieve the swelling. The patient also reports her bottom lip was swollen for one day but that improved and was resolved the next day. Patient is advised to take prophylactic Benadryl before receiving her next dose.

Patient developed dizziness and weakness. She did not totally pass out because she made it to her chair and did not fall on the ground. She described her vision going black. She said that she did not eat today at her normal times which could have contributed to the event. She is asking if the vaccine could have had anything to do with this? She has not had a previous episode like this before. She did have some minor injection site pain at the time of the vaccine but that has subsided. Follow-up call with patient on 1/30/31 at 19:37: Spoke to the patient. She is feeling better today. She did not see her doctor or go to the ED. She checked her glucose yesterday and it was high. She said she thinks her symptoms were from not eating her normal meals around the time of the vaccine.

Pt presents for s/e after 2nd dose COVID 19 pfizer vaccine today, about 1-2 hours prior to office visit. She called over to the medical staff because her right side of mouth became tingly, and her right eye hurt about 5 minutes after vaccine. The episode lasted about 10-15 minutes per Patient, and did not loose consciousness She brings in a rhythm strip with only BP- she denies having EKG. BR 218/94 and HR 63 @1224, and 195/99 HR 64 @ 1228. They called EMS, and pt declined to go. She denies any CP, SOB, no slurred speech or sudden weakness during the episode. Denies swelling of face or lips, no dysphagia. No meds administered at clinic. Pt has not taken any additional medications today.

migraine aura/migraine that was strong enough that she could not see; flashing lights; blocked vision/migraine was strong enough that she could not see; This is a spontaneous report from a contactable consumer reported for herself. A 87-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL1284), via an unspecified route of administration on left arm on 18Jan2021 at SINGLE DOSE for covid-19 immunisation. The patient medical history was not reported. Concomitant medication reported as unspecified (Caller states that she does take a few medications but nothing has changed with those in years, so she does not think anything else is relevant). Historical vaccine include flu shot and does have reactions. Caller stated she received Pfizer COVID shot first dose and within an hour she had migraine without the headache but did have the vision blocked out. It resolved after some time. she wanted to know the ingredient of the vaccine to see if she should take the second dose. Caller states that she had her first Pfizer COVID Shot on 18Jan2021. Caller states that she didn't have any of the ordinary reactions, both the caller and her husband had the shot and neither of them got a sore arm or swelling at the site. Caller states that after they stayed for a half an hour, and when they were driving back to, the caller started to get a migraine aura. Caller states that she has had them before, but not often, and she has not had one for about 10 years. So caller states that her aura started while they were driving, and then the caller's husband dropped the caller off at the grocery store. After being dropped off, caller states that her migraine came on strong. Caller states that her migraine was strong enough that she could not see, she was experiencing flashing lights, and blocked vision. Caller finally turned to another customer to ask if he could see the cucumbers in front of them. Caller states that she waited outside for her husband to get her. Caller states that migraine probably lasted for about 45 minutes. Caller is wondering if this could have been from the shot or not. Caller states that she does have reactions to flu shots sometimes, but not like this. Outcome of the events was recovered on 18Jan2021.

Patient was in the observation area and started to feel strange and her eyes started watering. EMS was on site and initiated blood pressure monitoring. Patients BPwas 174/95 and RR 77. Her blood glucose was 106. Patient stated she didnt take her morning meds. She was monitored for 15 minutes and felt better and went home with her daughter.

Called to assess pt in post vaccine waiting area due to c/o swollen tongue at 10 Am. Pt reports tongue swelling after her first dose, worse now after 2nd dose with sensation of swelling in her throat/back of tongue. No c/o itching, no visible urticaria. No shortness of breath/wheezing. Radial pulse in 70's. Pt reports tongue looks swollen to her in when she looks in mirror in the car. Med/allergy info in hand - multiple drug allergies noted. Did not meet criteria to receive epi pen, wamc EMS contacted to transfer pt to ED for further eval. Spouse headed to ED from fairgrounds site. Foglia MD

Patient reported tongue swelling that she could feel in mouth and back of throat. She reported this occurred after the 1st dose but got worse while she was in the post-vaccine waiting time.

About 6 day later, she developed a low grade fever (99.6), headache, her chest was feeling heavy and tight, she was achy all over, she had chills. She had a horrible cough (deep, barky cough, non productive cough) Her symptoms continually got worse. She also had an earache. She was having trouble breathing so we went to the ER on 02/16/2021. They diagnosed her with bilateral pneumonia and fluid on both of her lungs. She was discharged from the ER same day under my care, I am an RN. The prescribed her a Zpack (Azithromycin) 500 MG for 1 day, the next 4 days 250 MG, Naproxen 500 MG every 12 hours, Albuterol nebulizer treatments every 4 hours. ER doctor believes that the vaccine may of effected her immune system. She does have a follow up with Dr. on March 2nd. She is improving. She still has a mellitic/bitter taste in her mouth from the first vaccine. She is doing better but not completely over it.

About 2 days after receiving the vaccine, she bitter taste in her mouth. She still has it as of today. It is kind of metallic taste. She also has blurry vision and swelling in her eyes. It felt like she had discomfort behind her eyes. It was causing difficultly reading. This lasted about 2 weeks. It is not as blurry but her vision is not what it is was prior to receiving the vaccine. She went to Eye Center, they told her they didn't know what it was from. They gave her some eye drops and gave her antibiotic/steroid cream. She has a follow up appointment 2/26/2021.

Mom woke up this morning and has lost all vision following #1 of 2 Covid-19 vaccination on 02/25/2021

Pt had Covid vaccine on February 8th. Her daughter saw her on February 15th and noted right sided facial drooping. Pt noited her right eye had been tearing quite about for at least 2 days prior to the 15th.

She developed mild swelling of her lips just after midnight on 3/3/21, which she discovered after waking up to use the restroom. She then went back to sleep. She awoke the next morning (3/3/21) to find her lips, tongue, and back of her throat were swollen so much that she couldn't talk. She came to the ED where she received 125mg Solu-Medrol , Pepcid 20mg, and Benadryl 25mg. The swelling initially improved then worsened again and she was admitted to the hospital for overnight observation. Swelling improved and she was discharged on 3/4/21.

Tinnitus, weakness, headache, loss of thought process, can?t walk. Lasts about 80 minutes. 3 episodes so far. First time called Para medics, second time 4 days later went to Emergency room, CT scans, blood work, given fluid IV. 12 hours later same symptoms went back to ER told just lay down. First event 3/11

2/22/2021 9 PM (angioedema) swollen/red lips, flushing chest, red earlobes, red behind ears, difficulty swallowing when eating, throat congestion throughout the day for 4 weeks 2/24/2021 benadryl 25 mg up to 4 times/day; prednisone 10 mg increased to 30 mg 2/26/2021; famotidine 20 mg once/day; zyrtec 5mg discontinued after 2 days due to reactions - replaced with claritan 10 mg daily 3/1/2021 emergency room admission for observation continuing above medications

Patient was AAOx3, ambulating independently prior to obtaining vaccine. Medical Assistant gave patient vaccine in Left Deltoid. Patient ambulated to observation area and sat in a chair. Five minutes into her observation, patient reported not feeling well. Medical Assistant notified Nurse Practitioner. Upon exam, patient was pallor, eyes intermittently rolling back, lethargic and unable to keep her head upright, nauseous and dry heaving, developed rigors, unable to verbally communicate but did nod her head yes to having difficulty breathing. No hives or rash noted. Epinephrine 0.3mg Pen (Lot # 0FM406, Exp Feb 2022) was administered in Right Deltoid. 911 was called by the Vaccine Clinic Supervisor. Vitals: Temp 97.7, HR 77, BP 134/76 (sitting), Pox 96% Room Air. After Epi administration, patient continued to be lethargic and the only thing she stated was "I do not feel well" but was able to communicate with head nods. EMS arrived and patient was taken to a Hospital.

Pfizer-BioNTech COVID-19 Vaccine: at annual wellness exam seven days after vaccination patient reports headache, fatigue, vision changes, and seeing people who are not there. Patient atrributes symptoms to immunization. Vital signs within normal ranges. No rash, dizziness, lightheadedness. Patient will follow-up with neuro-ophthamology.

Restless legs; Reaction with her legs; Burning of my legs/my legs feels like they are hot; I am having a sort of numbness feeling in my legs/I am experiencing a sort of numbnessin my legs, in my legs in the muscles; hard of hearing; This is a spontaneous report from a contactable consumer. An 87-years-old female patient received BNT162B2 (COMIRNATY, PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection) dose 2 via an unspecified route of administration on 06Feb2021 (Batch/Lot number was not reported) and dose 1 via an unspecified route of administration on 16Jan2021 (Batch/Lot Number: EL8982) both as single dose for covid-19 immunisation. Patient's medical history and concomitant medications were not reported. On an unspecified date, the patient experienced restless, reaction with her legs, burning of legs/ legs feels like they are hot, sort of numbness feeling in legs/ legs in the muscles, hard of hearing. Therapeutic measures were taken because of restless legs which included over the counter drugs. Patient's lab data was not reported. Outcome of the events was not reported. When requested for probing, Reporter stated, "No." Further probing could not be done as reporter don't want to share further information. Hence, limited information was available over the call. Follow-up activities have been completed and no further information is expected.

I'm concerned about COVID vaccine possibly triggering a recurrence of post herpetic neuralgia in my mother, who hadn't had post herpetic neuralgia since 2015 14 hours after dose 2 of COVID vaccine administered on 2/23, patient awoke with sudden onset severe right ear and forehead pain, site of her initial herpes zoster rash in 2004. No visible rash or changes on eye exam (Pt is taking valtrex for eye sequellae of zoster). Other symptoms have included fatigue, bilateral axillary and neck lymph node tenderness, and some breathing discomfort. All symptoms are much improved but persist now (4/12/21).

STARTING HAVE SEVERE PAIN IN LOWER NECK UP INTO LEFT SIDE OF HEAD SEVERAL DAYS AFTER VACCINE. ER ON 3/15/21 SHOWED ARTHRITIS IN C-3. SENT TO DR FOR FOLLOW UP. 3/17/21 PUT ON ORAL PREDNISONE, PAIN SHOTS X4 IN AREA. 3/19/21 RETURN TO ER, INCREASED PAIN AGAIN, LOSE OF SIGHT IN LEFT EYE, CT SHOWED POSSIBLE VERTEBRAL ARTERIAL OCCLUSION WITH POSSIBLE DISECTION. ADMITTED. ALSO SAW MICRO VASCULAR CHANGES AND ATROPHY. NEURO CONSULT FOR THROMBECTOMY VS MEDICATION MANAGEMENT. PER FAMILY, PAIN MEDS, NO FURTHER MRI OF BRAIN, COMFORT CARES. PT DIED 3/22/21.

headache for 18 days; vision problems where her eyes were glassy; her muscles of her legs the first day bothered her; chills on and off; This is a spontaneous report from a contactable consumer (patient). A 87-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number and Expiration date was not reported), via an unspecified route of administration, administered in Arm Left on 21Jan2021 as single dose for COVID-19 immunization. The patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number and Expiration date was not reported), via an unspecified route of administration, administered in Arm Left on an unknown date in 2021 on Thursday at 02:00 PM as single dose for COVID-19 immunization. Patient's medical history was reported as none. The patient concomitant medication included unspecified flu vaccine (NDC/LOT/EXP unknown) on an unknown date at the end of Oct2020. She stated that she was lucky to be so healthy, she was active. An unknown date, after receiving the first dose of vaccine, the patient experienced headache for 18 days; described as the headache was not a pounding headache, it was a sickly headache at the back of her neck, like we would get when had a temperature. She did not had temperature. She also experienced vision problems where her eyes were glassy and bothered her and could not do her reading. The patient also experienced chills which were on and off and her muscles of legs the first day bothered her. The reporter stated that her doctor told her that the cases and deaths of COVID-19 are high and it would be better for her to receive the second dose despite her reactions. The reporter wanted to know if the Pfizer COVID vaccine dosage is weight based. The reporter stated that her friend mentioned that a 400 pound man may be given the same dose, so she wanted to know if the vaccine can be given based on weight. The reporter stated that she was not sure of lot number as it was hand written and says Pfizer COVID-19 LOT EL or EC, 3247. The reporter stated that her brother and two of her friends had the Pfizer vaccine and they do not have any side effects. Therapeutic measures were taken as a result of headache and the patient received treatment with ibuprofen IB tablets (UPC: 09661988088-1, EXP: Oct2021). The reporter stated that she was ecstatic or thrilled that she does not have headache at the time of report. She also stated that since even her muscles of her legs the first day bothered her, though it subsided after that. The outcome of the events vision problems where her eyes were glassy and chills on and off was reported as unknown whereas headache was reported as recovered. The outcome of the event muscles of her legs the first day bothered her was reported as recovering. Follow-up attempts are completed. No further information is expected.

1) Sudden Blurring of vision, lasting more than one month (still occurring), 2) partial loss of hearing in both ears, 3) nerve sensitivity when moving body and when objects (seats, walls, bed) touch skin, feeling like shooting pain on contact. 4) loss of muscle strength, and extremely sharp pain (like spear stabbing) when using muscles (see symptom #3 above). 5) fatigue and spontaneously falling asleep, even when standing or doing dishes. 6) toe nails deformity within weeks of shot, curling and turning sideways. 7) uncontrollable leg adema, severe with water leaking out of legs.

Pt.'s daughter reports 03/29/2021 pt. started experiencing symptoms of dizziness, nauseous, dry mouth, fatigue, severe headaches, and confusion. On and off symptoms daily until 05/10/2021 severe weakness ER (by ambulance) confirmed Stroke. Bed-riddened currently and still severe confusion.

Bells Palsy left side of face- paralysis was seen in the ER on 5/31. Was seen on 6/17 by PCP due to left ear pain was ordered steroids and to increase Gabapentin

On Tuesday, March 9th, a friend of mine went to my mother's home to take her to a scheduled dentist appointment. Upon arrival, she observed that my mother was disoriented and her vision was impaired. Specifically, her right pupil was completely off to the right side, her eye was irritated and slightly swollen. Per recommendation from the primary care office, my mother was taken to the emergency room. She remained hospitalized for two weeks during which time, several labs and x-rays were performed; several ideas surfaced regarding root cause including Miller Fisher Syndrome, mini-stroke, etc. but no final diagnosis was identified.

blood on her brain/clot on her brain; clot on brain and patient was in the hospital for 6 days; brain stroke; high blood pressure 220; headache on and off since she got the vaccine; was very sleepy; used to get cold; Paralyzed; can not talk; can not walk; she is bed ridden right now; her throat is not working good; This is a spontaneous report from a contactable Consumer (patient daughter). A 87-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection. Lot Number: ER8730), dose 1 via an unspecified route of administration, administered in arm on 27Mar2021 as dose 1, single for COVID-19 immunization (between 14:00-15:00) Medical history included the patient had ongoing high blood pressure when the patient was young but and was not taking high blood pressure medicines as did not need it and she had borderline pre diabetic and was supposed to take medication for pre diabetes but the patient was with the caller and her kids and always only takes Vitamin D and diet intake and controlled it like that. The patient had not taken medication for years. History of all previous immunization with the Pfizer vaccine considered as suspect reported as 1st dose. No additional vaccines Administered on Same Date of the Pfizer Suspect. The patient did not receive any other vaccines within 4 weeks prior to the vaccination. No adverse event reported prior to vaccination. The patient was hiding because she did not want the vaccine. The patient never went to the doctor, because the patient was very healthy before vaccination. The patient hates vaccines and did not want it and that is why such a hard time that day. Time of onset of adverse events they went to the hospital and realized The patient was like that at 10:30. The patient got the vaccine 27Mar2021, (Saturday) and the headache started (Monday)on 29Mar2021, that the headaches were always in the morning, The patient would wake up and they were on and off in the mornings. The patient was very sleepy and thinks that was because of the headaches, they were very strong headaches. When they used to give babies vaccines they would get sleepy and she thinks its the vaccine and to just lay down here and would put her on her bed and she laid down with the headache and she gave Motrin and she would fall asleep. The patient used to get cold and would put blankets on her and she would fall sleep and it was on and off and states for 2 weeks it was probably 3-4 times a week. The patient had blood on brain and was hospitalized with high blood pressure 220 on Mar2021 when she was at the hospital and had the brain stroke 10Apr2021, clot on brain and the patient was in the hospital for 6 days. The patient cannot talk and walk, bed ridden right now and paralyzed on an unspecified date in Mar2021. The patient was bed ridden right now on an unspecified date in Mar2021 and her throat was not working good on Mar2021. She had headache on and off since got the vaccine on 29Mar2021 and was very sleepy on an unspecified date in Mar2021, used to get cold on an unspecified date in Mar2021. Caller did not recall the day she was released. It was reported that, now she was ok. They did physical therapy for 2 months to see if they can bring back but were not able to. The patient was kinda like stuck and the only thing. The patient improved they removed the IG tube. The patient was eating through and she was now eating thick foods as throat was not working good, like baby food blended. States the card has the clinic site and when to go for the 2nd dose but she did not go back because of this. It was reported that, when they went to the hospital that day with the clot on brain the doctor asked if she had any bad news or any type or received anything thinks because of the high blood pressure was why he was asking. The patient was fine and watching TV and had a headache on and off since got the vaccine. The reporter stated that she told the doctor she got the vaccine 2 weeks ago and the doctor said it was the vaccine. The reporter stated that the patient did not know what testing was done, they were trying to give something for the clots from brain without getting surgery but it was not working and pressure was so high and the clots would not move, it was not able to do it. The patient did not know what they did but the other option was to remove the clots. The patient visited to emergency room and did not went to Physician Office. The patient was planning to take her to the doctor because of the headaches but was so busy and was having a project at work. The patient underwent lab tests and procedures which included blood pressure measurement: 220 mmhg on Mar2021 when she was at the hospital. The outcome of the event oropharyngeal discomfort was not resolved and outcome of the other events were unknown. Follow-Up (07Jul2021): Follow-up attempts are completed. No further information is expected.

sore arm; lightheaded and kind of dizzy; Her stomach doesn't feel great ("stomach isn't the best"); Dry mouth; nausea; This is a spontaneous report from a contactable consumer (patient). This 88-year old female patient received the first single dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 08Jan2021, for COVID-19 immunization. Medical history and concomitant medications were not reported. On 09Jan2021 the patient experienced sore arm. Since an unspecified date in Jan2021 she was lightheaded and kind of dizzy, her stomach did not feel great, she had dry mouth and nausea. She was feeling as if she could get sick (further specified as nausea). She had not got sick but her stomach wasn't the best. Events outcome was unknown. Information on the lot/batch number has been requested.

Client presented for 1st dose Pfizer vaccination. 10 minutes after vaccination reported tingling tongue and "medicnal taste" in mouth. Lips felt "strange". BP176/81;P 67. Able to swallow. Respirations regular at 16. History of allergy to pain meds and coumadin. Repeat BP 153/69. Still felt symptoms but no worsening. No visible swelling of tongue or lips. Third BP 20 minutes after initial onset was 138/67. Two family members present agreed to take client to nearby Urgent Care for further evaluation.

flushed in the face/warm; red face; tingling sensation of lips but no swelling; mild allergic reaction; This is a spontaneous report from contactable consumers. An 88-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiration date unspecified), via an unspecified route of administration on 20Jan2021 11:45 at single dose (left arm) for COVID-19 immunization. Medical history included lung cancer. The patient was not pregnant. Concomitant medications were not reported. It was reported that the patient had unspecified other medication in two weeks. The reporter's mother's experienced mild allergic reaction in Jan2021 and she wants to know whether or not she should be getting her second dose. She will be asking her doctor as well as they were advised by the nurse administering the vaccine and also the doctor's nurses who observed her mother afterwards, but she was also advised to contact Pfizer. On 20Jan2021, at 12:00, within 5 minutes, the patient experienced flushed in the face/warm, red face, tingling sensation of lips but no swelling, no increased blood pressure, no hives or rash, no tongue or throat swelling, no dizziness, no nausea. It was mild but concerning. The patient was treated with oral Benadryl and Pepcid IV (also reported as IV of peptids), and extended observation for 1 hour and 30 minutes. The events resulted in doctor or other healthcare professional office/clinic visit. The patient had no Covid prior vaccination and was not Covid tested post vaccination. The consumer would like to know if her mother was safe to receive the second dose of the Covid vaccine and if the reaction to the second dose of the Covid vaccine will be more severe with a history of an allergic reaction to the first dose. Outcome of event mild allergic reaction was unknown; outcome of the rest of events was recovered in Jan2021. Information on the lot/batch number has been requested.

Patient experienced moderate to severe symptoms of shaking, trouble breathing, jaw tightness, tightness in mouth, numbness and tingling in lips, difficulty talking, upset stomach, tremors and numbness to left side of face

About ½ hour after the vaccination, the tip of my tongue felt bruised and a little while later it began to swell, I put ice on it for 2 hours and by the time I went to bed it was all gone. And I?ve not had any other problems with it.

extreme lightheaded began approximately 2/28/21. tingling in left ear at bedtime, feel like my ears are stuffed as well as my head feeling that way, unsure is I should receive the second shot

She needs to get her magnifying glass, she states she's going blind/macular degeneration; She needs to get her magnifying glass, she states she's going blind/macular degeneration; temperature 99.2; vomiting; very tired; arm was sore, couldn't lay on it; This is a spontaneous report from a contactable consumer (patient). An 88-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: EM9809) intramuscularly, administered in left arm on 23Feb2021 at 10:30 (at age of 88 years old) at a single dose for COVID-19 immunization; gabapentin, via an unspecified route of administration from 08Feb2021 to 15Feb2021 at 100 mg, daily, then via an unspecified route of administration from 15Feb2021 (Batch/Lot number was not reported; Expiration Date: 08Feb2022) to an unspecified date, at 200 mg, daily for feet burn. Medical history included hiatus hernia surgery from Nov2019, surgery from an unknown date, vomited after surgery for three nights/days, gastrooesophageal reflux disease (GERD), cancer, feet burning, feet red, asthma and thyroid. Concomitant medication included paracetamol (TYLENOL EXTRA STRENGTH), fluticasone propionate, salmeterol xinafoate (ADVAIR) taken for asthma, montelukast sodium (SINGULAIR), fluid pill, vitamin D, vitamin C, potassium, acid reflux pill before nighttime before supper, thyroid pill, singulair pill. The patient previously took Codeine and percocet [oxycodone hydrochloride;oxycodone terephthalate;paracetamol] and experienced allergies. Two years before in Nov2019 she had hiatus hernia surgery. Her stomach went into her chest. She was in rehab. She had to have the surgery done twice. She went from one hospital and then she went to another and it was taken care of there. When she went to rehab after her surgery, all she did was vomit day in and day out. Her current vomiting reminds her of this experience. They finally did take care of it. She came out of the hospital and was vomiting. She clarifies she had problems with vomiting for the last 6 months before this current experience. She doesn't know what she's eating. They say it's acid and she has Gerd. She does try to get her exercises in. When she was in the hospital, they found she had cancer, which they are just watching for now. When querying what kind of cancer she has, the caller explains she didn't have them do a biopsy. She didn't want to go that far into it. She didn't want any extensive treatment. At first, they were keeping check of the cancer every 3 months. Now, she is going ever year. She last went in November. The patient experienced macular degeneration on an unspecified date, vomiting on 23Feb2021 at 17:30, temperature 99.2 on 25Feb2021 at 10:00, very tired on 23Feb2021, arm was sore couldn't lay on it on 23Feb2021. Patient had the first Covid vaccine Tuesday morning, clarified to 23Feb2021 at 10:30AM and around 5:30PM that night she started vomiting. She vomited all night long and all day Wednesday and Wednesday night, and this morning. So far, it had stopped. She was trying to hold water down, but she couldn't keep water down, the water would come up. She clarifies further she tried to take a sip but it kept coming up. She called her doctor who was a practitioner and she told her to drink ginger ale and maybe crackers. She told the doctor that her daughter sent her electrolytes and she was told that was fine to take. She tried toast this morning and she couldn't hold it down. She's been eating very slow, taking little bites at time and she had been holding it down. She did have temperature of 99.2 on 25Feb2021, but half hour or so before it was down to 96 now. She couldn't take medicine that she normally takes because she'll throw it up anyway. She tried to take a few of her pills but it didn't stay down, she threw them up. Around 9am, she took her thyroid and that stayed down. So far, that's doing good. She takes Advair for asthma and she took that, that's okay. She took her singulair pill. So far, the three of these medications have stayed down, and she took 2 Tylenol. Patient took Tylenol twice. She knows it was Extra strength, took 2 pills Tuesday night but it didn't stay down. She Took 4 Tylenol today, 2 pills this morning and 2 right before her CNA left at around 3pm. Caller mentions she can't see the dosage on her Tylenol bottle. She doesn't see the dose. She mentions she will get her magnifying glass to check it out. She's afraid because she had surgery a couple years before and she vomited after surgery for three nights/days, or whatever. Today (25Feb2021), when she spoke to her doctor she was advised to call Pfizer to let them know how the vaccine is affecting her. Right now, she feels pretty good, but she was very, very tired. She's going to lay down when she gets off the phone. She had a CNA with her today and she also spoke to the nurse practitioner. The last time she vomited was around 10am. When the CNA came in, she told the caller to call the doctor but she told the CNA she'd be fine. However, the CNA urged the caller to call her doctor and let them know what was going on. Her second dose was scheduled for 16Mar2021. Her doctor told her don't drink the water, drink the ginger ale and don't drink it too fast, and try crackers and toast. The patient took her temperature last night (24Feb2021) but couldn't read it that great, she thought it was 98. When the CNA came this morning (25Feb2021), she took it around 10:00AM and it was 99.2. She told the CNA to take another temperature because she didn't think she had a fever. When the CNA left, she had to leave at 3:00PM, her temperature was normal, it was 96. She thinks maybe her temperature went to 99.2 because she was drinking her tea. However, she wasn't drinking it right away, because she threw up on it. She stopped drinking an hour before her temperature was taken. She clarifies wasn't drinking the tea when the CNA came. She also mentions she broke up her the toast into little tiny pieces and felt like she was eating like a bird, but it didn't stay down so she stopped. The CNA came around 9am, maybe 8am, and clarifies it was maybe around 1030AM when she took the temperature. When the CNA left her temperature was at 96. The patient was very tired the same day she received the vaccine. She remembers went to bed with clothes on. Last night, she wanted to go to bed again with her clothes on but she couldn't stand it and she changed into her pajamas. Then, she went to the bathroom and vomited, she has a bucket by the side of her bed. It wasn't the dry heaves, stuff was coming up. She was still very tired currently. She makes the comment "I forget things and then I remember afterwards". She had to get under the light to see the Covid card, it's small, it is handwritten. Caller mentions she sees the month on it. Caller reports her arm bothered her for quite a while. Last night, she went to sleep on her left side and her arm was feeling better which gave her some hope. Her arm started hurting her the day she got the vaccine, but her arm wasn't red or anything. Her arm was feeling better this morning. She thinks if she can sleep on it and didn't hurt, it's getting better. The last pills she took were Gabapentin she has been on for about 2 weeks. She explains her feet burn during the night and the doctor recommended the Gabapentin for now. However, she has had too much time trying to stop the vomiting that that took over her feet burning, so her feet didn't bother her as much. She was initially prescribed 1 pill at night before going to bed at 10pm, then when the 1 pill didn't work for a week, the doctor increased it to 2 pills at bed time at 10pm because it takes an hour to work. She stated that she was going to take the Gabapentin on Tuesday night, which was a mistake because she threw it right up and it tasted awful. Caller makes the comment she has not given the doctor the report of how that reacted yet. When probed for an NDC, Lot number or expiry date for the Gabapentin, the caller explains she can't see writing, it's in small print. She does see the Discard After: 08Feb2022. She needs to get her magnifying glass, she states she's going blind. She's been told she had macular degeneration. She doesn't think the Gabapentin is agreeing with her. She reads that it "May cause drowsiness, operating vehicle which she doesn't drive, may cause dizziness, may cause vision. Call if you experience mood changes, sadness, depression.." She started out taking one pill of the Gabapentin every night from Monday to Monday. The second Monday, 15 Feb2021, she started taking 2 pills at night for a total of 200mg. She took it this past Monday night until she had the vaccine and then she took it again, and now she was not taking it anymore. Her burning feet wake her up during the night, it starts at her ankles and goes halfway up her leg. She had to put her feet on a cold floor. Normally, she feels good and she usually doesn't get pain so whatever little bit of pain she has, that's the pain she gets. Her feet were burning like that for month before she called the doctor. she didn't know. Her feet were red before they started to burn, this is the latest thing. During the day, she is fine, only a nighttime her feet burn. The patient underwent lab tests and procedures which included body temperature: 98 on 24Feb2021; 99.2 on 25Feb2021; 96 on 25Feb2021. Therapeutic measures were taken as a result of vomiting. She was going in for a test, clarified as an MRI on the 3rd of March for her eyesight. The action taken in response to the event for gabapentin was permanently withdrawn on an unspecified date. The outcome of the event "Pain in arm" was recovering, the outcome of the event fatigue was not recovered, the outcome of the events "temperature 99.2" and "Vomiting" was recovered, and outcome of other events was unknown.

I threw up my dinner that night, had 4 terrible shaking Chills over that weekend and continued chill for about a week, weakness in legs, fatigue, sleeping for hours, no energy, itchy skin, no appetite (lost 8 pounds), continued mental disorientation and unusual forgetfulness, also inablity to type correctly or to tell stories that I had just rehearsed, I also lost 20% of hearing in left ear, After 5 weeks I am about 95% OK physically, but still very slow with brain power and typing.

Syncopal episode, eyes rolled back, extremely diaphoretic and not completely out. CODE EMERGENCY CALLED. 911 also called due to hx of lung ca with mets.

chills; legs were weak and wobbly; legs were weak and wobbly; so tired; sleep for hours; no appetite; lost 20% of hearing in left ear; diminished mentally, unable to think or talk straight or type properly; I threw up; cold; lost 8 pounds; This is a spontaneous report from a contactable consumer (patient). An 88-year-old non-pregnant female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number was not reported), via an unspecified route of administration on 19Feb2021 11:45 as single dose for covid-19 immunization in a nursing home. The patient's medical history was not reported. No known allergies. Concomitant medication included paracetamol (TYLENOL) taken for an unspecified indication, start and stop date were not reported. The patient has not had COVID-19 prior to vaccination and has not been tested for COVID-19 post vaccination. The patient previously received the first dose of bnt162b2 (lot number: not reported) on 29Jan2021 on the Left Arm for COVID-19 immunization. On 19Feb2021 20:00 (8:00 pm), the patient experienced chills, legs were weak and wobbly, so tired, sleep for hours, no appetite, lost 20% of hearing in left ear, diminished mentally, unable to think or talk straight or type properly, threw up, cold for 2 weeks, and lost 8 pounds. The patient underwent lab tests and procedures which included weight: lost 8 pounds on 19Feb2021. No treatment was received. The reporter considered the events to have caused disability. The outcome of the event chills was recovered with sequela on 22Feb2021 while for the rest of the events was recovered with sequela on unspecified dates. Information on the lot/batch number has been requested.

the site is a little sore; pain in her left wrist/pain to right shoulder; pain to right shoulder and believes it is from either the fall, or torn rotator cuff; dry mouth; pain to right shoulder and believes it is from either the fall, or torn rotator cuff; This is a spontaneous report from a contactable consumer and other hcp received from. An 88-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), second dose at the age of 88-years-old via an unspecified route of administration on 01Apr2021 (Batch/Lot number was not reported) as single dose for covid-19 immunisation. Medical history included bypass graft in 2016 (five years ago), pacemaker placed in 2021 (about a month and a half ago). The patient's concomitant medications were not reported. The patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) on an unspecified date (lot number not reported) for covid-19 immunisation. The patient reported having pain in her left wrist, wears a band, and feels safe while performing activities. She further reported having pain to right shoulder and believes it is from either the fall, or torn rotator cuff. She had the vaccine on 01Apr2021 and reported that the site is a little sore. She further reported due to having dry mouth she was already drinking water all the time. The events occurred on an unspecified date in Apr2021. Patient reported placing ice pack to site, and taking tylenol. She also reported having various blood readings, and have shared readings with MD staff. The outcome of the events was unknown. Information on the batch/lot number has been requested.

Ear ache; Tiredness; This is a spontaneous report from a contactable consumer (patient's daughter) via Medical information Team. An 88-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date were not reported), via an unspecified route of administration on 20Apr2021 (at the age of 88-year-old) at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient developed an ear ache and tiredness since receiving the vaccine on 20Apr2021. The consumer asked these are normal side effects and how long will they last. Outcome of the events was unknown. No follow-up attempts are possible; Information about lot/batch number cannot be obtained.

the patient is experiencing an ear ache; patient being sleepy; This is a spontaneous report from a contactable consumer. A 88-years-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 20Apr2021 (Batch/Lot Number: EW0170) as single dose vaccinated at the age of 88 years old for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient experienced the patient is experiencing an ear ache and sleepy on 21Apr2021. Caller reported that the lot number on her Covid-19 vaccine was EW0170 and that the patient probably had the same lot number for her Covid-19 vaccine since the caller and the patient got the vaccines at the same location on the same day, 20Apr2021. The patient does not take any medications at all and is a very healthy woman. Caller reported that the patient does not take a single pill. Caller reported that because the patient does not take any medications, it is probably the reason why the patient's body acted the way it did. Outcome of events was unknown. No follow-up attempts are needed. No further information is expected.

2 months later, headache, body aches, dizziness, sinus blockage and significant loss of hearing in one ear. Facial numbness on one side.

she almost passed out however she was able to grab unto the bed; bowel movement with quite a bit of blood; Is having difficulty breathing; Slight temperature; Wakes up in morning with sweat; Food just doesn't taste right; Has been drinking a lot of water because she wants water; Mouth is so dry; Walking is much worse, has to hold onto everything; Weak; Not eating like she used to, eating the minimum to survive; Coughing and bringing up phlegm; Gets chills once in a while; Sleeping an awful lot; Coughing and bringing up phlegm; she had pressure in her heart; pain as aches and pain; Flu-like symptoms; This is a spontaneous report from a contactable consumer or other non hcp. An 88-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: EN6201; Expiration Date: 30Jun2021),via an unspecified route of administration, administered in Left Arm on 19Feb2021 in between 2:15-2:30 as 1st Dose,0.3mL, Single Dose for COVID-19 immunization. The patient's medical history included diabetes mellitus, blood pressure abnormal(High blood pressure), hospitalized prior to the COVID Vaccine. It was two years ago and she was hospitalized for COPD. Three years ago she went to visit her sister in and wound up with the Flu and Pneumonia where she almost died. She was still here. Cardiac disorder, atrioventricular block, heart problems for several years, Had a blockage, blood glucose abnormal, Had the Flu and that was how she felt. When she had a hard time breathing she did not know if it was the flu or pneumonia. So much stuff was put in her. Needles were being plunged in her. She did not know what she was given. It was a really rough time. Patient also broke her finger in Dec2020. Infection set in after her finger was set with a metal plate. The metal plate dug into her finger and created an infection. She was in excruciating pain. The metal plate was taken off and has been told she will have a mullet finger. Stated kids get it from sports and is where the finger just hands. The finger doctor told her there was nothing that can be done because the bone has disintegrated into her body. Concomitant medications included insulin glargine (LANTUS)Product strength and count size dispensed: 100 units ml 3mg prefilled pen, was originally taking Lantus, 20 at night, but it wasn't doing the job. Dose was split to 15 in the morning and 15 at night, NDC: 0088-2219-01,Lot: OF7051A,Exp: 2023 ; Insulin (HUMALOG) NDC: 0002-8799-01 ,Lot: Unknown, Expiry:Jun2022,Had to get into light to read Humalog. Didn't see lot number, taken for blood glucose abnormal. Doesn't take that often. Only takes if blood sugar is over 150. No History of all previous immunizations with Pfizer vaccine considered suspect were provided. With regards to prior vaccination within 4 weeks, stated she fell and hit her head and had to get four staples in Dec2020. She was given a vaccine for tetanus and diphtheria and stated maybe a slight rash or achy, a little red, but never any other reaction. No Additional vaccines administered on same date of Pfizer suspect. Did not require a visit for AES. The patient received the 1st dose of the Pfizer covid vaccine on 19Feb2021, scheduled for her 2nd dose on 12Mar2021. She says this was the 5th day of her having flu-like symptoms, which she previously reported. This morning she had pressure in her heart for which she took Nitro. As she was trying to get to the bathroom, she almost passed out however she was able to grab unto the bed and did not fall. She then went to the bathroom and had a bowel movement with quite a bit of blood. She does report a history of heart problems for several years. Had a blockage. Had one COVID Vaccine and now has all kind of Flu like symptoms. Had a slight temperature. Wakes up in the morning with sweat, pain, and food just didn't taste right. Had Flu before and was having a lot of Flu like symptoms. Was having difficulty breathing and coughing. Also had COPD. Wanted water and had been drinking a lot of water. Her mouth wa so dry. Stated she was sort of used to the difficulty of breathing. Had been in the hospital for COPD. Stated her walking wasn't that great to begin with, but now was much worse. She had to hold onto everything. was not eating like she used to, only the minimum to survive. She was weak. Had been having difficulty breathing a lot before the COVID Vaccine. Didn't know if she COVID Vaccine just got it started a little more. Was constantly blowing her nose and bringing up a lot of phlegm, but she knew that was from her COPD. Got the chills once in a while. Was freezing and then warm. Has been sleeping an awful lot. The patient underwent lab tests and procedures which included body temperature: 99.4 slight, glycosylated haemoglobin:10.Wanted to finally go out a little bit and walk around. Had been in the apartment for so long. Went back for second COVID Vaccine on 12Mar2021. Wanted to get back into the swing of things. Therapeutic measures were taken as a result of, she had pressure in her heart (cardiac discomfort). The outcome for the events was Unknown.

Swelling of eyes, lip numbness, tingling and dryness. Dizzy and weak. Client received Benadryl and was transported to hospital via EMS.

Patient had got the covid vaccine that very day she had swollen eyes she continues to have itchy swollen eyes and is starting on prednisone.

Patient developed left sided facial droop and left eye droop/paralysis on 1/17/21. No medical treatment was necessary. Hospice and family were notified. Symptoms continued on 1/19/21 and the nurse practitioner ordered Refresh tears to left eye three times a day x 14 days, tape eye shut at night as tolerated and start Prednisone 40mg orally x 4 days then 20mg orally x 3 days.

Systemic: TINGLING SENSATION ON TONGUE, SHAKINESS. PATIENT ASKED FOR BENADRYL FROM FACILITY AND WAS FINE . COUNSELED ON FALL RISK BUT SHE SAID SHE DOES FINE WITH BENADRYL AND ASKED FOR IT AND WAS COUNSELED AND

Rash around face and chest; bloodshot left eye. Hydrocortisone cream prescribed by facility APRN on 1/13; skin less red on 1/14 and peeling - no pain or itch. Dermatology recommendation of Aquaphor for the peeling.

Felt fine after shot. Around 3:45pm she was sitting on the sofa, saw a flash of light (which quickly disappeared) and she started vomiting. No fever or muscle aches. She felt better after getting sick and has been drinking/eating light meals.

Client c/o numbness and tingling of lips 25 minutes after receiving Pfizer vaccine. Client seen and assessed by EMjS. V.S. are B/P 143/79, HR 79, O2 96. Client voiced that sensation had stopped after 5 minutes and was cleared to go home by EMS.

Patients arm started to hurt in afternoon, by the evening dizziness to where should could not walk. On the following day, could barely walk, her speech was low and hoarse and her vision was not good. Given Tylenol by family members with additional food and water. The following day taken to PCP for blood work and a CT Scan w/wo contrast of the brain with lacunar stroke resulted.

Patient had second Covid Pfizer vaccine at 1429. After 30 min wait patient had BP, daughter brought her back into observation via w/c, patient c/o dizziness. Daughter reports last vaccine patient had dizziness and high blood pressure and needed to see doctor. Ate breakfast, given apple juice. At 315 BP-168/65, P-73, O2sat-98%. Denies shortness of breath or pain. Skin warm and dry to touch, color pink. Continued to observe. Patient drinking apple juice. Injection site without swelling or discoloration. At 325 BP-161/82, P-72, O2 sat 98%. Patient reports to daughter her upper lip is tingling like last vaccine. Daughter reports upper lip was tingling three hours after last vaccine, no medication taken. Duration up to three hours to go away per daughter. Lips without swelling or numbness at this time. Team Alert called. Report given to RN

Patient was recommended to be monitored for 1 hour due to her history of allergies. About45 minutes into her waiting period patient made us aware that she was feeling her lips were getting bigger and had an itchy nose. Vital signs were taken. BP=187/110, HR=96-110, o2sat=95-97%. Pharmacist made aware , patient received 25 mg po Benadryl. And was to remain in observation 15 more minutes. After 10 minutes of receiving the liquid Benadryl, patient complained of generalized itching , no hives. Patient was monitored for 15 more minutes and then patient was released with slight continued itching. Consulted patient to call primary physician concerning repeatedly high BP.

Pfizer-BioNTech COVID-19 Vaccine EUA: patient presents to emergency department (ED) reporting unremitting dizziness after receiving vaccination sixteen days prior. Dizziness is worsened by rising and associated with disequilibrium and vision changes. Vital signs all within normal ranges. Patient denies respiratory, gastrointestinal, and dermatologic symptoms. Physical exam is normal. Patient monitored, symptoms improved with hydration and good oral intake, and patient discharged stable to home with follow-up in place.

Pt developed extreme fatigue. Felt tired and sleepy. BP 170/72, HR 67, O2sat 97% RA. Reported having double vision. Denied chest pain, sob, palpitations, headache, dizziness. Sent to ER via w/c.

resident unresponsive verbally and favoring L side with R side flaccid unable to take AM med. The writer obtained BS 90. The resident has R side face drop with drooling noted. The resident responded to painful stimuli only. Pupils dilated. Supervisor at bedside BS 102 rechecked. The family opted for comfort measures only. Age 68 On 2/15/2021 Z51.5: ENCOUNTER FOR PALLIATIVE CARE, Patient expired 2/23/2021

Felt fine the same day. The next day:. Shoulder SEVERELY swollen with HUGE bump in and around lymph node, reddened, swelling, heat at inj. site, turned pink then purple then dark purple, throbbing in neck and head, severe headache plus migraine, difficulty hearing, could not move arm/wrist/fingers/hand, unable to hold fork etc. This lasted for 10 days after onset.

She had her second dose of the covid vaccine approx 8 days ago, the day after she was very tired and slept all day. Then yesterday when she awoke she had a sense of discomfort in the left eye, and a friend who helps them at home noticed that her left eye was slightly bloodshot. Yesterday she went to see her eye doctor who dx her with an incidental small burst blood vessel but did not advise stopping eliquis and said it should resolve within weeks. She has no loss of vision. However, in the evening when at home she said she had difficulty forming words - husband did not particularly notice a problem - she ignored it basically and went to sleep . Then this morning went to the hairdresser, noticed the word finding/ speech 'garbled' slightly problem again and walked into her pcp office - she was eval'd there at approx 1140 am and sent to ER by ambulance. Code green not called given the initial deficit was last night, CT head suggested possible subacute infract. She had no chest pain or pressure, trop noted as slightly elevated at 129 , Platlets 84 Diagnosed with Bilateral punctate infarcts throughout the brain, in cerebellum, occiput, left temporal and parietal lobes

After receiving a COVID vaccination, patient experienced mild SOB, tongue swelling and tingling. She was treated with Benadryl while she was at the vaccine site.