Pfizer

Pt is alert and oriented with a GCS of 15. Pt able to answer questions appropriately, name, DOB and any complaints, which pt stated no complaints. Staff stated pt wasn't speaking to them prior to arrival and pt's strength and ability to move from her bed to her wheel chair and vice versa has been compromised since she received first dose of COVID vaccination on the 12th. 911 was called when it appeared she could not speak and noted her left eye was no longer staying open. Pt able to speak clearly with EMS, but noted left eye continued to stay shut. No recent trauma, no ocular hx and no changes to recent medications. Assessment documented above, stroke scale negative. Speech was excellent, symmetrical smile, negative on arm drift, good grip strength and good push and pull with feet. BG of 103. Pt is wheelchair bound but independent for transferring from chair to bed but has been on a steady decline in terms of independence and needed 1-2 person assist for a week.

Ringing in ears and pain in both sides of neck. Pt alert, oriented, ambulatory, no weakness, no slurred speech

Patient experienced jaw pain with high blood pressure (200/72) within 15 minutes of receiving vaccine administration. History of aortic dissection.

According to medical report, Pt presented to the ED on 1/14/21 w/ cc of SOB for 1 day. She received her COVID-19 vaccine on 1/9/21. Pt stated that she developed a dry hacking cough 2 days prior to the vaccine on 1/7/21. Over the last few days prior to admission, she developed generalized weakness, SOB, loss of sense of taste and smell w/ associated decreased appetite and nausea ultimately SOB in the24 hours prior to admission. Final Diagnosis- acute hypoxic respiratory failure secondary to COVID-19 pneumonia. Pt died on 2/3/21. See Medical report for more information.

02/04/2021 2:15pm Felt Buzzed.. Energized ..Up lifted in Spirit 02/05/2021 2:00am Set up to go restroom.. slight Forehead Headache.. upon standing Dizzy unstable. Weak.. Used walk and furniture for support.. after seated on the toilet head pain increased.. Felt Nausea (did not Vomit)..headache passed.. returned to bedroom. This took 35 minutes 02/05/2021 2:35am seated on the bed.. felt Dry throat.. smelled Feverish ..Aches in Legs ..Right hand up to shoulder Stiffness(10minute duration).. 02/05/2021 3:00am felt fatigued.. feel asleep 02/05/2021 9:00am Awoke no issues.. 02/05/2021 10:30am Injection site left arm itchy.. no swelling .. no bruising.. tender to touch.. itchy sensation over full body

vision clouded, and it progressed towards the night; This is a spontaneous report from a contactable consumer (patient). A 90-year old female patient (not pregnant) received first dose of bnt162b2 (Pfizer-BioNTech COVID-19 mRNA vaccine, Lot Number EL9261 and Expiration Date 31May2021) via an unspecified route of administration on 21Jan2021 at single dose for COVID-19 immunisation. The patient's medical history included hypertension and AFib. The concomitant medications were included apixaban (ELIQUIS) at 5 mg, dofetilide at 250mg, metoprolol at 60 mg for hypertension. Patient mentioned that about 6-7 hours after she received the vaccine on 21Jan2021, her vision clouded, and it progressed towards the night. First it began in right eye and it started it was the time when patient usually retire so she went to bed and when woke up and vision was extremely clouded (both eyes). Patient had the night light on and could not see the night light. She could just see a glow. The morning after, it was gone. She said that she normally has perfect vision and never had this experience before. She says it was not an issue right now since it went away. She wanted to know if she should be concerned and wanted to report this event because it was bothersome and other people might have a similar experience. Not taking second shot if it was going to cause problem; concerned of getting 2nd shot. The outcome of events was recovered on 22Jan2021 without treatment given. No follow-up attempts are possible. No further information is expected.

Outbreak of rash all over body, causing rough, flaky skin; itchy, burning eyes. Neither antihistimine tablets nor eye drops provided any relief.

Patient received vaccine at 1100, placed in 30 minute observation area. 1105 alerted observer of sensation of numbness and swelling of tongue. Assessment of patients mouth shows tongue reddened to right side, no visible swelling, pt reports recently having a red cough drop. Covering attending present to take brief hx of patient and ordered patient to receive 12.5mg of Benadryl PO. Patient given Benadryl at 1110. Patient appears in NAD, hx of recent concussion after a fall. Resides in rehab center. After medication received patient monitored for additional 30 minutes and discharged back to rehab facility.

Client verbalized watery right eye without pain or discomfort. Client evaluated by Rescue Paramedics onsite. Client was observed for additional 15 mins. Client released by Paramedics at 10:05 am after symptoms were resolved.

The evening of the administration hands started to tingle, lasted about half hour. The next morning felt fine at noon the second day started with violent shaking chills which lasted one hour, at that time it slowly started to stop but felt icy cold with sweating. Took 2 tablets of advil 200mg at the beginning of shaking. After shaking slowed down could not talk, stand or hold up hands; she was drooling barely could swallow. She just wanted to lay down and sleep. This lasted about 30-45 minutes. Hands turned BLUE to her wrists lasting 15 minutes. Resolved without intervention. Very tired that evening. Slept for 12 hours. Back to normal the next day.

experienced dizziness for 4 days following the shot then on day 7 following the vaccine, she developed an eye hemorrhage.

the vaccine does not seem to be working like the first one; arthritic pains; A medicine taste in her mouth which appeared about 1 minute or so after receiving the 2nd shot of the vaccine.; This is a spontaneous report from a contactable consumer (patient). A 90-year-old female patient received the second dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: EL9269), via an unspecified route of administration in left upper arm on 12Feb2021 as single dose for COVID-19 immunisation. Medical history included arthritis. The patient previously took the first dose of bnt162b2 () for COVID-19 immunization. Concomitant medications were not reported. On 12Feb2021, the patient experienced a medicine taste in her mouth which appeared about 1 minute or so after receiving the 2nd shot of the vaccine and soreness at the injection site. She stated that she felt the arthritic pains more after the 2nd shot than the 1st shot. The 1st shot felt good and cleared up her sinuses. On 12Feb2021, the patient experienced does not seem to be working like the first one. The patient reported that with the first one she did not feel as bad and it is taking her longer to get over the second shot. The patient stated that with the first dose, her sinuses and her joint pain cleared up faster. The patient reported that her symptoms seem to be a little bit better on the day of reporting. She clarified that she got over her symptoms faster last time. Her left ear feels clogged up and it cleared up faster with the initial shot. She has arthritis on her right side with her hips and shoulder and stated that the joint pain is still there. It is still quite sore. On 12Feb2021, the outcome of the event a medicine taste in her mouth which appeared about 1 minute or so after receiving the 2nd shot of the vaccine was recovered and was unknown for the rest of the events. Information about lot/batch number has been requested.

It started with swelling, redness, and heat at injection site pretty soon after the injection on Friday 5/21. By Sunday, 5/23, patient had instability when standing and walking; her dementia had gotten worse; there was edema in her whole right arm; and she started having tremors. She was brought to Hospital by ambulance that afternoon and has since had decreased appetite and thirst; continuing swelling at injection site and in her whole right arm; terrible tremors; very low oxygen levels; and is almost comatose. The doctors there have said her kidney function has dropped to unacceptable levels and they are also monitoring her heart. She has been put on hospice care as of this time, 5/26.

Dehydrated; Lost her electrolytes; Her lips were cracked; Eczema; exhausted and she couldn't leave the bed; Hallucinating; Violent dreams; Strange aches in one of her arms and one ear; Strange aches in one of her arms and one ear; Has not had the same energy; This is a spontaneous report from a contactable consumer (patient). A 90-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration on 16Feb2021 (Batch/Lot Number: EL9261; Expiration Date: May2021) at the age of 90-years-old as single dose for covid-19 immunization. Medical history included allergies to Shellfish, penicillin, sulfa, mercury, and latex, the patient has been tested positive on 08Jan2021 for covid-19. The patient's concomitant medications were not reported. The patient previously received the first dose of BNT162B2 (Lot Number: EL9261; Expiration Date: May2021) on 26Jan2021 at the age of 90-years-old for covid-19 immunization and experienced exhausted, weak, so lethargic she could barely move, had chills, and she lost her sense of taste. For second dose: Most of these symptoms began on 16Feb2021 around 6:00 - 7:00 pm. The patient was exhausted and she couldn't leave the bed, started 16Feb2021, improved. The patient was hallucinating, started 16Feb2021, improved. The patient had chills, started 16Feb2021, improved. On an unknown date in Feb2021, the patient was dehydrated to the point to where her lips were cracked, the patient was so dehydrated and couldn't get enough water she drank so much water that she lost her electrolytes which was why she was hospitalized. The patient was hospitalized on 28Feb2021 and released on 01Mar2021, they gave her an IV for treatment. The patient had violent dreams, started 16Feb2021, improved. The patient had strange aches in one of her arms and one ear, started 16Feb2021, improved. The patient has not had the same energy since the shots on 16Feb2021, she's going to physical therapy for this. The patient had eczema, started 28Feb2021, ongoing. The outcome of the events eczema was not recovered, the outcome of the event dehydrated, lost her electrolytes and lips were cracked and 'has not had the same energy' was unknown, the outcome of the other events Hallucinating, Violent dreams, 'Strange aches in one of her arms and one ear', 'exhausted and she couldn't leave the bed' was recovering.

nausea; dizziness; blurred vision; stomach is starting to hurt; I am unable to function in a normal capacity/could not get out of the bed.; sick; Im not alert long enough; The initial case was missing the following minimum criteria: unspecified product. Upon receipt of follow-up information on 09Jul2021, this case now contains all required information to be considered valid. This is a spontaneous report from a contactable consumer (patient) received from a Pfizer colleague. A 90-yerar-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) on 27Feb2021 (lot number: EN6198) at dose 1, single, then second dose on 20Mar2021 (lot number: EP1534, batch number: EP7534) at dose 2, single; both via an unspecified route of administration at the age of 90-years-old for COVID-19 immunisation. Medical history included glaucoma and brain tumor. The patient has no previous vaccinations within 4 weeks. Concomitant medications were reported as none. Historical vaccine included flu vaccine back when the patient was a teenager and experienced allergic reaction that broke out with a rash, shaking, and itching. On 27Feb2021, after the vaccination of the Pfizer COVID vaccine, the patient experienced bad reactions daily. The symptoms include nausea, dizziness, and blurred vision. The patient has been unable to work because of it. These events caused the patient to seek medical attention from her primary care provider and vision care provider. The patient has a history of glaucoma, making it very difficult. The patient had to get a CT scan on an unspecified date because her doctor thought that a tumor may have come back to her brain, but the result of the CT scan was clear, and the tumor was not back. As a result, the doctor prescribed medication for dizziness (taken 3 times per day) and nausea (taken as needed). The patient stated that she was unable to function in a normal capacity from an unspecified date in 2021 without the daily treatment medications and still the treatment medications were not always effective in reducing the symptoms. The patient stated that the nausea was getting worse every day. At 5am, it woke her up and she took the pill and lasted a couple of hours but it came back and took another pill. The patient was taking ondansetron 4 mg orodispersible tablet taken under the tongue. On an unspecified date in 2021, the patient's stomach was starting to hurt and takes another pill for this. The patient reported that her ophthalmologist did the examination on an unspecified date in 2021 and stated that this examination had no difference from the previous examination on an unspecified date. The patient stated that her daughter also had the vaccine and had a sore arm for two or three days. The patient also reported that she could not get out of the bed. She had a blurred vision and cannot read without a magnifying glass. It was terrible and the patient had never been this way. The patient takes a medication for the blurred vision and it doesn't last. The patient cannot function, and her doctor already knows this. The patient will see her doctor again on the 26th. On an unspecified date in 2021, the patient was sick all day because of the nausea. The patient had 4 doses of medication and it did not last anytime. On an unspecified date in 2021, the patient was not alert long enough. Yesterday, the patient's nausea woke her up at 5am. She took a pill under the tongue, and before 8am, nausea attacked her again in a couple of hours and all day long. All day yesterday, the patient was nauseated like a morning sickness when pregnant. The nausea quieted down after the patient took a tea but started again after lunch. The patient stayed sitting all day. The patient reported that she experienced the same events after the second dose. The events nausea, dizziness, and blurred vision resulted to physician office visit. Outcome of the events alertness decreased, nausea, dizziness, and blurred vision was not recovered, and for other events was unknown.

Immediately, felt burning at injection site, then mild headache, lips tingling. . About 40 minutes later, lips and tongue swelling, and uncomfortable swallowing.

Saturday night (4:45) 1-23-21 - swollen right ear, itchy head and some welts on upper body Sunday morning (8am) 1-24-21 - face and eyes swollen, itchy and welts or rash all over upper body

Ears blocked, pressure in head, loss of hearing. Next day -pain in abdomine followed by diahrea - general not feeing well,

This is a spontaneous report from a contactable Consumer. A 91-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number EL3249, Expiry Date 31May2021 ), at single dose into the left arm on 20Jan2021 at 11:30 am for COVID-19 immunization. Medical history included problem with gallbladder in the last 4 months. Concomitant drugs were none. The patient had never problem with flu and shingles shot. On 20Jan2021, the day of vaccination the patient felt fine and told everyone it was a breeze. On 21Jan2021 morning she was getting ready to go to the store at 1130am, it was about 24 hours after getting the shot, and she felt dizzy, achy, her eyes ached and were weak, she felt feverish but had no fever and was a bit nauseated. The patient also reported loss appetite the same day. On 22Jan2021 around 11am she felt a little better. She checked her temperature and blood pressure normal. She has had a little nausea in the evening and was dizzy. On 23Jan2021 she felt a little weak but felt better and her appetite was better. At the time of reporting the outcome of the events was unknown.

tingling around the mouth area and lips; her mouth or lips were moving in a way that she had no control over/It was just a feeling she was having; This is a spontaneous report from a contactable consumer (patient). A 91-year-old female patient received the first dose of BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE)Lot # EL3247, via an unspecified route of administration on 19Jan2021 18:00 at single dose at left shoulder for covid-19 immunisation. Medical history included osteoporosis from Aug2020, rash on her legs from Aug2020, (lower leg below the knee, she was using a steroid but she had stopped as she was told not to use it too often by her doctor and just use Vaseline to keep the skin moist. She was asked if she had used any steroids but she hadn't used it in the past week and maybe only once in the previous week but couldn't be certain it wasn't in the last 10 days. She resisted the urge to use Mometasone 0.01 as it damaged the skin.); allergies to Sulfa a few years before. The patient reported her daughter who died at 41 years old of breast cancer. There were no concomitant medications. There was no additional vaccines administered on same date of BNT162B2 and no prior vaccinations within 4 weeks.The patient previously took brimonidine tartrate/timolol maleate (COMBIGAN) a few years before and experienced allergies, the eye drops didn't her any good at all and was told not to use it anymore. She previously received flu shot most every year and never had a problem. She stated that evening on 19Jan2021 she felt fine and then the next morning on 20Jan2021 she experienced tingling around the mouth area and lips. Almost as though her mouth or lips were moving in a way that she had no control over. She looked in the mirror and saw no evidence of it moving but could feel it moving. It was just a feeling she was having. The feeling was about the same. The first 2 days was on just the right side but she has had now had 2 occasions where it was on the left side. This was not constant, just occasionally during the day. She wanted to know if this was a known side effect and will it go away. She wanted to know if she should receive the second dose of the vaccine considering these side effects.The outcome of the events was not resolved.

This is a spontaneous report from a contactable consumer. A 91-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3249, expiry date: 31May2021), via an unspecified route of administration on 21Jan2021, 09:30 at a single dose on left arm for COVID-19 immunization. Medical history included oesophageal dilation procedure from 11Jan2021 to an unknown date and had trouble swallowing from an unknown date and unknown if ongoing. There were no concomitant medications. The patient received the first dose of the vaccine on 21Jan2021 and everything was pretty good. Nothing bothered her until yesterday, Sunday morning. Her throat is not sore but swollen. She feels it is in her tonsils, like her tonsils are swollen. When she gets ready to swallow it is hard sometimes, she can swallow but it feels like something is in the back of her throat like her tonsils are swollen. She has had headaches off and on. She asked if these were normal symptoms after the vaccine. Reported her second COVID-19 Vaccine is scheduled for 11Feb2021 at 9:30AM. Reported she had 3 negative COVID-19 virus tests before. She said each time she had the COVID-19 virus test done was before a scheduled procedure. She said her last negative COVID-19 virus test was on 08Jan2021 before a procedure on 11Jan2021. She clarified she had trouble swallowing and had an esophageal dilation on 11Jan2021. She said she was put to sleep for the procedure. Clarified she has had an off and on headache, a sore throat that feels like her tonsils are swollen, and a pain that shoots through her ear occasionally. She said all her symptoms started late on Saturday (23Jan2021) or early Sunday (24Jan2021). Reported she took 1 Tylenol Extra Strength 500mg capsule yesterday evening (24Jan2021). She said she does not have the box with the UPC number for the Tylenol Extra Strength 500mg capsule, providing: Lot Number: PBA023, and Expiration Date: Dec2022. Reported she left her COVID-19 vaccine paperwork at her daughter's house. She said her daughter read some of the COVID-19 vaccine side effects over the phone to her, but sore throat wasn't one of the listed vaccine side effects. She said she was calling Pfizer to find out if a sore throat was a side effect of the COVID-19 vaccine. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on 08Jan2021. More information available (Y/N): No. Therapeutic measures were taken as a result of throat is not sore but swollen, headaches off and on and pain that shoots through her ear occasionally. The outcome of the event "throat is not sore but swollen", "headaches off and on" and "pain that shoots through her ear occasionally" was not recovered while of the other events was unknown.

Significant loss of vision R eye-awoke on Feb 6 and noted splotches in vision of R eye. Workup suggests compromised blood flow to that eye

She had the vaccine on Thursday and no visible side effects. On Saturday she was very weak and had to be lowered to the ground. She was drooling and staring vacantly and was not responding to questions. This lasted for a bit. I called the ambulance which took her to the hospital. They hydrated her and sent her home with no idea what caused it. The next day she was sitting on the toilet and passed out with her eyes closed. She started drooling. I again called the EMTs and they came. She had come to and they said she fainted and it was probably because she was having a bowel movement. This has not happened before or since these two episodes. I do not know if she should get the next shot.

I had such pain all night and I still have it. It is all around my neck and up to the top of the ears and then my right shoulder down the front and to the back and all the way down to my fingertips; I had such pain all night and I still have it. It is all around my neck and up to the top of the ears and then my right shoulder down the front and to the back and all the way down to my fingertips; I had such pain all night and I still have it. It is all around my neck and up to the top of the ears and then my right shoulder down the front and to the back and all the way down to my fingertips; I had such pain all night and I still have it. It is all around my neck and up to the top of the ears and then my right shoulder down the front and to the back and all the way down to my fingertips; torn rotator cuff; I have a slight headache in the back of my head too; This is a spontaneous report from a contactable consumer (patient). A 91-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Lot number EL9262), via an unspecified route of administration on 27Jan2021 at single dose for COVID-19 immunization. Medical history included High blood pressure. Concomitant medication included olmesartan medoxomil for high blood pressure and pravastatin sodium. The patient stated she was 91 years old and that was why she got the first shot of the Covid19 vaccine Pfizer about 10 days ago (27Jan2021). Last night (05Feb2021) she had such pain all night and she still had it. It was all around her neck and up to the top of the ears and then her right shoulder down the front and to the back, she had a torn rotator cuff there and all the way down to her fingertips she had pain. Event onset last night, during the night. Like 9 days well, coming into the 10th day. She did not know why she have it. It was fine until last night and now it was terrible. She had a slight headache in the back of her head too on an unspecified date in 2021. She had been taking Tylenol and put some Icy Hot, you rub it on when you have pain but it did not do anything. She wanted to know will she get the same type of reaction when she get the second shot. There was no expiration date on it. There was nothing else. The outcome of the event slight headache in the back of head was unknown and the outcome of the other events was not recovered.

Dizzy; not feeling well; Constant noise started in my head, sometimes on right, sometimes on left, most of the time my entire head/a "shush"ing sound, like steam evaporating from a teakettle letting out steam; This is a spontaneous report from a contactable consumer, the patient. A 91-years-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot Number: Unknown),via an unspecified route of administration in the left arm on 27Jan2021 at 15:00 (at the age of 91-years-old) as a single dose, for COVID-19 immunisation. The patient had no known medical history or allergies.The vaccine was administered at a Nursing Home/ Facility. Concomitant medications included macrogol 3350 (MIRALAX) and losartan potassium (LOSARTAN POTASSIUM) 25 mg. Historical Vaccine includes BNT162B2, Dose 1; Administration date: 06Jan2021 at 03:00, Lot Number Not Provided, in the left arm. On 31Jan2021 at 12:00 the patient experienced dizziness, malaise and tinnitus. No other vaccines were given within 4 weeks. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination the patient had not been tested for COVID-19. The clinical course was reported as follows. About 4 days after Second shot, on '31JAN2021 at 12:00' patient started to get dizzy and not feeling well. Constant noise started in my head, sometimes on right, sometimes on left, most of the time my entire head. It is like a "shush"ing sound, like steam evaporating from a teakettle letting out steam. This has been for 2 weeks. The patient went to the Emergency Room and/or Doctors Office and was checked, vital signs normal, had scan of head and stomach, EKG and bloodwork. No treatment was given for the events.The noise has never subsided in the past 3 weeks. . The patient underwent lab tests and procedures which included blood test: unknown results on and unknown date, electrocardiogram: unknown results on an unknown date, Scan of head and stomach unknown results on an unknown date and vital signs measurement: normal on an unknown date. The clinical outcome of the event dizzy, malaise and tinnitus was not recovered. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.

she feels like she is another world and has to lay down frequently; she feels like she is another world and has to lay down frequently; She has been experiencing intermittent dizziness; she feels like everything is a blur; injection arm is "black and blue."; This is a spontaneous report from a contactable consumer (patient) reported that a 91-years-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot Number: unknown) via an unspecified route of administration on 28Mar2021 as SINGLE DOSE for COVID-19 immunization. The patient medical history and concomitant medications were not reported. She has been experiencing intermittent dizziness, she feels like everything is a blur, she feels like she is another world and has to lay down frequently, vaccination site bruising on an unspecified date. Her injection arm is "black and blue." She wants to know if this is normal after the vaccine, she states she is going to an eye doctor appointment tomorrow 20Mar2021. No PQC involved. The outcome of events was unknown. No follow-up attempts are needed; information about lot/batch number cannot be obtained.

This is a spontaneous report from a contactable consumer. This 91-year-old female consumer (patient) reported for herself that she received bnt162b2 (COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on 06May2021 (at the age of 91-year-old) at 1st dose single for COVID-19 immunization. The patient was scheduled for her second dose tomorrow. The patient medical history and concomitant medications were not reported. On May2021, after the first dose the patient experienced metallic taste that tasted iodine, patient mentioned that it went away immediately. It was reported that patient did not provide her prescribing physicians information. Patient wanted to know if this has been a reported side effect of the vaccine and if so, should she proceed in getting her second dose. Her physician advised her to proceed in taking the second dose. Response: Spoke as per attached (Off-Label or No Info) (v15.0). No info found as per the CONS-what are the risks of the vaccine (v7.0) and the updated FACT SHEET FOR RECIPIENTS AND CAREGIVER, under WHAT ARE THE RISKS OF THE COVID-19 VACCINE. Also spoke from the FAQ-COVID-19 Vaccine-receiving second dose after side effect from first dose (v1.0) stating that "The decision to receive the second dose for any other reason cannot be made by . We refer you to speak to your healthcare provider about the risks of the vaccine compared to the risks of potentially not being fully protected against COVID-19 infection. Your healthcare provider knew your health situation and has access to information that can better help inform this decision. Referred to HCP for best clinical recommendation. The outcome of event was recovered on May2021. Information on the lot/batch number has been requested.

Patient stated she felt her lips and tongue were possibly swelling about 40 minutes after vaccine administration. Swelling was not visible to nurse.

tongue feels a bit swollen; This is a spontaneous report from a contactable consumer (patient). A 92-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) Solution for injection (lot number: EL3249 and expiration date unknown) via an unspecified route of administration on 27Jan2021 (at 92 years old) at a SINGLE DOSE for COVID-19 immunization. The patient's medical history was not reported. Concomitant medications were unspecified; patient is taking a lot of medications. The patient stated that she just had the vaccine on Wednesday, 27Jan2021 and her tongue feels a bit swollen on an unspecified date in Jan2021. But it was getting better now. Patient asked what she should take as it seems to lighten a little bit. Since then it was quite bad, it is still swollen but not as bad as it was. Outcome of the event was recovering.

No illness or vaccines prior to the COVID-19 shot on February 13, 2021. Monday, February 22, 2021, around 4 p.m. experienced sharp pains that would come & go behind right ear/neck area Tuesday, February 23, pain continue to come & go behind right ear/neck area in late afternoon into evening; trouble sleeping Wednesday, February 24, still having pain behind right ear/neck in early a.m. Contacted Primary Care Physician, Dr. (Internal Medicine) in early a.m. and had office visit. Prescribed Cefdinir 300MG capsules (Antibiotic) and sent for X-ray - Xr C Spine Min+ 4 Vw. X-ray showed arthritis and began taking prescription. On Wednesday, February 24, As day progresses, pain is now continuous. Thursday, February 25, Pain is throughout the day behind right ear/neck area. Late afternoon into evening, a small amount of rash has now developed on back area and side area of neck. Lymph node is swollen on right side back of neck. More pain behind ear. Pain is more severe late into evening. Trouble sleeping. Took Cefdinir as prescribed. Friday, February 26, contacted Dr. due to small amount of rash appearing on right side of face, right shoulder blade, behind neck, behind ear, and into hairline along with continued pain. Dr. diagnosed shingles over the phone. He prescribed medication for shingles and pain. Antibiotics were no longer taken. Shingles - Valacyclovir 1gm tablets. Pain - Aceteminophen/COD #3 as needed. Pain is more severe. Pain radiating into right ear. Can't sleep. From February 26 to March 5 shingles medication was taken daily. Additional rash developed. Pain was more severe/continued and trouble sleeping. From February 26 to March 4 pain medication was taken on Tuesday, March 2 and Thursday, March 4. One pill only to assist with sleeping. Monday, March 1, reported situation to Pfizer over the phone. Information on when to discontinue shingles & pain medication was obtained from Pfizer, and doctor prior to receiving second shot on Wednesday, March 10, at 9:30 same location as first shot. Shingles medication was finished on Friday, March 5. Pain medication was stopped on Friday, March 5 until after second shot. Pain medication resumed on Friday, March 12 and continues only as needed. Normally just one pill. As of Tuesday, March 23, rash, pain, swollen lymph node seems to be starting to improve.

13 days post vaccination patient wakes up with a slight itch in here ears. By 4pm she reports a sudden hearing loss in her right ear. On day 14 she proceeds to get very weak with vertigo, nausea, and anorexia. No temp or other signs of illness. On day 15 we take her to ER and work up was negative. On day 16 we take her to ENT no explanation of the sudden hearing loss but is told she is totally deaf in the right ear and needs a hearing aid in the left. She did not have this prior to the vaccination and it was a sudden onset.

The patient is having a hard time hearing me, she is hard of hearing in one ear; the pain was radiating in her ear and behind there; Rash/She still has the rash all over/ rash is behind ear, all down the back side of her neck, side of the neck up to hairline/right side of face/collar bone and little on back; swelling in the lymph nodes behind her right ear; trouble sleeping; sharp pain that would come and go behind her right ear/Ear pain was reported as worsened.; pretty big blotches; arthritis; shingles; This is a spontaneous report from a contactable consumer (patient's son). A 92-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) dose 1 via an unspecified route of administration, administered in left arm up at the top on 13Feb2021 at 10:00 or 10:15 (Lot Number: EN6200) (at age 92 years old) as single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient previously received shingles shot for immunization. The patient's son said that a week and a half after receiving the 1st dose of the Pfizer-BioNTech Covid-19 Vaccine, the patient developed shingles and severe pain. He wanted to know if his mother should still go ahead and receive the 2nd dose. If so, how long does she have to wait to receive it. He said his mother received the 1st dose on 13Feb2021, and was scheduled for the 2nd dose on 01Mar2021 or 10Mar2021. After the shot, a week and a half later (Feb2021), the patient got what the doctor thinks is shingles. The reporter and patient didn't know if she should get the second vaccine. The shot was not given by her doctor or at his office. The patient was healthy before and she's in quite a bit of pain, should she get the next shot because she's worried about it. The patient's second dose was scheduled already on 10Mar2021 but hasn't been able to get a hold of the place when calling them. The patient had the shot on 13Feb2021, on Monday 22Feb2021 the patient had sharp pain that would come and go behind her right ear. Patient stated she hates the pain. The patient had swelling in the lymph nodes behind her right ear a couple of days later. On 23Feb2021 the pain continued off and on behind the patient's right ear and she was having trouble sleeping. On 24Feb2021, the patient went to the doctor and he prescribed antibiotics because he wasn't sure that's what it was. There were no spots on the patient yet, the patient had more pain than before in the back, but she did not have a rash or swollen lymph nodes. The patient's lymph nodes were swollen in the back of her neck Thursday night (25Feb2021). The pain continued, it was more severe. The patient developed a rash on Thursday (25Feb2021). Friday the doctor prescribed the medicine for shingles. On 28Feb2021, the pain was radiating in her ear and behind there, you'll see her wince. The patient didn't get red blotches yet. Monday and Tuesday the pain was sharp, kind of sticks and then it was gone, it came and went, yesterday it was constant all day and Saturday it wasn't constant. Saturday the pain was constant. Thursday you could feel the knots in the lymph nodes, they have gone down some today. There is a little improvement in the patient's ear lymph node swelling. The patient has ear pain. The doctor looked in the patient's ear on Wednesday the 24th, the pain radiates, on the outside and the inside, it's just pain, shoots there and behind there. The pain has gotten worse over the week. The pain is intermittent, not constant and when it comes it's really sharp, she's had more over the weekend where its coming more often. The patient was having trouble sleeping starting Tuesday evening, it was fair but by Wednesday the trouble sleeping wasn't bad yet, the patient was still able to sleep, she has had to sleep sitting up, but by Wednesday, she hasn't been able to sleep well. The patient states that she has slept better now that she's on medication, last night was the first time she slept well. The shot was given in the left arm, all of this is on the right side. The patient has had no vaccines before, she wasn't sick before this. She still has the rash all over, the rash is behind the patient's ear, all down the back side of her neck, side of the neck, up into her hairline slightly, on the right side of her face, on her collar bone, and a little on her back. People say they got a bad case. No further clarification provided. Reports these are pretty big blotches (Feb2021). The rash was about the same, between Thursday, Friday and Saturday the patient developed more of them. With the rash, the reporter noticed more on Friday and Saturday. Today the rash is there but it has not changed. For her history, the reporter stated she's on normal medication, she didn't have anything before this. The patient is not in a nursing home, resides in her own home, not in a facility, she's is able bodied to stay at home. The patient is mentally alert, walks with a cane when needed, she does everything on her own. The patient's doctor sent her for x-rays behind her right ear and face, facial, shoulder, and behind the ear area, behind the neck area on 24Feb2021. The patient's doctor's office called and said it showed arthritis. The reporter states that this pain is not from the arthritis. The caller mentions that the patient got a shingles shot, it was a one-time shot, and she did not have a reaction to it. The patient was having a hard time hearing, she is hard of hearing in one ear. The patient was recovering from trouble sleeping and swelling in the lymph nodes behind her right ear; not recovered ear pain and rash; while unknown for the rest of the events.

lips swollen; Tongue got cut; This is a spontaneous report received from a contactable consumer (patient). A 92-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number: Unknown), via an unspecified route of administration in right arm on 05Mar2021 at 10:00 AM as 1ST DOSE, SINGLE for covid-19 immunisation. Medical history included blood pressure, cholesterol, panic attack, macular degeneration from an unknown date and unknown if ongoing. The patient has allergies to Cipro XR; Macrobid; Keflex; Levaquin. No family medical history was provided and no relevant tests were performed. Concomitant medications included azilsartan kamedoxomil (EDARBI) 40 mg for blood pressure; azilsartan medoxomil, chlortalidone (EDARBYCLOR) for blood pressure; nebivolol hydrochloride (BYSTOLIC, take once daily by mouth) 5 mg for blood pressure; rosuvastatin calcium (CRESTOR) 20 mg for blood cholesterol; aspirin [acetylsalicylic acid] 81 mg for anticoagulant therapy; pregabalin (LYRICA) 25 mg; midodrine hydrochloride 2.5 mg; olanzapine (ZYPREXA) 2.5 mg; omeprazole (OMEPRAZOLE) 40 mg; alprazolam (ALPRAZOLAM) 0.5 mg for panic attack; ciclosporin (RESTASIS) 0.05 mg for macular degeneration; captopril (CAPTOPRIL) 50 mg, (take only as needed) for blood pressure; linaclotide (LINZESS) 72 ug; triazolam (TRIAZOLAM) 0.25 mg; doxepin (DOXEPIN) 10 mg; diclofenac (DICLOFENAC), 1 % gel apply as needed for arthritis. Concomitant products from a list written by patient's caregiver. He doesn't know the dosage or how long his mother has been taking many of the mediations. Patient had no previous history of immunization with the Pfizer vaccine considered as suspect. The patient did not receive additional vaccines on same date of the Pfizer suspect. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. His mother got the first dose of the Pfizer COVID 19 vaccine two weeks ago 05Mar2021 at 10:00AM in the right arm. In about four hours after the vaccine, on 05Mar2021 her lips were swollen; they read that it is one of the known side effects. Then next day they went to the family doctor who prescribed Benadryl. She took it for about a week but her lips are still swollen. His mother told him she noticed her tongue has had a few cuts in it but he is unsure of the exact date. His mother is not in bad condition and but she did have a severe reaction. She is scheduled for the second shot next week 26Mar2021. They stopped the Benadryl a few days ago because they are planning to see a specialist in allergies and heard they might want to do some testing so he wanted his mother to be clear of the Benadryl. Not have any product or information to provide NDC, UPC, lot or expiration for the Benadryl his mother took. The events resulted in a visit to physician or ER: Monday they saw the family doctor who prescribed Benadryl for lips swollen. The outcome of lips swollen was recovering, while with other events was not recovered. Information about batch/ lot number has been requested.

She began with an earache and dizziness. Pain got so severe that she could no longer take it. Went to the doctor which she was put on pain medications. Went to ER on 1/6 and on 1/7 went to her PCP. Still in severe pain.

Chief complaint: redness on skin; redness right eye first, then left Patient informed immunizer on the second dose date; per nurse. MD checked out with no problem/concern in the eyes.

10 mins after injection, patient reported her tongue felt "rough and swollen". Reports being able to "taste vaccine". BP 189/110. 25mg benadryl given PO and patient given snack. Approximately 30 mins after injection, patient reports her tongue and lips were swelling. BP 170/128. Epi-pen administered, EMS called and patient transported to hospital at 12:45pm.

Loss of taste; More pronounced with salty/meaty flavors; This is a spontaneous report from a contactable consumer (patient). A 93-year-old non-pregnant female patient received first dose of BNT162B2, lot no. EL9265, via an unspecified route of administration (right arm) on 31Jan2021 14:00 at a single dose for COVID-19 immunization at an administrative office of healthcare group. Medical history included COPD, asthma, hypertension, and atrial flutter. She had no known allergies. Concomitant medications included prednisone, azithromycin, rivaroxaban (XARELTO), and 3 others. No other vaccine in four weeks. No covid prior to vaccination. The patient experienced loss of taste and more pronounced with salty/meaty flavors, sweets can still be tasted on 02Feb2021. No treatment received for the events. No covid test post vaccination. The outcome of the events was not recovered.

Exhaustion- continuing Chills-continuing Severe Mental Fog- some improvement Loss of taste- somewhat better Loss of Appetite- some improvement in the last few days Overly cold in general Generally debilitated - continuing

Patient received vaccine and approximately 30 minutes afterwards began experiencing tongue swelling, bilateral hip, knee, leg and shoulder pain, and dizziness.

over about an hour increasingly achy, arm pain, fever, nausea, high blood pressure, lower lip numb (sometimes a sign of a TIA), some confusion (sometimes the sign of a TIA) The severe nausea came in waves, lasted a couple of hours and cleared by Midnight before she went to sleep.

94 yo F presented from assist living with slur speech for 1 day, last seen well on 1/30. Pt has a PMH of dementia (Baseline, she will keep saying, "help me, help me", AOX3, using walker, could go to bathroom by herself), hx breast cancer (s/p lumpectomy, chemo, Tamoxifen, currently not on tx), HTN, HLD, vaginal bleeding (no further work up by family), overactive bladder (on solifenacin), hx of MI (undocumented, no PCI or CABG), spine stimulator placed. According to patient's daughter, she saw her January 30, she was doing okay after the vaccine. On 1/31 when the daughter called her on the phone, she knows she has some slurred speech, when she saw patient in the facility, she noticed her gait becomes unsteady. She decided to bring her to the hospital. 1/30, she noticed the patient has spilled up some water, otherwise denies fever, chills, shortness of breath, pain, chronically, she has constipations taking laxative. In the ED, pt was afebrile, 36.1, heart rate 85, blood pressure 130/61, respiratory rate 18, saturations 98 on room air. Labs shows, sodium 134, potassium 3.6, bicarb 28, BUN 18, creatinine 0.97, glucose 119, WBC 12.5, hemoglobin 11.8, platelet 239. PT INR 1.09, COVID negative. CT head suggestive of subacute infarct. Possible including small vessel ischemic changes. Chest xray questionable patchy left retrocardiac atelectasis or pneumonia. EKG shows atrial fibrillation's heart rate 71, QTc 610. Case was discussed with neurology in the ED, patient was not a TPA or embolectomy candidate. CT head suggestive of acute/subacute cerebellar infarct. Patient does not have any residual or sensory deficit except expressive aphasia. Neuro saw patient, mentioned patient appears to have had a stroke that by the CAT scan criteria is already subacute. The patient was admitted on the stroke pathway. The patient has new onset atrial fibrillation and therefore should be considered for anticoagulation. The patient cannot have an MRI of the brain due to her spinal cord stimulator but given that the stroke is already subacute on the CT without any signs of hemorrhagic conversion she could be started on this at this point. If she gets started on anticoagulation the aspirin should be stopped. If the patient cannot go on anticoagulation or does not want to then she might be a candidate for dual antiplatelet therapy for secondary stroke prevention. 2D echo shows normal ejection fraction of the left ventricle estimated at 70 to 75%. Regional wall motion abnormality was not observed. Right ventricle systolic function is normal. Moderate aortic stenosis. Cardio was consulted for anticoagulation, From cardioembolic prevention standpoint, anticoagulation is recommended to prevent CVA. However, she has significant risks for bleeding given recent vaginal bleeding (investigation not pursued to spare her comfort), age, comorbidities, etc. Again, further discussion between family and primary team is required regarding risks vs benefits. Was evaluated by speech-language pathology present minimal oral dysphagia no overt clinical signs of aspiration, recommended to continue with NDD 2 diet/thin liquid. Patient was discharged to ECF.

Vertigo last week that stayed for five days; pain at the injection site; 2 stroke like symptoms/ like she was having a TIA (Reporter confirmed TIA as Transient ischemic attack); Blood Pressure 170/130; Fatigue; Joint ache; Nausea; Vomiting; Fever 100.1; Stress; 2 stroke like symptoms/numbness in her lip; Pervasive aching; Momentary confusion; , like she was having a TIA; Not able to answer questions; she still has not recovered her strength; This is a spontaneous report from a contactable consumer (patient's daughter). A 94-year-old female patient (mother) received 1st dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) (Lot# EL1283), via an unspecified route of administration on 23Jan2021 13:00 at a single dose for COVID-19 immunisation. The patient's medical history included ischaemic stroke, haemorrhagic stroke in Aug2019, pulmonary embolism, deep vein thrombosis (DVT), cholesterol, myalgia condition, blood pressure, thyroid, sleep and vertigo. The patient concomitant medications included amlodipine for blood pressure, calcium carbonate/colecalciferol (CALCIUM + VITAMIN D), rosuvastatin calcium (CRESTOR) for cholesterol, levothyroxine for thyroid, eszopiclone (LUNESTA) for sleep medication, ascorbic acid, cupric oxide, dl-alpha tocopheryl acetate, xantofyl, zeaxanthin, zinc oxide (PRESERVISION AREDS 2), prednisone for myalgia condition, and escitalopram. The patient experienced fatigue, joint ache, nausea, vomiting, blood pressure 170/130, fever 100.1, stress, stroke like symptoms, numbness in her lip, momentary confusion; like she was having a TIA; not able to answer questions, tired, pervasive aching, all on 23Jan2021 19:00. Events reported as follow: patient had the Pfizer vaccine on Saturday around 1 pm and Saturday (Clarified 23Jan2021) night she had severe side effects for about 4 hours. When probed for side effects, the reporter stated it increased gradually over time. So, first patient had joint achiness and then she experienced nausea and vomiting. The reporter took her blood pressure. It was 170/130 and so reporter called EMS and they came up and her blood pressure had gone back down to normal and they recorded she had a fever of 100.1. EMS believed that the combination of the 'violence' of the onset and the fever caused her blood pressure to spike but she had a history of ischemic and hemorrhagic stroke. So, the reporter was concerned that the stress and whatever that was going on the reaction, the reporter was concerned that it was going to cause her a stroke. Patient had 2 stroke like symptoms, one was that she had numbness in her lip and the second was that she had momentary confusion, like she was having a TIA (reporter confirmed TIA as Transient ischemic attack). The only symptom of that was when the reporter asked her the name of her children she gave the names of her grandchildren but that confusion cleared up quickly and she was fine for a while but not able to answer questions, sharply. By the time that EMS got there patient was sharp again, no problem. For treatment, the reporter gave patient aspirin. The reporter put some Salonpas patches on her joints. It was like the analgesic patch. It was an external patch that patient put on. Patient usually does not need them that was why she was taking the prednisone to treat that kind of pervasive aching. The reporter also gave her the fluids, Gatorade kind of stuff to replace her fluids from throwing up and that kind of stuff. One more thing, it all started with an extreme fatigue but that seem normal but it seemed to lead into the other symptoms. Like it was a big day to go out and get the vaccine. So, she was a little bit tired. This was a very deep fatigue that was part of it too. Reporter stated only 81 aspirin (later clarified as treatment) as she could not go back on blood thinners because she had the hemorrhagic stroke. As of 11Feb2021, it was reported that patient still has not recovered her strength since 23Jan2021 19:00 and was reported as ongoing but improved. On 03Feb2021, the patient had vertigo that stayed for five days and was now improved. The patient was scheduled for the second dose on 13Feb2021. The immediate effects her mother had after the first dose of the vaccine were pain at the injection site; fatigue; fever; nausea. Mentions she also had some confusion and they were worried that the patient might be having another stroke. But all of this cleared up; all of this in a violent episode that lasted about four hours. Today she wants to report that her it took her a week for her mother to recover. Adds her mother could walk for half an hour before the vaccine but since the vaccine she still has not recovered her strength. Adds her mother has only been able to walk about 15 minutes with a walker and resting a lot, for a couple time in three weeks and this was their main way of maintaining her health. Adds her mother also had some vertigo last week that stayed for five days but she has had that in the past. Adds actually she still has the vertigo a little and she can tell when her mother bends her head. Outcome of blood pressure 170/130, she still has not recovered her strength and vertigo was recovering, outcome of events pain at the injection site, fatigue, fever, nausea and confusion was recovered on 23Jan2021 23:00; other events was unknown. No investigation assessment. Follow-up (11Feb2021): New information received from the same contactable consumer (patient's daughter) includes: reporter details, medical history, reaction data and course of events.

Client reported a metallic taste in her mouth, heaviness in her chest, headache, lightheadedness. On site EMS attended to client. B/P 130/70, EKG done-normal sinus rhythm. Client declined to be transported to the hospital. Client monitored for 30 minutes, reported that she felt "a little better" and wanted to go home. Client driven off site by her daughter. Client and daughter encouraged to call 911 in case of emergency and follow up with primary doctor. Verbalized understanding.

Two days after the shot, my mouth developed sores inside both lips, the lower lip was swollen. Inside lower lip blisters erupted. From then the soreness spread into the floor of my mouth and under my tongue. It was difficult to eat as the food would scrape the sore parts. I have been washing my mouth with Oragel two or three times a day, and am now rinsing with salt water. My lips are so dry I have to keep lip balm on them continuously. Today feels a little better but still have soreness in parts of the mouth, and roof of mouth. Am worried regarding the second shot due on the 26th.

Pt had acute ischemic stroke involving right vertebral artery 16 days after dose number one of Pfizer vaccine. She developed sudden dizziness and loss of leg strength, fell to floor. it took 7 hours until she was found and taken to hospital, so did not receive TPA. CTA on 2/27/2021 showed occluded V4 segment of rt vertebral artery. residual deficits currently include imbalance, loss of lower extremity strength (now in wheelchair), loss of hearing and discordant occular movement.

disoriented a little; Has been terribly sick, almost continually; Hurts mostly in back and legs and has difficulty walking; Hurts mostly in back and legs and has difficulty walking; Hurts mostly in back and legs and has difficulty walking; eye sight went; hearing was not good to begin with but now her hearing is much worse; hearing was not good to begin with but now her hearing is much worse; Of course, is kind of out of it and doesn't know exactly what to say even though knows what wants to say; has no energy; terribly congested; has cough that turns into a violent sneeze, a couple sneezes; has cough that turns into a violent sneeze, a couple sneezes; has a runny nose and all the symptoms of a bad cold but the caller doesn't think she really has a cold.; has a runny nose and all the symptoms of a bad cold but the caller doesn't think she really has a cold.; hurts so bad; This is a spontaneous report from a contactable consumer (patient). A 94-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in arm left on 08Apr2021 (Lot Number: EW0151) as dose 2, single at the age of 94-years-old for covid-19 immunization. The patient medical history included: ongoing hearing was not good. There were no concomitant medications. The patient received the first dose of bnt162b2 (Lot Number: PN6208) on 10Mar2021 in left upper arm for covid-19 immunization. The patient will be 95 years old in just a few more days. The patient received the second dose on 08Apr2021. The patient was fine until about Dec2020. The patient had been terribly, terribly sick almost continually. The patient took half a pill Fenofibrate a day. The patient is going to be 95 years old very soon and the patient had always been very, very active. The patient was never sick. All of a sudden, the patient had shut down to almost nothing. The patient had no energy. The patient hurt so bad, whole body had been so sick and can do very little and had to rest. The patient hurts mostly in her back and her legs and had difficulty walking. This began a month ago, everything began a month ago. The patient's whole system is out of whack. The patient will have all kinds of time to get to the bottom of this. The patient was just at the primary care physician's office yesterday, 15Jul2021 and the physician was at the whit end. The patient was terribly congested, had cough that turned into a violent sneeze, a couple sneezes. The patient had a runny nose and all the symptoms of a bad cold but the patient didn't think she really had a cold. The patient clarified congestion and sneezing began a month ago. Patient stated everything occurring began a month ago. The patient's eye sight and hearing went at the same time, really bad. This began about a month ago. Everything all of a sudden happened over night. The patient felt great and was doing yard work and very, very active almost 95 year old. The patient is down to zero now. The patient stated her eye sight is worsening. The patient stated her hearing was not good to begin with but now her hearing is much worse. Of course the patient is kind of out of it and didn't know exactly what to say even though the patient knew what she wants to say. The patient is disoriented a little. The patient stated all of this began a month ago. The patient stated all of these symptoms did not come gradually, it was like overnight. The patient got up and everything was there at once, not one think after another. Everything was there when the patient got up, the patient was a different person. Outcome of the events eye sight went and hearing went was not recovered, of other events was unknown.

I woke up in the night with severe indigestion, a pain in my left jaw and pain in the back of my ribs near my heart. It?s subsided in about one minute time. This morning I woke up with some right arm pain but it was short-lived too. I have felt fine since...

Bell's Palsy Left side-3/08/2021 Seen at Emergency Room and was given treatment of Prednisone, ValAcyclovir, and ointment to left eye at night. She experienced severe left sided neck and left ear pain on Saturday 3/06/2021 and then got drooping of left mouth and left eye around 3 pm on Sunday, 3/07/2021, and was seen at healthcare Clinic and Emergency Room 3/08/2021 2 Doses Pfizer given: #1 on 1/21/2021 and #2 on 2/11/2021

her legs were red, the back of neck, stomach and arms; a little swelling under eyes and middle of back; rash all over the body; This is a spontaneous report from a contactable consumer.A 96-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection; Lot number: EL9264), via an unspecified route of administration on 02Feb2021, 6PM as single dose at left arm for covid-19 immunisation. The patient medical history included scoliosis, skin problems off and on prior to the vaccine and have dermatitis and other skin issues which had been diagnosed for years. the patient concomitant medication was not reported. on her legs were red, the back of neck, stomach and arms and a little swelling under eyes and middle of back and chest had some rash, states it is a dry rash. States that on Monday prior to the vaccine, one of her cheeks was red, that by yesterday she had a rash all over. the patient was is shrinking from scoliosis. On 03Feb2021, the patient had a rash come over her body . the outcome of event rash was not recovered. outcome of events her legs were red, the back of neck, stomach and arms and a little swelling under eyes and middle of back was unknown. No follow up attempts are possible. No further information is expected.

cannot focus with her eyes; full body aches and pains; This is a spontaneous report from a contactable consumer. A non-pregnant 97-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; lot number EN6201) via an unspecified route of administration in the right arm on 18Feb2021 at 15:00 (at the age of 97-years-old) as a single dose for COVID-19 immunisation. Medical history included breast cancer survivor from an unknown date and unknown if ongoing. Prior to vaccination the patient was not diagnosed with COVID. It was unknown if the patient had any allergies. Concomitant medications included pilocarpine hydrochloride 1% ophthalmic from an unknown date for an unknown indication and levothyroxine from an unknown date for an unknown indication. The patient had not received other vaccines in four weeks. The reporter stated that her mother said she could not focus with her eyes and had full body aches and pain on 21Feb2021 at 09:00; further reporting she is generally in good health without any complaints. No treatment was provided for the events. The clinical outcomes of cannot focus with her eyes and full body aches and pains were not recovered. It was also reported the patient was not COVID-tested post vaccination.

fatigue; Eyesight; Dizzy; bell's palsy; This is a spontaneous report from a contactable consumer (patient's son). A 97-year-old female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Batch/lot number: EN6207) intramuscularly in the right arm on 11Mar2021 at 14:00 as a single dose for COVID-19 immunization. Patient's medical history included glaucoma for more than 25 years - 'implants caser' (as reported), thyroid disorder for more than 25 years, eye disorder, and gastrointestinal disorder. The patient had no other prior vaccinations to the COVID vaccine. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Batch/lot number: EN6201) intramuscularly in the right arm on 18Feb2021 at 15:00 as a single dose for COVID-19 immunization and experienced cannot focus with her eyes and full body aches and pains. Ongoing concomitant medications included timolol ("Timnol") drops for the eyes since more than 5 years, levothyroxine sodium (LEVOTHYROXIN) pill for thyroid since more than 20 years, and omeprazaole pill for stomach for 5 years. One week after the second injection (Mar2021), the patient experienced Bell's Palsy at 20:30, reported as serious for important medical event. On 12Mar2021 at 22:00, patient was dizzy and 'eyesight', both events reported as non-serious. It was further described as, "She saw patient over everything so she slept. Day after 2nd she had to had most of day as too Dizzy/fatigued to be mobile. Dangling/twisting side of face last 7 days ongoing." The patient did not receive treatment for Bell's palsy, dizzy or eyesight. The clinical outcome of Bell's palsy was not recovered, of dizzy was recovering, of eyesight was recovered on unspecified date, of fatigued was unknown.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021185916 Same patient, reporter, event, different vaccine dosing

Extremely dry mouth / regularly experiences a dry mouth, but this is more than it typically is.; Extremely dry mouth / regularly experiences a dry mouth, but this is more than it typically is.; loss of taste; This is a spontaneous report from a contactable consumer (Patient, self-reported). A 97-year-old female patient (who was not pregnant at the time of vaccination) received first dose of BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number and expiry dates were not provided), via an unspecified route of administration, on 07Feb2021 at 14:30 (age at the time of vaccination 97-years-old), as single dose for covid 19 immunisation. The patient medical history included Hypertension, Diabetes. No allergies were reported. The patient concomitant medications included Metformin , Januvia, Enalapril, HCTZ, levothyroxine. Patient did not receive other vaccine in four weeks of vaccination. Patient was not diagnosed with COVID, prior vaccination. Patient has not been tested for COVID, post vaccination. It was reported that the patient received her first dose of the COVID vaccine on 07Feb2021. On 15-FEB-2021 13:00 she had experienced a drier than normal mouth since that time; ongoing for the last 18 days and loss of taste. She is scheduled to receive her second dose of the vaccine on 01Mar2021. Her daughter is calling because the dry mouth condition seems to have been exacerbated after her mother received the first dose of the vaccine. she is questioning if this is a possible side effect of the vaccine, and of her mother should receive the scheduled 2nd dose. Her daughter stated that her mother regularly experiences a dry mouth, but this is more than is typically is. The Caller's (Withheld) took her first dose on 07February2021. A week after that, she's still not experiencing any side effects. But now, she is having a really dry mouth. Caller, She, is asking if that is one of the possible side effects of the vaccine Patient did not receive any treatment for the events. The outcome of all events was not resolved. Follow up #1 (27Feb2021): This is a follow up spontaneous report from a contactable consumer. This 97-year-old female consumer(patient) reported for herself that: New information included: age added, event information added, events onset date and time added Follow up#2 (27Feb2021): This is a follow up spontaneous report from a Pfizer sponsored program. This consumer (patients daughter) reported for a 97-year-old female patient (reporters mother) includes: Dose administration date was updated. No follow-up attempts are needed; information about lot/batch number cannot be obtained.

PMH Afib, BiV PPM, HTN, pHTN, hypothyroidism, hemorrhoids, hearing loss, macular degeneration, squamous cell carcinoma, Parkinsons brought to ED after her caregiver found her in bed in AM w/a "dark substance in her bed" and minimally responsive. On admission vomiting x1, no cough, no SOB, abnormal CXR, covid+ Admission originally planned by IMS, but CCM asked to take over due to rapid decline.Pt w/ shallow breathing, guarded prognosis.In the morning on May 1, 2021 around 830 in the morning patient found to be without any pulse or breathing. DNR DNI with pupils fixed and dilated without any spontaneous breathing. No pulse palpated.pronounced dead at 8:30 a.m.

AT 10:50 AM (5 MINUTES POST VACCINATION), FELT LIKE 'HEAD IS FILLING UP, MY LIPS ARE PUFFY, AND I HAVE NUMBNESS UNDER MY EYES AND NOSE'. RECEIVED BENADRYL 12.5MG AT 10:59AM. CONDITION RESOLVED BY 11:15AM. MD WAS NOTIFIED.

Received first dose of Pfizer vaccine in left deltoid on 4/8/21 at 7:30 am. At 10:00 am, she called her niece and complained of extreme fatigue. At 12:00 pm, she complained of worsening fatigue and blurry vision. At 3:40 pm, she complained of loss of appetite but denied fever and chills. The niece was unable to reach her by phone after 4 pm, so she came over to the decedent?s residence at 6:15 pm to check on her. The niece found her lying face up in bed ?gasping for air.? She then became unresponsive and EMS was called. The decedent was pronounced at 8:11 pm after unsuccessful resuscitative efforts. Autopsy showed hypertensive and atherosclerotic cardiovascular disease with marked partially calcific coronary atherosclerosis; marked pulmonary edema; and pleural effusions. The brain was saved for neuropathology given the history of blurry vision.

confused and tired; confused and tired; ear infection as well as an ongoing infection; ear infection as well as an ongoing infection; This is as spontaneous report received from a contactable consume. A patient of 101-year-old non-pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number/Expiration date: Not reported) via unspecified route on 20Jan2021 at 12:00 PM, as a single dose in the right arm for COVID-19 immunization. Patient's medical history included conjunctive heart failure, can't walk, allergies, chronic infection in hip. The patient was not allergic to medications, food and other products. Concomitant medications included spirolactone, Asprin (acetylsalicylic acid), Ceflex (cefaclor), Lasik (furosemide) and Esclaminapin. The patient did not receive other vaccines in four weeks. The patient had not diagnosed with COVID-19 prior vaccination and was not tested since the vaccination. On 28Jan2021 at 04:45 PM, 7days after the vaccination, the patient experienced confusion and tired. The patient also had ear infection along with ongoing treatment which included Keflex. The patient visited to clinic due to events. Event of ear infection was not sure if it was caused by vaccine. Outcome of events was resolved with lasting effects. Information on the lot/batch number has been requested.