Pfizer

injection site pain/arm hurts tiredness headache slight muscle pain/joint pain ***nausea feeling lousy arm feels like its blown up but doesn't look like it is

Late in the day of the shot on 01/21/2021, site on arm began to hurt and got worse in the increasing 2 days. Red very warm rash began at the injection site and spread to the size of a soft ball. Today, 01/25, the site is still red and swollen but not as poinful. Temperature is normal. Along with the affected infection site from 01/21, had a series of fevers ranging from 99.9 - 100.9. Usual body temperature is 97.6. Along with this, severe body aches, fatigue, malaise, deep depression and bed stay for 2 1/2 days. Took Tylenol. Today, 01/25/21 at 11:27AM, temperature is 98.3.

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.

Pt reports that she received her first dose of Pfizer Covid vaccine on 01/21/2021. She reports that on Saturday 01/23/2021, she was doing yoga and started to develop severe dizziness and the room "kept spinning." Pt reports that this morning she woke up out of a dead sleep and started to experience that severe dizziness, and states that she could not even "walk a straight line." She states that she has been very unsteady on her feet. She states that her whole body felt "shaky." All symptoms have resolved.

1/23/2021 extreme vertigo at 10:00 AM lasting aabout 2 minutes 1/25/2021 at 4:00AM woke out of a sound sleep with strange sensation of spinning. dlosed eyes tights and fell back asleep That morning upon waking at 6:00 AM and getting out of bed, I could not walk and I was extremely dizzy. I made myself get up and all i could do was stumble. Had to hold on to wall. could not put one foot in front of the other. My head felt very heavy like it wasnt attached right..... after Deep breathing and other calming techiques during the day, I was able to walk straight. Tues 1/26/2021 I contacted my Doctor and told him my story. 1/27/2021 I developed a rash across my nose and cheeks which is today.

02:42PM 110/50, HR 80, RR 20 appears anxious Reports doesn't routinely take FSB "I goes how I feel" Needs transportation to return home. Denies eating today. No family. 03:07PM Left ambulated to car independently

I had no reactions with the first dose. The next morning on the 28th I woke up and couldn't get out of bed. I tried to get out bed and couldn't my husband had to come help me. I could barely walk because I hurt so bad. He helped me to the bathroom and then to my chair in the living room. It hurt so bad I couldn't stay long. My husband helped me back to bed, I stayed in bed all day besides when I needed to go to the bedroom. Today I am shaky, my stomach is bothering me, I can walk today but I real tired and shaky and have to come right back to my chair to sit down. I am better then I was yesterday. If I don't feel better by noon I will call my doctor.

Patient reported scratchy, irritated throat with some tightness. She was able to swallow and reported that drinking water made her throat feel better. No chest pain or shortness of breath. She reported some anxiety. VS: BP 133/81, HR 83, O2 sat 96-97% on RA Patient felt stable and went home after over 30 minutes of observation.

36 hours after vaccine, on 01-30-21 went to bed at 9;00 PM. Could not sleep. Mind darting about and remembering past experiences. At 11;00 PM I started feeling cold with muscles twitching in legs. Got out of bed with difficulty walking and shaking and teeth chattering. Shaking became more intense. Put on more clothes and sat by fireplace. Took 2 Tyneol and ate banana. Continued to shake all over for 10 mins. Shaking so much could not hold phone. Subsided. Startrd again lasting for 10 mins. Subsided and finished at 11:30 PM. Stayed up until 1;00 PM. To bed and had difficulty sleeping. Feel alright today.

Patient was observed for 15 minutes after the vaccination administration, felt fine, and left the facility with her husband. The 2 of them drove 2 blocks away to a restaurant to eat. Midway through her meal, she reported that she started to feel "funny" like she was "drunk" or something, and felt nausea and hot/sweaty. Her husband got her in the vehicle and drove to the vaccination facility, When he arrived, she was obtunded and "out of it." No respiratory distress, No noted rash, but some clamminess/diaphoresis. She was initially examined by FNP and cursory limited neuro exam while patient was seated did not reveal any gross motor deficits. FNP called 911 and staff called for me. When I arrived, patient was groggy, but responsive. She was A&O x3 and in no distress. Pulse 54, strong and regular (normal rate for her per patient--on a Beta blocker). BP 120/74. O2 sat 97% on outdoor cold air. Patient was able to move all extremities equally and with equal strength. Lungs CTA, Heart regular no murmur, abdomen soft. Patient complained of continued malaise/grogginess and nausea, no vomiting. EMS arrived, checked glucose, which was "normal" (I didn't hear the result) and patient declined transport. I discussed ER evaluation vs. continued monitoring by me. Patient and husband requested monitoring. Patient stayed in the vehicle with her husband, I gave the husband my phone number to call if any worsening. I checked on her 5 minutes later, then 10 minutes after that. By that time, her adult daughter had arrived. We again discussed continue family monitoring vs. ER. The family wanted to take the patient home to monitor. Patient stated "If I could just go to bed, I think I will be fine." I called to check on the patient at 6p. She had rested well and was improved. She still felt a bit groggy, but otherwise was feeling better. I called to check on the patient 1/29 at noon. At that point, husband stated that she was "back to normal. Symptoms and signs appeared to be consistent with a vasovagal response. I suspected symptoms may have been prolonged by her Beta blocker

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.

not feeling well/general malaise/feeling sick; feeling really bad; a bad headache; feeling sick and nauseated/nausea; worried it will not go away; frustrated; This is a spontaneous report received from a contactable consumer (patient). A 76-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: ELI283, expiry date unknown), via an unspecified route of administration in the right arm, on 11Jan2021, at single dose, for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient reported she had her first vaccine on 11Jan2021. On 19Jan2021, the patient was feeling really bad, had a bad headache, general malaise and was feeling sick and nauseated. She was not feeling well and has not been feeling well the last 3 days. She thought the side effect would be right after getting the vaccine however hers started on 19Jan2021 (2 days ago). She stated she had an awful headache which she still has and had nausea. She wanted to know if it was normal to have happened this far away from receiving the vaccine, this amount of time from the vaccine. The patient reported that she is not quite as bad now, but she still feels it. The patient was worried it will not go away (Jan2021). The patient became frustrated and stated that she was just trying to find out if what she was feeling was normal. The patient also thought she had COVID and took a test in Jan2021 but she did not have COVID (negative). The outcome of the events "not feeling well/general malaise/feeling sick", "feeling really bad", "a bad headache" and "feeling sick and nauseated/nausea" was recovering; and the outcome of "worried it will not go away" and "frustrated" was unknown.

Pt received injection, then collapsed, with no memory of event. Pt was unresponsive approximately 15 seconds. HR 52 & irregular, BP 110/80

"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 %.

Slight headache began about 6 hrs after shot. Extreme tiredness and light headedness hit the morning of the next day. Complete loss of energy...and I am a VERY energetic person. Tiredness and light headedness has continued from 2/4 thru 2/13 with no let up. 11 hrs of sleeping at night after being on couch all day. NO loss of appetite, taste, smell, fever, or aches. Headache lasted only a few days.

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.

Got awake morning following vaccination feeling much like I did when I first became ill with COVID. Spent whole day in bed. No appetite. Felt a little better next day but knew I was about to pass out so laid down in hallway where my husband found me. Got better as day went on and feel fairly well today. Also had a mild case of night sweats last night. They were awful when I actually had COVID - for about 2 weeks.

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

CLIENT STATES 9:15AM ON 2-5-21 SHE WAS PASSENGER IN CAR AND HUSBAND NOTICED THAT SHE HAD STOPPED TALKING AND WAS JUST STARRING X 2 MIN, THEN BECAME RESPONSIVE AND TALKATIVE AGAIN. SHE WAS 'NOT QUITE HERSELF FOR ABOUT 3 DAYS'. MRI, MRA, CT OF BRAIN & U.S. OF CAROTIDS DONE. DX WITH RT TEMPORAL/PARIETAL CVA. NOW ON PLAVIX & ASA 81MG. HAS APPT WITH NEUROLOGIST 2-17-21. REMAINS 'NOT QUITE HERSELF AND OFF BALANCE'.

Patient received 2 doses of COVID-19 vaccination in same arm on same day (several minutes apart). No symptoms reported, aside from anxiety-induced blood pressure elevation

Pfizer-BioNTech COVID-19 first dose, 1/23/2021, little reaction. second dose, 2/13/2021: headache one day later, disorientation/foggy mind 2 days after, then cleared up, muscle pain was short-lived, moderate chills, feeling unwell with weakness, restless leg syndrome (managed since 2004 with medications) returned 10 days after second shot.

Patient complained of racing pulse, anxiety, dizziness during 15 min observation time. BP elevated 175/91, HR 120-130. pOx 99% RA. talked patient through deep breathing, anxiety reducing exercises. Vitals started to come down (153/71, HR 96). Patient then complained that she was feeling unwell again, very dizzy, HR increased as well as BP again. 911 called to patient to go to ER for evaluation.

migraines; anxious; headache; This is a spontaneous report from a contactable consumer, the patient. A 76-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot number EL1283), intramuscularly, on 23Jan2021 at 11:30 (at the age of 76-years-old) as a single dose in the left arm for COVID 19 vaccination. Medical history included stress related to work and a preservatives allergy which give her headaches. Historical vaccinations included pneumonia vaccine (UNKNOWN MANUFACTURER but reported as "Pneumonia 13") on an unspecified date "four years ago" after which she developed a headache which she attributes to an allergy to unknown preservatives. She never received the second "Pneumonia 13" because of the reaction with the first one. She also reported that she has had this same reaction of headache attributed to allergy to unknown preservatives when eating fast foods and foods with sauces. Concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. The vaccine was administered at a County Convention Center. On 23Jan2021 at 11:45, fifteen minutes after she received the vaccination, the patient developed a headache which she has had ever since she got in on Saturday. She also stated that it feels like "a migraine on steroids." She did tell the person at the clinic where she received it. She stated that she is "hypoallergenic" and she had to sit for thirty minutes after receiving it. She was already anxious and about fifteen minutes in, she developed the headache and nothing has helped so far. She added that she has not had a headache in a long time and that is why she feels it is the shot. She reported that what she took for treatment did not work. These treatments included: Acetaminophen Extra Strength 500mg NDC 21130-111-90. Lot 9ME2806A, expiration 20Jul2021. Count size is 500 caplets, Motrin Ibuprofen tablets 200mg. Lot 6ME1058A, Expiration Sep2018. Count size 100 caplets which when taken was an expired product, SalonPas Roll On Lot 192498, Expiration Jan2022. Count size is 1 container with 3 fluid ounces or 88ml and Neck Wrap and Wrist Heat Wraps which is reported as "a generic equivalent of Thermacare" with Lot number 91211OC16, Expiration 10Dec2022. She did not take the heavy duty Motrin because it was out of date. She commented that all of these things had helped in the past. The clinical outcomes of the event headache, migraine and anxiety were reported as unknown.

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

Patient began feeling tired 1 hour post dose. At 3 hours post dose, patient began feeling woozy, dizzy and disoriented. Patient got dizzy and passed out while walking to bathroom. She fell and sustained a significant laceration to her arm. She continued to feel dizzy and "just not right" several times over the hour until she finally called 911. When paramedics arrived, she continued to lose consciousness and required full assistance to be placed onto the stretcher. Her BP was all over the place for the better part of 6 hours, with highs as high as 145/95 and lows as low as 81/42. This reaction lasted for a total of 8 hours.

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.

On first shot, within 1 day I had all the symptons of Covid 19 (severe headache, sore throat, cough, loss of taste and smell, muscle pain, extreme fatigue). Within 2 hours after the second shot, I became foggy brained. I was not able to think properly or at times u was not sure where I was and what i was doing. I was also very unstable in walking.

Within 8 hours of the vaccine, I experienced severe muscle weakness (could not lift arms above head; could not stand from sitting position without pain). During night, could not turn over in bed without pain. This lasted for 3-4 days. Treated with Advil. Next symptoms were joint pains and stiffness and back pains, which also lasted about a week. Treated with Aleve and hot/cold compresses. Final symptoms are severe swelling and stiffness of hands and fingers, with cracked, peeling skin. I have had this for about a week now and it is not improving. Cannot grasp anything with either hand. Middle and index fingers on both hands useless.

Extreme fatigue, muscle pain, headache. Difficulty getting out of bed. Slept 23 hours a day for 6 days. Increasing muscle pains for 3 weeks.

At 8:58 patient drinking water during obs report when swallowing she feels a lump in her throat. VS 165/85; 78; 99%. CAT call made. 9:07 pt reports no increase enclosure of throat. 100% o2 hr 84, ER nurse arrived assessment made, patient to ER for further observation.

Heavy, aching legs from the knee down. Knees throb. Right shoulder intermittent aching. Walking affected in that the aching reduced distance I could comfortably cover. Dragging body after a walk beyond a quarter of a mile. worst symptoms in the evening and night. Sleep disturbed on many nights. tylenol helped but did not always allow for a good sleep.

Patient complained of "Whooshing" in her ears and nervousness. Blood pressure taken. BP elevated. Patient's husband states that this "whooshing" has been going on for about a year. No trouble breathing, no itching, no rash, no swelling of mouth our throat. Patient advised to consult a physician related to elevated blood pressure. Patient declined EMS.

Terrible nightmare during night of injection. Smothering and paralyzed feeling. Shouting out in my sleep. Husband finally woke me . When I got up to take a Motrin I was disorientated. Did not know where I was. . Next day experienced several sudden feelings a syncopye. Lasting a few seconds. Had to grab on to something due to a feeling that I was going to fall. It lasted just a quick second or two. Happened several times that day. Like what I would think a TIA would feel like. Arm was just slightly tender and stinging the first day,. In the night it was aching and hot up into my neck. The next morning it was fine again. Just tender and a little stiff. I attempted to report this on line at instructed on forms given me when I left the site. however the CODE that was to be sent to my phone never came. I then entered the wed site and attempted to report it there. . Finally I called my primary Dr and he has instructed me to report this to the person giving the second injection. I doubt they will know what to do seeing as they are volunteers with little experienc.e

Headache first and 2nd day. A week later woke me up 2 nights in a row but only lasted 12-15 minutes. Skipped heart beats day after and the next am, none since. Rash of red irregular dots about the size of a pencil eraser with bumpy raised flesh directly on veins. started 2 weeks after, lasted 4 days, loss of appetite, much more intense joint pain and sleeplessness which comes and goes.

A cough began 3 days after the vaccine. On the 4th day I woke up with a fever, heavy cough and heavy head cold. I slept the whole day. The fever was gone by morning of the 5th day, but I felt like a piece of "rubber" the following 2 days. The cough has lingered until today (2 weeks after the first vaccine).

Pt reported "feeling funny" several minutes after receiving the vaccine. The individual was moved from a vaccination pod to an observation area where she was monitored and observed for 30 minutes. Vitals: 1340 95/63, HR 82, 94% on room air; 1350 100/64, HR 70, 94% on room air. Pt verified symptoms resolved and was escorted via ambulation out of facility.

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.

Felt much like I did when I had COVID virus and after the first short. In bed for almost 2 days. No fever but just felt awful. Did not eat or do anything. Worst part was the intense pain at injection site in right arm. Pain was excruciating and it took 6 days for it to subside. Sleeping was especially problematic.

1st vaccine on 2/20 and reported feeling "lousy" afterwards. On the evening of 2/23 felt like she was going to pass out. Felt worse when she woke the next morning. Presented to the ER on 2/24 with chest pain and "indigestion". Found to be in A.Fib with RVR. Vomited in ER triage. On 2/25 developed altered mental status, hypotension, hypoxemia. She was intubated and transferred to the ICU with severe lactic acidosis/shock/multiorgan failure. Had Right lower lobe infiltrate and right pleural effusion. Diagnosed with pneumonia and possible ischemic bowel. Died on 2/26. Family requested autopsy.

12 hours post vaccination I developed chills, headache, unable to relax (shaking). 24 hour post vaccination I was exhausted and slept for 24 hours. Now, at day 3 post vaccination, I am still tired, unable to do anything that requires exertion.

3/5 Anxiety attack with increased heart rate ...lasted about 20 minutes after taking one half of a cyclobenzaprine and full glass of waterand deep breathing; had another evening of March 10. much shorter duration.. After second shot, day after slight headache and bone tired...tiredness continues to present and my head feels like is has a vise or a helmet on it. Also have developed a kind of dermatitus but don't know for sure if I had it before and didn't realize it. I just want to sit down or lie down...My leg/butt muscles feel not up to the job...and in general thru today I just feel "off". Some days better than others.

I think I am having a bad reaction to my covid shots. The first shot was 1/31; a week later on 2/7 I started having headaches that travel around my head: some are behind my eyes and my teeth ache; some more like migraines that go up the back of my head; some more on the top of my head or on the side. My sense of taste changed. My second shot was 2/27. The day after I slept all day. The headaches continued (I have had a headache of one kind or another since 2/7). I had a tooth that broke off last June and was removed on March 8. I thought the tooth was infected and part of the headache problems, but since then I have been having really bad fibro pain and for the week of 3/8- 12 I ran a fever, had chills and more headaches. I was on amoxicillin from 3/8 to 3/14, but the tooth was not that badly infected and is healing well. The headaches do not seem to relate to the tooth. I have had a headache every day since 2/7 of various intensity and in different areas of my head. I am extremely fatigued and need to nap some days. My fibromyalgia symptoms are worse than they ever have been and some nights keep me awake. I also muscle stiffness and spasms in my neck occasionally. This is not normal for me. I saw a ARNP on 3/16 and she tested me for neurologic symptoms. Here are her notes: NEUROLOGIC: negative findings: speech normal, mental status intact, cranial nerves 2-12 intact, gait, including heel, toe, and tandem walking normal, Romberg negative, muscle tone normal, muscle strength normal, rapid alternating movements normal, finger to nose normal, reflexes normal and symmetric I have a video appointment with my primary care provider 3/26 to discuss this further

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.

Headache, nausea but no throwing up, tiredness, lack of energy, soreness at the sight of the injection. Feeling generally bad all over, aching muscles, much like the symptoms of the covid 19 but only lasted a day and a half. I had covid in December through the new year and it last 3 1/2 weeks.

Patient daughter told clinic team her mother was not feeling well after receiving vaccine. Daughter also states patient was lightheaded and unbalanced prior to receiving vaccine. After receiving vaccine, patient became diaphoretic, light headed, BP 110/82. States her blood sugar was normal at breakfast, but could not remember #. Daughter states patient showing signs of confusion. Gave patient soda in case BS related. Decision was made to take patient to ED for further evaluation of DM vs. reaction to CoVID vaccine.

she did not have a reaction to first. After the second she got very cold and felt miserable like her legs had weights on them- this only lasted 1-2 days. Then two weeks later she got a ring around the injection site- and developed intense itching, burning, and erythema and warmth at the site and axillary lymph node swelling. The muscle on her arm were tender and swollen as well. The lymphadenopathy, and arm pain and swelling lasted for over a month. Pfizer : Lot: 12831/8/21 Lot 9261 1/25/21

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

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

she felt like she was dying, it was a strange feeling, like out of body feeling, she knew she was feeling sick; fall; bladder issue; sinuses; body aches; she was miserable; this was painful than the other shots she has taken; Chills; she was worn out/She was tired; nausea; Malaise/feeling sick; her "armpit" hurting; muscle and joint pain; muscle and joint pain; headache; This is a spontaneous report from a contactable consumer. A 76-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCIN) lot number: EL3247, via an unspecified route of administration, administered in left arm on 10Feb2021 as single dose for COVID-19 immunisation. Medical history included multiple sclerosis, Chronic obstructive pulmonary disease (COPD), overactive bladder, osteoporosis, sinus headache, allergies also bother her, back issues, and broken femurs from 2019. Concomitant medications were not reported. The patient received her first dose of the Pfizer COVID vaccine on 10Feb2021 and is due for the second dose tomorrow. The patient stated that she has really heavy reaction from the first dose, she felt like she was dying, fall, bladder issue, had headache, nausea, sinuses, body aches, muscle and joint pain, she was miserable, her "armpit" hurting, this was painful than the other shots she has taken. The patient wanted to know if its ok to take her nebulizer and other pain medications she is taking generic for Norco. The patient clarified that she had headaches, feelings with her muscles and joint, nausea, and then there was the big symptoms that hit her, she felt like she was dying, it was a strange feeling, like out of body feeling, she knew she was feeling sick. She herself didn't know what was wrong and so she couldn't go to the ER, she doesn't know what this is, it lasted 24 or more hours. The patient stated that it was the malaise, she's never had malaise before, it scared her. She is getting the second dose tomorrow and she is scared to death. The headache, muscle and joint pain and armpit hurting started 10Feb2021 while nausea and malaise/feeling sick started on 11Feb2021. The patient recovered from the event armpit hurting and malaise/feeling sick on an unspecified date. The outcome of the event headache, muscle and joint pain, was not recovered. The outcome of other events was unknown.

transferred from shoulder to her neck; shoulder was in pain/ elbow and shoulder were in pain; injection area is a little sore; I cant sleep at night; She can't position her arm in a way that is not painful; deep muscle ache pain; she was miserable; 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, solution for injection, lot number: EL9266, expiration date: Mar2021), via an unspecified route of administration in left arm on 23Feb2021 as single dose for COVID-19 immunization. Patient's medical history included stomach problem and bleeding problems in her stomach. There were no concomitant medications. The patient said that absolutely everything was okay until she went to get the shot, and was even okay the evening of the shot, then it went down hill from there. She said nothing she has that is related to the pain in her arm, or that she feels she should provide. She did not had any other recent vaccinations or started any new medications. The patient stated that the injection area was a little sore and the area became bigger and bigger by Wednesday (24Feb2021). She woke up on Thursday (25Feb2021) and her elbow and shoulder was in pain, described as a dull pain. The patient stated she has a stomach problem where she can't take medicine. She started treating her pain with aspirin cream with Lidocaine. She said that its kind of worked, it didn't take it away, but more manageable. Now it's been 6 days later (01Mar2021), it was reported a deep deep pain in the point she can't sleep at night. She can't position her arm in a way that is not painful. It was getting unbearable. It transferred from shoulder to her neck on Friday (26Feb2021). It got worse Thursday evening and has been the same since. Patient said, "I am not going to get the second shot if this pain does not go away or if I am going to experience this again." The patient was calling about a possible side effect and was wondering if anyone else had it and does it go away. She was suffering, she wanted to know if the pain she is in, that she is still experiencing will go away. She said that she had a deep muscle ache pain to the point she can't sleep at night. Patient stated that her pain began as soreness at injection site that started Wednesday and then it just got worse and worse and became deeper and deeper just between her shoulder and elbow, a deep constant achy pain. During the day when she is using her arm she can kind of forget the pain, but at night there was no comfortable position she can put her arm in without pain, so she has not been sleeping the last 3-4 nights, she can't sleep, she was miserable. She said she would rather get COVID than this, it was ridiculous. As she has bleeding problems in her stomach, she can't take anything to treat the pain, so she was trying to use lidocaine on her arm, which did at first give some relief but no longer works. She said that the only number listed on the bottle was next to "EXP date, LOT: 19C506, EXP: Mar2021 (as reported)." The outcome of the events was not recovered.

nauseas; hot flashes; slight sore throat; feel a little punk; slight soreness at injection site in my left arm; This is a spontaneous report from a contactable consumer or other non hcp. A 76-years-old female patient received bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection, Lot number: Batch/Lot Number: EL9264; Expiration Date: unknown), dose 1 via an unspecified route of administration in Arm Left on 04Feb2021 09:00 as SINGLE DOSE for COVID-19 immunization. Medical history was unknown. There were no concomitant medications. The patient experienced slight soreness at injection site in my left arm (vaccination site pain) on 04Feb2021 with outcome of recovered, feel a little punk on 08Feb2021 with outcome of unknown, nausea, hot flashes, slight sore throat on 09Feb2021 with outcome of not recovered. The patient is scheduled for the second dose on 25Feb2021. No follow-up attempts are possible. No information is required.

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.

Patient was hospitalized from 3/11-3/15 for mental status changes. No obvious etiology found. On admission she was found to be + for SARS-Co-V2. She had no respiratory symptoms and was not treated. She was discharged to

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.

She got the vaccine, when she came home she started feeling the fatigue that she felt after the 1st vaccine. She then started feeling very cold, laid down and watched TV. She then had chills all night and did not sleep well due to that. When she got up on Tuesday the chills were gone but had a slight headache off and on throughout the day, her temp was 97.2. Throughout the day she would get warm spurts/hot flashes, as well as fatigue. She did sleep that night, and when she got up yesterday morning still had the hot flashes and it was 94.2, and took it twice due to it being so low. She was like that with fatigue and not able to sit up. She went to bed, took some Tylenol and rested. The heat feeling it started going away. Around dinner time she felt more like herself, the headache was gone and her temp was 97. She was doing pretty good, and the last thing she had was she felt on her cheeks and noticed a rash on her face, like a prickly heat type rash. Before she went to bed she put Neosporin on it, and when she got up this morning it was almost gone but still has a tiny few bumps. The arm itself did not hurt at all. Feels that it is a stressful situation as to where to get the vaccine and having to travel to get it as it's not available in locations closer to their homes. The people at the pharmacy were great, but had to travel and if it wasn't for her daughter she would probably not have her shot.

09:11 - 76 y.o. female with h/o Graves disease brought in by EMS presenting with altered mental status after COVID vaccine. The pt reports that she received the first COVID vaccine several weeks ago and immediately afterwards she felt warm and had some difficulty focusing and walking. This resolved and she has since felt well. Today at 0800 she had her second dose of the COVID vaccine. About 15 minutes later she had an acute change in her mental status. She became disoriented and slow to answer questions. She also started having difficulty walking. She was also noted to be hypertensive with systolic BP in the 200s. She was subsequently sent here by the doctor at the vaccine clinic via EMS. Currently the pt is feeling somewhat improved and more back to her baseline. She notes that she still does not feel quite herself. Notes that her symptoms feel similar to her reaction after the first vaccine except much worse. Sates she takes Levothyroxine but no other medications. She last had her thyroid numbers checked in January and they were somewhat "off."

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.

is here today for ED follow-up on A-fib. Patient stated she is not taking Eliquis. She had no side effects from her first COVID-19 vaccine. After the 2nd one she had muscle aches, headache, freezing cold, and "weird", and felt really badly then at 9:30 PM, 32 hrs after the 2nd vaccine dose she felt the a-fib started. She had not been in a-fib in many years. Cardiology had already recommended eliquis but she was holding off. She had diltiazem from 2017 that she tried but with out relief. They rate controlled her but she remained in a-fib, started eliquis, and she went home. For 2.5 weeks she had headache and chest pain, other muscle pain, felt horrible, until she stopped the Eliquis. Since stopping the Eliquis, she still has occasional mild chest pain, and headache, and flushing. Her current chest pain is left chest, not radiating. The quality varies, stabbing pain in a very small location at times, may be associated with eating. She did have a stress test years ago and was "fine". She had a dental appointment planned that she had to cancel, she has moved it to May 4th.

Death R41.82 - Altered mental status N39.0 - Urinary tract infection N17.9 - Acute kidney injury (CMS/HCC) A41.9 - Sepsis (CMS/HCC)

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.

Unable to speak, (stroke like symptoms), was taken to ER and was treated for a stroke but was later determined to not have had a stroke. Was unable to function for two days. After two iv ingested antibiotics she started to talk and walk. There was never a diagnosis given for the 3 days spent in ER.

Headache; Shrunk; Weight gain; Not feeling that great; Dizziness; Felt weird when went for walk; This is a spontaneous report received from a contactable consumer (patient). A 76-year-old female patient received the first dose of BNT162B2(PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number: EL3249, expiration date: 31May2021) via unknown route of administration in right upper arm on 21Jan2021 at 11:00, at a dose of 0.3mL as a single dose for Covid-19 immunization in Hospital and received new refill of Mycophenolate mofetil, which is an immunosuppressant at a dose of 250mg, 2 capsules by mouth two times daily for focal segmental glomerulosclerosis on the same day (21Jan2021). Medical history included diagnosed allergies, compromised immune status, respiratory illness, genetic /chromosomal abnormalities, endocrine abnormalities (including diabetes and obesity), kidney problem and focal segmental glomerulosclerosis. Concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 30Jan2021, the patient experienced the dizziness, that started 10 days after the first dose of the vaccine and on the new refill of Mycophenolate mofetil and patient felt weird when she went for walk. On 01Feb2021, the patient was not feeling that great. Last Saturday (30Jan2021) and again today she felt some dizziness, felt weird, but did not think it can be blamed on the vaccine, or did that happen. She enquired whether that could also interact with the vaccine and had zero reactions until last Saturday. So, she wanted to check with Pfizer first and then with her kidney doctor. At that time, she was dizzy and could not shake it all that morning lone. Patient was on Mycophenolate mofetil for 2-3 years and it was a refill she just started on. With the timing right then with the dizziness wonders if related to the new batch she started that day. Unable to provide the NDC, Lot, or expiry for the Mycophenolate mofetil, but provided a discard date of 19Jan2022 from the white manufacture bottle and mentions (name) label over bottle. Mentioned that she does not take product as read on bottle it has been changed after discussion with the provider. Was using this prescription 2 in the morning and 1 at night and since she has been having the dizziness, she has switched to taking it 1 in the morning and 2 at night. Did read on the instructions that this can cause dizziness, but she had taken this stuff for over 3 years and was trying to figure out if it's a bad batch or not. On an unspecified date, the patient experienced headache and thinks she was shrunk and may have gained some weight. The outcome for the events dizziness, felt weird when went for walk, not feeling that great was not recovered and for headache, was shrunk and may have gained some weight was unknown. Information about lot/batch number has been requested.

Her legs got weak; she lost coordination; anxiety was exacerbated by her terrible fatigue; depression was exacerbated by her terrible fatigue; nervousness was exacerbated by her terrible fatigue; nervousness was exacerbated by her terrible fatigue; She noticed that her blood pressure raised after receiving the first dose of the covid vaccine.; Total exhaustion/she is so tired; could not sleep; She experienced pain at the injection site./Her pain got worse and worse; left or right toe will get stuck; hysterical; she is stressed; did not have complete energy; She states that her illness is too much; This is a spontaneous report from a Pfizer sponsored program received from a contactable healthcare professional (patient). A 76-year-old female patient received bnt162b2 (BNT162B2 reported as PFIZER COVID-19 VACCINE), dose 1 intramuscularly administered in the right deltoid on 30Mar2021 10:00 (Lot number: GR8732 or 6R8732 [as reported]; Expiration Date: 31Jul2021) as a single dose for covid-19 immunisation. Medical history included blood pressure/hypertension; had breast cancer twice with the last time was in 2010 to unknown date which was 23 years later than the first time she had it (1987). She had infiltrating ductal cancer, stage one, that was HER-2 positive. She states that this is the most malignant breast cancer. She had to have extensive chemotherapy and also took Herceptin every 3 weeks for a year. The overriding symptom from her cancer was extreme fatigue; has been in chronic fatigue syndrome and in bed for 7 years, she was getting over chemo and she can barely walk. She has trouble walking long distances; had a mastectomy from 2010 to an unknown date without lymph node dissection; had a central node dissection; took a wheelchair to the hospital whenever she received the first dose of the covid vaccine; ongoing anxiety, depression and nervousness which is not new to her. She has had this on and off for the past year; and antihistamine that raises her blood pressure dangerously, it does not matter which kind of antihistamine whether it is Benadryl or over the counter. The only antihistamine that does not raise her blood pressure was a children's allergy medication. She took half of a children's dose. It did not raise her blood pressure, but it did not stop her itching. Family history included her mother's sister and she are very sensitive to medications. She has the same type of problems. As her mother's sister has aged, her problems have gotten better. As caller gets older, her problems are getting worse. Concomitant medication included carvedilol taken for blood pressure on unknown therapy dates. The patient previously took dupilumab (DUPIXENT) for skin conditions that having itching which she had side effects (Lot number: 0LU23A; Expiration date: Feb2023). Dupixent is a medication used for skin conditions that having itching, not cirrhosis, she cannot remember the name of the skin condition. Her skin started itching around Jun2020 or Jul2020. She saw eight different dermatologists. She found a doctor who was an itch specialist. Dupixent is the only thing that is going to work for her because antihistamines raise her blood pressure dangerously; and one time her doctor made a mistake, he ordered her hydroxyzine 25mg PO (Per oral). The doctor did not look on her chart to see her allergy list. She cut the pill in half and took half a dose. By the time she realized what she took, she was having so much itching. She woke up and felt like her head was going to explode and her blood pressure was 220/112. She took three tablets of her antihypertensive medication. She taken carvedilol 3.125mg. She did not even bother going to the hospital because by the time they would have saw her, and treated her, she could have had a stroke. The hospital is slow to treat people. Because she is a nurse practitioner, she knew that 3 tablets would be the correct dose for how high (Apr2021) her blood pressure was. She also previously took Benadryl but that raises her blood pressure dangerously. The patient reported that she received her first dose of the covid vaccine on 30Mar2021 and she had many side effects. She reported that the most predominant symptom is total exhaustion. For the first seven days after receiving the first dose of the covid vaccine, she was in bed for seven days nonstop. She placed a large grocery shopping order. She was able to get up and use the bathroom and cook small meals. She had someone come in to help her with the dishes, and to clean up the house. She talked to her internist of 20 years, and he told her to take the vaccine. Within five minutes, she started getting side effects. She inquired if it was safe to take the second dose of the covid vaccine. She has been so fatigued that she has been in bed for a 3 weeks-time frame and then her Blood pressure went up, it was 200 something, like 223/103. She went to the ER, and the ER said her blood pressure was not bad (Apr2021), they put her in the waiting room, and because she waited so long, she just got up and left the ER. Since she is so tired and her Blood pressure is high, she has made an appointment with the doctor. She added that the second week after receiving the first dose of the covid vaccine, she was able to get up every other day and go somewhere but the next day after she went somewhere, she was in bed all day and did not have complete energy (2021). She added that her refrigerator was going out, so someone drove her to department store 30 minutes away. She walked from the car, to the refrigerator section in department store, walked into the mall to get ice cream and then walked back to the car. By the time she got home, she immediately got back in her bed because she was so worn out. That was on Saturday. She was in bed all day yesterday. This morning, she feels better than yesterday. She thought about going to the store yesterday, but she knew she did not have the energy to go. Someone is coming later today to help her, and they will have to go to the store for her since she does not have any family nearby. She mentioned that the total exhaustion began on 31Mar2021. She took a wheelchair to the hospital whenever she received the first dose of the covid vaccine. She has trouble walking long distances. She called the hospital before she went, and the hospital did not have any wheelchairs she could use. The hospital cleared everything out of the way so they could fit the most patients as possible in the building. She had trouble walking the day that she received her first dose of the covid vaccine. Someone wheeled her in and out using her own wheelchair. She cannot go to the grocery store. Using a wheelchair is the only way she could have in and out. She could walk from her wheelchair into the examination room, and then after she went right back into her wheelchair. She is glad that she called because she does not know what she would have done without a wheelchair. It is hard for her to go on, sometimes she just feels like crying. Her trouble walking does not feel 100 percent, but it has gotten better. She is anxious, depressed and nervous also. Before her breast cancer, she had chronic fatigue. She could volunteer at a clinic for a few hours a week. She had radiation, and that caused exacerbation of her chronic fatigue. Her doctor told her that for some people, chemotherapy will make chronic fatigue better and that chemotherapy could help her chronic fatigue. Before she got chronic fatigue syndrome, she had a lot of energy. She used to work in an ICU that had 15 patients, with ambulatory patients on the outside. She worked six days a week then she transferred to a hospital where she took care of patients after they had open heart surgery. She used to be a very high energy person. Her exhaustion has gotten better, because she can get up every other day and leave the house. She cannot stop doing life. It is difficult for her that she cannot go to the grocery store. After seven days, she could go out every other day. Whenever she went to a certain company, she almost fell. Her legs got weak and she lost coordination on Tuesday (06Apr2021). Since then, it has happened a little bit here and there. It is almost like she is not sure when it will happen. In an instance, she can be working in the house, and her left or right toe will get stuck. This happens to her occasionally after chemotherapy. She noticed that her blood pressure raised after receiving the first dose of the covid vaccine (Apr2021) and she takes medication (small dose of carvedilol) for hypertension. She takes her blood pressure medication every other day. Out of the past four days, her blood pressure has been elevated twice (Apr2021). If her blood pressure is elevated more than normal, her doctor prescribed for her to take an extra dose. Her blood pressure has not been elevated dramatically. She did take an extra dose of carvedilol because her blood pressure was within the scope of her blood pressure expertise. She went to the ER and the ER said her blood pressure was not bad (Apr2021), they put her in the waiting room and because she waited so long she just got up and left the ER. Since she is so tired and her Blood pressure is high, she has made an appointment with the doctor. She also stated that her blood pressure went up yesterday last night (18Apr2021), not right after getting the first dose. Last night at 6:00 PM, she took a nap and after she woke up took her blood pressure, she didn't feel anything in specific, she always takes her blood Pressure pill twice a day anyway. When she checked her pressure, it was 223/120 (Apr2021) and immediately took 2 Carvedilol 3.125mg and went to the ER, by the time she got there it was down significantly (Apr2021), but she is anxious and sat there and waited. They said they were going to do some blood work and an EKG but they left her there, so she decided to take a company home. Her Blood pressure has been up, she then went to sleep and after (Apr2021), it was 189/105, 183/105, and 165/95, she is a nervous wreck. She was ill for a long time, she had cancer twice, now she lives alone, she has been alone for all these weeks, her friends are here and there and come over. The Last 3 weeks she has been alone. She hired someone, but it was expensive. Now she feels hysterical (2021), after she saw her blood pressure, last night she was crying, and called the neighbor and they drove her right to the hospital then she was waiting in the ER for so long. She got her first shot on 30Mar2021 and she couldn't do anything in bed for 7 days, she is supposed to get the second shot tomorrow (20Apr2021) but doesn't want to be in bed again like that. She is anxious, depressed and nervous that began on 03Apr2021. During the week, she is distracted by the market. She has not been able to trade, because she does not trust her judgment right now. She did buy one this morning. Anxiety, depression and nervousness is not new to her which she has had this on and off for the past year. She has a lot going on. She needed to sell her two-story house and move to a one-story house that is easily assessable to healthcare and meals. She thinks this is disabling in face that she does not feel strong enough to make a decision. She cannot make a decision and she does not feel good enough too. Her anxiety, depression and nervousness was exacerbated by her terrible fatigue. She is experiencing awful symptoms. She went to the grocery store, and the stumbled and went into a company. She had to carry her milk and other items in slowly, and little by little. She thought this is awful, and she got into bed. She could not do anything. She mentioned that her illness is too much (2021). She was crying and she lives alone. The patient mentioned that the pain at the injection site began four hours after receiving the first dose of the covid vaccine. She received the vaccine at 10:00 AM then started getting really bad pain about 6:00 PM and then about 10:00PM or 11:00PM, it started to get unbearable. By 12:00AM (31Mar2021), the pain was so bad that she could not sleep because of the pain. She was in agony. She took took Tylenol and it did not touch her pain, but her pain got worse and worse, so she took three Tylenol tablets then they worked. She her friend and asked him to come over since she is afraid to take narcotics. She just laid there in bed and spent all night in agony. She tried a thing she put in the freezer and tried heat. She does not remember if either of those worked. The pain resolved about 2 days after. The patient declined safety report, saying that she is stressed and anxious (2021), she just wants to be transferred for her question. The reporter considered the events fatigue aggravated serious and 'anxiety, depression and nervousness was exacerbated by her terrible fatigue' with seriousness criterion of disability while the events blood pressure raised lower extremities weakness of and coordination impaired as medically significant. The outcome of the events fatigue aggravated recovering; as for the events blood pressure raised, 'anxiety, depression and nervousness was exacerbated by her terrible fatigue', lower extremities weakness of and coordination impaired were not recovered; while the event vaccination site pain was recovered on 01Apr2021 (reported as 2 days after). The outcome of the other events was unknown.; Sender's Comments: Based on the information provided, the events fatigue aggravated and 'anxiety, depression and nervousness was exacerbated by her terrible fatigue' with seriousness criterion of disability while the events blood pressure raised lower extremities weakness of and coordination impaired as serious (IME).Based on the plausible temporal association and product safety profile, the reported events are possibly related to the vaccine BNT162B2. administration. This case will be reassessed upon receipt of additional information.

03/09: presents to the ED with palpitations that began 90 minutes prior to arrival. The patient has a history of paroxysmal atrial fibrillation but has not had an event for many years. She had her second Covid vaccination yesterday and did have flulike symptoms including headache, myalgias, and shakiness through the last night. She wonders if this triggered her symptoms. No chest pain, dyspnea, or lightheadedness. 23: 18. Cardizem 17.5 mg IV. 03/10 still in ER 00: 17. The patient is discussed with hospitalist. would not recommend admitting the patient given her stability. The patient's atrial fibrillation responded very well to the IV Cardizem. Her atrial fibrillation is now in the 80s. She is asymptomatic. CHA2DS2-VASc score of 2. 00: 18. Cardizem 30 mg p.o. The patient is quite concerned about stroke. Her mother died of CVA. We will start anticoagulation today pending cardiology follow-up. Eliquis 5 mg po. Recommended follow up with cardiology 03/16 visit with cardiology Paroxysmal atrial fibrillation Established Recently symptomatic with RVR after Covid vaccination Rhythm controlled with flecainide 100 mg twice daily Rate controlled with diltiazem 120 mg daily ? CHA2DS2-VASc Risk Factors/Score: AGE(>=75), Female Gender and 3 points: "moderate-high" risk - Stroke risk as 3.2% per year and 4.6% risk of stroke/TIA/systemic embolism. o HAS-BLED Risk Factors/Score: Age > 65 years and 1 Points - "Low Risk" - 3.4% annual risk of major bleeding in one validation study and 1.02 bleeds per 100 patient-years in another validation study. Continue Eliquis 5 mg twice daily for embolic prophylaxis (creatinine 0.76 on 3/9/2021) 04/02 appt with PCP for ER follow up Patient is here today for ED follow-up on A-fib. Patient stated she is not taking Eliquis. She had no side effects from her first COVID-19 vaccine. After the 2nd one she had muscle aches, headache, freezing cold, and "weird", and felt really badly then at 9:30 PM, 32 hrs after the 2nd vaccine dose she felt the a-fib started. She had not been in a-fib in many years. Cardiology had already recommended eliquis but she was holding off. She had diltiazem from 2017 that she tried but with out relief. They rate controlled her but she remained in a-fib, started eliquis, and she went home. For 2.5 weeks she had headache and chest pain, other muscle pain, felt horrible, until she stopped the Eliquis. Since stopping the Eliquis, she still has occasional mild chest pain, and headache, and flushing. Her current chest pain is left chest, not radiating. The quality varies, stabbing pain in a very small location at times, may be associated with eating. 04/20 ER visit: Patient is a 76 y.o. female who presents with palpitations that started this evening, sudden onset, has a history of paroxysmal atrial fibrillation, and is maintained on 100 g of flecainide twice daily and diltiazem daily. She also has short acting diltiazem 60 mg tablets to take for episodes of breakthrough arrhythmia. She took a 60 mg short acting diltiazem prior to arrival She endorses some chest pressure with this though not severe, denies any dyspnea diaphoresis or nausea Not anticoagulated 04/29 Follow up with PCP For years she has been well controlled on low dose methimazole. Recently she has had 2 bouts of a-fib, when trying eliquis prescription and again following her 2nd COVID-19 vaccine. Upon recheck her TSH remains suppressed and FT4 elevated. Increasing from 5 to 10 mg methimazole now. Left side of thyroid is palpably thickened with no nodules noted. Recommended Ultrasound. Explained that if nodules are seen, a follow up image may be indicated to assess nodule activity. Not in a-fib today. C/o general malaise, shakiness, chest tightness, & flushing. Graves since 2006 She is feeling out of sorts, shaky, flushing, chest tightness, recurring headache. She has to stop and rest when trying to do activities as she will feel weak. Not sleeping well. Systolic BP labile, from 105, to 155, to 135.

she has a little bit of skin that is very dry; Pain under breastbone; Welts; lumps in her skin underneath; Swelling: lips, face swollen, arms, hands, fingers, left foot, left kneecap left thigh, feet swelled up like a balloon; Fingertips felt tingley; rash on her palm, a red circle; hand was hot and itchy; hand was hot and itchy; Tired and exhausted; toes feel puffy; urinary tract infection; not sleeping; Rash, painful; This is a spontaneous report received from a contactable consumer (patient). A 76-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 20Feb2021 (Lot number: EL9262; Expiration date: 31May2021) on the left arm at 0.3 mL, single for COVID-19 immunization. Medical history included AFib from 2009 and ongoing; allergies to antibiotics and Penicillin; shellfish allergy. No family medical history. Concomitant medications included nitrofurantoin (monohydrate/macrocrystals; Manufacturer: Alvogen Inc) from 17Mar2021 to 24Mar2021 for urinary tract infection; prednisolone from 10Apr2021 to 10Apr2021 for rash; chlorphenamine maleate (ANTIHISTAMIN) from 12Apr2021 for rash; and taking unspecified medications for a long time. The patient previously took the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 30Jan2021 (Lot Number: EN6201; Expiration Date: 30Jun2021) on the left shoulder at 0.3ml single for COVID-19 immunization. Patient previously also had something else 10 years ago that didn't work, it was not a vaccination; took doxycycline hydrochloride (DOXYCILLIN) and amoxicillin that both experienced allergies. No additional vaccines administered on same date of the Pfizer suspect. No prior vaccinations (within 4 weeks). Stated that she had a urinary tract infection and was put on antibiotics for 7 days. Two days after starting the medication, she came down with a rash. The patient husband, who was a family physician had never seen a rash like that in his 40 years of practice. In the newspaper, there was a woman who got the vaccination, but not sure if it was Pfizer, and had a rash; the article had a picture of the rash the woman had, after the vaccine. Patient stated that her rash looked worse than the woman in the newspaper. The rash happened after the second vaccine, several weeks later, but after the antibiotics. Patient was allergic to a lot of antibiotics. She stated she may have this problem, the rash because she was allergic to a lot of antibiotics. When she got the rash, she went to the Urgent Care and was given a Prednisone shot and Prednisone pills. She got some relief taking the Prednisone. Patient weight as about 5' 4", she gained 8 pounds over the year while being stuck in her house. Patient stated she hasn't seen healthcare provider in a while, but she called him and he gave her the antibiotic prescription. Patient experienced the rash was painful on 17Mar2021 and she could feel when another one would start happening. Patient put ice on it to sop the pain and moved the ice packs around as it was reactive to pressure. Stated if there was anything tight, like underwear, or sitting on the couch, she would get welts and lumps, initially mentioned the top of her head. Reclarified itchy in later part of report. Patient got a prescription for her medication on 17Mar2021 and took it for 7 days, and then the rash happened a couple of days after she stopped the medication. As she had a little bit of skin that was very dry and she can see a line where the rash was. The rash pretty much gone, but not 100 per cent gone. Stated she went to the Urgent Care walk in, when she noticed the rash. Patient had two Covid tests, one was a blood test and one was a nose swab; reported both as negative. Stated she should have gone to the emergency room, but the doctor, in the Urgent are gave her a Prednisone shot. The only reason she didn't go because of the Covid, pandemic, so she went to the Urgent Care. The last medication that she took for the rash was an antihistamine on 12Apr2021, and last Prednisone pill was 10Apr2021; both pills were effective in treating the rash. Patient had a Zoom call with an allergist, and the doctor saw the rash with the help of a flashlight and altered the Prednisone dose. Patient had pain under breastbone that it was really bad and the day before she went, to the Urgent Care on the 28th or 29Mar2021, may in the early afternoon. Stated it was going on the whole time, intermittently, not constant in the last few weeks. She didn't know what was causing it as she had blood work to rule out gallbladder issues and that was not back to rule out a Shellfish allergy. Patient had welts and it all blends in from when she first noticed the rash a couple of days before she went to the Urgent Care. Answered as they were faded out, it was severe, then acute, then extreme for a week or more, and improved with steroids and then faded. Patient had lumps and it started two days before she went to the Urgent Care. Stated when she was sitting on the couch, reclarified, the cords of the pillow put pressure on the areas and it hurt and felt like welts. When she pushed on her skin, here were lumps in her skin underneath, and they hurt and were hot. Described the areas of the lump as buttocks, top of head, legs, arms, groin, underwear line, ear, ear lobe and face. Patient had swelling of lips, and they looked like she had Botox. Also reported additional swelling of arms, hands, fingers, arm from the wrist up to elbow, left foot, left kneecap, left thigh, and her feet swelled up like a balloon. It was better now. Patient had fingertips felt tingley. The palm of hand that patient got rashes in response to pressure and was trying to open a bottle. When she did she got a rash on her palm, a red circle and her hand was hot and itchy. Started as two days before she went to the Urgent Care. Stated she was tired and exhausted from not sleeping and the redness faded away and then it went away a couple of days ago with the help of the steroids. Patient had toes, feel puffy that described as the feeling when she goes to the dentist after she gets Novocain, the feeling. Patient had tired and exhausted. Stated she was tired the first few days until the rash peaked, as she was up all night for two nights icing the rash. Stated she was better but was not doing too much and didn't get out of the house, only when she had to. Lab data included on unspecified dates the blood work for urinary tract infection was negative; negative results for two Covid tests, one was a blood test and one was a nose swab; blood work to rule out gallbladder issues and that was not back to rule out a shellfish allergy. No events required a visit to emergency room or physician office, but patient went to Urgent Care and had a Telehealth appointment. The outcome of events "Rash; Welts; Swelling" was recovering, while of the other events was unknown. No follow-up attempts are needed. No further information is expected.

She had no pain from the initial shot but then that night she stated she felt horrible, aches and pains and her cough worsened. a week later she said that the symptoms were just as bad, she was extremely tired also. Nauseated as well. She did not believe that she had a fever.

Dizzy,Fever, Disoriented, (expected: arm soreness, heat, swelling administered frozen pea bag) rash on forearms,, not hives, passed out for 9 hours I thought I would just relax with my frozen peas and watch tv. 9 hours later, I was slumped on the couch, tv had not been turned on , I was fully dressed including shoes, no blanket or pillow, very cold all the lights that I had turned on were still on and it was 5:10 in the am I had not brushed my teeth or taken evening medication. I had warmed left overs in the oven thinking I might just be hungry. Oven was off but oven door was open food was uneaten except for a couple of bites. I live alone. I still work and manage everything on my own.

she is a little tired; slight headache; arm hurt; she felt lousy; fever/she was running at 99.5 low grade fever; didn't feel well; She had chills; didn't sleep well; This is a spontaneous report from a contactable consumer. A 76-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection) via an unspecified route of administration, administered in Deltoid Right on 26Jan2021 15:00 (at the age of 76-years-old) (Batch/Lot Number: EL1283) as SINGLE DOSE for covid-19 immunisation. No additional Vaccines Administered on Same Date of the Pfizer Suspect. The patient was not Vaccine Administered at Facility. The patient had no medical history (including any illness at time of vaccination). The patient had no family medical history relevant to AE(s). There were no concomitant medications. Historical vaccination included flu vaccine for the indication of flu vaccination which gave a reaction of sore arm. On 26JAN2021 patient experienced fever/she was running at 99.5 low grade fever, didn't feel well, she had chills, didn't sleep well, arm hurt and she felt lousy. The patient underwent lab tests and procedures which included body temperature: 99.5 on 26Jan2021 low grade fever; Her normal temperature is 96-97.0. On 27Jan2021, the patient had slight headache. On 28Jan2021, body temperature was 98.1 and she is a little tired, but her fever was 98.1. Therapeutic measures were taken as a result of fever/she was running at 99.5 low grade fever, didn't feel well, she had chills, didn't sleep well, slight headache, she is a little tired, arm hurt, she felt lousy. The patient got the first dose yesterday and had some reaction. She got a fever, her arm hurt and she felt lousy. She also mentioned that she took Tylenol yesterday. She and her husband got the vaccine on Tuesday 26Jan2021. Her husband was fine except for the sore arm but she didn't feel so well. Her normal temperature is 96-97.0 but she was running at 99.5 low grade fever and didn't feel well. She had chills and didn't sleep well. Last night she had a slight headache, chills, and didn't sleep well but today is much better. She has had no other symptom but was taking Tylenol. When speaking with her sister, she was told by her that she read Tylenol could effect the efficacy of the vaccine. She wants to know does it effect the efficacy, also her husband and her had a martini to celebrate getting the vaccine. Is that ok. The night of the 26Jan2021 she had chills that left her she was hot then cold. On 27Jan2021, later in the evening, she had a slight headache and then it went away later on that evening. Treatment: She could not gotten through the day without the Tylenol. Today, she is a little tired but her fever was 98.1 when she last took her temperature. She is much better today. The only way to describe yesterday is that she felt really lucky. The patient had no prior vaccinations (within 4 weeks). No AE(s) require a visit to Emergency Room. The patient had no relevant tests. The patient is healthy. The seriousness of the events was reported as non-serious. Outcome of the events fever/she was running at 99.5 low grade fever, She had chills, didn't sleep well, slight headache was reported as recovered on 28Jan2021, didn't feel well, she felt lousy and arm hurt was reported as unknown, she is a little tired was reported as not recovered. No investigation assessment needed. Follow-up attempts are completed. No further information is expected.

not wanting to eat; headache; chills; cold; tired/very tired; just not feeling good/felt really bad/feeling so bad; weak/weakness; miserable; nausea/nauseous; This is a spontaneous report from a contactable nurse. A 76-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) via an unspecified route of administration (administered in arm Left) on 29Jan2021 at 11:30 AM (at the time of 76-year-old) at single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date it was reported that her first dose of Pfizer vaccine on 29Jan2021. first dose of the vaccine by injection. Stated having side effects yesterday. Today patient has headache, chills, tired, just not feeling good, weak and miserable. Then all of the sudden yesterday she felt really bad. She was very tired with cold, chills, nausea and weakness. she received the first dose of the Pfizer COVID 19 vaccine on 29Jan2021 at 11:30 AM in the left arm. She was not sure of the time because she was feeling so bad and adds she has not gotten up out of the chair today. Then on 2Feb2021 in the afternoon, she started to felt really bad. Mentions that she thought she was nauseous because she was so nervous about getting the vaccine. Adds it wasn't really just like nausea but more like not wanting to eat. She stopped having chills last night. She was scheduled to get the second dose of the vaccine 19Feb2021. Patient mentioned she was shrinking due to natural aging. The outcome of chills was recovered on 02Feb2021 for tired/very tired and malaise (PT) was not recovered for weak/weakness and nausea (PT) was recovering while for other events was unknown. The reported events felt really bad, tired, nausea and weak were considered as related to suspect product. 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.

weak; does not feel well; Stomach is upset 24/7; TSH is off; skin so itchy; dry heaves; nauseated/Nausea; sore arm; I don't like the way I'm feeling; This is a spontaneous report from a contactable consumer (the patient). A 76-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EW0773) via an unspecified route of administration in left upper arm on 04May2021 11:00 at age of 76-year-old at single dose for COVID-19 immunisation. Doctor wanted her to get it. Caller said that her doctor told her she wouldn't make it if she got COVID. Her heart couldn't pump very well and was very weak. Other medical history included a lot of allergies (They made her sit in a recliner for 30 minutes) and thyroid disorder. No further details provided by the caller regarding her thyroid condition. Caller did not think there were any other medical conditions that she had that would be relevant as she was pretty darn healthy. Family medical history relevant to AE: Not that she knows of. Daughter had the shot and was sick for 2 days. She had the Pfizer. No vaccine administered on same date of the Pfizer suspect. No history of all previous immunization with the Pfizer vaccine considered as suspect. No prior vaccinations (within 4 weeks). Concomitant medication included levothyroxine sodium (SYNTHROID) taken for thyroid from an unspecified start date for 20 years and ongoing. Got the shot 04May2021. Dry heaves on 04May2021: Didn't really throw up, but she had them all day. Still has them but not as bad. Nausea/ nauseated on 04May2021: It was actually kind of steady. Caller was able to eat and drink, not that she wanted to. She did not know what to do with herself. She was eating and drinking. She took TUMS [CALCIUM CARBONATE] and always had a cast iron stomach. Skin is so itchy on 04May2021: Skin started itching right away, that evening that she got the shot. She even used a back scratcher. It was all over and still felt the same. Treatment: Had taken diphenhydramine hydrochloride (BENADRYL) maybe once or twice and when she went to bed. She didn't take it steady. She did not take the TUMS steady either. Yesterday, she felt better, and currently felt worse again. Had a little more energy and was feeling good. Sore arm on 04May2021: Was sore right away, after the shot. It was still sore but it was better. It was not red or anything. Treatment: Took 1/4 of a paracetamol (TYLENOL), 325mg, so it was 12 or something. Weak on an unspecified date and did not feel well on an unspecified date. Her blood pressure was good and she has no fever. She also stated her stomach was upset 24/7. She didn't like the way she was feeling after the first dose (May2021). She just wish this would go away. She didn't feel good. 10 days was a long time to have a reaction. Tests: Recently had blood work and everything was normal. Even her thyroid stimulating hormone (TSH) which she got tested for every month is fine. It was off but currently was regular. The event did not require a visit to emergency room or physician office. Her next shot was on 25May2021 and was scared to get it. The patient asked what would happen if she did get the second dose. The outcome of events "skin so itchy", "nauseated/nausea" was not recovered, of events "dry heaves", "sore arm" was recovering, of "TSH is off" was recovered, of other events was unknown.

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.

My mom had the 2nd vaccine and was the sickest she's every been for one day. At the time she experienced Delirium. She had been diagnosed with Mild Cognitive Disorder prior to the vaccine. She seemed to recover from this episode but 2 months later she went from Mild Cognitive Disorder to Hallucinations, Delirium and a full blown Advanced Lewy Body Diagnosis. We are unable to explain how she has progressed to this degree and wondering if the vaccine could have accelerated her path. She is currently in a Facility and will have to be moved to 24 Care in a Memory Care Unit

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.

urge to have a BM; left side of head had a funny sensation; Chills; hot flashes in my upper body; feels strange and voice has changed; feels strange and voice has changed; suddenly had to have a bowel movement; This is a spontaneous report from a contactable consumer or other non-HCP. A 76-years-old female patient (at the age of: 76-years) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EN6203; Expiration Date: 30Jun2021), via an unspecified route of administration, administered in Left Arm on an unspecified date as 1st dose, single for covid-19 immunization. The patient Medical history was not reported. Concomitant medication included losartan potassium 50 mg once a day, ergocalciferol (VIT D) and calcium taken for an unspecified indication, start and stop date were not reported. No vaccination within four weeks prior to the first administration date of the suspect vaccine and No Family medical history relevant to ae and relevant tests. The patient experienced chills, hot flashes in my upper body, feels strange and voice has changed, and suddenly had to have a bowel movement on 02Mar2021, urge to have a bm and left side of head had a funny sensation on an unspecified date. she got the first dose of the Pfizer Covid vaccine this morning around 08:00 AM, then the person who gave her the shot asked her what medication she takes and she told them, they did not say anything to her about it. States she took her medication for blood pressure around 09:30 AM at her regular time to take the medication, wants to know if it is okay Takes Losartan Potassium 50mg one time a day, states she took it with Vitamin D and Calcium. And States her voice is changed, she feels strange, states around 10:20 wanted to take bowel movement suddenly, could be a regular thing, states she feels some sort of hot flash sensations not bad, here and there and then feel chills. The patient underwent lab tests and procedures which included weight fluctuates between 144 and 145 on unspecified date. The outcome of the events feels strange, and voice has changed was not resolved and other events was unknown. No follow-up attempts are possible. No further information is expected.

Legs Wouldn't Work; she couldn't walk; Slurred speech; Really sharp pains inside her head; Lymph Node Abnormal; Confused; foggy; This is a spontaneous report received from a contactable consumer (patient). A 76-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 2 via an unspecified route of administration, administered in right arm on 31Mar2021 (Lot Number: EW0150) at the age of 76 years, as a single dose, for COVID-19 immunisation. Medical history included cerebrovascular accident (Mini Strokes), TIAs ( states she has had a few of them; the last one was years ago), Car Wreck with head pain on the side of the head. The patient's concomitant medications were not reported. Historical vaccine included bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) dose 1 via an unspecified route of administration, administered in right arm on 10Mar2021 (Lot Number: EN6208). The patient did not receive any other vaccines within four weeks prior to the vaccination On 01Apr2021 the patient experienced legs wouldn't work; she couldn't walk, she had slurred speech, really sharp pains inside her head, she was confused, and felt foggy. In April2021 she had lymph node abnormal. The patient was hospitalized from 01Apr2021 to 05Apr2021 (4 days). The patient had lab tests and procedures on unspecified date, which included computerized tomogram with Contrast: normal; electroencephalogram (EEG): abnormal; x-ray: abnormal lymph node. The verbatim chronological clinical course was reported as follows: the patient stated she received her second shot on 31Mar2021 and on 01Apr2021, she ended up in the ER and admitted to the hospital because her legs wouldn't work, she couldn't walk and she had slurred speech. The patient thinks the time of onset of the events was in the afternoon but stated it is foggy because she was a little confused at the time. Patient stated she also had a x-ray and it showed that her lymph node was abnormal. She also had really sharp pains inside her head. Patient stated that the event legs wouldn't work, couldn't walks, it was ongoing but she was doing Physical Therapy and she is starting to get back to her normal. In terms of the really sharp pain inside her Head, the patient stated that she was in a car wreck and had some head stuff and this really brought it out really sharp which she has never had before. The patient stated she thinks the vaccine just brought out her TIAs and she has had headaches in the side of her head but these were a lot sharper. The patient reported that she goes to her Neuro Doctor next week. The patient stated she went back to the doctor and he did a computerized tomogram (CT) with contrast. She stated that when she was in the hospital, her EEG was abnormal. She stated per the report of the x-ray guy, he said that the abnormal lymph node was caused from the shot, the Covid shot. She stated tomorrow she has an ultrasound or some kind of test to see if she needs to have a biopsy of the lymph node. The clinical outcome of she had slurred speech, really sharp pains inside her head, she was confused, and felt foggy was recovered. The clinical outcome of experienced legs wouldn't work; she couldn't walk, was recovering. The outcome of the remaining event was unknown.

Within a few days, I had some joint pain, headaches and fatigue. I was also disoriented. Those symptoms lasted 1 week to 10 days. I took Tylenol. This is long term issue (happening before the vaccine): Thyroid- I was going through a series of tests that the doctor was doing. My diet was changed and the medications were changing. I called the doctor most recently about Pinworm- went to see grandchildren and got that from them. They prescribed me Pinworm Medicine - the active ingredient is - Pyrantel Pamoate. I started taking that on June 10th. That's helping with my symptoms. I have to wash everything all the time. I have to repeat the Pinworm medication on the 24th of June.

Inability to sleep night after second dose, itching of (pre-existent) eczema and several new hives on shoulder, breast, legs.; Itching of (pre-existent) eczema; This is a spontaneous report from a contactable consumer, the patient. A 76-year-old non-pregnant female patient received her second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: EN6208), via an unspecified route of administration in the left arm on 18Mar2021 at 10:00 (at the age of 76-years-old), as a single dose for COVID-19 immunisation. Medical history included eczema, taste disorder, gastro-intestinal reflux, arthritis, drug allergy (sulfa drugs) and breast cancer (small lump). The patient previously received first 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 10:00, as a single dose for COVID-19 immunisation. Concomitant medications included losartan (MANUFACTURER UNKOWN), pantoprazole (MANUFACTURER UNKOWN), rosuvastatin (MANUFACTURER UNKOWN) and sucralfate (MANUFACTURER UNKOWN) all for an unknown indication from an unspecified date and unknown if ongoing. Prior to the vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested positive for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient had not tested positive for COVID-19 since the vaccination. On 18Mar2021 at 12:00, the patient experienced inability to sleep night after second dose, itching of (pre-existent) eczema and several new hives on shoulder, breast, legs. The patient self-administered EUCRISA and hydrocortisone was given as treatment for the events. The clinical outcomes of the events insomnia and itching were recovering. No follow-up attempts are possible. 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.

couldn't sleep, up all night; chills; With the second vaccine, her arm hurts; 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, Batch/lot number: E20792 (but she doesn't know for sure) and Expire Date: unknown) intramuscularly administered in left arm on 04Feb2021 10:15 (at the age 76-year-old) as dose 2, single for COVID-19 immunisation. Patient took her first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/lot number: unknown and Expire Date: unknown) intramuscularly administered in left arm on 14Jan2021 (at the age of 76 years), and stated that arm was really, really painful on 15Jan2021. Vaccination facility type was physician's office. The patient's medical history was not reported. She mentions she takes thyroid pills as concomitant medication. No further details provided or obtained regarding this statement. None of the additional vaccines administered on same date of the suspect. The patient did not receive any Prior vaccines within 4 weeks. With the second vaccine in feb2021, her arm hurts but it is not anything she cannot stand. However, she didn't sleep again all night last night. She was so tired but she could not sleep. She has taken other medications and she does have insomnia. She has tried melatonin for sleep and it worked just the opposite. It kept her up all night. Caller verifies she has no NDC, Lot number or expiry date for the melatonin, this was a while back. She mentions someone also told her to take Benadryl which typically makes one sleepy but she stayed up all night when she took it. She confirms she has no NDC/UPC, Lot, or expiry date to provide. She took that a while back. She was just wondering if the vaccine could cause patient not to sleep it was weird. The first vaccine she had, her arm was really, really painful. She was up all night but she was up because her arm was in so much pain. She just inquired if this could be a side effect of the vaccine and there been any reports of this. In Feb2021,She also had the chills which she read was normal. She mentions she does have sleep medication but she didn't know if it was safe to take after having a shot. Every once in a while she takes it. Caller mentions she did have a blood test done, not too long ago. Like cholesterol and everything and it was good. Caller verifies this was prior to receiving the vaccine. Caller was curious if this common or anybody else have trouble sleeping after receiving the vaccine. No emergency room visit and physician office visit was reported. Treatment was received for couldn't sleep, up all night. The outcome of events was unknown. No further details were provided or obtained. Follow-up attempts are completed. No further information is expected.

Stumbled and broke her right arm in 3 places; Stumbled and broke her right arm in 3 places; Got a big chip in her hip; Chipped the acetabulum on her pelvis, there is a big chip on that, but it did stay in place, so no surgery is needed; Precipitous drop in energy level; Fuzzy mentally; Acute lethargy; A little arm soreness; Low blood pressure; She wasn't feeling well; In a lot of pain with the chip in her hip; Fell on her right side and it was in her house, of course, on her tile floor; Low cholesterol; 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 VACCINE, Lot Number: EN6206; Expiration date was not reported) on the right deltoid on 11Mar2021 (09:45) as a 2nd dose, single, with route of administration unspecified, for COVID-19 immunization at the clinic (not in a military facility). Medical history included ongoing hypothyroidism diagnosed probably 10 years ago. Concomitant medication included levothyroxine for hypothyroidism. The patient had previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EN6201; Expiration date was not reported) on 17Feb2021 on the left deltoid for COVID-19 immunization. On 12Mar2021, the patient had a little arm soreness. On 13Mar2021, the patient had precipitous drop in energy level (50% drop in energy her level; then 30% down at the time of reporting); was fuzzy mentally enough that her friends event noticed it; and had acute lethargy. On 20Mar2021, the patient had stumbled, and right arm x-ray AC and lateral showed she broke her right arm in three places; got a big chip in her hip; and right hip x-ray showed she had chipped the acetabulum on her pelvis (there was a big chip on that), but it did stay in place, so no surgery was needed. The patient had a surgery on the right arm, and had to have a 4-hour surgery to replace the Olecranon where it should have been, and a plate and a couple of screws. The events, 'stumbled and broke her right arm in three places', 'got a big chip in her hip' and 'chipped the acetabulum on her pelvis', were assessed as serious (medically significant). On an unspecified date in 2021, the patient had low blood pressure (110/60); was not feeling well due to the second dose of vaccination; was in a lot of pain with the chip in her hip; fell on her right side and it was in her house, of course, on her tile floor; and had low cholesterol. The reported events had resulted into an emergency room visit and physician's office visit (orthopedics). The outcome of the events was recovering for 'stumbled and broke her right arm in three places', 'precipitous drop in energy level', 'fuzzy mentally' and 'acute lethargy'; was not recovered for 'got a big chip in her hip'; was recovered on 14Mar2021 for 'arm soreness'; and was unknown for all the other events. No follow-up attempts are possible. No further information is expected.

My reaction to Pfizer #2 lasted for 8 weeks and went through three phases. Throughout this time, I had swollen glands under my jaw. 1)The morning after the shot I awoke to severe nausea and vomiting and had to get prescription anti-nausea meds. 2) A few days later my bowels went wild with lots of rumbling and gas and frequent bowel movements. 3) The swollen glands in my jaw cycled between getting better and then worse, and I had and bouts of feeling unwell and fatigued. I went from sleeping 7-8 hours per night before the vaccine to sleeping 9-10 hours a night. Some days I was fine. Then I would have a bad day. One day I was fine in the morning then crashed after noon -- like when I had mononucleosis at 17.

tremor; insomnia; intense itching; loose stools; This is a spontaneous report from a contactable consumer (patient). A 76-years-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection; Batch/Lot number was reported as unknown) via an unspecified route of administration on 26Feb2021 at 10:30am (at the age of 76-years-old) in left arm as dose number unknown, single for covid-19 immunization at Hospital. Medical history included breast cancer and known allergies as IgG reactions to many substances both from an unknown date and unknown if ongoing. No other vaccine taken on same date. Prior to vaccination, the patient was not diagnosed with COVID-19. Post vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccine within four weeks. Concomitant medications received within two weeks included pregabalin (LYRICA); ascorbic acid (VITAMINS C); colecalciferol (VITAMIN D [COLECALCIFEROL]); melatonin (MELATONIN) and fexofenadine hydrochloride (ALLEGRA) all taken for an unspecified indication, start and stop date were not reported. The patient experienced delayed reaction two days after vaccination which included intense itching, insomnia, loose stools, and tremor on 01Mar2021. The patient received treatment for the adverse events occurred. The outcome of the events was Recovering. No follow-up attempts are possible; Information about lot/batch number cannot be obtained.

Since February 19th I have been in constant pain. Difficulty in walking, exercising, and every day activities. 1. Covid Toes: One inflamed, swollen and discolored toe on each foot. Constant pain. Painful to touch. Spurts of searing, burning pain on back side of toe. 2. Exacerbated arthritic pain in both hands. Joints in fingers and thumb are swollen and extremely painful. Voteran for treatment. Referral to Rheumatologist

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.

anxiety attack on Feb 5 and again on Feb 17...did not seek medical attention...took a baby aspirin and a half a muscle relaxer. both dissapated on their own. Had another much more serious attack June 15 with heart rate at 126...visited ER...they did ECG but after waiting in receiption for over an hour my heart rate and bp were back down within normal range. Have also been having "flushes" through my system like warm water is being put into my system...lasts seconds..sometimes increased heart rate other times not. June10-11 major spike in blood pressure. with 3 day hospital vist as a result. Now on BP meds.

Patient states that a few hours after getting second vaccination she experienced edema and nerve pain in her legs that traveled up past her ankle causing her to not be able to sleep. She does have some edema and neuropathy as part of her history but she states that this was much more severe than normal.

After receiving the vaccine, she verbalize feeling different in her head and headache. She was evaluated onsite by Fire Rescue and Dr. onsite and released home at 10:50 am feeling better.

20 MINUTES AFTER RECEIVING VACCINE, SHE COMPLAINED THAT SHE FELT A HOT SENSATION THROUGH HER BODY RIGHT AFTER THE VACCINE THAT LEFT AS QUICK AS IT CAME. SHE COMPLAINED OF FEELING LIKE THERE WAS A "LUMP IN HER THROAT". SHE DENIED ANY SWELLING OR DIFFICULTY BREATHING, ONLY THAT IT FELT LIKE A LUMP IN HER THROAT. THIS SYMPTOM GOT BETTER IN BY THE TIME SHE LEFT THE HD AT NOON.

Complaints of dizziness and weakness resulting in a fall with injury, hypoxia (resulting in initiation of supplemental oxygen continuous since 1-16-2021),acute hypotension, elevated heart rate, complaints of feeling unwell, increased confusion.

sore arm, chills, low-grade fever, muscle aches, foot pain (arthritis?), loss of appetite, fatigue (enough to go to bed), stayed in bed all afternoon, got up for dinner (couldn't eat normal amount) and went back to bed and slept all night. Woke up ok on January 21 but still have light fatigue.

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.

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.

Restriction in normal breezing when sleeping, feels like a lump in my lower throat; Restriction in normal breezing when sleeping, feels like a lump in my lower throat; This is a spontaneous report from a contactable other healthcare professional (patient herself). A 77-year-old female patient (not pregnant) received her second dose of bnt162b2 (BNT162B2 also reported as Covid19 Brand: Pfizer, lot EK4176), intramuscular in left arm on 15Jan2021 15:45 at SINGLE DOSE for Covid-19 vaccination. Medical history included Irritable Bowel Syndrome, Sinal Stenosis, Atrial Fibrillation, Lactose intolerant and Gluten intolerant. She received her first dose of bnt162b2 on 23Dec2020 (lot number: EL128), given via IM in left arm. Concomitant medications included paracetamol (TYLENOL), atropine sulfate, diphenoxylate hydrochloride (DIPHENOXYLATE/ATROPINE) and metoprolol tartrate. The patient experienced restriction in normal breezing when sleeping and felt like a lump in her lower throat on 15Jan2021 22:00. No treatment given. The outcome of events was not recovered.

she is having a problem with balance and dragging her right leg/balance was off; felt foggy; She has to walk very slowly; her arm started to feel funny. Patient stated it was not painful but felt numb; 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; lot number: EL8982; expiration date: 31May2021), via an unspecified route of administration (anatomical location: Arm left) on 18Jan2021 at 14:30 at 0.3 mg, SINGLE DOSE for COVID-19 immunisation. Patient's medical history included 'hyperthyroid' from an unknown date and unknown if ongoing. Patient has no prior vaccinations within 4 weeks. There were no additional vaccines administered on the same date of Pfizer suspect. Patient has no history of previous immunizations with the Pfizer vaccine considered as suspect as this was the first dose. Concomitant medications included levothyroxine sodium (L-THYROXINE [LEVOTHYROXINE SODIUM]) for 'hyperthyroid'. The patient reported that she received her first dose of COVID vaccine yesterday (18Jan2021) afternoon at 2:30. Patient stated that at 09:00 pm last night (18Jan2021), her arm started to feel funny. Patient mentioned that it was not painful but felt numb. Patient stated that today (19Jan2021), when she woke up, she is having a problem with balance and dragging her right leg. Patient also mentioned that she also felt foggy. Patient would like to know if these are common side effects. Patient would also like to know how long the symptoms will last. Patient also stated that she has an appointment tomorrow with her HCP and she will be unable to drive in the current state she is in and will have someone else drive her to the appointment. It was also reported that patient was calling on the line calling about the Corona shot and clarified it to be the Pfizer COVID Vaccine. Patient initially stated she received her first dose around 2'oclock yesterday (18Jan2021). Patient mentioned that she is having a reaction that she does not see on the list. Patient received the injection in her left arm and her left arm feels funny which is to be expected, but her right leg is dragging. Patient also reported that her balance was off which it never was. Patient added that she also felt foggy. Patient was calling to see if this was a side effect and if it is, when will it go away. She started to notice her right leg dragging this morning around 7:30 am on 19Jan2021. She thought it would go away. Around this same time she noticed her balance was off. She has to walk very slowly. As she walks by she has to touch the wall and that is not like her at all. She is normally very active. Normally she walks for an hour as an active person. This feeling is not like her. She started to feel foggy this morning when she woke up. Patient clarified that time of vaccination was 2:30 pm. Vaccination facility type was reported as hospital. The events were assessed as non-serious. Outcome of the event 'her arm started to feel funny. Patient stated it was not painful but felt numb' was unknown, outcome of the remaining events was not recovered.

Persistent headache followed 12 hrs later by mild dizziness, nausea, feeling vaguely ?off, now in 4th day. BP slightly elevated this morning 138/80.

head started to spin when she put her head down on the pillow; dizzy /light headed, passed until she went to sit up and get out of bed/ Her head feels like it is swimming mostly when she gets in and out of bed. When she lays her head down and picks her head up; foggy headed/ floaty heady feeling/ she puts her head down, it is like woah this is strange; arm tenderness that lasted for 24-36 hours/ arm was a little sore/ little achiness in her arm; This is a spontaneous report from a contactable consumer (patient). This consumer reported similar event for 2 patients. This is the first of 2 reports. A 77-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EL3248, Expiration date: 30Apr2021), via an unspecified route of administration on 16Jan2021 at single dose for COVID-19 immunization. The vaccine was administered in a hospital. The patient is taking medication for ongoing blood pressure and ongoing thyroid. Ongoing concomitant medication included metoprolol succinate for blood pressure and levothyroxine sodium (SYNTHROID) for thyroid. She received the vaccine on Saturday 16Jan2021. It went very well. On 16Jan2021, she had a little bit of arm tenderness that lasted for 24-36 hours. Her arm was a little sore. The odd thing is that something took place when she got into bed on Sunday night 17Jan2021 which was 30 hours after the vaccine. Her head started to spin when she put her head down on the pillow. She was very dizzy. She was light headed/ foggy headed. That passed until she went to sit up and get out of bed. It happened again. It has been happening on and off for the last 3 days. She has checked her blood pressure because she is on a low dose blood pressure medicine. Her blood pressure was okay. Everything else seems to be normal. She gets that dizziness for a very short period of time. Her head is not a headache. It is so hard to explain. It is like a floaty heady feeling. She did have a little achiness in her arm. When she puts her head down, it is like woah this is strange. Her head feels like it is swimming. It is mostly when she gets in and out of bed. When she lays her head down and picks her head up. She provided that her height as 5'1" to 5'1.5". The event arm tenderness that lasted for 24-36 hours/ arm was a little sore/ little achiness in her arm recovered on 18Jan2021; outcome for all other events was not recovered.; Sender's Comments: Linked Report(s) same reporter/drug, similar event, different patient

Itching/She was itching on her knee, leg, arm, neck, and ears.; She had hives on the knee; The two that had her most worried was the memory loss and chest pain; Chest pain; It was like she went blank. She was looking around and she could not remember names she was trying to figure out name street; Spasms/spasms were like in her back where her shoulders were and it was bulging; It hurt from her neck and up into her head.; It hurt from her neck and up into her head.; 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; lot EL3246, expiration date unspecified), via an unspecified route of administration on 10Jan2021 (around noon) at single dose (left arm) for COVID-19 immunization. Medical history included ongoing diabetes, ongoing blood pressure high/blood pressure, ongoing heart problems; heart disease, kidney disease, history of itching, fluid (imbalance), stroke so taking for clotting, history of neck issues and she was allergic to a lot of medications. Ongoing concomitant medications included ubidecarenone (COQ-10), zinc, torsemide for fluid, clopidogrel for had a stroke so taking for clotting, insulin glargine (LANTUS) for diabetes and isosorbide mononitrate, carvedilol, irbesartan and amlodipine, all for blood pressure. Patient reported that she got the injection on Sunday and then later she started to get spasms on 12Jan2021. These spasms were like in her back where her shoulders were and it was bulging and it hurt from her neck and up into her head. She mentioned she was 77 years old and sometimes she has to think about a word before she gets it out, but yesterday (14Jan2021) it was different. It was like she went blank. She was looking around and she could not remember names she was trying to figure out name street on and this lasted 15 minutes and then it went away. She confirmed she does not have it right now. It did not last a long time, but it scared her so bad. Then yesterday evening (14Jan2021), she started to have funny chest pain. She told her husband if it did not go away she would go to the ER. However, after an 1 hour it went away. It was like a sticking pain. The chest pain lasted for an hour and started around 18:00. On an unspecified date, she started itching at night. She has a history of itching, but this was out the box. She had hives on the knee. It was crazy. She itched all over. She had to get out of bed and sit in a chair until 1:30AM. She was still itching, but it was not as bad. Patient reported that due to the kidney disease she has itching, but the itching she was having after this COVID Vaccine was different and more. It was out of the box. She confirmed this was the first injection and now she was scared to get the second injection. Patient reported that the itching started when she went to bed. She went to bed around 21:00 and around 21:30, she got out of bed because she was itching so bad. She stated there was not anything different on the bed. It was the same thing that was up there the night before. She did not change the sheets or anything. She had to get up and sit in a chair and she could not believe how bad her knee was itching. She was itching on her knee, leg, arm, neck, and ears. She stated she takes a lot of medications. She was very funny with medications and they have to work with her to get the right one for her. Due to having these other conditions was why she wanted to get the COVID Vaccine. She reported she will have her blood drawn next week. The two that had her most worried was the memory loss and chest pain. However, these passed and she did not go the ER or physician office. She was afraid if she gets the second injection this will happen again and she may not come out as well form it. Prior vaccinations within 4 weeks was none. Outcome of events spasms/spasms were like in her back where her shoulders were and it was bulging and itching/itching on her knee, leg, arm, neck, and ears was recovering; chest pain was recovered on 14Jan2021 at 19:00; and outcome of the rest of events was unknown.

I feel like I have a lump in my throat and I have a hard time when I lay down breathing it feels like just something caught in my throat and it was not there before; I feel like I have a lump in my throat and I have a hard time when I lay down breathing it feels like just something caught in my throat and it was not there before; This is a spontaneous report received from a contactable consumer (who is also the patient). A 77-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK4176, expiry date: unknown), via an unspecified route of administration, on 15Jan2021, at single dose, for COVID-19 immunization. Medical history included inflammatory bowel disease. Concomitant medication included diphenoxylate from 14Jan2021 for inflammatory bowel disease. The patient stated, "I feel like I have a lump in my throat and I have a hard time when I lay down breathing it feels like just something caught in my throat and it was not there before. I never had that before and it feels like I have a hard time when I lay down to breathe and I was wondering if that has anything to do with the side effect of this vaccine." When asked for treatment, patient stated, "No, because it just started yesterday (15Jan2021). That is why I called you. I wanted to know if that dangerous. Do I have to go to an emergency clinic because today is Saturday and everything is closed or should I just do not worry about it." The outcome of the events was unknown.

she did not feel totally right; some high blood pressure; she has an irregular heart beat; This is a spontaneous report from a contactable consumer (patient). The 77-years-old female patient received first dose of BNT162b2 (BNT162B2, lot number: EL3248), via an unspecified route of administration on 18Jan2021at SINGLE DOSE for covid-19 immunisation. Medical history included diagnosis of irregular heart rate prior to the vaccine, about 4-5 years ago, allergy, Cholesterol. The patient experienced some high blood pressure on Jan2021, she has an irregular heart beat on Jan2021. "I developed some high blood pressure after getting the vaccine." she has developed a very high blood pressure reading and that is unusual for her, states she went to a walk in clinic on Tuesday and then to the doctor today. Caller states that it really concerns her that someone who is medically savvy as she could have a serious problem. stated that she did not feel totally right while she was waiting afterwards, states that she came home and laid around and the next morning, she can tell when it is high because she is chronically low. Caller states the next morning the top number of her blood pressure was 166, states bottom number is never out of sync (AS REPORTED). Caller states she could feel it really bad yesterday, really bad states she took the pressure once and it was 182/94 and a little later it was 192/84 and that is when she went to the walk in clinic. Caller states she has an irregular heart beat and she takes a blood pressure medication to treat that, takes 25mg once a day at night time. Yesterday morning she took another one before she went to the walk in clinic to help treat the high blood pressure, so she had 50 mg in 12 hours; when she got there they checked it and it was 178/72. She also takes an allergy medication and something for cholesterol that she has been taking for years. She called on 21Jan2021 around 5pm regarding the Pfizer covid vaccine. She called because she was having blood pressure issues and two different doctors thought it was covid vaccine related. It has taken since then till today to get a reasonable blood pressure. Her thoughts are not to get the second dose. She is asking if she will have any protection if she does not get the vaccine and if there will be any adverse effects if she goes not get the second vaccine. The outcome of the event was unknown. No follow-up attempts possible. No further information expected.

bad allergic reaction; itching and welts, like hives; itching and welts, like hives; didn't get any sleep last night; 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: EL3302 and expiration date not provided), via an unspecified route of administration in the left arm on 18Jan2021 18:00 at a single dose for COVID-19 immunization. The patient has no medical history. Concomitant medication included other medications that she has never had a reaction to. The patient stated that she got her first dose of COVID vaccine on 18Jan2021 evening. On 19Jan2021, she had a bad allergic reaction, itching and welts, like hives or whatever that started on her arms that progressed to the rest of her body especially the buttocks, everywhere. She did not get any sleep on 19Jan2021 and was itching. She called the doctor's office to see if they could help her and they said they couldn't and told her she needed to contact the health department "or something." They aren't familiar with the vaccine and does not want to do anything that would put them in a legal situation. She stated she has an appointment on 08Feb for her next dose and she doesn't know if she can go through this again. She asked what can she do about this reaction. She started to get itching and "stuff" that was not bad until last night (unspecified date). She stated that it was like she had hives all over and itching out of control. She did not get any sleep and is still itching out of control. She wanted to know if she goes back to hospital if they will be able to do anything for her. It was her first shot and is scheduled for her second one on 08Feb2021. She was wondering will she have to go through all of this again. She had noticed hives on her arms on 19Jan2021 morning but mostly now are on her buttocks and thighs. She stated that she had thought it was an allergic reaction to a fabric softener that she changed to. No treatment was given in response to the events. She has stated that she takes other medications that she has never had a reaction to. She does not think that they were related to this. The outcome of the events was not recovered.

Patient complained of dizziness and said she was going to pass out. Observation nurse called site clinical lead over, at that time the patient was responding to verbal cues. Mask was taken down and she was guided to take slow deep breaths, continued to report feeling as though she was going to pass out. Site clinical lead then noted patient with fixed gaze to the size, clenching hands and rigid posture. Observation nurse called for EMS assistance. Patient breathing slowed, mouth open, eyes remain fixed to the size with rigid posture for 5-10 seconds. Patient did not respond to any verbal cues. Site clinical lead and observation nurse lowered patient to the floor, at which point patient became responsive. Responded correctly to reason for visit to site, location and how she was feeling. Denied history of seizures or stroke. Reported feeling anxious and needing to use the bathroom. Did not appear to lose bowel control at any point. Patient was very diaphoretic and pale, but alert overall. Cold compresses applied to forehead and back of neck while patient remained supine. EMS arrived and had patient sit up, at which point she again became very pale and reported feeling as through she was going to pass out. EMS transported to hospital for further evaluation.

"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

By the time 24 hours passed, I felt fine. Around 1:00 the following day I began to feel generally sick. I felt tired, headachy, nauseous. I rested and felt worse and worse. I soon began chilling -- couldn't get warm. After a couple hours, I took my temp and it registered 101.1. I went to bed feeling quite unwell. When I awoke the next morning, I felt pretty good and felt fine all the next day.

trouble sleeping; right arm plus red; right arm feel ithcy inside; night chills; headache; arm hurting/right arm pain was more painful; This is a spontaneous report from a contactable other health professional (reported for herself). A 77-year-old non-pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection) (Batch/lot number: E69261), via an unspecified route of administration in right arm on 27Jan2021 11:15 at single dose for covid-19 immunisation in hospital. Medical history included, two stents, hernia, prior to vaccination, the patient was diagnosed with COVID-19. Concomitant medication within 2 weeks of vaccination included omeprazole, rosuvastatin, ticagrelor (BRILINTA), metoprolol, sucralfate (SUCRA). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously took amoxicillin sodium; clavulanate potassium (AUGMENTIN), carisoprodol, clopidogrel bisulfate (PLAVIX) all experienced allergies. First it was arm hurting first night on 27Jan2021, then next night on 28Jan2021 chills, headache occurred, last night on 29Jan2021 she had trouble sleeping. Her right arm pain was more painful, plus red, feel itchy inside, took diphenhydramine (BENADRYL) 1 tablet. The events were non-serious. The patient's COVID test post vaccination included nasal swab on 27Dec2020 with result negative. Outcome of the events was unknown.

dont want to eat anything; hot and cold chills; headaches; muscle pain; fever; joint pain; injection site swelling; redness; nauseated; swollen lymph nodes on throat; face swelling; fast heartbeat; body didn't feel well; chills; didn't feel like herself; light headed; felt weak; tired/slept all day; 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/batch number and expiration date were unknown), via an unspecified route of administration on 22Jan2021 15:30 at a single dose on right arm for COVID-19 immunization. Medical history included breast cancer 16 years ago, patient on defibrillator from Oct2016 (it was reported that this past October2020 would have been 4 years since she had the defibrillator put in), ongoing congestive heart failure, ongoing (COPD) chronic obstructive pulmonary disease, sinuses problems, back and hip problems, positive for COVID-19 from 11Jan2021, and hurting. The patient's concomitant medications were not reported. The patient previously received flu shot for immunization on unspecified date. On Saturday (23Jan2021), the patient reported that she "slept all day, felt weak, light-headed, and tired". The patient stated, "I have problems breathing anyways". The patient stated she "doesn't want to eat anything". On Sunday (24Jan2021), the patient "felt good", then Monday (25Jan2021), "didn't feel too bad". On unspecified date, patient experienced hot and cold chills, body didn't feel well, and breathing problems. She has breathing problems because she has COPD. Other things in the list of the adverse events (from the paperwork she was given) that the patient experienced include tiredness, headaches, muscle pain, chills, fever, joint pain, injection site swelling, redness, nauseated, feeling unwell, swollen lymph nodes on throat, face swelling, a fast heartbeat, dizziness, and weakness. Right now (26Jan2021), the patient did not even feel like going to her doctor's appointment (on Thursday). She just didn't feel like doing anything. She didn't feel like herself on 26Jan2021. She clarified on 11Jan2021 (prior to vaccination), she went to hospital because she was hurting. She clarified it was in and out of the Emergency Room. She was never admitted into the hospital. They ran some tests urine, blood, EKG tests. All the tests came back good. The patient underwent COVID test on 11Jan2021: positive; and same test on 22Jan2021: negative. Outcome of the events was unknown. Information about lot/batch number has been requested.

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

Chills, vomiting, diarrhea, sweats, tremors, dizzy, headache, unsteady gait, fever 101. Symptoms lasted for 24 hours and then I was feeling bad and in bed for 3 days. I took Tylenol for symptoms. I called my doctor and was advised to take Tylenol.

Maybe this is not what is qualified as "adverse", but i have not been able to get out of bed, eat, or do anything but sleep for 2 days. Runny nose and stuffed up sinuses, low grade temp not above 100.5. Muscle aches It is now almost 6 pm Sunday. I think I can eat some soup now. Temp is gone I think I'm recovering.

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.

fuzzy thinking; fatigue; pressure in head; dizzy; This is a spontaneous report from a contactable consumer (patient). A 77-years-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: L33U2) via an unspecified route of administration in Left arm on 20Jan2021 11:30 AM (at the age of 77-years-old) at SINGLE DOSE for COVID-19 immunization. The patient's medical history included high cholesterol, back scoliosis. Concomitant medications included cholesterol, vitamins, minerals. The patient was not pregnant. No known allergies. No other vaccine in four weeks. The patient experienced fatigue, pressure in head, fuzzy thinking, dizzy on 22Jan2021 06:00 AM. Events resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. Treatment received for the events. AE treatment included antibiotics. No other vaccine in four weeks. No COVID prior vaccination. COVID tested post vaccination: Nasal Swab (normal and rapid) tested on 02Feb2021 showed negative result. The outcome of the events was not recovered.

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.

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

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.

patient c/o lightheadness at 11:55am. Blood pressure was 142/90. Consulted with Doctor. observed for 10 more minutes. Patient started c/o numbness in face, shortness of breath and chest pain around 12:05pm. 02 was 99%. Consulted with Doctor and paramedics called. Patient was confused and had difficulty with balance while being transferred to ambulance. Transported to medical Center at 12:18pm

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.

Felt jumpy on the injection site/right arm started jumping/"been jumping, jumpin jumpin jumpin", a muscle twitch; Felt jumpy on the injection site/right arm started jumping/"been jumping, jumpin jumpin jumpin", a muscle twitch; Arm is sore; Heart is pounding; I'm a little jittery. I am very nervous; I'm a little jittery. I am very nervous; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer (patient) reported that a 77-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EL8982; Expiration date was not reported), intramuscularly on the right arm on 27Jan2021 (10:00) at a single dose for COVID-19 immunization at the school/student health clinic. Medical history included diabetes diagnosed about 12 years ago; high blood pressure diagnosed about 30 or 40 years ago; and weight loss. Concomitant medication included insulin (INSULIN) for diabetes. The patient previously took influenza vaccine, sitagliptin phosphate (JANUVIA) and tramadol (ZALDIAR); and had rash on both medications. The patient had previously received a flu shot around the 6th or 7th of Dec2020. On 27Jan2021, at "about 4PM", the patient had felt jumpy on the injection site/right arm started jumping; it had "been jumping, jumpin jumpin jumpin, a muscle twitch". Also on 27Jan2021, at "about 4PM", the patient's arm was sore; heart was pounding; was a little jittery; and was very nervous. The outcome of the events, 'felt jumpy on the injection site/right arm started jumping', 'had "been jumping, jumpin jumpin jumpin, a muscle twitch"', 'arm was sore', 'heart was pounding', 'little jittery' and 'very nervous', was unknown.

Started with chills, fever. Next morning could hardly get out of bed. Very weak and throwing up black liquid. Could not take care of self for 2 and one-half days. Very weak for 4 days. I was sick with the 1st vaccine for a day one-half with chills and fever but nothing compared to the 2nd one. I will not taken another Pfizer vaccine ever.

Admitted to hospital on 1/28/21 from nursing home with altered mental status and UTI. PMH of heart failure, CKD, afib, COPD. discharged on 2/2/21. COVID negative during this admission. Readmitted on 2/28/21 for AMS, family was unable to wake patient up for an hour prior to calling EMS. Upon admission, found COVID positive.

Shortly after vaccination, upper legs felt weak and head felt as if she was "floating" similar to being put under anesthesia. Day 2 developed Redness and rash on chest and lower back. Day 3 developed a large cold sore on lower lip. Day 4 - 4 more cold sores on upper and lower lips. Day 5-6 fatigue. She was observed for an hour, offered water and juice following the vaccine and was released home.

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.

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.

Patient states she reacted immediately after receiving the vaccine. States that she felt dizzy & light headed, her BP went up to 163/90 and she had tingling in her feet "as if I were wearing tight compression socks". Medical record indicates that she called 911 the day after her vaccine & reported dizziness & slurred speech. She was told to go to the ER, but did not go. She reported to her PCP's office that she had arm itching, she was anxious & fatigued as well. She also reported that she "felt funny in the back of her throat" & seemed to be coughing more. Headache also reported.

Nervous Anxiety; This is a spontaneous report from a contactable consumer (patient). A 77-year-old non-pregnant female patient received her first dose of bnt162b2 (BNT162B2 reported PFIZER BIONTECH COVID-19 VACCINE; lot number: EL9265; expiration date: unknown) at vaccination age of 77-year-old via an unspecified route of administration in the left arm on 27Jan2021 13:30 at a single dose for covid-19 immunization. The patient's medical history concomitant medications were not reported. The patient was not diagnosed with COVID-19 prior vaccination. The patient previously took naproxen (ALEVE) but had allergies to Aleve. The patient reported that she had nervous anxiety for second day (28Jan2021). The event did not receive treatment. The patient has not been tested for COVID-19 since vaccination. The outcome of the event was not recovered.

I have been having excruciating stabbing pain between T5 and T 6 on the right side of my back.; have not slept for two days; This is a spontaneous report from a contactable consumer (patient) reported for herself. A 77-year-old female patient (Patient was not pregnant at the time of vaccination) received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number: EL3249, Expiry date: unknown) via an unspecified route of administration on 08Jan2021 on left arm at single dose for covid-19 immunisation. Medical history included High blood pressure. The patient did not have allergies to medications, food, or other products. Concomitant medication patient received within 2 weeks of vaccination included latanoprost, timolol maleate (LATANAPROST) Eye Drops, levothyroxine (LEVOTHYROXINE), amlodipine (AMLODIPINE). The patient previously took first dose of BNT162B2 (lot number: eK5730, Expiry date: unknown) on 18Dec2020 at 11:00 AM at a single dose for covid-19 immunisation. The patient stated I have been having excruciating stabbing pain between T5 and T 6 on the right side of my back on 26Jan2021 at 06:15 PM. It is a constant stabbing pain have not slept for two days. Ice helps a little nothing else. The events were considered as non-serious. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The adverse event result in Doctor or other healthcare professional office/clinic visit. 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 event. The outcome of the events was unknown.

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.

Beginning 2-4(injection date) dull headache on top of head 2-6 vertigo began(room spinning), followed by sinking feeling in head, followed by spasms in center of head felt like seizures. 2-19 hospitalized for CT Scan of Head 2-23 EEG in Doctor Office

Fever of 101 for one day, extreme ongoing, almost incapacitating fatigue is still continuing almost three weeks and counting

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.

little tight around my neck and throat, like a tightness; Tightening in my neck and around my mouth area; As soon as I got the shot I felt a little strange; My arms hurting a little; I did not eat anything; This is a spontaneous report from a contactable consumer (patient). A 77-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/lot number: EL9263), via an unspecified route of administration on 25Jan2021 (at the age of 77-years-old) as a single dose for covid-19 immunisation. Medical history included ongoing low thyroid and mostly it's food allergies. Concomitant medication included levothyroxine sodium (SYNTHROID) 125 ug, daily for low thyroid. The consumer stated, I took the vaccine on Monday (25Jan2021), three days ago and as soon as I got the shot I felt a little strange and I came prepared because I do have some reactions sometimes. Mostly it's food allergies but I guess was being prepared, so I took Benadryl with me and I took it out of the packet. When probed for the treatment, consumer stated, "I just took Benadryl as soon as I got the shot I felt a little strange and I was prepared and I took my Benadryl with me and we stayed there I guess about 45 minutes until I felt better it would have been 12:15 and I was fine." The consumer stated, "I have been trying for two days, that was in my arms hurting a little on an unspecified date in Jan2021 and then today (28Jan2021) around noon I was feeling a reaction again. I had the tightening in my neck and around my mouth area that's where I usually get the reactions from, but for two days I have been fine and I did not eat anything on an unspecified date in Jan2021 out of the way to give me a reaction to it. Now I took 2 Benadryl and it subsided but it's still tight around my neck and a little tight around my neck and throat, like a tightness. What am I supposed to do? After I took this shot on Monday today is Thursday and I am having the same reactions that I had when I took (incomplete sentence) (pending clarification). The outcome of the events as soon as I got the shot I felt a little strange was recovered on 25Jan2021, little tight around my neck and throat, like a tightness and tightening in my neck and around my mouth area was not recovered and other events was unknown.

The next morning, she could hardly wake up and had no appetite. Saturday still no appetite but did drink and slept a lot, also extreme fatigue, headache. Neck and up the back of head was very painful. Had muscle pain throughout. Feels really good today.

A few weeks after receiving the vaccination she felt confused, was going to drive. Ended up having a seizure she said and was taken to Hospital and then to another Hospital. Stated was there for 3 days.

weak feeling; heartbeat climb up and up; unnerving; This is a spontaneous report from a contactable consumer (patient). This 77-year-old female patient received dose 2 of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number EN5318; expiration date 31May2021) via an unspecified route of administration on 05Feb2021 at 11:30 (at the age of 77-years-old) as a single dose in the left arm for COVID-19 immunization. Medical history included high blood pressure and high cholesterol. The patient was not pregnant at the time of vaccination. The patient was not diagnosed with COVID-19 prior to the vaccine. The patient did not receive any other vaccines within 4 weeks prior to the vaccine. Concomitant medications included losartan, escitalopram, and atorvastatin from unknown dates for unspecified indications. The patient received dose 1 of BNT162B2 (lot number EL1284; left arm) on 15Jan2021 at 11:00. The patient previously received codeine on an unknown date for an unknown indication and experienced allergy. On 06Feb2021 at 13:00 the patient experienced a weak feeling and heartbeat climb up. The patient had a weak feeling, had to sit down and took her pulse with oximeter and her Apple watch. She watched her heartbeat climb up and up. She tried yoga breathing but could not slow it down. She was not sure how long this went on because it was very unnerving, but it reached as high as 105 before it started to go down. The beats went up, then down, finally started to keep going down. Once more there was a wave of the weakness through her before she stayed in the 73+ range. The patient was usually in the 60's. Since then the patient's heartbeats have been what is usual for her. During the episode the patient's husband found "rapid heartbeat" on the paper they received. The patient was concerned this happened a day after the vaccine, not within an hour. The events were reported as non-serious. The patient was not hospitalized and did not receive any treatment for the events. The outcomes of weak feeling and rapid heartbeat were recovered. It was also reported that since the vaccination, the patient had not been tested for COVID-19. No follow-up attempts are needed. No further information is expected.

1. I feel like I am going to fall, unstable gait with head pressure. 2. Generalized dizziness. 3. Scared and my heart races.

On 3/14/21 @ 2304 : 77-year-old female patient presents emergency room with generalized fatigue body aches dry cough shortness of breath and subjective fevers as aggressive worsening since Friday. Patient received a 2nd dose of the pfizer COVID-19 vaccine on Friday 3/12/21 and states her symptoms worsened since then. Chest x-ray showed patchy bilateral infiltrates with concern for COVID pneumonia, also questionable vascular congestion as patient does have significant history of heart failure with pacemaker. EKG revealed paced rhythm 87 beats per minute. Emergency room patient was placed on BiPAP and responded well, patient was given vancomycin and cefepime for sepsis protocol.

One week post vaccine, caller's mother started to feel "phlegm-y", coughing up clear phlegm. The next day she was more lethargic, coughing. Called her PCP, recommended Robitussin and Mucinex which she took. Continued to feel worse. No fever although she had cold sweats. She felt a lot of GI pain, fullness, could not eat/drink. Called PCP again by the 4th day of feeling bad. Recommended Augmentin and she took 2 doses. On 3/12 and 3/13, had difficulty breathing, coughing. Called EMS on 3/14 and taken to hospital where she was treated for dehydration and pneumonia with a broad spectrum antibiotic and vancomycin, IV. Given morphine for pain. She tried to take a GI cocktail which she felt like she was choking on. That evening on her BP bottomed out. They continued to give IVFs to raise BP as fast as possible. She was unable to receive chest compressions due to aorta issue and her heart gave out and she stopped breathing on 3/14.

disoriented- forgot; She was panicked; disoriented- forgot; This is a spontaneous report from a contactable consumer reported for herself. A 77-year-old female patient received her first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), intramuscularly on 24Feb2021 11:00 AM (at the age of 77-years-old) for COVID-19 immunization. The patient was not pregnant. The patient had not medical history. the patient's concomitant medications were none. The patient waited the 17 minutes when they said to wait and then she felt to be okay at that point. About a half hour after having gotten the vaccine, person got into her car. She went to drive home and became completely disoriented, forgot her name and where she lived. She drove to her old address. Friend called her at around 12:30 to check in on her. She was panicked, she was still disoriented, did remember her name, but had difficulty with her address and thought she had a stroke. A friend made her pull over and asked her to call 911, but she wanted to go home. She was much better when she calmed down and the and determining that a stroke likely wasn't the case. The patient did not receive any treatment. No covid prior vaccination. Her second dose was scheduled for 18Mar2021. The outcome of the events was unknown. Information about batch number was not available and is going to be requested.

Within 5 minutes I became very light headed and weak. Also very hot and shaky. They had to put me into another room that was much cooler and put me into a recliner with feet up, ice behind my neck and on my forehead. I was pushing water so it was not dehydration, and I had eaten my normal healty breakfast also so not low blood sugar. This was my second shot and I had the same reaction with the first shot. It took about an hour before I could stand and walk again, but was still a bit shaky and faintly light headed for about another hour.

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

"Pt presented to Clinic for her vaccine. Post vaccine, pt was feeling faint/weak and was pale. Pt sts feeling short of breath prior to arrival. Pt has hx of lung cancer. Pt was drained last at home on 3/14 per pt husband. EMS performed 12 lead and checked vitals. Pt color improved upon lying on stretcher for a few minutes. Pt's pulmonologist was contacted to see if they want her to go to her appointment scheduled at 1330 or to be transported to ED. Pt. was then transported via EMS to ED." Pt was inpt from 3/18/21 - 3/21/21 with diagnosis of E. Coli bacteremia, recurrent left pleural effusion with drain in place, resolved hypoxia on oxygen, follicular non Hodgkin's lymphoma, pancytopenia, poor appetite, insomnia. Patient was started on cefepime and then Rocephin per Infectious Disease team but she continued to the duration of this admission until ultimately transitioning her to oral antibiotics with Cipro twice daily to complete 7 day course from 03/19; this prescription was sent to her pharmacy upon discharge. Discharged home with hospice services (per pt /family preference) for comfort care

Extreme Fatigue -falling asleep whenever I sit down up to 20 hours in one day. Memory loss including names of medications and exercises which I have been doing 2 times daily for back problems for the last 5 months. Gout type pain for a couple hours, which started and stopped suddenly!

confused; suspected UTI; This is a spontaneous report from a non contactable consumer. This consumer (daughter) reported for a 77-year-old female patient that A 77 years old female patient (not pregnant) received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) on 08Mar2021 at single dose via an unspecified route of administration for COVID-19 immunization. Relevant medical history included hypertension. Concomitant medications were not reported. On 09Mar2021 at 09:00 patient was taken to ER as was confused and not herself. The patient was being held overnight. The patient was hospitalized and UTI. was suspected. At the time of the reporting the patient was unknown. No follow-up attempts are possible; Information on the batch/lot number could not be obtained. No further information is expected.

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.

She had been in her usual state of health until tonight. Assisted living facility staff called. He mentioned that the facility staff had earlier noticed that she was dragging her right foot and and has been needing more assistance with activities. The patient was walking and did not feel well. She was lowered to the ground and had a witnessed cardiac arrest. The ambulance was called and she was reportedly found to have pulseless electrical activity. She was given Epinephrine and Amiodarone with return of pulse. The patient was brought to the Emergency Room and was evaluated by ER physician. EKG showed atrial fibrillation, ventricular rate = 66, RBBB with Brugada pattern. She was emergently brought to the Cath Lab. Cardiac catheterization showed normal coronary arteries but EF 35-40%. Repeat EKG showed atrial fibrillation with rapid ventricular response = 110, RBBB. Therapeutic hypothermia was initiated. The patient was admitted to the ICU on mechanical ventilation with TV 350 RR 14 PEEP 5. She is sedated with Propofol and Fentanyl IV. She is on Levophed IV. ABG showed pH = 7.22, pCO2 = 53, pO2 = 66, O2 sat = 88%. Lactate level = 9.5. WBC 8.8, Hgb 13.4, Hct 46, Platelets 138. Na 138, K 3.2, Cl 102, bicarb 20, BUN 16, Crea 1.19, estimated GFR = 44 mL/minute. Magnesium 2.7. Glucose levels have ranged from 273-312. Pro-Calcitonin = 0.26. Albumin 3.7. SGOT 262, SGPT 294. Troponin elevated at 47. Pro-BNP = 600. Urinalysis showed large blood. Chest x-ray showed vague peripheral pneumonitis. Endotracheal tube is in place. COVID-19 test by PCR is negative (2/5/21). COURSE IN HOSPITAL The patient was admitted to the ICU and was followed by Pulmonary/Critical Care. Patient was maintained on mechanical ventilation, sedated with propofol and fentanyl IV. Vasopressors were administered (Levophed IV). She was managed with therapeutic hypothermia. She was followed by Cardiology. Foley catheter was inserted for close input/output monitoring. Neuro checks, vital signs, daily weights, pulse oximetry, cardiac telemetry and fingersticks were monitored. She was given sodium bicarbonate IV due to metabolic acidosis. She was also given insulin IV drip. Potassium chloride IV was administered due to hypokalemia. The patient was given amiodarone IV. Platelet count was noted to be low but stable. Glucose levels were within acceptable range. Metabolic acidosis resolved. Hypokalemia resolved. Hypomagnesemia resolved. There were elevated LFTs which improved. Elevated CPK also improved. She was taken off hypothermia protocol. Sedation was decreased and she was able to open her eyes with verbal stimulus but unable to follow commands. Ammonia level was normal. Neurology evaluated the patient. EEG showed left periodic epileptiform discharges consistent with severe diffuse encephalopathy. Chest x-ray revealed right upper lung and left mid lung increasing opacity for which meropenem IV was started. Levophed was discontinued. Initially she had peripheral cyanosis, but this resolved upon discontinuation of vasopressors. Brain MRI was done demonstrating diffuse bilateral small and moderate-sized ischemic foci throughout the cerebellum and cerebellar region suggestive of embolism. There also was chronic marked atrophy and moderate small-vessel gliosis. CIRCUMSTANCES SURROUNDING DEMISE Based on neurologic evaluation, her prognosis for meaningful neurologic recovery was thought to be extremely poor. The patient was evaluated and followed by Palliative Care. She does not have family members and had designated her neighbor friends as her power of attorney. They have known the patient for a ling time and they know that she does not want to live like this. A decision was therefore made for comfort care measures only. Compassionate extubation was performed on February 12, 2021. The patient passed away on February 12, 2021, at 6:39 p.m.

Vomitting, loss of appetite, very tired and disoriented 3/21/2021. Very low appetite 3/21/2021 - 3/26/2021

Patient admitted to hospital with altered mental status and fever. Found to meet SIRS criteria by recurrent fever and tachycardia, but no white count and otherwise hemodynamically stable. Urine cultures and blood cultures were drawn and did not demonstrate growth. Body imaging was done without e/o of infection. Patient started improving 1 day after admission (2 days after the second Pfizer COVID vaccine) without much intervention save for supportive care (antipyretics, antiemetics, etc.)

Community member, Dose #2 During post vaccination observation, lightheaded & elevated HR to ED with headache & anxiety, improved & discharged to home

The 2-3 days after the shot my mom got a fever (over 100 degrees) and the chills which we were able to control with Tylenol for the most part. However, over the next 4 weeks, my mom gradually lost the ability to control her bladder function, and her ability to transition between sitting, standing and lying down w/o help. She also exhibited even more difficulty with walking than she did before (shuffling). My mother experienced pain all throughout her body, and the pain became as bad as an 8-9 in a range of 1-10. She struggled to raise her arms, reach her arms out, or grasp objects. She lacked energy, she would sleep for 10 hours every night, and she had difficulty concentrating and remembering what she was reading,

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)

She got the vaccine, did not have any reaction or that she was even given a vaccine. Then around 7:00 PM her arm started to get a little sore but kept moving it and massaging it. She then could not move anything by 10:00 PM, and had gone straight to bed as she felt so bad. She was dizzy, light headed, and these symptoms continued all night and all day Thursday. She dozed to sleep off and on all day Thursday and was in so much pain, didn't have to move to have pain. She is still having some pain today, but feeling much better. She still is a little bit dizzy. Feels as if she laid down she could sleep for a long time. She has pain in her back area, her arms, her hips. She did not take anything for her reaction as was told not to take aspirin and does not use other medications. She feels exhausted and if she moves her arm too much and also her legs then they start to hurt. Getting in and out of bed is easier today, but she could not get them over the bed to get in or out on Wednesday. Her neck also hurt to turn. She had similar symptoms to when she had the COVID virus in November/December. She had been hospitalized for it twice, was informed that she had a stroke after she had passed out.

I am 77. I had the Pfizer vaccine, March 9th, with a terrible reaction starting 2 days after. I couldn't use my brain to think, to read with comprehension, to remember things I wanted to remember and had difficulty finding my words. This lasted for 3 days when the fog began to lift. I also had some shortness of breath(SOB) and very low energy. The CDC has said that when giving the injection it is no longer necessary to aspirate (pull back on the syringe) which I was taught to do as a young nurse to ensure that you are not giving the injection into a vein (blood would appear in the syringe.) It is supposed to be given into the muscle which has plenty of veins so if you don't aspirate, how will you know if you are injecting into a vein? A week later, I ended up going to the local hospital ER because of the SOB and had Chest xray, EKG, brain Cat Scan and blood work which were all normal. I debated about getting the second shot but decided to get it as long as the injector gave the injection as I had been taught. Fortunately she was very experienced and agreed to inject me using the pullback method after I explained what I had gone through the 1st time. So for the second shot I had the sore arm but no other reaction. I think Dr is making a mistake about the pullback decision. Do we even know what happens if the vaccine is injected into a vein? I am not certain if my first shot was injected into a vein because the injector never pulled back to check. I have not heard of anyone else with my experience.

a really bad headache; a very sore arm; fever with temperatures of 100.3 to 101F; She's not feeling good at all; Feels miserable/horrible and woozy; This is a spontaneous report from a contactable consumer. A 77-years-old female patient received bnt162b2 (Formulation: Solution for injection), dose 2 via an unspecified route of administration on 09Feb2021 as SINGLE DOSE for covid-19 immunisation. Medical history included , thyroid disorder from an unknown date and unknown if ongoing Thyroid is low ,diabetes mellitus from an unknown date and unknown if ongoing. Concomitant medication included metformin at 500 mg taken for diabetes mellitus, start and stop date were not reported and levothyroxine sodium (SYNTHROID) at 100 mcg taken for thyroid disorder, start and stop date were not reported. The patient previously took Historical Vaccine BNT162B2 (she got her first shot on 19Jan2021 with no side effects; Batch/lot number: EN9581; Dosage text: Once by injection in the left arm )on 19Jan2021 for Covid-19 immunisation. The patient experienced a really bad headache, a very sore arm , fever with temperatures of 100.3 to 101f, she's not feeling good at all , feels miserable/horrible and woozy on 10Feb2021. she received the 1st dose of the vaccine last 19Jan2021 and had no side effects. She received the 2nd dose yesterday and woke up in the middle of the night due to a really bad headache and a very sore arm. She woke up today and still had the symptoms along with a fever with temperatures of 100.3 to 101 F. She's not feeling good at all and is asking if these are all common side effects of the vaccine and on what she should do. The patient underwent lab tests and procedures which included body temperature: 100.3 fahrenheit on 10Feb2021 she took it again at 1:25 and it got up to 101. The action taken in response to the event for bnt162b2 was not applicable. The outcome for the events a really bad headache, fever with temperatures of 100.3 to 101F, and Feels miserable/horrible and woozy not resolved and for other events was unknown. Information on the lot/batch number has been requested.

sciatic nerve just blow up. This time it quickly turned into tremendous pain; no energy; I slept most of the time; tired; chills; fever; headache; flu-like ache; muscle pain; queasiness; This is a spontaneous report from a contactable consumer (patient). A 77-years-old female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL9263), via an unspecified route of administration, administered in left arm on 19Feb2021 at 13:15 (at the age of 77-years-old) as single dose for COVID-19 immunisation. The patient took the first dose of BNT162b2 (lot number E13246) on 27Jan2021 at right arm for COVID-19 immunisation. Medical history included High blood pressure (BP) and cholesterol, all managed. The patient had also history of sciatica nerve pain in in early Jan2021, resolved with 5 days of meloxicam. Concomitant medication included atenolol, hydralazine, pravastatin and budesonide/formoterol fumarate (SYMBICORT). The patient reported that 2 hours after vaccination, at home, she felt tired, quickly turned to chills and fever. Body temperature was 99.9 F. She never run temps. This was followed by headache, flu-like ache, muscle pain, queasiness, and just terrible in general. She spoke with nurse who gave her shot to see if I should take any fever reducers. She said try to hold off, but if bad, take Tylenol or Ibuprofen. On 20Feb2021 sciatic nerve just blew up. She had an episode in early January, but Meloxicam worked in 5 days and she was fine. This time it quickly turned into tremendous pain-could not walk without help, trouble getting in or out of bed and to the bathroom. She was screaming out in pain. She started taking Tylenol and then Ibuprofen. Nothing helped. She had a few Meloxicam pills left and took one 22feb2021. Temps were rising daily (101.5) chilled, no energy. She slept most of the time straight chair. Sciatica was better, but not gone. Day 9, she walked outside, temp was normal. She was sent for flu & Covid tests (nasal swab), both negative. The outcome of events was recovering. No follow up attempts are possible. No further information is expected.

1325 Pt sitting in chair in OBS. Pt appeared slightly vague and hands shaking. Pt did grasp bottle of water when given. Pt unable to open water bottle and increase hand trembling noted. Pt began leaning forward. Pt did not respond when asked name or if she needed help opening water bottle. Pt became unresponsive and slouched forward with left UE contracted and gerbilled words unable to identify. EMS activated. Pt eased to floor without complications with EMS asst. Pt aroused after appx 10-15 sec with verbal cuing. Pt alert and oriented, unable to remember all details, diaphoretic. Pt asst to med eval room via WC. Within 2 minutes of obtaining pt demo and info, pt displayed another episode as previous: unresponsive, left UE contractured and diaphoretic. EMS assessed eyes/pupils-fixed and non-reactive. Pt arouse again with vague and confusion. Pt denies hx of SZ or TIA. No loss of bowel or bladder. Reports dizzy and confused. IV started to left posterior wrist by EMS and EKG complete-SR. TC to pt daughter information given. Pt to be transferred to medical center. Pt A&O. Pt transferred to stretcher with asst. and HOB elevated. Pt with personal belongings and reassured to return in 3 weeks for 2nd dose of vaccine.

Chills, sweats, fever for 2 days Excruciating headache for 3 days Nausea, severe for 3 days Nausea, moderate to light for 4 more days Weakness 5 days Dizzy, foggy condition for 5 days These symptoms were simultaneous for close to a week Not inclined to get booster in 12 months

she and they thought she was having a heart attack; she must have passed out because she didn't remember all the tests; she got a sharp pain underneath her left rib cage/pain was number10/still had pain off and on, periodically; broke out in sweat, real bad, number 10, she broke out in a clammy sweat; hard to breath, she got a sharp pain underneath her left rib cage; the muscle that goes around her heart, it was having like a charley horse; heart rate, She says 102, 103, it went up to 200 in the ambulance.; chest pain; Nausea; hard to breath, she got a sharp pain underneath her left rib cage; 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; lot number EL3246), via an unspecified route of administration, administered in left arm on 04Feb2021 09:00 as single dose for COVID-19 immunization. Medical history included ongoing atrial fibrillation for a about 6 years , ongoing anemic for the last 20 years, glaucoma from 1998, had both eyes operated on and in 2016 she was operated on again, cataract had this 4 years ago in she says, in 1918, 1919, she clarifies 2018, Cardiac pacemaker insertion which pacemaker that controls her heart so the pulse does not drop below 65. She says that pacemaker was implanted, she thinks, 2014 maybe, blood pressure, arthritis throughout her body and had 30 operations, body doesn't absorb what she eats, anxiety, asthma, muscle spasms; she reported she has had a lot of surgeries, both of her ankles have had triple fusions, these were in 2005, 2010, 2014, 2018, both her ankles were fused, she had 5 surgeries on her feet; she has had both of her knees replaced because of arthritis, 2012 and 2015 she believes, had numerous other surgeries and she doesn't want to go through all of them, a right shoulder reverse rotator cuff repair, she had a rotator cuff put in, she doesn't have a rotator cuff, this happened in 2019, her left shoulder, because of an automobile accident, rotator cuff was so damaged that they couldn't repair it, she has minimum use of her left arm and has had operations on her left shoulder in 2005; had a pacemaker put in about 6 years ago, the next morning they kept her overnight, they came in, they took an Xray, she had to go back 2 days later because the lead had come of the heart, they had to go back in an reattach the lead to the heart; 2 years ago her pacemaker was going all over her chest, the doctor did not believe her and it landed under her armpit, it was the size of an orange, the doctor thought it was a lump, she went to the hospital, her pacemaker started falling apart, they took it out and put a new one in, it was about 4 years ago; a lump in her breast, she has been put under 30 times, they were all necessary, nothing for glamorizing; had surgeries in her left arm and some fingers than were numb. There was no prior vaccinations within 4 weeks, no events prior vaccinations and no family history. Ongoing concomitant medication included baclofen taken for muscle spasms for about 2 years, calcium for arthritis and her bones degenerate for 30 years, ergocalciferol (CALCIFEROL VIT D) taken for gets anemic real easy for 20 years, duloxetine taken for anxiety, taking this about 3 years ago; ferrous sulfate taken for anemic real easy for about 20 years; folic acid taken to rebuild cells taking this she thinks in 2015, furosemide taken for a diuretic to get rid of fluid for 2 years, metoprolol tartrate taken for atrial fibrillation, and blood pressure, taking this since she had her pacemaker put in; montelukast for asthma for 20 years; hydrocodone bitartrate, paracetamol (NORCO) taken for arthritis for 20 years, and warfarin taken for blood thinner/thin the blood out so she doesn't get blood clots; and adults vitamins for bone supplement and metabolism for 20 years as her body doesn't absorb what she eats. She says she takes a lot of medications and when she does blood bloodwork she was low so they make her take them. The patient previously took rivaroxaban (XARELTO). On 06Feb2021, the patient experienced she thought she was having a heart attack. The patient reported that she had to call an ambulance at 11:30 at night, she thought she had a massive heart attack. She had chest pain, nausea, it was hard to breath, she got a sharp pain underneath her left rib cage. She stated that when the ambulance got here they thought she was having a heart attack, they did nitroglycerin, when they got to the house, when in the ambulance on the way to the hospital they did another pill of nitroglycerin when they got to the hospital. The pain was a number 10. She stated she broke out in sweat, once they got her all hooked up they got to the hospital 6 miles away to the hospital. She was there for 2 full days, they did Xrays, dye in her, checked her hears, and did bloodwork. When she had chest pain, she reported they gave the morphine, it lasted about 6 hours; she still had problems breathing, they took her, she must have passed out because she didn't remember all the tests, she was in and out of it, the severe pain stopped after 6 hours, still had pain off and on, periodically. When she got pain in the ambulance then the nausea went away. After the hospital nitro and another shot for the pain, the nausea stopped. After the hospital after this they gave morphine and the pain subsided a little but didn't totally go away until 6 o'clock in the evening, she still had problems breathing because every time she breathed she got pain under her left rib cage. She says the sweat was at home, real bad, number 10, she broke out in a clammy sweat, on the 6th when she was having pain. She says that after the hospital, a couple days after that, she saw her cardiologists, he told her what happened, it was related to vaccine, it was the muscle that goes around her heart, it was having like a charley horse, he says it felt like you're having a heart attack, her tests said her heart was good. She talks about her blood pressure and heart rate, and says 102, 103, it went up to 200 in the ambulance. She says they thought it was a heart attack, her blood pressure was usually low blood pressure and all the symptoms she was having was because of her muscle having a charley horse that felt like it was coming from the heart, if they had contacted him, he said she would have just needed a massive amount of anti-inflammatory and it would have stopped the pain. The events required an emergency room visit. She wanted to know if anybody else has been hospitalized for massive heart attacks and says that's what she was having. The patient had her second shot on 22Feb2021. Outcome of event nausea was recovered on an unspecified date; and outcome of the rest of events was unknown.

Pfizer COVID Vaccine EUA Patient received Pfizer vaccine 3/3/21. COVID Positive 3/20/21 3/20/21: Patient is a 77-year-old female with past medical history of bilateral breast cancer (post bilateral mastectomy), CHF, CAD, CKD stage II/III, HTN, obesity, obstructive sleep apnea (not on CPAP), and spinal stenosis presenting today. Patient presented via ambulance her daughter. Patient was unable to cooperate, HPI obtained from patient's daughter. Patient's daughter stated approximately 1 week ago patient started to be "unresponsive" and was not talking/responding often. Mostly answered "yes/no" questions. She seemed the be "acting different". When asked, pt denied any pain over the last week. Her daughter denies any infectious process such as fever/chills or cough cough. Her daughter notes approximately 2 years ago patient has similar event, was seen in the ED, but nothing remarkable was found. Reviewed today, patient's daughter stated the patient had a "shaking "episode in had "on responses ". It was described as "shivering" and a blank stare during this unresponsive state. Episode lasted approximately 1 minute. The daughter denied any history of strokes or seizures. Pt usually lives with another daughter and so the daughter present was unable to verify if pt takes her prescribed medications daily. Her daughter denies knowing any Advance Directives or POA set up. Smoking, alcohol, and illicit drug use were denied. Pt was seen 9/2019 for a similar event with concern of stroke vs syncope vs TIA that resolved on its own. 3/25/21: 77-year-old F presented on admission that began approximately 6 days prior. HPI obtained from patient's daughter on admission. Patient's daughter stated approximately 1 week ago patient started to become "unresponsive" and was not talking/responding often. Mostly answered "yes/no" questions. Patient's daughter stated the patient had a period of unresponsives and was shaking her left arm on the day of admission. It was described as "shivering" and a blank stare during this unresponsive state. Left sided weakness was noted. In the ED, vitals signs significant for 88% on room air. CXR showed bilateral infiltrates in lower lobes, CT of head was unremarkable, EKG normal sinus with sinus arrhythmia, CT of chest completed due to elevated D-Dimer showed no PE but showed ground-glass airspace disease and stable 14mm nodule at lower pole of right thyroid. Pt was admitted for Acute Encephalopathy with unknown etiology. COVID testing came back positive. Patient started on Routine COVID management protocol which included IV dexamethasone, remdesivir, vitamin D, vitamin C, zinc, with daily labs (d-dimer, CPK, CRP, CMP, LDH until stable/not upward trending). Patient to continue vitamin D, vitamin C, and zinc upon discharge to rehab. Patient had MRI obtained which showed scattered foci of acute infarcts right posterior parietal lobe/multiple foci of acute microhemorrhages likely hypertensive. Neurology consulted, stated infarct could be due to COVID so continued on lovenox and stopped aspirin. Recommended to keep blood pressures 110-140/80-90. Last documented note from neurology was 03/22/2021 - contacted multiple times but unable to reach afterwards. Discharging patient on xarelto for 30 days and recommending to follow-up outpatient to transition to aspirin and plavix. With this management on board, patient's symptoms improved significantly since admission. Patient discharged in stable condition to rehab.

allergic response to isopropyl alcohol in second dose of COVID vaccine; 1st dose last 22Jan2021 - 2nd dose was on 08Feb2021; 1st dose last 22Jan2021 - 2nd dose was on 08Feb2021; doesn't feel good; one heck of a temperature; By doing what she did, if that negated the COVID vaccine/ That's what she was afraid of; redness and swelling in her right arm; redness and swelling in her right arm; feeling hot all over the body; This is a spontaneous report from a contactable consumer. A 77-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection, lot number and expiry date not reported) via an unspecified route of administration on 08Feb2021 at a single dose for covid-19 immunisation. The patient's medical history included weakened immune system because of the alcohol allergy (started while 19), and aches and pains. Concomitant medications were not reported. The patient received the first dose of bnt162b2 (expiry date May2021) for COVID-19 immunisation at the age of 77 years old last 22Jan2021 administered on the upper righthand arm later clarified as upper right arm; and she was still going through that systemic reaction when she had her first COVID vaccine. The patient asked on regarding how effective the vaccine was related to receiving steroid therapy. Patient was advised by doctor to go to urgent care to have a covid test to see if she and husband were exposed to covid before the vaccines kicked in. Patient stated that on an unspecified date in 2021, she still didn't feel well and was running one heck of a temperature (increased). Patient reported she had a severe allergic reaction to the vaccine. She filled out the forms. Patient felt like she should be put in the hospital. She has a horrific allergy to alcohol. Each time she receives an injection it gets worse. She knew when she received the second dose that the third ingredient was alcohol. She thought about was worse, the virus or the reaction. Within a minute of taking the vaccine she had a reaction. She reported it at the site and was watched for a half hour. Her question was "because she took prednisone immediately after getting the vaccine does that negate the shot?" She was not asked the name of the steroid that she took. She was taking prednisone 20mg, 2 tablets as soon as she gets a shot then 2 daily Monday-Friday. It was still going through her system and it was reeking havoc on her. If she goes to the hospital they will give her Benadryl and monitor her. Patient stated that on 08Feb2021, she had an allergic response to isopropyl alcohol in second dose of COVID vaccine. Patient stated that she had both COVID shots and had adverse reactions and took some medicine for the adverse reaction and now the patient was concerned it might mess with the shot, it might not work for her as it should. She knew that this was going to be a long process and she knew her allergies were rare, but they were there. She is allergic to isopropyl alcohol, even if it is in shampoos or liquid soaps, she gets reactions. She had her first COVID vaccine and she had her own hospital cleanser that she has with her at all times and she used it which was not a problem. For her second COVID vaccine, the nurse was naming the 3 ingredients that were in the COVID vaccine and asked if she was allergic to any. She said this last shot had alcohol in it, she sat with her husband next to her, and thought which was worse: getting COVID, the cases in the city are high, or having a reaction to the alcohol. She chose the latter. When it went into her arm she immediately knew she was getting a reaction. She had steroids with her just in case this happened. Each time the reaction happens, it gets worse. She said she sat for half an hour and has been on steroids until last Friday. She was supposed to be on them for days. On Friday, she was wondering if taking the steroids negated the effectiveness of the COVID vaccine and that's why she called in. She knew that this was rare and it was not something that the company going to say that the company know how to fix it. Patient worked in the health unit of a university as a hiring and firing people person. So, she was around it, but she was not a doctor or a nurse. So, she guessed the answer was no. Last week she received her second COVID vaccine. She said, she has got to get rid of 5 pounds, but it's harder to do that when you're older. She experienced the reaction from the isopropyl alcohol within her second dose of the COVID vaccine last week, 08Feb2021. She said she was still going through it and will for a while. When asked for the outcome, she said she couldn't answer that honestly. She said she didn't feel good (2021). Period. She knew that when she goes through this it takes, each time, an extra 4 to 5 days to get over it. When she got up this morning, she didn't feel good. Her husband asked if she wanted to go sailing, and she said not in 30 degree weather, but for her to say no to sailing, her husband knew she didn't feel well. She couldn't say worse, but she can say she didn't know how long it was going to be, which was scaring her. By doing what she did, if that negated the COVID vaccine, then lets go from there. That's what she was afraid of. When she tells people she is allergic to alcohol, and when it happens, they look at her like "nobody is allergic to alcohol." She is 77 and has the aches and pains of a 77 year old, which she hates. But she doesn't think there are related medical conditions to what she experienced. This (allergy to alcohol) started when she was 19 and it has gotten progressively worse. So she tries to be careful. She says this was her, not dumb, but her decision that she made and now she is concerned. She said no to any tests done. She had the immediate reaction and she knew what to do. Patient further reported that she has allergy to alcohol and had an adverse reaction after the 2nd shot due to alcohol swab and on an unspecified date in 2021, she experienced redness and swelling in her right arm and feeling hot all over the body. Patient asked if her doctor will prescribe Benadryl to manage my allergy will it affect the effectiveness of the PFIZER-BIONTECH COVID-19 VACCINE. Therapeutic measures were taken as a result of the event "allergic response to isopropyl alcohol in second dose of COVID vaccine". The patient did not recover from the event "allergic response to isopropyl alcohol in second dose of COVID vaccine". The outcome of the other events reported was unknown. Information on the Lot/Batch Number has been requested.; Sender's Comments: Linked Report(s) : 2021167304 PFIZER INC

I felt very tired verbatim/ exhausted; low energy; felt lousey for about 6-8 hours; This is a spontaneous report received from a contactable consumer (reporting on herself). A 77-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VAC-CINE, Formulation: solution for injection, Lot Number: EK9231and Expiration Date was not reported), via an unspecified route of administration in in Arm Left on 12Jan2021 12:00 as single dose for COVID-19 immunization. Medical history included, asthma, urticaria from an unknown date and unknown if ongoing , crohns disease all from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. Historical vaccine includes first dose of BNT162B2 for covid-19 immunisation and experienced drug ineffective, covid-19 pneumonia, rash. The patient previously took cephalexine and experienced drug hypersensitivity. It was reported that when patient received her second injection, 2 was out of Quarantine for Covid. Also she asked her doctor If she Should even both to have this injection because apparently she had had Covid pneumonia, through by 02Jan2021. She was feeling a lot better , she was advised by her doc to go ahead & have it., which she did. No problem from Noon when she got shot to Noon Next day, but after lunch ,felt very tired, exhausted & low energy, was very wcepcited, lay on the cover, went to bed early & woke up next day feeling fine. Test: Blood test for HLA-B27 had lite @ 3x the testing Date: 15 years ago Also 25 yrs ago Result: Yes always 3x Comment: This is for Ankylosing spondylitis, Crohn's disease, Citifies, All of which she have had, the as ongoing.The outcome of the events was unknown.

Tiredness/was in bed most of the time for two days, but was up some. She was awfully tired; slept a lot; This is a spontaneous report from a contactable consumer. A 77-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 15Jan2021 (Batch/Lot Number: EL8982) as single dose for covid-19 immunisation.The patient medical history was not reported. It was reported that she is on high blood pressure medication. It was reported that she had chemo years ago. She dont have no product name or NDC/Lot/exp to provide. The patient's concomitant medications were not reported. On an unspecified date the patient experienced tiredness/was in bed most of the time for two days , but was up some. she was awfully tired and slept a lot. The events were considered as non-serious. She had first dose of COVID vaccine on 15Jan2021. She was in bed most of the time for two days, but was up some. She was awfully tired. She guesses she slept a lot. This was from 2PM to 9PM. It was reported that tiredness, she didn't pay too much attention to when it started. Forgot what time of the day it was. She did ok up until she went to bed and then slept. She slept a lot the next day. The COVID vaccine is the first shot she has had a problem with. The outcome of the events was unknown.

Client c/o sore LD. Minutes later c/o neck and shoulder pain. Nurse called EMT to do vitals on client. Client also explained that she was very nervous. Vitals taken BP 129/69, HR 66, Resp 19. Recheck BP 131/73. Client advised level of pain/discomfort down and released.

could not walk or eat; could not walk or eat; sore arm; doctor took a test and the caller has antibodies and they are there but not very strong; anaphylactic reaction; excruciating pain in the body; felt like if her internal organ were shutting dow; was so weak her husband fed her and made sure she was drinking; This is a spontaneous report from a contactable consumer (patient). A 77-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), second dose via an unspecified route of administration on 08Mar2021 15:30 (3:30 PM) (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunisation. Medical history included hashimottos (reported as hoshimottos) Diagnosed 35 years ago, hypermobile Diagnosed 20 years ago, and disorder nomia Diagnosed 25 years ago; all unknown if ongoing. Concomitant medication included levothyroxine sodium (SYNTHROID); diazepam (VALIUM); and levothyroxine (LEVOTHYROXINE); all taken for an unspecified indication, start and stop date were not reported. The patient previously took bnt162b2 on 15Feb2021 for covid-19 immunization first dose at the left arm and experienced immobile for a day, cannot walk, weakness and sore arm. The patient was to know if there is going to be a booster for the Pfizer covid vaccine. The patient stated she received the Pfizer covid vaccine both doses and she is calling to report the reaction she had with the first and second dose to help other patients, she said she was close to death after the second dose. In the middle of the night she was awaken due to excruciating pain in the body, like truck ran over her. The patient heard that someone had same reaction who was in the hospital, with similar symptoms to covid. She said she felt like if her internal organ were shutting down. She does not do well with the antibiotic, and does not go to the doctors. She could not walk or eat after the second dose. She said she has hashimoto dysautonomia hypermobility. she said she thinks she might have had anaphylactic reaction. The patient added that she has lived through it and her experience has been very unusual. The caller has underlying conditions that may have caused this event, she received the second dose on 08Mar2021, it was a horrible experience but since she is still alive she would want to report it. The caller does have strange reactions to chemicals and she typically goes to naturopaths and holistic doctors because of this. The caller also has multiple autoimmune disorders and feels like that may have played a part in this reaction. It was added that further added that she received her second dose 08Mar2021 at 3:30pm and had a little bit of a sore arm, she was thinking positive thoughts about all of this because she never gets vaccines. At 2:00am on 09Mar2021 the caller was awaken in excruciating pain, every surgery she has had or accident manifests in the greatest pain. The pain was excruciating the caller took over the counter pain medicine and diclofenac and it didn't help. The caller is unsure of what she took, she may be making this up. The caller felt like she was dying, she felt like her internal organs were shutting down, it happened all week. The caller was so weak her husband fed her and made sure she was drinking. The caller thinks she would die if she had to have a booster shot of this vaccine. The caller has never had anaphylactic shock, could this have been anaphylactic shock? All of the pain from a surgery all occurred at once and her entire body was wrecking, in horrible pain, that she does not think heroin could have taken care of. After the second vaccine she was literally so weak that she felt like all of her vital organs were shutting down and it lasted for 6 days, like she got hit by a truck, like had beat her up. The caller knows that there are new found reactions with (Company name) and they stopped thousands of doses because of it, she saw this in the news today. The patient wanted to make note that she has underlying autoimmune diseases, she is unsure if there is a correlation between this and her reaction. The caller was changing from her thyroid medicine and her thyroid went very high with the generic brand so she was swapped to Synthroid in the middle of this. The caller was on levothyroxine and it wasn't working, her thyroid was sky high (Unknown lot number and expiration date Feb2022). The caller was going through all of these changes as well when she received the vaccine. The caller's doctor took a test and the caller has antibodies and they are there but not very strong. The caller doesn't want to be spreading something because she is feeling healthy and fine today. The outcome of the events was unknown.

This 77 year old white female received the Covid shot on 03/13/21 and went to the ED on 4/10/21 and was admitted on 4/10/21 with hyponatremia with excess fluid volume, acute respiratory failure with hypercapnia, transient confusion, acute heart failure, shortness of breath and went to the ED again on 4/18/21 with cerebral infarction and died on 4/29/21 . Please refer to the other details submitted within this report and contact the person who submitted this report via email for additional follow up details and investigation.

Burning back pain in the first lumbar dermatome distribution starting on 3/10. Drop attack on 3/17 leading to Hospital admission 3/17. Episodic acute confusional state leading to readmission to Hospital 3/24 A clinical diagnosis off absence seizure made prompting beginning Keppra with no further episodes of seizure The Neurologist as noted above

afib and tachycardia for 3-4 days; afib and tachycardia for 3-4 days; chills; lethargy; kind a brain fog; felt like I had a cold spent 2 days feeling like that; She has as temperamental immune system. She is extremely sensitive. She reacts to everything; This is a spontaneous report from a contactable consumer (patient) via Medical Information. A 72-year-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose at the age of 72-year-old for COVID-19 immunisation. The patient medical history included temperamental immune system (she is extremely sensitive. She reacts to everything). The concomitant medications were not reported. on an unspecified the patient experienced atrial fibrillation (AFIB), tachycardia, chills, lethargy, brain fog, felt like i had a cold spent 2 days feeling like that, hypersensitivity. Therapeutic measures were taken as a result of AFIB, tachycardia. The outcome of events was unknown. The course of events was as follows: On an unspecified she had reacted to the first vaccine: the first day she was fine. The next day she had chills, lethargy, kind a brain fog, felt like she had a cold and spent 2 days feeling like that. On Day 3 she had AFIB and tachycardia for 3-4 days saw the heart doctor and got medicine for that. She had a temperamental immune system. The stress test was super important. She was wandering if she had the Pfizer vaccine a week after the stress test. She got it at the university, and she wandered if they were restricted to give it to her a few days after my scheduled date: They wanted to rule out blockage in her heart. She was having a test done around the same time as the 2nd Pfizer vaccine. She wanted to know if she could get the 2nd dose of the Pfizer vaccine later/ a week after the stress test. She wanted the vaccine, it was important. On 04May21 she was going to have a dye based test checking your heart, a stress test. The stress test was scheduled the same morning as her 2nd dose of the Pfizer COVID vaccine. She was advised to consult with your doctor or pharmacist for further guidance.

Fatigue extreme; Not want to eat breakfast, did not have energy just wanted to sleep/ feel very weak; Dizzy; Spinning around like in a tunnel/ Vertigo; Had like 4 attacks a day and I did not hold down laying in bed and looking up ceiling and ceiling starts spinning; Frightening; little warm in the arm; Resting heart rate but the oxygen was running low it was like 84-80; I don't feel good;; Hit me like a rocket; This is a spontaneous report received from a contactable consumer (Patient) via a Pfizer Sponsored program. A 77-year-old female patient received second dose of BNT162B2, (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: Not Reported), via an unspecified route of administration on 16Feb2021 as single dose for COVID-19 immunisation. edical history included ongoing hypertension, ongoing COPD (chronic obstructive pulmonary disease) and ongoing acid reflux. Concomitant medication included metoprolol succinate at 50 mg, once a day for hypertension, alprazolam (XANAX) at 2.5 DF, twice a day for anxiety, albuterol at Every 3 to 4 hours as needed for chronic obstructive pulmonary disease, budesonide at 5 mL, twice a day for chronic obstructive pulmonary disease, arformoterol tartrate (BROVANA) at twice a day morning and night for chronic obstructive pulmonary disease, tiotropium bromide (SPIRIVA) Inhaled through the mouth, once a day as a bronchodilator, aspirin, omeprazole (PROTONIX) at 40 mg, once a day for Acid reflux, diltiazem at 300 mg, once a day for hypertension and unspecified vitamins. Patient historical vaccine included first dose of BNT162B2 for COVID-19 immunization received on 26Jan2021 and experienced warm arm. It was reported that, the patient had a very bad experience with the shot. On Tuesday in this rehabilitation, they were giving out the shot, this was her second shot in this place. The first shot she had no reaction, just a little warm arm. On an unspecified date in Feb2021, the second hit her like a rocket, the day after the shot or the day over the shot just a little warm in the arm nothing really, the next day woke up extremely fatigued did not even want to eat breakfast did not have the energy just wanted to sleep and she said what was going on with her and then she got up very fatigued. Then the physical therapist came in to give physical and they "supposed to" (not clarified) her. It showed a good blood pressure everything was good resting heart rate, but the oxygen was running low it was like 84-80 and she knew she was because she could feel it while she was walking and patient told them she does not feel good, she felt very weak and thought it must be from the shot. So that went on then and go on to this same thing very dizzy on the next day of second shot on 17Feb2021, spinning. That day spinning around in like a tunnel. She had like 4 attacks a day and she did not hold down that she was laying in her bed and she was looking up in the ceiling and this ceiling starts spinning with the whole room. That was 4th of those on Thursday, Wednesday she was just tired, Friday she had less of them but the same thing spinning around, never fell down but again it was not while she was standing up. The physical therapist said to her sit up do not lay down in the bed. Now she was taking pulmonology medication through a nebulizer. Patient also taking bronchodilator and she take a prednisone pill 20 mg, albuterol and she take other medication. Patient did the Covid test when he had blood work up. They do a blood work up every 2 weeks here. But everything was good. The outcome for events was reported as unknown. Information about lot/batch number has been requested.

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.

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.

She got her vaccine, a little diarrhea, a slight headache, foggy brain, overwhelming fatigue, slight nausea for a few days and then it stopped. She is having these symptoms again, and is having this for the third time which started a few days ago with the same reactoin, plus muscle weakness, just feeling sick like, crappy feeling.

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

a terrible time sleeping; feet and hands were ice cold; chills; coughing; sneezing; blowing her nose; Felt like she wanted to vomit; Felt short shots in her heart and lungs; Felt short shots in her heart and lungs; Can't eat much food; Feels an erratic short pain on right side of head; Seems like she got the COVID virus for 24 hours and wants to know if that would make her contagious to other people; Seems like she got the COVID virus for 24 hours and wants to know if that would make her contagious to other people; very bizarre dreams; pains underneath her arms; 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, Solution for injection, Lot Number- UNKNOWN) via an unspecified route of administration on 01Feb2021 (at the age of 77-years-old) as 2nd dose single for COVID-19 immunization. The patient medical history and concomitant medications were not provided. The patient experienced a, had to use tons of blankets to get warm, very bizarre dreams (bizarre experience), pains underneath her arms. On 01Feb2021 experienced terrible time sleeping, feet and hands were ice cold, chills, coughing, sneezing, blowing her nose, felt like she wanted to vomit, felt short shots in her heart and lungs, cannot eat much food, feels an erratic short pain on right side of head. Got the second Pfizer shot on Monday (01Feb2021). Patient was seeing dreams and wild things. Woke up yesterday (02Feb2021) morning and it seemed to dissipate by yesterday noon time. Seems like she got the COVID virus for 24 hours and wants to know if that would make her contagious to other people. Clarified she is referring to the COVID-19 shot. The patient agreed that experienced these symptoms after receiving the second dose of the Pfizer COVID-19 vaccine and they lasted about 24 hours and today patient feels fine. The reporter was concerned that patient may have had COVID, possibly from the vaccine, and wants to know if she was contagious. It was queried if patient had a positive COVID test after receiving the second COVID-19 shot. Patient did not address question and stated she only received the first and second COVID-19 shot. The outcome of the events suspected COVID-19, drug ineffective, pain in extremity, abnormal dreams, sleeping disorder was unknown while for the other events was recovered on 02Feb2021. 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.

headache; tiredness; got sleepy; felt a little bad; cysts bleeding; breast pain; knot in the vaginal area right in the fold of pelvis and thigh inside of the pelvis that was painful; cysts in the rectal area; rash on her face and it's itching/ rash started in her face and ear, all on the left side, on her ear half way down the outside of the ear; soreness in arm; This is a spontaneous report from a contactable consumer (patient). A 77-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in left arm on 12May2021 11:30 (Batch/Lot Number: EW0168) as 1st dose, single for covid-19 immunisation. Medical history included acne and migraine. The patient's concomitant medications were not reported. No other vaccinations within four weeks prior to the first administration date of the suspect vaccine. On 12May2021, patient experienced soreness in arm. On 13May2021, she had symptoms of rash on her face and it's itching, and the rash started in her face and ear, all on the left side, on her ear half way down the outside of the ear. She could see all the pimples on the face so she put hot water on it and used rubbing alcohol, which she thought would help curb the itching and dry it up, the bottom of the ear lobe is very much active going into jaw area still. She also had headache, and tiredness following her dose, the doctor told her if headache was severe, take a Tylenol with codeine, she took something with codeine and it went away after about three hours. She also had some breast pain (only in the enfold of her breast closest to the middle of her chest), sore to the touch, and it was very sore for about 24 hours, and that it hasn't fully resolved. Then, while bathing, she noticed a knot in the vaginal area right in the fold of pelvis and thigh inside of the pelvis that was painful, large, and the size of a quarter, if she push on the pelvic bone area, it would be painful. Also, while bathing, she identified cysts in the rectal area; after bathing she was trying to identify what they were, when she touched it, it hurt, it felt like a ball and eventually it went down and she caused them to bleed, not a lot of blood, just a small amount. She also started getting more growths in the vaginal area/bottom area near the rectum. Patient got sleepy and now made herself go lay down and she doesn't usually do that. She felt a little bad, she didn't think it was severe side effects, she knew things were going on that she could pinpoint to what would possibly happen but not these cysts. She was recently seen by her gynecologist, a week ago, and none of these problems were apparent at that time. No Emergency Room or Physician Office visit. Patient had blood work done on 07Apr2021 and 10Apr2021 before the vaccine. The outcome of cysts bleeding and soreness in arm was recovered on 13May2021, itching rash, breast pain, painful knot, cysts in the rectal area was recovering, headache was recovered, other event outcome was unknown.

Horrible feeling; Blood pressure goes high; Joint hurt; Fever/ very low temperature; This is a spontaneous report from a contactable consumer via Pfizer-sponsored program. A 77-years-old female consumer (patient) reported for herself that she received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/Lot Number was not reported) via an unspecified route of administration on an unspecified date as a single dose for covid-19 immunization. The patient previously took tylenol as per her common sense and epipens (double dose) for swollen mouth and lips (due to a cleaner) two months ago. Concomitant medications were not reported. As per the description, it was reported that the patient was scared because she didn't had anyone. She was hesitated to get a vaccine. She experienced some reactions after her 2nd dose of the Pfizer vaccine. Her joint hurt and she was in a bad situation. She had a very low temperature than the normal temperature, blood pressure was high when she got upset. She was very angry that she had fever and had nobody to ask a question. She reported that no one told her about a high fever (100.4) or to go to the hospital. She said it was not worth it for her to get a fever. She reported the information on the paper was very vague and not clear, she felt horrible as she suffered and wanted to let know. She wanted to complain that the temperature of fever was not written and none of those were approved. She was asked to contact her local doctor. That was the most horrible experience for her. The patient underwent lab tests and procedures which included blood pressure measurement as high, body temperature as and 100.4. The outcome of all the events was unknown. No follow-up attempts are possible. Information about lot/batch number cannot be obtained.

my chest to all the way up to my neck was brilliant, brilliant red and felt like really hard sandpaper; my chest to all the way up to my neck was brilliant, brilliant red and felt like really hard sandpaper; around my neck 2 long red lines, It looked like someone is trying to strangle me; my whole body got covered in little red spots, and then slowly it started to peel off and the peeling was even on top of my hand; when as far as the top of my neck where the chin starts because I thought oh my god it has got my face too but it stopped their but everything else is got it; I am still peeling, my rear end is still peeling skin off, It's like big sheets coming off, It's like big sheets coming off/skin is still 'fluffing' off; It scares the hell out of me; This is a spontaneous report from a contactable consumer (Patient). A 77-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for Injection; Lot number: EW0753; Expiration date: unknown), via an unspecified route of administration on 29Apr2021 (at the age of 77-year-old) as 2nd dose, single dose in left arm for COVID-19 immunisation. The patient's medical history included surgeries. Concomitant medications were not reported. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for Injection; Lot Number: EW0173), as single dose for COVID-19 immunisation. On unspecified date in May2021, a few days later after second dose, the patient's chest to all the way up to neck was brilliant, brilliant red and felt like really hard sandpaper, and around neck 2 long red lines, it looked like someone was trying to strangle. The patient went to the dermatologist, they did not know what it was, and they sent the sample out. In the meantime, the patient's whole body got covered in little red spots, and then slowly it started to peel off and the peeling was even on top of the hand, the patient still peeling, her rear end was still peeling skin off, It was like big sheets coming off, It scared the hell out of her, she did not know what was going on. Patient just told that no one else was having that kind of reaction that she had. It really scared her when it reached this far on the top of her neck where the chin starts because she thought oh my god it has got on the face too, but it stopped their and everything else got it. The first symptom was on her chest and that became brilliant red and looked like she was on fire and that was just as hard as a sandpaper. That was the first thing and slowly other things started, that brilliant red start and her body all started coming out with red spots. It did not itch and slowly it started to 'fluffing' off and the skin was still 'fluffing' off. Patient had the second vaccine almost a month ago. On the top of her hand there was peeling. It scared her to death because this thing has not been happened it was 6 months and she do not know why she got it and really do not know. She just wanted to report because she went to her own doctor and then to dermatologist. The clinical outcome of the events was unknown. Follow up needed, further information has been requested.

Soreness at injection site (3 days) Swollen lymph glands (2 days) Lethargy (2 days) Fever spikes (day following shot) Brain fog (2 weeks) Achiness in shoulders & neck (2 days) Diarrhea (2 weeks - ongoing)

Last night all of the sudden the skin on my left leg started to fell like a had a sunburn; it started to feel like it was burning and tingling in different spots, pinching, stinging feeling kind of like when you have a sunburn; it started to feel like it was burning and tingling in different spots, pinching, stinging feeling kind of like when you have a sunburn; it started to feel like it was burning and tingling in different spots, pinching, stinging feeling kind of like when you have a sunburn; she did not get a good night of sleep; exhausted; too I was very aware of my stomach, now feel the tommy again and burning is getting less; This is a spontaneous report from a contactable consumer (patient). A 77-year-old female patient received first dose of bnt162b2 (COMIRNATY, Solution for injection, Lot Number: unknown) via unspecified route of administration on 25May2021 as single dose for COVID-19 immunization. Medical history included drug hypersensitivity. The concomitant medication was not reported. Patient reported that in May2021 after the first dose of the vaccine patient was exhausted for 5 full days, her arm never hurt but she was very aware of her stomach and for 5 days she had to seat still and that finally past. On 10Jun2021 all of the sudden the skin on her left leg started to feel like a had a sunburn, it started to feel like it was burning and tingling in different spots, pinching, stinging feeling kind of like when you have a sunburn, she tried to put the Aspercreme on it thinking that her take care of this terrible feeling but that did not help it made it worse so she washed it off. This all started off around 9:30 pm last night she finally got in bed around 10 pm. Patient was trying to sleep with her leg outside of the covers because it felt like it needed to be cooled down, she had AC on and fan. "she did not get a good night of sleep because she kept feeling her leg and did not know what else to do for it. "This morning she was very tired of course from last night, very aware of her stomach again which happen along of getting the first shot for those 5 days and she was exhausted and then too she was very aware of her stomach, now feel the tommy again and burning was getting less, but she had no clue was this was something anybody has reported. Patient was highly sensitive to medications. Patient never get any type of immunizations prior to this since she was a child. in a week she will be 78 years old, she was due for her second shot on 15Jun2021.The outcome of the event exhaustion was recovered, stomach burning sensation was recovering and sunburn, burning sensation, tingling sensation, feeling abnormal, sleep disorder was unknown. Information on Lot/Batch number has been requested.

Started with left hand being useless, then shaking. Shaking moved up to elbow. She tried to take off her sweatshirt and her arm froze--this is the last thing she remembers. Husband called 911 and she went to the ER. She had had a seizure and they found 2 brain lesions. She had a CT scan and an MRI in the ER. There was memory loss in the beginning and slurring of words. She felt a weighty fatigue. Was put on Keppra for seizures. Had consults with neurology, a neurosurgeon, a neuro-oncologist--all unsure of what exactly these brain lesions were. Back left lower part of brain: a small lesion, which was basically ignored Right side, towards front, part of brain, on top of and/or intertwined with motor strip: not sure what this is, a stroke or tumor (the neurosurgeon and neurologist had differing opinions) 2/22--1st MRI--shows 2 spots between these 2 MRIs the bloodwork, CT scan, and ultrasound are done--results normal 3/23--2nd MRI--larger lesion is bigger. Was not thought to be a cancerous tumor 4/23--3rd MRI--Looks like larger lesion is improving. A scheduled brain biopsy is postponed 5/20--4th MRI--the small spot is almost gone and the larger spot is much smaller, about 1/8th the size of the February MRI. According to the neuro-oncologist, this was an atypical stroke.

After 2nd Pfizer shot (1-25-2021) FINE FOR 6 HRS. THEN SLEPT 36 HRS!Had Covid antibody test in MA in early June and had NO antibodies!! Please advise-- should I have the shots again or a booster. My Dr. here in MA says she doesn't know as CDC hasn't issued any guidance. I am immunocompromised with RA but stayed off the Plaquenil after the first shot (Jan 4, 2021) till 2 weeks after the 2nd shot to Rev up my immune system.

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

Little bit weak today; sore muscle; body ache; had chills too; I would feel bad.; if I smell food, it would you know kind of sickening but I ate,; I had unwell feeling, like you getting the flu; This is a spontaneous report received from a contactable consumer (patient). A 77-years-old (reported currently 77 and half, 78 in august so) female patient received first dose of bnt162b2 (PFIZER-BIONTECH mRNA COVID-19 VACCINE, solution for injection, Lot number was not reported), via an unspecified route of administration on 22Jan2021 (age at vaccination: 77 years) as single dose for covid-19 immunisation. Medical history was not reported. The patient's height is about 5 (feet) 3 (inches) and right now her weight this morning was 116.7 (pounds), closer to 117 (pounds) (not captured in tab). Concomitant medications included vitamins once a day (multiple vitamins), calcium plus D (calcium, colecalciferol) per day, ciclosporin (RESTASIS) for dry eyes (in eye twice a day). On 22Jan2021, the patient had first shot and started having a sore muscle and the body ache and everything; on the same night she had little bit chills too, but side effects were mostly at night and then about (incomplete sentence). And then during the day she was fine, and it was just during the evening when she would feel bad. And then about Thursday (dates unspecified) when she woke up and she had unwell feeling, like getting the flu. And then at times like if she smells food, kind of sickening, but ate, had a good appetite. Sometimes she would get up and would feel better. The symptoms had gradually gotten better and went to a grocery shopping in-between the time, but it was sick, but now she would not be sick again and she was almost back to normal today. She was wondering is this normal to have this kind of symptoms for 2 weeks. When questioned about stop date of events, she reported that she was not feeling really bad right now, she just feels, just a little bit weak today (05Feb2021), feel like everything's going away. When questioned about outcome of event: consumer stated, she thinks she was recovering. The patient did not take any treatment. She did call her doctor and didn't seem to be concerned. She didn't take any Tylenol or anything else. She did not have the seizure; she did not have injection site swelling or redness or so. She reported alright and was going to have her next one. The outcome of event asthenia was unknown and for other events it was resolving. Information on lot/ batch number has been requested. Follow-up attempts are completed. No further information is expected.

Today whelps are fading, but light red; Itching; Was sitting on the sofa and it felt like something bit her/Awful; Whelps on back near shoulder and side of breast; Whelps very red, like blood red, raised; This is a spontaneous report from a contactable consumer or other non hcp. This consumer (patient) reported that a 77-years-old female patient received bnt162b2 (BNT162B2, Formulation: Solution for injection, Batch/Lot number: EL8982), dose 1 via an unspecified route of administration, administered in Deltoid Right on 27Jan2021 14:30 as 1ST DOSE, SINGLE for covid-19 immunisation. Medical history included heart surgery from 17Mar2020 to an unknown date. There were no concomitant medications. Patient did not had family medical history and illness. Patient did not had any history of previous immunization. On 04Feb2021, the patient experienced Whelps on back near shoulder and side of breast; Whelps very red, like blood red, raised; Itching and was sitting on the sofa and it felt like something bit her; On 05Feb2021, Today whelps are fading, but light red. Patient did not performed any relevant test. Patient took COVID vaccine because she wanted to be protected from the virus, it was awful. It was reported that caller reports she had the COVID shot on 27Jan and everything was fine. Yesterday she had some whelps on her back near the shoulder and on the side of her breast. It was so very red, like blood red yesterday and itching. Today they are fading, but are light red. Yesterday she was sitting on the sofa and it felt like something bit her. Then she noticed the whelps and they were raised. Still has a few on the breast and one almost on the dark area near the nipple and still itching right now. No other vaccines given the same day or 4 weeks prior. No problems with vaccines in past. They called her to come get the vaccine due to her age group. Patient had no AE prior vaccination. Patient was not visited to emergency room and physician room. The clinical outcome of event Whelps very red, like blood red, raised was recovering; Was sitting on the sofa and it felt like something bit her was unknown; while all other event was not recovered. Follow-up attempts are completed. No further information is expected.

hard time walking; tiredness; foot swollen; foot hot to touch; Since receiving the vaccine she has been sleeping a lot for about 3 days; Foot pain; foot redness; This is a spontaneous report from a contactable consumer. A 77-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number: EL9261)via an unspecified route of administration, administered in Left Arm on 02Feb2021 at 12:00 (at the age of 77-years-old) as DOSE 1, SINGLE for COVID-19 immunization. The patient's medical history included parkinson's disease, transient ischaemic attack, hypersensitivity, sinus disorder, Cardiac disorder, vaginal infection, pain, incontinence, antidepressant therapy, hallucination, unspecified vitamin D deficiency. No relevant tests done. The concomitant medications included ongoing estradiol (ESTRACE VAGINAL) taken for vaginal infection from 2019, ongoing colecalciferol (VITAMIN D 3) taken for vitamin d deficiency, ongoing pimavanserin tartrate (NUPLAZID) taken for hallucination from 05Feb2021,ongoing venlafaxine (VENLAFAXINE) taken for antidepressant therapy, ongoing carbidopa, levodopa (RYTARY) taken for parkinson's disease, ongoing mirabegron (MYRBETRIQ) taken for incontinence, ongoing atorvastatin calcium (ATORVASTATIN CALCIUM) taken for cardiac disorder, ongoing aspirin [acetylsalicylic acid] (ASPIRIN [ACETYLSALICYLIC ACID]) taken for transient ischaemic attack ,ongoing clopidogrel bisulfate (CLOPIDOGREL BISULFATE) taken for transient ischaemic attack, ongoing paracetamol (ACETAMINOPHEN) taken for pain, ongoing loratadine (LORATADINE) taken for hypersensitivity, sinus disorder, ongoing ascorbic acid, biotin, calcium, colecalciferol, cyanocobalamin, dl-alpha tocopheryl acetate, folic acid, potassium iodide, pyridoxine hydrochloride, retinol acetate, zinc sulfate (CENTRUM MULTIGUMMIES WOMEN), amantadine hydrochloride (AMANTADINE HYDROCHLORIDE) taken for parkinson's disease. Since receiving the vaccine she had been sleeping a lot for about 3 days (on 03Feb2021). Caller stated she knew that was supposed to be a side effect. Adds her mother was a Parkinson's patient and usually able to walk using a walker. She was having a hard time walking (03Feb2021) and had to use the wheelchair. Clarifies her mother started sleeping quite a bit about three days after the vaccine on Friday 03Feb2021. Mentions previous to this on Wednesday after the vaccine, her mother was complaining of foot pain (on 03Feb2021) towards the side midway on the foot in the arch and on the top where you tie your shoe. It was almost like she dropped something on it but she did not. It was slightly swollen on the top and red and warm (on 03Feb2021). Friday when her mother started sleeping so much, they had resort to the wheelchair. She took her to see the nurse practitioner on Friday for the foot, who sent her to the ER for an X-ray on Saturday so they went out again on Saturday to get the foot x-ray done. The foot was not broken. They did treat her mother's foot with Cephalexin. Her foot was fully recovered now. Her mother's tiredness (on 05Feb2021) was persisting and she was having a hard time just getting up from the bed and to go across the room even though the foot was fine. Today they have a message into her neurologist. Adds today was the first day her mother started talking about needing or wanting to go to the hospital for her tiredness and not being able to walk (06Feb2021) Her mother was scheduled for the next dose 23Feb2021.The patient underwent lab tests and procedures which included x-ray limb: the foot was not broken on. Therapeutic measures were taken as a result of foot pain, foot redness, foot swollen, foot hot to touch.The outcome for the events foot pain, foot redness, foot swollen, foot hot to touch was recovered/resolved on 08Feb2021 and not recovered/not resolved for rest of the events. Information on the lot/batch number has been requested. Follow-up attempts are completed. No further information is expected

right arm is unbearably painful after injection/My arm is hurting so bad; didn't sleep all night because of the pain/I really can't sleep enough, I mean it's hurting; This is a spontaneous report from a contactable consumer. This 77-year-old female patient received second dose of bnt162b2(PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: EM9809, Expiry date not reported) via unspecified route of administration in right arm on 03Feb2021 (at age of 77-years old) as single dose for Covid-19 Immunization. Patient medical history includes high blood pressure. Patient concomitant medications include Amlodipine (once a day) used for blood pressure from unknown date and ongoing, Hydrochlorothiazide, lisinopril (once a day) used for high blood pressure from unknown date and ongoing. Patient previously received first dose of bnt162b2(PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number:EK9231, Expiry date not reported) via unspecified route of administration on 15Jan2021 as single dose for COVID-19 Immunization. On 03Feb2021, patient had shot at noon, she got the injection in her right arm, she developed the arm pain last night about 8 or 9 pm. She said it will feel better one minute, and then she will have a sharp pain going through her arm again. Patient experienced like her arm is hurting so bad; patient stated that I really cannot sleep all night because of the pain/I really cant sleep enough, I mean it is hurting. Patient right arm is unbearably painful after injection and stated that she did not let nothing get around the injection area and she rubbed her arm with alcohol.Caller verifies she talked with a man yesterday and reported this information and gave information on what was on her vaccine record card. Caller verifies she was not provided with any type of reference number.Upon follow up reporter stated that the reason she got it because she works at the hospital, what mandated, and she got it. Patient stated that, I am having a problem so I could get the paid today, okay but look can I rub my arm with some alcohol. Consumer was informed about Pfizer Medical information department.Treatment received for event by taking Tylenol. Patient underwent lab test and procedures include blood pressure measurement is high on unspecified date. The outcome of events was not recovered. Follow-up (04Feb2021): This is a follow-up spontaneous report from a contactable consumer. This consumer reported for a patient (mom) that: new information include vaccination at right arm and updated age 77years on onset of reaction, concomitant medications,Treatment received for event. Follow-up attempts are completed. No further information is expected.

Difficulty breathing/she could barely breathe; felt like her "left lung is made of stone"/felt like her left lung felt like it was going to her back; had pain in shoulder blade; felt like she is not getting enough oxygen/she was not getting enough oxygens to her brain; slept for 12 hours; she was angry and upset; she was angry and upset; her voice has changed; she has some wheezing but it is coming from in between her soft and hard palate; States after the vaccine was tired and lethargic; States after the vaccine was tired and lethargic; This is a spontaneous report from a contactable consumer. A 77-years-old female patient received bnt162b2 (BNT162B2, Batch/Lot number: EL9264, Expiration Date: 31May2021), via intramuscular, administered in Arm Left on 09Feb2021 (Age at vaccination 77 Years) as 1st dose, 0.3 ml single for covid-19 immunisation. The patient had past drug event to a reaction to the inhaler that was prescribed to her, had excruciating pain in feet, hands and knees never happened in her life. Inhaler was Albuterol sulfate, HFA, inhalation areol, 90mg per actuation, 18gm, inhale 2 puffs into lungs every 4 hours as needed for SOB, she did have Covid in Nov2020 prior to the vaccine, concomitant medications were not reported. The patient experienced she had been calling since the 16-17Feb2021, a week after she had the first vaccine shot on 09Feb2021 states about 2 hours after the first Pfizer Covid vaccine, she had difficulty breathing thought maybe it was a side effect from she had Physical Therapy earlier that day, but stated as the week went on the difficulty breathing, even walking down stairs, become more difficult, states the following Tuesday, she went to Physical therapy and everything went okay and when she came home and walked two houses down the road to her neighbours house to drop something off. she could barely breathe on 09Feb2021, felt like her "left lung is made of stone"/felt like her left lung felt like it was going to her back, had pain in shoulder blade, felt like she was not getting enough oxygen/she was not getting enough oxygens to her brain, slept for 12 hours and went to urgent care, (unspecified date in 2021) she was angry and upset she has some wheezing but it was coming from in between her soft and hard palate, her voice has changed sounds gravel-y, stated after the vaccine was tired and lethargic. She laid her head down on the table and went to sleep for 2 hours at the kitchen table, does not believe she had brain damage. She wanted to know she did not have good experience with first dose. Her second dose was due today and stated she will be late for her second dose, also wanted to know "YES or NO" about taking the second dose. States the urgent care doctor told her they have a theory that she already had antibodies in her body and then the influx of antibodies from the vaccine caused the reaction. The patient underwent lab tests and procedures which included sars-cov-2 test and she did have covid-19 on Nov2020 states she did have Covid in Nov2020. Patient received treatment of Stated she went to urgent care and they gave her a breathing treatment. The outcome of events was difficulty breathing/she could barely breathe was recovering, rest of the all events outcome was unknown. No follow up attempts are possible. No further information is expected.

I'm freezing and all kinds of things on a daily basis; pain; chills; headache; 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, Formulation: Solution for injection, Lot number: EL9265 and Expiration date: unknown), via an unknown route of administration, in left arm on 03Feb2021 (at the age of 77-years-old) as dose 1, single for covid-19 immunisation. Medical history included hypertension, internal bleeding and take special medications to keep her CBC where it needed, thyroid cancer, cancer, cholesterol, rheumatoid and osteoarthritis from an unknown date, she bruise all the time, depression and PTSD since her husband has committed suicide. Concomitant medications included methotrexate taken for neoplasm malignant; folic acid taken for blood cholesterol, start and stop date were not reported. Patient took chemotherapy for rheumatoid arthritis. She was feeling like she had covid all her life because she was in pain, has chills and freezing and all kinds of things on a daily basis. She bruise all the time, but did not get bruise from the vaccine. The first dose of event was very uneventful. Patient had intramuscular injection before and the pain she had was just terrible. She don't want any more pain in her life. She wanted to ask what are the risk of bleeding with the vaccine and also wish to know the information about risks and blood thinners was in the fact sheet so she could read about that before getting the shot. She goes back on 21Feb2021 for the second dose. She made it clear that, she has a autoimmune disease of rheumatoid arthritis and did not want to take a shot in the muscle. She would have an adverse in next two weeks. She does not told anything about the second dose. The man that gave her the shot said that the side effects depended on her immune system. It could be nothing. She has a headache from holding the phone. She wanted to ask if she takes a blood thiner when she got the vaccine. She does not take a blood thinner. She has a internal bleeding and has to have routine CBC's. As long as her count is at a certain point she does not have to have an operation. The patient underwent lab tests and procedures which included full blood count: unknown results on an unknown date. Outcome of events was unknown. Follow-up (11May2021): Follow-up attempts completed. No further information expected.

very very itchy.; inflamed; these isolated spots on your right and your left elbow and one side of my face and my neck, so it was isolated, it was not a rash but so itchy and red and inflamed; big red blotch that was very itchy; I was going crazy; didn't sleep; My asthma has been worse; hive like hard bumps around elbow of same arm, as well as near ear of right side.; This is a spontaneous report from a contactable consumer (patient). A 77-year-old non-pregnant female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EM6198) via an unspecified route of administration on 02Mar2021 (at the age of 77-year-old) as dose 2, single for COVID-19 immunization. Medical history included years ago penicillin allergy but have had since, bug bites allergy, allergic to mosquito bites and to insect bites, asthma, minor arthritis/spine, acid Reflux, high cholesterol. Concomitant medication(s) included atorvastatin calcium (STATIN), folic acid and multi-vitamin, vi taken for an unspecified indication in two weeks. The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection) administration on right arm on 09Feb2021 (at the age of 77-year-old) as dose 1 single for Covid-19 immunization and experienced similar event with 2nd dose along with large blister. The patient did not receive any other vaccine in four weeks. Prior to vaccination, the patient was not diagnosed with COVID-19. Post vaccination, the patient had not been tested for COVID-19. On an unspecified date in Mar2021, the patient experienced similar events happened again after 2nd vaccine 02Mar2021 in same spots, no big blister just both elbows and neck, very very itchy as well as hive like hard bumps around elbow of same arm, as well as hive like bump near ear of right side. Followed by very itchy bumps on left arm at elbow site. Patient informed that after the 2nd shot it affected 2 elbows and the neck but no blister (same as the first but the first had the giant blister) and had gone to 2 physicians who didn't know what it was or if it may be an allergic reaction no one had identified it. Patient thought it was bug bites (allergic to mosquito bites and allergic to insect bites). It was so inflamed for a month patient was going crazy and doctor gave prednisone and Zyrtec. The 3rd person, patient spoke with thinks it's covid arm. No one can tell her what it was. Patient been to a dermatologist and internal doctor. Thinks it's the reaction to the covid vaccine. The problem with the reaction was when it's so inflamed. It feels like she got mosquito bite (like when she get a reaction) and didn't sleep the whole night. The doctor said, "I can't tell if it's a bug bite because it's so inflamed." Patient's asthma has been worse. It's horrible to have this. Thinking patient had bed bugs, it's been driving her crazy for a month. Patient informed that it's not just some itchiness, at first sight she thought she had insect bites. It happened in two locations under the right side of my neck which is like a big red blotch that was very itchy at the same time on my right arm and so the second time it happen it was not that bad, just in these isolated spots on right and left elbow and one side of face and neck, so it was isolated, it was not a rash, it was like an allergic reaction to mosquito bite but so itchy and red and inflamed. The doctor gave the patient antihistamine and now taking prednisone. Patient also asked about tests available to see if she had an allergic reaction to the pfizer vaccine. If the vaccine had histamine or would people who had allergies to bug bites have allergies to the Pfizer vaccine. The outcome of events hive like hard bumps around elbow of same arm, as well as hive like bump near ear of right side and very very itchy was recovering and rest all events was unknown. No follow-up attempts are possible. No further information is expected.

My mother has had her share of health problems predominantly relating to her Afib diagnosis,however after every dose she experienced side effects that have set her back in ways that were completely new,loss of memory Sluring her words, really bad head aches leading up to the first and second stroke.She was able to drive live on her own had sweet and kind,funny personality now that is all gone. She is a shell of who she was and our family just simply misses her,I truly just wish that we would have had been warned of the possible risks to patients like her prior to getting the vaccine.No matter how small the possibility of adverse reaction.We would have chosen to keep her longer.

Patient presented to the ED and was subsequently hospitalized on 3/11/2021 for acute cystitis with hematuria and acute kidney injury. Patient presented to the ED and was subsequently hospitalized on 4/19/2021 with generalized weakness and confusion. These visits are within 6 weeks of receiving COVID vaccination.

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.

July 28 2021 woke up with slight cough , sore throat, also had some knee pain July 29 woke up 4;30 am With Excruciating knee pain and swollen knee , could not walk . My husband and son In law had to help me get up Also had sore throat and laryngitis Not sure if the above is related to my second shot 7/22/21 or not

Admitted to hospital 1/14/2021 with acute mental status changes, hypoxia, pneumonia (previous positive COVID 12/18/2020) ICU 1/14/2021-1/16/2021, currently hospitalized PCU level of care

vaccine on 1/20/21. Fatigue, confusion on morning of 1/21/21. Pt's family concerned could be due to vaccine vs infection vs dementia.

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

She has shrunk; weighs less. Maybe 154 pounds. She was 170; she got first dose of Pfizer COVID vaccine on Monday 04Jan2021/She will get the second dose on 01Feb2021; she got first dose of Pfizer COVID vaccine on Monday 04Jan2021/She will get the second dose on 01Feb2021; had congestion; Coughing; choking; body was more than hot it was burning/body turned very hot; could not sleep/two sleepless nights; This is a spontaneous report from a contactable consumer. A 78-year-old female patient received the 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK9231), via an unspecified route of administration on 04Jan2021 at a single dose for COVID-19 immunization, ciprofloxacin (CIPRO), via an unspecified route of administration from an unspecified date at an unknown dose and frequency for an unspecified indication and pirfenidone (ESBRIET), via an unspecified route of administration from an unspecified date at an unknown dose and frequency for an unspecified indication. Medical history included pulmonary fibrosis (diagnosed between 2007-2010), Lymphoma type B, blood pressure (abnormal), cholesterol (abnormal), vertigo, biopsy, tightening of legs and feet, drip (nasal) and pain. Concomitant medication included gabapentin for tightening of her legs and feet, diphenhydramine hydrochloride (BENADRYL) for drip (nasal) and meloxicam for pain. It was reported that the patient took the vaccine and had two sleepless nights on 05Jan2021, her body turned very hot but she have some conditions. Sleepless nights: they have been really rough nights. Scary. Coughing and choking. She thinks the vaccine kicked in and started beating the hell out of it. The patient clarified that she is having sleepless nights because of the coughing, choking, and burning and she feels that it is related to the vaccine kicking in. She slept last night, 14Jan2021. The cough is starting again today (as reported). She hopes it calms down. When she said her body was hot, like burning she was describing her sleepless nights. She is afraid. She is keeping in contact with her doctor. She figured she better call because more people are on this medication. The patient also experienced congestion on 06Jan2021. It was reported that the patient has shrunk and weighed less. Maybe 154 pounds. She was 170. The action taken for ciprofloxacin and pirfenidone was unknown. The outcome of the event congestion was not recovered, while unknown for the rest of the events.

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??

Headache; Dizziness/Lightheaded; Gait and speech disturbance; Gait and speech disturbance; Tired; Brain fog; This is a spontaneous report from a contactable consumer. A 78-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration on 16Jan2021 14:30 at SINGLE DOSE at left arm for COVID-19 immunization. Medical history included Sjogren's, asthma, low Igg, A-Fib, osteoporosis. The patient has known allergies: Methylparaben, Rocephin, lidocaine, oats. Concomitant medications included metoprolol, hydroxychloroquine sulfate (PLAQUENIL), apixaban (ELIQUIS), propafenone. On 16Jan2021 14:30, the patient experienced Headache, dizziness, lightheaded, gait and speech Disturbance, tired, brain fog. The outcome of the events was unknown. The patient did not receive treatment for the events. Information on the lot/batch number has been requested.

she had a wave that started at the top of her head and felt like she was losing consciousness and the wave went down her head and into her chest; Chest tightness; like she was going to faint or go to sleep; like she was going to faint or go to sleep; she barely had a little pain at the COVID-19 Vaccine injection site that went away quickly; This is a spontaneous report from a contactable consumer, the patient. This 78-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number: EL3249), dose 1 , single dose via an unspecified route of administration in the left upper arm on 08Jan2021 at 09:15 AM (at the age of 78 years-old) for COVID-19 vaccination. Relevant medical history included ongoing high blood pressure in Dec2020. Concomitant medications included valsartan (DIOVAN) 160mg tablet, once a day from 10Dec2020 and ongoing for high blood pressure and clobazem (CALM) from Jan2021, lot: 1115941, expiration: Mar2022. The patient did not receive any other vaccine within 4 weeks prior to the vaccine. On 08Jan2021 at 09:15 AM, the patient barely had a little pain at the COVID-19 vaccine injection site that went away quickly. On 18Jan2021, the patient had chest tightness and a wave that started at the top of her head and felt like she was losing consciousness and the wave went down her head and into her chest. She said it was like she was going to faint or go to sleep. She said the wave went down to her chest area and stayed for a big portion of the day. She said she had a heaviness in her chest, clarified as a chest tightness. She said she has no heart issues. The patient still had some tightness in her chest and it may be just from worry. She said she was normally calm, so she was not sure about what was causing her current chest tightness. The patient did not think what she experienced on 18Jan2021 was serious enough to contact her primary care doctor. There were no relevant laboratory tests done. The patient did not require a visit to the emergency room or physician's office. The clinical outcome of event, barely had a little pain at the COVID-19 vaccine injection site was recovered on an unknown date in Jan2021. The clinical outcome of event, wave that started at the top of her head and felt like she was losing consciousness and the wave went down her head was recovered on 18Jan2021 after treatment was given. The clinical outcome of chest tightness was recovering after treatment was given. The clinical outcome of like she was going to faint or go to sleep was unknown.

Headache; Chills; cognitive confusion, serious and unprecedented; extreme fatigue; weakness; nausea. These symptoms have continued to the present, 2/6/2021.

AMS-Fever-UTI-myoclonic jerks-unresponsive <6hrs post 1st covid vaccine. AMS-UTI- post 2nd covid vaccine

Severe Muscle ache over entire body. 1st day bedridden. 3rd day improving. 1st evening trying to sleep I had very vivid, realistic dreams.

lot not documented in EMR Call center call from adult son queryi8ng if symptoms were vaccine related.. Reported 78 yo mother awoke restless, agitated, could not describe what was wrong. She was Audibly moaning in the background, had difficulty responding to his instructions. Assessment revealed FSBG of 27. corrected with oral juice. Assessment after recovery did not identify any change in habits, had not missed meals, changed medications and is not on insulin; has no history of similar events.

At about 2:00 a.m. on Feb. 6th I was awakened by nausea and vertigo that lasted until about 10:00 that morning. Sat. afternoon I was feeling much better.

little depressed; not feeling like herself; weak; tired; This is a spontaneous report from a contactable nurse (patient). A 78-year-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL0140 and expiry date unknown), via an unspecified route of administration on 09Jan2021 at a single dose for COVID-19 immunization. The patient received the first dose on the left arm on 19Dec2020 10:30 (lot number: EL0140). Medical history included hypertension. There were no concomitant medications. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient had no side effects after the first vaccine except for a little tenderness which went away. On 11Jan2021, after receiving the second dose, she felt really tired but which went away. On 20Jan2021 (last Wednesday), she started to feel tired, weak, and not feeling like herself. On 22Jan2021, the patient was a little depressed. She did not have a headache. Her blood pressure was fine and she never had a fever. She had an X-ray back in Sep2020. Her vision is good. She is not hurting anywhere. She doesn't feel as strong. She doesn't understand the tiredness, weakness, and depression. Outcome of the event tired was recovered on 11Jan2021, of the events doesn't feel like herself and weak was not recovered, and of the event depression was recovering. The reporter assessed all the events as related to the bnt162b2. The events depression and doesn't feel like herself were reported as serious: medically significant while the other events were reported as non-serious.; Sender's Comments: A possible contributory role of bnt162b2 in triggering the onset depression and doesn't feel like herself cannot be excluded, considering the plausible temporal relationship. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.

unconscious; no heart rate/heart was not beating; all of the sudden she stopped breathing and her heart stopped beating; COVID 19 test positive; act funny, kind of quiet and not talking which was unusual for her; pressure was 60 over 4; This is a spontaneous report from a contactable consumer (patient husband). A 78-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EN5318), via an unspecified route of administration on 28Jan2021 16:00 at single dose at left arm for covid-19 immunization. Medical history included kidney ablation (ablation on the kidney cancer 5 years ago), kidney cancer, blood pressure, neuropathy, pain, had a urinary tract infection 19Dec2020 and they saw the cancer came back, radiologist read the CAT Scan and said the size of the tumor 1.5 to 2.4. Concomitant medications included acebutolol for blood pressure taking for years, diclofenac for neuropathy using for 10 years, oxycodone for pain taking 19 years; all ongoing, and oxycodone hydrochloride (OXYCONTIN) for pain. Patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. Family Medical History was none. The caller stated that he was not sure if the Pfizer COVID-19 vaccine could have given patient (his wife) COVID-19 or not. He also stated that when they received their vaccines the facility was very crowded as was the hospital when the wife was getting her blood work done so he was not sure when or where she contracted COVID-19. On 29Jan2021, patient was very busy running several errands including going to the hospital for bloodwork and a nuclear medicine injection as part of a work up for kidney ablation that the patient was supposed to have completed, patient was in the process of getting ready to have an ablation on her kidney and had the nuclear scan for her kidneys and then went to get a COVID test. After they got home, patient sat down at the computer and she started to act funny, kind of quiet and not talking which was unusual for her. So at about 1700PM the husband went in to ask her what kind of music she would like and he found her unconscious in the chair. He took her blood pressure and it was 60 over 4; with no heart rate; she was just barely breathing, he could tell by the way her mouth moved. He tried to breath for her, all of the sudden she stopped breathing and her heart stopped beating. He called (phone number provided) and they rushed her to the hospital, and the paramedics verified her heart was not beating and they started to do resuscitation. Then they finally pulled her out of the chair and put her on the floor and she started to breath. When they took her to the ambulance she was still not quite coherent; she didn't know what was happening. She was taken to the hospital emergency room and stayed there for 12 hours and they monitored her with an EKG and only saw one spike for 6 seconds. They discharged her on 30Jan2021 afternoon and she has been totally normal 100 percent since then. Since she had been home she had been doing well and has had no other events. Added patient had never had a heart problem before. Caller stated that he was not sure if this event was related to her receiving the vaccine or not. Now they had to stay in quarantine 10 days until 08Feb2021 since the COVID test given at the hospital on 29Jan2021 night when she went in was positive. Patient was scheduled to received the second shot 18Feb2021. Outcome of events unconscious, no heart rate, pressure was 60 over 4 was recovered on 29Jan2021, events started to act funny and stopped breathing was recovered on 30Jan2021, outcome of other events was unknown. The adverse events resulted in emergency room/department or urgent care, patient was taken to the ER and monitored for 12 hours but no admission. No history of all previous immunization with the Pfizer vaccine considered as suspect. No additional vaccines administered on same date of the Pfizer suspect.

I was in A Fib; feel strange; felt like my heart was racing; I felt shaky; This is a spontaneous report from a contactable consumer (patient). This 78-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number: EL963), via an unspecified route of administration on 26Jan2021 12:00 at single dose in the left arm for COVID-19 immunization. The patient medical history included borderline high blood pressure, high cholesterol, Hashimoto's, hypothyroid. The patient's concomitant medications included rosuvastatin, levothyroxine sodium (LEVOXYL), hydrochlorothiazide and lisinpro received within 2 weeks of vaccination. The patient previously took ezetimibe (ZETIA) and experienced drug allergy. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient was not pregnant at the time of vaccination. After sitting in recovery room for about 10 minutes following injection patient began to feel strange. Patient called the nurse on duty and said she felt like her heart was racing. The nurse took her BP and pulseox and administered a mini EKG. Then the nurse called the EMT on duty who gave patient a six leader EKG and said patient was in A Fib. Asked if patient had ever had A fib before, patient said no. Then asked if patient wanted to go to the hospital, patient said no. After sitting with the EMT for five minutes or so another EKG showed patient was no longer in A Fib. Patient felt shaky for the rest of the day, but is normal now. Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, patient has not been tested for COVID-19. The adverse event resulted in doctor or other healthcare professional office/clinic visit. No treatment received for the adverse event. Outcome of the events was recovering.

Received Pfizer 1/22/2021. RNA+ 2/4/2021. S/S SOB, cough, confusion. COVID assoc. resp. failure, stage 4 lung cancer, COPD, HTN, former smoker. patient in hospice and died 2/10/2021.

After vaccine a feeling of something going thru my body. Got very hot and dizzy. Sat in chair and nurse took my blood pressure which spiked to 208. I was shaking and my heart was pounding. I was rushed to the emergency room. Put on IV, Heart monitor, lung x-ray and blood test. Blood pressure was still at 188 at 2:00 PM. Asked to leave at 3:00 PM, I still did not feel good but I needed to get home, because my husband was home my himself and very upset. I am his caretaker. My pressure dropped to 158 at 10:00PM I had bad headaches for 4 days and I still get them once in a while. I do not have high blood pressure, my blood pressure is usually between 120 - 130.

I had right knee replacement surgery in 2018 and developed severe neuropathic pain in right leg . He pain subsided with time . After I got vaccine the pain came got . Now I have tingling , electrical like feeling , hot foot. I am applying ice. It tweaks me up at night.It is annoying

10 minutes after vaccination, patient noted onset of dizziness, feeling "strange", tingling in her left hand, and palpitations. At 15 minutes after vaccination, her blood pressure was found to be 200/84 LA and HR90 . O2 sat 98% on RA. T 98.2 F. Pt remained alert and in no distress, but continued to feel dizzy and unwell. Her repeat blood pressure was 184/84. EMS was notified and patient was transported to the emergency room.

Malaise, weakness , headache, chills, severe abdominal pain, this continued through the night. Unable to sleep due to abdominal pain, considered calling ambulance. In morning, diarrhea, nausea, poor appetite. Now 2:30 pm. , pretty much recovered

patient stated she had chest pain while in observation area, patient was alert and oriented, patient stated that she was nervous, emergency services were called and patient was taken to ED

she was "Just not feeling myself - nothing I can even describe in detail, just vaguely not myself; Did not want supper; This is a spontaneous report received from a non-contactable consumer (patient herself). A 78-year-old female patient (not pregnant) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; Lot number: Not available), via an unspecified route of administration on 23Jan2021 to 23Jan2021 at single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient had no allergies to medications, food, or other products. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. It was unknown whether the patient received any other medications within 2 weeks of vaccination. Patient was not diagnosed with COVID-19 prior to vaccination. The patient had not been tested for COVID-19 since the vaccination. The patient reported that on Monday (2 days post-vaccine on 25Jan2021) she was "Just not feeling myself - nothing, she can even describe in detail, just vaguely not myself. Did not want supper so had scrambled eggs and toast and went to bed early. Woke up feeling fine. She hardly ever felt other than fine and she could not think of anything other than the vaccine on Saturday that was unusual. On Sunday, she felt fine and today she feel fine". Treatment was not received for the events. The outcome of the events was recovered on Jan2021. No follow-up attempts are possible; Information about lot/ batch number cannot be obtained.

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.

freezing to death; Chills; Fever; Headache; I was just really kind of blah, just didn't feel good at all; I just kind of feel, I am blah, I am tired; I was just really kind of blah, just didn't feel good at all; I just kind of feel, I am blah, I am tired; I have mouth full of fever blisters; This is a spontaneous report from a contactable consumer, the patient. A 78-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot unknown, second dose) solution for injection intramuscular on 06Feb2021 (at the age of 78-years-old) at single dose for COVID-19 vaccination. Medical history included blood pressure and heart disorder. Concomitant medications included metoprolol succinate (TOPROL XL) for heart medicine and hydrochlorothiazide/losartan potassium (LOSARTAN/HCTZ) for blood pressure. Historical vaccine included BNT162B2 for COVID-19 vaccination on an unknown date and had no problems with the first shot. On 06Feb2021, the patient experienced freezing to death; chills; fever; headache; was just really kind of blah, just didn't feel good at all; I just kind of feel, I am blah, I am tired; mouth full of fever blisters. Treatment for the events freezing to death, chills, headache, feeling bad, tired included acetaminophen (TYLENOL). The outcome of the events freezing to death, chills, headache, feeling bad, tired and mouth full of fever blisters was unknown. The outcome of the event fever was recovered in Feb2021. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.

Day 5 of Moderate to severe bilateral hand and wrist pain following Pfizer 1st COVID-19 injection 0n 02/21/21. Unable to prepare meals, wash dishes, do laundry or other daily chores. My son is typing this message for me. At this time I do not plan to get the second injection. Am sending this message to the CDC and Pfizer. Two 650MG Tylenol gives me little relief. I'm hopeful that someone might suggest something else.

Patient has episode of amnesia possibly cause by seizure. Patient also had headache, chills, fatigue.

"Pfizer-BioNTech COVID-19 Vaccine EUA" My left arm/shoulder had pain shortly after the vaccination. Tha pain has been there since day one (1). I have not been able to raise my arm above my shoulder level without pain. It has been difficult to perform a number of daily activities.

felt fairly decent/feel bad; she "came down with covid"/test positive for COVID; she is kind of weak; her heart was racing; aching/aches; she ran a fever that got up to 101; cough; her arm got sore; allergies; This is a spontaneous report from a contactable consumer (patient). A 78-years-old female patient receive first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number: EL1283) on 15Jan2021 at single dose in left arm for COVID Prevention. Medical history included ongoing High Blood Pressure, she was diagnosed approximately 5 years prior to starting blood pressure medications in 1998. Concomitant medication included hydrochlorothiazide, valsartan (VALSARTAN AND HYDROCHLOROTHIAZIDE) at 320mg/12.5mg, once daily, by mouth from 1998 and ongoing, amlodipine besylate at 5mg, once daily, by mouth at night from 1998, both for High blood pressure. The patient stated that she did not realize, but she must have been exposed to the COVID Virus, prior to getting her shot. She stated that on 15Jan2021, she went and got her Pfizer COVID shot, and that same day, by the time she got home, she was starting to feel bad and it went downhill from there. She mentioned that on the same day on 15Jan2021, she "came down with covid". She finally went in on 22Jan2021, and got tested, and she did test positive for COVID. The patient was tested Positive for COVID-19 on 22Jan2021. She did believe she was getting better. On 29Jan2021, she felt fairly decent, and today, she is kind of weak but she is assuming that will happen. She was scheduled to go back for her second dose on 08Feb2021, and she is wondering if there are recommendations about the second dose, for people who tested positive for COVID after having gotten the first dose. When queried for her PCP contact information, she stated that her head is not working really great and she feels stupid she did not have this information handy to provide. She states that the first week with her symptoms, she just figured she did have the virus. She had a cough but it never got down to where she had trouble breathing, and she just figured that her body had to go through, whatever it was going to go through, and as long as the patient felt like she was okay, there was not anything anyone could do, she just had to play it out. When she did finally go get tested, the doctor told her to get on Nyquil and Ibuprofen, so that is what the patient has been taking, and she feels like it has helped a lot. Before she saw the doctor, she was taking Acetaminophen, but the doctor told her to do the Nyquil and Ibuprofen, so that is what she has been doing. By the time she got home from getting her vaccine, her heart was racing. She took her blood pressure and it was okay at 125/73, and her heart rate was 72. She has high blood pressure and she takes two medications for that, so she took her night time blood pressure pill and the fast beating of her heart went away. The next day, she got to aching. She has had all different aches, and she ran a fever that got up to 101, and the rest of the time it was 100 or 99, but the fevers were not all day long, they would just come and go. Now she has had no fever in four or more days, and she is doing better. She does still have the cough, but she also has allergies so she does not know what is causing the cough. As far as the reaction to the vaccine, just her arm got sore. But she thinks she was exposed prior to getting the vaccine and just did not know it. she stated that the people took her temperature the day of the shot and she didn't have a temperature. She did not receive any other vaccines on the same day as the COVID vaccine. The outcome of fever was recovering, of cough and allergies was not recovered, of her heart was racing was recovered.

Weak and fatigue. Not wanting to eat or drink. Unable to walk without holding onto items. Sleepy, but unable to sleep. Nine days after 2nd shot still having the same symptoms.

I was vaccinated with Pfizer for the first time 11 days ago. Within a few minutes of being vaccinated, I felt nauseated but I did NOT throw up. I have been sick ever since with one thing and another. For the first several days after being vaccinated, I had a sore arm, which I expected. I have also experienced extreme fatigue, chills, nausea, muscle and joint aches, a sore throat (briefly), an occasional headache, tenderness in my left armpit and along the left side of my rib cage, stomach pain and diarrhea and at times, a low-grade fever and sweating. My memory and ability to focus on my work have been affected. Yesterday (March 13), I felt OK all day and thought I was better at last, but after I ate dinner, I vomited and had diarrhea. I told my primary care physician about all of this in an email and she replied that my symptoms were "normal." I'm not so sure. I haven't read of anyone else feeling so sick for so long after the first dose of Pfizer.

Slightly Nauseous; Slightly dizzy; Thinks it activated her reflux; clogged up; This is a spontaneous report receive from a contactable consumer (patient herself). A 78-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection and lot number EL9626) via an unspecified route of administration on the left arm on 28Jan2021 09:30 at single dose for COVID-19 immunization. Medical history included ongoing Reflux. Concomitant medication included esomeprazole sodium (NEXIUM). Patient previously took BNT162B2 on 07Jan2021. On 28Jan2021 20:00 the patient experienced slightly nauseous, slightly dizzy, thinks it activated her reflux and clogged up. Seriousness was reported as non-serious. Outcome of events was recovering. No follow-up attempts are possible. No further information was provided.

BECAME DISORIENTED, DIDNT RECOGNIZE STREETS IN HER NEIGHBORHOOD, HALLUCINATIONS (SHE SAW OLD FRIENDS IN THE LIVING ROOM WHO WERE TALKING). SHE DID NOT KNOW HER OWN HOUSE, WONDERED WHERE SHE WAS. ABOUT 6 HOURS AFTER THE VACCINE SHE STARTED TO BECOME MORE LUCID, REALIZED THAT SHE WAS NOT ACTING NORMALLY. ALL SYMPTOMS RESOLVED AND SHE WAS BACK TO NORMAL 3 DAYS LATER.

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.

Migraine 10 hours? Headache and foggy head on and off for four weeks? Muscle pain and weakness upper arms, thighs to pelvis, sometimes buttox Most difficulties with muscles are during the night and upon arising in a.m. At least four days I was unable to function. Tylenol helped for short periods.

03/23/2021: Patient presented and was admitted through ED for right lower extremity pain after a recent fall. CT of the pelvis which showed to have Comminuted subtrochanteric proximal right femoral shaft fracture with angulation. She had difficulty walking, and difficulty with activities of daily living skills. Patient had PMH of arthritis. Per the EUA, hospitalizations are to be reported irrespective of attribution to vaccine.

Intermittent, indescribable cool feeling in chest,was feeling odd; 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 EN6206 and expiration date was not reported) via unknown route of administration on left arm on 08Mar2021 as single dose for covid-19 immunisation. The patient medical history was not reported. Concomitant medication included levothyroxine sodium (LEVOTHYROXIN) for two weeks. Past drug medication included Codeine and experienced Known allergies. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19; Since the vaccination, the patient had not been tested for COVID-19. On 09Mar2021 patient had intermittent, indescribable cool feeling in chest and was feeling odd. As a result, patient had doctor or other healthcare professional office/clinic visit. It was unknown if treatment was received for the adverse events. The outcome of the 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.

caller doesn't feel great; Headache; was exhausted/she was so worn out, she just felt zapped; had chills; fever of 100; overall a feeling like she had the flu; had no appetite; felt sluggish; she slept most of the day; This is a spontaneous report from a contactable consumer. A 78-year-old female (pregnancy unknown) patient receive second dose in series of bnt162b2 (BNT162B2, Solution for injection, Lot number: EN5318), via unknown route of administration on Right arm on 03Feb2021 09:00 (the day of vaccination), at single dose for covid-19 immunisation. The patient's medical history includes High blood pressure, and historical vaccine Caller had the First Dose on 13Jan2021 and it was Lot number EL3302. Caller had the Second Dose on 03Feb2021, and it was Lot number: EN5318. Caller reports that she got both doses via injection into the right arm. Concomitant medications were not reported. It was reported that caller states that she would like to talk about side effects from the COVID vaccine. Caller had the first dose of the product on 13Jan2021 and the second dose, this past Wednesday at 09 AM. Caller states that she was fine the whole rest of that day but then she woke up at 3 AM the next day and everything had changed. Caller states that she had a headache, she was exhausted, had chills, a fever of 100, it was overall a feeling like she had the flu. Caller is wondering if these are known side effects of the product because the caller's husband also got the vaccine, and he did not have any of these symptoms. Caller states that her primary care doctor is her Gynecologist and he is not aware that the caller even had the vaccine because she only goes to him once a year. Caller confirms the product was not prescribed to her by anyone in particular. Caller states that she had just read about the product and saw stuff on TV and thought that because of her age she should get it. Caller states that her brother in law is a physician and he told the caller to get the product. Caller states that her brother in law got the shot too and after his first shot he was fine but he had a few symptoms after the second shot, where he was feeling like he had the flu but he did not have as many symptoms as the caller had. Caller states that she got through the whole day of the day she had the injection and everything was great until 3 AM the next morning and she woke up with all the side effects. Caller states that she was so worn out, she just felt zapped, she had no appetite, a dull headache, she slept most of the day, fever of 100, and overall she felt sluggish. Now today, caller doesn't feel great, but she has no symptoms, she is just washed out. Caller states that she just guesses she did not know to expect that from the product. Caller states that she had heard there were some side effects and some people get them more than others but her husband did not get a single one. Caller is also wondering if the side effects will just go away on their own. Caller had no other vaccines on the same days as her doses of the COVID vaccines. Caller states that she has not had any bloodwork done in a while.

Headache at base of skull 1st night (Sun), next morning all muscles ached, significant pain in many joints, tremendous fatigue, inability to concentrate, dizziness. Swelling, pain, redness left arm shoulder to elbow.Took Tylenol, spent most of the day in bed. Not hungry. By Tues I felt much better, but fatigued (still needed 2 naps), little appetite. Wed continued recovery, but weak, arm continued red, swollen, painful to the touch. Today, Sunday and a week after injection, I feel normal.

She got the vaccine, had no reactions. She told them that she was going to have a procedure and they told her that it would be okay for her to have the vaccine. Then she had the procedure on 3/25/21 and then 2 days later she lost the use of her legs. She has fatigue, no energy whatsoever, it took 3 days for her to be able to get up and walk, and slept on the floor as she could not use her legs to get into the bed. She did call her doctor about 5 days later and he thought that it could have been a combination of the vaccine and anesthesia from the procedure. She continues to have the fatigue and no energy whatsoever.

3/27 got 1st pfizer vaccine in her right arm had injection site pain for a week and finally resolved the next day woke up with severe right arm pain, hurts to lift it sleeps on side and this also hurts it no weakness but hurts to raise it up no prior injuries no trauma pain in lateral shoulder, minimal neck pain, no pain distal to elbow no numbness or tingling on warfarin so has been afraid to take anything for this pain 5/10 at rest and much worse with movement

2/24/2021 thru 3/1/2021 - Left Arm pain and tenderness at injection site - less pain each day. Treatment: Tylenol Caplets (temporary relief) 3/3/2021 - Left Upper Arm Tricep Muscle noticeably Swollen and Hard when touched- No pain. Treatment: Cold compresses (little relief) 3/8/2021 - Left Arm Periodic Tingling up and down under skin, in addition to Swollen Tricep Muscle Treatment: Cold compresses & Tylenol Caplets (temporary relief) 3/25/2021 - Urgent Care for Swollen Upper Arm & Tingling discomfort Advice: Continue Cold Compresses, Monitor and follow up with Primary Care Provider 3/29/2021 - Continued Left Arm Tingling and increasing Pain at Left Upper Back & Shoulder, weakening Left Arm Strength, usage challenge, sleep discomfort, Tricep Muscle less swoIlen, Treatment: Cold Compresses and Tylenol (temporary relief) 4/12/2021 - (Pending) earliest available appointment with my Primary Care Provider

Pt reported sharp, pinching 2/10 pain in chest. Patient reported nervousness and a history of similar episode when stressed. Pt vitals assessed. BP 164/78, HR 56, 98% SpO2. Patient denied itchiness, rashes, hives, and difficulty breathing. Pt given water. Pt advised to stay for further observation. Pt reassessed at 1625. BP 162/78, HR 59, 97% SpO2. Pt denied difficulty breathing, itchiness, rashes, and hives. Patient offered transportation. Patient declined transportation. Patient left facility at approx. 1630 with steady gait and unlabored respirations.

Pt sated I just don't feel well and thinks she just got worked up with everything Happening. BP 166/77 HR 102. Said she didn't take meds today. . She signed refusal.

Altered mental state, memory loss, confusion, diagnosed as transient ischemic attack, most symptoms resolved in 24 hours

Blood clots in Lungs; No longer able to do activities of daily living; Almost fell to floor from sitting position; short of breath; total body exhaustion/fatigue; sleepy throughout the day; unstable, weak; debilitating symptoms bedridden/unstable, weak; debilitating symptoms bedridden; passed out completely while sitting; Unable to complete daily 1 mile walk at park/Unable to take stairs; Lightheaded/dizzy; This is a spontaneous report from a contactable consumer. A 78-years-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm Right on 26Mar2021 15:00 (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunisation. Medical history included patient had COVID-19 Dec2021 and recovered completely in 2 weeks. Symptoms: fever, sleepy. Went back to daily walk after 2 weeks. No loss of smell, no loss of taste, no mental changes- was very happy with my complete recovery. Took vaccine 26Mar2021 at recommendation of doctor to be safe from variants. Regret deeply, still hospitalized as of this writing. Concomitant medications included ramipril; rosuvastatin calcium 40mg; levothyroxine, all taken for an unspecified indication, start and stop date were not reported. The patient previously took sulphur and experienced allergies. The patient experienced unable to complete daily 1 mile walk at park/unable to take stairs on 27Mar2021, lightheaded/dizzy on 27Mar2021, passed out completely while sitting on 28Mar2021, unstable, weak on 30Mar2021, short of breath on 31Mar2021, total body exhaustion/fatigue on 31Mar2021, sleepy throughout the day on 31Mar2021, almost fell to floor from sitting position on 09Apr2021, debilitating symptoms bedridden/unstable, weak on 26Mar2021, debilitating symptoms bedridden on 26Mar2021, no longer able to do activities of daily living on 13Apr2021, blood clots in lungs on 14Apr2021, all with outcome of not recovered. Reported adverse event: 27Mar2021 - Unable to complete daily 1 mile walk at park. Lightheaded, dizzy 28Mar2021 Dizzy, passed out completely while sitting. Revived and taken to hospital by ambulance 28Mar2021 Admitted to (hospital name withheld) 30Mar2021 Discharge from hospital - unstable, weak 31Mar- 08Apr2021 - short of breath easily. Unable to take stairs. Discontinued daily walk, weak, total body exhaustion, sleepy throughout the day 09Apr2021 - Almost fell to floor from sitting position. Patient's daughter lowered patient gently to the floor. Revived shortly 13Apr2021 Saw primary doctor Dr (name withheld). Shared her debilitating symptoms bedridden since Covid-19 vaccine on 26Mar. BP taken from lying down, sitting and standing was markedly different and explained caused passing out and lightheaded. No longer able to do activities of daily living 14Apr2021 - Exhaustion and fatigue, her daughter to her back to the hospital 14Apr2021 - Passed out in Emergency Room @ (hospital name withheld). Admitted. Blood clots in LUNGS. The events resulted in: Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Hospitalization, Life threatening illness (immediate risk of death from the event), Disability or permanent damage. The patient was hospitalized for unable to complete daily 1 mile walk at park/unable to take stairs, lightheaded/dizzy, passed out completely while sitting, all from 28Mar2021 to 30Mar2021. The patient underwent lab tests which included blood pressure measurement: markedly different on unknown date. Patient was not pregnant. No other vaccine in four weeks.Patient had covid prior vaccination. No covid tested post vaccination. The treatment received for events included Heparin administered, still hospitalized as of now. Information about Lot/ Batch number has been requested.

Sundowning/sundowners; feel tired/Tiredness; headache on right side of head/not terrible, not like a hangover; Muscle pain/all over her body; chills; low temperature/was just a couple digits off; Joint pain/all over her body; during these days that she felt so awful she couldn't work her way through it; had a bad spell; felt bad; restless legs; felt unwell; tossing and turning, trouble sleeping; tossing and turning, trouble sleeping/did not sleep except for a couple of times; This is a spontaneous report from a contactable consumer. A 78-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) lot number: EN6199 and expiration date: Jun2021, via an unspecified route of administration, administered in right arm on 15Mar2021 as single dose for Covid-19 immunisation. Medical history included arthritis, diabetes, hypertension, rotator cuff repair, cancer (mom and dad both have passed from it. two uncles and grandparents have had cancer. cancer is pretty relevant in the family), alcoholism (mom and dad both have passed from it). Concomitant medication(s) included metformin taken for diabetes mellitus, metoprolol tartrate taken for hypertension, losartan potassium and lovastatin, ascorbic acid, betacarotene, biotin, calcium, chlorine, chromium, copper, cyanocobalamin, dl-alpha tocopheryl acetate, folic acid, iodine, magnesium, manganese, molybdenum, nickel, nicotinamide, pantothenic acid, phosphorus, phytomenadione, potassium, pyridoxine hydrochloride, retinol, riboflavin, selenium, silicon, thiamine, vanadium, vitamin d nos, xantofyl, zinc (CENTRUM SILVER +50). The patient stated that she was fine until a few days ago, 4 or 5 days ago she started to feel tired, headache on one side of her head, muscle pain and chills, low temperature, joint pain and just felt unwell. By the weekend the patient stated that she was down on the couch and her son was worried about her and suggested that she go to the hospital, which she refused. The patient described the headache as 'just there', states not terrible, not like a hangover. Since waking up today, she has not had a headache. She also added that she had trouble sleeping on Saturday night (03Apr2021). She stated she did not sleep except for a couple of times and she was just tossing and turning and took ibuprofen and it didn't help. The patient stated that the muscle pain and joint pain was all over her body. She had rotator cuff surgery on her right-side years ago and during this time she was carrying groceries on her own and her left shoulder started throbbing like the rotator cuff pain that she had in the past and she recognized it right away. She stated that she is not real sure if the muscle pain in her shoulder is a result of the vaccine or not. She has full of arthritis and was not sure if the pain is caused by the vaccine or not, but with her regular arthritis, if she has been sitting and gets up and walks around she is able to work her way through it, but during these days that she felt so awful she couldn't work her way through it. The patient stated that she feels like she has been suffering from sundowners but states she feels it's not related to COVID vaccine. She writes herself notes and forgets what notes mean. The patient was on hold so long with the first one. The patient had her first vaccination on March 15th and she am supposed to go back Wednesday April 7th for the second one. She had a bad spell for about 4 days last week. Today, she feel fine and have no temperature. She didn't have a temperature when she felt bad. The patient was having chills, restless legs, couldn't sleep. Now, the patient was feeling better. The patient recovered from the event headache unilateral, muscle pain, chills, body temperature decreased, generalized joint pain and feeling unwell on 05Apr2021, for events difficulty sleeping and restless was recovered on 04Apr2021. The outcome of other events was unknown.

I had an unsettling waking event happen to me yesterday morning, so I didn?t feel like I could gather myself to be at an appointment after the event. I was very disoriented upon waking. I could not gather my thoughts and memories. Things like: I knew I was in a city , but didn?t know where the city was in the world; and other things like that. It was as though I had stepped out of my life and didn?t remember enough to step back in. It only lasted maybe 5 min, but was completly disconcerting & disarming. I?ve never had a similar event. And it came after another disarming 10 min bout of dizziness / sense of off-balancedness and a very slight nausea the night before. It too, was arresting because I had had no alcohol to drink for months. I felt continually better during the early morning and didn?t think about it much during the rest of the day.

patient reports "feet feel dizzy and chest feels funny" and mild headache. Patient laid down, neuro exam wnl. At 11:48am, patient reports feeling relief.

after vaccination, patient began to feel lightheaded and dizzy, experienced syncope. after waiting for about 15 minutes she began to complain about chest pain. We decided to call 911 as she was extremely agitated and tremors

cataract; nausea; Diarrhea; nervous; This is a spontaneous report from a Pfizer sponsored program. A contactable 78-year-old female consumer reported for herself that she received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: unknown) via an unspecified route of administration on left arm on 04Feb2021 at single dose for COVID-19 immunization. The medical history of the patient included high blood pressure (Caller mentioned this was diagnosed in her late 50s or early 60s, and she was 78 now). She also had history of irritable bowel disease and hiatal hernia which was diagnosed years ago. She said that she did not had any other recent vaccinations or started any new medications. However she takes high blood pressure pills and stomach medicines and a medication for her bowels. It was reported that she had cataract in Feb2021 for which she underwent cataract surgery on 18Feb2021 taking eye drops- Prolensa every morning for 1 and half week. On an unknown date in Feb2021, she was nauseated and had diarrhea. She says she got the shot 04Feb2021 then a few days later she had diarrhea. She mentioned that she was scheduled to get the second shot today i.e. 26Feb2021 Friday, and her son saw on tv some people can get diarrhea, which she did not know before. She said that she had not gotten a temperature, and her BP was fine. She mentioned that she had irritable bowel disease anyway, and usually when she has that it clears in a week. She says that she would like to know if it is safe for her to get the second shot. On an unknown date in Feb2021, she experienced nervousness and it will have repercussions. She said that her son said there was some program on TV that listed all those things, some that were not in the paperwork she got. She had been nauseated or had diarrhea, and she called before, and some people get diarrhea, and she was supposed to check and see if she should get second shot. The outcome of all the events was unknown. Caller mentioned that she called her provider, but they were not going to get back to her in an hour and a half before she would go to get the second dose. She says she got the first dose of the vaccine at (Pharmacy) and says that she thought her diarrhea was better and then it came back the day before yesterday. She mentioned that her vaccine card was handwritten, and she could not read the writing on it. She says it mentioned (Clinic site) and that the handwriting was horrible on the card, and she could not tell if the LOT was E129EG. She says NDC/EXP were not provided on the card. The caller said that she has either got to get the shot or cancel this one, but if she cancels this one she does not know when she would be able to get second since the appointments are all booked up in (State). No follow-up attempts are possible; information about lot/batch number cannot be obtained.

feeling a click right before her fast heartbeat then drink water and slows it down/something clicks in body, heart beats really fast; really bad pain in her right knee; muscles really tight; didn't feel so good; she was scared to death, her nerves; anxiety; very frightened; 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), via an unspecified route of administration, administered in arm right on 21Jan2021 (at the age of 78-year-old) (Batch/Lot Number: EL1283) as 1st dose, single for covid-19 immunisation. Medical history included hypo thyroiditis (does not have it anymore, it was 30 years ago when she was a teacher), knee that was broken twice and allergic to antibiotics from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. On an unspecified date, the patient experienced feeling a click right before her fast heartbeat then drink water and slows it down/something clicks in body, heart beats really fast, really bad pain in her right knee, muscles really tight, didn't feel so good, she was scared to death, her nerves, anxiety and very frightened. The reporter stated that feeling a click right before her fast heartbeat then drink water and slows it down, was happened after she got her first covid shot. The patient asked to know if it was safe for her to get the second dose of the vaccine. The patient wondered if anyone else, she had the first Pfizer vaccine, later clarified as the COVID vaccine, a week ago last day before the time of this report, and she used to have a really fast heartbeat, but it slowed down, and once in a while, it was fast and stuff, now she had this happened twice, where she felt something click in her body, her heart beats really fast, and she drank water immediately, it slows down, has anyone said this after getting the vaccine. She has been on the phone for two hours. She never had a little click, she had thyroid hypo thyroiditis and every evening she would have a fast heartbeat, her blood pressure would go, but she never had when she would feel this little click, like a little, and her heart was really fast in morning of the report, it was really fast, and the minute she drinks water, it slows it down, it does not make sense. Also, her muscles are really tight, she was 78 and having a hard time with this pandemic, her nerves not good, she was nervous about the vaccine. She stated she was a teacher, and her weight was 106-107 pounds. About the event feeling a click right before her fast heartbeat then drink water and slows it down/something clicks in body, heart beats really fast, the patient stated, unknown when this started, exact date unknown, this has happened twice, this morning was the second one, and the minute she drank water, it slows it down, but it was very very fast, and she did not feel so good after, she was scared to death, her nerves are shot, she has trouble with anxiety, she was feeling ok now. She was nervous about what was going on and would feel better if someone else said they experienced the same. About the event muscles being really tight, the patient stated she has knots, her muscles are tight in her shoulders and neck lots, last night she was writing recipes, she does recipes boxes for her grandkids, and she was using her right arm a lot, she does not get to go to spa since the pandemic, she has not gotten to go to her for over a year. Her husband rubbed it out, and she did heat. Her muscles were tight right after she did it, so it could be something, it said if you think you had a symptom and also the second night after, she had a really bad pain in her right knee, it lasted one night, it was a knee that was broken twice, which may be why it was that leg. She was very very frightened to take it, she reacts to things strangely, when she has any procedure, they always say they never had that happen to anyone, she was allergic to antibiotics, different things happen when she takes different things, she was nervous about the whole thing, which may have to do with it. The second dose is on 12Feb2021. The outcome of the event muscles really tight was recovering and unknown for other events. Follow-up attempts are completed. No further information is expected.

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.

back was so stiff; extremely difficult to stand; When I was in a standing position, an Electric bolt of pain shot in my Left Groin and down the R of my Left thigh into my L knee on down inside the L calf, Left ankle and left toe.; When I was in a standing position, an Electric bolt of pain shot in my Left Groin and down the R of my Left thigh into my L knee on down inside the L calf, Left ankle and left toe.; When I was in a standing position, an Electric bolt of pain shot in my Left Groin and down the R of my Left thigh into my L knee on down inside the L calf, Left ankle and left toe.; so dizzy I could not stand up; no appetite; brain fog; I shuffle very short distances and very slowly trying to avoid a fall.; toes and bottoms of feet were also totally numb; This is a spontaneous report from a contactable other health professional (patient). A 78-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via unspecified route of administration, in the right arm, on 15Mar2021 08:45 (lot number: EN 6207), at the age of 78, at single dose for COVID-19 immunization. Facility where the most recent COVID-19 vaccine was administered was at the hospital. Patient medical history was not reported. Concomitant medications included losartan, hydrochlorothiazid and fexofenadine hydrochloride (ALLEGRA) for unspecified indications. The patient previously received first dose of bnt162b2 via unspecified route of administration, in the right arm, on 23Feb2021 14:30 (02:30 pm) (lot number: EN 5318) for COVID-19 immunization. On 15Mar2021 11:15, exactly 2 and a half hours after receiving the second dose of vaccine, patient tried to stand up but experienced back was so stiff; it was extremely difficult to stand. When patient was in a standing position, an electric bolt of pain shot in her left groin and down the right of her left thigh and into her left knee on down inside the left calf, left ankle and left toe; all on 15Mar2021 11:15. The pain has been constant and the most horrible pain she have ever suffered, as reported. It was reported that patient have never had this type of episode before in her life, which causes her to believe it has been a side effect of the 2nd dose of the vaccine. The pain continues to this day, at the time of reporting. Patient also experienced being so dizzy, she could not stand up; no appetite and brain fog on 15Mar2021 11:15. Before the shot, patient reported she can walk 50 blocks daily for the past 10 years. After 15Mar2021 (on unspecified date in Mar2021) she shuffles very short distances and very slowly trying to avoid a fall. Her toes and bottoms of feet were also totally numb when she wakes up each morning, since unspecified date in Mar2021. Treatment was received for the events (unspecified medications) on 28Apr2021 and physical therapy. Patient went off the medications the doctors gave her on 28Apr2021, choosing to tolerate the pain. The pain to this day, somewhat diminished. The events resulted to a Doctor or other healthcare professional office/clinic visit. Events were assessed as serious, disability. Outcome of the events was not recovered. No follow-up attempts are needed. No further information is expected.; Sender's Comments: Based on temporal assosciation, the causal relationship between BNT162B2 and the events, musculoskeletal pain, dyssastia, groin pain, pain in extremity, arthralgia, postural dizziness, hypoesthesia, feeling abnormal 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.

headache; hard to sleep; This is a spontaneous report from a contactable consumer (patient herself). A 78-years-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot Number: EL9262), via an unspecified route of administration in left arm on 26Jan2021 (at the age of 78-years-old) as single dose for covid-19 immunisation. On an unspecified date, the patient started receiving lisinopril (LISINOPRIL) Dosage text: 20mg, 1 tablet, oral for blood pressure measurement, cardiac disorder and was Ongoing. No lot number was provided for Lisinopril due to Product dispensed in pharmacy vial. The patient was taken Covid vaccine due to her age and heart issues. Relevant medical history and concurrent conditions included pacemaker inserted on Oct2011 and ongoing, had it replaced Jan2020. No further details provided. Pertinent Details include surgical procedures and dates were Pacemaker inserted Oct2011 and Jan2020. No other AE following prior vaccinations. No family Medical history relevant to AEs. Relevant Tests were none. History of all previous immunization with the Pfizer vaccine considered as suspect was None. No Additional Vaccines Administered on Same Date of the Pfizer Suspect. No other Prior Vaccinations were taken within 4 weeks prior to the first administration date of the suspect vaccine. No Other Products were reported. No Investigation Assessment. On an unspecified date in Jan2021, the patient experienced headache and felt hard to sleep. It was reported that patient getting a bit of a headache almost every day for almost 2 weeks. Patient reported about 2 weeks ago she got the first dose of the Pfizer Covid vaccine. She wants to know if this was expected and if it will be worse on the second dose. She had a question about the side effects. It's not serious, but she just had like a headache every day and wondered how long side effects supposing to last. Patient got the vaccine on Tuesday, 26Jan2021 and the headaches started like the next day. It was still there sometimes worse than others and at night it had bothered her more. She doesn't have them nightly and it's hard to sleep. No further details provided. Patient Mentioned she did see the cardiologist and her medication Lisinopril was increased to 20mg once daily. Does not know if that had anything to do with the headaches. Patient clarified the headaches were before she had the medication increase. Not visited Emergency Room due to events. Event headache caused Physician Office to visit. Outcome of the events was not recovered. Follow-up (08Feb2021): This is a follow-up Spontaneous report from a contactable consumer. New information included patient details, RMH, Outcome of the events. Description of Product Complaint: Did see the cardiologist and her medication, Lisinopril was increased to 20mg once daily. Clarifies the headaches were before she had the medication increase. Unable to provide NDC, Lot or expiry from pharmacy bottles. Product strength and count size dispensed: 20mg Follow-up attempts are completed. No further information is expected.

kind of unsteady on her feet; dizziness; her head was feeling peculiar; This is a spontaneous report from a contactable consumer (patient). A 78-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left on 30Jan2021 09:20 (Batch/Lot Number: EL5318) (at the age of 78-years-old) as a single dose for covid-19 immunisation. The patient medical history included blood pressure issue from an unknown date and ongoing. Concomitant medication(s) included atenolol (ATENOLOL) 25mg take once daily by mouth and benazepril (BENAZEPRIL) 20mg take once daily by mouth taken for blood pressure for years (unspecified). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient stated that she got the vaccine on saturday (30Jan2021 09:20) and she didn't have any side effects except dizziness. Mention she didn't see that as one on the list. Adds she was dizzy when she wakes up and feels dizzy right now if she moves her head just right. Patient was asking is are we aware of this side effect. Patient further stated that after vaccination she was sitting in the car waiting for 15 minutes she was laughing with her family and she noticed her head was feeling peculiar. Adds that may have been the start of it (dizziness). Adds the peculiar feeling was kind of right in the center of her forehead. States she thought maybe she was dehydrated and slammed water all day long yesterday and as she was going to bed she felt dizziness. Today she noticed she was still dizzy and kind of unsteady on her feet. Patient was scheduled for the second dose of the vaccine on 20Feb2021. At the time of this report head was feeling peculiar (feeling abnormal) and dizziness were not recovered and the event kind of unsteady (Unsteadiness) on her feet was unknown. Follow-up attempts are completed. No further information is expected.

I had the vaccine and three hours I was on a walk and I had to turn around half a mile and come back home and I had extreme fatigued for a whole month and my husband would have to wake me up three times a day to feed me, I have severe head aches, my kidney level functioning drop to above 50, then the second month I would sleep 3 3 hour nap for the day, I could not get my stamina back. I went about 2 days later to the doctor. She did some blood tests, I have had 4 of them, and all of them have been fine. Now is month 4 and I am slowly recovering, my heart doctor gave me Colchicine and I have been on that for 5 days. I have to get up 7 times in the night to go to the bathroom for diarrhea. In the 29th of June I will have an ECHO cardiogram.

Patient said shot hurt badly, arm was sore but felt better after 15 minute observation time. Patient was able to grocery shop after and felt fine. She started to feel bad later in the day and went to bed around 8PM. Patient says she could not sleep, dozed on and off and had chills and sweats. When she woke up at 5:30AM, she said her legs felt like they had been crushed, she was in extreme pain and her legs felt paralyzed and she could not move them an inch. She had to use her arms to move her legs. She states it took her an hour to get to a chair. She sat in the chair for 45 minutes and was then able to gradually prop herself up to a dresser and eventually made it to her bathroom. Her condition gradually improved over time and she was able to walk much better on 5/29, Today she reports no leg pain, but reduced energy levels.

Shaky; Warm; My face turned red; My hands were shaking; I felt my heart skipping with irregular heart beats; The nurse measured my blood pressure and it was 183/95 with a pulse of 104; This is a Spontaneous report from a Contactable Consumer (patient, self-reported). A 78-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number: EL9265 and expiry date was not reported), via an unspecified route of administration, in Arm Left, on 03Feb2021 at 08:30 AM, as a single dose for COVID-19 immunization. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccine in four weeks. The patient's medical history included hypertension, chronic lymphocytic leukemia, osteoporosis, glaucoma and known allergies: reaction to epinephrine (cannot have Novocain with epinephrine), reaction to histamines and tyramine. Concomitant medications included metoprolol succinate (TOPROL XL), Amlodipine, Levothyroxine, and Atorvastatin. The patient was not diagnosed with COVID prior vaccination. The patient was not tested for COVID post vaccination. The patient reported that on 03Feb2021, about 7-10 minutes after receiving the shot, she started to feel extremely shaky and warm. Her face turned red, and her hands were shaking. She felt her heart skipping with irregular heartbeats. The nurse measured her blood pressure, and it was 183/95 with a pulse of 104. She was observed for an hour. The patient did not receive treatment for the events. Outcome of the events was recovered on an unknown date in Feb2021. Follow-up attempts completed. No further information 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.

very serious extreme anxiety; nausea, severe nausea, where she couldn't eat; Severe Headache; Abdominal pain; Dry heaves; she had a morbid feeling; feeling of doom; lost 13 pounds; hypothyroid went to hyperthyroid; Aversion to Food; Anorexia; nausea, severe nausea, where she couldn't eat; This is a spontaneous report from a contactable Nurse (patient). A 78-years-old female patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration, administered in Arm Left on 11Jan2021 10:50 (Batch/Lot Number: EJ1686; Expiration Date: 20Mar2021) as 2ND DOSE, SINGLE, vaccinated at the age of 78 years old for covid-19 immunisation. Patient received the first dose on 21Dec2020. Medical history included ongoing hypothyroidism Diagnosed 20 years ago, ongoing colitis, ongoing proctitis, ongoing diverticulum, ongoing gastrointestinal pain, and breast cancer. Concomitant medications included levothyroxine sodium (SYNTHROID) taken for hypothyroidism, start and stop date were not reported. Caller states she was told by a couple of doctors that she needed to report this. Caller states her first vaccine was 21Dec2021 and then her second dose was on 11Jan2021. Caller states four days after the second dose, she wound up in the ER with severe headache, abdominal pain, dry heaves and she had a morbid feeling. Caller states after that, she saw her doctor and for two months she had problems with nausea, severe nausea, where she couldn't eat, lost 13 pounds, hypothyroid went to hyperthyroid, very serious extreme anxiety, which she is still battling. Caller states the Endocrinologist felt it could've been associated with the vaccine. Caller states the ER ran tests and abdominal scans and all they showed were the usual things she knew she had, nothing new. Caller states she asked the ER doctors, and they said they didn't know if it was related and when she asked Endocrinology, they said they don't know for sure. Caller states her Primary doctor said it could be related, anytime a person has a vaccination, if they are immunocompromised or have inflammation, it can possibly trigger this and events occur. Caller states she had dry heaves, an aversion to food, lost weight, and had terrible anxiety, all four days after vaccine. Caller states after the first vaccine, she was fine. Caller states after the second vaccine, she woke up that morning four days after, it was acute, this had never happened before and she had a feeling of doom and dry heaving. Caller states it took her two months, before she started to eat and put the weight back on. Caller states the nausea is gone and she is able to eat and put weight back on. Caller states she still has extreme anxiety and she is seeing a doctor for that and is being medicated so it is persisting by improved with medicaiton. Caller repeats, this all happened four days after her second injection. Caller states no one knows that much about the vaccine but they said something that this reaction should be reported. Caller states the nausea and other GI issues lasted for about two months, but she can't give actual dates of when it recovered. Caller states she doesn't know dates of when the other side effects recovered, but they only thing she still has is the anxiety. Seriousness: Caller states the Nausea was disabling, she couldn't eat at all, she had to drink ensure and boost. Caller states the rest were medically significant. She was worked on by her PCP and Endocrinologist, and they adjusted her thyroid medication to bring back down her levels, and she is sure that is part of the reason for her anxiety and anorexia. Caller states before she had hypothyroid. Treatment: Suppositories, Zofran, Reglan, Anxiety Medication, Adjustment of the thyroid medication Synthroid. States when she lost an extreme amount of weight, her thyroxin increased, so they dropped her dose to the normal range. Causality: Caller states she feels it is related because it was an acute onset and rare for her, even though she is older, she is healthy. Caller states she has had breast cancer but nothing that stopped her from working. Caller states it is hard to know, but she thinks it is related. Caller states her one son was home and called and said mom looks like she is going to pass out and she is not an alarmist and usually would say no, but she said yes, he better make sure that she gets to the ER, she felt impending doom, with abrupt onset. Tests: Caller states they did an Endoscopy and Colonoscopy because of her abdominal pain and they found colitis and proctitis and every, itis, a person can think of along with diverticulosis and inflamed gut, but she already had those, they were not caused by the vaccine, she had them in the past. Outcome of anxiety was recovering, of others was recovered in Jan2021.; Sender's Comments: Based on the temporal relationship between events anxiety, nausea, headache, abdominal pain, retching, malaise, weight decreased, hyperthyroidism, decreased appetite, eating disorder and company suspect BNT162B2, the causal relationship cannot be denied. 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.

Fatigue/I am still tired; My chin is like its frozen like I had been to the dentist and my right side of my lip is frozen; My chin is like its frozen like I had been to the dentist and my right side of my lip is frozen; This is a spontaneous report from a contactable consumer (patient herself). A 78-year-old female patient received BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- EN6198) via an unspecified route of administration on 04Mar2021 as 2nd dose, single dose (at the age of 78-years-old) for COVID-19 immunization. Patient medical history included high blood pressure, mastocytosis and stage III kidney disease. To stabilize the high blood pressure she takes a bunch of other stuffs too. The concomitant medications included montelukast, aspirin [acetylsalicylic acid], fexofenadine hydrochloride (ALLEGRA). Patient reported that she takes Allegra with two Aspirin because that activates the Allegra. Historical vaccine included BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- EL9269 (as reported)) via an unspecified route of administration as 1st dose, single dose for COVID-19 immunization. About the lot number of first dose patient stated, she believes its FL, its EL9269. On an unspecified date in Mar2021, patient experienced fatigue, she was still tired, her chin was like its frozen like she had been to the dentist and her right side of her lip was frozen. Patient stated she had the usual symptoms, she had the second shot on 04Mar2021 and she was fatigue the 2nd day she guesses that was normal and the following day, she was still tired today. The other thing that she did not see that the usual thing was her chin was like its frozen like she had been to the dentist and my right side of my lip is frozen like she had been to dentist. She meant is that something that happens sometimes to different part of your body where the virus settle or the vaccination settles or maybe it will go away or (statement incomplete) she was wondering if you ever heard that before she meant you hear lots of things but (statement incomplete). Patient stated, in general are there drugs that cause a problem when you take them before you take the vaccine or may be there is not. She meant she takes a lot of things but and she took Aspirin she guessed she should not have taken that before she took it but. Patient did not receive any treatments for the adverse events. Lab work information included patient stated she had done just a routine physical on 05Feb2021 and she did have blood work done then. Patient further stated she had her chart for data care as her chart it might say on this. They checked her kidneys as sometimes she was considered stage III kidney disease, they check that, she did not know. The outcome of the event fatigue was not resolved while of other events was unknown. No follow-up attempts are possible. No further information is expected.

She felt 'weird'.; she noticed a cooling effect at the bottom of her ribcage; This is a spontaneous report received from a contactable female consumer (Patient) and a contactable consumer (husband). A 78-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Left on 08Mar2021 15:50 (Batch/Lot Number: EN6206) as single dose for covid-19 immunisation. Medical history included hypothyroidism from an unknown date and unknown if ongoing. Concomitant medication included levothyroxine (LEVOTHYROXINE) taken for hypothyroidism from an unspecified start date and ongoing and multivitamins. The patient experienced she felt 'weird'. (feeling abnormal) (non-serious) on an unspecified date with outcome of unknown, she noticed a cooling effect at the bottom of her ribcage (feeling cold) (non-serious) on 09Mar2021 with outcome of not recovered. Follow-up attempts completed. No further information expected.

12 hours after vaccine patient developed bilateral lower extremity "paralysis". She felt feverish and achy at night, didn't sleep well, and at 6am decided to get up and couldn't move her legs. She remembers using her hands to move her legs over. She tried to stand but slid down off the bed. It took about an hour until she could put weight on them. Felt normal by the next day. Exam and labs 1 week later normal. Back to baseline active self. Denies LOC, no upper extremity sx, no edema. Didn't try to wiggle her toes. Was advised not to get the booster dose.

I woke up the next morning with a very soar arm, a fever, chills and so achy. The next day, the fever and chills were gone, but I felt worse. Very weak, my legs felt as though they couldn't hold me up. I was so exhausted. I am still having issues. I thought I was feeling better, I thought, but I am still experiencing the issue with the weak legs, being so tired. I also feel light headed lately. I did see my family doctor 2x and spoke with him on the phone a couple times. He did blood work, all came back good.

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.

This is a spontaneous report from a contactable consumer reported (herself). A 78-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number & Expiry date not reported) via unspecified route of administration in left arm 28Apr2021 16:15 (at age of 78-years-old) as 1st dose, single dose for COVID-19 Immunization. Patient medical history includes ongoing blood pressure, ongoing (Gastroesophageal reflux disease) GERD reflux, ongoing back pain. Patient had allergies to things like hay fever, pollen, dust, mold. Historical vaccine include Shingles shot on unspecified date and experienced flu. If she had the booster, she would not have shingles. Patient past drug includes Zantac for about 6-8 months ago. Other conditions include scoliosis, has had back operations. She has lost a lot of height due to scoliosis. Patient concomitant medications include irbesartan used for prevention of high blood pressure from unspecified date and ongoing, metformin hydrochloride (METFORMIN ALPHARMA) (1000 mg, 1x/day frequency) used for preventative for Diabetes, she does not have Diabetes from unknown date and ongoing, Famotidine (20mg) taken for GERD reflux from 6 to 8 months from unspecified date, Vitamins taken from unspecified date and unknown till ongoing. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. On Apr2021, Patient experienced shingles, pain in her back, rash on lower back which are ongoing and does not feel great, itching or burning in her back was worse. She is unsure if it started the day before or the day of the vaccine. Patient received treatment for events by Mederol/ Methylprednisolone 4 mg for pain as prescribed by the doctor only taken for 1 day/ 6 pills. Also took an Advil the day before and the night of the shot. Patient didn't visit any emergency room but just called her physician. she had a rash on back which doctor confirmed was shingles. The patient had a side effect after the first dose of the vaccine. She asked should I get the second dose. The patient wanted to know if it is accurate that she can delay the 2nd dose up to 6 weeks. She is supposed to get her second dose of Pfizer Covid Vaccine this coming Wednesday, 19May2021, but she still has shingles and does not feel great. As noted in the Fact Sheet for Recipients, you should not get the Pfizer-BioNTech COVID-19 Vaccine if you had a severe allergic reaction after a previous dose of the vaccine or if you had a severe allergic reaction to any ingredient of the vaccine. In response to caller, they suggested to consult healthcare provider they know your health situation and has access to information that can better help inform this decision. Second Pfizer Covid Vaccine shot, she said it is scary, and the doctor said it was scary for her not to take it, all. The Outcome of events was recovering. Follow up attempts are needed. Further information has been requested.

spasms; her arms "tightens up" during the night; having trouble sleeping/she barely sleeps 3-4 hours per night; muscle in her arm tightens up so tight it wakes her; both arms hurt from her elbows to shoulders and it is terrible at night.; This is a spontaneous report from a contactable consumer (patient) via medical information team. A 78-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, #lot: ER8737, expiration date: 31Jul2021) via an unspecified route of administration administered in Arm Left on 03Apr2021 (at the age of 78-years-old) as single dose for COVID-19 immunization. Medical history included ongoing breast cancer diagnosed 2.5 years ago and still being followed for it, ongoing irritable bowel syndrome diagnosed 5-6 years ago and had muscle aches in her legs from cholesterol medicines in the past. Concomitant medications included acetylsalicylic acid (ASPRIN, strength: 81 mg) at 81 mg once daily, bumetanide (strength: 1 mg) at 1 mg tables, 2 tablets on Monday, Wednesday and Friday and one tablet the rest of the week, glucosamine, methylsulfonylmethane (GLUCOSAMINE & MSM) one in the morning and one at night, 2x/day), letrozole (strength: 2.5 mg) at 2.5 mg once daily, levothyroxine (strength: 25 mg) at 25 mg, alternate day, lisinopril (strength: 5 mg) at 5 mg one at night, loratadine (CLARITINE), lorazepam, omeprazole (strength: 20 mg) at 20 mg, alternate day, probiotics once daily, calcium (strength: 600 mg) at 600 mg twice daily, vitamin c (ASCORBIC ACID, strength: 500 mg) at 500 mg once daily, vitamin d3 (strength: 500 mg) at 500 mg once daily, simethicone (strength: 125 mg) at 125 mg once daily. It was reported that within 2 days after vaccination, on 05Apr2021, the patient right arm started hurting from elbow to shoulder along with left arm then started hurting also but doesn't recall at what point it started. Patient thought that pain was due to the vaccine since in her left arm was also in pain. Further patient described pain as excruciating at night, in the evenings or when lays down, and tolerable during the day. On an unspecified date, the patient specified about the spasms and arms that tightens up during the night, which keep her up. On an unspecified date, the patient added she barely sleeps 3-4 hours per night, despite the muscle relaxant she takes. Patient further explained she cannot lift her arms as high in the morning and provided the following example: she couldn't open her venetian blind or put her coat without help. She specified the pain eases up during the day and can't move her arms as it hurts, the pain on a scale of 1-10 was a 15. Reporter assessed the event as non-serious. On unspecified date the patient underwent lab tests and procedures which included left arm x-ray and left arm x-ray found to be negative. The outcome of the events both arms hurt from her elbows to shoulders and it is terrible at night was not recovered while the outcome of the rest of events was unknown. Follow up attempts needed. Further information is expected.

feels dragged out and a little shaky; feels dragged out and a little shaky; This is a spontaneous report from a contactable Consumer or other non-health professional (patient). A 78-years-old female patient received first dose of BNT162B2 (BNT162B2, PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number, Expiration date and NDC number was not reported), via intramuscular route of administration, administered in right arm on 02Feb2021 at 14:30 hours as 1st dose, single dose (at the age of 78-years-old) and on 23Feb2021 at 14:30 hours as 2nd dose, single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On 03Feb2021, patient felt good. On 04Feb2021, patient feels dragged out and a little shaky. Patient stated that in two weeks she has to go back for second. She and her husband got their first shot on Tuesday, 02Feb2021. They felt good the net day. Today she feels dragged out and a little shaky. Patient asked was that normal. The case was classified as non-serious. The outcome of the events was unknown. Information on the lot/batch number has been requested. Follow-up (23Mar2021): This is a follow-up spontaneous report from a contactable consumer. This 78-year-old consumer reported in response to Non-HCP coversheet and questionnaire sent. Follow-up attempts are completed. No further information is expected.

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.

Individual contacted 06/27 to report event s/p 2nd Pfizer COVID-19 injection. Caller shared she experienced left arm pain 3 days following injection, pain persists in left arm and is constant, unable to reach above shoulder level, unable to lay on left side, complains of weakness in left arm, unable to sleep, complains of weight loss and "acid reflux" since receiving vaccine. Denies any fever, rash, cough, cold symptoms s/p vaccine. She states she has treated with her PCP and Occupational Therapy for her complaints with no relief, she relates PC and OT have diagnosed her with "bursitis".

One day after first dose of Pfizer vaccine, patient was admitted for fever, weakness and altered mental status. At admission exhibited SIRS (fever, tachycardia), ultimately no infection was identified on work up.

dizzy; cramping in stomach; hard to swallow solid food; body shook; chills/teeth chattered; BP rose to 170/89; felt jittery; This is a spontaneous report from a contactable consumer or other non hcp. This consumer reported that a 78-years-old female patient received bnt162b2 (BNT162B2, Formulation: Solution for injection, Batch/Lot number: EN6200), dose 2 via an unspecified route of administration, administered in Arm Left on 17Feb2021 14:00 as DOSE 2, SINGLE for covid-19 immunisation. Medical history included ongoing high BP Onset date: 5+ years Stop date: Ongoing Pertinent details: Controlled; ongoing acid reflux disease Onset date: 10+ years Stop date: Ongoing Pertinent details: Controlled. There were no concomitant medications. On 20Feb2021, the patient experienced BP rose to 170/89; felt jittery; chills/teeth chattered; body shook; On 21Feb2021, dizzy; cramping in stomach; hard to swallow solid food. The patient underwent lab tests and procedures which included blood pressure measurement: 217/105 mmhg on 28Jan2021, blood pressure measurement: 170/89 mmhg on 20Feb2021, pyrexia: 103 on 28Jan2021. It was reported that patient took 2nd shot on Wednesday 17Feb. On Saturday 20Feb BP rose to 170/89 felt jittery. On Sunday 21Feb become jittery, dizzy, BP high and had cramping in stomach. Hard to swallow solid food. Went on until doctor ordered Dicyclomine. It helps. On Saturday 20Feb had chills for 2and half hours. Teeth chattered and body shook. Stomach was still cramping after 2and half weeks and solid food is hard to swallow. I have an appointment with a gastrologist. The clinical outcome of all events were unknown. No follow-up attempts are possible. No further information is expected.

She got her vaccine, and started feeling real dizzy and stumbling around and cold not do anything, and has had no energy and was in a wheelchair for a little while. She went to her PCP and he told her that she had an infection from the Covid shot, and gave her some antibiotics and some prednisone. This did not help. She was able to walk with her rolling walker before but since then she has had this problem. Her hands hurt, burn, turn red. She drops things steadily. When she gets up in the morning she is not able to do much as she drops things. She still has the same symptoms, and still having no energy and not herself. Her son has now moved in with her to help her as she is not able to take care of herself anymore.

Nausea; Flu like symptoms; a flare with hands and achiness/sitting for long times everything started hurting; Condition aggravated/flare/a flare with hands and achiness; Bilateral cataracts; Depression; Vomiting; Back pain; Foot pain/fingers hurt; Shoulder pain; Localised erythema; her joints continued to be swollen at times; Diabetes; Heart disorder; Osteoarthritis; Joint range of motion decreased; Lower extremity mass; finger would not bend was straight as a board; Burning finger; one finger was bruised looking; swollen finger on left hand/hand swelling; This is a solicited report from a non-Pfizer sponsored marketing program (MARKETING PROGRAM NAME NOT AVAILABLE) received by Pfizer from AbbVie Inc. A contactable consumer (patient) reported that a 78-year-old female patient received tozinameran (PFIZER BIONTECH COVID-19 VACCINE), dose 2 intramuscular in Mar2021 (Batch/Lot number was not reported) as dose 2, single for covid-19 immunisation; adalimumab (HUMIRA, Solution for injection in pre-filled pen), subcutaneous from an unspecified date to Feb2021 at citrate free 40 mg, 1 in 1 week for moderate to severe rheumatoid arthritis and moderate to severe adult crohn's disease. Medical history included moderate to severe rheumatoid arthritis, moderate to severe adult crohn's disease. The patient's concomitant medications were not reported. The patient previously received first dose of tozinameran intramuscular in 2021 for covid-19 immunisation. The patient previously took adalimumab from 05Dec2019 and experienced lack of drug effect; On 16Apr2020, the patient experienced body aches. On 01May2020, the body aches resolved; fatigue from 2019, Urinary tract infection from 2020 to 2020, recovered; recurrent urinary tract infection from 2020. She had another urinary tract infection and she was placed on another unknown antibiotic therapy. On 14Apr2020, the patient was taking ciprofloxacin shot for urinary tract infection however it made her sick and had vomiting, depression and pain and therapy stopped. The patient experienced events of condition aggravated, flare, cataracts on both eyes (bilateral cataracts), nausea and flu like symptoms and non-serious heart condition (heart disorder), osteoarthritis affected knees and hands, two fingers on left hand and thumb would not bend was straight as a board, joint range of motion decreased, lump on left knee (lower extremity mass), one finger was bruised looking/burning (burning finger) and swollen finger on left hand from 02Mar2021, hand swelling, depression, diabetes, vomiting, after taking covid vaccines, a flare with hands and achiness/sitting for long times everything started hurting, back pain, foot pain, shoulder pain, redness in the hand (localised erythema) and swelling in hand with humira (adalimumab). Pfizer biontech covid-19 vaccine (tozinameran) was considered suspect. She was hospitalized due to extreme flares, body aches, flu like symptoms and nausea. She went to the eye specialist and was diagnosed with cataracts. she was told by her primary physician that she had a heart condition. she reported that her joints continued to be swollen at times and painful. She had shoulder, back pain, foot pain and also had osteoarthritis that affected her knees and hands. She took humira weekly and thought humira helped with pain. She also had diabetes. She stopped humira after taking covid 19 vaccines. She had swelling and redness in her hands and lump on her left knee. Her fingers were swollen, hurt and look bruised. she could not bend two fingers on left hand and thumb. she feels that all of her symptoms started after the second Pfizer covid 19 injections. She developed body aches and a flare with hands, achiness and restarted taking her humira. In 2021, she had cataract surgery on both eyes and had the outcome for the cataract surgery on both eyes was reported as recovered. when sitting long times, everything started hurting. It was unknown if patient was enrolled in a covid-19 vaccine trial. The patient was treated with kenalog, prednisone and amoxcillin. The patient underwent lab tests included body temperature: normal value. The action taken in response to the events for adalimumab was unknown. The outcome of events flare, cataracts, nausea, flu like symptoms, was recovered; everything started hurting, back pain, swelling of fingers was not recovered; other events was unknown. The report was considered involved or prolonged inpatient hospitalization and other medically important condition. Causality for humira (adalimumab): the reporter's causality for the event(s) of flare, body aches, nausea, flu like symptoms, depression, vomiting, lack of effect and urinary tract infection with humira(adalimumab) was a reasonable possibility. the reporter's causality for the event(s) of cataracts on both eyes, heart condition, fatigue, osteoarthritis affected knees and hands, two fingers on left hand and thumb would not bend was straight as a board, lump on left knee, one finger was bruised looking/burning and swollen finger on left hand after covid vaccine/hand swelling onset 02Mar2021, diabetes, another urinary tract infection, after taking covid vaccines and developed body aches and a flare with hands and achiness/sitting for long times everything started hurting, back pain, foot pain, shoulder pain, one finger was bruised looking/burning and swollen finger on left hand after covid vaccine/hand swelling onset 02Mar2021, redness in the hand and swelling in hand was not provided. Abbvie's opinion is that there is no reasonable possibility that the events of flare, cataracts on both eyes, fatigue, osteoarthritis affected knees and hands, two fingers on left hand and thumb would not bend was straight as a board, lump on left knee, one finger was bruised looking/burning and swollen finger on left hand after covid vaccine/hand swelling onset 02 mar 2021, depression, diabetes, vomiting, lack of effect, after taking covid vaccines and developed body aches and a flare with hands and achiness/sitting for long times everything started hurting, back pain, foot pain, shoulder pain, one finger was bruised looking/burning and swollen finger on left hand after covid vaccine/hand swelling onset 02Mar2021, redness in the hand and swelling in hand are related to humira(adalimumab). Abbvie's opinion is that there is a reasonable possibility that the events of body aches, nausea, flu like symptoms, urinary tract infection and another urinary tract infection are related to humira(adalimumab). Abbvie's opinion is that the event of heart condition is not assessable. The reporter's assessment of the causal relationship of the events with the suspect product was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment. No follow-up attempts are needed; information about batch/lot number cannot be obtained.; Sender's Comments: Reported events nausea, flu like symptoms, and vomiting are assessed as related to the suspect drug based on drug safety profile and temporal association. Other events are probably associated to patients underlying condition and are not related to BNT162B2. Case to be re-assessed upon receipt of new information.

went right back to sleep after her call and didn't wake up till next morning,; dull headache; head was swimming; blood pressure went to 220/blood pressure was really high; black spots across my face; swimmy headed; legs didn't feel like they would hold her up/felt like my legs weren't going to hold me up; weak; very fatigued; This is a spontaneous report from a contactable consumer (patient). A 78-years-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: ER8731), via an unspecified route of administration, administered in left arm on 15Apr2021 13:15 (at the age of 78-years-old) as a SINGLE DOSE for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. She had her shot and just had a bad reaction to her very first shot. She came home, states sometimes she may doze off for 15 minutes or so but she fell asleep until at 16:00 she was woken up by a call from a friend. On 15Apr2021, she felt very fatigued and weak on Friday; later adds she was tired the day of shot as well. She laid around all day sleeping on Friday. On 17Apr2021 Saturday her legs didn't feel like they would hold her up and so she laid around again all day. On 18Apr2021 Sunday she knows had gotten up to go to bathroom a couple of times in the night; but then in the morning she was going to get up and felt faint; later adds she felt dizzy; states her head was swimming and she saw black spots and it scared her to death. Adds she thought she should go and sit up in the living room. But even after she sat down, sitting straight up, she kept seeing black spots. A friend took her to the emergency room (ER) for the dizziness and seeing spots. At the ER they found her blood pressure was really high; she thinks it was 220 over something, she forgot the bottom figure. They put an IV in to give her medication; did an electrocardiogram; a chest xray; blood work; a urinalysis and all of those tests everything was fine. The ER staff helped her to bathroom and her head was still swimming but they said that was because her blood pressure was still high. Adds her blood pressure went down on it's own and she had no medication for the blood pressure. They told her you are remarkable at your age to not to be on medication. She saw her doctor yesterday. Reports at the doctor's office her blood pressure was about 128/63. The doctor told her it was kind a low and that she basically runs low. She was not dizzy anymore on Sunday after her blood pressure went down. Adds she got a dull headache yesterday but she thinks it might of been a caffeine headache because she has had a caffeine headache in the past when she had to stop caffeine for a test or something. She has to take the second dose on 06May2021, and her doctor told her to take it; but she is scared to death. She asking for a recommendation as to whether she should get the second dose. The adverse event resulted the patient to visit emergency room and was not admitted and also visited to physician office. Outcome of the event hypertension was resolved on 18Apr2021, while for events- black spots across my face, dull headache, swimmy headed, feeling abnormal, head was swimming was resolved on 19Apr2021 and that for fatigue, weak was not recovered and sleep disorder was unknown. No follow-up attempts are possible. No further information was expected.

High levels of burning when urinating as well as most of the time. Sense of urgency in needing to pee. Discomfort- feeling like shards of glass between my legs. Sleep at night limited to 1.5 hours before needing to pee. Started 4/17/2021 and continuing up to today (7/13/21)

same pain feeling in bladder and pelvis; Sore arm; had pain that was just in the knee replacements, where knee replacements; Pain; pain in her pelvis; Standing up feels weird; This is a spontaneous report from a contactable consumer or other non hcp. A female patient of an unspecified age received BNT162b2 (CONMINTARY, Solution for injection, Lot No: EN6200), via an unspecified route of administration, administered in the left arm on 28-JAN-2021 16:00 as 1stdose, single for covid-19 immunisation. The patient received second dose BNT162b2 (CONMINTARY, Solution for injection, Lot No: EL9261), via an unspecified route of administration, administered in the left arm on 05-MAR-2021 16:00 as 2nd dose, single for covid-19 immunisation. The patient's medical history included ongoing cardiac disorder heart condition , ongoing hypertension high blood pressure , cardiac operation from 25Jan2020 to 25Jan2020 heart surgery , knee arthroplasty from Jan2014 to an unknown date double knee replacement surgery made out of unknown titanium and plastic , office visit from an unknown date and unknown if ongoing foot doctor appointment , biopsy uterus from an unknown date and unknown if ongoing scheduled for a biopsy on her uterus , breast cancer from Sep2020 to an unknown date breast cancer , arthritis from an unknown date and unknown if ongoing arthritis , immunisation from an unknown date and unknown if ongoing very active , genetic counselling from an unknown date and unknown if ongoing genetic testing relative for breast cancer, heart surgery for other conditions was 2 heart stents placed, double knee replacement surgery was the prosthetics are each 9 inches made out of unknown titanium and plastic. Caller interchangeably referred to surgical date as Jan2014 and about 5 years ago. She was fine without any assistance for about 4 years never needed to use canes or walkers only at 1st when had replacements-did for that immediate after surgery-was down 4 months with replacements. Foot doctor appointment was she will tackle soon. Scheduled for a biopsy on her uterus was she is concentrating on that once she gets past that they picked that up in annual pelvic exam about a month ago; if that doesn't have any lasting need for any further treatment she will tackle this knee pain, breast cancer was 1st stage taken care of no further mammograms not on any medication for it; operated on Sep2020 until now another part of her needs to be looked at no reason it won't be nothing just questionable if something might be brewing; just going to do a biopsy of uterus because of ultrasound need to be looked at again. Arthritis was definitely what caused the knee surgeries. Very active gone on to have a full life radio program curates the art in her town. Does her own grocery shopping. Lives alone since husband died. Patient tested her for genetics relative to breast cancer she is not passing anything on to her daughter of the female breast genes don't think it goes any further. Patient does not take a lot in the past she had very serious lyme disease; no real relapse in that last 10 years; before that she spent 10 years in treatment for lyme disease so she could go back to that. 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. Concomitant medication(s) included celecoxib (CELEBREX) taken for pain, start and stop date were not reported; thyroid (ARMOUR THYROID) taken for thyroid disorder from 2001 to an unspecified stop date. The patient experienced pain in her pelvis on 31Jan2021, same pain feeling in bladder and pelvis on an unspecified date, sore arm on an unspecified date, had pain that was just in the knee replacements, where knee replacements on unspecified date, pain on 31Jan2021, standing up feels weird on 28Jan2021.This is report 1 of 8. The patient who reported pain standing up feels weird and sore arm after first dose of Pfizer Covid-19 Vaccine. Pain on the 3rd day after the first dose of Pfizer Covid-19 Vaccine she woke with pain in her pelvis and thought she had a urinary tract-captured as provided as only urinary tract- which she doesn't usually have. Then on the 4th day after first dose of Pfizer Covid-19 Vaccine she had the same pain feeling in bladder and pelvis. She was seeing a cancer doctor that day for a 6-month check-up who ran a urine sample, and it was negative. She knew it was negative because that symptom was pretty intense on 3rd and 4th day but then it was gone. The pain took her all the way back to when she had the knee replacement surgeries; she was on Morphine then which she can't do that now; they wouldn't give it to her. She had using Advil and some Celebrex which she was not supposed to use those because of her heart condition which was under control. Advil and Celebrex taken for the pain have done nothing for the pain they are doing nothing they don't touch the pain. Her family doctor suggested she try marijuana. her cancer doctor was trying to get her medical marijuana; but nothing's happened in 6-8 weeks. Pain was making her crazy, did buy the marijuana it comes like candy like little gummy bears to try to alleviate the pain that way but did not get the medical marijuana. The oncologist talked to his secretary and she was told they would contact her in 6 weeks. 6 weeks went by and they haven't contacted her. The Oncologist texted her she told him she hasn't gotten the medical marijuana card yet and you have to pay for the card. So her daughter in Massachusetts can buy marijuana that's legal there-so the patient tried little bit of a gummy bear which did nothing for the pain; so she tried a little more of a gummy bear which still did nothing for the pain; then another day she tried a whole gummy bear which still did nothing for the pain in her knees but she felt kind of fogged up in the head, after 6 days after the first dose of Pfizer Covid-19 Vaccine she woke up with both knees that she had a knee replacement in in 2014; and she had basically gotten over most of it; the 6th day after the shot she woke up and had pain that was just in the knee replacements where knee replacements both were. It was excruciating pain it woke her up and she has been pretty bad ever since. That was the most extreme day of pain was 6 days after the first dose of Pfizer Covid-19 Vaccine. It was pretty bad and then it woke her up 10May2021 also. For the pain Advil doesn't touch it she has taken 600mg of Advil every day which she was not allowed to take because she had 2 stents in her heart during heart surgery performed in 2020. They don't really want you to take Advil or anything after that. She's pretty much suffering and was probably going to end up in pain management. She got the second dose of Pfizer Covid-19 Vaccine and that second dose didn't make any difference did not worsen or affect events. She has to use a walker now; she had really gotten pretty much through that major surgery 5 years ago the double knee replacement surgery which she verified as being in 2014. She never got really great, but she could walk without a cane or any assistance. 09May2021 she when went to the cemetery to spread her deceased husband's ashes and had to use 2 canes so the pain definitely came from the Pfizer Covid-19 Vaccine. The patient reporting adverse events with Pfizer Covid-19 Vaccine. Mentioned she has been using Advil and some Celebrex taken for pain which have done nothing for the pain they are doing nothing they don't touch the pain. Advil expiry: Jul2023 Lot: WJ22828 UPC/NDC was Unknown on top over the code they use when they do inventory or all. Patient has friends with hip replacements and knee replacements, and no one was saying anything about pain with their replacements. She was thinking the Pfizer Covid-19 Vaccine was just attacking the foreign particles in her body which are the knee replacements. Celebrex: Lot/NDC/Expiry: Unknown dispensed in pharmacy vial. The outcome of the event pain in her pelvis was recovering, same pain feeling in bladder and pelvis, sore arm, had pain that was just in the knee replacements, where knee replacements was unknown, pain was recovering, standing up feels weird was recovered on unspecified date. No follow-up attempts are needed. No further information is expected

Prior to March 21, 2021 patient was able to walk on her own (although pace was slow), get in and out of bed or chairs, able to dress herself, use the toilet and shower and communicate verbally (although voice was not very loud. She received the second Pfizer/BioNTech COVID-19 vaccine 2:30 PM on March 18, 2021; on March 21, 2021 she had gotten up at 4:00 AM and was walking through the kitchen when she found herself on her back on the floor and was unable to get up. She required help in getting up and has not been able to walk on her own ever since. She requires help in getting in and out of bed, in and out of chairs, cannot use toilet and shower on her own, is unable to dress herself and her voice has become a whis

Every day since she got the vaccine she has had fog, lightheadedness, and dizziness worse than when she had COVID; Every day since she got the vaccine she has had fog, lightheadedness, and dizziness worse than when she had COVID; Every day since she got the vaccine she has had fog, lightheadedness, and dizziness worse than when she had COVID; fatigue; had so many naps; cutting the zinc in half because it made her terribly sick; This is a spontaneous report from a contactable consumer (patient). A 78-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left on 11Feb2021 at age of 78-year-old (Batch/Lot Number: EL3249) at single dose for COVID-19 immunisation; zinc (manufacturer: Nature Bounty), via an unspecified route of administration from an unspecified date (Batch/Lot Number: 529254-01; Expiration Date: Nov2024), at 50 mg daily for immunity. Medical history included COVID-19 in Sep2020 and her primary symptoms were different than the typical symptoms, she had the fog, lightheadedness, and dizziness, she healed up pretty good, but she would occasionally have a bout with it. Concomitant medication included colecalciferol (D3, Brand: Nature Bounty, lot number: 506697-01, expiry: Sep2023) taken for immunity. Additional vaccines administered on same date of the Pfizer Suspect were none. History of all previous immunization with the Pfizer vaccine considered as suspect was none. Prior vaccinations within 4 weeks were none. Back in probably 1958 she had a reaction to the Polio vaccine for immunization. She didn't remember the symptoms and they said to stay away from it. She had shingles vaccine for immunization and had no problem. The patient did not have lot number or expiry for the Polio Vaccine. She didn't have lot and expiry for the Shingles vaccine. She got the Shingles vaccine in 2019 because she had a friend that had shingles and it wouldn't go away. Her friend had not gotten the shingles vaccine. The patient's friend recommended that patient get the shingles vaccine. She had the opportunity to get the first vaccine on 11Feb2021 and she asked her doctor if she should do it with her having continued symptoms. The doctor said yes and for her to take Zinc and D3. So that is what she did. Every day since she got the vaccine she had fog, lightheadedness, and dizziness in Feb2021 worse than when she had COVID. She was fine the first 24 to 30 hours. When she woke up the next day in Feb2021 she was dizzy again. Then it has gone off and on. She can't even go grocery shopping without holding onto the cart an begin fearful. When she sat she was fine. She imagined she had fatigue. She had never had so many naps. The patient clarified that she lay down because of dizziness. The patient asked how does that relate to her getting the second one. That was the first one and they said the second one is worse. She is a caregiver and it can't get worse. They said the first shot is 85% effective is that enough and asked if that last for very long. She used to be 5 foot 2 inches. She saw her doctor on 25Feb2021 and doctor thought she should still have the vaccine. she was still leery. The 26Feb2021 is a better day, but she had felt real promise before. She took supplements. She thought she read that you shouldn't take anything for immunity. The patient asked if the zinc and D3 is considered for immunity because that is what the doctor told her to take it for. She had to cut the zinc in half because it made her terribly sick in 2021. It was 50mg, but since she was cutting it in half she is taking 25mg per day. She did not have any test or bloodwork since the vaccine. She wished the doctor would have done something when she messaged doctor on 25Feb2021 on app. She would feel better if someone else said she should get it. The events did not required a visit to emergency room. The action taken in response to the events for zinc was dose reduced. The outcome of the events was unknown. No follow up attempts are possible. No further information is expected.

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.

1300 - After vaccine administration pt c/o dizziness/lightheadedness. Skin was pale & diaphoretic. Assisted to supine position on floor. Feet elevated. BP 190/80, Pulse 96, RR 28 Axox3. 1305 pt remained on floor confusion noted, Axox1, repetative questions BP 189/80, states "Why am I here?" 1310 Pt. remained in supine position, continues to ask repetitive questions even after re-orienting to person/place/time. Husband states "I think she's just nervous." 1320 Pt. continues to show signs of confusion, states "What happened, who are you? Why did I get a covid vaccine? who gave it tome?" 1320 911 called 1345 Pt. transported to Hospital via Medic

Vaccine at 11:;50 am. 9:30 pm severe pain in left leg with cramps. then right leg but not as severe. pain all night, no sleep. Next day, severe pain back, upper left started about 4:30pm. then pain all over, muscular. lasted al night. Better next morning but still muscular pain.

very dizzy felt like I was going to faint, could not shake it, was at work went home. went to bed and slept 10 hours outcome= was fine when I woke up

Dizzy and light headed, mild nausea, weak and tired with occasional shortness of breath. Elevated blood pressure causing headaches. I have been unable to send this via the phone/text. I am exhausted from this continued distress. Normally very active and healthy.

I didn't receive, I just went to my apartment and probably went to bed early. I was not having any adverse things happen but 2 days later I went through 'hell' in my dreams. People were worried because I made wild phone calls and complaints. I had even written notes and passed them out, I live in a huge apartment complex.

Pt received COVID 19 vaccine at 1400. While in 30 minute observations area patient had c/o chest pressure, SOB, lightheadedness, Patient appears in NAD, skin PWD, patient is restless. Patient requesting b/p to be checked. Patient taken to first area where EMS on duty assessed patient. B/P 190/8-0 HR 90, RR 18, SaO2 96% on RA, CBG 144. Patient sitting in wheelchair and did state that she had a history of HTN and did not take prescribed medications, Lisinopril, Norvasc, today. Pt also take venlafaxine for anxiety. Pt observed by EMS, given snack, and water. Patient reports improvement of symptoms. VSS: b/p 156/70, HR 88, RR 18. Patient cleared by EMS and discharged home at approximately 1445.

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

Soreness at the site in injection. Couldn't sleep that entire night. Woke up with sweats and chills. Felt absolutely exhausted the following day with little to no appetite. Slept soundly (unusual for me) that night and felt absolutely fine the next day.

heavy sweat; night of shot arm hurt so bad I could not sleep, arm still sore; night of shot arm hurt so bad I could not sleep; achy; chills; 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, lot number: EJ1686), via an unspecified route of administration on 19Jan2021 10:30 AM at single dose for COVID-19 immunisation. Vaccine location was Left arm. Patient was not pregnant at the time of vaccination. Prior to vaccination, the patient was diagnosed with COVID-19. Patient was allergies to penicillin, keflex lisinopril and Spiriva Respimat. Other medical history included asthma and heart electrical problem. Concomitant medications the patient received within 2 weeks of vaccination included many for asthma and heart etc. Patient administered the most recent COVID-19 vaccine at Facility. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Since the vaccination, the patient has not been tested for COVID-19. The patient experienced shot arm hurt so bad and she could not sleep became achy and chills in the night of 19Jan2021, slept deeply Wed (20Jan2021) and Thursday (21Jan2021) nights. The patient experienced heavy sweat in the night of 21Jan2021 (Thursday) bedclothes very wet in morning Friday (22Jan2021) feel better but arm still sore. Patient was not received treatment for the adverse events. The outcome of events reported as recovering. All events reported as non-serious: adverse event resulted in none of seriousness criteria.

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.

I had no issues with the first dose. When they gave the 2nd dose, I felt strange feeling in my arm. I felt fine after that until the night. About 8PM I got a bad headache, I was so cold all over and I could not get warm, My blood pressure was 153/93. Body aches all over. My skin be sensitive it felt like it hurt to touch my skin. I couldn't sleep last night and was up and down all night. Today I still got a headache. I have been taking Tylenol which didn't help and tried Excedrin. I feel very tired today but I was awake a lot last night. I still have the chills as well.

her adverse event as having absolutely no saliva at all about 2-3 minutes later after getting the COVID-19 vaccine; did not have a good night's sleep; anxious; This is a spontaneous report from a contactable consumer reporting for herself. A 79-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number unknown reported as "EL9281 or EL9261" as the reporter cannot tell, pending clarification, expiry date: 31May2021), via an unspecified route of administration on 28Jan2021 12:00 at SINGLE DOSE (first dose) for covid-19 immunisation. Medical history included COPD from an unspecified date (not taking any medication for COPD) and she was 5'5 and has gotten a little bit tinier on an unspecified date. The patient's concomitant medications were not reported. On 28Jan2021, the patient stated everything was perfect and she was made to sit there for 15 minutes. The patient reported her adverse event as having absolutely no saliva at all about 2-3 minutes later after getting the COVID-19 vaccine. Her mouth stopped producing the saliva almost immediately and it was total. She stated she never had anything like that before. She stated it did not make her feel ill. She was still breathing alright, so she did not tell anybody. She did not have a good night's sleep and anxious about whether she won't be able to breathe with this experience. At 07:00 the next day, everything went back to normal and it was very noticeable for her. She was concerned about taking the second shot in 3 weeks considering her experience with the first shot. The patient stated afterwards that the information provided to her helped her to be relived and be confident about taking the second shot. Outcome of the event was recovered on 29Jan2021 07:00. Information on the lot/batch number has been requested.

began to hallucinate; Dizzy; bed nightmare; This is a spontaneous report from a contactable consumer. A 79-year-old female patient received the second dose of the bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE Expiration Date: May2021), via an unspecified route of administration on 31Jan2021 at 79-years-old at a single dose for COVID-19 immunization. Medical history included high blood pressure from an unknown date and unknown if ongoing, shrunk a little from an unknown date and unknown if ongoing ("about 5'9 and I was always 5'10 but I think I shrunk a little"). Concomitant medications included nebivolol hydrochloride (BYSTOLIC) taken for blood pressure high from an unspecified date to an unspecified date ("I have blood pressure, high blood pressure. I am taking a blood thinner. I was taking the other one, but they told me to look the other one (BYSTOLIC). It (BYSTOLIC) is a new drug I would say."). The patient previously received the first dose of the bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) for COVID-19 immunization on an unknown date and experienced adverse event ("no problem, nothing happened, there were minor things here and there"). On an unspecified date in Feb2021, the patient began to hallucinate (medically significant), dizzy (non-serious), and bed nightmare (non-serious). The patient did not receive treatment due to the events; "No, I just ignored it." The clinical course was reported as follows: The patient stated, "I took the virus vaccination shot (clarified as COVID 19 vaccine). The first one, there was no problem, nothing happened, there were minor things here and there. The second one I took was just this past Sunday. Something weird happened not right away, not the first day but probably it was second day, second or the third day, I am pretty sure I am not sure exactly, I think. I was not keeping track of all of that." The patient began to hallucinate; and when she got out of her bed, she suddenly had a feeling that she should look back. The patient stated that she looked back and there was her deceased sister (who died 37 years ago; according to the patient) and her daughter who was still alive; both were looking at her. The patient further reported the following: "They remained in my bed beside me. Okay, I ignored it and thought it was kind of funny because I know that my daughter is in (place name) and my sister is deceased. So, I am having a bed nightmare or something, so I ignored it. Then next thing it happened for a few days and then the dog that we just had euthanized, my daughter (name) had cancer and it was euthanized and what happened is, I was sitting on my sofa and I have seen the dog come out of my bedroom going to the bathroom but only the back of her and she disappeared. Then I spent the night at my other daughter's house and somewhere in the middle of the night I was awake in my something and I woke up and I looked over into my sistert's dining room and there was my brother standing there looking at me and there was two of his children sitting at the table also. I thought this is getting a little weird." The patient reported that nothing like this happened before. The patient wanted to understand the event because she "never had been dizzy from my drug, taking the drug (unspecified medication) that made me dizzy but that not the same thing what is going on here." The clinical outcome of the events was unknown. The batch/lot numbers for the vaccine, bnt162b2, were not provided and will be requested during follow up.

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.

Per NP note, "...presented to vaccine cancer center to receive first dose of COVID 19 vaccination. First dose of Pfizer vaccine (Lot # EN6202) administered. Immediately after administration, Pt complained of acute mid-sternal chest pain described pressure. EKG completed, Pt observed for an additional 20 minutes, reported spontaneous resolution of symptoms. Prior to discharge pain completely resolved, lungs clear to auscultation , cardiac exam with normal S1 & S2,no rubs, gallops or murmurs. Pt admitted to being anxious, has a documented history of white coat syndrome."

2/26 - severe flu symptoms (achy, no energy), drastic increase in memory related issues (has mild cognitive impairment) 2/28 - vomiting and diarrhea

Second dose of Covid vaccine given on 2/7/21. Administered at central location. Taken to hospital for possible stroke like symptoms with drooping to right eye and mouth, difficulty swallowing, and feeling odd. Admitted and treated from 2/18/21 thru 2/22/21.

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

pt stated that she had a sore arm and trouble sleeping. Pt contacted her PCP about not being able to sleep so she was given a RX for Trazodone 50mg but pt is concerned about taking it due to the side affects.

shaking chills (rigor) 12H post shot; muscle aches; headache; fatigue (slept all next day); brain fog; 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: el3247 and expiry date: unknown), via an unspecified route of administration on 28Jan2021 10:45 at a single dose for COVID-19 immunization. Medical history included mild asthma and mild hypertension. Patient was not pregnant at the time of vaccination. The patient did not receive any other vaccine within 4 weeks prior to covid vaccine and had unspecified medications within 2 weeks. The patient experienced shaking chills (rigor) 12H post shot, lasted 3 hrs; also has muscle aches, headache (3days), fatigue (slept all next day), brain fog on 28Jan2021 23:00. Outcome of the events was recovering. Patient took ibuprofen 36 hours after shot as treatment for the adverse events. The reporter considered the events non-serious. Patient was not diagnosed with COVID-19 prior to vaccination and had not been tested since the vaccination.

The patient had near-syncope and confusion about 2 minutes after receiving a vaccine. She is diabetic and hadn't eaten at all yet and thought it was more of a metabolic derangement. She was sent to the ER.

Progress Notes APRN (Nurse Practitioner) ? ? Family Medicine Cosigned by: MD at 3/8/2021 3:04 PM COVID VACCINE CLINIC 3/8/2021 Patient Date: 3/8/2021 MRN: Subjective Pt is a 79 y.o. female who was seen at COVID Vaccine Clinic today for her first dose of the COVID 19 vaccination. She was given the Pfizer vaccination in the left deltoid muscle. During her 30 minute waiting period after the injection, the patient began to experience lightheadedness. She denied rash, difficulty breathing, difficulty swallowing, wheezing, throat tightness, hoarseness, itching, dizziness, facial swelling, lip swelling and tongue swelling. This provider was notified of patient reaction and she was then assessed in the emergency bay area. Monitored patient for severe reaction symptoms, including but not limited to blood pressure abnormality , rapid progression of symptoms and respiratory distress. Past Medical History: Diagnosis Date ? Allergic rhinitis, cause unspecified ? Allergy ? Asymptomatic postmenopausal status (age-related) (natural) ? Atrial fibrillation (HCC) PAF ? Breast cancer (HCC) ? Calculus of kidney ? Depressive disorder, not elsewhere classified seasonal ? Egg allergy ;No flu vaccine due to egg allergy ? Measles without mention of complication ? Mixed hyperlipidemia ? Obstructive sleep apnea (adult) (pediatric) ? Osteoarthrosis, unspecified whether generalized or localized, unspecified site ? Other complications of anesthesia, initial encounter hard to wake up ? Outcome of delivery, single liveborn ? Rubella without mention of complication ? Tinnitus ? Unspecified essential hypertension ? Unspecified hypothyroidism ? Varicella without mention of complication ALLERGY REVIEW OF SYSTEMS: Patient denies chills, fever, malaise/fatigue, sore throat, frequent throat clearing, eyes watering, eyes itching, puffy eyes, eye redness, cough, chest tightness, shortness of breath, wheezing, rash, hives, eczema, itching of skin, dizziness and headaches Negative for vision changes: + lightheaded: Previous Reactions: vaccines d/t hx of egg allergy. Objective Vitals Vitals: 03/08/21 1313 BP: 126/64 Pulse: 61 SpO2: 99% Physical Exam Constitutional: General: She is not in acute distress. Appearance: Normal appearance. She is well-developed. She is not diaphoretic. HENT: Mouth/Throat: Mouth: Mucous membranes are moist. Pharynx: Oropharynx is clear. Eyes: Extraocular Movements: Extraocular movements intact. Conjunctiva/sclera: Conjunctivae normal. Pupils: Pupils are equal, round, and reactive to light. Cardiovascular: Rate and Rhythm: Normal rate and regular rhythm. Pulses: Normal pulses. Heart sounds: Normal heart sounds. Pulmonary: Effort: Pulmonary effort is normal. No respiratory distress. Breath sounds: Normal breath sounds. No wheezing. Skin: General: Skin is warm and dry. Neurological: General: No focal deficit present. Mental Status: She is alert and oriented to person, place, and time. Gait: Gait normal. Psychiatric: Mood and Affect: Mood is anxious (slightly, improved after removal of mask for a few minutes. Pt placed mask back on. Feels better). Behavior: Behavior normal. Thought Content: Thought content normal. Judgment: Judgment normal. Assessment/Plan Treatment included: see physical exam Follow up response to treatment: excellent. Patient discharge: Stable to go home and follow up with PCP. Differential Diagnosis: Vaccine-Related Anxiety (include misc mental health) Anxiety Pt observed in bay area for 15 minutes. Improved and is doing well. Pt assisted out via wheelchair by husband. Pt declined help out. She felt well in standing position in the medical bay prior to discharge. Pt declined water and snacks. F/up with pcp as needed. APRN Electronically Signed 3/8/2021 1:33 PM

nausea; She was just not quite herself; feeling hot and sweaty; feeling hot and sweaty; not feeling well; shaky; nervous; This is a spontaneous report from a contactable consumer (patient). A 79-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: EL9265), via an unspecified route of administration, on 02Feb2021 12:00 at a single dose on the right arm for COVID-19 immunization. Medical history included asthma, knee surgery, and bulging disc. The patient had an MRI on an unspecified date in Jan2021 (a week and a half prior to the date of initial report) with result of bulging disc. Concomitant medications included fluticasone furoate (ARNUITY ELLIPTA) for asthma; She was supposed to take 1 puff a day. However, being in the house, she had no problems, she had maybe used it twice a week since she hasn't had any problems, she last took 1 puff on 01Feb2021). She was also taking vitamin pills concomitantly. On 04Feb2021 23:00, 2 days after the vaccine, the patient had sweats, was wringing wet, and was not feeling well. Her hair was wet, and she was sweating. She was okay on the morning of 05Feb2021 but not herself. She had a little nausea on 05Feb2021. She was just not quite herself on 05Feb2021 but doesn't have the sweats. She further reported that she had her first shot on 02Feb2021 12:00. She was fine and had no problems. However, on night of 04Feb2021, before bed, she started getting hot and sweaty, like she was wringing wet. She didn't feel good, but 2 days had gone by and she was fine. She also went to bed with something like chills (later clarified as not chills), she went to sleep on the morning of 05Feb2021 and felt okay but not that great. When queried when the chills started, she said that it was not really chills, she was just very sweaty, wringing wet. She stated that she never sweats, and in this case her whole hair was wet. Being older, she was wondering what was going. Her feeling hot and sweaty subsided during the night. She did start to feel nausea, or she thought maybe she hasn't had anything to eat and so had a half banana and then she was okay. She thought she was hungry and felt funny, she had the half banana and was okay. She also felt a little shaky and nervous on 04Feb2021; however, it all subsided after going to bed. At the date of report, 05Feb2021, she felt okay but she didn't feel completely herself. Her second dose is scheduled on 26Feb2021 at 9:15 AM. Outcome of events feeling hot and sweaty was recovered with sequel on 05Feb2021. Outcome of event not feeling well was unknown. Outcome of event nausea was recovered on 05Feb2021. Outcome of the events shaky and nervous was recovered on 04Feb2021. Outcome of she was just not quite herself was not recovered.

nausea, severe headaches and bodyaches, extreme weakness, vomit, cough, fever, chills, unable to perform daily activities, took bonine and tylenol

Uncontrollable shaking, inability to walk, inability to talk, hands hot to the touch, incontinence, inability or desire to eat - all began 4:30pm on the day after first vaccine given (Tuesday 2 Mar 2021) . Patient had to sleep in a reclining chair for 3 nights and was prompted to drink water and was given one Tylenol 650mg. During this time patient needed INCREASED assistance with toileting and could not have a shower with assistance (instead was given a sponge bath). Symptoms lessened over the three days and patient returned to her baseline by Saturday 6 Mar 2021.

Very severe malaise, nausea, lack of appetite, weakness, urinary frequency (every 15 min x 2 days - urine totally colorless though I was not drinkiing anything, yellow tint gradually reappeared over next 3 days), no fever, memory and concentration much worse than usual, could not even think well, joint pain ,prolonged excessive sleepiness (nearly has resolved after 2 weeks)

Very sore arm. Achey joints muscles, extreme fatigue, stiff neck, "fuzzy" thinking. Most gone after one day. Arm still a little sore.

Headache; very sore joints; so weak had trouble walking; so weak had trouble walking; went to bed night of vaccine didn't get up till Sat morning; This is a spontaneous report from a contactable consumer (patient). A 79-years-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot number Unknown), dose 2 via an unspecified route of administration, administered in right arm, on 25Feb2021 at 12:15pm (at the age of 79 years old) as single dose, for COVID-19 immunization. Facility where the most recent COVID-19 vaccine was administered was reported as Public Health Clinic/Veterans Administration. Medical history included allergies to sulfa. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient was receiving other medications within 2 weeks of vaccination however they were not provided. The patient received dose 1 of BNT162b2 (Lot number EL-9262) in right arm. The patient did not receive any other vaccines within 4 weeks prior to the BNT162b2 vaccine. On 25Feb2021 at 18:00 (6:00pm), the patient experienced headache, very sore joints, so weak had trouble walking and "went to bed night of vaccine didn't get up till sat morning". Treatment was not received for the events. Since the vaccination, the patient has not been tested for COVID-19. The clinical outcome of the events headache, very sore joints, so weak had trouble walking and "went to bed night of vaccine didn't get up till sat morning" was recovering. The batch/lot numbers for the vaccine, PFIZER-BIONTECH COVID-19 mRNA VACCINE, were not provided and will be requested during follow up.

patient had dizziness about 5 minutes after the vaccination, patient felt like she needed oxygen and so we decided to contact ems once she stated she was having feelings of passing out. patient was seen by ems an ekg was run, blood pressure was 200/100 and the ems advised her that this may be a panic attack related to getting the vaccine that the increase in blood pressure was not a hypertensive emergency. patient then chose to stay and wait for her daughter to come pick her up. her blood sugar was also taken and it was 99 within normal range.

2 hours after shot extremely antsy . Within 2 days walking normal was a problem which continued for a couple of weeks. "Fuzzy" brain is still happening. 0- 60 is still continuing.

delirious; could not even form a thought; Dry cough; difficulty breathing; vomiting; This is a spontaneous report from a contactable consumer (patient). A 79-year-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration at the age of 79-year-old, administered in Arm Left on 23Feb2021 13:30 (Lot Number: EL9267) as single dose for COVID-19 immunization. Medical history included hypertension, glaucoma, and COVID-19. The patient had no known allergies. The patient was not pregnant. Concomitant medication included amlodipine taken for an unspecified indication, start and stop date were not reported; latanoprost taken for an unspecified indication, start and stop date were not reported. The patient experienced delirious, could not even form a thought, dry cough, difficulty breathing, vomiting on 24Feb2021. Adverse event: February 24; All side effects listed by CDC except vomiting, also had dry cough, difficulty breathing and delirious (could not even form a thought). No treatment received for the events. The outcome of the events was recovering. The event delirious was considered as serious (medically significant). No other vaccine in four weeks. The patient was diagnosed with COVID prior vaccination. Not COVID tested post vaccination.

Cold; Felt drugged; Tired; Chills; This is a spontaneous report from a contactable consumer (Patient) reporting on herself. A 79-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number was not reported) via an unspecified route of administration on 09Feb2021 as single dose for COVID-19 IMMUNIZATION. Patient medical history and concomitant medications were not reported. On 09Feb2021, the patient experienced tired, chills.Clinical course of the events includes: On 10Feb2021, the patient states the next day in the afternoon she got a little tired and cold, she laid down for a while, had dinner at 6, had a bowl of chili and got really, really tired, states she was so tired she could not even put her dish on counter, states she felt drugged is the only way she can describe it.The patient states that she got in bed and she got the chills, they lasted for hours, the next day towards the evening got chills again and that lasted about 3 hours and they were gone by 11Feb2021. Patient was in the car and does not have card with her at this time and could not provide much details about product. The outcome for the events was reported to be recovered on 11Feb2021. Information on batch/lot number has been requested.

About 2 weeks after administration and patient returned to clinic and complained of left upper arm pain from vaccination that awakes her at night. No warmth or redness. Patient was encouraged to follow up with PCP.

2ND DAY AFTER 2ND SHOT, EXTREME PAIN IN HIP JOINT YOU SIT ON; NO UPPER BACK PAIN. TOOK 2 EXTRA STRENGTH TYLENOL ACCORDING TO DIRECTIONS EVERY 6 HRS UP TO LIMIT FOR 2 DAYS. AFTER 1ST SHOT, 2ND DAY, EXTREME PAIN ONLY IN RIGHT HIP; TOOK EXTRA 2 STRENGTH TYLENOL EVERY 6 HOURS FOR ONE DAY. WASN'T SURE IF CAUSE WAS WEATHER(THOUGH I'VE NEVER HAD THIS HAPPEN BEFORE) OR SHOT. TODAY i AM SEEING MY MIND HAD BEEN FOGGY, ONCE AGAIN NOT FORGETTING TO TAKE MEDS; RETURNING TO DOING DAILY LIVING TASKS, BED AND DISHES ETC.

Vomiting and diarrhea two hours after shot. Foggy head for 4 days. Severe joint pain for for 3 days. All ended 04/02/21 except for fatigue which has been ongoing.

about 3 inches below site she had a rash/rash was about 3 inches below the injection site; below site she had a rash, It was still red; below site she had a rash, swollen, little bit of swelling; below site she had a rash, it was still little sore to touch; below site she had a rash, itchy; Second day I was still tired; had no appetite; Extreme tiredness; chilling; Small fever of 100.5; dull headache; Slept for about 12 hours; This is a spontaneous report received from a contactable consumer (patient). A 79-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), second dose via an unspecified route of administration, administered in Arm Left on 28Mar2021 at age of 79-year-old (Lot Number: EN6208) at single dose for COVID-19 immunization. Medical history included a little bit asthma, pine allergy, oak allergy, food allergy, 'blood pressure', stroke. Concomitant medications included losartan taken for blood pressure; hydrochlorothiazide taken for blood pressure; omeprazole; fluticasone taken for allergy; acetylsalicylic acid (BABY ASPIRIN); vitamins. The first shot she had, she ended up with a small bruise about the size of a quarter but she did not have any bruise with the second shot. The patient just wanted to report the side effects from the second Pfizer COVID-19 vaccination. She received the second one in the afternoon on 28Mar2021. And on 29Mar2021, just a little less than 24 hours later, it was at about 13:30, she got hit with extreme tiredness and she got in the recliner and got a little blanket and then she started chilling. She did not have the shakes but she couldn't get warm. She ran a small fever of 100.5 and this was for about 4 hours. And she had a dull headache. She slept for about 12 hours out of 16 that day on 29Mar2021. And then, the second day on 30Mar2021 she was still tired and had no appetite and the third day on 31Mar2021 about 3 inches below site she had a rash, swollen and itchy and 01Apr2021 was the fourth day, but it was still sore. The swelling was way down but the rash was still there and it is still itchy. She did take paracetamol (TYLENOL) that first day for the headache and chills. The paracetamol she took was two of them and they were 8 hour arthritic dosage. When paraphrased the concern, the patient stated the rash was about 3 inches below the injection site. It was still red, little sore to the touch, most of swelling down and there was little bit of swelling and red and it had gone down on 01Apr2021. Treatment for events included paracetamol and she had laid down and slept. The outcome of rash, swollen, sore below the injection site were resolving, the red and itchy below injection site was not resolved, the outcome of other events were 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.

Pneumonia; got Covid; doesn't have her appetite back; still kind of shaky/was trembling and shaking; lives with her niece and she found her in between china cabinet and fireplace and asked her how long she been there and she didn't know/going to the bathroom on herself and she doesn't recall that; This is a spontaneous report from a contactable consumer (reported for herself). This 79-year-old female patient received her first dose of the BNT162B2 (Pfizer covid vaccine, Lot number: ER2613 expiry date: unknown) via an unspecified route at left arm as a single dose on 23Mar2021 11:00, for Covid-19 immunization. Medical history included diabetic, cholesterol, acid reflux; had a reaction to tetramycin: she had shortness of breath, sweating, and light headed-ness, 30 years prior to this report. She stated that it was a form of penicillin and they didn't have penicillin so they gave her something else. Concomitant medications included metformin(METFORMIN) for diabetic, fexofenadine hydrochloride (ALLEGRA) and ibandronate sodium (BONIVA). It was reported that she skipped Boniva, that she usually would take at the end of the month. On 25Mar2021, two days after first dose, she got covid and pneumonia . She visited emergency room and was admitted in the hospital from 26Mar2021 till 05Apr2021. The patient did not have her appetite back, felt still kind of shaky, and was trembling and shaking. She did not remember what happened on the 24Mar2021 and 25Mar2021. It was stated that she was improving but she was not back to par. she was not trembling. She stated that she was not fully recovered. She was scheduled for her second dose in 2 weeks on 13Apr2021. It was stated that she had got a list of concomitant medications she was taking (unspecified names) and she did not think any of them would have interacted with this and she was taking them way before she got the Covid shot, also stated that she did not think she had bad underlying issues. The patient had her blood sugar checked and was given her insulin because of Covid and something else. She did not receive any additional vaccines on same date of the Pfizer Suspect or prior vaccinations (within 4 weeks). The patient did not have any Antipyretic (around the date(s) of Vaccination). The patient was recovering from the event of Pneumonia. The outcome of the events of doesn't have her appetite back and shaky/was trembling and shaking was not recovered, however the outcome of the events of Covid and did not remember what happened on the 24Mar2021 and 25Mar2021 was unknown. No further information was provided.

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.

Since the second dose of the Pfizer vaccine, up to and including today, I have had daily periods of fogginess. I feel as though I am wrapped in cotton and am seeing things from a distance. These events generally go away in anywhere from 15 minutes to half an hour. Sometimes the recur in the same day, sometimes not. When I am in the fogged state, when I take a step, I find I have no control of, or contact with my lower limbs and I stumble. This has been going on for over a month. And the feeling of exhaustion felt after dose #1 and dose #2 has continued intermittently.

exhausted/tiredness; She says she feels a little fuzzy, like she is not thinking clearly; Discomfort; mild malaise; Trembling; 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; Solution for injection; Lot Number: EN6202; Expiry Date: 30Jun2021), administered in left arm on 03Mar2021 (at the age of 79-years) as SINGLE DOSE for covid-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date in Mar2021, the patient experienced discomfort, mild malaise, trembling, on an unspecified date she says she feels a little fuzzy, like she was not thinking clearly and she says she was not able to do anything due to exhaustion. she has been having three days of discomfort and mild malaise for a week. The patient says she was not able to do anything due to exhaustion, so she thought Pfizer would want to know. She says that she could not type due to trembling to complete a report online. Patient second dose was on 26Mar2021, and they did not ask for her vaccine card, so she does not have and was not able to provide NDC/LOT/EXP from the second dose. She says that the NDC was not provided on her vaccine card for the first dose. The patient mentions a COVID test, but says that this was just a paper, she had forgot that she had a card, the test was to do a job. Patient says it was the second dose that she had a reaction after. She says she got both doses in her left arm. She says her reaction was discomfort and mild malaise beginning Saturday. Patient said that it has not got better or worse, she was having intermittent trembling periods where she would feel ok but then start shaking and be exhausted again, so it has been about the same since Saturday. Patient said that she will be ok for a couple hours, and then it will all start again, and she will shake all over. Patient felt a little fuzzy, like she was not thinking clearly, and so tired and trembling. The patient said that her prolonged reaction was not enough to go to the hospital, but she was not feeling so good, and thinks maybe people should be warned. The patient did not receive any treatment for adverse event. The outcome of the events was unknown. No follow-up attempts are needed. No further information is expected.

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.

SOB began within 24hrs of receiving second vaccine dose on 03/31/2021. Scheduled appt with PCP for 4/27/2021. Up to that date she continued to experience SOB. Unable to breath in supine position. Had to sleep in chair. Developed 4+ pitting edema in lower extremities. On 4/27/2021 the PCP sent patient to Hospital ER. Patient was admitted to cardiac floor.

pt started having strange pains all over her body and was extremely tired wanting to sleep all the time. She stays in constant pain. She states her existing wounds and health conditions were heightened and quadrupled the pain. Pt went to PCP on 2/15/21. She had a FU on 3/29/21. She was sent for multiple tests. She was referred to NP. She saw a NP on 3/16/21. She was prescribed gabapentin medication and physical therapy. She had a strange reaction to the meds so is no longer taking it and goes for PT eval on 5/7/21. She now has trouble sleeping now and is still in pain.

The exact dates and information of the vaccine is not available to me. She presented to my care after being admitted to the hospital with altered mental status. She has had cerebral ischemia since her vaccination, e.g. she's had a stroke.

vary sore arm; pain in part of the neck; bad headache; Injection site swelling; Injection site redness; Nervousness; Feeling unwell; Arm pain; Vomiting; Her neck hurts; Her hurting shoulder; This is a spontaneous report from contactable consumer. A 79-years old contactable female consumer (patient) reported for herself that she received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/lot number: EW2171), via an unspecified route of administration on 27Apr2021 at single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. Historical vaccine included BNT162B2 on 27Mar2021 for covid-19 immunization (first dose and lot number- ER8732). On an unknown date, the patient experienced very sore arm, pain in part of the neck, bad headache, injection site swelling, injection site redness, nervousness, feeling unwell, arm pain and vomiting. The outcome of the events was unknown. No follow-up attempts are needed. No further information is expected.

I'm Nervous; First dose Moderna, second dose Pfizer Vaccine; This is a spontaneous report from a contactable consumer (patient). A 79-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), at same age, dose 2 intramuscular, administered in left arm near shoulder on 17Feb2021 16:00 (Batch/Lot Number: EL9266) as single dose for didn't want to get the virus; covid-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), dose 1 via an unspecified route of administration in left arm near shoulder on 28Jan2021 (Batch/Lot Number: EL9269), at unspecified dose for didn't want to get the virus. Medical history includes cholesterol and thyroid. Concomitant medication included simvastatin taken for cholesterol from 2011; levothyroxine taken for thyroid from 2011. Patient had pneumonia vaccine about 5 years ago (2016) and arm swelled up for almost 6 months and was red, never received second pneumonia vaccine. She is not pregnant at vaccination time. The patient was nervous. Patient went to the doctor for a physical. She received first dose Moderna Vaccine and the second dose Pfizer Covid Vaccine. She didn't' know she received the Pfizer Covid Vaccine until she waited the first 15 minutes after the Pfizer Covid dose two was administered. Patient went to get a physical, took a blood test to see if had antibodies, there are none. She just found out there are no antibodies and stated she was nervous. Patient surprised got two different vaccinations. The outcomes of events were unknown. No follow-up attempts are needed. No further information is expected.

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.

nauseous; couldn't sit up; spinning; This is a spontaneous report from a contactable consumer. A 79-year-old female consumer (Patient) reported that she started to receive BNT162B2 (BNT162B2, formulation: Solution for injection, vaccinated at the age of 79-year-old) via unknown route of administration from 21Jan2021 16:00 to 21Jan2021 16:00 at single dose daily for covid-19 immunization. Patient's medical history was reported that, I have allergy to penicillin and sulfur but this was 50 years. Felt like my throat and ears were closing. Concomitant medications were not reported. It was reported that caller she received the first dose of the Pfizer vaccination on 21Jan2021 at around 4 in the afternoon. She had a bad reaction. She drove 1 hour and 45 minutes away and she was fine that night. Caller stated, "The next morning, I was nauseous. I couldn't sit up. I had to call my daughter to help me sit up. When I tried to sit up. it was like it was I had to push (myself and my daughter) up a mountain in a tornado. I couldn't control my body even if you tried. It was a very severe reaction if not vertigo. It was awful. spinning widely, nauseous. I called the doctor and he prescribed some vertigo medication/nausea medication. We tried an Epley maneuver for vertigo. spinning uncontrollably. which ear it was in. did the epley maneuver itself. I couldn't bend down. The last week or so I've been cautious but ok, tried to seen ENT and I have a therapist to help me do that Epley maneuver again. I don't want to set off anything. I don't know if you had any reports of any like that? I'm due to get my next shot 11Feb2021 and I have to drive 2 hours again and will have to drive home again. I'm most concerned and my doctor feels I need to get the second dose too. I reported to VAERS. The outcome of events was "unknown". Information on lot/ Batch number has been requested. 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.

She got her vaccine, she had no symptoms. The following day had very little soreness and nothing else. Went to bed, woke up soaking wet, diarrhea, vomiting, dizzy. She did not have skin feeling funny like with regular flu, but mostly all intestinal. She changed her clothes and then was shivering and could not get warm, and had hard shaking chills. She slept very little and has had it continuous since the vaccine. She has been falling a sleep a lot, day, night and was previously very active and now falls asleep at a drop of a hat. Over the past week and a half has had the cold chills less, but has awakened moist. She is having the diarrhea and GI issues less, but feels nauseous at times during the day. She is still waking up between 11:00 and 2:00 waking up, but falls sleep a lot, does not have a regular schedule as she did before. It is not debilitating as much but still tired a lot.

Depressed/depression; It has caused diarrhea that has persisted for 8 weeks; Soreness/her shoulder was sore; This is spontaneous report received from a contactable consumer (patient sister, Caregiver). This is report 1 of 2. This report is in regard to the reporter's sister. A 79-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: Unknown, NDC number: Unknown, Expiry Date: Unknown), via unspecified route of administration on an unspecified date (about two months ago) as 2nd dose single for covid-19 immunization. The patient had History with Oral lichen planus From an Unspecified date and unknown if ongoing). Concomitant medications were not reported. Patient did not have any other product. Reporter stated that, she doesn't know the specific day of vaccination. It has caused diarrhea to the patient that has persisted for 8 weeks. GI doc gave Lomotil, and it helped a little bit. She has had to change her diet and cut out vegetables because it made the diarrhea worse. Patient was very depressed. Patient wanted to know if It was reported earlier and why would it cause the ongoing diarrhea. Patient had seen that that it causes sometimes severe diarrhea, but it didn't say how long it will last. Patient was concerning about if someone need to take an immunosuppressive medication to stop the diarrhea. She was afraid her doctor is going to tell her she needs to take an immunosuppressant medication. It also had stated like, if the Pfizer aware that people have to take medications that shut down the immune system. Upon follow up on 27May2021, reporter stated that, patient was very depressed (on unspecified date) about it. She had a tendency of having autoimmune problems, that she had oral lichen planus, sometimes called burning mouth syndrome. Her doctor diagnosed her with oral lichen planus, which is an autoimmune reaction to bell peppers, she was eating a lot of bell peppers. patient has a hyper immune system. She did not take any type of autoimmune medications no Humira or immunosuppressive medications. Patient took the COVID-19 vaccine 8 weeks ago and patient developed the diarrhea by the 4th day after the vaccine. Patient had never had diarrhea her entire life. Patient went into shock. Her sister's diarrhea was still ongoing. The gastro doctor gave her sister Lomotil and the Lomotil was working to a point, it prevents the worst of the diarrhea. Her stool was coming out very loose. Reporter did not have the NDC number, lot number and expiry date for the Lomotil, stating it was a prescription, chemical name called atropine or something (as reporter). Patient changed her diet and was becoming depressed. Normally, her sister is a person very concerned for her health and she would have a plant-based diet with multiple vegetables, and now her sister can't do that. patient felt her life depends on having a healthy diet. Patient had vaccinated at pharmacy or something, reporter was concerned that, patient got a good vaccination that was not corrupt in any way. Reporter was urging patient to get the vaccine because she travels and goes to a different country and this and that. So, she could be able to travel. patient has a hyperactive immune system, it appears so anyway. Reporter was using her own words when she uses the term hyperactive immune system, so this may not be medically accurate. Her sister has oral lichen planus which is a bad problem. patient was eating a lot of bell peppers. Bell peppers produce an immune reaction, because they contain a chemical called solanine. patient was eating a lot of bell peppers because the internet said they were healthy and contained a lot of vitamin A. she got an immune reaction to the bell peppers, and the immune reaction produced sores under her sister's tongue, very painful sores. Patient had side effects happen three or four days later after the vaccine- it started as diarrhea and she thought it would stop. Patient's shoulder was sore. reporter mentioned she doesn't know when patient's soreness began and ended. The soreness did completely go away for patient. No Additional Vaccines Administered on Same Date of the Pfizer Suspect. Event Did not require any visit to emergency Room or Physician Office. Prior Vaccinations within 4 weeks of the suspect vaccine and events following prior vaccinations were none. Patient's Family Medical History was related to the autoimmune stuff, clarified as the oral lichen planus. Patient had oral lichen planus and was previously treated with steroids. The oral lichen planus started with sores under her sister's tongue. Her sister was treated twice with steroids. Patient said the steroids were successful. Patient's sores were treated with a steroid once and then the sore returned so she went back to the same doctor, and the doctor treated her again with steroids. The second time, the sores went away. At that point, this condition was called burning mouth syndrome, which is on the internet, it was a known condition that is very painful. The doctor diagnosed it as burning mouth syndrome. The diarrhea her sister is experiencing was causing a psychological effect. Reporter stated that, there was no warnings of if a person who has an overactive immune system shouldn't take the COVID vaccine, there was no kind of warning. Reporter seriousness for all the events were Unspecified. Outcome of all the events were unknown. Information on the lot/batch number has been requested.

I still have extremely horrible muscular skeletal full body pain and have not been able to manage my normal duties at home after receiving 2nd dosage of the vaccine. I have gone for acupuncture, massage therapy, and water therapy; however, none of the treatments work. I was prescribed Tramadol and it just isn't working for my symptoms.

Chief Complaint Patient presents with o Shortness of Breath HPI 79 year old female patient with a history of hypertension and diabetes presents to the emergency department with complaint of dyspnea since March 3. Patient states that she received her first COVID vaccine last week and felt like she initially had mild chills. No fever, denies chest pain or leg swelling. Patient notes her symptoms have become progressively worse over the past couple days, she has been uncomfortable at night sleeping. She states she feels short of breath all the time, even at rest. Assessment: 79 year old female patient presents to the emergency department with complaint of worsening shortness of breath for over one week. Differential diagnosis: Pneumonia, hypoxia, acute respiratory failure, CHF, flash pulmonary edema ED Course and Disposition: Patient received about 1 min of therapy from a duo neb treatment and became increasingly anxious and hypoxic. Patient became progressively more anxious and was unable to keep non re breather mask on. SpO2 in the low 80s patient anxious stating "help me, give me a tranquilizer", unable to speak in full sentences and acutely confused. Patient was intubated by Dr. for acute respiratory failure, tolerated well. BP and HR improved after labetalol. Chest xray showed patchy opacities suspicious for viral or atypical bacterial pneumonia. Clinical presentation and acuity of condition concerning for flash pulmonary edema. COVID negative. Treated with Rocephin and doxycyline to cover pneumonia. IV lasix given for diuresis. Patient will be admitted to the ICU. I had a detailed discussion with the patient's daughter regarding the historical points, exam findings, and any diagnostic results supporting ICU admission. Based on the patient's history, exam, and diagnositic evaluation, there is indication for further emergent intervention and inpatient treatment. Discussed case & plan with Dr. who also independently evaluated the patient and agrees with the course of care and plan. Critical Care There is a high probability of imminent or life threatening deterioration due to respiratory failure. Acute interventions include develop tx plan w/pt or surrogate, eval pt's response to tx, documenting the case, initial hx & physical exam, order & review of radiology studies, order & perform tx & interventions, re-eval of pt's condition and vent management.

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.

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.

She thought she might die; Felt a bit strange and wasn't sure what she was feeling.; feeling her heart beating really hard she felt it from her hips, trunk up to breasts/ chest.; This is a spontaneous report from a contactable consumer (patient). A 79-year-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm Right on 06May2021 16:30 (Batch/Lot Number: EW0173; Expiration Date: Aug2021) as 0.3 ml, single dose for covid-19 immunisation at the age of 79-year-old. Medical history included ongoing diabetes, ongoing joint injury, She had a need for knee surgery. The patient has never had any vaccines in her life, not the flu shot or measles or anything. There were no concomitant medications. On 06May2021, the patient felt a bit strange and wasn't sure what she was feeling, feeling her heart beating really hard she felt it from her hips, trunk up to breasts/ chest and thought she might die. The events felt a bit strange and wasn't sure what she was feeling, feeling her heart beating really hard she felt it from her hips were recovered on 06May2021, outcome of thought she might die was unknown. The events didn't result in visit to Emergency Room or Physician Office. She received the dose 2 (Lot EW0182, EXP date Aug2021) on 27May2021. The clinical course was reported as: after she received the vaccine she stayed around 30 minutes and seemed ok so she left. She received her shot at 4:30 pm and after she got home she decided she wouldn't know what to do if she had side effects so she decided to lay down on her bed. She states she thought she felt a bit strange and she wasn't sure what she was feeling. After 3 and half hours, while laying on her back, she describes feeling her heart beating really hard she felt it from her hips to the trunk, up to breasts/ chest. Her heart was beating so hard, like thump thump thump, it did not get fast or slow, it was just steady. It was beating so hard that she could feel is shake the bed that she was laying on. The patient stated the doctor has already been informed about her events. She states she didn't call anyone because she thought she might die and she was afraid to move to call. She told herself to just relax, relax, relax so the stress wouldn't bother her. She states the events lasted 3-4 hours but scared to pieces and she was to scared to reach for the phone. she did not go to the doctor about it but told her doctor about it during her check up a couple weeks later and she did routine labs but not for that. She states she is a diabetic. She states she lives alone and is a relatively new widow. The patient stated she has never had any vaccines in her life, not the flu shot or measles or anything. Follow-Up (29Jun2021): Follow-up attempts are completed. No further information is expected.

rash around the injection site and some on the chest, on both of my arms on my neck my face and sides on my right leg; rash came on both of my arms on my neck my face and it was peeling on the face; Within a half an hour swelled a little bit and then went down.; rash around the injection site and some on the chest that went away; the swelling on the face also; a lot of itching; Really Disturbed quality of sleep.; rash came on both of my arms on my neck my face and it was peeling on the face; This is a spontaneous report received from a contactable consumer (Patient). A 79-year-old non pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: EN5318), via an unspecified route of administration, administered in Arm Left on 23Feb2021 10:00 (at the age of 79-year-old) as dose 2, single for covid-19 immunisation. Medical history included allergy to penicillin. Concomitant medication included LOSARTAN, METOPROLOL, DILTIAZEM HCL, MAGNESIUM P. AMINOBENZOATE. Patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. The patient had not been tested for COVID-19 since the vaccination. Patient historic vaccine included bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: EL9262) via an unspecified route of administration, administered in Arm Left on 28Jan2021 10:15 AM as dose 1, single for covid-19 immunisation. On 04Mar2021, within a half an hour swelled a little bit and then went down. After second shot in about two days rash around the injection site and some on the chest that went away but then rash came on both of her arms on her neck her face and it was peeling on the face the swelling on the face also. Then the rash was on her chest on her sides on my right leg. It had continued since the 1st of March. She did have to go to Urgent Care twice and get medication. She was not able to get into her doctors office She was just now going to be able to go on July 7th. The medication helped temporarily. She was going to do a natural bowel cleanse and then a liver cleanse and then a kidney cleanse to try to get this eliminated. She reported a lot of itching. Really Disturbed quality of sleep. Had gone on for so many months she was tired of it. But she reported, it was better than getting covid and being in hospital with heart or lung problems. Events were reported as serious by the reporter. Patient did not receive any treatment due to adverse events. On an unspecified date in 2021 the events swelled a little bit and rash around the injection site and some on the chest was recovered and other events was not recovered.

tested positive for Sars-COV-2; tested positive for Sars-COV-2; Felt terrible and hardly out of bed; Felt terrible and hardly out of bed; This is a spontaneous report from a contactable consumer (patient). A 79-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in arm on 29Jan2021 08:00 (Batch/Lot number was not reported) as dose 2, single, via an unspecified route of administration, administered in arm on 08Jan2021 08:00 (Batch/Lot number was not reported) as dose 1, single for covid-19 immunisation. Age at vaccination was 79-year-old. The patient medical history was none. Family medical history relevant to the events was none. Concomitant medications included hydrochlorothiazide, triamterene (TRIAMTEREEN/HYDROCHLOORTHIAZIDE) taken for blood pressure measurement; vitamin B12; ascorbic acid (VITAMIN C); colecalciferol (VITAMIN D 3); biotin. Prior Vaccinations (within 4 weeks) included: She got a flu shot, but she did not know the date of when she received it last. She did not remember whenever she got her shingles shot. It was two shots, that she got from Pharmacy. She thought she got the second shingles shot in Mar2021. She thought she got the first shingles shot six months before that (2020). Lot number and expiration date were unknown for both doses of the shingles shot. The patient experienced that she tested positive for Sars-COV-2 on 11Jul2021. She stated her symptoms consist of respiratory, a bad cold, chills. She felt terrible and hardly out of bed. She did not have fever. Coughing, cold. She walked three miles a day. The patient underwent lab tests and procedures which included Rapid covid test: negative on 11Jul2021, Send off covid test: positive on 11Jul2021. The outcome of the events was unknown. Information about lot/batch number has been requested.

lump that looks like the top third of a small egg, on the clavicle; closer to the joint than to neck. It felt like bone. No pain. It seemed to "spread out." Wider, but not as defined; Aches after movement, such as going for a walk or vacuuming; right lymph node in my neck was tender; scratchy throat; slept on-and-off for most of the day; following the second vaccine I ran alow grade fever the following day.; This is a spontaneous report from a contactable consumer, the patient. A 79-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER2613) via an unspecified route of administration in the right arm on 17Mar2021(at the age of 79-years-old) as a single dose for COVID-19 immunisation. Medical history included chronic kidney disease stage 3 from an unspecified date. The patient had no known allergies. 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: EN6202) via an unspecified route of administration in the right arm on 24Feb2021 at 16:15 (at the age of 79-years-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 18Mar2021 the patient experienced low grade fever. On 20Mar2021 at 06:00 the patient experienced mass, ache, lymph node tenderness, itchy throat, sleep disturbance. It was reported that third morning following second vaccine, the patient woke up with a lump, that looked like the top third of a small egg, on her clavicle; closer to the joint than to her neck. It felt like bone. No pain. It seemed to "spread out." Wider, but not as defined. The past few days it was back with a vengeance. Aches after movement, such as going for a walk or vacuuming. Also, following the second vaccine she ran a low-grade fever the following day, her right lymph node in her neck was tender and she had a scratchy throat. As it progressed, it felt as if her throat was closing, and then it disappeared just about the time she was getting concerned. She had slept on-and-off for most of the day. The next day she was fine, but still had the bump. The patient did not receive any treatment for the events. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of events mass, ache, lymph node tenderness, itchy throat, sleep disturbance, low grade fever was not recovered at the time of reporting. No follow-up attempts are needed. No further information is expected.

Patient presented herself to LPN slurring words and 'not herself'. Upon evaluation, patient denied drinking alcohol, knew she was not able to speak correctly and visibly frustrated . With great difficulty she was able to communicate that she had a headache and was slightly dizzy. Failed FAST and does have a history of CVAs. EMS called and patient was taken to ER where they admitted her for observation post Stroke. Per the hosp nurse, patient received tPA treatment and will be moved to step-down unit when a bed is available.

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."

24Hr, 01/09/2021-post vaccine found in room on floor- very shaky and SOB, again later the same day-incontinent urine, confused, pain in extremities with movement, sent out to hospital. returned same evening. 01/12/2021- difficulty communicating, confused- sent out to hospital, returned same day. 01/15/2021- symptoms improved

Pt. left POD after receiving vaccine and waiting allotted 15 minutes. Pt. then returned to POD clinic because was feeling flushed. Pt. also c/o headache. Pt. was noted to be very shaky and have elevated blood pressure upon assessment. BP: 198/92, rechecked 179/82, RR: 16, O2 sats: 98%. Assessed by local EMS. Pt. plans to follow up with PCP.

Patient came back from cardiology appointment (at 2pm) unresponsive. It was reported that she had vomited while at the appointment. She was confused when she could be aroused, stating that she does not have a name.

I began with mild arm ache 24 hours after vaccination, 72 hours later the site became swollen, red and itchy. Overall I feel fatigued and lost my appetite. In addition when I had CoVID in September I experienced difficulty falling or staying asleep. I experienced that last night again. I am very tired but unable to fall asleep.

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.

This is my second report. Had headaches 2/12 days. Feeling out of my skin and irritable. Hope to feel better soon. Don?t know whether to take second shot on Feb. 18 2021.

began to run a fever, so she had a COVID test which came back positive; began to run a fever, so she had a COVID test which came back positive; her arm began to be sore; feels pretty crummy; This is a spontaneous report from a contactable consumer (patient). An 80-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK9231), via an unspecified route of administration on 07Jan2021 likely around 2pm-ish at a single dose for COVID-19 immunization. Medical history included diabetic from 1993 to an unknown date. There were no concomitant medications. The patient called about the Pfizer BioNTech COVID19 vaccine and says she took the first shot on 07Jan2021, then one week later, 14Jan2021, she began to run a fever, so she had a COVID test on Monday 18Jan2021, which came back positive. She says she has had a fever at the time of report for the 7th day. The patient received the vaccine and doesn't know if she is willing to get the second shot after this. The patient was asking if it could be a false positive, can she take ibuprofen, can she take the second dose and could the vaccine cause coronavirus. She says that she got the first dose of the vaccine, it was injected into her left arm, and it wasn't painful, she felt so good, then night of 07Jan2021 her arm began to be sore, her vaccine arm was now ok, she started feeling sick a week later. She has been taking Tylenol only, since she heard that it is not good to take Ibuprofen. Tylenol EXP: Mar2024, LOT: SEA054, she says that the Tylenol is 325mg, and she has been taking two at a time, she takes it when she needs it for the fever, she tries to space out doses 5-6 hours. Her temperature on morning of 20Jan2021 was the highest it has been, 102.1 degrees Fahrenheit. She says she has kept a log, it has also been 101.4, 100.5, after it started out a week ago at 99.7, 99.1, 99.5, and then on Saturday, unknown date in Jan2021, it started climbing up, it has been 100.4 degrees Fahrenheit last two to three days and higher, she feels pretty crummy. She has had a positive COVID test which she took Monday 18Jan2021 and the results came back morning of 20Jan2021 on the phone, it is unknown which test exactly they used. She says it was the 2-3 day one with a swab, she did her own swabbing and swabbed each nostril with the same swab really well. The events were reported as non-serious. Outcome of the event her arm began to be sore was recovered in Jan2021, for the other events was unknown.

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.

severe body aches starting evening of vaccine (dose #1), along with worsening weakness. Vaccine given 1/26/2021. Pt with ED visit for body aches 2/8/21 (high ESR > 100). Then admitted for observation 2/9/21

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.

I was like and off balance; I was tired and I wasn't quite myself, I wasn't myself; I was just feeling like tired and a little bit weak-ish; I was tired and I wasn't quite myself, I wasn't myself; I was just feeling like tired and a little bit weak-ish; I was tired and I wasn't quite myself, I wasn't myself; I was just feeling like tired and a little bit weak-ish; Little bit light headed /The way I was laying down I got more dizzy; This is a spontaneous report from a contactable consumer (patient) An 80-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number/expiration date unknown) on 20Jan2021 at single dose via an unspecified route of administration for COVID-19 immunization. Relevant medical history included blood pressure problems and Blood sugar abnormal (a little bit of blood sugar). Concomitant medications included metoprolol tartrate for blood pressure management. On 22Jan2021 the patient experienced 'little bit light headed /the way I was laying down I got more dizzy' and 'was tired and I wasn't quite myself, I wasn't myself; I was just feeling like tired and a little bit weak-ish'. On an unspecified date the patient also complained 'I was like and off balance'. At the time of the reporting event outcome was unknown. Information on Lot/Batch number has been requested

severe sinus like headaches come on in evening with severe neck pain.; hard to sleep; severe sinus like headaches come on in evening with severe neck pain.; This is a spontaneous report from a contactable consumer. An 80-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 19Jan2021 10:30 at single dose (Lot # EL8982, EXP-20May2021) for covid-19 immunisation Medical history included Osteoporosis of spine, left thyroid removed, acid reflux. Known allergies: penicillin, latex. No other vaccine in four weeks. No COVID prior vaccination. Concomitant medication included levothyroxine sodium (SYNTHROID), lisinopril, colecalciferol (VIT D3), omeprazole. The patient experienced after 2nd day severe sinus like headaches come on in evening with severe neck pain. Have had this for 4 nights, hard to sleep. Events start date: 20Jan2021 08:00 PM. Treatment included Advil (cold and sinus) every day to help. It did help, but did not like to take this type of medicine that often. No COVID tested post vaccination. Outcome of events was not recovered.

This person received the 1st dose COVID-19 vaccine Pfizer @ 08:13am. Then @0930 am, c/o "feeling something on top of her chest, heaviness of chest", sweaty hands, clammy, chest pain. Rapid Response Team called at 09:35 am. Transferred to Emergency Room. In ED: Diagnosis included but not limited to STEMI, NSTEMI, unstable angina, anxiety. At 10:04am- based on EKG, code STEMI was called. Consultation with cardiologist. Then the patient was sent emergently to Cath Lab. The patient was admitted to ICU, intensive care, following Cath Lab

To ED 1/28/2021- 17:06 complaints of racing heart, and increased blood pressure. ED - B/P 200/107- very anxious. Administered 0.1mg oral Clonidine and B/P significantly improved - at discharge B/P 177/76.

pt states that she had a left arm and mild body aches for a couple of days after getting the covid vax. Three or four days later she started getting dizzy and nauseated. She says she feels hungry even after she eats. Pt states the dizziness comes and goes and is normally in the morning. She doesn't feel right and feels unsafe when she walks like she may fall. Pt contacted her PCP on 2/23/2021 and they just told her to see if the symptoms went away and the FU if they did not.

Chills, vomiting, worsening confusion. Patient had vomiting that began about 48 hours after vaccine dose. Had subsequent chills. No fever. Evaluated by her primary care provider on 2/26 AM and the ER at Hospital on 2/26 PM. Noted to have chills, nausea and vomiting in the ER. Also noted to have tachycardia, likely related to her atrial fibrillation. She had been unable to take her home medications due to vomiting and had missed her rate controlling medications. She was given IV Zofran and Tylenol with good control of her chills and vomiting.

She had the Pfizer vaccine of Feb 1st and then a bladder botox injection of Feb 2nd at 915am. At 2pm on Feb 2nd she started to feel "absolutely terrible" with extreme fatigue ,mental fogginess and throat pain with tightening sensation in her throat. it has gradually "gotten a bit better" but she still has these symptoms.

Had shallow breathing; Very weak; Could not walk; Disoriented; Wanted to sleep; Incoherent; couldn't/wouldn't eat; Dehydrated; This is a spontaneous report from two contactable consumers (primary reporter was patient's husband). An 80-year-old female patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date were not reported), via an unspecified route of administration on an unspecified date at a single dose for COVID-19 immunization. Medical history included ended up in the hospital for 2 weeks with pneumonia and COVID-19 at the end of last Summer. The patient's concomitant medications were not reported. The patient's husband reported that the patient received the first Covid shot about a week to two weeks ago. She went to the facility and got the shot and was fine afterwards until she came home. Later that afternoon, she started showing symptoms of problems, was weak and couldn't walk, disoriented, wanted to sleep, was incoherent, couldn't/wouldn't eat, was very, very much having trouble, shallow breathing. He tried to stay right her and eventually it got to be scary for him with her shallow breathing. He ended up calling an ambulance and she went to the hospital. They gave her tests and was there until about 4 or 5 in the morning before she started showing signs. She was dehydrated was a part of it. The tests were showing the symptoms were improving and she was beginning to come out of it fortunately with doctor's care because he didn't know what to do. He had been going through materials and she is coming up on another shot next Monday and does not want her to go through that if it can be helped. She was coming up for the second shot. Saw something on the tv that rattled him to his bones. It had been found that people who had Covid virus previously and then got the shot may not need a second shot. He is trying to flush that out to whether or not that is something or not that she should be considering. They have the card to go back to the same place for the second shot and they are trying to figure if they need to set up an appointment now. Hoping that this was the worse of it and it is hard for them to call back and his physician is not an expert on this and he got Pfizer's office contact number and decided to call. Outcome of the events was recovering. Information on the batch/ lot number has been requested.

On 3/6/21 - One hour after the shot, left facility and drove home -- my nose became quite stuffy -- muscus membrane swelling mainly -- not much phlegm to be cleared out - settled down about an hour later without taking any medications. Starting on 3/7/21 - Sore & stiff muscles in both arms - aching joints and muscles in legs also, stiff neck and waves of nausea that come and go. - also very groggy & fatigued On 3/8/21 - Woke up more aching, swollen glands under left arm and headache starting - took only Tylenol for the headache . Rest of symptoms still in effect. Stayed home from work to take it easy. Hoping things will pass by tomorrow or Wednesday

Myocarditis/had another virus that went to her heart; trouble remembering; incredible fatigue; could sleep around the clock; brain fog; This is a spontaneous report from a contactable nurse (Patient). An 80-years-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL9265), intramuscular at Right Deltoid from on 16Feb2021 11:00 at single dose for covid-19 immunisation. Medical history included stomach was burning, heartburn, low thyroid, myocarditis and was hospitalized a year ago, Milroy's disease, and low potassium, heart disorder and Back disorder. Concomitant medications included bumetanide (BUMEX) Has been taking for about 40 years for Milroy's disease, rosuvastatin calcium (CRESTOR) from Jan2020 for Myocarditis, levothyroxine Has been taking for 40 years for low thyroid, tramadol Started about 10-12 years ago for back, metoprolol from Jan2020 for heart, omeprazole (PROTONIX) Started taking about 8 years ago for stomach was burning and heartburn, potassium Has taken for 40-50 years for low potassium, vitamin B12, vitamin D3 and baby aspirin 81mg, all were ongoing. The patient received first dose of BNT162B2 (lot number: EL8982) on an unknown date for covid-19 immunization and she got a really sore arm. The patient experienced Myocarditis/had another virus that went to her heart on an unspecified date, brain fog on 17Feb2021, trouble remembering on an unspecified date, incredible fatigue on 17Feb2021, could sleep around the clock on 17Feb2021. The clinical course as following: injection was on 16Feb2021. She has had incredible fatigue. She was asking how long is the fatigue going to last. She knows it is a side effect but she could sleep around the clock. She stated she goes to bed at 6PM if not before then and gets up at around 8AM and by 9AM she could go back to bed. She is sorry she got the shot because she is miserable. She mentioned she has been reading up on the vaccine and it said "you might have fatigue for a day or two". Her fatigue has now been 8 days. She thought "how long is this going to go on". Patient reported that with the first shot she got a really sore arm. Stated she thinks the person giving the injection put the darn thing through her bone. She thought it was to be expected, but it feels like the person who administered the vaccine was a poor shot giver. She provides the first Covid Vaccine Lot number: EL8982. With the second shot her arm did not get sore at all. The only thing she's having was the fatigue, she can hardly walk past her bed without wanting to get back in it. She tries to get up to shower and fix her hair and be motivated and she's been fighting the fatigue all day to not get back in bed. When probed for the seriousness criteria of the fatigue, the caller explains she doesn't think it's that significant. She thought it will go away. However, she was just coming out of myocarditis. She was just in the hospital for myocarditis and they did a heart cath and she has no plugged arteries, nothing. They couldn't find anything other than she had another virus that went to her heart. She had another virus a year ago January. She wonders if COVID was out there then, because she had never been so sick with the flu. She kind of diagnosed her problem and it was like a wave over her body. She also had a terrible irregular pulse. When she went to the hospital the next morning, her cardiac enzymes were 4.5 times more than normal, her troponin was out of sight. She doesn't think that would have a bearing because she should be coming out of that myocarditis because of the medication the doctor put her on. She doesn't know if that would complicate it, too. Her heart doctor said a lot of people have myocarditis, especially athletes, but they are young and fall over dead. 90% of the time, its myocarditis because you don't know you have it. She reports she's getting a foggy brain. Her son asked her who her dentist was because she had a root canal and she couldn't think of the dentist's name. She thinks her son threw that in because her son knew that she wouldn't be able to remember. She's not confused. It's just difficult to get the word out, but if she waits a couple minutes, she has the answer. She is also getting old, too. She lives by herself; she has no stimulation and she thinks that is significant to her circumstances. She thinks it's a problem with the COVID-19 injection. Caller explains she had blood work very recently about 2 weeks ago. She just looked at lab reports and everything was okay except one of the vitamins was a tiny bit high (she can't remember what the vitamin was), but nothing she was worried about. It could have been a Potassium was a little high, but she is not worried about that. Her main question is how long the fatigue last, she thought for only 1-2 days. She mentions she took her temperature every morning and its always like 97 something and it's never wavered. The outcome of the events brain fog, incredible fatigue, and could sleep around the clock was not recovered and the outcome of the other events was unknown.; Sender's Comments: Based on the information provided, viral myocarditis is most likely due to a viral infection in this patient with cardiovascular co-morbidities and is not related to suspect product. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate. This case will be reassessed upon receipt of additional information.

She got out of bed at 2AM to go to bathroom and doesn't remember a thing. She fell face down on tile floor.

Caused severe dementia symptoms for an active elderly female. Female was able to live independently and take care of every day activities, such as bills, cooking, cleaning, driving, grocery shopping, e.t.c. After vaccination, elderly female had symptoms of rapid dementia. Female needed constant supervision daily and was no longer independent. After 6 weeks, elderly female is able to continue every day activities with minimal supervision.

Multiple strokes resulting from blood clots starting 10 days past 2nd shot. Fuzzy headed with headache prior to strokes.

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.

reported Blood Pressure jumping/blood pressure shot up; nausea; headache; icky feeling; patient experienced light headedness, dizzy and icky feeling; This is a spontaneous report from a contactable consumer or other non hcp (patient herself). A 80-years-old female patient received second dose of bnt162b2 (BNT162B2, Formulation: Solution for injection, Lot Number: EN6204, Expiry date: Unknown) via an unspecified route of administration in left arm on 10Mar2021 13:30 as single dose for covid-19 immunisation. Medical history included hypertension, caller says she has had hypertension prior to getting vaccine. The patient previously took first dose of bnt162b2 (BNT162B2, Formulation: Solution for injection, Lot Number: EN6201, Expiry date: Unknown) via an unspecified route of administration in right arm on 17Feb2021 as single dose for covid-19 immunisation. There was no family history relevant to adverse events. There were no concomitant medications. Additional Vaccines Administered on Same Date of the Pfizer Suspect. The patient had not received any other vaccine within 4 weeks prior to the vaccine. On 13Mar2021, patient experienced light headedness, dizzy and icky feeling, on 15Mar2021, experienced blood pressure jumping/blood pressure shot up and on an unspecified date patient experienced nausea and headache. Caller says she has had hypertension prior to getting vaccine. Caller got her 2nd dose, "last Wednesday on 10Mar2021". Caller says she had no issues until Saturday/Sunday. Caller experienced: nausea, light headedness, icky feeling, headache. Caller says she has never had a "continuous headache before". Caller had a pre-existing appointment with doctor that Monday after. During appointment, caller had systolic blood pressure reading of 205. Caller says the doctor "gave me a little orangeish coloured pill, she was monitored after that in office." Caller says she was told to go to emergency room from doctor office. Caller had EKG and blood work done at emergency room and sent home to continue to monitor blood pressure and follow up with her doctor. Caller is asking, "has anyone else reported Blood Pressure jumping". Caller also says, "I know people have headache and nausea, how long does that usual last" Caller asking how long her headache might last. Dizzy/Lightheaded/Icky feeling: She said that she still has a kind of a funny headache. She said that she is never really sick and can't even remember having a cold. Caller said that her blood pressure is currently in the 140's and 150's systolic. She said that it has been high for a number of years, but it has never been as high as 205 that she can recall. Caller said that her blood pressure dropped while she was at the hospital and she was discharged from the emergency room. The caller was not admitted to the hospital. Caller does not remember the diastolic number from her blood pressure. The patient underwent lab tests and procedures on 13Mar2021, which included blood pressure measurement: systolic was 205. The outcome of the events light headedness, dizzy, icky feeling and blood pressure jumping/blood pressure shot up were recovering and nausea, headache were unknown.

March 27,28,29 Severe diarrhea, foggy head. March 29 Altered mental status, symptoms of stroke, loss of memory for short period of time, diarrhea,headache-recurrent. Low sodium levels

Within ten days her Alzheimer's progressed rapidly, she could no longer coherently answer questions, she is confused as to the day, month, year, not recognizing family members. This is not usual for her.

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

Patient immediately began felling unwell after vaccination. Patient felt "generally unwell" and in a daze. Never alleviated, but second dose received. Patient then developed hypertension, tachycardia and was diagnosed with Afib within 2 weeks of vaccination. Patient was hospitalized and a pacemaker was placed.

arteries in my head on that side is narrowing, were narrowed.; seizure; it felt like somebody hit me on the head; I am sleeping a lot; violent headache; my body jerked; This is a spontaneous report from a contactable consumer (patient). An 80-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: ER8733), via an unspecified route of administration on 06Apr2021 (at the age of 80-years-old) as a single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient previously received the first dose of BNT162B2 on an unspecified date for COVID-19 immunisation. Consumer stated, "What happened when I came home exactly at 1:50, I had it exactly at 5:15. I thought somebody shot me in the head. I had the TV remote in my hand, and it felt like somebody hit me on the head and remote went flying across the room and on to the floor. That was the first time and a half hour later it happened again I had a teaspoon in my hand at the dinner table, my body jerked and that went across the room than it happened two more times. I had nothing in my hand. But I jerked in my body, body jerked and a violent headache for 6 days now. I have had MRI of the head and I have to see if my neurologist, but he cannot see me till the 30Apr2021." Lab work: Consumer stated, "I went and had the MRI." When asked for any other help, consumer stated, "No, but I still don't know. I still have to go to my neurologist and my artery doctor because they said my arteries in my head on that side is narrowing, were narrowed. So, I am in for a long holiday. I had to go to a lot of doctors to figure out what they are going to do, and I am sleeping a lot, there is something wrong. I just want Pfizer to know just something not right with that. If you want also my husband but he came with me and he had shot with me. He had headache for five days but nothing else just the headache for 5 days from the same LOT." On 21Apr2021, information due to 2nd shot of Pfizer was again reported. She had a reaction 4 hours after that shot, kind of like a seizure, she had a TV remote in my hand and out of nowhere it when flying out of my hand across the table and onto the floor, this result happened 4 times within two hours that same day. Have had headache for 16 days since. The patient underwent lab tests and procedures which included magnetic resonance imaging: unknown result on an unspecified date. The outcome of the events was unknown.

Patient had severe aching after wk of vaccination starting (4/20/21) and currently still has (5/3/21) with difficulty getting out of bed

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.

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,

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.

shingles; rash on right inner thigh; leg was painful and tender to the touch; didn't sleep well; This is a spontaneous report from a contactable consumer (reporting for herself) via the medical information team. An 80-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Left on 24Feb2021 (Batch/Lot Number: EN6203; Expiration Date: Jun2021) as 1ST DOSE, SINGLE for COVID-19 immunization. Medical history included surgery in the fall for cervical disc and cholesterol. Concomitant medication included simvastatin taken for cholesterol, start and stop date were not reported. On 25Feb2021 (reported as "the next day"), the patient noticed on her inner right thigh it felt like a rash but there was nothing there, but it felt like there was. The leg was painful and tender to the touch. The patient also didn't sleep well and talked to someone on 27Feb2021 (reported as Saturday) and said it sounds like shingles to them. The patient talked to the doctor and they felt like it was shingles. The doctor put the patient on medication which has really helped a lot. The rash was not getting worse, it has just stayed a little better and the same. The doctor prescribed her prednisone and valacyclovir, 1mg three times a day. The rash seemed to get worse in the evening, it was painful all around her leg, she thought it was a blood clot, but then realized no because the pain was on the outside it doesn't feel like it was on the inside. The rash wasn't red, Friday late afternoon it started being raised. The pain in her leg was sensitive but not like it was. The patient has kept her leg covered, its impossible to do this because of where it was on her leg. The pain was worse Friday night, the patient was able to sleep Saturday night, it was still sensitive. The outcome of the event didn't sleep well was recovered on 27Feb2021 while the outcome of the other events were recovering.

pain all over body; Chest pain; Leg pain; severe pain on her neck, she couldn't lift her head; Monday morning she couldn't get out of bed.; the red blood cell count was low; the hemoglobin was low; having to use a walker; anxiety; her heart starts racing; has been taking steroids and her weight has shot up like crazy now she is 120 lbs; The platelets which is the ones that do the clotting, normal high is 200 and hers were higher than normal at 760; This is a spontaneous report from a contactable consumer (patient) via Pfizer-sponsored program. An 80-year-old (currently she just turned 81-year-old) female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in arm left on 03Feb2021 3:20 PM (Batch/Lot Number: EN5318) as single dose at the age of 80-year-old for covid-19 immunisation, as care provider for her husband, administered at a COVID vaccine clinic setup. Medical history, family medical history and concomitant medications were none. She has been very healthy. Before BNT162B2 first dose, In Jan2021, 2 weeks prior BNT162B2, she got the second dose of shingles shot (VARICELLA VACCINE) for immunization with no adverse effect. No adverse effect occurred following prior vaccinations. No other history of all previous immunization with BNT162B2. No additional vaccines administered on same date of BNT162B2. In Feb2021 she experienced pain all over body with outcome of recovered, chest pain with outcome of recovered, leg pain with outcome of recovered, severe pain on her neck. In 2021 the patient experienced the platelets which is the ones that do the clotting, normal high is 200 and hers were higher than normal at 760, she couldn't lift her head, Monday morning she couldn't get out of bed, the red blood cell count was low, the hemoglobin was low, having to use a walker, anxiety, her heart starts racing, has been taking steroids and her weight has shot up like crazy now she is 120 lbs. The patient underwent lab tests and procedures which included in 2021: haemoglobin: low, platelet count: 760 higher than normal at 760, red blood cell count: low , weight: 120lbs. Therapeutic measures were taken as a result of events. The course of events was as follows: After she got the first dose she had some adverse reactions in 2021: she had pain all over body, chest pain, leg pain, severe pain on her neck, that she couldn't lift her head. She has seen some specialists to seek assistance, she has seen a hematologist, and a rheumatologist. She has been on steroids and she was not yet done with the second dose of the Pfizer COVID 19 vaccine. Her doctor was very aware. When this started 3 months before, she 110 lbs but she has been taking steroids and her weight has shot up like crazy now she is 120 lbs, she told her doctor that she had no more fat clothes she will have to get off of the steroids, they blame everything on steroids. She said nothing else is relevant she was fine, in fact she was dancing the weekend before, that Saturday night she went to a Portuguese evening and was learning to do their dances and Monday morning she couldn't get out of bed. She refused to go to Emergency Room for the events. She has seen her doctor who requested she see a hematologist and a rheumatologist because she was having pain in her legs, she was having to use a walker. The hematologist found that her blood was out of whack. The platelets which was the ones that do the clotting, normal high is 200 and hers were higher than normal at 760, higher than what they call the high normal. The events pain all over body she had chest pain, leg pain, severe pain on her neck may have began a week after the vaccine in Feb2021. The pain was not ongoing, it was gone. They gave her massive doses of steroids she was taking 15 mg of steroids and right now they are lowering it. She had not the pain now but it was worse than childbirth. She has recovered completely from the pain, she felt fine now she has to wait until they take the steroids away again. She stated a lot of the blood, the red blood cell count was low, the hemoglobin was low, everything was low except for the platelets. So they told her to wait. She stated they blame everything on the steroids. Her anxiety started and her heart started racing, they said it was steroids, she was hungry they say it was steroids, she told the doctor she was gaining weight, they say it was steroids. No further information provided. She went to physician on 28Apr2021, the blood hematologist and they say it seemed that most blood work was back to almost normal everything was going down, the treatment she was receiving was working, the platelets were going down. She confirmed she had to wait to come off the steroids to get the second dose and she asked the doctor if she could get the second dose, she still wanted to get it but they told her she has to wait until she is completely off the steroids. The outcome of pain all over body, chest pain, leg pain, severe pain on her neck, she couldn't lift her head was recovered in 2021, of platelets which is the ones that do the clotting, normal high is 200 and hers were higher than normal at 760 was recovering, of she couldn't get out of bed, the red blood cell count was low, the hemoglobin was low, having to use a walker, anxiety, her heart starts racing, has been taking steroids and her weight has shot up like crazy now she is 120 lbs was unknown.

Patient is an 80 y/o right handed female who is totally independent at baseline who received her Pfizer vaccine out of the country (1st dose 2/19/21, 2nd dose 3/12/21). She was reactive to both shots, reporting arthralgias, headache, low grade fever, chills. She had a rise in blood pressure later during the day of her shot as well as the next day (up to 180/70, from baseline of 130/70). She also had an episode of epistaxis several days after her first shot. She traveled independently out of the country on 3/31/21 to visit her son on a leisure trip. On 4/5/21 she had headache, dizziness/lightheadedness, and did not feel well, and her systolic BP was 198, after which she took additional 40 mg of lisinopril. Her BP subsequently decreased to systolic BP of 130 mm Hg on 4/5/21, but over the next few days she had labile BP with a range of BP of 125 to 171/ 58 - 68. She was meticulous in checking and recording her BP several times a day, and she increased her lisinopril dose to 40 mg po qd from 20 mg po qd given the higher than usual blood pressure range. On 4/10/21 her BP was as follows: 6:30 am, 148/60 (she took her daily lisinopril 20 mg po); 11:30 am: 132/52; 3 pm: 171/69 (she took additional lisinopril 20 mg po) after which her systolic BP decreased to 130. Then around 6:20 pm the same day (4/10/21), she had acute onset of headache, vomiting, left sided weakness, SBP 220, and was witnessed to have rapid change in mental status. There was no antecedent trauma to the head. EMTs were called immediately and she had loss of consciousness during the ambulance ride to the ED, after about 20 minutes of symptom onset, with agonal breathing and bradycardia to the 40s, but never lost her pulse. Upon arrival to the ED out of the country, her Glascow Coma Scale (GCS) was 6, she was rapidly intubated and stabilized. Head CT demonstrated massive intraparenchymal hemorrhage (140 cc) within the R temporal parietal and occipital lobes, with cerebral edema and 14 mm midline shift, associated with small subdural hematoma and small intraventricular hemorrhage within the temporal horn and body of the R lateral ventricle. They reported hyperdense "spot sign" within the intraparenchymal hematoma compatible with active hemorrhage, no evidence of venous thrombosis, no masses, no arteriovenous malformations. She had 2.5 mm aneurysm right that was thought to be incidental finding unrelated to her event. She was taken emergently to the OR on 4/10/2021 for decompressive R hemicraniectomy, which she underwent successfully with minimal blood loss. She had no coagulopathy and her platelets and hemoglobin were normal. She remained in the Neuro ICU for 3 weeks. She received a tracheostomy two weeks after her presentation, and was weaned off the ventilator. She is breathing spontaneously after 5 weeks from presentation. She remains in coma or minimally conscious state, with GCS score of 5-6 as of 5/13/2021.

cut her left thumb right across the top with a cat food can lid; couldn't vacuum because she was so weak.; felt that she needed to lay down because she was so tired; felt like she had the full blown (COVID-19) Virus; regurgitating; nausea hit her like 'bang'; little bit of diarrhea; Weakness; felt deathly ill for a month; vomited up the Cephalexin 500mg; lost 25 lbs. in a month and a half.; very acute bronchitis that hit her after her first COVID-19 Vaccine; coughed and coughed for about 2-1/2 weeks; thought she had whooping cough; This is a spontaneous report from a contactable consumer (patient). A 80-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left on 28Mar2021 at 15:30 at the age of 80 years old (Batch/Lot Number: ER8727) as 1ST DOSE, SINGLE for covid-19 immunization. Medical history included uterine cancer (uterine cancer at 28 years old, had surgery for the uterine cancer); renal cancer (kidney cancer battled for 8-1/2 years. did not want another surgery, doctors did liquid cobalt treatments); nasal cavity cancer (had surgery to remove the cancer on nose about 7-8 years ago. had big hole taken out of her big Irish Cherokee nose. Thought the cancer was from her cat always hitting her with its claw on that side of her nose), bronchitis ( all her life) , radiotherapy (liquid cobalt treatments) , arthritis in back , kidney infection, pertussis, cytogenetic abnormality (missing half of a chromosome). Concomitant medication included estrogen nos (ESTROGEN NOS) 0.06 mg, 1x/day half of the pill in the morning, taking estrogen since she was 48 years old, meloxicam (MELOXICAM) 15 mg, 1x/day half of the pill at night for three years for arthritis in her back, cefalexin (CEPHALEXINE) taken for kidney infection, start and stop date were not reported. The patient previously took B12 shot every month (no additional information provided. No Additional Vaccines were Administered on Same Date of the Pfizer Suspect. No other vaccines were given within 4 weeks. The patient experienced felt like she had the full blown (COVID-19) Virus, regurgitating, nausea hit her like 'bang', little bit of diarrhea, Weakness, felt deathly ill for a month on 28Mar2021; lost 25 lbs. in a month and a half, very acute bronchitis that hit her after her first COVID-19 Vaccine, coughed and coughed for about 2-1/2 weeks, thought she had whooping cough, vomited up the Cephalexin 500mg on Mar2021; felt that she needed to lay down because she was so tired, couldn't vacuum because she was so weak on 09Mar2021, cut her left thumb right across the top with a cat food can lid on 10Mar2021 Treatment was given for cut on left thumb received 7 stitches in her left thumb on 10May2021 and bronchitis. Relevant Tests were reported as None. The clinical course was reported by the patient as follows patient received her first COVID-19 Vaccine dose on 28Mar2021 at about 3:30PM, and by 6:30PM, she felt like she had the full blown (COVID-19) virus. She stated started regurgitating. The nausea hit her like 'bang' and she had a little bit of diarrhea, and was really weak. She felt deathly ill for a month. Today (10May2021) was one of the first days she got dressed, and was up for the whole day. She said some days, she could not get up for more than an hour or two, and then she would have to go back to bed because she was so weak. Her doctor told her since the second COVID-19 Vaccine dose was supposed to be a little rougher than the first COVID-19 Vaccine dose, he didn't want her to get the second COVID-19 Vaccine dose. She said she was 80 years old, and had always been very self-sufficient. Stated she beat cancer 3 times. The patient called her physician, and her doctor wanted her to go to the hospital but didn't want to go. The doctor told her to take Cephalexin 500mg for 2-1/2 weeks, and then drop down to 1 Cephalexin 200mg nightly. Caller mentioned she kept Cephalexin 200mg and Cephalexin 500mg on hand in case she had symptoms of a kidney infection because she lived in a mountain town, and wasn't close to her doctors office. Since she had a history' kidney cancer she had more kidney infections'. Patient would take Cephalexin 500mg if she was hit hard with a kidney infection, and she would take Cephalexin 200mg is the kidney infection symptoms were just starting. Patient vomited up the Cephalexin 500mg. She said she lived on ginger ale and water. She stated she lost 25 lbs. in a month and a half. She said she was trying to gain back some of her weight now. No further details provided. Patient developed a very acute bronchitis that hit her after her first COVID-19 Vaccine. She clarified she coughed and coughed for about 2-1/2 weeks. She said she thought she had whooping cough, and had no way to stop the coughing. She could not vacuum because she was so weak. She said she went outside yesterday, and was outside for 20 minutes. She said she felt so weak, she went inside and laid down on her couch. She said she fell asleep for 4 hours. She said her weakness was like nothing she ever experienced before. Felt energetic and would start to do something, and then felt that she needed to lay down because she was so tired. She said she would go lay down, and then wake up 4 hours later. She doesn't think she was positive for the COVID-19 Virus. No further details provided. Patient stated she cut her (left) thumb (right across the top with a cat food can lid) this morning. She said the clinic in the valley, put 7 stitches in her left thumb today. The clinical outcome of the events Regurgitating, Nausea, Diarrhea, Vomited recovered; weakness, Ill feeling, Acute bronchitis, cough was recovering, while the remaining events was unknown. Follow up attempts are needed. Further information has been requested.

When she woke she felt like she did when she had Covid/felt like she had Covid; Chills; headache; temperature of 99.6-100.1F/Fever; I still felt a little tired; my arm was killing me; felt weird; felt weird like she was unsteady on her feet; This is a spontaneous report from a contactable consumer (patient). An 80-year-old female patient (Weight: 53.52 kg, Height: 157 cm) received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration, administered in Arm Left on 26Feb2021 08:30 as 1ST DOSE, SINGLE for covid-19 immunisation. She is unable to clearly identify the Lot due to illegible handwriting on the vaccine card. She thinks it is EN6200 or EN06200. Vaccination Facility Type: Clinic sponsored by (Name). Vaccine not administered at Military Facility. Medical history included covid-19 from 2020. She was also told that she might not need to get the second dose because of having antibodies. When she had Covid it was mild. She did not have the traditional symptoms. It affected her gastrointestinal system more. It was weird. Prior Vaccinations (within 4 weeks) was None. There were no concomitant medications. On 26Feb2021, after she got the vaccine, her arm was killing her. It was awful. She took Tylenol for it. Around 3-4pm she was feeling a little bit weird/"felt a little funny" like she was unsteady on her feet. She was not dizzy. She woke up the next day, 27Feb2021, felt "rotten", "almost like I felt when I had covid/ felt like she had Covid. Same symptoms, milder form": slight headache for 3 hours, chills lasted a couple of hours, temperature of 99.6-100.1F for 3 hours. She was awful in the morning and better as the day went on. It remined her of when she had Covid. After symptoms went away, she still felt a little tired. Didn't feel as good as she did before the day she took the vaccine. Caller said the vaccination Nurse told her that she might have more reaction because she may still have antibodies. Caller asking did she need to get 2nd dose? Should she expect reactions from the second dose? She still plans on taking it. The outcome of arm was killing her was recovering. Her arm is better but if she lays on her arm she can still feel it. The outcome of felt a little tired was unknown. The patient was recovered from other events on 27Feb2021. Information on the lot/batch number has been requested.

the day after 2 nd covid shot, family called to report fever 101.3 , mental status changes, incoherence, fatigue/tiredness, was instructed to call 911/visit ER for eval/tx. was admitted at Hospital and discharged after 24 h.

her heart beats heavy; she did not lay down back in bed; light headedness/ she experienced dizziness; nausea; This is a spontaneous report from a contactable nurse. An 80-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, left arm on 02Feb2021 at a single dose (at the age of 80 years-old) for COVID-19 immunization. The patient's medical history included vertigo, arthritis, anemic, muscle spasms, high cholesterol quadruple vessel bypass graft and patient concomitant medications included as atorvastatin, cyclobenzaprine. On 03Feb2021 during the night patient experienced dizziness, light headedness, nausea, heart rate abnormal, activities of daily living impaired. Patient's normally her heart beats heavy but that was normal to the patient. The patient had already been diagnosed with vertigo prior vaccination. Patient paperwork stated that it was not recommended to receive the second dose, but patient wanted to know if what patient experienced qualified for her not to take it. The patient known second dose was higher than the first dose. There were unknown investigations done. The labs from last time patient went for them, they were concerned patient LDL was very low and the cholesterol was off, this was about a month ago. The outcome of the events dizziness, light headedness and nausea was recovered. The outcome of the remaining events outcome was unknown. No follow-up attempts are needed. No further information is expected.

hallucinations; neurological disorder classified as early Alzheimer's/dementia; neurological disorder classified as early Alzheimer's/dementia; neurological disorder classified as early Alzheimer's/dementia; This is a spontaneous report from a contactable pharmacist. An 80-year-old female patient (non-pregnant at time of vaccination) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 17May2021 as single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not provided. Unknown if the patient received any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient did not diagnose with COVID-19. Since the vaccination, it was unknown if the patient had been tested for COVID-19. On 17May2021, the patient was admitted to the hospital due to hallucinations, neurological disorder classified as early Alzheimer's/dementia. AE resulted in Emergency room/department or urgent care, Hospitalization. Unknown if patient had treatment received for events. The outcome of the events was unknown. This report was assessed by the reporting pharmacist as serious; the seriousness criteria was caused/prolonged hospitalization. Information on the lot/batch number has been requested.; Sender's Comments: The information available in this report is limited and does not allow a medically meaningful assessment. Based on the limited information provided, the reported events are likely intercurrent condition that is unrelated to BNT162B2. This case will be reassessed once 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 RAs, Ethics Committees, and Investigators, as appropriate.

Woke up with excruciating pain in right hip; Could barely walk; Was tired the next morning on the 12th; severe chills of her life with her entire body shaking; Hard to get warm and sleep; This is a spontaneous report from a contactable consumer (patient). An 80-year-old non-pregnant female patient received second dose of BNT162B2 (Pfizer covid-19 vaccine, Solution for injection, Lot number: EL 9266, Expiration date: Unknown), via an unknown route in the left arm on 11Feb2021 at 15:00 as a single dose for covid-19 immunization. Medical history included known allergies: sulfur as a preservative and in any form and her blood does clot, but more slowly. Concomitant medications included Atenolol, 25 mg 2 times a day. Historical vaccine included first dose of BNT162B2 (Pfizer covid-19 vaccine, Solution for injection, Lot number: EL 8982), via an unspecified route in the left arm on 20Jan2021 at 16:00 as a single dose for covid-19 immunization. Patient did not receive any other vaccine in four weeks. On 11Feb2021 night and 12Feb2021 at 15:00, patient experienced most severe chills of her life with her entire body shaking, hard to get warm and sleep. She was tired the next morning (12Feb2021). She took a nap in the afternoon and woke up with excruciating pain in right hip and would barely walk (12Feb2021 at 15:00). Her severe pain continued. Adverse events resulted in doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. Patient received unknown treatment for the events. The patient underwent lab test and procedure which included sonogram on 18Feb2021. The clinical outcome of the severe chills with her entire body shaking, hard to get warm and sleep, tired was recovered, patient received a sonogram on 18Feb2021 and the next day the pain (excruciating pain in right hip) suddenly disappeared (19Feb2021) and outcome of event barely walk was also recovered (19Feb2021). No follow-up attempts needed. No further information expected.

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.

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

The 1 smaller bruise is a different color reddish.; Large Bruise; small Bruise; small and large Bruise was reported as worsened.; The bleeding at injection site; Swooshing feeling/distinct feeling; This is a spontaneous report from a contactable consumer (patient). A 80-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: EN5318) via an unspecified route of administration on 29Jan2021 as 1st dose, single (High Up on the left) for covid-19 immunisation. Medical history included Pre-diabetic from an unknown date and unknown if ongoing. Concomitant medications included levothyroxine sodium (SYNTHROID) taken for an unspecified indication, start and stop date were not reported. The patient received first dose on 29Jan2021. The swooshing soaring feeling was just immediate through the body upon a receiving the injection on the same day. The bleeding at injection site also occurred the same day 29Jan2021. The bruising she noticed the next morning, she was surprised she didn't think to pay attention to it the day she got the vaccine and so noticed it the next day after when she took off the Band-Aid on 30Jan2021. She arm was not sore but its just a discomfort more than any other injection however she heard on the news this was common. When she took the band-aid off the bruise was larger than the Band-Aid, it was larger than a 50-cent piece, Caller stated that she has pictures available. Caller clarified that she actually has 2 Bruises. 1 Large and 1 small. The small bruise looks like where the needle was injected, then next to it was the large bruise, the Bruises are adjacent to each other but has like a different make up. The 1 smaller bruise was a different color reddish. The larger bruise was purple, brown quite dark with a yellowish ring around. She again stated that she has a photo. The swooshing feeling only happened during administration, it lasted for a couple second after the shot. It lasted 15 seconds and went away, as if she wanted to fall over. The shot was like going under surgery. It was a distinct feeling. The large bruise seems strange, darker, and yellow around. The Small bruise looks brighter in color, more saturated in color, its not faded but getting more pigmented. Patient stated the product complaint includes she had received her first dose on 29Jan2021 she had bleeded when she received her first dose of vaccination, she stated that she had blood on her bandage, and she thought when she was going to surgery and she had shot in milder version and she had a bruise of size of 50 cent piece she thought this administration of vaccine might impact the development of antibodies. Covid Card: She needs a magnifying glass. Lot EN5318. It was a printed sticker on the card. Expiry Date is not on the card. The outcome of the events the bleeding at injection site, the 1 smaller bruise is a different color reddish was unknown and Large Bruise; small Bruise, small and large Bruise was reported as worsened was not recovered and Swooshing feeling was recovered on 29Jan2021. Follow-up attempts completed. No further information expected.

Huge bruise 50 cent dollar, did it get in the blood; Feeling like before surgery; This is a spontaneous report from a contactable consumer reporting for herself. An 80-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot Number and Expiration date was not reported), via an unspecified route of administration on an unspecified date (age at the time of vaccine 80-year-old) as unknown, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. on an unknown date, the patient experienced huge bruise 50 cent dollar, did it get in the blood; and had that feeling like before surgery. Patient questioned about what happens if administered in wrong distribution system. Clinical outcome of the events was unknown. 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.

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.

costochondritis; severe pain; can't sleep at night and stays up all night; pain is became worse as time gone on and they are getting desperate; This is a spontaneous report from contactable consumer or other health care professional (patient husband). An 80-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for Injection, Batch/Lot number: EP1533 and Expiration date Unknown) via an unspecified route of administration, administered in left arm on 30Mar2021 (at the age of 80-year-old) and first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for Injection, Batch/Lot number: EN6205 and Expiration date Unknown) via an unspecified route of administration in arm left on 09Mar2021 (at the age of 80-year-old) as single dose for COVID-19 immunisation. Patient received enoxolone, glycol salicylate, levomenthol, tocopheryl acetate (SALONPAS 30) from Jun2021 and permanently discontinued for pain, ibuprofen (IBUPROFEN) from an unknown date and ongoing for pain, codeine (CODEINE), from and unknown date and ongoing for pain and nerve ending blocking medication for an unknown indication from Jun2021 and ongoing. The patient's medical history and concomitant medications were not reported. Additional Vaccines Administered on Same Date of the Pfizer Suspect If applicable, list of all vaccines administered on same date with the Pfizer vaccine considered as suspect were reported as none. The patient has been having severe pain that was increasingly getting worse. Has been to the emergency room twice and seen multiple doctors and various specialists and given multiple drugs for relief that have not helped. They have scheduled to see a pain specialist in next week. At that time they really had not tried it to the vaccine at all. Costochondritis has been suggested and various other related spine issues and stuff. Stated her pain was getting severely and progressively worse and she could not sleep at night and stayed up all night. The pain pill given, it was just not lasting long enough and she only took it once a day and gets a little relief, but no sleep and up all night. Has been alternating heat and ice and it did not do it. They have not been able to sleep 80-90% of the nights and was up if not part but all night. It became worse as time gone on and they were desperate. They used the Salonpas and one burned her skin so they quit those about 2 weeks ago, sometime early June. The area has improved when she quit using those, but the skin was still sensitive and rough feeling. They had one medication prescribed when went to the emergency room, but she ran out of them and another medication. Was told she did not need to use the prescription ones and to used the over the counter ones and so they bought the Salonpas and it burned her. She was given anti-inflammatories and used Tylenol in the early stages and it helped a little bit, but not doing it now since given a pain medication. Unable to provide the name of anti-inflammatories or the Tylenol UPC, Lot, and expiries. Believes one of the anti-inflammatories may have been a supped up Ibuprofen, but could not recall, but it did not help. They believed the pain medication may have Codeine in it because it was only prescribed for a little bit at a time. It's one of those addicting type things. Has tried taking this pain medication in the evening to sleep, but that didn't work and she had so much pain in the morning. Has now been taking them in the morning and that lasts for 8 hours, but she was not allowed to take anymore until the next morning. The relevant tests were reported as none. Follow-up attempts are needed. Further information is requested.

Glaucoma; Crohn's aggravated; Platelet count decreased; Ill feeling; Illness; Confused; Blood disorder; This is a solicited report based on the information received by Pfizer [manufacturer control number: 21K-163- 3983476-00] from a non-contactable (patient) A 80-years-old female patient received bnt162b2 (PFIZER BIONTECH COVID-19 VACCINE ), dose 1 intramuscular on 14Feb2021 (Batch/Lot number was not reported) SINGLE at age of 80 years for covid-19 immunisation; adalimumab (HUMIRA), subcutaneous from an unspecified date (Batch/Lot number was not reported) and ongoing, at unspecified dose for crohn's disease. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient experienced glaucoma (medically significant) on an unspecified date with outcome of not recovered, Crohn's aggravated (medically significant) on an unspecified date with outcome of not recovered, confused (non-serious) on an unspecified date with outcome of unknown, blood (non-serious) on an unspecified date with outcome of not recovered, ill feeling (non-serious) on an unspecified date with outcome of not recovered, platelet count decreased (non-serious) on an unspecified date with outcome of unknown, illness (non-serious) on an unspecified date with outcome of unknown. The patient underwent lab tests and procedures which included platelet count: decreased on unknown date. The clinical course was reported as follows: On 14Feb2021, patient received first dose Of COVID-19 Vaccine manufactured by Pfizer. The patient experienced non-serious reactions to covid vaccine/confused/ill/platelet count dropped to dangerous level, glaucoma, illness/blood disease and crohns flare up with humira (adalimumab). There was no reported medical history. On unknown dates, the patient experienced reaction to covid vaccine/confused/ill/platelet count dropped to dangerous level, glaucoma, illness/blood disease and crohns flare up. Pfizer biontech covid-19 vaccine was also considered suspect. Additional information: It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.The action taken in response to the event(s) for adalimumab was dose not changed . Reporter's causality for Humira for Crohns aggravated was "Reasonable possibility" while for the other events was "No Reasonable possibility" Reporter's causality for PFIZER BIONTECH COVID-19 VACCINE was not reported for all events . The reporter's assessment of the causal relationship of the events with the suspect product was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment. No follow-up attempts are needed; information about lot/batch number cannot be obtained.; Sender's Comments: The events glaucoma, Crohn's aggravated, blood disorder, and platelet count decreased more likely represent intercurrent medical conditions in this 80 yo patient and are considered unrelated to the suspect drug. Patient was using adalimumab for Crohn's disease. Adalimumab may have contributed to decrease in platelet count and blood disorder given is known safety profile. Events malaise and illness are possibly related to the suspect drug based on known drug profile. The remaining event confusion is attributed to intercurrent or underlying conditionsin this 80 yo patient, and are considered unrelated to the suspect product. This case will be reassessed upon receipt of additional information.

Losing balance, leaning to one side; Diarrhea; Pain in legs cannot stand, pinching like small animals in body; Pain in legs cannot stand, pinching like small animals in body; Can barely walk legs hurt so much; Feels like she is dragging one leg; Itchiness on body; Feeling quite weird; This is a spontaneous report from a contactable consumer or other non hcp. This case was split to capture events after first and second dose of vaccine. This is the first of two reports, reflecting events after the 1st dose. An 80-years-old female patient received BNT162b2 (Pfizer Covid Vaccine, Solution for injection, lot number: EN0196, NDC and expiry date was unknown), via an unspecified route of administration, administered in Arm Left on 27Jun2021 as DOSE 2, SINGLE for covid-19 immunisation. Historical vaccine BNT162b2 (CONMINTARY, Solution for injection, Lot No: EN0164), via an unspecified route of administration, administered in Arm Left on as 07Jun2021 as 1stdose, single for covid-19 immunisation. Medical history included deep vein thrombosis from an unknown date and unknown if ongoing Verbatim: DVT Thrombosis Right Leg. There were no concomitant medications. The patient experienced itchiness on body on 27Jun2021 with outcome of recovered , feeling quite weird on Jun2021 with outcome of unknown , pain in legs cannot stand, pinching like small animals in body on Jul2021 with outcome of not recovered , pain in legs cannot stand, pinching like small animals in body on Jul2021 with outcome of not recovered , can barely walk legs hurt so much on Jul2021 with outcome of not recovered , feels like she is dragging one leg on Jul2021 with outcome of not recovered , losing balance, leaning to one side on an unspecified date with outcome of unknown , diarrhea on an unspecified date with outcome of unknown. Outcome of the events experienced itchiness on body was re-covered, feeling quite weird, losing balance, leaning to one side diarrhea was unknown, pain in legs cannot stand, pinching like small animals in body, pain in legs cannot stand, pinching like small animals in body, can barely walk legs hurt so much, feels like she is dragging one leg was not recovered .

Patient started gasping and wheezing about 10 minutes post vaccine injection. She turned red and gasped for breath. She started crying and hyperventilating. I used an EpiPen on her immediately within 2 minutes of her turning red and she seemed to calm down for a few minutes. She was able to talk and ask questions. We gave her water to drink but then she started crying again and seemed to have more anxiety. Paramedics came within 15 minutes and took over.

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.

Sick; Got real weak; Just did not feel right; Aching; Headache; Fatigue; Drowsiness; This is a spontaneous report from a contactable consumer (patient herself). An 81-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot# EL3249), via an unspecified route of administration on 14Jan2021 at single dose for covid-19 immunization. There were no medical history and concomitant medications. Patient stated she got sick after the shot on 14Jan2021 and she got her first Covid vaccine on Thursday 14Jan2021, she did not know how to get an appointment, said to make an appointment for her second dose, stated she tried to make an appointment for 04Feb2021 and they told her everything was booked, caller was looking for availability of the vaccine in her area, stated she cannot drive all the way to get the second vaccine. She had some aching, headache, fatigue, drowsiness and got real weak and just did not feel right on 14Jan2021. She stated she really wanted the vaccine because they have lost 5 people in her neighborhood to Covid. Caller wanted to know if she should still feel the side effects if that was normal and if when she got the second dose will she be safe from Covid. Caller stated she was still having headache today. Her daughter was nurse and she said those were normal side effects of the shot. She did not want to report this. She was better than she was on Thursday. She was not calling to report anything. She was calling because she was supposed to get the second shot. Outcome of fatigue, drowsiness, sick and not feel right was unknown, outcome of other events were not recovered.

pain on her left shoulder where they gave her the shot/had pain where they she had the injection in her arm; To the point where she felt like she "was going to pass out"; kind of weak/ having "no energy"/ she does not seem to have the energy/ it just droopy; felt dizzy; She has not been sleeping good; having a funny feeling; This is a spontaneous report from a contactable consumer (patient). An 81-year-old female patient receive first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EL8982), intramuscularly on 15Jan2021 16:15 at single dose in left arm for COVID-19 immunization. Medical history provided as none. There were no concomitant medications. There was no additional Vaccines Administered on Same Date of the Pfizer Suspect. There were no vaccines received within 4 weeks Prior Vaccinations. The reporter stated she received the first dose of the COVID-19 vaccine on 15Jan2021 (Friday) and felt fine. She added it then made her kind of weak on next Saturday morning on 16Jan2021, to the point where she felt like she was going to pass out on 16Jan2021, but it went away after laying down. She stated she felt pain on her left shoulder where they gave her the shot on 20Jan2021 but is fine today (21Jan2021). Lastly, she mentioned having no energy. She asked if her symptoms were reported sided effects of the vaccine. She has been having a funny feeling in Jan2021 and does not know if it is from the vaccine. She clarifies that she does not seem to have the energy on 16Jan2021. When she got home she was ok, the next day after she got the shot, she thought she was going to pass out and felt dizzy for about an hour on 16Jan2021. She has not been sleeping good for the last few days since Jan2021 and states that may be why she does not have the energy. For event does not seem to have energy, reports it comes and goes, states it just droopy and it may be she had pain where they she had the injection in her arm on 20Jan2021. She is asking if this is normal. The patient declined any Treatment. The reported adverse events did not require a visit to Emergency Room and Physician Office. The reported stated it wasn't that bad. The outcome of event Dizzy was recovered on 16Jan2021. The outcome of the event "was going to pass out" was recovered in Jan2021. The outcome of event "pain on her left shoulder where they gave her the shot/had pain where they she had the injection in her arm" was recovered on 21Jan2021. The outcome of event 'kind of weak/ having "no energy"/ she does not seem to have the energy/ it just droopy' was not recovered. The outcome of the other events was unknown.

Following the vaccine, the patient reported feeling "loopy" and a "little nauseous" about 20 minutes after vaccine was given, and attributed this to likely not having eaten earlier. The patient was found not to be diabetic and was given some crackers, juice and water. She was offered to go to a private room for further monitoring, but declined. Her condition did not improve, so she was taken to a private room for monitoring and observation at about 2:30PM. Vitals were taken, she was still feeling poorly and had very high blood pressure (>200 systolic). She declined the ED. At 2:40PM, her blood pressure did not decrease, so the ED was called to take her in, and she agreed.

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.

tired; restless night of sleeping/poor sleep; This is a spontaneous report from a non-contactable consumer. An 81-year-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number EL3247 and expiry date unknown) via unspecified route of administration on 22Jan2021 at single dose for Covid-19 immunization in a hospital. The patient's medical history and concomitant medications were not reported. The patient was not diagnosed with COVID-19 prior to vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced having a restless night of sleeping the night of having gotten the COVID-19 vaccine (22Jan2021). The patient was tired the next day (23Jan2021) but was unsure if it was related to poor sleep itself or as a side effect of the vaccine, otherwise she felt good and did not seek any medical attention. The patient has not been tested for COVID-19 since the vaccination. The patient did not receive treatment due to the events. The outcome of the events restless night of sleeping, tired was recovered. The reporter considered the event non-serious; did not results in death; not life threatening; did not caused/prolonged hospitalization, not disabling/incapacitating, no congenital anomaly/birth defect. No follow-up attempts are possible. No further information is expected.

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.

Four days after receiving the vaccine, I started having disturbing dreams every night. I wake up between 2 and 5 am with high anxiety related to the dreams. This has been happening regularly and it disturbs my sleep and increases my stress and anxiety.

Very dizzy/ Light headed; I felt very washed out and thought I was tired/ exhausted; Lethargic; She still has a little weakness; Almost like a flare up of Hashimoto; a scalp problem, but nobody knows what it is/ Whatever she has, the vaccine aggravated it 10 times worse; a scalp problem, but nobody knows what it is/ Whatever she has, the vaccine aggravated it 10 times worse; she was feeling bad; The injection site was red, hard, kind of warm; The injection site was red, hard, kind of warm; The injection site was red, hard, kind of warm; joint pain, knees, feet, even my hands; joint pain, knees, feet, even my hands; It felt like some kind of nerve ending issue; She was also very off balance; This is a spontaneous report from a contactable consumer (patient). An 81-year-old female patient started received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL3249), via an unspecified route of administration at left arm on 23Jan2021at a single dose for COVID-19 immunization. Medical history included ongoing Hashimoto's disease; scalp issue; abrasions on her head like eczema; and weight loss. She was diagnosed a couple of years ago with Hashimoto. A thyroid disorder. She is not on a thyroid medication. They have just been watching it to see. She took the shot. For background, the last couple of months the patient has had abrasions on her head like eczema. She has been going to the Dermatologist for the last year. They have been trying to figure out what is going on. Concomitant medications included Phentermine for weight loss. The patient took the shot on a Saturday 23Jan2021. She did fine Sunday, but by Sunday evening on 24Jan2021, she was feeling bad. On 24Jan2021, the patient experienced injection site really red, hard and warm but didn't hurt; head broken out so bad; and joint pain. On 25Jan2021, the patient felt very dizzy/ light headed, fatigue and lethargic. As the evening went on for two to three days later from the vaccination, she experienced side effects. She got up in the middle of the night that night, and her head was broken out so bad that she couldn't comb her hair. There were least 100-150 small little bumps on her head. They almost feel like they have oil under them. They were sore and very irritated. Her scalp was blood red with inflammation. This has went on the course of 8-9 days. She also had joint pain really bad. Almost like a flare up of Hashimoto. She hasn't been having issues with it. It was like her skin was on fire. Even regular water in the shower feels like it was burning. It felt like some kind of nerve ending issue. She was also very off balance, and light headed. She never ran a fever. She was so exhausted that she couldn't get out of bed for the last 8 days. She is scheduled for the second shot. She is scheduled for the second dose 16Feb2021. Her doctor told her to go ahead and get the other shot, but she would like more information. She did not have a prescribing doctor. She got the vaccine at a a local hospital where she goes for testing. She could never get through to get ahold of the hospital so she tried to go through another facility. She finally got an appointment through the hospital. She was wondering if it is okay to get the second shot. She has had a scalp problem, but nobody knows what it is. They have tried to treat it with a steroid. She has seen several who don't have a clue what is could be. Whatever she has, the vaccine aggravated it 10 times worse. The joint pain was almost 100 % better since yesterday. It was mostly in her feet and knees. She was very dizzy and light headed. She wasn't falling all over the place or anything. That has improved over the last day or two. The first night, she got up to go to the bathroom, and she lost her balance but caught self. she was very careful from then on. She has fatigue as well. She still has a little weakness since the 25Jan2021. She never lost her appetite, but she felt very lethargic since the 25Jan2021. She has recovered from most of these issues, except for her head. She is in very good health except for her thyroid issue. That she has been diagnosed with for a couple of years, and the stuff in her hair. They don't know what has caused that. Every test has been negative. She thought at one point it could be the medication she was on. She was taking Phentermine to lose weight. She was wondering if it would have any recourse, but her doctor said no. She quit taking it the day before the shot just in case. She hadn't taken it again until today. The dose is 37.5mg. The way she felt at first, she felt like she had COVID. The patient stated, "I had some reaction to the (first) Pfizer covid 19 shot I took on 23Jan2021 wanted to ask if I would be able to take the 2nd shot. I took the shot fine, got home. The injection site was red, hard, kind of warm. My arm was never sore but the day after into Sunday I felt very washed out and thought I was tired. I have a thyroid issue, I've been having a scalp problem and this sometimes come with my thyroid issue. Little bumps in my scalp, they were kind of under control because of the Clobetasol propriate foam that I put in my hair and ever since then my skin is on fire. But the main thing I was exhausted, joint pain, knees, feet, even my hands. I laid around and for 5-6 days and today is the first real good day. I still have the bumps but I'm seeing a different dermatologist. I have an over active immune system Hashimoto's disease and something can set up a flare." The outcome of the events almost like a flare up of hashimoto and a scalp problem, but nobody knows what it is/ whatever she has, the vaccine aggravated it 10 times worse was not recovered; events she was feeling bad, joint pain, knees, feet, even my hands, very dizzy/ light headed, i felt very washed out and thought i was tired/ exhausted, lethargic and she still has a little weakness was recovering; events the injection site was red, hard, kind of warm was recovered in Jan2021; and outcome of the other events was unknown.

my head and ears closed down; my head and ears closed down; she doesn't sleep all night long; her body was shaking; my heart was beating out of my chest; felt a little lazy and tired; tinge-y pains in her heart; SVT; shortness of breath; 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, Batch/lot number: EL9261, Expiry date: 31May2021), via an unspecified route of administration on 19Jan2021 at Single Dose (dose unknown; by injection once to left upper arm) for covid-19 immunisation, levothyroxine sodium (SYNTHROID), orally from an unspecified date to an unspecified date at 0.75 mg once a day, and orally from an unspecified date to an unspecified date at 0.88 mg, once a day for thyroid disorder. Medical history included cancer, heart stents, irregular high blood pressure, breathing problem, underactive thyroid, back problem. The patient's concomitant medications were not reported. The patient took a flu shot 20 years ago for immunization and got really sick, took Pneumonia shots for immunization and was fine. On 19Jan2021, the patient had a little lazy and tired. On 21Jan2021, her heart was beating out of her chest, like she had a drum going off; beating so fast and rapid it, and her head felt closed off and ears- she could feel heartbeats in her head; on 21Jan2021, her body was shaking. In Jan2021, she had a couple tinge-y pains in her heart and shortness of breath; she had SVG, she thought, it was irregular heartbeats coming from the top of her heart. Details were as follows: On 22Jan2021, she woke up in the morning around 3-4 am and said "my heart was beating out of my chest and my head and ears closed down." The sensation subsided by 8 am. She called her family MD who did not respond so the following Monday she was in contact with her cardiologist who put her on a Holter monitor for a few days. He later told her she had SVT and prescribed a beta blocker for her to take. The patient stated "I am so allergic to medicine." She took Plavix after a stent 5 years ago and was fine taking it for a few years. Then she had another stent placed, was prescribed Plavix again, and was "so sick and dizzy and short of breath - it was the Plavix." States that she can take Cipro, ibuprofen, and synthroid and that her list of allergies is about "2 pages long." The patient wanted to know if she should take the second dose? her cardiologist advised that she not take it. Caller states she doesn't want to take the second dose and probably won't. She had a long history of allergic reactions to medications. She never had the flu, she hasn't had mumps, chicken pox, measles, occasionally, rarely a cold, about 20 years ago, she took a flu vaccine and got so sick after the shot and never took it again, she never got the flu, she does take Pneumonia shots and was fine. States she seems to have a natural immunity against typical disease you can catch. Other things, she had cancer, heart stents, and things of that sort, as far as infectious diseases, she had no problems. She had a reaction she thinks came from the COVID shot. She had a blood test and it showed her thyroid went a bit more underactive, so about 2 weeks ago, her Synthroid was raised from 0.75mg to 0.88mg, so 0.88mg was a new medication, but it was minimal. Communication: Caller was advised to slow down to assure accurate documentation. Synthroid 0.75mg: no NDC, lot, expiry. States this has been her only change in meds recently. She got that Synthroid the same day as she got her COVID vaccination, which was 19Jan2021, that afternoon, she got a Pfizer COVID vaccination. Also she got a prescription for her new Synthroid. The first day, 19Jan2012, she had no reaction at all, she took two Tylenol, someone suggested. She felt a little lazy and tired, for the rest of Tuesday, then Wednesday she felt more tired, she laid around on the couch watching TV, she stayed in her pajamas, had no serious reaction, just tired, then Tuesday and Wednesday, and then on Thursday night, she never did anything on Thursday either, she went to grocery store, was not feeling better, and on Thursday, 21Jan2021, at 3AM, she was awakened from sleeping, she did not sleep all night long, she got up often, her heart, she never had this before and had 3 stents, her heart was beating out of her chest, like she had a drum going off, it was beating so fast and rapid and her head felt closed off and ears- she could feel heartbeats in her head, and this went on, she didn't want to call, she lives by herself on a farm, and thought to wait and see if it goes away, and about 7AM, it was basically really bad from 3AM to 5AM, and at 7AM it went away, the rapid heartbeat was so far throughout and her body was shaking, and chest was so she never had it happen before. At 8AM she called her family doctor office, she wanted to go and see them and she was told she wasn't in that day, they would send a note in the computer to get back with her. The doctor did not get back with her all day Friday, and then she felt ok Friday, Saturday, and Sunday, she had a couple tinge-y pains in her heart and shortness of breath, but her heart didn't feel like it was beating out of rhythm. Then Monday morning she called her heart doctor, he said he doesn't know, it doesn't sound to him like it was the Synthroid, since it was a small change of dose, but he didn't know about COVID but he hadn't heard it as being an after effect, but he said to come by 2:30PM on Monday, to be fitted with a heart monitor, which she wears on her heart and it listens 24/7, listens to her heart function, so she wore that, he said to bring it back on Monday and leave it in the office, and she did that, she wore it Friday, Saturday, Sunday, and Monday, she never had that really huge feeling in her in heart anymore, she thought it was a waste of time, then she got a call from the heart doctor on Tuesday, he asked how she was feeling, she said she was fine, and sorry if she caused a commotion and he said she has a heart problem now, she said she didn't feel anything, but her heart is beating erratically, and he doesn't know why she didn't feel it, he said she has SVG, she thinks, it is irregular heartbeats coming from the top of her heart and he says he will send in a prescription to the pharmacy to get a beta blocker, she thinks Metoprolol. The pharmacy just got the medicine in and she is sitting there waiting now. He told her a couple months ago, her heart sounds fine, there seemed to be nothing the matter. She asked if it was the COVID vaccine, he said he doesn't know, and she asked if she should take the second dose on 09Feb2021, he said no, he doesn't think he wants her to take it, she is going to see him in 2 weeks and will try the medicine, but she wanted to report what happened to her. Has Pfizer heard of anyone having rapid heartbeat after COVID vaccination. States she is overweight. Second dose is scheduled for 09Feb2021, at 1PM. Caller states going from 0.75mg to 0.88mg on Synthroid is a minimal adjustment, it can go up to the 200's for underactive thyroid, it's minimum, she is supposed to take it on an empty stomach, first thing in the morning with water. She has had underactive thyroid since she was 20 years old, so for 40 years, and had no problems with Synthroid before. The patient had irregular high blood pressure: it is high during the night and normal during the day, and if she would take, she had been going to physical therapy, she had a back problem, it came from a different thing, her knee is bone on bone, and they want her to get a knee implant, but when she limps on her knee it makes her back, it hurts from not walking straight, so she went to physical therapy, and what was causing high blood pressure, if she took Ibuprofen or Aleve, it would significantly increase her blood pressure, so she has a sensitivity to pain medicine, especially Ibuprofen and Advil, it increases her blood pressure, and often when she doesn't have it in her system, her blood pressure is much more normal. She does not have Ibuprofen, Aleve, Advil to provide lot/expiry, she is in her car. She is interested, she feels she won't take the second vaccine, she wants to see what they say, she also wants to ask how much protection with just the first shot? The action taken in response to the event for levothyroxine sodium was unknown. The outcome of the events heart was 'beating out of chest', 'head and ears closed down' was recovered in Jan2021, of other events was unknown.

Received 1st dose Feb 3 @ 7am. Felt minor soreness for 2 days. Felt fine afterwards. Feb 12 developed flu like symptoms, headache mild fever, tiredness. Symptoms progressed Sat & Sun. Monday she was speaking with her brother who said she wasnt making sense. Called ambulance & brought her to hospital. Ran CT scan, multiple MRIs and did spinal tap. Diagnosed with HSE enciphilitis. Has had multiple seizures. Very confused, can barely speak, doesnt recognize or understand who people are. Troubling motor skills.

Patient became flush and light headed after her 2nd shot of Pfizer. Patients BP was 140/78 and continued to rise to 170/80, pulse dropped from 78 to 62, patient developed facial redness and after 90 minutes of observation she became to feel a lump in her throat. No difficulty breathing or respiratory issues.

Vaccine reaction, initial encounter, pain left deltoid, no erythema, vaccine given 4 days ago, suspect she is having localized pain from injection, fairly thin arms, making it more pronounced, treat supportively, stable condition at time of discharge, pain described as achy, hurts when moves her arm, pt. having some memory issues and relies on husband most of the time, arthralgias and myalgia, [t discharged home, tylenol prn, follow up with Dr if not improving over next 2 weeks.

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.

SQUESSING SENSATON IN HEAD AND DIZZY WHEN MOVED HEAD SLIGHTLY' . DIAHREA STOMACH ACH AND SLEPT HOURS AND HOURS AND WEAK.

Patient felt short of breath, lump in throat w/ difficulty swallowing, head ache & dizziness. Vitals 220/120, tachycardia, 98% on RA Treated w/ Benadryl 50, Pepcid 40 prednisone 60

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

Difficulty breathing about 8 hours after receiving the vaccine. Also felt panicky due to not being able to catch breath.

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

Approximately 5 hours after vaccine, she started experiencing slight confusion. By morning she was completely confused, didn't know where she was, didn't know her daughter, was trying to take her medication by chewing them, couldn't speak, etc. BP extremely elevated. CT and labs all negative. Admitted to hospital. By the next morning she was more clear, but is still somewhat confused and still has memory loss.

Right upper arm intense pain . 45 minutes later I laid down in bed and it was like explosions in my upper body, torso and arms. Intense pow-pow, - pow pow pow on and on for an hour Intense in my left arm but continued constantly for about an hour. When it subsided I got intense chills radiating up and down my legs,. That stopped and I had regular chills throughout my body. Started to have a headache. Went to sleep after some time, and when I awoke the next morning, I had such fatigue, I could hardly get out of bed. I spent the next two days sleeping most of the day. I did not eat because I just wanted to sleep.

headaches/her head hurt; fever; threw up; pain across her shoulder; top of my arm swollen and then it ran straight to my back; suffering pain; arm was real sore /pain in the left arm/her arm felt like it was going to fall off; sick as a dog; She was very upset; nausea; her back still hurts to move/it ran all way over to my back; didn't feel like eating; sneeze; 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 mRNA VACCINE; Lot Number: EL3302) via an unspecified route of administration in the left arm on 26Jan2021 (at the age of 81-year-old) as a single dose for COVID-19 immunisation. The patient medical history and family medical history. 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 reported that she was administered with the first dose of the vaccine on 26Jan2021, and she has been feeling sick as a dog since she got it. The patient wanted to know about the ingredients used in the formulation of the Pfizer's COVID-19 vaccine. It was reported that patient had been suffering pain on 26Jan2021. The patient took pain pills for the pain. On 26Jan2021, the patient arm was real sore, her arm felt like it was going to fall off/pain in the left arm and on 27Jan2021, the patient experienced hurting in her head/ headaches. The patient reported that she would not have taken the vaccine if she had known her arm would hurt like that. On 27Jan2021, she started having sharp pain across her shoulders, through her shoulder blade to the middle of the back . She tried a heat pad, ice packs and the pain just keep shooting and she believes she had a fever with it. She threw up. She was very upset with all of this and mentions that her husband had passed away. It was reported that patient took pain medication referring to Robaxin 500mg and it didn't work. She also took Methocarbamol 500mg and it helped a little but not a lot. Adds she called the paramedics. The paramedics examined her and told her they had been to the Navy hospital several times and it was very crowded and they advised her to take Tylenol. She took the Tylenol 325mg and she went to sleep but when she woke up she still had the real sharp pains. She thinks the Tylenol helped some. She also took Ibuprofen via oral route at a dose of 400mg as needed per the instruction of the paramedics at. Mentions her symptoms were improved but her back still hurts to move on an unknown date in 2021. She has not eaten except to take medicine. She didn't feel like eating on an unknown date in 2021. She was scheduled to receive the second dose on 16Feb2021 but wanted to refuse because she heard it is even worse than the first time. The patient reported that she experienced sneeze on an unknown date in 2021. The patient reported ‘top of my arm swollen and then it ran straight to my back and I cannot get no relief on 26Jan2021; I really get sick with pain I mean with pain, it ran all way over to my back (as reported). It was reported that Pain is so bad; I have been in pain; I have been laying, it's hurt me so bad (as reported). The patient also experienced nausea on an unknown date in 2021. The patient was suggested to rest until feel fine. The patient called the ambulance but they (staff) confirmed no need of emergency room and want the patient to rest until she was fine. They told her not to get up and she don't want to get up either. Therapeutic measures were taken for suffering pain, pain across her shoulder, headaches/her head hurt, her back still hurts to move/it ran all way over to my back, top of my arm swollen/her arm was real sore and pain in the lefts arm/her arm felt like it was going to fall off. The patient did not receive any treatment for the events. The events were reported as non-serious by the reporter. The outcome of the events pain, sick as a dog, nausea, her back still hurts to move/it ran all way over to my back, didn't feel like eating, sneeze, she was very upset, arm was real sore /pain in the left arm/her arm felt like it was going to fall off was unknown while for other events was recovering.

feeling shaky/she is nervous about the palpitations.; soreness and swelling at the injection site; soreness and swelling at the injection site; she experienced palpitations when she went to bed; her arm was sore; maybe she was dehydrated; This is a spontaneous report from a contactable consumer (patient). A 81-years-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) , lot EL9269, expiration date 20May2021, via an unspecified route of administration on 05Feb2021 (at the age of 81 years old) as a SINGLE DOSE in the right arm for covid-19 immunisation. Medical history included ongoing High Blood Pressure Diagnosed about 35 years ago (1986) and ongoing Diabetes Type 2 Diagnosed about 20 years ago (2001). Concomitant medication included oral nifedipine from Sep2020 and ongoing at 30 mg, 1x/day for High Blood Pressure, ubidecarenone (COQ-10), bifidobacterium lactis (PROBIOTIC [BIFIDOBACTERIUM LACTIS]), acetylsalicylic acid (BABY ASPIRIN) one every other day. Historical vaccine information included BNT162B2 on 15Jan2021, Lot number EL8982, Expiry 20May2021 first dose via injection into the left arm for COVID-19 immunisation at 81 years old. She had no reaction at all to the first dose. The patient's arm was sore the day of the vaccine on 05Feb2021. On 08Feb2021, she experienced palpitations when she went to bed. She got into bed and was trying to fall asleep, she started to get palpitations.She sat up and walked around, and took a acetaminophen (TYLENOL) and water, because she was thinking that maybe she was dehydrated in Feb2021 or something, and it seemed to go away, and she did fall asleep and she slept for several hours, very well. Then, around 7am this morning, the palpitations started a little again, but not as bad as last night. She had breakfast and then was okay again. Then she sat down in front of her computer, and the palpitations started again. The palpitations are not constant, they come and go. On 09Feb2021, the patient experienced feeling shaky but states this might be because she is nervous about the palpitations. On 09Feb2021, she experienced soreness and swelling at the injection site. Treatment for palpitations was acetaminophen (TYLENOL). Outcome of her arm was sore, feeling shaky/she is nervous about the palpitations, soreness and swelling at the injection site and maybe she was dehydrated was unknown. Outcome of palpitations was not recovered

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.

About 4 days after receiving vaccine, started to get a headache which lasted for about 1 week. Also felt like I was coming down with something. Felt nauseous at times but had no vomiting. Spent about 2 days in my recliner because of overall feeling of unwell ness.

Pt states she received vaccine around 10am. States "it ached going in and then was ok until noon". Reports she took Ibuprofen with no effect. States left arm "ached" and rated pain 8/10 at that point. Reports she took a 45 minute nap and after waking, could not lift her arm. Reports "by supper she could not grip, arm felt weak". Reports took APAP at supper and before bed with no effect. Reports she could "not cover herself up in bed nor dress herself before bed". States she woke up in the middle of the night to use the restroom and could not pull up her pants herself. Was then not able to go back to sleep due to the pain. Reports she then took an Excedrin (around 3am) and by noon she could move her arm "about

dizziness / vomiting both occurring now paramedics called. Conference call operator / patient's daughter. Pt rcvd Covid vaccine 2nd dose yesterday. patient having protracted vomiting/dizziness. pt does get medication for dizziness regularly and has history of stress induced vomit. pt not feeling well. Daughter able to provide some of the information regarding vaccine but very nervous and d/c as soon as EMS arrived. Agency had recommended to have EMS evaluated and transport as needed. Adv pt should f/u w/PCP ASAP. Adv to call back if any questions. Adv daughter that she may get call back from PIC/Covid Hotline.

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.

After the nurse said old gee and kept wiping my arm; It went up to about 180, 190 even 200 over 80; The test results shows that I have no antibodies; Anxiety; This is a spontaneous report received from a contactable consumer for herself. The consumer reported the similar events for the patient with different dose. This is the second of two reports. This 81-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, LOT: EL9266), via an unspecified route of administration administered in left arm on 26Feb2021 as single dose for COVID-19 immunization. Medical history included cholesterol. The patient was taking medication for her cholesterol. The patient received the first dos of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number: EL9264) on 26Feb2021 in left arm for COVID-19 immunization and after the first dose about 8 days later, her blood pressure went up very high. Its normally never get that high. It went up to about 180, 190 even 200 over 80 and then she saw her physician was put on some blood pressure medication, and she got better. When the patient received the first dose, she have a headache and was slightly nauseous. Then the patient had her second vaccine. After that the same thing happen about a week later. her blood pressure went very high (went up to about 180, 190 even 200 over 80), and she suffered because of it with a lot of anxiety in 2021. The patient want to know something about that the blood pressure went really very high. It was still not regular; it was very irregular. When she went for the second dose, she did not even looked when the nurse was putting a needle in her arm so, she felt that the needle went in but shortly after she heard the nurse said oh jeez and she know the nurse put it right in her arm. Shortly after the nurse said old gee and kept wiping her arm. Later she noticed the nurse had a gauze under the band aid. The patient thought maybe she was bleeding, she did not have a look, she ended up with a bandage over it and that was it, other day she see it did not have any blood on it. And she wondering if she got the full dose of the second vaccine, she had absolutely no side effects immediately after over the next day. Also, she took a test for antibody and that came out negative in 2021. She was still experiencing the high blood pressure after the second vaccination as well. The physician had prescribed the medication for blood pressure went very high with losartan 75 mg. The outcome of blood pressure went very high was not recovered. It's over. It's between a 140-150. The outcome of other events was unknown. No follow-up attempts are needed. Further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021299032 same patient/drug, different dose/event

light headedness; queasiness; I was functional but I wasn't myself; This is a spontaneous report from a contactable 81-year-old female consumer reported for herself started to receive first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/lot number: EL9263), via Intramuscular on 29Jan2021 at single dose in arm left for covid-19 immunization. The patient relevant medical history included I have environmental allergies pollen (took an antihistamine), mild asthma and paroxysmal atrial fibrillation. Concomitant medication included fexofenadine hydrochloride (ALLEGRA) for environmental allergies. Past drug included Allegra (before I took the shot and I also gave an Allegra to my husband before he took his shot, and he was fine). On an unknown date, the patient experienced a mild reaction which was light headedness, queasiness and it lasted several hours. She was functional but she wasn't herself. After about several hours the patient began to feel somewhat better. The patient didn't take any treatment for the events. The outcome of the events was recovering.

chronic muscle tension; Bladder infection; couldnt sleep; shaky; pain; numbness; This is a spontaneous report from a contactable nurse (patient). This 81-years-old female (at the time of vaccination weight; 58.97 kg, height; 160 cm) nurse reported that she received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number; EL9269) Is COVID19 vaccine a Pfizer product; Yes, COVID19 vaccine manufacturer; unspecified, NDC number, expiry date; unknown via an unspecified route of administration from 02Feb2021 at 04:00 pm to 02Feb2021 at 04:00 pm at single dose (dose number;1) on left arm for covid-19 immunisation. Identification of the country where the drug was obtained: Country of authorization/application. Vaccination Facility Type; Health facility, Vaccine Administered at a Facility; No. Patient's medical history included thyroidectomy had in 1968, blood pressure, neuropathy, back surgery, breast cancer (dates unspecified), family history relevant to AE; none. Past drug event included Aromasin for breast cancer; inflammatory response, historical vaccine included Tetanus Diphtheria; about 4 weeks before, no specific information available. Relevant Tests: Urinalysis on 09Feb2021, diagnosed with bladder infection. Specific values not provided. Concomitant medications included levothyroxine, 88mcg one time a day by mouth for she been taking this since she had thyroidectomy for thyroid, amlodipine, 5mg one time a day from 5 years or so for blood pressure. Caller received the first dose of the Pfizer covid vaccine a week ago. 24 hours after vaccination on 07Feb2021 she could not get comfortable from a lot of pain, which went on for 24-36 hours. She went to urgent care for this and the doctor made her take a urinalysis and diagnosed her with a bladder infection. She was given antibiotics for this and the symptoms have gotten a lot better. She went to the ER on 10Feb2021 and the physician diagnosed her with chronic muscle tension. Caller also added that she had an underlying neuropathy from a back surgery as well as inflammatory response to medication she took for breast cancer 20 years ago. She wanted to check if her side effects may be related to the covid vaccine. Caller needs some information, stated she had the first dose of the Pfizer vaccine a week ago today, 02Feb2021 at the (Name) (Name), states she also has some underlying conditions, like neuropathy and that sort of thing associated with a back surgery she had 3 years ago, states numbness has been increasing over time. Caller states that the first 24 hours after the vaccine were fine, night after 24 hours couldn't sleep, pain, numbness and shaky and just a train wreck on 07Feb2021. Caller states she was so uncomfortable she went to urgent care. Doctor stated the symptoms could be a urinary infection, was diagnosed bladder infection on 09Feb2021 and was prescribed Keflex for treatment. Thinking perhaps it was coincidental, has had an inflammatory response to another medication Aromasin for breast cancer treatment. States this was before, 15 years ago, does not have information to provide, no lot, expiration, or NDC number. States she is just familiar with the inflammatory thing. Caller's question is have we had any reports such as this, any inflammatory responses. The events were not considered serious. Investigation Assessment: No. Did any AE(s) require a visit to: Emergency Room; no, Physician Office; Yes, patient went to Urgent Care. If Yes, which AE(s); pain and numbness. If the patient was hospitalized, how many days was the hospital stay; Not hospitalized. The outcome of events of pain, hypoaesthesia, insomnia and nervousness was recovering while for cystitis was unknown and for muscle tightness was unknown..

She felt a warmness in her body after the shot within an hour, but it went away; It is painful there today, but she has not taken pain medicine. It is painful in the top of her right shoulder.; She still cannot lay on her left side.; She was afraid she was going to loose her right arm too. The left arm; funny feeling through out body; excruciating pain in left shoulder and down shoulder blade where she had her cortisone shot/It is painful in the top of her right shoulder; right arm where she got the vaccine was hurting; The muscle on the whole arm hurt/Hip was hurting; The left arm would just hang. She could not move it.; This is a spontaneous report from a contactable consumer. A 81-year-old female (Patient herself) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EL9261, Expiration date: Unknown) via an unspecified route of administration in the right arm on 23Jan2021 24:30 at SINGLE DOSE for COVID-19 Immunization. The patients medical history included right arm/ shoulder replaced (She had her right arm/ shoulder replaced and reversed 5 years ago in Dec2015). Concomitant medication included cortisone on 07Jan2021 at 4 shots shoulder pain. On 23Jan2021 the patient experienced funny feeling through out body, excruciating pain in left shoulder and down shoulder blade where she had her cortisone shot/It is painful in the top of her right shoulder, right arm where she got the vaccine was hurting, Hip was hurting, The muscle on the whole arm hurt, She was afraid she was going to loose her right arm too. The left arm, The left arm would just hang. She could not move it, She still cannot lay on her left side, She felt a warmness in her body after the shot within an hour, but it went away. On 28Jan2021 the patient experienced It is painful there today, but she has not taken pain medicine. It is painful in the top of her right shoulder. Her Left shoulder is very bad, but she is refusing to get it done because it is a whole year of recuperation all over again. Her left shoulder gets painful so the doctor gives her cortisone shots. Three weeks prior, she had an injection of cortisone down the left shoulder blade and into the top of the shoulder. When she got home, after the COVID vaccine, she just had that funny feeling in her throat. Her body was fine. She thought she was fine. She called her brother and kids and told them she had no reaction. Then in between 20-21 that same day, all at once, she experienced excruciating pain in her left shoulder, and down her shoulder blade where she had received the Cortisone shots. Her right arm, where she got the shot was hurting as well. The muscle on the whole arm hurt. She was afraid she was going to loose her right arm too. The left arm would just hang. She could not move it. All she could do was lay down and not move. It was terrible. Sunday afternoon, she had Norco on hand, and took some of that. That helped it a little bit. Her pain level she would say was a 20 on a 1-10 scale. It was like she never had a cortisone shot. It was painful Sunday and Monday. She took a pain pill Monday morning and Monday night. Sunday night and noon time she took a Norco as well. The next day, she just took one at night, but there was still pain there. She didn't call because she kept think tomorrow it will get better. Now, finally it has subsided some. Yesterday, 28Jan2021, she had to take a pain pill because she could feel it coming back. Before that, she hadn't taken any Norco in 24 hours. It is painful there today, but she has not taken pain medicine. It is painful in the top of her right shoulder. It is like it is attacking the weakest links in her body. She can feel it in her hip too. She still cannot lay on her left side. Her right arm is still sore in the upper arm, between the elbow and shoulder. Before it was her wholearm though. She felt the funny feeling all through her body, it went up to her head. She has a therapist that works on her too. The pain was on her left side, and went right on down her body. She felt a warmness in her body after the shot within an hour, but it went away. She felt better after she left the place she got the vaccine. She had to wait her 15 minutes. She went and got something to eat, and 10 minutes later, she was feeling better. The vaccine seemed to affect everything she has been treated for. She also has a nurse that checks on her every week too, and the nurse is coming over today. Her shoulder is bone on bone. Her left shoulder gets painful so the doctor gives her cortisone shots. Three weeks prior, she had an injection of cortisone down the left shoulder blade and into the top of the shoulder. When she got home, after the COVID vaccine, she just had that funny feeling in her throat. Her body was fine. She thought she was fine. She called her brother and kids and told them she had no reaction. The outcome of the event It is painful there today, but she has not taken pain medicine. It is painful in the top of her right shoulder and She still cannot lay on her left side, The left arm would just hang. She could not move it was unknown, She felt a warmness in her body after the shot within an hour, but it went away was recovered, and outcome of all other events was recovering. Information about lot/batch number has been requested.

Feeling unwell; lower back is killing her; left leg pain; left thigh swollen/left calf swollen; feeling really bad and may go to emergency room; in lots of pain/had some pain Sunday; This is a spontaneous report from a contactable consumer. A 81-years-old female patient received bnt162b2 (Pfizer-BioNTech COVID-19 vaccine, Solution for injection), via an unspecified route of administration, at dose 1 administered in Arm Right (Arm Right Upper) on 04Feb2021 15:30 to 04Feb2021 15:30 (at the time of 81-years-old) as single dose for covid-19 immunisation (due to age 81). The patient's medical history was not reported. There were no concomitant medications. She was in a lot of pain this morning. Yesterday she was fine and on Sunday she had some pain on Feb2021. Today she feels unwell and her lower back is killing her, has left leg pain, the left thigh is swollen and the calf of the left leg is swollen on 10Feb2021. Mentions she had her first Pfizer BioNTech Covid-19 vaccine last Thursday. No other vaccines given the same day or 4 weeks prior. No problems with vaccines in past. Later mentions she feels really bad and might go to the emergency room. No further details provided. The outcome of events was not recovered. No follow-up attempts (needed or possible). No further information expected. Information about lot/batch number has been requested.

Arm and legs are shaking; Jerking; Joints are painful; joint pain especially in the finger; Feeling weird; This is a spontaneous report from a contactable consumer (patient's husband). An 81-year-old female patient received the first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EL9265), via an unspecified route of administration, on 27Jan2021 at 11:45, at a single dose, for COVID-19 immunization; and rosuvastatin, via an unspecified route of administration, in Feb2021 for 3 days, at an unspecified dose and frequency, for blood cholesterol. The patient's medical history included high blood pressure. The patient's concomitant medication included ongoing amlodipine for high blood pressure. The patient's husband was calling about the COVID-19 vaccine and he is not sure if what the patient was experiencing was because of the vaccine or a prescription drug (rosuvastatin) she took but her arm and legs are shaking like jerking and joints are painful on 04Feb2021. The medication the patient's husband was referring to is rosuvastatin which the patient takes for cholesterol. The patient took this for 3 days and she started feeling weird in Feb2021, so she stopped taking. The patient's husband not sure what to do since the patient went to the doctor and the doctor did not find anything, she went to the emergency room. The patient was hospitalized for two days. The patient also saw a specialist neurologist who recommended to take more tests, but the patient is waiting for the tests. In 2021, the patient had a magnetic resonance imaging (MRI) and electroencephalography (EEG). The patient was experiencing joint pain especially in the finger at night still (the joint pain is not in the arm and legs but in her finger). This started a few days later and was still going on. It has stayed the same and some days are better and then some days are worse. The patient was admitted to the hospital in 2021 for 2 days due to events. No treatment was received for the events. The action taken in response to the events for rosuvastatin was permanently withdrawn in Feb2021. The outcome of "Feeling weird" was unknown. The patient had not recovered from "Joints are painful; joint pain especially in the finger". The patient was recovering from the remaining events.

3rd or 4th day after shot: Extreme fatigue, severe weakness, shakiness, especially in lower extremities. Often trembly with complete lack of appetite (lost 6 pound in 2 weeks). Only wanted to sit or lie down- unable to go for daily walk (no strength). No fever or respiratory symptoms. This extreme condition lasted for approx. 10 weeks, during which time I saw my doctors five times for diagnosis or assistance. They could find no reason for my sudden symptoms except for adverse reaction to the vaccine, and were unable to assist. I mostly sat and laid around for 10/11 weeks , after which my symptoms improved gradually, and I am feeling better at this time.

her blood pressure was off/her blood pressure was off, she clarifies it was high; thyroid was off; she went to the hospital ER for A fib (Atrial fibrillation); funny feeling; she is nervous to go out; This is a spontaneous report from a contactable pharmacist (patient). A 81-year-old female patient received second dose of BNT162B2 (Covid shot, PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: Unknown), via an unspecified route of administration on 11Feb2021 as single dose for COVID-19 immunisation. Patient's medical history included stroke (She did have a problem 2 years ago, she had a stroke but other than that she has been active). Patient had historical vaccine at 81-year-old BNT162B2 on 25Jan2021 lot number EL9262 for Coronavirus immunisation. There were no concomitant medications. The patient experienced she went to the hospital ER for a fib on 04Mar2021, her blood pressure was off/her blood pressure was off, she clarifies it was high (hypertension), thyroid was off, funny feeling, she is nervous to go out. She said the second dose was 11Feb2021 and she first noticed the atrial fib 04Mar2021, she went into the hospital 04Mar2021 and was discharged 05Mar2021. The patient underwent lab tests and procedures which included blood pressure was up and blood pressure was off on an unspecified date. When probed for causality reporter states, it could be related but she is not sure because she just cant understand how everything, her thyroid, her blood pressure went up, way up, and her heart. She really doesn't know, she thinks it is pretty serious, she is nervous to go out. She confirms it was requiring hospitalization, they kept her, the cardiovert was that afternoon and they kept her until next morning. The outcome of event was unknown. Information related to lot/batch number was requested.; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the events atrial fibrillation, hypertension, and thyroid disorder and the suspect drug. 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.

weakness in arms and legs; shortness of breath; she felt terrible; achiness; energy level is just no energy; chills; could not walk across the room; This is a spontaneous report received from a contactable consumer (patient). An 81-years-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in left shoulder upper arm from 13Mar2021 02:00 to 13Mar2021 02:30 (Batch/Lot Number: EN6207) as single dose for COVID-19 immunization. The patient medical history and concomitant medications were none. No family history. No additional vaccines administered on same date. No Prior Vaccinations within 4 weeks. Patient received 1st dose of the Pfizer COVID vaccine on 13Mar2021 and experienced side effects on 31Mar2021. She mentioned that she could not walk across the room (2021) due to shortness of breath that began 31Mar2021 and was ongoing and about the same, her temperature was not high, down by 1 which would then be the onset of her chills (2021) which would come and go, just like a roller coaster, she felt terrible, had achiness, could not decide what to eat, and would feel better for 2-3 hours but felt bad right away. She mentioned that she felt just terrible and that all she wanted to do was die. Patient had whole body aching that was off and on since 31Mar2021 and not it finally diminished starting yesterday; she had weakness in her arms and legs that began not right away but on 04Apr2021 and was better; her energy level was just no energy and it started on 31Mar2021 and ran through 05Apr2021 and thank goodness the energy finally came back and she is finished now with that and feeling better since yesterday; she felt better but that only lasts 2-3 hours and she felt bad again and the chills start in again. She mentioned that she took acetaminophen and ibuprofen for the achiness, whenever needed. Patient stated she had no treatment, no visit to the HCP or emergency room and just took acetaminophen and ibuprofen and did not know when the took them but it was just in that timeframe. This morning, she had Gatorade to regain electrolytes and felt energized. As of calling, she was finally been feeling better and ally symptoms have decreased. AEs did not require a visit to ER or MD office. Outcome of shortness of breath was not recovered, outcome of achiness and weakness in arms and legs was recovering; outcome of other events was unknown. No investigation assessment. No follow-up attempts are needed. No further information expected.

started to speak gibberish and was taken to the emergency room; out of it; combative; started to speak gibberish and was taken to the emergency room; out of it; combative; She can't remember anything after the emergency room/She has no recollection; This is a spontaneous report from a contactable consumer (patient). A 81-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), at the age of 81-year-old via an unspecified route of administration, administered in the left arm on 04Mar2021 (Batch/Lot number was not reported) as single dose for covid-19 immunisation. Medical history included diabetes mellitus, blood pressure abnormal. There was no other vaccinations within four weeks prior to the first administration. Concomitant medications included ongoing metformin taken for diabetes mellitus; lisinopril taken for blood pressure abnormal, both taking for quite a while; at least a few years. The patient previous took first dose of BNT162B2 at the age of 81-year-old via an unspecified route of administration, administered in the left arm on an unspecified date as single dose for covid-19 immunisation. The patient experienced started to speak gibberish and was taken to the emergency room; out of it; combative on 06Mar2021. Caller stated she was perfectly fine and healthy prior and up to that time and the day after. Caller stated on Saturday she got up in the morning and was talking to a friend when all of a sudden something was going wrong. Caller thanked God she was at a friend's because if she had been home she would have died. Caller stated she was rushed to the ER and after 3 MRIs that confirmed that she was not having a stroke or something similar. Caller stated she spent 6 days in ICU and 2 weeks in a rehab center, went back to friends house for another week, before she went home because she was not comfortable being home by herself because she was to take her blood pressure often. Caller stated she was perfectly fine after the first shot and after the second one. It was 2 days and she had this terrible reaction and it was the only thing it can be put down to so everything else had come up normal. On 06Mar2021, caller explained she was actually getting ready to groom one of her dogs. She got up and felt fine and she was talking to her friend and another one of her friends and all of a sudden she started to talk gibberish, so her friend asked if she was having a stroke. Her friend took the caller's blood pressure and said they were going to the hospital and her friend took her to the emergency room. Caller stated that was all she can recall. She can't remember anything after the emergency room. According to her friend, caller was out of it, getting combative, and all kinds of stuff going on. She had no recollection, she remembered getting in the car to go to the hospital, but then had no recollection. Caller stated she just went to see the doctor a week ago and got a good bill of health. The doctor said she was pretty much good; she's improved. Caller stated her doctor told her she did not have a stroke and they did not definitively know what happened; the only thing she can put it down to was a reaction to the Pfizer COVID-19 vaccine. The outcome was recovering. Information about the Lot/batch number has been requested.

Blood clot in lungs and leg; Trouble breathing/Shortness of breath, but not as bad; didn't feel right; Chest tightness; Slightly ill; Sore arm, in left arm where the shot was; Slightly tired; This is a spontaneous report from a contactable consumer. An 81-year-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in the left arm on 10Feb2021 (Batch/Lot Number: EN6201) as SINGLE DOSE for covid-19 immunization. Medical history included Type 2 Diabetes from 2004 and ongoing, High Blood Pressure from 2000 and ongoing (reporter stated she was 81; it's not very high, usually when she goes to the doctor). Concomitant medications not specified but reporter mentioned that everything she has been on she has been on long time; she takes blood pressure medication because sometimes it is high. She has not had started any new medication prior to starting vaccines or during both vaccines. The patient previously received flu shot (September). The patient received her first vaccine dose of bnt162b2 (Lot # EL9262, Expiry date UNKNOWN), on 20Jan2021, at 1:30-1:45, in the left arm and experienced sore arm and slightly tired. The reporter stated that after her second vaccine on 10Feb2021, she had a sore arm, (left, where shot was) and was slightly tired from 10Feb2021 until 12Feb2021. She confirmed she noticed this started the same day, 10Feb2021. On 31Mar2021, she felt slightly ill and had some slightly trouble breathing. She saw her doctor who did some tests. The next day 01Apr2021, her tests came back and the doctor told her to go to the hospital. While in the emergency room she had a CT of the lungs that showed blood clots in both lungs. She was admitted to the hospital where on 02Apr2021 they did a ultrasound of her legs. She was told she had blood clots in her right leg. She stated she had no symptoms of blood clots in her legs like redness, sore, swelling, or hot. She was asked if she had fallen suddenly, had an accident, or was sitting for a long time, traveled a long distances. On 02Apr2021 she had a Echocardiogram and was told her heart was ok. Caller stated she was given Lovenox shots in the hospital. She did not have Lot # or Expiry date on the Lovenox. She stated on 02Apr2021 after having two Lovenox shots that day, she met with a Vascular Surgeon who started her on Eliquis that evening. She stated she started taking Eliquis that evening. She stated she took 2 tablets, twice a day, for a week. Now she takes one tablet, twice a day, ongoing. The Eliquis tablet says 5mg. She stated she was discharged on 03Apr2021, that evening. Patient went back to the emergency room on 10Apr2021 after speaking with a nurse at (university name withheld) because she had tightness in the chest but the shortness of breath, her breathing was not as bad. She just didn't felt right. She stated she was not admitted. Patient stated she saw a NP (name withheld) with (university name withheld) Pulmonary the day of 31Mar2021. When discussing the tests performed that day, Chest X-ray, D-Dimer, and Pro INT, CH asked caller the results from them. She did not provide results, just stated she had looked up her results in "EPIC mychart" while getting the result information from the office. Where she was instructed to go to the hospital. She went to the Clinic of the Vascular Surgeon at (Hospital withheld) on Wednesday 14Apr2021 and was feeling better. Her second appointment with them will be in July. Where they will do another ultrasound of her legs and talk about the medication. She has an appointment with her primary on 19Apr2021. The outcome of events Trouble breathing (recovered on 14Apr2021), Shortness of breath, but not as bad (recovered on 12Apr2021), Sore arm, in left arm where the shot was (recovered on 12Feb2021), Slightly tired (recovered on 12Feb2021) Chest tightness (recovered on 12Apr2021), and didn't feel right was recovered. The outcome of event Blood clot in lungs and leg was unknown.

Feeling bad; shingles; 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 at the age of 81-year-old, intramuscular, administered in left arm on 22Jan2021 09:30 (Lot Number: EL3302) as single dose for COVID-19 immunisation. Medical history included asthma (diagnosed several years ago) and she was not having any problems with that and she has actually been doing really well with it because she has stayed inside so much. The patient's concomitant medications were not reported. The patient has no prior vaccinations within the 4 weeks. The patient received the first COVID-19 vaccine on 22Jan2021. She started experiencing shingles on 12Feb2021 (reported as three weeks later). She was scheduled for the second vaccine on 12Feb2021, however she postponed that because of the shingles. She was feeling bad on an unspecified date and does not know what she should do. The event shingles resulted in physician office visit. She did have blood work done on an unspecified date and everything was normal. She did take Valtrex for 2 or 3 days as treatment for the event shingles, but she had a reaction to that had a lot of achiness and joint pain, so she didn't take the full dose. The outcome of the events was unknown.

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.

rash on her arm./2 spots/it went down to her arm and elbow; Experiencing pain down her shoulder to her hand/excruciating pain/pain in her arm; shingles on her arm; hardly sleep at night; This is a spontaneous report from a contactable consumer (patient). An 81-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot number was not reported), via an unspecified route of administration on 29Mar2021 (at the age of 81 years old) as 2nd dose, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient previously received the first vaccination of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) on Mar2021 for COVID-19 immunization and had no reaction. It was reported that on 29Mar2021, she received the second dose and 10 days later (08Apr2021), she started experiencing pain down her shoulder to her hand. She described it as "excruciating pain". It lasted for almost 7 days and is still ongoing. She could hardly sleep at night due to the pain in her arm. It looks like she may have shingles on her arm, as per her doctor. She added that she now has a rash on her arm. Yesterday, she had 2 spots and today it went down to her arm and elbow. Her doctor prescribed her antivirals. The outcome of the events shingles on her arm, hardly sleep at night and rash on her arm./2 spots/it went down to her arm and elbow was unknown; outcome of Experiencing pain down her shoulder to her hand/excruciating pain/pain in her arm was not recovered. She also added that her daughter received the vaccine and also has pain in her arm now. No follow-up attempts are needed; information about lot/batch number cannot be obtained.

"Pfizer-BioNTech COVID-19 Vaccine EUA" - patient admitted with Covid-19 after 2 doses of vaccine (2/18/21 and 3/11/21) 81F history of diabetes mellitus, HTN admitted to hospital 4/6/21 with septic shock, hypothermia, COVID+ pneumonia, pseudomonas bacteremia and AVN blockade. Patient had been having worsening lethargy, dry cough (only associated with eating), and right axilla pain for 1-2 days. Found to be hypoxic with nadir O2 saturation 87% on 4/6/2021 (day of admission). COVID-19 positive test on 4/6/2021. No sick contact reported. Patient problem list included hypoxia, respiratory failure, septic, pseudomonas aeruginosa with bacteremia, COVID-19, right upper lobe consolidation and bilateral effusions, hypernatremia, diabetes. On 4/12/2021, patient also noted to have altered mental status with decreased muscle tone on left side (CVA work up reviewed) and hypernatremia. No nuchal rigidity, No photophobia, and brain MRI findings on 4/13/2021 and on 4/16/2021 were negative. -- > unlikely meningitis/encephalitis. Treatment included Remdesivir, Tocilizumab, Dexamethasone, Antibiotics. 4/6-4/11 in ICU; 4/11-4/17 Med-Surg; 4/17/21 Patient expired.

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.

I received the vaccine at 3:15, due to my allergies I stayed for 45 minutes. I walked to car and felt dizzy driving home. I was seeing lighting bolts in visual field. I felt fatigued and foggy. I had chills, fever, a pain from the top of my legs to my feet . I had no reaction on the arm that I received the vaccine, I had pain in the opposite arm. I had pain from my neck to my waist in the back of me, no pain in chest area. Each day following I had headaches that went into optic migraines. Continues from the shot up to present. I have been taking Tylenol each and every day. I don't normally take over the counter medication. I have had less stamina since the injection. I am doing 50% of my daily routine due to fatigue

she doesn't feel good; can't catch her breath; rib cage is kind of sore; Chills; This is a spontaneous report from a contactable consumer (patient). A 81-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number: unknown), via an unspecified route of administration on 23Feb2021 as 2nd dose, single for COVID-19 immunization. Medical history and concomitant medications were not reported. On 23Feb2021 (last night), patient experienced chills. At 21:30, rib cage was kind of sore. On 24Feb2021 at 21:00, patient can't catch her breath. It was reported that chills stopped last night. Outcome: attempted to capture outcome of chills, unable to confirm if recovered completely or with last effects. The patient stated that they stopped last night, she does not have chills now but she does not feel good. Patient was calling to see what should she do. Should the patient go to a walk in. It was reported that patient handed phone to (name), because she said she had to catch her breath, to provide mailing address who also provided details intermittently during report. However, patient provided most of details during interaction. The patient was calling because she wanted us to advise her on what to do to get relief. She went online for urgent care and could not be seen until 11:00. She was hoping we would be able to get her in at Banner. She mentioned she waited almost an hour to wait to talk. The outcome of the event can't catch her breath was not recovered and outcome of the event chills was recovered and outcome of the others events was unknown. Information on the lot/batch number has been requested. Follow-up (14May2021): Follow-up attempts completed. No further information expected

Patient reported that they normally feel fatigue, but after receiving the vaccine they have felt the fatigue become even more pronounced, to the point that she feels like she will pass out when she stands up.

Heavy right foot 4/13 in afternoon. Then Thursday at 2:30am got up to go to the bathroom and had a difficult time walking and returned to bed afterward and had tingling sensation in right arm. Next morning still felt odd and at 8:00am went to primary and he sent her to the ER room. They ran many test and then discovered she had a stroke. There was damage also to the heart. She had lost all mobility in her right side but has since regained it. Transferred to hopital for 3 days. Many test ran. Never previous heart damage or issue with Blood pressure. Supplement list cont. - Immune Defense, B, Apha GPC, Theanine

rash on left arm which was itchy, red and warm; troubles with memory; This is a spontaneous report was received from a contactable consumer or other non hcp. Follow up (24Feb2021) received from a contactable consumer was processed together with initial information. An 81-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: EN6202), via an unspecified route of administration, administered in right arm on 22Feb2021 as 2nd dose, single for covid-19 immunisation. The patient's medical history included high blood pressure. Concomitant medications included metoprolol, amiodon and hydralazine all used for high blood pressure and dates were unspecified. On 27Jan2021, the patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number- EL9262) first dose, single for covid-19 immunisation. On 23Feb2021, next day of vaccination the patient developed rash on left arm (the opposite arm from where she got the vaccine) states it itches, and it was red and a little warm. It was reported that the patient applied some hydrocortisone. She also had troubles with her memory. The patient had not recovered from the rash on left arm and the outcome of the event troubles with memory was unknown. No follow-up attempts are possible. No further information is expected.

feeling weak/had no energy all day; nervous; a lot of pain in the injection site (left arm); chills; a mild fever/Fever chills; one swollen lymph node on the right side; muscles aching; tiredness; This is a spontaneous report from a contactable consumer (patient). A 81-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/Lot Number: EL9261; Expiration Date: 31May2021), via an unspecified route of administration, in left arm on 01Feb2021 11:30, as 1st dose, single for covid-19 immunisation. Medical history included sinusitis from an unknown date and unknown if ongoing, neuropathy peripheral from an unknown date and unknown if ongoing and anxiety. Patient explained that she had trouble with the flu shot prior, having weakness and low blood pressure and that's why she got so nervous to get it, she was exhausted from that. There were no concomitant medications. After the onset of events, her husband suggested to take benadryl, and so she took 1 yesterday. Patient received the first dose of the Pfizer COVID vaccine 01Feb2021. Medical Conditions was she actually had a physical a week ago, her heart is fine, the doctor said her blood work was normal. Patient was calling about the Covid Vaccine, she got it the day before yesterday. She experienced "a lot of pain in the injection site (left arm) the first night after the injection. She also experienced tiredness on 01Feb2021, chills, a mild fever on 02Feb2021, one swollen lymph node on the right side on 02Feb2021 and has been feeling weak. She reported that she spoke with someone else prior to speaking with medical information and stated she gave them "her information" about the side effects. Her muscles aching, the chills, the swollen lymph node on the right side started on 02FEB2021. She was also mostly tired with no energy she had a little bit fever since she had the chills. She was just feeling unwell like she got the flu. Caller stated that it was just the normal flu shot, she hasn't had it for 5-6 years now. She has no lot number to provide. Her doctor said if it causes trouble then don't get it, a couple times she was in urgent care because of the low blood pressure, like she was going to pass out. The chills she just had once or twice yesterday. She didn't take a temperature. She clarifies that it was just 1 lymph node that was sore and raised, she can barely feel it today, it went down. Today she still felt the weakness and tiredness. Caller would like to know if it was ok for her to take Tylenol for her post vaccination symptoms. The patient underwent lab tests and procedures which included blood pressure abnormal was low and blood test was normal. Investigation assessment included All tests were normal. Patient does have anxiety; however, caller thinks that it was this covid situation and the depressing news every day. Outcome of the events tiredness was not recovered, event one swollen lymph node on the right side was recovering and unknown for all other events. Follow up (03Feb2021): This is a follow up spontaneous report from a contactable consumer. This consumer reported, new information included: Description of the reporter patient characteristics (age weight, height), relevant medical history and concurrent condition, reaction/events (onset date outcome), suspect Information, lab test were updated. Follow-up attempts are completed. No further information is expected.

Two days after patient's first vaccine@ about 4 pm, I could tell that something was wrong with her. Every day she and I play cards, but this day she was really struggling. She couldn't figure out where any of the cards went, and was missing every play. I tool her up to lay down. At about 6pm, her eyes looked really glassy and she was unable to speak clearly. Her words were very slurred, and her sentences did not make any sense. I called 911, and they came and took her to the ER. The doctors said that she had a small stroke. She was put on a low dosage of blood pressure medicine, and was hospitalized for 6 days to monitor her. During that time many tests were run on her. 2nd Vaccine- 2-24-21 Two hours after returning from getting the second vaccine, the patient went upstairs to go to the bathroom and she passed out onto the bathroom floor. Again, when talking to her, her words were slurred. She was very weak. I called 911 again. Initially they were not going to take her, but when she went to get up she fell back down. She was too weak to walk, so they took her to the ER again. She was released to go home that evening. Sher saw her primary doctor and was referred by her oncologist to see a hematologist. She endured a three month waiting period until she could be tested for APLS. She will go this Friday to find out the reslts of that test. Additionally, she saw her vascular neurologist, Dr. He looked at her scans and said it was NOT a stroke. He said that her body basically had a surge as a result of trying to fight off the vaccine. He said that the CAT scan that was done at the time she went to the ER the first time did NOT indicate signs of a new stroke, but that what they were seeing on the scans was from her past stroke. Dr. said that he saw no indication that she had another stroke and that her body was just reacting to the vaccine. He said that all of the symptoms that she had were all things that could happen because of the surge.

accompanied with a panic attack; 2nd dose- went into a tachycardia event that was beyond anything she has ever had in the past 40 years; trauma; 2nd dose- extremely exhausted; This is a spontaneous report from a contactable consumer (patient) reported for herself. An 81-years-old female patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration on 15Mar2021 (fairly early in the day) (Batch/Lot Number: EN6198) as 2ND DOSE,SINGLE for covid-19 immunization, at the age at vaccination of 81 years old. Anatomical Location of Administration of Pfizer vaccine considered as suspect: She did not really remember but she tends to think it was in her right arm for both. Medical history included tachycardia (This all started when she was 43 years old, and usually gets them periodically; benign with a regular rhythm), ongoing panic attack had for 40 years, ongoing anxiety (reported as she was an anxious person and at first she thought that it was just her anxiety kicking in but the event was beyond anything in 40 years that she has ever experienced). Historical vaccine included first dose of BNT162B2 on 24Feb2021 (Lot Number: EN6200) for covid-19 immunization and experienced tired a little bit. The patient's concomitant medications were not reported. The patient experienced 2nd dose- went into a tachycardia event that was beyond anything she has ever had in the past 40 years (hospitalization) on 17Mar2021 with outcome of recovered on unknown date, accompanied with a panic attack (hospitalization) on an unspecified date with outcome of unknown, 2nd dose- extremely exhausted (non-serious) on 15Mar2021 with outcome of recovered on 15Mar2021, trauma (non-serious) on an unspecified date with outcome of unknown. Reported as she got her second dose on 15Mar2021 and both her husband and her were extremely exhausted, not sleepy, just tired. They were told to expect that though. There was no pain or nothing at the injection site for her. Then 2 days later she went into a tachycardia event that was beyond anything she has ever had in the past 40 years. She knew how to take care of these events and they are usually accompanied with a panic attack and she can usually calm it with breathing. But this was extreme, it was beyond anything in the past 40 years that she has ever experienced. Her husband took her to the hospital and they checked her out and she was okay and her heart did calm down. But what was interesting was that ever since that event on 15Mar2021 she had not had 1 panic attack or one tachycardia episode. She had a slight one not to long ago but it was not like the ones that she used to get. She used to get these events fairly often in a short period of time. She is not sure if the COVID vaccine did anything, but she was grateful if it did but she just wanted to make that comment about the good. 2nd dose- She was extremely exhausted and this began soon after she had the COVID vaccine fairly early in the day. Her and her husband came home soon afterwards and looked at each other and said that they were tired and it was not sleepiness, it was not like they needed a nap. It was profound tiredness and exhaustion. Her husband had it more so but they were both in bed for a couple hours. Neither had pain in the injection site though. This lasted for several hours into the evening. 2nd dose- Her tachycardia event was on 17Mar2021 which was two days after her COVID vaccine. Her husband took her to the emergency room in the early evening that day and when she got there the event was still occurring but it was not as severe. She was in the emergency room for a couple of hours, so late that night she was released and when she went home she was tired. Which she usually is tired after her tachycardia events occur. But while in the emergency room everything checked out. She confirms that she has recovered completely. She was curious if anyone else has reported anything with this same kind of thing she has experienced. She is amazed because she has had lots of trauma in the last week with her grandson and normally an event like that would have her over the top but she has been calm about it. He was 21 years old and he attempted suicide and she cannot believe it. He was out of state and she was so close to him. At the very last moment he told his dad that he is making a mistake and he just can not stand the isolation from college. This normally would send her into the worst but she has been very calm and maybe it just has not all hit her yet and then also the recent events with her husband would normally make her very frightened. She is glad that she has not had any tachycardia events but this all started when she was 43 years old and she usually gets them periodically. She declined a transfer since it is lunch time and she needs to wake her husband for his lunch. She remembered reading articles while she was waiting for her first dose and tachycardia jumped out at her as a side effect and her husband first thought was that seeing that triggered her but she didn't have anything after the first dose so she dismissed it but then it occurred after her second dose. She was more amazed that she has not had an attack since then and she has not had any tachycardia and she has had them for years and she is just so grateful. The events require a visit to Emergency Room. Not to Physician Office: not really because she did it on her own and then she got in contact with her doctors. Information on Lot/Batch number was available. Additional information has been requested

Intense pain in upper thigh, both legs; sometimes unable to walk/ could barely walk/ could hardly walk; muscle weakness; Cannot sleep at night; Had pain pretty much all day, This was intense pain and it kind of changed a little bit during the day; muscle pain in arms; 'BUN' test was outside of the parameters; This is a spontaneous report from a contactable consumer (patient). An 81-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in Arm Left on 01Mar2021 (Batch/Lot Number: EN6205) (at the age of 81 years) as 2ND DOSE, SINGLE DOSE for COVID-19 immunisation. Patient was not pregnant at time of vaccination. Medical history included low back pain, overactive bladder urgency, allergies: dye in CT scan, type 2 diabetes mellitus, flu, been achy, hip replaced about 2 years ago in 2019. Concomitant medications included metformin taken for an unspecified indication, start and stop date were not reported; atorvastatin taken for an unspecified indication, start and stop date were not reported; glimepiride (GLIMIPRIME) taken for an unspecified indication, start and stop date were not reported; omeprazole taken for an unspecified indication, start and stop date were not reported. Patient previously took modafinil (PROVIGIL). Patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left on 08Feb2021 14:30 (Batch/Lot Number: EL9264) (at the age of 81 years) as single dose for COVID-19 immunisation. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, was the patient was not diagnosed with COVID-19. Since the vaccination, patient has not been tested for COVID-19. It was reported that patient experienced intense pain in upper thigh, both legs, sometimes unable to walk, general muscle weakness, began 48 hrs post-2nd vaccine (also reported as occurring on 10Mar2021 22:00). Became less in 24 hrs, became intense again in another 24 hrs, and has continued ever since. Patient cannot sleep at night. Patient clarified she had it ever since 48 hours after second dose on 01Mar2021 and it's very unpleasant and does not know what to do about it and wanted to report it. These did not happen immediately and after second vaccine, patient did not have any problem till 48 hours, 10 o'clock, she had it on Monday at 12:00 and at 10 o'clock in the evening on Wednesday, she started to get intense pain on right side, she could barely walk and she have never had pain there before and she tried to walk and she was 81, she goes to the bathroom frequently with bladder issues and that was hard and it went on all night. In the morning, she had it not only in right leg but upper side like above the knees but in the front not in the back of the leg and then the next day, when she woke up and then, she had it in the upper side in left leg and closer to the groin and more like around and didn't know what to do and she wasn't going to go to an emergency ward as she was 81 and she doesn't go around that easily. Patient called her doctor, and patient had pain pretty much all day and he said how was it now and told him that it was slightly better. He said more than likely it will go away but he kept saying these are the kind of side effects that they were reporting though flu like achiness was nothing like what she had, she have had the flu (history) and been achy (history) but this wasn't like that. This was intense pain and it kind of changed a little bit during the day but it was still there. Her doctor said, if it doesn't go away by tomorrow morning which was Friday, then make an appointment and come in to see her, she will do blood work or whatever. So, she got an appointment for 2:30, by noon, it was just gone totally gone like if it never had been there. She cancelled the appointment then yesterday she got it back again and she could hardly walk but it wasn't as intense, it was really painful and hard for her to walk and it was around both legs and she doesn't know what to make of that, she went to rheumatologist because she thought she might be having muscle pain in arms from something else, he did some blood work (unknown results), he couldn't make anything out of it and he said he will look at the blood work and he gave her kind of a steroid cream to rub on arm (treatment) which she thought she had a problem but months ago (consumer was not sure). Now she couldn't sleep last night, it was so uncomfortable, and she had to go to the bathroom several times and again it really hurts to walk. So, that was what happened to her and she would not call that achiness of the flu at all. Regarding treatment, patient took Tylenol, do take other medications but nothing unusual and take the same that she always have and by the way the intense pain was only in one leg for twelve to twenty hours and then all of a sudden it began in the left leg as well and slightly with different pace but still on. The one in the right leg was most intense, she could barely stand. For laboratory test, the 'BUN' test was outside of the parameters and after getting several tests he did, she wanted to see if she had some sort of rheumatoid thing and they are all in her record. This was not one of the typically adverse reactions that people reported at least according to what she read and according to aspects of it. The outcome of events pain, muscle pain in arms, and BUN abnormal was unknown while for other events was not recovered. No follow-up attempts are needed. No further information is expected.

This is a spontaneous report from a contactable consumer (patient). A 81-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection Batch/Lot number: EP7534, Expiration Date was not reported), via an unspecified route of administration, administered in left arm on 18 Mar 2021 (at the age of 81-year-old) as 1st dose, single dose for COVID-19 immunization. The patient medical history included chest pain, high cholesterol, congestion in her throat and lungs. It occurred prior to Christmas 2020. She had issues from COVID-19 and stated that she feels weaker because she used to walk like 4 miles a day and now, she was not walking due to the pandemic. Concomitant medications included atorvastatin (LIPITOR [ATORVASTATIN], taken for high cholesterol; acetylsalicylic acid (ASPIRIN 81). Patient did a cardiac test, and they came back negative. Heart was fine. It still has not resolved though. Patient reported that she had the first dose last week and had a couple of things that she needed to report. She usually has a rapid heartbeat and has always been able to feel her heart beating and been able to hear heart beating. Caller said that she had her heart tested because of her having a rapid heart rate previously. Caller said that since the dose, she could not feel any sensations around her heart and even if she turns over to push up on her arm, she could usually feel her heartbeat and now she could not. She also could not hear it anymore. She said that it is kind of strange, unusual for her. Caller said that she could feel her heartbeat when she was watching TV. Caller said that she could not feel any sensations around her heart now on 18Mar2021. She said that the next night, 19Mar2021, she felt a buzz from her feet up her left size up to her neck. It was like a shock buzz, but it did not last. Last night, 21Mar2021, she had from her waist to her chest a big jolt to her system. It was just the one jolt. She tried to call her doctor to report this, and they directed her to call Pfizer. She said that she feels fine otherwise. She said that she has gained weight during the pandemic. Caller said that her not being able to feel the sensation in her heart started the evening of her receiving the vaccine 18Mar2021. Her toes do feel like there is a different sensation in them, but they are not really numb, but feel different. That started on the second night 19Mar2021 and this ongoing. It does not feel bad, just different. Second dose was scheduled for 08Apr2021. She may not get it if her symptoms are not resolved. The outcome of the event cannot feel any sensations around her heart and toes do feel like there was a different sensation in them was not resolved, outcome was resolved for events felt a buzz on 19Mar2021, outcome was resolved for event had from her waist to her chest, a big jolt to her system on 21Mar2021.

blood pressure went up very high, It went up to about 180, 190 even 200 over 80; Anxiety; Headache; slightly nauseous; This is a spontaneous report from a contactable consumer reported for herself. An 81-Year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; formulation: solution for injection; Lot Number: EL9264; expiration date: unknown), via an unspecified route of administration in left arm on 05Feb2021 (at the age of 81-Year-old) as single dose for Covid-19 immunization. The patient medical history included cholesterol and taking medication for cholesterol. The patient stated, she received her second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL9266; formulation: solution for injection; expiration date: unknown) via unspecified route of administration on 26Feb2021 as single dose for Covid-19 immunization. The patient stated this was the story. She received her two doses of the Pfizer vaccine and the last one received was two and half week ago. Now it's two and half week later and found that number one, after the first dose about 8 days later (unknown date in Feb2021), her blood pressure went up very high. Its normally never get that high. It went up to about 180, 190 even 200 over 80 and then she saw her physician. So, the physician put her on some blood pressure medication, and she got better and then had second vaccine. After that the same thing happen about a week later. Her blood pressure went very high, and she suffered because of it with a lot of anxiety. She wanted to know something about that the blood pressure goes really very high. It was still not regular; it was very irregular. Also, the other thing she wanted to talk about was that when she received the first dose, she had a headache and was slightly nauseous on unknown date in 2021. When she went for the second dose, she did not even look when she was putting a needle in her arm so, felt that the needle went in but shortly after heard her say oh jeez and she know she put it right in her arm, she thought might be she was bleeding, she did not have a look, ended up with a bandage over it and that was it, other day she see it did not have any blood on it. So, one of her friend told her that he had a similar thing happen to him where he felt that some of the vaccine was running down his arm (Further clarification was unknown, hence split was not made) and she was wondering if she got the full dose of the second vaccine, she had absolutely no side effects immediately after over the next day. Also, she took yesterday a test for antibody and that came out negative. The caller wanted to know that if she had antibody now with the two doses. Also asked does the blood pressure go up very high after the two doses. The patient underwent lab tests included antibody test with results shows no antibodies on unknown date, blood pressure (It went up to about 180, 190 even 200 over 80) on unknown date in Feb2021. On an unknown date, the blood pressure was between a 140-150. The patient received treatment included Losartan 75 mg. The adverse events resulted in physician office visit. The outcome of the events was unknown. No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021289470 same patient/drug, different dose/event

Severe muscle pains in both arms, could not lift arms to put clothes on, couldn't use arms worse at night. felt like cutting into arms with scissors or knife did not sleep, callsed drs that week, they all said it would go away. Lasted about 8 days. Never felt pains like this. A couple of weeks later arthritis dr gave me a steriod shot which helped. but still have troubles lifting arms and moving fast up to this day

NA from Rehab called RN (on her cell phone) on 7/9/21 to report this patient had an AE 1.5 hours after receiving her Pfizer COVIC vaccine. Patient had SOB and increased anxiety. Her 02 sats dropped in to the 80s. Her MD was alerted and he ordered O2 at 2 liters, benedryl and constant O2 monitoring. Pt was given her usual Lorazapam and Hydroxazine for anxiety and appeared increasingly anxious. Pt. was monitored continuously until symptoms subsided on 7/10/21. She was then back to baseline. RN followed up with facility and reported this AE on the website.

she felt her scalp itch like there were bugs on it/Scalp was just itching like crazy; headache; muscle and joint pains; muscle and joint pains; chills; temperature was 99.8 so the next time I took it and it was 100.8; felt lethargic; didn't get sleep that much; my throat closing up; This is a spontaneous report from a contactable consumer, the patient herself. An 81-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot number: ER8732; Expiration Date: 31Jul2021), via an unspecified route of administration, on 26Mar2021 (age at vaccination: 81-year-old), as single dose for COVID-19 immunization. Medical history was reported as none (not heard anything from anybody). There were no concomitant medications; she did not take any medications because she did not know if it was permissible. The patient previously received first dose of bnt162b2 (Lot Number: EN6198 and Expiry: 30Jun2021) on 25Feb2021 and she did not experience side effects from that dose. The patient reported that, yesterday (26Mar2021) was fine, it did not hurt the arm and everything, however, at 2 o'clock this morning, on 27Mar2021, she felt her scalp itch like there were bugs on it. Her scalp was just itching like crazy, and it would not stop itching so she just had to run her fingers through there, got a little bit of alcohol and just kind of rubbed it in there but it was just something under the skin. She then experienced headache, muscle and joint pains, chills, and a fever. She took her temperature, and it was 99.8 so the next time she took it, and it was 100.8, but since then it had got down to 99.7, so she still felt like she had fever. She had a feeling that she was slow and just did not want to do anything and that was how she left the day because she did not know whether she was going to react to it or not but there was no swelling around the injection site, no nausea, did not have swollen lymph gland, heart beat was not fast, did not have a bad rash, dizziness (not clarified further if had dizziness or not), no weakness, maybe weakness from no sleep because she hardly had any sleep and also felt lethargic. She did not see any swelling of face or throat, so she was mainly worried about her throat, maybe her throat closing up. She mentioned that these not concerned her and as long as she could swallow, she did not panic and could bear it. She said that she had been through so many shots in her life and she never had a reaction like that before so she did not think she would be required to go to the emergency room or anything like that because she just did not feel, but she said yes that was important that she take care of this, but it was not emergency in her book. She was so hungry, she just had a muffin and was not vomiting yet, she did not think anything would happen like that, as she did not think it was serious. Reportedly, she did not throw up and she felt like it would be more bearable for her to have food in her belly. She told that, she purposely did not have any lab test done because she knew this COVID was coming up and she had to have 3 boosters that she needed to take, but she was going to take them 2 weeks after. She also reported that, she did not take corrective treatment for fever and itchy scalp, as someone told her not to take anything, Tylenol or an Aspirin, so she did not. The outcome for the events: fever and itchy scalp was recovering (It was improved throughout the day and she walked around the house a lot just, because she exercises), and the outcome was unknown for the rest of the events. No follow-up attempts are possible. No further information is expected.

Blood clots, strokes, death I believe that there were subtle unrecognized signs starting in March - off balance, slurred speech, confusion- thought to be diabetes related. I would have her check her sugar and it would be fine, but I dismissed it as a good thing that her sugar was ok. It didn?t cross my mind until the major strokes that it could be related to the vaccine. She had major strokes in May as a result of blood clots in heart and head. I strongly believe that her death is related to the vaccine. She was well, and had her diabetes under control, and three months after getting the vaccine, she was dead.

82 y/o female, PMHx of CA, DM, HTN, hyperlipidemia, IBS, osteoporosis, RLS, seizure disorder, bladder prolapse, and diverticulitis admitted for altered mental status, elevated blood pressure, nausea and shaking, on 6/22/21. Pt tested positive for Covid, but did not exhibit symptoms except may fever. Pt has chronic ulcers on bilateral toe with purulent drainage, undergoing wound care. Toe ulcers found to be source of infection. Was put on clindamycin, Flagyl, and vancomycin (but developed allergic reaction to vancomycin). Pt was discharged to home on 6/23/21.

arrives to the emergency department by POV presenting with a chief complaint of tachycardia onset today. The patient received his COVID vaccine this morning. He states that he does not feel ill, but the only way he can describe how he is feeling is "being lousy". He has had associated palpitations without feeling like his heart is pounding. He denies ever having COVID. He typically takes one baby Asprin per day, and his last dose was this morning.

This is an 82-year-old female with history of cerebellar degeneration, who had her first COVID vaccine today around 11 a.m. she was in her usual state of health prior to that time. About two and half hours afterwards she became nauseated. She had several bouts of emesis and then had a fall. She was found to be hypotensive and bradycardic. The ambulance crew actually gave her atropine at the same because she had a pulse in the 30s, improved her quickly and she presented to the ER. She is to remain very orthostatic, received several liters of IV fluid as now symptomatically better. She remains a little nauseated. She denies any headache, diarrhea, fatigue, or myalgias. She does not feel quite right. She is still dizzy with sitting up.

got the 2nd vaccine on Thursday and already had symptoms from 1st vaccine but became weaker, vomiting, diarrhea. headache went to the ER Sunday . She was coherent just weak. Did Xray of stomach found out she had colitis , started her on antibiotics and admitted her and by the next morning She started having delusions, almost like having a seizure. on blood work her magnesium was low. She started retaining fluid. Thought maybe she had stroke but CT showed nothing. Now she doesn't know who she is and just repeating numbers. Pt is currently in the ICU. She has a feeding tube now do to not eating.

Daughter contacted the clinical location for vaccination to inquire regarding if her mother was confused when at the location to receive her vaccine as she ended up in the ED 2 hours later with a diagnosis of stroke. completing VAERs due to how closely the vaccine was to the event.

On February 1 at about 6 AM, I spoke to my husband about his doctor's appointment at 9:00 am each day, then at 7:40 AM, after showering, I asked my husband who was fully dressed, "Where are you going?" He responded, " Did you forget?" There was momentary brain fog and I didn't remember that he had this 9:00 am appointment-- more questions and difficulty with a quick recall for the answers; I and my husband became more and more concerned. As the day progressed and I revisited the episode, I consider that it was an aberrant event that I should report. I am journaling each day in case this or something else occurs.

Nauseous; nervous; This is a spontaneous report from a contactable consumer(patient). An 82-year-old female patient received first dose of BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 20Jan2021 at single dose for covid-19 immunization, fish oil, lactobacillus casei (RESTORA RX), via an unspecified route of administration from 21Jan2021 08:30 to an unspecified date at unknown dose and frequency for an unspecified indication. The patient's medical history and concomitant medications were not reported. The patient was calling in regards to the Covid Vaccine. She had the shot(covid vaccine) on 20Jan2021 at about 10 or 10:15AM. After her First dose, She had a doctor appointment at 11:20, 20Jan2021, the doctor put her on a new medicine, the Restora RX was in capsule form, she started that on 21Jan2021 at 8:30AM. She was nervous. She was nauseous on 21Jan2021 at about 8:30AM. She was a little nauseous and was basically trying to find out which one was causing it, the vaccine or the new medication. The name of the new medication was "Restora Rx". The action taken in response to the event for fish oil, lactobacillus casei was unknown. The outcome of the events was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained.

12 hours post vaccination - couldn't lift feet off floor, had to shuffle her feet to walk, headache, brain fog, memory difficulties, body ache, sinus drainage, extreme tiredness, tenderness at injection site, increased shortness over breath 24 hours post vaccine- mild headache, tiredness, joint pain, lethargy, no pain at injection sight, able to walk fine, mild shortness of breath,

Patient was hospitalized, presenting to the ED with confusion/encephalopathy. She was also found during her hospitalization to have hypoglycemia, CAP, UTI, and liver cirrhosis with elevated LFTs/ammonia. She was given antibiotics and lactulose to manage. Patient recovered and was later discharged

Had major vertigo on my first shot. Saturday i felt the feeling like i was off the floor again . not so much vertigo but like i was floating. yesterday i ate lunch and very quickly after i got diarrhea very suddenly and i felt i emptied my entre body This morning i have had pain in my stomach but seems to be subsiding as the day goes on.

Early morning on 2/16 woke up disoriented and found myself lying on the floor in a hallway between bedroom and bathroom. Not sure how I got there. Attempted to vomit but only gaged. Friend called at 700am and I wasn't making much sense. Later in the day I seemed alright, became cold in the evening and fever had returned. At 4 am morning of 2/17 I woke up soaking wet. Went back to sleep and seemed to be fine when I got up at 8am. It is now 2 weeks since I had this shot and I have experienced no further problems. My daughter-in-law Is a doctor and she said I should report these side effects.

gets 102 degree fever; Could not speak much next two days; Within one hour or so after: found on floor, fell on right side; unable to speak like a TIA; disoriented; This is a spontaneous report from a contactable consumer. An 82-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 12Feb2021 at 13:00 at single dose for COVID-19 immunisation at the age of 82-year-old. Medical history included dementia, high blood pressure, allergy to drugs with sulfer. Concomitant medications included 2.5 Amlodipine, 81 mg aspirin, 0.5 clonazepam, 20 mg Escitalopram, 10 mg melatonin, 5 mg memantine, 15 mg mirtazapine. The patient was not pregnant. The patient received first dose of received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 22Jan2021 at single dose for COVID-19 immunisation at the age of 82-year-old. Within one hour or so after the vaccine administration: the patient was found on floor, fell on right side, disoriented, unable to speak like a transient ischemic attack (TIA), out of it. The patient could not speak much next two days. Don 14Feb21 at 15:00, the patient got 102-degree fever. The patient was treated for the events. The patient was recovering from the events. Information on the lot/ batch number has been requested.

started acting strange, paranoid; started acting strange, paranoid; she forgets things; dementia; This is a spontaneous report from a contactable consumer (patient's daughter) An 82-year-old female patient received the 1st dose bnt162b2 (BNT162B2) at single dose in arm on 22Jan2021 for Covid-19 immunisation, administered a Clinic. Medical history included macular degeneration from Aug2020 and treated with Saffron and Eylea. The concomitant medications included: Saffron, an herb, started a few weeks before the vaccine was administered for macular degeneration, Eylea shot for the macular degeneration and she got a shot within a few weeks of getting one of the vaccines but this is not a new medication for her. No additional vaccines administered on same date of BNT162B2. No prior vaccinations within 4 weeks. The patient experienced dementia in Jan2021, started acting strange, paranoid on 24Jan2021, she forgets things in Jan2021. The events did not require a visit to Emergency Room or Physician Office. Course of events: About 2 days after the 1st shot she started acting strange, paranoid. Her mom lives with her daughter, son in law, and 21-year-old grandson. She though they were stealing from her, her daughter and grandson. Reporter explained she knew this sounded like classic dementia and she forgot things like everyone does but this was uncharacteristic and she was fine up until 3 days after the shot. They have called her primary care doctor who has done blood test looking for a UTI or infection and that came back good. The doctor also did a CT scan and it came back good. Caller explains that the event was about the same since it started. The outcome of dementia was unknown, of started acting strange, paranoid was not recovered. The patient received the 2nd dose of bnt162b2 (BNT162B2) at single dose in arm on 12Feb2021 for Covid-19 immunisation, administered a Clinic. Information on the lot/batch number has been requested.

From admitting hospitalist: received 2nd dose of "COVID vaccine" on 2/16. Felt fine until approx. 2 days later when she experienced increasing fatigue and "feeling poorly" . Stated she spent most of the last week in bed due to severe fatigue. Admitted to the hospital 2/28/2021 with new onset Afib with rapid ventricular rate and new diagnosis of CHF with fluid overload upon arrival.

Patient's family concerned regarding increased confusion and arm pain post covid vaccination. Insistent that an adverse event form completed. Resident had covid-19 in November 2020, then a uti, and CHOLELITHIASIS WITHOUT OBSTRUCTION right before the vaccine series started.

Vaccine recd 1/20 and 9 days after I got really sick and still having breathing trouble and short of breath, now using breathing treatments, I'm having a hard time walking, weakness all over, headaches, and I feel so out of it.

Pfizer-BioNTech COVID-19 Vaccine EUA: patient reports within four hours of vaccination development of rash on trunk, headache, and feeling "spacey" and fatigued. Also reports rash with first vaccine dose. Does not report and respiratory, neurologic, or respiratory symptoms. Symptoms resolved with diphenhydramine.

itchy skin all over body, but primarily on my upper back where a red rash appeared following each of the two vaccine shots. Not sure of the date ot its first appearance following Shot #1 ; I felt fine for four days after shot # 2, then the itch and rash intensified so that I had great trouble sleeping. My upper back is itching now as I type, but seems to have begun to fade; and, the rest of my body is pretty pretty much itch free. I began applying an herbal tincture to the rash on my back on March 1st which seems to be helping calm it down.

king size belly ache; pooped all over herself; weak and too through; severe diarrhea; This is a spontaneous report from a contactable consumer (patient, self-reported) via medical information team. A 82-year-old female received first dose of BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: EL9262, expiry dates not provided, NDC#; unknown), via an unspecified route of administration, in arm left, on 27Jan2021 14: 00, as single dose for COVID-19 immunisation. The patient medical history was not reported. The patient concomitant medications were none. It was reported that the patient experienced severe diarrhea on an unknown date in 2021, also reported that She got a king size belly ache the following Saturday and pooped all over herself. She is weak and too through; all events on 30Jan2021. The outcome of the event diarrhea was unknown and other events were recovering.

Systemic: Allergic: Difficulty Breathing-Medium, Systemic: Dizziness / Lightheadness-Severe, Systemic: pt was very anxious -Severe, Systemic: Shakiness-Severe, Additional Details: after pt received her shot she shopped in the store and then sat down and was very anxious, dizzy, and was shaking uncontrollably

dizziness; hallucinations; disorientation; fever/she had fever again; pain in the arm/pain in left arm; loose appetite/without appetite; forgetting things and words; could not even put up a sentence; difficulty breathing; needed help to walk; needed help to get dressed and eat due to hands tremor issue; vomiting; pneumonia; stopped eating; she was always tired; sleepy; stiffness in extremities; oxygen was low; she was not responsive/following instructions; This is a spontaneous report from a contactable consumer reporting for herself. An 82-year-old female patient (not pregnant) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 14Feb2021 08:45 on Left arm at single dose for COVID-19 immunization. Medical history included Hypertension. Concomitant medications included acetylsalicylic acid (ASPIRIN PROTEC), atorvastatin, losartan. The day of the vaccine administration she had fever and pain in the arm on 14Feb2021 20:00, next day on 15Feb2021 started with dizziness, hallucinations, disorientation. As the days went on in 2021, she started to loose appetite, forgetting things and words, she could not even put up a sentence but most importantly she had difficulty breathing, needed help to walk, get dressed and eat due to hands tremor issue. Afterwards; she had fever, vomiting, pneumonia and stopped eating, she is always tired, sleepy, with stiffness in extremities and pain in left arm. She was 1 day hospitalized and we had to bring her back to hospital because her oxygen was low, she had fever again, without appetite and she was not responsive/following instructions. All events were resulted in Emergency Room Visit and Physician Office Visit, Hospitalization for 1 day. Treatment received for the events included Oxygen, fluids, antibiotics. Lab data also included covid test type post vaccination=Nasal Swab on 01Mar2021 with Negative result. The outcome of the events were not resolved. Information on the lot/batch number has been requested.

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.

She has not been feeling right; she does not feel normal/ Fuzzy head; she feels very sick; She feels like her symptoms from her thyroid have like over taken her body; She feel like everything is aching, everything hurt; everything burns; It's hard for her to have her balance; This is a spontaneous report from a contactable consumer. An 82-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: EN6202), via an unspecified route of administration at the age of 82 years, on 07Mar2021 at a SINGLE DOSE for covid-19 immunisation. Medical history included ongoing thyroid disorder. The patient's concomitant medications were not reported. The patient previously received the first dose of BNT162B2 on an unspecified date for covid-19 immunization. The reporter stated, "I am a daughter for patient who got the Pfizer shot". On an unspecified date, the reporter further stated, "I am calling in regards to my mother, she is 82 years old and she got her second vaccine on the 7th, on the Sunday and ever since then, she has not been feeling right, she has a condition where she has too many antibodies for her thyroid, but the first shot she got she felt fine after. This time she feels like her symptoms from her thyroid have like over taken her body and she feels very sick, she does not feel normal, she feel like everything is aching, everything burns, everything hurt, her head is fuzzy, it's hard for her to have her balance, it's only after she got the second shot she started feeling like that, the next day Monday, so we don't know what to do because we don't know how long will this last, she feels like she is dying, which is lot for my mom to say because she can take some pain, so I want to know the way this functions." The outcome of the events was unknown.

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.

After the vaccine, after I sat down, I started to feel shaky and felt light headed. My blood pressure was elevated and wasn't going away it lasted for a while. I went to UC to be seen.

nauseous/ queasy/ Terribly nauseous; tired/ fatigue; slept right through the night; This is a spontaneous report from a contactable consumer or other non hcp. A 82-year-old female patient received bnt162b2 (BNT162B2, solution for injection), via an unspecified route of administration on 31Jan2021 as SINGLE DOSE for covid-19 immunisation. Medical history included diabetes mellitus from an unknown date and unknown if ongoing Verbatim: Diabetic, thyroid disorder from an unknown date and unknown if ongoing Thyroid medication. Concomitant medication included levothyroxine (LEVOTHYROXINE) taken for an unspecified indication, start and stop date were not reported; losartan (LOSARTAN) taken for an unspecified indication, start and stop date were not reported; simvastatin (SIMVASTATIN) taken for an unspecified indication, start and stop date were not reported; (OCUVITE) taken for an unspecified indication, start and stop date were not reported. On an unspecified date, the patient experienced nauseous/ queasy/ terribly nauseous, tired/ fatigue, slept right through the night. The patient underwent lab tests and procedures which included weight fluctuation: 112, 110, 111 on It's about 112 pounds, once day it's 110, 111 it depends on (incomprehensible word). The action taken in response to the event for bnt162b2 was not applicable. The outcome of the events was unknown. Information on the lot/batch number has been requested.

Drowsiness, driving collision, feeling "like no body is home", didn't feel like herself, felt like a "zombie"

She developed widespread hives that have lasted for two weeks, prolonged debilitating fatigue and weakness that have left her unable to participate in her life. 15 days later she is still struggling with shortness of breath and extreme fatigue and hives.

Side effects started day 2 after vaccine administration. Pt started with fever, vomiting, abdominal distension, spot where she had previous hernia surgery was bothering her. She spent a whole day in bed and then felt better. Just follow home care treatment.

Pt states hx of anxiety and was throwing up with abdominal painprior to arrival as well. Given 4 mg SL zofran with mild relief of nausea, abdominal pain persisted: Pt presents with nausea/vomiting which she attributes to anxiety. States she has had severe anxiety about getting vaccine and has been vomiting with abdominal pian throughout the day. She is noted to be extremely hypertensive today, denies hx of hypertension. She was given 4 mg SL zofran with resolution of nausea however abdominal pain and hypertension did not resolve. Of note, pt has a hx of Whipple procedure Nov 2019 and reports she has had intermittent abdominal pain since that time. Report called and pt escorted via wheelchair to the ER

Within 2 hours, hallucinations, fainting and falling down first two days. Total 4 times. Muscle weakness in legs, mild confusion then and continues.

4/10/21 ER HPI: 82 y.o. female who presents to the Emergency Department by paramedics from a local nursing home. The patient is an 82-year-old female with a known history of end-stage renal disease, diabetes, and coronary artery disease. She presented to the emergency room after being transported from a local nursing home. Apparently, the patient was acting a little bit more confused than normal and she was looking more short of breath than normal. The nursing home nurse stated that her oxygen saturations were in the upper 80s without oxygen and the patient looked visibly more short of breath than normal. Because of this, the nursing home made the decision to send the patient in. When paramedics arrived at the nursing home they placed 2 L of oxygen on her and her oxygen saturations went up into the high 90s. The patient does dialysis on Monday, Wednesday, Friday. She did not miss a dialysis treatment this week. The patient has had her coronavirus (COVID-19) vaccine and several months ago did have coronavirus (COVID-19) at the local nursing home. The patient does have mild dementia and so is somewhat of an unreliable historian. Transferred to pleural effusion

PT complained of multiple symptoms (nerves, fatigue) looked distressed. Empress ALS checked out. Run #43202 High BP, no history of. Hooked up to oxygen tank, started to calm down, BP lowered a little but still high. (175/105). 12 lead was clean. Transported BLS to Hospital. Run # 43296

Pt received Dose #1 of COVID-Pfizer vaccine on 3/15/21 and Dose #2 on 4/1/21 (location pt received is unknown by this reporter); pt was presented to ED on 4/25/21 @ 1427 with confusion, dysarthria, R-sided weakness. Head CT showed L sagittal sinus thrombosis and pt was started on a heparin drip per protocol. On 4/26/21 pt still noted to have RUE weakness, however speech had improved. Pt is still hospitalized in the ICU as of this report on 4/26/21.

was fine until Thursday evening 4/22/2021. Started feeling body aches and restless. Friday morniing 4/23/2021. She woke up and went to the bathroom. Go out and fell and went into cardiac arrest. #12: GAD, Fibromyalgia, migraine, ventral hernia, hypothyroid, hypercholesterolemia, neuropathy, Hx of Covid-19

could hardly walk; arm was very sore; stomach was upset; Slight Headache; Diarrhea; Slight fever; Muscle ache; felt bad; Sore throat; bled after her injection; This is a spontaneous report from a contactable consumer, the patient. An 82-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot: ER8727), via an unspecified route of administration in the left arm on 25Mar2021 between 15:30-16:00 (at the age of 82-years-old) as a single dose for COVID-19 immunization; apixaban (ELIQUIS) via an unspecified route of administration at 5 mg twice a day from an unspecified date in 2018 and ongoing as a blood thinner/for the heart. Medical history included diabetes (started a couple of years before 2018), arthritis, lupus since 2020 (started just 6 months ago), high cholesterol, heart disease, all ongoing; as well as aortic valve replacement and pacemaker in 2016; she had all 3 types of arthritis: osteo, rheumatoid, and the one with the rashes, she has had aches and pains for a long time; arthritis pain; heart surgery in 2016; COVID-19 in the last part of Jul2020 to the first 2-3 weeks in Aug2020 (and then tested negative on 19Aug2020) with the following symptoms: bad headache, muscle aches, diarrhea, loss of smell and taste, "just about everything" for almost 4 weeks, autoimmune disease, diuretic and muscle relaxant therapy. Ongoing concomitant medications included glimepiride for diabetes from 2014, potassium tablet as a diuretic from 2016, furosemide as a diuretic from 2016, metoprolol for the heart from 2016, atorvastatin for cholesterol, hydrocodone for pain, tizanidine as a muscle relaxant, cinnamomum verum (CINNAMON) capsule, ascorbic acid (VITAMIN C), fish oil, ubidecarenone (COQ-10), vitamin D3, paracetamol (TYLENOL ARTHRITIS PAIN) tablet for arthritis pain, and an unspecified multivitamin. There were no additional vaccines administered on the same date or 4 weeks prior to BNT162B2. On25Mar2021, the patient bled after her injection, the blood started running down her arm when they pulled the needle out. The patient experienced sore throat on 25Mar2021 at 22:00, which was not excruciating, and the patient did not take anything for it. After waking the next morning, the sore throat was gone. The patient took paracetamol daily in the morning, and she wasn't sure if that was why her sore throat went away or not. She stated that when she had COVID disease the paracetamol didn't help her sore throat or headache at that time. The patient then started to have muscle ache on 26Mar2021 and a slight fever, never over 98 degrees, and she felt bad. The patient's normal temperature was around 97 degrees. The patient experienced a slight headache on 27Mar2021, diarrhea for 1 day and stomach upset on 27Mar2021 and then diarrhea again on 31Mar2021 for 1 day. The patient didn't take anything for the diarrhea, it was not that severe. The muscle aches continued in the upper part of legs, thighs, upper arms to her elbows. The patient had never had a hurting like that in her muscles and on an unspecified date, the patient could hardly walk since it was hurting so bad. On an unspecified date, the patient's arm was very sore. The events did not require an emergency room or physician office visit. The patient did call her doctor because she was hurting so bad who informed her that he had heard of other people who had the disease were having a reaction to the first vaccine. The action taken in response to the events for apixaban was dose not changed. The clinical outcome of sore throat was resolved on 26Mar2021 (duration 1 day), muscle ache was resolved on 03Apr2021 (duration 8 days), slight headache was resolved on 04Apr2021 (duration 8 days), diarrhea occurring on 27Mar2021 was resolved on 28Mar2021 and diarrhea occurring on 31Mar2021 was resolved on 01Apr2021, slight fever was resolved on 26Mar2021 (duration 1 day), stomach was upset was resolved on an unspecified date, and of could hardly walk, arm was very sore, bled after her injection, felt bad was unknown. No follow-up attempts are possible. No further information is expected.

Approximately 40 hours after second Pfizer vaccine, patient complained of pain in lower right leg, and a cold foot, lethargy, weakness, feeling unwell. 3 days later, shortness of breath, difficulty breathing, rapid heartbeat, and confusion began. Went to Medical center on 4/20/21, diagnosed with DVT, PE and clots in and around the heart and passed away on 4/21/21 of cardiac shock in the setting of pulmonary and arterial thrombosis.

Second shot, cold light temp, diarrhea, injection site pain, arthritic knee hurt badly- felt fuzzy and lightheaded for everyday since shot. Added 5/7 some days super duper tired Pfizer 03/13/ 2021 left arm. No medicine, has arthritis,

This is a spontaneous report from a contactable consumer (patient). A 82-year-old female patient received first dose of bnt162b2 (COVID-19 VACCINE, solution for injection, Lot Number: ER8737; Expiration Date: Jul2021, NDC number: Unknown), via an unspecified route of administration on 07Apr2021 (at the age of 82-year-old) at single dose for COVID-19 immunisation. Medical history included had headaches most of her life, she knew it was her cervical spine because of bone spurs, arthritis, and bulging disc; she has also had change in vision, she was coming down the road from seeing her cardiologist and was looking down the road, out of right eye the road continued straight, but out of her left eye it looked like the road was turning off to the left, it was actually going straight, her eye doctor had told her that her eyes were no longer compatible, she was having five prisms put in her glasses, the neurologist was concerned, the eye thing started four or five months ago; she had shrunk to 4 foot 10 inches or 4 foot 11 inches, she used to be 5 foot 2 inches and shrunk because she had osteoporosis. The patient's concomitant medications were not reported. Patient reported that she had diarrhea one day in Apr2021. She started coughing some yesterday (14Apr2021). Then she was coughing more a little later. That was not what she would normally do. 14Apr2021, she was moving her winter clothes out to her summer clothes. She worked for three to four hours. Then she got so sore and was hurting all over. She felt the same this morning (15Apr2021). She was wondering if muscle aches could be a part of it. She was really hurting last night (14Apr2021) all over. She woke up this morning and felt sore. She was better now. It was from the waist up to the rib cage and all the way around. It was general, all over. She felt so badly last night (14Apr2021) and didn't feel great this morning. Another reason she was calling was because she saw her neurologist three days before and he scheduled her for an MRI of her head and brain. She had the appointment for the MRI on the 21Apr2021. She had been told that particular test was a magnet test and not radiation. She wanted to make sure there was nothing in the vaccine. They were not sure what the vaccine was going to do. They were not sure what was dealing with. Diarrhea started a couple of days before in Apr2021 when she was out of town, just for one day. It had stopped, she had recovered completely from the diarrhea. Coughing started on 14Apr2021. It was kind of a deeper cough. She had a little coughing 15Apr2021, but mainly body aches that started late 14Apr2021. She hobbled around and went to bed and got up to go to the bathroom and was having a hard time walking because she was so sore on 14Apr2021. The soreness was all over the body. She was having the MRI on her brain and head because she had been having headaches in Apr2021. She has had headaches most of her life. She had seen him (neurologist) several years before. She knew it was her cervical spine because of bone spurs, arthritis, and bulging disc. The doctor said that was the reason for a headache, but this was a different headache. It extended from behind her eye on the left side to the back of her head. It came on suddenly and she would have it for two to three days. Then that side of the head when she was turning in the left direction was sore and hurts. The headaches that felt different had been on and off for the past several months. She would have them for 3 days running and then maybe get a reprieve. She didn't want to take the second vaccine and had that on top of each other with the MRI. She wondered if she could take the second vaccine a little later. She was not comfortable getting it around the same time of the MRI. The outcome of the event diarrhea was recovered in Apr2021, sore was recovering, outcome of the other events was unknown. No follow-up attempts are needed. No further information is expected.

Was very weak, dizzy, poor memory. I felt very extreme health reaction for over 7 days. It was my error not acknowledging allergic to Sulfa.

can barely think; stated that she is a mess; can barely walk; This is a spontaneous report from a contactable consumer. An 82-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as 1st dose, single (at the age of 82 years) for covid-19 immunization. The patient's medical history included allergic to sulfa and brain damage (she was hit by a drunk 30 years ago). The patient's concomitant medications were not reported. The patient experienced can barely think, stated that she is a mess, can barely walk on an unspecified date. It was further stated that she had a shot a week ago. Stated she made an error. When they acknowledged if she was allergic to drugs or medication she did not acknowledge that she was allergic to sulfa. Stated that she had brain damage because she was hit by a drunk 30 years ago. Stated there was sulfa in the medication and the brain damage was hitting her hard. Stated that she's a mess. Wanted suggestions as to what to do since she was in this state. She has it set up for the second shot and wanted to know if she should have a second shot with the same ingredients for Pfizer Cod 19 virus vaccine. Stated that she went online to see if it had sulfa in it. Stated that she had an initial reaction to sulfa before an it was extreme. Stated she should have looked it up beforehand. It has been a whole week and she can barely walk. Stated that she can barely think. The outcome of the events was unknown. Information on 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.

Lymphedema in her legs/ got lymphedema about 5-6 days after the second Pfizer vaccine; Legs were hurting like the devil; Legs were about six times the size they should be/ she has intense swelling; Peeing too much; Doesn't feel right; she is just so weak; This is a spontaneous report received from a contactable consumer (patient). An 82-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EL9261; Expiration Date: 31May202, NDC: 59267-1000-2), via an unspecified route of administration, administered on left arm on 06Feb2021 at 12:00 as 2nd dose, single for COVID-19 immunisation. Medical history included ongoing emphysema, ongoing breast cancer from 2007 (she did not take chemo, just radiation) and ongoing follicular lymphoma from 2014 (did not take chemo, just radiation. Cancer was in the bone marrow, said she didn't think that has anything to do with it, has had two operations) and bone marrow cancer. The patient previously took budesonide/ formoterol fumarate (SYMBICORT) she was using SYMBICORT, but her doctor switched it a few months ago, back to ANORO), prochlorperazine maleate (COMPAZINE) she takes a couple of times per month, takes 10mg when she feels nauseated and pseudoephedrine hydrochloride (SUDAFED) she takes when she needs it. Concomitant medications included furosemide (LASIX) at 40 mg, twice a day (one 40mg pill in the morning and one 40mg pill at night) from 1985 to an unspecified date and then increased to 80 mg, twice a day (two pills (80mg total) in the morning and two (80 mg total) at night) from on an unspecified date and ongoing for blood pressure; ongoing simvastatin (ZOCOR) taken for high triglycerides; umeclidinium bromide/ vilanterol trifenatate (ANORO). Patient thought she has been on Lasix since 1985 but can't remember back that far. She was taking Zocor for a long time and stated Anoro Inhaler was a fairly new medication. For Anoro inhaler, patient stated she pulls back the thing and didn't know, maybe it pinches a pill and inhales the white powder. Relevant family medical history included none and both parents were deceased. Patient stated that her oncologist does blood tests once every four months, a test for markers and stuff like that, CBC, metabolic panel and bloodwork every 4 months. The patient previously took first dose of BNT162B2 (Lot number: EL3246, Expiration date: 30Apr2021, NDC: 59267-1000-2) via unspecified route of administration in left arm on 14Jan2021 12:00 pm for COVID-19 immunisation. It was reported that, the patient has very sexy legs, but she doesn't anymore, says she got lymphedema about 5-6 days after the second Pfizer vaccine in Feb2021. She was now going to physical therapy, to bear her out and try to understand what she's saying. Caller states 30% of the people there that have had cancer and had radiation, get the same side effect she has had, some people have it in the arms, she got hers in her leg, says she has intense swelling, called lymphedema, says her legs look like they belong on an elephant. Caller said at the physical therapy place, 30% of people who have come in for help had radiation treatment for some kind of cancer, all have different kinds of cancer, but the swelling, the lymphedema, was the side effect they've all experienced. Caller states that no one has called Pfizer and let Pfizer know, states she won't take the booster, won't have anything to do with this, says it's too scary. Caller states she was an active person, never had a problem with legs swelling or anything like that and now, her look like legs that belong on an elephant. Caller states the correlation seems to be with radiation treatment, because she has bone marrow cancer, and other ladies have breast cancer, states the only thing we all have in common was different treatments but in her own case she had no chemo, but she did have radiation. It seems like with radiation this swelling was an after effect. Caller says it's 2 or 3 things, not just that they had cancer or radiation treatment, says those of us who had radiation also got this swelling. Caller states she never had any trouble with legs or anything, says she was an active person. States some people experienced this four days after the vaccine, says hers started six days after the vaccine, says she woke up one morning, and her legs were huge. States usually legs were smaller in the morning. Caller wonders what were the ingredients that causes swelling. Caller states she doesn't know how to explain it, says like overnight turned a switch on and now her legs were going to be big and fat and ugly. Caller states the reason she's calling was because at physical therapy last Thursday, other people who had the shot had the same side effect, says the only thing the lady said, she wasn't sure if she was a nurse or not, was the relationship was not with the kind of cancer, but the radiation treatment and the shot has been causing this and wasn't surprised. Caller says she was told that about 30% that they're handling now had the Pfizer vaccine. Caller thinks that's all they gave in the state NC, no other vaccine here, says it just seems to be with this. Caller states the lymphedema, hers was in her legs, others have it in their arms, she doesn't know why it's happening. Caller states about six days after the second shot, she can't remember exactly what day, about six to seven days, she woke up one morning, and her legs were hurting like the devil in Feb2021, stated her legs were about six times the size they should be in Feb2021. Caller states usually in the morning, the swelling goes down, but this woke her up out of the blue like zap, says no warning, no nothing, just one day she woke up and that where it was. Caller states her doctor increased Lasix, she used to take one 40mg pill in the morning and one 40mg pill at night, increased it to two pills (80mg total) in the morning and two (80 mg total) at night. Caller states she is now only taking one-and-a-half-pills this morning, because she doesn't feel right and she was peeing too much in Feb2021 and was not feeling right. She doesn't want to get dehydrated. Caller states she has a doctor appointment 10Jun2021 and was going to tell him she was taking less because she was just so weak in Feb2021. Says she was weak because she's taking too much Lasix, states she was taking two 40mg morning and night. Caller states she was just concerned, she has big legs, fat legs, she calls them fat. The patient not visited emergency room. The events result in the patient visited physician office. Patient reported that she has had no shots for four months however she was going to get the high dose flu shot on 01Oct2021. No relevant tests were performed at the time of this report. The outcome of the events lymphedema and Legs were about six times the size they should be was not recovered and outcome for the other events was unknown. No further details provided. Follow-up attempts are needed. Further information requested.

At time of vaccination my arm hurt badly. 24 hours after the vaccine I had fever and chills. On the 3rd day I woke up with sharp pain down my left arm, pain in my back and neck. On the 5th day I got lightheaded and dizzy. My blood pressure reached to 186/110 with a horrible headache. Went to the doctor and had a CT scan and stress test done. After 5 weeks my body is back to normal.

bothers her is that her problem remembering words is getting worse./: Knees hurt was reported as worsened.; it started from the top of her neck and her balance was off, she felt "fuzzy-headed"; She has been experiencing periods of tiredness where she does not want to do anything; increased forgetfulness in addition to her intermittent light headedness; increased forgetfulness in addition to her intermittent light headedness; Was cold; diarrhea; her knees hurt her; chills; mild fever; her arm was hurting; Arm was just a teensy bit sore at the injection site; Felt a little like balance was off; So tired I don't want to do anything; 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, solution for injection, Lot Number: EN6199, Expiration date: Jun2021), via an unspecified route on 13Mar2021 (age at the time 82-year-old) as 2nd dose, single dose in the left arm for covid-19 immunization. The patient medical history included osteoarthritis, fibromyalgia (reported that she was diagnosed with fibromyalgia close to 20 years ago, between 15-20 years ago). The patient concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EL9269), via an unspecified route on 20Feb2021 at 10:00 (age at the time 82-year-old) as 1st dose, single dose in the left arm for covid-19 immunization. On 13Mar2021, the patient experienced armed was hurting, armed was just a teensy bit sore at the injection site, and the next day, on 14Mar2021 she had diarrhea and her knees hurt her and had chills and mild fever, was cold and felt a little liked balance was off. Patient reported that the next day, 15Mar2021, she was fine, on 16Mar2021 it started from the top of her neck and her balance was off, she felt fuzzy-headed, fuzzy headed feeling was now not so much, but she would have a day where she was so tired that she doesn't wanted to do anything. Patient experienced periods of tiredness where she did not want to do anything was reported as worsened and reporting increased forgetfulness in addition to her intermittent light headedness. Patient reported that she called the pharmacist who informed her that some reactions would go on for a few weeks. She reported that she was a senior, and most seniors had a problem where they couldn't remember a word then blinked and could've thought of it. She reported that the thing that bothers her was that her problem remembering words was getting worse and the problem remembering words had gotten worse from her baseline after she received the covid-19 vaccine, but it had stayed the same since originally worsening from baseline. Patient reported that the difficulty remembering words worsened around the same time that her fuzzy or lightheaded feeling began, and temperature was 99. 7. Patient explained that her armed did tended to hurt a little and that she received her shot in the affected armed and she was not sure if the diarrhea lasted the second day or not, but it resolved completely. she had a teeny problem with her knees and the covid-19 vaccine really nailed it. She reported that since she received the second dosed of the covid-19 vaccine, her knees had been terrible. She reported that what's really bothering her now was her knees. She reported that her knees were hurting so bad that she could've hardly walked. It was reported that patient visited to physician office. The outcome of the events diarrhea was resolved on Mar2021, armed was hurting was resolved on 14Mar2021, chills, mild fever, cold was resolved on 15Mar2021, felt a little liked balance was off was resolving, her knees hurt, so tired I did not want to be done anything was not recovered and other events was unknown. Information on lot/batch number was available. Additional information had been requested.

The morning after I received the vaccine, I started feeling tired and my arm was quite sore. The following day, I had a fever of probably 100. I had chills and my heart rate and blood pressure went up. Since I have A-Fib, it was irregular. After several hours, my HR went back to normal and that is when I called my Cardiologist NP. She said that she thinks it's related to the fever I had. The next day, I felt a tad better, but fatigue and generally not feeling well lasted a few days. I feel that it took about a week before I felt normal again. About two months later, I was making plans to go out of town and I became very ill. I started having chills, fever, nausea and extreme fatigue. I may have taken some Tylenol. I was drinking a lot of water because I did not have an appetite. A couple days later I felt a little better so I did not contact my doctor, but I did go to an urgent care (05/22/2021) and had a COVID test. The test came back negative and I felt better two days later. On Monday, I started feeling bad again and I contacted my PCP, and I went to see him on Tuesday. He ran some blood tests and another COVID test, which came back negative. The fatigue just stayed around for quite some time. He monitored my sodium and chloride and they were both low so the doctor wanted them monitored. I was admitted into the hospital for two days. I was on liquid restriction. I had a bunch of tests ran that came back negative. I did have an AMA test which did come back positive. I am still on water restriction, but I am feeling much better. I'm a bit leery about receiving a booster shot.

within 24 hours after second dose of vaccine my mother complained of chest pains and shortness of breath. She saw her Primary Care Dr on 5/10/2021 after experiencing dizziness, fatigue, confusion. She had lost a considerable amount of weight during this time and I was concerned and accompanied her to the doctor visit. Dr prescribed cyanocobalamin B-12 as she had been defficient in her latest blood analysis on 3/15/2021. She also added Donepezil 5mg tablet daily and trazodone 50 mg nightly to help with sleep. She gave referral to get Neuroligical evaluation. My mother had a driving episode on 4/30/2021 where she was taken to Medical Center and some Scans were taken of her brain that were apparently normal they contacted me to pick her up around 2:30 AM 5/01/2021. The number on her release folder to obtain medical Records. My mother was residing with me my home until her appointment for evaluation . She passed away on 6/02/2021 in my home.. Dr was contacted to sign off on her Death Certificate . I have not received Death Certificate as of today but I believe the cause she was putting was Natural Causes due to age.

lightheadedness; very very tired for a day or two; Memory was worsened than that it was before; This is a spontaneous report from a contactable female consumer. This consumer(patient) reported for herself that: An 82-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EN6199), via unspecified route of administration in left arm on 20Feb2021 (at the age of 82-years) as single dose for covid-19 immunization. The patient medical history included osteoarthritis and fibromyalgia. Concomitant medications were not reported. On 21Feb2021, the day after the first dose of covid-19 vaccination, the patient experienced lightheadedness for a day and then it was gone. She stated that she felt "very very tired for a day or two" on an unspecified date in 2021 and then was alright for a while. On an unspecified date in 2021, after the first dose, her memory was worsened than it was before. She stated that she had met two people, who had the same thing. She stated that she had initial symptoms one day and after that she had other things. The patient confirmed the vaccine was Pfizer Covid-19 vaccine. She wanted to know early that how long these symptoms would last and if more symptoms would appear. The outcome of the event lightheadedness was recovered on 22Feb2021. The outcome of the event tired was recovered on an unspecified date in 2021. The outcome of the event memory impairment was unknown. Reporter seriousness for Memory was worsened than that it was before: Unspecified Additional information has been requested.

She just feels terrible; Trouble walking; Splitting headache; Shortness of breath; Cough; She can't do her daily activities/she feels out of sorts; This is a spontaneous report from a contactable consumer. This 82-year-old female consumer (patient) reported. A 82-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH, COVID-19 vaccine, solution for injection; Batch/Lot number: EN5318), via intramuscular, administered in Right arm on 07Feb2021 at 14:00 (at the age of 82-year-old) as 1st dose, single for covid-19 immunisation. The patient Medical history included cough from 19Jan2021 to an unknown date, dyspnoea from 19Jan2021 to an unknown date, malaise from 19Jan2021 to an unknown date. On the 19Jan2021, she was not feeling well and went to a medical facility and had blood work, a chest x-ray, and a Covid-19 swab done. They said that she probably had Covid, but they weren't sure. She was sent to another facility and had a antigen test. Her swab came back from the swab test a few days later and came back positive. On the 20Jan2021 they did a throat swab and it came back negative that she did not have Covid-19. She went back to the first facility about 10 days later and they did another throat swab and she tested negative. The concomitant medications were not reported. No 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). No Prior Vaccinations (within 4 weeks). The patient was not ill at the time of vaccination. On 08Feb2021, the patient experienced splitting headache, felt terrible, Trouble walking. The reporter stated that the Covid-19 Vaccine and reported that she had the vaccine on 07Feb2021 and on 08Feb2021, she was feeling so horrible that she went to her physician. She said that she had a splitting headache and does not know if it is associated with the vaccine. It is Thursday, and she still has a headache, shortness of breath, and she just feels terrible. The patient reported that she also had cough. She said that she can't do her daily activities and she feels out of sorts. She feels like she does not want to do anything and the headache hurts. She does not know if it is a migraine or what, but it hurts. She reported that she has been having trouble walking. She stated that this started this past week since she had the vaccine, since 08Feb2021 and stated that it is persisting. The headache is driving her crazy. The adverse events resulted to visit physician office. They prescribed her a Z-pack of Azithromycin and an albuterol Inhaler. The outcome of the events Splitting headache, She just feels terrible, Trouble walking were not resolved and other events were unknown. Follow-up: Follow-up attempts completed. No further information expected.

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

Problems with Sleep; can't sleep the required hours; Horrible Extreme Fatigue; had 2 blood tests done and both were abnormal with no answers from the doctors; poisoned by the vaccine; developed a tick in her right eye; neurological problems; last February or March but she could not remember the date; This is a spontaneous report from a Pfizer- COVAX. A contactable 82-year-old female consumer(patient) reported for herself that she received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EL3247, Expiry Date, NDC number: not reported), via an unspecified route of administration, administered in Arm Left on 05Feb2021 at 14:00-15:00 (did not exactly remember) as 1st dose, single for covid-19 immunization. The patient's medical history and concomitant medications was not reported. It was reported that it had been many years since she had taken vaccines. She stated that she got her first dose last February or March but she could not remember the date. She stated that she experienced side effects from the vaccine, and she had problems with sleep, she could not sleep the required hours. Her blood tests, 2 of them, were abnormal. The doctors said that they did not know whether they were abnormal. She had horrible extreme fatigue. She reported that she wasn't going to take the vaccine but every doctor pushed her to take the vaccine and so she took it, and now this company had destroyed her health. She reported that she was 82 and she was in good health. She just heard about the extreme fatigue, she didn't know that was from the vaccine also. She assumed that the vaccine caused her neurological problems. She developed, about month and a half ago, she developed a tick in her right eye and she didn't know what it was from. Her side effects started in the early Spring, probably March. She knew something was different but she didn't put it together with the shot and she didn't think about it. She did not visit emergency room as wasn't smart enough to go to the ER, she never thought it was from the vaccine. She went to doctor with the extreme fatigue and that was how found out about abnormal bloodwork and then she had more blood work done and it was abnormal too. These were things she had never had before. She was not sure if she went to the doctor in March or April. She knew that she had 2 blood tests done and both were abnormal with no answers from the doctors. She had not received her second vaccine. Also, stated that she was poisoned by the vaccine. No treatment taken as nobody knew what to do. She stated that like an idiot, she took it. The outcome of all events were not recovered except the outcome of event short-term memory impairment was unknown. Follow-up attempts were needed. Further information was expected.

Day after shot, body aches, very tired, brain foggy. Lots of pain in left neck, from ear to shoulder. Very sick for first week, slowly got better over the next 2 weeks. The ache in my neck is still there. I have lupus and it had gotten much worse after the vaccination and has stayed bad.

Muscle pain on my arm; I had a bad day; Runny nose; Headache; Very tired and very weak; Very tired and very weak; This is a spontaneous report from a contactable consumer. A 82-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in arm left on 21Jan2021 (Batch/Lot Number: EL3247; Expiration Date: May2021) as dose number unknown, single (at the age of 82-years-old) for covid-19 immunisation. Medical history included that she had pacemaker and breast cancer. Concomitant medications included letrozole once a day and olmesartan medoxomil (BENICAR) 20mg, oral, once a day due to pacemaker and Letrozole. The patient stated that she was 83 years of old, second of all her doctor wants her to take it because she had breast cancer. The patient was very tired and very weak on 22Jan2021. The patient experienced few days of runny nose, headache and she bad day on 25Jan2021. The patient stated that last day she had experienced was 25Jan2021 and since then she had been fine but all of a sudden on Saturday the 06Feb2021, she started having like muscle pain on her arm, the one she got the shot and Saturday, Sunday and today. Last night she put some kind of cream for the muscle pain relief and little bit better this morning. She enquired if that was normal to have pain after almost so many days after the vaccine. The outcome of the event runny nose, I had a bad day, headache, very tired and very weak was recovered while the outcome of Muscle pain on my arm was recovering. Follow-up attempts completed. No further information expected. Amendment: This follow-up report is being submitted to amend previously reported Information: To delete the event "Off label use in unapproved indication", added breast cancer in the medical history, removed the indication breast cancer for drug bnt162b2 and added COVID-19 immunisation and deleted At Risk classification.

She noticed some shortness of breath upon exertion, especially after her walk; I am not sleeping well, but I don't sleep well anyway and don't think it's related to the vaccine.; This is a spontaneous report from a contactable consumer (patient). A 83-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration, administered in arm right on 28Feb2021 at 13:20 (at the age of 82-years-old) (Batch/Lot Number: GN6202) as DOSE 1, SINGLE for covid-19 immunization. Vaccination facility type was Physician Office. Vaccine was not administered at Facility. The patient's medical history was not reported. Concomitant medications included a lot of unspecified pills. History of all previous immunization with the Pfizer vaccine considered as suspect was none. Patient had no other vaccines on the same day as the suspect product. Prior Vaccinations (within 4 weeks) was none. Patient stated after her first vaccine dose, over last 5 days on an unspecified date in Mar2021, she noticed some shortness of breath upon exertion, especially after her walk, she wanted to know if it was normal because it only occurred during exertion. Patient also stated that other than that I haven't had any side effects, I am not sleeping well, but I don't sleep well anyway and don't think it's related to the vaccine, she also stated her second dose was scheduled on the 24th day instead of 21st day. Patient stated that she was prescribed an inhaler by her doctor a couple years ago, but she never used it before, but she tried using it yesterday but she did not know if it helped or not, since she only felt the shortness of breath when she was doing a brisk walk. The patient would call doctor will call she would probably just tell me to take my inhaler.Caller states that she noticed that when she takes her 30 minute, daily walks, she is getting some shortness of breath. Caller states that she got her Pfizer COVID vaccine shot, a week and a half ago, and she is wondering if that could be a side effect of the product, or if it is a symptom of COVID. The events did not result in emergency room/ physician office visit. The patient was not admitted to hospital due to events. Relevant test reported as none. Therapeutic measures were taken as a result of she noticed some shortness of breath upon exertion, especially after her walk (dyspnoea exertional). The outcome of the events was unknown. No follow-up attempts are possible. No further information is expected.

weird feeling in her head; headache; she thought she would pass out; This is a spontaneous report from a contactable consumer or other non hcp (patient). An 83 year old elderly female patient received BNT162B2 (Pfizer-Biontech Covid-19 Vaccine, Formulation: solution for injection, Batch/Lot Number EN6201, expiration date unspecified), via an unspecified route of administration on 20Feb2021 as DOSE 2, SINGLE for covid-19 immunization (82 year when vaccinated). Previously the patient received BNT162B2 (Pfizer-Biontech Covid-19 Vaccine, Formulation: solution for injection, Batch/Lot Number EL9263, expiration date unspecified), via an unspecified route of administration on 29Jan2021 as DOSE 1, SINGLE for covid-19 immunization. Medical history included patient catheterized reason unspecified. The patient's concomitant medications were not reported. On an unknown date, the patient came home and experienced weird feeling in her head with headache and she thought she would pass out. Patient stated that she had a minimal reaction to the second dose. She had no problems the day she got it other than a weird feeling in her head later that day. It was a strange, weird feeling with a headache. She says for about 5 minutes, she thought she would pass out. She laid back in her chair and then she felt better. She said what else was she going to do, she would probably die if she didn't get the vaccine. The patient also had 2 CT scans and 2 MRI but the results are unknown at the time of report. The outcome of the events was reported as unknown at the time of report.

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.

New onset altered mental status after fall. Per son, she was found in bed, unresponsive at around 12:15 AM on 1/10 by her husband. Brought to the emergency room and admitted, Began treatment for UTI w/ CTX. Discharged 1/11/21 with f/u appointments

83yo female resident who died after receiving Pfizer BioNTech vaccine. On 1/14/2021, the patient reportedly got up in the middle of the night with c/o feeling "blah", restlessness, and nausea. VS normal, no other s/sx. At 4:15am, the patient was asked to go back to bed, assisted by a nurse and GNA. At 6am, GNA was going to do morning VS and found the patient unresponsive, no pulse, no respirations. GNA notified the nurse. At 6:03am, CPR started and EMS called. At 6:15am, EMS arrived and took over. At or around 6:30am, EMT called time of death

legs from the knees down especially kept patient awake at night from itching; Patient got it in the upper left arm in the muscle it was not hurt when it went in but it was kind of hurting now; Reaction on both legs they covered in red spots and at knees it was especially bad/it's more like a color; kept patient awake at night from itching/it woke patient up; red spot over the injection site; also there was a swelling just that gone bad; it was more like a discoloration in skin; Hurting so bad like a waxing kind of stinging and burning; Hurting so bad like a waxing kind of stinging and burning; skin it felt very warm; This is a spontaneous report from a contactable consumer (patient). An 83-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EK92321), via an unspecified route of administration on 06Jan2021 at single dose at left arm for covid-19 immunization. Medical history included arthritis and lost a couple of inches from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. Patient had the Covid-19 shot on 06Jan2021 and had reaction on both legs. They were covered in red spots and at knees it was especially bad, it wasn't like bumps, it wasn't like rash it's more like a color and skin it felt very warm and legs from the knees down especially kept patient awake at night from itching and the itching started on 07Jan2021 night into 08Jan2021 and it woke patient up and patient was just calling at knees. So patient got up and went into bathroom and patient put some anti-itch that's what patient husband had for his allergies. Patient said the spots on knees, the red spots are basically gone but they were still there and the left knees was specially bad and you can feel through pants even that it's warm on these places but when rubbing hands on it you can't feel rash or anything, it was more like a discoloration in skin, there was also a red spot over the injection site, patient would say about the size of a tennis ball and also there was a swelling just that gone bad but and it was okay really but it was there, patient had at a place on belly and it was gone, so let do something else but the discoloration on leg the splotches, patient guess they called splotches not a rash like a pimply rash but just there and they itch something there but it was getting better now. Patient was about 5'4' or maybe 5'4.5', and patient weighed a 141. Patient had 2 Covid test that were negative. Patient got the vaccine at the College. Patient got it in the upper left arm in the muscle it was not hurt when it went in but it was kind of hurting now, but it was okay. Patient put some kind of cream as treatment. The adverse events resulted in neither doctor or other healthcare professional office/clinic visit, nor emergency room/department or urgent care. Patient was going to because it was hurting so bad like a waxing kind of stinging and burning but then patient just put more cream on it and it would stop, it was going to the doctor on 09Jan2021 morning but it was so much less and now patient didn't think she feel any ill effects. Outcome of all events was recovering.

Left side of neck had pain when moving neck for 1.5 days. Sat. eve 23 Jan. I had a temperature of 100. degrees and felt punky. Sunday morning temperature normal and neck felt better.

Patient experienced flushing and tachycardia about 15 minutes after vaccine. Patient was sent to urgent care for brief observation and found to be hypertensive as well. Ultimately thought be a large component of anxiety after vaccination, and patient was discharged without complication.

coughing; fatigued / tired; Not felt good/ Not been myself; My body has not been normal like my specimen not good and it was dark; I am very irregular with going to bathroom so I have not felt good; Might have ulcer because it burns when I eat anything; Might have ulcer because it burns when I eat anything; I have aches, body aches; Slept like all the way around the clock; This is a spontaneous report from a contactable consumer (the patient). An 83-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot E13246), via an unspecified route of administration on 05Jan2021 (at the age of 83-years old) as a SINGLE DOSE for Covid-19 immunization. Medical history included hypertension, reported as pretty regular, from an unknown date and unknown if ongoing. Family medical history included bleeding ulcer from her mother. Concomitant medications included benazepril and felodipine for hypertension. The patient experienced my body has not been normal like my specimen not good and it was dark; i am very irregular with going to bathroom so i have not felt good; might have ulcer because it burns when i eat anything; I have aches, body aches; slept like all the way around the clock all in Jan2021; I was coughing and felt fatigued / tired on 15Jan2021; and not felt good/ not been myself in Jan2021. The patient underwent lab tests and procedures which included body temperature which was checked 3 times with no fever on an unknown date. Therapeutic measures were taken as a result of slept like all the way around the clock which included ibuprofen (ADVIL). The outcome of the events bowel movement irregularity, burning sensation, ulcer, pain, hypersomnia, cough, fatigue and malaise was unknown.

Shortness of breath, rapid heart, nervous, oxygen dropped I had to rush her to Emergency Room at hospital. She was placed on oxygen, giving multiple breathing treatments, rocephine, and steriods.

Woke up around 5 am ( 20 hours after shot) in excruciating pain and decided I needed to get up and walk around. Next thing I know, I had obviously blacked out, because I was on the floor on my back and had no recollection of prior events. Have no idea how long I was out, but once I got my bearings and got back in bed, I was fine.

Severe headache; confusion; unable to get clear thoughts communicated; This is a spontaneous report from a contactable other healthcare professional. An 83-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot/batch number and expiration date not reported) intramuscular on the left arm on 15Jan2021 10:45 at a single dose for COVID-19 immunization. The patient had no medical history. The patient's concomitant medications were not reported. On 16Jan2021 08:00 AM, the patient experienced severe headache, confusion, unable to get clear thoughts communicated. No treatment was received. Patient was not pregnant. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. There were no other medications the patient received within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Post vaccination, the patient has not been tested for COVID-19. No known allergies. Outcome of the events was not recovered. Information on Lot/Batch has been requested.

Tired; Dizzy; unstable; shoulder/injection site pain; shoulder/injection site pain; Arm pain; This is a spontaneous report from a contactable consumer (patient). An 83-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration, on 15Jan2021 (at the age of 83-years-old) at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced shoulder/injection site pain and arm pain in Jan2021 and tired, dizzy, and unstable on 16Jan2021. The clinical course was reported as follows: The patient initially experienced shoulder/injection site pain and arm pain. On the next day after vaccination, she felt tired, dizzy and unstable. The day after was much better and on the fourth day after vaccination, she was back to normal. The clinical outcome of shoulder/injection site pain, arm pain, tired, dizzy, and unstable was recovered on 18Jan2021. No follow-up attempts are possible; information about lot/batch number cannot be obtained.

My mom became very disoriented for 2-3 full days. She couldn't remember her birthday, where she was, her doctor's name, etc.... We took her to her doctor and she thought she had a stroke. We went to the ER for every test possible. She became disoriented and also had to put adult briefs on her. On Sunday she was driving and on Monday she was totally disoriented. My dad called and I rushed home 2 1/2 hours away. This was a terrifying event. She was glossy eyed and couldn't read. She didn't have any paralysis; thank goodness. It was all pretty much mental.

12 days after first vaccination: Dizziness; high blood pressure; nearly passed out; right arm numbness; inability to grip or pick up items with fingers; feeling of "lopsidedness"; unsteady on feet, requiring assistance to walk. Primary care physician recommended ER visit where possible stroke was diagnosed. Hospital MRI confirmed: " Left acute arterial ischemic stroke, MCA (Middle cerebral artery)" . Spent 2 days in hospital with high blood pressure, dizziness. Residual right finger numbness upon release.

Within 24 hours after the Pfizer vaccine pt experienced low grade fever of about 100 degrees. This was accompanied by mental status changes . She was taken to hospital and admitted overnight to rule out stroke . All symptoms resolved within 24 hours . She is now fine

pain in my chest/stomach; pain in my chest/stomach; she couldn't sleep last night at all she was awake all night; had strange visions flashing in my head while trying to sleep; acid reflux/burping up acid; 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, lot number: TL9261, expiration date not provided), via an unspecified route of administration on 25Jan2021 16:30 at a single dose for COVID-19 immunization. The patient has no medical history and there were no concomitant medications. On 25Jan2021, the patient experienced having acid reflux, pain in her chest/stomach that lasted all night last night and was worse when lying down. When she burped, it relieved some pressure. She had strange visions flashing in her head while trying to sleep on 25Jan2021. The patient was wondering if she was having a reaction from the vaccine. On 25Jan2021, after over an hour after the vaccine, she started having severe pain in the chest and stomach area and she couldn't sleep last night at all. She was awake all night, burping up acid. She was wondering if those were reaction to the vaccine, should she go see her doctor or what should she do about that. She got her first dose on 25Jan2021 and she started having chest and stomach pain the same day at about 6 PM. She was burping acid all night and early in the morning of 26Jan2021 and she was having these strange things like pictures going to her head that were weird. She was not sleeping but they were strange images, they were strange, they weren't normal. She says with that added in it sounds crazy. She has her vaccine card that says she should get the next one 15Feb2021. She wanted to avoid catching the corona. She had drank acid yesterday and she was wondering if that was causing her to have acid reflux. She clarified that she drank a lot of acidic liquids on 25Jan2021 and she was wondering if that might have had something to do with it, like orange juice and cranberry juice so she is wondering did that have anything to do with it, the acidity maybe made her stomach have acid reflux because she has had that in the past. She asked if she should go to the doctor. The outcome of the events was unknown.

PATIENT WAS ADMITTED TO ER FOR ALTERED MENTAL STATUS / UTI SEPSIS WITH SEPTIC SHOCK / COVID AND COVID PNA PATIENT WAS ADMITTED TO ICU AND DIED . POA WISH TO WITHDRAWL EXTRME MEASURES

Instant sender headache lasting 4 days, extreme high blood sugar, fatigue, tender left underarm lymph nodes, brain fog for 5 days

Patient resides in an assisted living facility and received the second COVID-19 vaccination. She experienced fatigue in the morning following vaccination. She fell on 2/22/21. Ambulance was called and she was transported to the hospital. Initial symptoms included fever of 101 F, disorientation, left face droop, unresponsive to commands and loss of memory.

Hypertension: systolic pressure above 200 at pharmacy, taken to emergency department and physician determined the hypertension to be anxiety related.

After the first vaccine on 2/4/21 in left arm pain subsided on day 3 Mild pain appeared 2 weeks later. After the second dose in right arm on 2/25/21 left arm pain rapidly intensified without physical Sxs, interfering with sleep and normal activity. Worse with sitting, lying on either side , radiating into the shoulder. Nerve like pain but also point tenderness in several areas. Present without change niw almost for one week.

Immediate brain fog and continued for 2 days; This is a spontaneous report from a contactable consumer (patient). The 83-year-old female patient receive second dose of bnt162b2 (BNT162B2, COVID 19, brand: Pfizer) , via an unspecified route of administration on 15Feb2021 on Right arm at single dose for covid-19 immunization. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient previously took first dose of bnt162b2 (BNT162B2, COVID 19, brand: Pfizer) , via an unspecified route of administration on 25Jan2021on Right arm at single dose for covid-19 immunization. The patient experienced immediate brain fog and continued for 2 days on 15Feb2021 12:00 PM with outcome of recovered. No treatment received. She is not pregnant. Facility type vaccine was other. Information on the lot/batch number has been requested.

within 24 hours; near syncope, brain fog, fatigue/weakness, exac of underlying anxiety secondary to symptoms; these have been episodic. Brought to ER The Four Paramedics that came to take her to the ER stated they were overwhelmed with calls for post covid vaccine problems and that ALL of their vehicles were out on calls many due to this. Agressive workup including CT, EKG, Cardiac monitoring, CTA neck and Brain, Carotid and peripheral dopplers and vascualar surgeon consultation revealed nothing. Told it temporally had to be assoc with the vaccine?? I am reporting so that this can be evaluated for confirmation.

Fever; Dizzy; didn't feel right; little chills; Blood pressure was kind of low; This is a spontaneous report from a contactable consumer (the patient). An 83-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number not provided), via an unspecified route of administration on 04Feb2021 around 14:30 or 14:45 (at the age of 83-years-old) as a single dose for COVID-19 immunization. The patient had no medical history or concomitant medications. The patient previously received the first dose of the COVID-19 vaccine on an unspecified date, 3 weeks before, for COVID-19 immunization. On 05Feb2021, the patient experienced fever, dizzy, didn't feel right. On an unspecified date in Feb2021, the patient experienced little chills and blood pressure was kind of low. The clinical course was as follows: The patient got her second COVID shot last Thursday 04Feb2021. She felt fine. Then, on Friday evening (05Feb2021), she started feeling bad. She had a fever and was dizzy, little chills and her blood pressure was kind of low. She had been trying to drink not today (as reported). Today was Monday (08Feb2021), and she still had a low fever. She still didn't feel right. She hasn't felt right since Friday and was improving a little. Her fever wasn't that bad now, but at night it was a little over 100. The clinical outcome of fever, dizzy, didn't feel right was recovering. The outcome of other events was unknown. Information on the lot/batch number has been requested.

diagnosis of confusion/ about 2 hours after vaccine she became disoriented, couldn't figure out how to get her seat belt on. the next day she couldn't even dress herself; This is a spontaneous report from a contactable consumer. An 83-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; Lot number was not reported) via an unspecified route of administration, administered in Arm Left, at the age of 83-year-old, on 20Feb2021 13:15 as SINGLE DOSE, for covid-19 immunisation. Medical history included seizure, cardiac disorder, diabetes mellitus, hypertension, blood cholesterol abnormal, and thyroid disorder. Patient is not pregnant at the time of vaccination. The patient did not receive other vaccine in four weeks and was not diagnosed with covid prior vaccination. Concomitant medications included trazodone, potassium chloride (KLOR CON), furosemide, irbesartan, levetiracetam, metformin hydrochloride (MEFORMIN), metoprolol, warfarin sodium (JANTOVEN), nitrofurantoin (NITROFUR), acetylsalicylic acid (BABY ASPIRIN), melatonin, levothyroxine, apoaequorin (PREVAGEN [APOAEQUORIN]), cyanocobalamin (B12 [CYANOCOBALAMIN]). The patient previously took codeine linctus and experienced drug hypersensitivity, hydrochlorothiazide and experienced drug hypersensitivity. On 20Feb2021 13:15, about 2 hours after vaccine, she became disoriented, couldn't figure out how to get her seat belt on. The next day she couldn't even dress herself. this onset was very sudden. The patient was sent to a nursing home with the diagnosis of confusion. The patient was hospitalized for 2 days in response to the event in 2021. The patient did not receive any treatment in response to the event. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on 21Feb2021, sars-cov-2 test: negative on 23Feb2021, sars-cov-2 test: negative on 01Mar2021. Outcome was not recovered. Information about lot/batch number has been requested.

83yo F w/ PMH significant for HTN, chronic thrombocythemia, and glaucoma followed by Heme-Onc without treatment who presented to ED 03/15/21 via EMS complaining of generalized weakness. She had felt well and had been in her usual state of health, and was able to cook and enjoy a turkey dinner with 5 individuals on 03/07/21, but on 03/08/21 she began to develop progressive generalized weakness up to the point where she remained in bed for several days. She could not support herself when attempting to rise from bed. She noted poor PO intake with nausea, no vomiting. Loose stools for several days, no noted stool blood. Did endorse waves of lightheadedness and had fallen backwards three times in the prior week, reportedly due to poor balance when standing. She was unable to elaborate regarding the falls but admitted to hitting her head at least once, unable to say if she lost consciousness or if she felt presyncopal symptoms before falling. She had initially presented on 03/12/21 to ED for evaluation, workup negative, labs and imaging normal. CT brain found no acute process. She was sent home with arrangements for home PT. She returned to ED 03/15/21 when symptoms had not improved. In the ED she was found to be afebrile, significantly hypertensive, mildly tachycardic, + orthostatic vital signs. Labs significant for heme occult positive stool, proBNP 397, WBC 10.1, H/H 13.4/39.9, PLT 493, UA neg for infection. COVID neg. CXR found slightly increased interstitial markings. MRI brain found no acute intracranial abnormality. She was evaluated by PT and found to be unsafe to DC home as she could not ambulate without leaning backward and to the right and needed 1-2 assist. She was admitted to HM service for further management. She has remained consistently afebrile. She continues to experience significant gait instability, cognitive slowing, and difficulty with finger-to-nose testing with noted dysmetria, no focal weakness.

Family members report the individual felt confused and presented with slurred speech. They took the individual to a local emergency room where it was determined their blood pressure was significantly elevated. The individual has since been transferred to a different hospital.

A-Fib; cardiologist saw it on the computer, an arrhythmia; hard poundings that were very bad, clarifies like fist continually pounding in her chest; feeling something strange, like a flurry by the heart; This is a spontaneous report from a contactable consumer (patient). An 83-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot Number: EN6198, Expiration Date: Not reported) via an unspecified route of administration on arm on 19Feb2021 13:30 at single dose for COVID-19 immunization. The patient's medical history included ongoing bronchiectasis (At least a year but not sure). Concomitant medication included ongoing tiotropium bromide (SPIRIVA; 18 ug, capsule) via nasal route at 18 ug, once a day (inhalation/At least a year but not sure) for bronchiectasis. It was reported that, the patient had her first vaccine on 19Feb2021. On 20Feb2021, she started feeling something strange, clarifies like a flurry by her heart, she doesn't know what really. She states that on 21Feb2021 and 22Feb2021 she had hard poundings that were very bad, clarifies like fist continually pounding in her chest. On 23Feb2021, she saw the cardiologist and he put her in the hospital. She states that it was probably a reaction from the vaccine, it was A-Fib. It was probably a reaction, but nobody can say, she was 83 but healthy, no diabetes, high blood pressure or anything except one little thing. Today was the date for the second dose, and she was reluctant to get it. Caller clarifies that the pounding subsided on 21Feb2021 and started again on 22Feb2021 and on 23Feb2021 she went to the cardiologist. Treatment included Aleve hard poundings that were very bad, clarifies like fist continually pounding in her chest AE: clarifies that it was going for quite a while, it was undeniable on 21Feb2021. States on 22Feb2021, it lasted a few minutes. feeling something strange, like a flurry by the heart AE: states that it was there for a minute. A-Fib: states that the cardiologist saw it on the computer, an arrhythmia. States they saw it at the doctor's office on the computer, she didn't feel it on 23Feb2021. States it is unknown if it started on 21Feb2021, 22Feb2021, 23Feb2021. States she doesn't know when it ended, she was put in the hospital. States she didn't feel it to know so she couldn't identify it, but it showed on the computer. Treatment with Aleve, but no other treatment, she was afraid to take anything. Hospitalization: Caller states that she went to the cardiologist on 23Feb2021 and states he saw on the computer the AFIB and admitted her. Clarifies that he sent her to the emergency room and then she was put upstairs into a room and may have been admitted when she went upstairs, she was there for a couple of days. She states that they didn't have a room at the time, they had lots of people with Covid. States she was admitted on 23Feb2021. She states she was released on she believes the 26Feb2021 but could be 26Feb2021 or 28Feb2021 but believes 26Feb2021. States the was put on medications to monitor to see what would coincide with each other, she is not sure. Patient was started on the following medications during her hospitalization and prescribed them. Metoprolol 25mg once a day by mouth, started when admitted to the hospital. Dofetilide 250mg capsule twice a day by mouth, started after admission to hospital. Blood thinner called Eliquis 2.5mg twice a day by mouth, started during hospitalization. Clarifies that she was not on these medications before the vaccine, she started them when she was at the hospital and takes them now. States she was one medication, but she stopped taking it right away and it has nothing to do with this. For event A-Fib, which results in Emergency Room visit and Physician Office visit. The seriousness of the events was reported as hospitalization. The event Feeling abnormal was recovered on 20Feb2021, Chest discomfort was recovered on 22Feb2021, Arrhythmia was recovered on an unspecified date in 2021, whereas unknown for another event.

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.

16 days post first Pfizer corona virus vaccine, patient experienced hallucinations of see multiple people in the backyard who were not there. Hallucinations occurred again 2 hours after 2nd dose of Pfizer covid vaccine (injected 4/15/2021 lot EW0153, left deltoid).

83 YEAR OLD FEMALE COMPLAINED OF FEELING FUNNY AFTER RECEIVING THE VACCINE. ON SITE EMS RESPONDED. VITALS LISTED BELOW. WITH HER BLOOD PRESSURE SO OUT OF RANGE, EMS WANTED TO TAKE HER TO THE HOSPITAL, BUT SHE REFUSED AND WENT HOME.

Bones aching, - elbows, arms and hands numb - nausea, diarrhea, no appetite - sleeping all the time - depressed , excessive sweating on the left side of face and neck - excessive phlegm production as well as left eye buringin

This is a spontaneous report from a Contactable consumer (patient). An 83-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EN5318), dose 1 via an unspecified route of administration on 05Feb2021 as a single dose for COVID-19 immunization. There was none medical history. Concomitant medication included atenolol taken for an unspecified indication, start and stop date were not reported. Her leg was swollen and there was edema and there was a lump on the side and it was pink or getting red and she was on medicine (Clarification Unknown) for 7 days, twice a day and the leg is still (incomplete sentence), the edema has gone down some. The leg was still pink and it is tender to touch and if she stand on her leg for too long or walking around too much it hurts. She got pain. She was also sleeping whereby she was watching television and all of sudden she was sound sleep and she wake up over an hour or two after that and then she awake for a while but she have no trouble sleeping at night again. She had chest pain and it's not angina because that she did have (Further clarification was unknown if consumer had angina in past hence not captured on tab) but it's a sharp pain and it does not want her taking Nitroglycerin because it went away and it last for maybe (incomplete sentence) it just like a stabbed wound. She was dizzy. That's still, it's not like what it was but it is getting less but she was still dizzy. She cannot walk a straight line. She lived in an apartment house and she had to walk down the hall to go down the stair but she sometime had to stop because she was dizzy. she kind of lean against the wall for few seconds and then she continued on. Concern was not the word for it. It made her very nervous and the circulation was very poor in both feet now and one leg, the right leg that has the pink and still the tenderness in that leg. The foot turns very dark pink and the big toe that she had turned dark purple. She wrote everything down and she will say this at the time after the injection she did not have any problem until about four days later but she did have problem with doing my cross- word puzzles and doing her puzzles. She could not do any of her puzzles, nothing was computing in her brain (Clarification unknown) but that's coming back slowly, so is that to be expected. Start date of event: Consumer stated "It was 4 days after the 5th, about 09Feb2021. She went there and saw a doctor an MD of course and she went there on 12th so it was a week later. She went because the pain was terrible. The outcome of events Leg is still pink and it is tender to touch; If I stand on my leg for too long or walking around too much it hurts, I got pain; Dizzy; is not recovered, all of sudden she was sound sleep; Cannot walk a straight line; Nervous; Circulation is very poor in both feet now; Foot turns very dark pink and the big toe that I have turned dark purple; Nothing was computing in my brain; pain was terrible was unknown, outcome of the other events was recovering. No follow-up attempts are possible. No further information is expected.

lactic acid was high; dementia had suddenly progressed; spot where her lung was starting to collapse; potassium, Vitamin D and Vitamin B12 were low; potassium, Vitamin D and Vitamin B12 were low; potassium, Vitamin D and Vitamin B12 were low; stopped talking; Cellulitis in her arm/ cellulitis was further down her arm, around her wrist hand area (Her wrist was huge, hot, red, and her hand was swollen); it burned when she peed; blood in her urine; wanted to sleep/getting worse with sleeping; was shutting down; she was dehydrated because her urine was dark; urine was dark; began just feeling bad/having like a terrible time/having a hard time/really not feeling good; more confused; lethargic; had trouble her getting up/was having to do everything for her, feed her, bathe her; couldn't walk; lost her appetite; arm was sore; This is a spontaneous report from a contactable consumer (patient's daughter). An 83-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3247), via an unspecified route of administration, administered in the left arm, on 24Feb2021, as single dose, for COVID-19 immunisation. Medical history included mild asthma, dementia (moments like putting things in the wrong place and being forgetful) and was confused. There were no concomitant medications. Historical vaccine included the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK9231) received at age 83 years, on 03Feb2021, for COVID-19 immunisation. On 24Feb2021, after the second vaccinations, the patient's arm was sore. On 06Mar2021, the patient began just feeling bad, was having like a terrible time, having a hard time, was really not feeling good; was more confused; lethargic; had trouble getting her up, was having to do everything for her, feed her, bathe her; couldn't walk and lost her appetite. On 09Mar2021, the patient was shutting down. On the same day at 18:30, the patient had gone in the bathroom and said it burned when she peed. So, the patient was taken to urgent care so it would not get out of hand. At the urgent care, they said she has a UTI, there was blood in her urine so they gave her Cipro but they cultured her urine and it grew no bacteria but there was still blood in her urine and she was getting worse with sleeping and she didn't even get up to eat. The patient was also dehydrated and her urine was dark. The events dehydrated, urine was dark, it burned when she peed, blood in her urine required emergency visit on 16Mar2021. The reporter thought the patient was going to die. On 16Mar2021, in the ER, they did blood work (unknown result), chest xray which showed she had a spot where her lung was starting to collapse (they said it was a tiny place, from not getting up and moving around, they said it would correct itself) and the patient's potassium, Vitamin D and Vitamin B12 were low. They did a CT scan of the head and chest to look for stroke or seizure and there was nothing. They blamed it on her dementia that had suddenly progressed. The patient was hospitalized from 16Mar2021 to 18Mar2021. On 12Mar2021, the patient experienced cellulitis in her arm. The reporter clarified that the cellulitis was further down her arm, around her wrist hand area. Her wrist was huge, hot, red, and her hand was swollen. On 24Mar2021, the patient followed up with the family doctor because the hospital wanted her to follow up with a GYN because they didn't feel it was urinary at all. When the reporter took the patient in to see the doctor, she couldn't walk in, she had to roll her in a wheelchair, she had stopped talking again. On 26Mar2021, the doctor sent the patient to the emergency room (unspecified reason) and they kept her. They said her said lactic acid was high. She was admitted on 26Mar2021 and discharged on 29Mar2021. On 29Mar2021, the patient's potassium was 3.3 and her lactic acid level was back to 2. The patient was recovering from lactic acid was high; potassium, Vitamin D and Vitamin B12 were low; began just feeling bad/having like a terrible time/having a hard time/really not feeling good; more confused; lethargic; had trouble her getting up/was having to do everything for her, feed her, bathe her; couldn't walk; lost her appetite; was shutting down; stopped talking. The patient recovered from cellulitis in her arm/ cellulitis was further down her arm, around her wrist hand area (Her wrist was huge, hot, red, and her hand was swollen) in Mar2021; and arm was sore on 29Mar2021. The outcome of events spot where her lung was starting to collapse, dementia had suddenly progressed; she was dehydrated because her urine was dark; it burned when she peed; blood in her urine; and wanted to sleep/getting worse with sleeping was unknown.

Moderate sore arm on first day and night, slight fatigue on second day, On third day (Wednesday) depression, sadness, lack of interet in normal activities, difficulty concentrating as normal. Better on Thrusday.

Presented to ED w/hx of harsh, nonproductive cough (4/7) & subsequent positive COVID-19 test (4/13) despite receiving Pfizer vaccines (1/21 & 2/16). Continued to have worsening cough w/occasional SOB, generalized weakness affecting daily activities and poor oral intake. Found to be febrile, hypotensive w/increased confusion. Imaging revealed opacity of R middle lobe & bilateral lower lobe consolidation concerning for pneumonia. Was admitted for additional management of sepsis & acute hypoxic resp failure secondary to COVID-19 on 4/22. Treated w/dexamethasone & started on ceftriaxone for asymptomatic Ecoli UTI. Pt ultimately discharged (4/29) w/extended antibiotic course for MSSA bacteremia w/ID follow-up on 5/24

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; soreness in that left shoulder; swelling; Area was warm to touch; could not sleep last night; had light mild pain in left shoulder at the site of injection; This is a spontaneous report received from a contactable consumer (husband). This consumer reported for a 83-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration on 07Apr2021 (Batch/Lot number was not reported) as single dose for covid-19 immunization. On an unknown date Medical history included cancer of thyroid, mitral valve replacement and use of a pacemaker. Concomitant medications were not reported. On Apr2021 the patient experienced had light mild pain in left shoulder at the site of and could not sleep last night; On 20Apr2021 the patient experienced pain and soreness in that left shoulder, swelling, area was warm to touch, could not sleep last night. The report received as, the reporter's wife got the first dose of the Pfizer Covid 19 vaccine on 07Apr2021 and had light mild pain in left shoulder at the site of injection for 2 days. Then 12 days later, on either 20Apr2021 or 21Apr2021, she developed pain and soreness in that left shoulder again, down to her elbow, with swelling and area was warm to touch. She did not have a fever. It bothers her and she could not sleep last night. She is scheduled for the second dose on 28Apr2021. Outcome of the events was unknown. No follow-up attempts are needed; information about lot/batch number cannot be obtained.

like someone sucked all the energy out of her; have general feeling of not feeling well; muscle pain; I am so tired I can hardly go; She is 5 feet 5 inches now, she is shrinking; aching; This is a spontaneous report from a contactable consumer. A 83-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: FN5318 and Expiration date was not reported), via an unspecified route of administration, administered in Arm Left on 30Jan2021 (at the of 83-year-old), as single dose for COVID-19 immunization. Medical history included atrial fibrillation from Apr2016 to an unknown date. Concomitant medications included apixaban (ELIQUIS) 5 mg , twice daily, taken for atrial fibrillation from Apr2016 and ongoing and blood thinner. The patient reported that she had her first dose of vaccine on Saturday 30Jan2021 and on 01Feb2021, the patient got up during the night and noticed she was so tired she can hardly go, she also experienced muscle pain, felt unwell like someone sucked all the energy out of her. so tired can hardly go, I have muscle pain, have general feeling of not feeling well, On an un-known date, she also experienced aching. It was also reported that the patient was 5 feet 5 inches and was shrinking. The reporter wanted to know if this could be related to the vaccine and how long does it last. The patient reported she was hurt so bad she was treated her symptoms with Advil. Declines to provide HCP information. NDC and expiration date unknown, not listed on card. The reporter stated that the Lot number starts with either E or F and clarified it as F. She also had difficult time with the last number to the lot number, stated that it could possibly be K, but reported it as 8. The outcome of the events so tired she can hardly go, muscle pain, felt unwell like someone sucked all the energy out of her was reported as recovering, while events aching and shrinking were unknown. Follow-up attempts are completed. No further information is expected.

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.

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.

Received 2nd shot 4/16/21 SARS-COV-2 (COVID-19/PFIZER) mRNA BNT162B2 (PF) IM (LNP-S) EUA, beginning of May patient started to become OCD with her purse and wallet, on 5/12 she put ravioli that was to be boiled into the microwave and started a fire. After she did so, she realized it was wrong and said "how stupid" "why did I do that". I proceeded to make dinner for her and her meals for the next day, I advised her that I was going to take her to the hospital on Friday 5/14 for a Mental Health check as she began to decline. She returned home from but had her stay with me didn't trust her to stay alone. I followed up with her CP, Neurologist and Cardiologist, during her visits she struggled with words but was aware something was wrong as she stated "i just want the old me back". From 5/15 thru 6/1 her mental health only worsened, she had no cognitive functions (phone, tv, computer) unable to eat on her own and shower. We placed her in a Memory Care Facility on 6/2, she fell the next day and was hospitalized with a broken hip, she is now in rehab. The current reports are she is not eating well, put on a puree diet since she is having swallowing issues, cannot talk and attention span is minimal, The PET Scan determined Alzheimer's with Picks Disease. She showed absolutely no signs of decline prior to the 2nd vaccine.

Right leg bothering her; mind went blank and she was unable to think of her email address to provide; Arm soreness and arm soreness was getting worse/arm was sore; This is a spontaneous report from a contactable consumer (patient). An 83-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number and expiration date was not reported), via an unspecified route of administration on 21Feb2021 as single dose for covid-19 immunisation (at the age of 83 years). The patient medical history and concomitant medications were not reported. The patient experienced right leg bothering her and mind went blank and she was unable to think of her email address to provide on an unspecified date, arm soreness and arm soreness was getting worse/arm was sore on 21Feb2021. The patient received her first dose of the Covid-19 vaccine on 21Feb2021, and her arm was sore on the 21Feb2021 (that night) and on the 22Feb2021 (next day) but went away. The pain came back two and a half weeks later, and her 2nd shot was scheduled for this 13Mar2021 (Saturday). It seemed like it was okay after the first two days, but now it was back. Her arm had been sore, all week; on 10Mar2021 (today) it was really sore. She also mentioned her right leg was bothering her (start date: unspecified), but she didn't think that's related to the vaccine. She did not know if it was like just really dull before and she did not really notice it. It seemed like it was okay, and all of a sudden, each day she felt a little sore and today was really sore. She confirmed after the vaccine she had arm soreness and the arm soreness was getting worse. On 13Mar2021 (Saturday), it would be 3 weeks since she received the first dose. She took ADVIL as treat-ment, and but it didn't seem to help (Usually, ADVIL helps her). She did have TYLENOL and wanted to know if you can alternate TYLENOL and ADVIL. While attempting to provide email she commented her mind went blank and she was unable to think of her email address to provide (start date: unspecified). In concern to height, she thought she had shrunk. She wanted to know if it was normal for the pain to come back after about 2 and a half, almost 3 weeks and since this arm was sore, will she have to get it in her other arm. Therapeutic measures were taken as a result of arm soreness and arm soreness was getting worse/arm was sore. The outcome for arm soreness and arm soreness was getting worse/arm was sore was not recovered, and for another event was unknown. No follow-up attempts are possible; information about lot/batch cannot be obtained.

Patient presented to emergency department on 6/4/21 with altered mental status. During workup patient was found to be COVID-19 positive. Patient had fever at time of admission which was believed to be caused by COVID-19 infection. She was admitted for lacunar infarct and acute encephalopathy. She was started on dexamethasone for COVID-19 management, but was stopped as there was no major change in disposition with treatment. During the course of the hospital stay, she was deemed asymptomatic for COVID-19 and her symptoms were more likely to be attributed to other causes.

Began experiencing severe psychotic behavior on 3/8/2021. These symptoms worsened on 4/15 (second dose on 4/5). Patient became delusional and began having regular hallucinations. She was seen in 3 different emergency rooms without any improvement in her symptoms. She was then sent to Behavioral clinic and treated with psychotic medication. He r symptoms began to resolve around the date of 5/8/21. She continues to be on psychotic medication but current doctor is talking about removing these as she has seemed to stabilize.

Pt was vaccinated on 3/9/21 and 4/6/21 with Pfizer vaccines. Prior to her recent hospitalization she or the daughter had no knowledge of her severe hiatal hernia but she did admit to early satiety and poor po intake for a few months. Patient is an 84-year-old female with a past medical history significant for hypertension, hyperlipidemia, recurrent urinary tract infections who presented to the emergency room on 6/1/2021 due to some dysuria, frequency, nausea, vomiting and increased confusion. She denied any fever or chills or any abdominal pain but did report some acid reflux symptoms and poor appetite. she was ultimately admitted with a suspected urinary tract infection. She was also profoundly electrolyte depleted with hypokalemia, hypomagnesemia and hyponatremia due to poor p.o. intake. She was started on IV fluids and electrolyte repletion was also started on Rocephin based on her old cultures and subsequently admitted. Patient's urine and blood cultures ultimately produce no growth and a urinary tract infection was ruled out. She was found the day after admission with a large amount of black emesis covering her sheets. When questioned patient reported that she had been vomiting during the night. Stool OB was ultimately positive. Her DVT prophylactic heparin was discontinued. She was started on IV Protonix. CT of the abdomen pelvis was ordered. CT revealed nearly the entire stomach was above the left hemidiaphragm with air-fluid levels but there was no significant distention seen. The case was discussed with our general surgical team and the decision was made to transfer the patient to a higher level of care for a GI/EGD evaluation .She was transferred on 6/3/21. She was ultimately discharged on 6/7/21 home after being found to have a gastric volvulous. On 6/21 she returned for Robotic-assisted laparoscopic repair of a giant hiatal hernia with Bilateral placement of pleural pigtail catheters as both pleural linings were densely adhesed to the hernia sac. The plan was to discharge her home on 6/25/21.

feels terrible after receiving the second dose; This is a spontaneous report received from a contactable consumer (patient herself). A 83-year-old female patient received bnt162b2 (BNT162B2, Solution for injection, Batch/Lot Number: EL3302), dose 2 via an unspecified route of administration, administered in arm Left on 03Feb2021 (at the age of 83-year-old) as single dose for covid-19 immunisation in a pharmacy. The vaccine was not administered in a facility. The time the vaccination was given between 13:00 to 14:00. The patient's medical history was reported as none and concomitant medications were not reported. The patient received first dose of bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, on an unspecified date (Batch/Lot Number: unknown) as single dose for covid-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. The patient did not receive other additional vaccine administered on the same day. History of all previous immunization with the Pfizer vaccine considered as suspect was none. The patient experienced feels terrible after receiving the second dose on 03Feb2021. The patient did not visit emergency room. No relevant tests was reported. The outcome of the event was resolving. Follow-up attempts are completed. No further information is expected.

Chills, fever, weakness, exhaustion, nausea, abdominal distress with diarrhea, sore belly, insomnia, back muscle pain, unusual dreams, hallucinations. Symptoms on and off to varying degrees for a month, especially muscle pain. Fatigue was constant.

Numbness, starting at feet going upward to entire leg. Weakness in muscle affected by polio (legs). Unexplained physical and mental fatique, wants to sleep all the time. Trouble walking up and down stairs or around curves. Chronic joint and muscle pain. Restless legs. Trouble with swallowing. Cold intolorance. Sleep disorders. Low endurance. Memory and concentration problems.

ACCORDING TO THE PATIENT'S AND SON'S NARRATIVE, SHE EXPERIENCED BRAIN FOG AND NAUSEA AND VOMITTING IMMEDIATELY AFTER HER FIRST DOSE. SHE CAME BACK FOR HER 2ND DOSE AND SAID HER SYMPTOMS JUST GOT WORSE. THE IMMUNIZING RPH SAID THAT SHE ASKED THE PT HOW WAS HER FIRST DOSE AND SHE SAID THAT EVERYTHING WAS OK AND DIDN'T HAVE ANY PROBLEMS. WHEN SHE CAME TODAY, SHE SAID THAT SHE WAS JUST DISCHARGED FROM THE HOSPITAL AND STAYED THERE FOR 2 MONTHS. THEY TOOK OUT HER GALL BLADDER AND SAID IT STILL DIDN'T FIX THE PROBLEM. THE SON SAID THAT NOW SHE CAN'T EAT NORMAL NOW AND CAN ONLY EAT A TABLESPOON OR SO NOWADAYS AND STILL FEEL VERY SICK.

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.

Insomnia; This is a spontaneous report from a contactable consumer (patient). An 84-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 09Jan2021 13:00 at a single dose for COVID-19 immunization at a Public Health Department. The patient's medical history and concomitant medications were not reported. The patient experienced insomnia on 10Jan2021 01:00 with outcome of not recovered. No treatment was given for the event. Patient is not pregnant. The patient was not diagnosed of COVID prior vaccination and has not tested for COVID post vaccination. Information about Lot/Batch number is requested.

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.

hasn't slept all night; Itching; This is a spontaneous report from a contactable consumer (patient). An 84-year-old female patient received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, lot number unknown and has been requested), via an unspecified route of administration on 10Jan2021 at single dose because COVID is getting worse and she is in a home. Medical history included 17 back surgeries, has lost a good bit of weight, ongoing pain, ongoing arthritis and ongoing sleep disorder. Concomitant medication included hydrocodone bitartrate, paracetamol (manufacturer unknown) from an unknown date and unknown if ongoing and morphine pump (manufacturer unknown) for pain which she has had for eight years that is right under the skin. The patient was also taking something (unspecified) for arthritis and they give her something (unspecified) to help her sleep. The patient got her first shot on Sunday, 10Jan2021. She has not had effects or anything. However on 13Jan2021, she started itching. She stated that honest to God she hasn't slept all night on an unspecified date. She is itching all over. She wanted to know if this was something that comes with the vaccine. She thought if she would have something it would have happened on Monday or Tuesday and at the time of the report it was Thursday. She stated that she was not that concerned. She was just calling to pass this along. She added that she is in good shape structurally. She was not worried as someone might have the same effect. This could just be side effects. The outcome of the event itching was recovering while the outcome of the event hasn't slept all night was unknown. Information on the Batch/Lot number has been requested.

Systemic: Other- Patient mildly panicked and had some mild shortness of breath 15 minutes after injection of 2nd dose. Pt monitored for full 30 minutes after which symptoms quickly resolved. No epinephrine given. -Mild

really sick; In bed 2 days; Could not eat; Hurting all over and joints aching; Hurting all over and joints aching; Fever and really cold; Fever and really cold; Left arm was sore after injection; Left arm was sore after injection and she had a lump and was itching; Left arm sore after injection with lump and itching; This is a spontaneous report from a contactable Nurse reported for mother. An 84-year-old female patient received the 1st dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3249) via intramuscular at arm left on 13Jan2021 13:00 at single dose for prevention because of age group. Medical history included hypothyroid diagnosed many years ago, having Covid in Jun2020. Concomitant medications were unknown. The patient was really sick from an unspecified date. The reporter was starting to wonder if the patient should take the second dose. The patient was in bed for 2 days, could not eat and was hurting all over at 23: 00 on 13Jan2021. Her joints were aching at 23: 00 on 13Jan2021. She had a fever and not really chills, but she just never could get warm and was really cold at 23: 00 on 13Jan2021. She went to bed and woke up on that same date, 13Jan2021, and it started at 11pm. She guessed it was disabling. As it went on, it got better. By Friday, she was finally able to eat. She has plenty of weight to fall back on for not eating. By Friday, she started eating again. She was still not back to normal yet though. She just felt like she could not get up. The fever only went on for a few days. Left arm was sore after injection and she had a lump and was itching 13Jan2021. It worried her. The lump was still itching and sore, but was getting better. Reporter stated that the shingles vaccine did the exact same thing to her with the lump under her skin and itching. It was given on her hip because she had small arm and they were scared to give it in her arm. The reporter wanted to know if there were elderly people in the trial and did any of them have COVID. No additional vaccines administered on same date of the pfizer suspect. Seriousness for In bed 2 days was reported as disabling. Seriousness for Could not eat, Fever and really cold was reported as not serious. Seriousness for Left arm sore after injection with lump and itching was reported as medically significant. Outcome of the events Fever and really cold, really sick was unknown, of other 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. There is limited information provided in this report. Additional information is needed to better assess the case, including complete medical history, diagnostics, 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.

About 2 hrs after the injection my arm/needle site and shoulder and down my arm to my hand had pain. My arm can;t lift up to comb my hair. I have limited motion and pain

Generalized weakness and body aches. Clinic stated that the pt was anxious and was "not feeling good". Pt states she feels SOB. O2 is 97% on RA. Pt does have bilateral edema in lower extremities. Pt does have a history of dementia. Clinic sent patient to the emergency room due to these symptoms.

2nd dose headache prior to leaving vaccine site, dizzy that after noon, still headache took Tylenol did sleep fair, next day, spaced out, also had periods of sweating, around 7pm I felt exhausted, then started aching , did this throughout the night and continued thought today , took my Blood pressure pressure was normal but indicated I was having a-fib, I just feel out of sorts and haven't contacted my physician because of the expectation of side effects, After taking my BP I realized the reason for my sweating was due to A-FIB ,caused by vaccine

I just got done going to the bathroom (2-4-2021) and was zipping up my pants when I fainted. I fell backwards into the bathtub knocking down both shower doors. My legs were hanging over the edge of the tub. One shower door fell on my upper right chest area. This happened just over 24 hours from when I received the vaccine. I had not felt bad at all from the vaccine. Didn't sleep too well that night (2-4-2021) because I hurt due to the fall. I called my doctor on 2-5-2021 to let her know I fainted 24 hours after receiving the vaccine and wondered if that was due to it. I do feel weak today (2-5-2021).

could not get her head around what day it was/ her brain was not working right; disoriented/disorientation; body not responding/she couldn't function; This is a spontaneous report from a contactable Other Health Professional (patient). An 84-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 28Dec2020 by injection once to right deltoid (Batch/lot number: EL0142), second dose of BNT162B2 via an unspecified route of administration on 18Jan2021, both at single dose for COVID-19 immunization. There were no medical history and concomitant medications. Investigation Assessment: No. The patient had second her COVID shot, the vaccine, on 18Jan2021, and she is a very healthy 84 years old with no health problems, and she woke up on 19Jan2021, and was disoriented, she could not get her head around what day it was, this was so rare, she normally goes to the fitness center and excursuses, but her body was not responding, her brain was not working right, it was a strange ordeal, so she got in the shower, to get her circulation going, and she couldn't shower, she got all wet, and had to get out and lay on a towel, she couldn't function, it was very scary, and very atypical. Her disorientation went away by 10AM on 19Jan2021- she did not see anyone or go to a provider. Her body started not responding around 7:30 when she got up, and by 9 or 10AM, she was functioning again. The patient didn't think this was from vaccine, she had seen enough vaccine reactions to various vaccines, and this was not a vaccine reaction, she thought what is happening? Is this a stroke, or a vascular event, she has since recovered but was still very shook, anxious about what it was, what happened until an hour or so after, it was still under her. Causality: Unknown, she didn't think of the connection until someone else did, she was describing it and the other person said it was because of the vaccine, as this person was a skeptic and doesn't want the vaccine herself, and this was not a typical response, but then she got to thinking. The outcome of disoriented/disorientation and body not responding/she couldn't function was recovered on 19Jan2021, the other event was unknown. Seriousness: it was disabling at the time, she was concerned she had a stroke, she was checking her grasps and her face and legs, she was obsessing. Seriousness for disoriented/disorientation and body not responding/she couldn't function was disability. Information about lot/batch number has been requested.; Sender's Comments: A possible causal association between administration of BNT162B2 and the onset of serious events cannot be excluded, considering the plausible temporal relationship. The underlying medical conditions in the advanced old patient considered confounders. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate

Patient is a 84-year-old female presenting to the emergency room with anxiousness, generalized weakness and one episode of vomiting/nausea surrounding her Covid vaccination this afternoon. On exam patient appears mildly anxious, has no evidence of allergic reaction, lungs are clear and equal bilaterally. Patient is resting comfortably, speaking in complete sentences. Shortly after physical exam patient was noted to have oxygen saturation of 90 to 92%, subsequently placed on 2 L nasal cannula. Will obtain CBC, CMP, chest x-ray, EKG. We will also give patient 500 cc of fluid and 4 mg of Zofran for control of nausea and vomiting. We will continue to monitor patient. No leukocytosis, no AKI, electrolytes within normal limits, chest x-ray without evidence of underlying pneumonia or pneumothorax. I have reevaluated patient, patient has been reporting a ongoing headache for which she has a history of and takes Fioricet, requesting Fioricet. Will order Fioricet. We attempted to take patient off of her oxygen however when taken off the oxygen she drops to 88% on room air. Patient reports ongoing generalized weakness and nausea which has required an additional 4 mg Zofran. Given that patient has been monitored for couple of hours and has had ongoing nausea and vomiting, generalized weakness in the setting of hypoxia when taken off of oxygen will obtain troponins and admit patient to the hospital for obs. I have spoken to Dr. who has accepted patient to observation with telemetry for further management. Patient was informed of admission status, with no further questions at this time.

Patient received her first covid vaccine on 1/27/21. on 1/30/21 she presented to the emergency department complaining of nausea, she had a negative work up, felt better and was sent home. on 2/5/21 she returned to the emergency department more ill-appearing and complaining of "feeling sick". she had fatigue, chills, decrease in activity level. her work up at this visit revealed multiple metabolic abnormalities, sepsis and bacteremia. She ultimately passed away at this visit with at cause of death listed as acute liver failure, pneumonia, and DIC>

fast heartbeat; increased BP; weak; dizziness; nausea; headache; confused; a little soreness in her arm; felt like she could pass out; didn't know who she was, she just kept walking and walking; funny feelings; This is a spontaneous report from a contactable consumer (patient). An 84-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL0142, expiry date not reported), via an unspecified route of administration on the right upper arm on 21Jan2021 17:00 at single dose for covid-19 immunization. Medical history included oral cancer from an unknown date and unknown if ongoing. There were no concomitant medications. The patient previously received flu vaccine for immunization and reported that it made her sick for 10 days 4 or 5 years ago. The patient previously took Tylenol (takes 1 instead of 2, Everything she takes half the recommended dose). The patient experienced fast heartbeat, increased BP, weakness, dizziness, nausea and headache on an unspecified date in Jan2021. It was further reported that she had a fast heart beat, her blood pressure went real high, she was dizzy and weak. This was while she was there and being watched for the 15 minutes by a nurse. She is 84 years old and doesn't take any medication; she did have oral cancer but with no chemo as it had not spread and this was 2 years ago. It was explained that the patient didn't feel good about it but she drove home. When she got home she was confused and felt like she could pass out. She walked through the house didn't know who she was, she just kept walking and walking. It was a strange feeling that lasted 15-20 minutes. She called her son late in the afternoon and told him to check on her to make sure she made it through the night. She still had funny feelings over the next few days but at this point she only has the dizziness that happens occasionally. She notes also that her blood pressure was checked at home by her and was higher than normal the first few days after but is now normal. Over the next day she had a headache and a little nausea, but it was not severe. She also mentions having a little soreness in her arm but not bad. She did read about the side effects and states she had the elevated heart rate, increase in blood pressure and dizziness right after getting it. The patient wonders could she ask for smaller dose, she only weighs about 110lb. When she spoke with her doctor she was told that the COVID virus is worse than what she experienced after the vaccine. She has not been to the doctor since getting the vaccine, she just talked to them. The patient underwent lab tests and procedures which included blood pressure measurement: high and heart rate: fast on Jan2021. The patient was recovering from dizziness, the outcome of nausea was unknown and the patient recovered from the rest of the events on an unspecified date in Jan2021.

Found down - day after vaccination. Fall, potentially acute encephalopathy / confusion, hypertension (potential for non-compliance with antihypertensive medications?) - patient with known severe to advanced dementia / mild cognitive impairment. Likely related to hypertensive encephalopathy with post-COVID vaccine prodrome with underlying advanced dementia. Situation: hospitalization after a fall and hypertension emergency Background: Pt is an 84 y/o female pt with a log history of dementia, has been able to live alone safely until most recent illness/hospitalization. Assessment: Pt received her 2nd COVID vaccine on Saturday. On Sunday, pt's sister was unable to get a hold of her as her sister calls her daily due to her dementia. After several phone calls, her sister went to pt's home and found pt on her bedroom floor. There was some blood found, not sure from where. Sisiter was unable to get pt up so EMS was called and pt was taken to ED. She was evaluated, her BP was very elevated, she was admitted and testing was done. Head CT/MRI was unchanged. X-ray of her R shoulder shows a vertical non-displaced fracture of the greater tuberosity of the proximal humerous, no surgical intervention is recommended at this time, pt instructed to wear a sling for now. Pt is discharged home with Home Care and family support.

First dose Pfizer given at assisted living on 1/14/21 she was subsequently admitted to hospital and got her second dose but Moderna was given instead of Pfizer on 2/8/21. She had been improving but in the days following the Moderna vaccine she developed fever and then her mental status declined. She was discharged back to assisted living. Suspected UTI, and moderate dementia, placed on hospice (2/12/21). Died on 2/13/21.

The second dose was really my first covid vaccine shot. That evening for both, I started aching a lot in both arms and shoulders, couldn't sleep and extremely tired the next day. The following day I was back to normal and the symptoms gone. The second shot had a little stronger symptoms. I had covid in early November, 2020 in case that matters. Also, I had a flu shot late October and had a severe reaction which led to my being diagnosed with covid.

1/23 - Mild injection site discomfort. Appetite loss compared to previous day. Beginning loss of mental acuity compared to previous day. 1/24 - Continued loss of appetite. Near complete loss of ability to move. Continued decline of mental acuity. Very little speaking. 1/25 - Stopped speaking completely. Loss of bowel control in the evening and continued until death. Complete loss of appetite. 1/26 - Near complete loss of ability to swallow. Moved to hospice 4:00pm. 1/27 - Died 4:00am

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.

pressure all in her head and all over her body; pressure all in her head and all over her body; Feeling flushed; Nausea; feel her heart beating; legs feet and hands would feel tingly; She went to bed around 1am. This went on all night off and on. She slept maybe about 3 hours total.; This is a spontaneous report from a contactable consumer (patient). A 84-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, NDC number: Unknown, Batch/lot number: EL9261, Expiry Date: 31May2021), via an unspecified route of administration in the left arm on 22Jan2021 at 0.3 mL, single for she did not got COVID. Medical history included continuing A-fib, takes medication for this everyday. Diagnosed at least 10 years ago. The patient's concomitant medications were not reported. Last night (25Jan2021) her symptoms started. She was unsure if it was from the vaccine or not but she was thinking it was, she had not had it before. Around 11 pm last night (25Jan2021) she got a pressure all in her head and all over her body. She felt flushed. She had nausea. She could feel her heart beating. She could really feel it. It was not abnormal. She did have A-fib, but this was normal, not like A-fib. Her took her blood pressure which was normal. She took her pulse which was normal. She went to bed around 1am. This went on all night off and on. She slept maybe about 3 hours total. Sometimes her legs feet and hands would feel tingly. And the flushing continue- it feels like her body was hot, but it was not hot to the touch. She had felt better this morning when she got up, but she did have one bout when she was just sitting here. She had improved overall. Caller stated she already spoke to the safety department but did not have any reference number to provide. The outcome of event 'Feeling flushed' and 'Sometimes her legs feet and hands would feel tingly' was recovered on 26Jan2021, of the other events was recovering.

slept for 1 1/2 days directly after the shot; slept the whole day; This is a spontaneous report from a contactable consumer (patient). An 84-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL0140 and expiry date: unknown), intramuscular on the left arm, on 07Jan2021 at a single dose for COVID-19 immunization. There were no medical history and concomitant medications. When she had the first dose she slept for 1 1/2 days directly after the shot on 07Jan2021. She got the shot in the morning and she slept until 10, so she was not really sure how long she slept. The next day she slept the whole day too. She had no pain and is better. Outcome of the event was unknown.

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"

1. VERY TENDER DELTOID AND UPPER LEFT ARM. 2. GENERALIZED ACHING OF ENTIRE BODY. 3. UNABLE TO SLEEP FOR 6 HOURS. 4. TOOK 500 MG TYLENOL. 5. ACHING AND LOW-GRADE TEMPERATURE CEASED. 6. FELL ASLEEP FOR 8 HOURS. 7. AWOKE AND PAIN HAD SUBSIDED. 8. DID NOT INGEST FOOD BUT DID DRINK WATER. 9. ON 03/11/2021 AWOKE AND EXPERIENCED NO FURTHER PROBLEMS.

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.

She got the vaccine, she had no effects, and no reaction whatsoever. The husband had no side effects either. On 3/16/21 they were on their way to go to bed and the bedroom is upstairs and she was fine, she was in the bedroom getting ready for bed, and her husband followed 15 minutes later and when he got upstairs she was sitting in a chair next to the bed, and he noticed that when he spoke with her that she did not speak clearly back, and was very low tone, not much loudness to her speech. He didn't think much about it, and he talked with her again and noticed that she seemed to be having some difficulty talking, but he could understand what she was saying if he paid close attention. He then realized that something was wrong, and asked her how she felt and she said she felt strange. She was trying to take a pair of socks off and could not reach them. She tried to lift her leg to put one knee over the other for her to remove them and was not able to do that. He helped her take the socks off, she wanted to put some cream on her foot and was not able to do so, which is her usual routine. He put that on her foot while he was talking to her, and her speech was different than it was earlier. She was wearing a turtle neck shirt and was not able to take it off to get dressed for bed. Her husband assisted in dressing her to get ready for bed. He was thinking that she may have been having a mini-stroke. She tried to get up from the chair and was not able to get up on her own. He went to try to help her to lift her and it was hard. When she did get her bottom up off the chair she stayed in a bent position and was not able to stand up. He put her back down on the chair and tried some more times, and ultimately able to get up and he was able to get her into the bed (the chair was next to the bed). She could sit on the edge of the bed, but was not able to move her legs on her own to get into the bed. He struggled to get her in the bed and was not in a mood to talk and just leaned over on one side to try to go to sleep. He told her he was going to get the walker in the basement for her to use. He brought up the walker and put in by the bed, and informed her that it was there, and reached to see where it was in the event that she needed to use it through the night. She did get up around 3:15 this morning to use the bathroom and her husband asked if she needed assistance, and she said that she was able to get up and go to the bathroom, and moved her legs just slow and was able to use the walker. She was feeling much better at that time. She got up one more time during the night and was not in need of the walker and was back to bed. This morning when they got up at 8:00 Am and she was back to her normal self. She came down the steps and was like nothing had ever happened. They called her son who works in the hospital and he told them to call us to see if there were any other people that had the same reaction. She stated while he was giving me this information that she did not recall a lot of the events that he was telling me.

misery accompanied by frighteningly high blood pressure surges 206/102 for someone who typically registers 100/70

She developed chills she couldn't control and fell asleep all afternoon, evening and through the night. I spoke with her twice and my uncle and aunt checked on her three times, all three she was freezing cold and too tired to get up. In the morning, she was dazed, cold and walked to the bathroom, where she collapsed to her death. Paramedics could not revive her. My mom died Saturday morning - within the 24-hour period of her vaccine. She was feeling so great leading up to it, active, stripping the guest bedroom sheets, bubbly, and excited for us to be able to finally visit her soon.

Altered mental status Intracranial hemorrhage (CMS/HCC) Hypertension Cerebral brain hemorrhage (CMS/HCC

around her neck looks swollen; rash on neck is brown; itchy; worried; This is a spontaneous report from a contactable consumer (patient). An 84-year-old female patient received first dose of BNT162B2 (Covid shot, PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/lot number: Unknown, Expiry Date: Unknown) via an unspecified route of administration on 23Jan2021 (at the age of 84-years-old) at single dose for COVID-19 immunisation. Patient's medical history included heart troubles. Patient's concomitant medication was heart medication. The patient experienced around her neck looks swollen, rash on neck is brown on 03Feb2021 and it was still ongoing and itchy, worried on an unspecified date. Patient stated she read information about a rash all over the body after the COVID vaccine. She has had none of the side effects. She read about severe allergic reactions. She does have a history or heart troubles. She was washing her hair on Wednesday, and she noticed around her neck it looked swollen. Like a little band around her neck. It could have been there before the vaccine. She called her doctor that same day and she said to call Pfizer, and that she thinks she should cancel the second one. She got her first COVID vaccine on 23Jan2021, and she is scheduled for the second 13Feb2021. She does take a heart medication. The place on her neck is not itchy. She knows the vaccine could cause a severe allergic reaction. She sees her dermatologist for Basal cells and other things that are itchy. This place on her neck, if it is a rash, is brown not red. She gets a lot of those places on her skin. Her doctor told her to call Pfizer and then cancel her second appointment. She just wants to speak to medical information first. She doesn't even know if it is a rash. She hasn't had any side effects. Her arm didn't even hurt. This little rash is only on her neck. She had worked as a dental assistant. She is just worried now about getting the second shot. The outcome of event for itchy and worried was unknown and for other events it was not recovered. Information on the Lot/Batch number has been requested.

Patient awoke on the morning of 4/6/2021 with disorientation, confusion and tremors. She presented to the ED for workup, diagnosed with a UTI and discharged home. The patient presented to the ED again on 4/11/2021 with ongoing altered mental status, tremors and anorexia. Family reports no improvement in patient's symptoms since onset (4/6/21). Patient now having difficulty finding words, shakiness on ambulation, hallucinations and tremors. Denies urinary symptoms, repeat urine culture was benign. Patient remains hospitalized as of this report (4/15/21) with fluctuating symptoms, Serial head CTs and lab studies also benign. Unclear etiology of symptoms.

Presented with recent history of falls with acute mental status change (confusion, hallucinations) - found to be COVID+. SpO2 92% RA, placed on 2L NC. BP 116/69, HR 100, RR 20. AKI (pk SCr 2.1) Treated with dexamethasone (stopped early due to clinical improvement and delirium), remdesivir, tocilizumab and intermediate enoxaparin dosing. Anticoagulation complicated by epistaxis. Renal function improve with increased PO intake. Discharged home with home services.

delusional; paranoid; intense and sudden unwarranted anger; more easily agitated; This is a spontaneous report from a contactable Non-healthcare Professional reporting for a patient. An 84-years-old non pregnant female patient received first dose of bnt162b2 (BNT162B2, solution for injection, Batch/Lot number: not reported) administered in left arm via an unknown route of administration, on 13Jan2021 as SINGLE DOSE for covid-19 immunization. Medical history included cardiac failure congestive (CHF), severe tricuspid valve regurgitation, renal failure. Concomitant medications in two weeks included Apixaban (ELIQUIS), Simvastatin (SIMVASTATIN), Levothyroxine sodium (LEVOTHYROXIN) Atenolol (ATENOLOL), Spironolactone (SPIRONOLACTONE), Losartan (LOSARTAN) Torsemide (TORSEMIDE). On 15Jan2021, the patient was delusional, paranoid, intense and sudden unwarranted anger, more easily agitated. There was no treatment for the events. The outcome of the events was not recovered. It was reported that patient has become delusional and paranoid, intense and sudden unwarranted anger, more easily agitated. The patient underwent lab test Possible exposure to virus before vaccination although tested negative (weekly testing for about 4 weeks prior, every 2 weeks prior to that). The vaccine was administered at nursing Home/Senior Living Facility. No other vaccine was in four weeks. Prior to vaccination, patient has not had covid. It was unknown whether patient was tested for covid post vaccination. The patient had known allergies to Pneumonia Vaccine. Information on the lot/batch number has been requested. 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.

tired from loss of sleep; nose was dripping; acid reflux/ it was worse than before; pretty sick; throwing up; loss of sleep; lightheaded and dizzy; She experienced soreness on her arm after the first shot; This is a spontaneous report from a contactable consumer (patient). An 84-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in arm left on 10Mar2021 14:30 (Batch/Lot Number: EL9269) as 1st dose, single for covid-19 immunisation. Medical history included ongoing shingles (but got the shot anyway), ongoing acid reflux (been years and years and years ago, way back in 1990s or so maybe later than that), high blood pressure from 2001 and ongoing, dry eye, macular degeneration, CPO because she was a smoker, 4 bypass surgery, allergic to a blood pressure medicine, blood thinner therapy, and bad sinuses. Concomitant medications included calcium carbonate, magnesium carbonate (TUMS) taken for gastrooesophageal reflux disease, start and stop date were not reported; amlodipine taken for hypertension from 2001 and ongoing; albuterol sulfate taken for ex-tobacco user, pulmonary oedema, start and stop date were not reported; krill oil taken for an unspecified indication, start and stop date were not reported; cetirizine hydrochloride (ZYRTEC) taken for hypersensitivity, start and stop date were not reported; aspirin taken for anticoagulant therapy, start and stop date were not reported; ciclosporin (RESTASIS) taken for dry eye, start and stop date were not reported. She experienced soreness on her arm after the first shot. Patient have acid reflux anyway and it seemed like it come up and it was worse than before, she was pretty sick last night on 15Mar2021 throwing up and still feeling pretty bad today from loss of sleep. Her nose was dripping and her head was all lightheaded, was dizzy and she was sick to her stomach. She sat in her recliner until about 3AM. Patient did not know if this was from the shot or what, but it was terrible. These things were not really ongoing on 16Mar2021, but she feels tired on 16Mar2021 from the loss of sleep on 15Mar2021. She took her antihistamine and her blood pressure pills and she was alright now, just tired from no rest. She reported that she was scheduled for her second dose of the product on 31Mar2021 at 150PM. Patient had blood work done at her last physical on 20Jan2020, and she reports that was all good. Outcome of the events was unknown.

Feeling ill; tiredness; headache; muscle pain; chills; joint pain; confused; Diarrhea; dizzy; This is a spontaneous report from a contactable consumer (patient). A 84-years-old (non-pregnant) female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: Unknown), dose 1 via an unspecified route of administration, administered in arm left on 10Feb2021 at 01:30 as 1st dose, single for COVID-19 immunization. The patient medical history included UTI and known allergies: Penicillin. The concomitant medication included fluoxetine, pravastatin and levothyroxine received in two weeks. The patient did not receive any other vaccine in four weeks. On an unspecified date, the patient experienced feeling ill, tiredness, headache, muscle pain, chills, joint pain, confused and diarrhea. Body, headache and tiredness through to Sunday afternoon. On Monday, the patient was still feeling dizzy. The patient did not had COVID prior to vaccination and was not tested for COVID post vaccination. The patient did not receive any treatment for the events. The outcome of the events was not recovered. Information on the lot/batch number has been requested.

blood pressure was 116/69, which was pretty low for her; last night when she had checked her blood pressure it was 180/90; she feels like she was hit by a truck; all she wanted to do was lay down and go to bed; she didn't feel good yesterday; walking really funny; didn't want to eat; had no interest in anything, like watching TV; all she wanted to do was lay down and go to bed; Joint pain; Muscle pain; her left shoulder really started to hurt; This is a spontaneous report from a contactable nurse(patient). A 84-years-old female patient received BNT162B2(PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection; Lot number and Expiration date: Not reported), dose 1 via an unspecified route of administration, administered in arm left on 08Mar2021 10:30 as 1st dose, single dose for COVID-19 immunization. No prior Vaccinations within 4 weeks. Medical history included diagnosed with Congestive heart failure a couple of years ago(ongoing) and she had been taking several blood pressure medicines for Congestive heart failure and had a shoulder replacement in the past. Back in Sep2020 patient blood pressure was down to 40/30 and she could hardly hold head up and she had to go to the hospital and be admitted. The patient's concomitant medications were not reported. On 08Mar2021, the patient left shoulder really started to hurt in the night. and on 09Mar2021, patient was not feeling good and her pain got really bad (joint and muscle pain), she told herself that she had to get to bed. She said she was really hurting, clarifying she had both joint and muscle pain. Every time patient moved she was crying and screaming from the pain. Her blood pressure had dropped. Patient said she knows her blood pressure gets very high with pain. Patient blood pressure medications can drop her blood pressure too fast, and too low. The patient underwent lab tests and procedures which included blood pressure measurement: her blood pressure was dropped to 116/69 mmhg, which was pretty low for her. She said last night when she had checked her blood pressure it was 180/90 mmhg. Patient was walking really funny, and hoped she did not fall. She was not interested in eating and She had no interest in anything, like watching TV all she wanted to do was lay down and go to sleep. On 10Mar2021, She feels like she was hit by a truck. It was reported on 09Mar2021(last night), things got worse; events left shoulder really started to hurt, did not feel good, joint pain and muscle pain was worsened. Patient reported she did not have a headache. She had been laying on her couch the whole time. Therapeutic measures were taken with 2 Tylenol PM 500mg (1000mg total) last night(09Mar2021) and again this morning(10Mar2021) but it did not work. Relatedness of drug to reactions/events was reported. No Investigation Assessment. The outcome of the events Joint pain, muscle pain, left shoulder really started to hurt and she didn't feel good yesterday was not recovered and other events was unknown.; Sender's Comments: Based on the temporal relationship and the information provided, A possible contributory role of the suspect product to the development of shoulder pain,malaise, gait disturbance, myalgia, decreased appetite, decreased interest and arthralgia 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.

Around 4/19/21 pt started experiencing shortness of breath that increased to the point of gasping for breath on 4/25/21. Her daughter (me!) visited and immediately called her pulmonologist who requested she immediately go to the hospital. The ER said she had an enlarged heart, and was checked in to the cardiac unit. Tests showed she had acute systolic and diastolic heart failure. She was first put on diuretics while further tests were done, and Tikosyn was later added to her list of regular medications. Within a week she was able to go home. She was on oxygen prior to this event from the pulmonary fibrosis, and was able to return to her prior settings on her oxygen concentrator within five days, but her ongoing discomfort has stayed at a heightened level, and her level of activity has not returned to her normal. Please note: she is an 84 year old with pulmonary fibrosis. It is not possible for me as her daughter (not a medical professional) to know if the original diagnosis of heart inflammation was related to her vaccination, but she had been relatively stable for more than six months prior to this hospitalization event and the onset of this sequence of events was identified by the doctors as being of unknown origin at that time.

Fever; Chills; Extreme fatigue; Confusion; This is a spontaneous report received from a contactable consumer, the patient. An 84-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; lot number: EZ6207) in the right arm via an unspecified route on 19Mar2021 at 03:30 PM as a single dose (at the age of 84-years-old) for COVID-19 immunisation. Medical history included congestive heart failure. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; lot number: EN6200) in the right arm via an unspecified route on 23Feb2021 at 03:30 PM as a single dose (at the age of 84-years-old) for COVID-19 immunisation. The patient did not receive any other vaccination within four weeks prior to the COVID-19 vaccine. The patient had received other 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. On 20Mar2021 at 10:00 AM, the patient had fever, chills, extreme fatigue, confusion. The patient did not receive any treatment for this event and the events didn't resulted in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events fever, chills, extreme fatigue, confusion was recovering at the time of report. No follow-up attempts are needed. No further information is 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

severe muscle weakness; felt unwell; she felt dizzy; had a brain fog but gone now; lousy; This is a spontaneous report from a contactable consumer (patient). A 84-year-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 01Jun2021 (at the age of 84 years old) as dose 2, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot number: Unknown) via an unspecified route of administration on 11May2021 as dose 1, single for COVID-19 immunization. On 01Jun2021, after 40 minutes of receiving the vaccine, patient experienced severe muscle weakness, dizziness, felt lousy and felt unwell. Patient also had a brain fog along with felt dizzy, lousy but gone at time of reporting. Patient wanted to know what she can do to end the side effects sooner because it was already 1 month. She took tylenol and took lots of water to manage the side effects. She did mention that it was better now but it does not go away. She had some health issues and does have muscle weakness periodically. The outcome of the event severe muscle weakness and felt unwell was recovering, she felt dizzy, lousy and had a brain fog recovered on an unspecified date in 2021. Information on Lot/Batch information has been requested.

ADMITTED TO HOSPITAL MORE THAN 2 WEEKS AFTER COMPLETION OF VACCINE SERIES COVID + ON 3/18/21 ADMITTED 3/19 WITH ALTERED MENTAL STATUS, LETHARGY, AND COUGH DISCHARGED ON 3/21

PATIENT RECEIVED THE SECOND COVID-19 VACCINE DOSE ON 01/18/2021 THROUGH A PHARMACY CLINIC THAT CAME TO THE FACILITY. THE FOLLOWING DAY SHE HAD CHANGE IN MENTAL STATUS AND HYPOXIA. LATHARGY WITH OXYGEN SATURATION OF 84%. DEHYDRATION

Patient developed fever to 102 within 24 hours with decreased mentation. Stopped eating/drinking despite aggressively treating fever. Was DNR B status. Family agreed to a trial of IV fluids on 1/21 but was not successfully started until 1/22 after several attempts. Family wanted only comfort measures with no transfer to hospital. Patient continued to have fevers to 102-103 range. Patient passed on 1/23 . Patient did test positive for COVID in early September without significant illness. She was in usual state of health prior to vaccination.

soreness on arm where shot was administered; heart palpitations; difficulty in eating; difficulty in sleeping; Concomitant drugs: INFLUENZA VIRUS (influenza immunisation); Concomitant drugs: INFLUENZA VIRUS (influenza immunisation); This is a spontaneous report from a contactable consumer, the patient. An 85-year-old female patient received BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine), dose number 1, via an unspecified route of administration in the left arm on 11Jan2021 at 12:00 (at the age of 85-years-old) as a single dose for COVID-19 vaccination. Medical history included high blood pressure from an unknown date and unknown if ongoing. Concomitant medication included influenza vaccine (FLU), hydrochlorothiazide, losartan potassium (HYZAAR) and metoprolol succinate (TOPROL XL). Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient reported having received the flu vaccine within 4 weeks prior to the Covid-19 vaccine. The patient did not have any allergies to medications, food, or other products. On an unspecified date in Jan2021, the patient experienced soreness in the arm where the shot was administered; and Concomitant drugs: INFLUENZA VIRUS (influenza immunisation). She took ibuprofen (ADVIL) for the soreness. In approximately 49 hours, the patient experienced heart palpitations that lasted about 24 hours, leading to difficulty in eating and sleeping. The clinical outcome of the soreness in the arm where the shot was administered, heart palpitations, difficulty eating and difficulty sleeping. The clinical outcome of Concomitant drugs: INFLUENZA VIRUS (influenza immunisation) was unknown. It was also reported that since the vaccination, the patient had not been tested for COVID-19. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow-up.

Height: she shrunk; aching in shoulders and uppers arms; aching in shoulders and uppers arms; her whole body has felt colder; She does not feel good; She has been pretty depressed with the pain; crying; This is a spontaneous report from a contactable consumer. An 85-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/lot number: EL3248), intramuscular in upper left arm on 13Jan2021 13:15 at single dose for covid-19 immunisation (prevent covid). There was no medical history. There were no concomitant medications. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. She got the flu shot and shingles shot way before the covid vaccine. The patient got her Pfizer covid vaccine last Wednesday on 13Jan2021. She had been aching in her shoulders and upper arms hurting real bad on 14Jan2021. She had some chills. She did not feel good and it did not seem to be letting up. The first day she was fine. She clarified that she did not experience chills, she felt colder on her whole body on 14Jan2021. She took ibuprofen (ADVIL) about 2.5 to 3 hours ago earlier as treatment. Height: she shrunk. She still had a good appetite. She had been pretty depressed with the pain, she was hurting and crying from the pain. No emergency room or physician office visit required. She was scheduled to get her second dose at the same facility. The outcome of events aching in her shoulders and upper arms hurting real bad, felt colder on her whole body was not recovered. The outcome of other events was unknown.

3:45 pm Patient c/o feeling dizzy at 3:45 pm. Daughter and son in law present and requested water. Patient took a few sips of water and soon after became cool and clammy. Patient became incoherent and was not responding to myself or her daughter. Became lethargic and couldn't hold her head up. Diaphoretic and skin remained cool and clammy. Client is not diabetic. Patient is on meds for B/P and did have cardiac bypass surgery 2 years ago. Daughter and I decided to call an ambulance. B/P 80/40 (L) and rechecked 5 min later and was 90/50. No SOB or trouble breathing. Lung sounds were clear and WNL. No respiratory distress noted. O2 sat 94%. Pulse 55. Ambulance arrived and took over care. Patient did get transferred to ER via ambulance per the daughter's request

Pfizer-BioNTech COVID-19 Vaccine EUA? Presents to the emergency department with syncope. Patient received her 1st dose of the COVID-19 1/28/21. She states she felt in her normal state of health yesterday. However, she was unable to sleep at all overnight. She took a nap between 5 a.m. and 9 a.m., Upon waking this morning, patient states she felt generally fatigued, had nausea with associated diffuse abdominal pain. Patient had 1 episode of emesis. No hematemesis. Immediately following emesis, she describes 1 to 2 episodes of syncope that occurred while she was seated in a chair. Patient did not fall or strike her head. She denies preceding chest pain, shortness of breath, back pain, numbness, tingling, weakness. Per EMS, patient was awake, somnolent but oriented, with stable vital signs including heart rate of 68, respiratory rate of 18, pulse ox of 90% on room air and blood pressure of 126 systolic. On arrival to the ED, patient appears somnolent, hemodynamically stable with normal blood pressure, afebrile. Patient feels symptomatically improved after 1 L normal saline bolus and Zofran. She was discharged home in stable condition.

patient received vaccine on Jan 23, 2021. developed weakness on Jan 25, 2021. Sent to ED on Jan 27, 2021 with hypoxia requiring 6 L O2, low Bp, declining mental status. Per family request transitioned to hospice and passed away on Jan 30, 2021

Late onset of side effects started on day 6 with mild sluggishness. Progressed to severe mental confusion and incoherence. Fever of 100 this morning (Feb/5) and wet cough with lots of mucous. Still going on and we are trying to control with Tylenol and Coricidine

Sudden slurring of speech slight mouth droopiness; Sudden slurring of speech slight mouth droopiness; Sudden loss of consciousness; difficulty in bringing her hand to mouth to eat-opposite arm from injection site / Difficulty walking, getting out of bed; Increasing confusion, soreness, pain, throughout as well as injection site; Increasing confusion, soreness, pain, throughout as well as injection site; Increasing confusion, soreness, pain, throughout as well as injection site; Difficulty walking, getting out of bed.; Severe lethargy, tiredness, sleepiness; Severe lethargy, tiredness, sleepiness; Severe lethargy, tiredness, sleepiness; This is a spontaneous report from a contactable other HCP. An 85-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Lot number: EK9231) intramuscular in left arm on 19Jan2021 16:00 at single dose for COVID-19 immunisation. Medical history included beginning signs of dementia, stage II breast cancer not immune compromised, no chemo no radiation only hormone therapy, and hormone therapy. There was no known allergies. The patient was not pregnant. There were other unspecified medications in two weeks. After 3-4 hours after injection on 19Jan2021 19:30 she had difficulty in bringing her hand to mouth to eat-opposite arm from injection site. Increasing confusion, soreness, pain, throughout as well as injection site. Difficulty walking, getting out of bed. Severe lethargy, tiredness, sleepiness. Day 3 after vaccine on 22Jan2021, all other symptoms still present and worsening, then sudden slurring of speech slight mouth droopiness, then sudden loss of consciousness. Could not be woke up for about 15 minutes then opened eyes but not aware of surroundings. Taken to hospital for work up. On day 4 after vaccine still confused not at normal baseline. Needs assistance in walking, eating, etc. Events resulted in: Emergency room/department or urgent care, Hospitalization for 7 days, Disability or permanent damage. The patient received treatment such as ER and ongoing hospital stay with Pt and OT for events. She received COVID test via nasal swab on 22Jan2021 with result of negative. Events outcome of difficulty in bringing her hand to mouth to eat-opposite arm from injection site, increasing confusion, soreness, pain, throughout as well as injection site, difficulty walking/getting out of bed, severe lethargy, tiredness, sleepiness was not recovered, while for others was unknown.; Sender's Comments: Based on temporal association, the causal relationship between BNT162B2 and the events cannot be excluded. The information available in this report is limited and does not allow a medically meaningful assessment. This case will be reassessed once 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.

I didn't sleep well night of Feb. 7, got up three times to pee. I got up finally Feb. 8 at 6:30 and tried to stand but was too dizzy. Finally I was able to get to the bathroom, where I had diarrhea. I managed to make and eat breakfast, but was on and off dizzy, one more diarrhea episode. Took my blood pressure around 10:45, not too high, but heart rate low: 45bpm. I was ready to drive to the woods and take a walk, no further problem.

I had all the symptoms I had when I was coming down with the disease. Cough, fatigue, headache, neck & shoulder aches, no appetite, blah feeling lasting 3 days

received COVID vaccination, Pfizer, LOT EL9264 and within 5 minutes of receiving the second dose patient reported lump in throat. Denies pain and no swelling of posterior pharynx upon assessment. BP126/74 HR 103 98% saturation on room air. 25 mg Benadryl administered. patient observed for 30 minutes post vaccination with resolve of all symptoms. Left area with family.

Two days after I got the shot, I felt severe "brain fog" (disoriented) all day. The third and fourth days after the shot, I felt severe dizziness at all times. (I had seasonal allergies at the time - sneezing and runny nose, and my doctor thinks this affected my middle ear, causing the dizzy feeling.)

This was the second shot, given on February 5, 21 days after the first one,. I was totally bedridden for several days, getting up only for necessities I lived on Ibuprofen. I would get up, take two Ibuprofen, and sit for an hour before I could func. My arm hurt. The worst part is that my brain felt as if it were all swelled up, pushing against my skull. I could not perform normal tasks at all , until the last couple of days. I could not think, reason or remember at all until the last 2-3 days, I had to get substitutes to teach my classes. I could not write nor communicate nor pay my bills. I have a manuscript overdue. I am now staying at night with friends, for neither they nor I trust me to function normally alone.

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.

"Patient with a PMH of HTN, Afib RVR (on Eliquis), nonischemic CMO, HFrEF (EF 25%), HLD, HLD, Fe deficiency anemia, Pulmonary HTN, rectus sheath hematoma presented to ED with LUE edema and pain that started a couple of hours after second dose of COVID vaccine adminstration. Patient had received COVID vaccine shortly after noon day prior to admit on RUE. She reports that she had been experiencing some nausea as well. She was admitted to the hospital for overnight observation secondary to transient alteration of awareness after she presented to the ED for arm swelling where experienced a syncopal episode lasting approximately 1 minute. She was monitored on cardiac tele which showed Afib with appropriate rate control overnight. For her left upper extremity swelling an U/S was done which was negative for thrombus, only a hematoma. Her arm pain was controlled and supportive with a compress. Patient had no further syncope, Afib rate controlled, and hemodynamically stable. Discharged home 2/24/21.

dizzy; stomach seems a little upset; didn't sleep very well; This is a spontaneous report from a contactable consumer (patient). An 85-year-old female patient started received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL9264 and expiry date: unknown), via an unspecified route of administration on the right arm, on 01Feb2021 at a single dose for COVID-19 immunization. The first dose was received on 11Jan2021 (lot number: EL0142) Medical history included GERD. Concomitant medication included pantoprazole and other unspecified product. Patient got the first shot of the COVID vaccine three weeks ago, and she didn't know anything had happened to her. She got the second dose of the vaccine yesterday at noon, and she was fine, although she didn't sleep very well on 01Feb2021. But the morning of 02Feb2020, she went in the kitchen and dropped some blueberries because the plastic boxes don't close easily, and she bent over to pick the blueberries up and she got dizzy. She did not know why she should get suddenly dizzy, and her stomach seemed a little upset, but she has no fever on 02Feb2021. Patient was just wondering if the dizziness is a side effect of the vaccine. Patient had no other vaccines on the same day as the COVID vaccine and stated when she had the incident where she bent over and was dizzy, it felt just really terrible, but she was feeling fine now, but the incident did shake her up a bit. Outcome of the events was unknown.

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

2nd injection given on 02/16/2021 Altered Mental Status admission on 3/3/2021 Intracranial bleeding Unresponsive Intracranial bleed Death on 3/6/2021

Several minutes after vaccine patient complained of dizziness and "feel funny". Also complained of "legs feel weak". Stated she usually does not have issues after vaccines/shots. States left arm "hurts" but had vaccine in right arm. She has history of cardiac stents.

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.

02/28/2021 @ 12:00 PM - sore arm, more than normal, at sight of injection; not feeling right 03/01/2021 @ AM - arm so sore that she could hardly move whole arm to hold stair rail; fatigued; not feeling right 03/04/2021 - diarrhea 6 x; fatigued; not feeling right 03/05/2021 - still had diarrhea; fatigued 03/06/2021 - 1/6 cup of urine only when she woke up in the morning; fatigued; diarrhea during AM; seemed to stop diarrhea PM and urinated maybe 2/3 cup urine more; found an almost unnoticeable bulge between the 2 collar bones above the sternum, still not feeling right 03/07/2021 - after waking up to go to the bathroom approximately 6:00 AM, incontinent wit BM, vomited

hoarse voice; felt like she had a big lump in her throat; difficulty swallowing; Allergic reaction; This is a spontaneous report from a contactable consumer (patient's daughter) received via Medical Information Team. An 85-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL9265), via an unspecified route of administration on 04Feb2021 (at the age of 85 years) at single dose for COVID-19 immunisation. The patient medical history included allergic to different medications. The patient's concomitant medications were not reported. It was reported that on 04Feb2021, the patient an hour after the vaccine developed a hoarse voice and two hours later felt like she had a big lump in her throat and had difficulty swallowing, their healthcare provider said he didn't believe it was an allergic reaction and was leaving it up to her if she wants to get it or not. The reporter stated her mother is allergic to different medications and those allergic reactions started the same way this did. The patient outcome of the events was unknown.

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.

I felt like I had covid again. Tired, mental fog, body aches. I had to go back on my O2 machine. I had Covid 11/26/2020.

blood tests, T-cells are up high; she's having a hard time; This is a spontaneous report from a Pfizer- sponsored program from a contactable consumer (patient). An 85 years old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via unspecified route of administration on 09Mar2021 at age of 85 years old at single dose for COVID-19 immunization. Medical history included she had pancreatic cancer 10 years ago and a breast cancer 5 years ago. Concomitant medications were not reported. Patient called to know if it was okay to undergo the following tests namely, CT scan with Dye and Nuclear bone scan as prescribed by her Oncologists due to readings on her blood tests, her T-cells are up high after getting her first dose of the Covid-19 vaccine today morning, 09Mar2021. According to patient she had pancreatic cancer 10 years ago and a breast cancer 5 years ago. Patient was very scared to undergo the Nuclear bone scan as it was something new to her and did not know how her body will react to such tests aside from the fact, she was having a hard time, making an appointment too. Outcome of events was unknown. Information on the lot/batch number has been requested.

About 8 hours after shot #2, started having headache and nausea. Was hard to think clearly. Was already having back pain which contributed to poor feeling. On 3/23/21 began to have vomiting, and felt very poorly on 3/24/21, then was hospitalized with vomiting and hyponatremia on 3/25/21. (Note, had bounce-back admission on 3/31/21 for 2 more nights for fluid overload.)

tested positive for covid; body aches; not feeling well; weakness; low grade fever; This is a spontaneous report received from a contactable consumer. A 85-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection, Lot number and Expiration date was not reported), via an unspecified route of administration on 23Feb2021 as SINGLE DOSE for covid-19 immunization. Medical history and concomitant medications were not reported. It was reported that patient received her first dose of the BNT162B2 vaccine on 23Feb2021 and day later she had symptoms of covid, body aches, not feeling well, weakness, low grade fever, tested positive for covid. In the second week she had to go to hospital for few days and was very week and still covid positive. Reporter wanted to know can patient take her second dose or if she needs to redo her series. The outcome of the events was unknown. information about lot/batch number has been requested.

The vaccine recipient was already diagnosed with Alzheimer's but was in an early stage of the condition and able to live independently. Beginning the day after the vaccine there was a marked and sudden cognitive impairment that severely affected ability to live independently, with (subjectively) worse memory, confusion, mood swings and anger outbursts, and loss of ability to do routine household tasks that she was previously able to do consistently without difficulty (e.g. making coffee, writing checks, heating up a frozen meal). This gradually improved over the next two months. She has now (as of April 17, 2021) returned to her pre-shot baseline level of function. Based on this event we have chosen not to subject her to the risk of a second shot.

Chills; Not feeling good at all; Achiness; Back pain; Stomach cramps; Felt terrible; It was a slight fever 99; cannot sleep; This is a spontaneous report from a contactable consumer. An 85-year-old female patient received her second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 10Feb2021 12:00 (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunisation. Medical history included diabetic. Concomitant medications were reported but was unspecified (patient stated that she have too many of them). The patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 23Jan2021 for covid-19 immunisation (85 years old). The patient experienced chills on 10Feb2021 22:00, not feeling good at all, achiness, back pain, stomach cramps, felt terrible, it was a slight fever 99 and cannot sleep on 10Feb2021. The patient underwent lab tests and procedures which included blood work: have a lot of blood work. Every 6 months she had to have my blood taken. Because of the pandemic she have not been going to doctor and body temperature: it was a slight fever 99 on an unspecified date. Therapeutic measures were taken as a result of fever included Tylenol. Outcome of the events was recovering. Information on the lot/batch number has been requested.

really being tired/ overly tired; Caller stated yesterday was worse; she had to go back to bed after she got up and was up a couple of times during the night; not feeling well; This is a spontaneous report from a contactable consumer or other non healthcare profesional via Medical Information Team. An 85-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/Lot number: Not reported) via an unspecified route of administration on 13Apr2021 as single dose for COVID-19 immunization. The patient took Tylenol 600mg before the vaccine for knee pain. The patient's concomitant medications were not reported. Historical vaccine included dose 1 BNT162B2 for COVID-19 immunization. On an unspecified date, caller stated that after second dose had them really being tired and yesterday was worse. Patient also stated she was overly tired and everything so the vaccine must be protecting her immune system. She had to go back to bed after she got up and was up a couple of times during the night. Patient stated her husband had a headache. Patient postponed her knee surgery but HCP until she had the vaccines as per HCP sugesstion. Patient mentioned she read not to take Tylenol before the vaccine. Patient wanted to know if she was still protected even though she took the Tylenol before the vaccine. Outcome of the events was unknown. No follow-up attempts are needed; information about lot/batch number cannot be obtained.

pt says she had violent shaking, like tremors for hours. She stayed in bed for about 4 days due to the fatigue. She had brain fog, dizziness and is unbalanced. She went to her PCP on 3/17/21. She had blood work with normal results. These symptoms continued all the way through to her 2nd vaccine.

pt says she developed tremors and difficulty with her balance. She has exhaustion, brain fog and fatigue. On 4/23/21 she went to her PCP. Pt was referred to a Neurologist. Pt has to scheduled this appt.

Could not sleep; Effected upper part of my body, my arms, my neck, my shoulders, It's been very severe/ /severe muscle condition; I had tiny bit of shingles on my side; I did not have memory of anything that happened/Do not remember all of it, I was out of my mind; This is a spontaneous report from a contactable consumer (patient). An 85-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EN5318, Expiration Date: unknown), dose 2 via an unspecified route of administration on 17Feb2021 as single dose for COVID-19 immunization. Medical history included blood pressure and cholesterol. Concomitant medications included hydrochlorothiazide taken for blood pressure and rosuvastatin taken for cholesterol. On 20Feb2021, the patient experienced could not sleep. In Feb2021, the patient experienced effected upper part of body, arms, neck, shoulders, it's been very severe/severe muscle condition, had tiny bit of shingles on my side, did not have memory of anything that happened/do not remember all of it, was out of my mind. The patient reported that she had some very severe muscle condition. She could not sleep. It was horrible. The patient understood that they put it in the muscle so that is why she was feeling that. It's been very severe, she was ok now and she think it is going to be better now. She have been taking treatment Tylenol 500 mg, two of them every 6 hours and the doctor gave a medication for tiny bit of shingles on my side to keep it from growing any further. The patient did not remember all of it, she was out of her mind. They took her to the hospital and then the patient underwent MRI to see if her brain was okay and they come up with a conclusion that is what it was and she did not have memory of anything that happened. The outcome of the events was recovering. No follow-up attempts are possible; No information is required.

After second dose: Symptoms began from March 9 - March 13 with a few day pause, then continued ongoing; Little appetite, lethargy, no energy, in bed sleeping 18 plus hours out of a 24 hour period, continued until the morning of March 13, unremarkable symptoms from March 14 thru March 22, March 23 in home nurse recommended she see a cardiologist, March 24th rushed to the hospital short of breath with irregular heartbeat; released from hospital 24 hours later -could not determine cause; 1.5 days later second visit to emergency room with the same symptoms; release from hospital 2 days laters; saw cardiologist, symptoms have persisted and progressed, currently only able to take 1/2 to 1/4 short breathes; about 15 minuets per 24 hour period will full breath capacity; 3+ pillow orthopnea: sitting up at 45 angle in order to sleep, any lower angle cannot breathe; symptoms ongoing and worsening, cause unknown

like she has been wanting to throw up/nausea, whenever she felt like throwing up; may be a stomach flu; weakness; has been feeling unwell; loss of appetite; she has been feeling shaky/nervousness; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot ER8733; expiration date: 31Jul2021), via an unspecified route of administration, administered in left arm on 25Mar2021 04:00 as single dose for covid-19 immunisation. Medical history included high blood pressure, and allergies to dust, grass, and loud smells like perfume, a lot of smells. The patient's concomitant medications were not reported. The patient received first dose of bnt162b2 on 04Mar2021 for covid-19 immunisation. She had her second dose on 25Mar2021 and had no symptoms until 20Apr2021. On 20Apr2021, she first went to urgent care because of her no appetite and they didn't do anything so then she went to the emergency room on 21Apr2021 because she tried to throw up. They gave her fluids but did not know the name of it, just that it took about 1 to 1 and a half hours. They took her blood and took her urine and did a chest x-ray. She did not have blood taken at the hospital emergency room but did have her urine taken and a chest x-ray and they didn't find nothing wrong with her. They stated it may be a stomach flu and she went home. She reported she had side effects and didn't know if it was supposed to happen. On 20Apr2021, she also had nervousness, and had no appetite, and was feeling shaky, weakness and has been feeling unwell. She has never had nothing like this and overall she has been in good condition. She stated that the side effects do not happen everyday and she tried to drink a lot of fluids and electrolytes, water and Gatorade and lays down in bed. She tried a little oatmeal but didn't have a taste for it so she ate a little soup, a noodle soup. She reported that she did not have an appetite this morning (as reported) but she did eat some soup and a lot of crackers. She was feeling good until this sickness. Her daughter stated she shouldn't have gotten the shots. She stated that maybe something was wrong, and she never had this before. Her primary prescribed Famotidine, one tablet a day 20mg, by mouth. She stated she just started taking the other day. It's for 14 days. She has 10 left, so she's been taking for 4 days. She was also prescribed Ondansetron at the hospital for nausea, whenever she felt like throwing up. She stated she does not like it and stated you put it on top of your tongue and don't drink water or eat with it. It was 1 tablet every 8 hours as needed. She reported that she was about 4'10" in height and she had shrunk because she used to be 5' height. She followed up with her healthcare provider on 04Apr2021 (as reported), who prescribed her something for acid reflux and she stated acid reflux wasn't it. The events loss of appetite and throwing up required a visit to emergency room. The patient had no previous immunization with Pfizer vaccines and no additional vaccines administered on the same date of the vaccine. There were no prior vaccinations within 4 weeks. Outcome of event may be a stomach flu was unknown; outcome of the rest of events was unknown. No follow-up attempts are needed. No further information is expected.

The day after first shot , patient was more paranoid, increase hallucinations, angry and started to lose ability to stand up straight, by day 8 she had total loss of leg control and torso, could not feed herself, dress herself and she was very combative and hallucinating constantly. We had to hospitalize her and she died March 6 in the hospital.

Presented to hospital with AMS with possible seizure activity. Daughter at bedside to assist with HPI, given patient's AMS. Daughter reports that she went over to see her mom at approximately 930 this morning and found her alert and oriented x3 with complaints of nausea, congestion and cough s/p her second COVID-19 vaccination, which she received yesterday. Daughter reports that at approximately noon, her mom had an episode of emesis, with her arms clenching up and shaking for approximately a minute, for which she called EMS. Daughter reports that her mom has been lethargic with AMS s/p episode. Daughter reports her mother has never had seizure activity before, but she has had several previous TIAs. She denies any recent injury, fall or medication changes. Patient lethargic with AMS noted, unable to follow simple commands, does tell me her first name with several prompts. PATIENT REMAINS HOSPITALIZED AT THE TIME OF THIS REPORT.

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.

The form did not provide a place to enter the date of both doses of the vaccine. The dates were: Covid-19 (Pfizer-BioNtech), given in right arm. 1st shot: Lot # EN6198, time of vaccination unknown; 2nd shot: Lot # EN6207, time of vaccination unknown. On April 19, patient complained about left shoulder pain and went to see her general practitioner. Tests were done to rule out heart issues. On April 20, she called 911 and went to one of the two local hospitals, complaining of shoulder pain. After an xray, the diagnosis was given as tendonitis and she was sent home and instructed to take 500mg Ibuprofen morning and evening. On April 23, a rash became apparent on her left arm. She had a follow-up appointment with her GP on April 27 and was diagnosed with shingles. She continued to get more uncomfortable and confused, and late on April 29, a neighbor took her to the other local hospital where she was admitted. A lumbar puncture test confirmed that she had herpes zoster virus in the spinal fluid. She was treated in the hospital with acyclovir by IV and was released from the hospital on May 4 to a skilled nursing facility where she rehabilitated until May 14, when she was sent home. She continues to be somewhat confused and has difficulty thinking of words - much more so than before her shingles episode.

Hospitalized 5/30-6/10 for altered mental status following recent bacterial sepsis and atrial flutter, discharged to hospice, died 6/16. Primary cause of death acute respiratory failure, underlying cause COVID-19 pneumonia

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.

urinary tract infection; sore arm; limited her ability to do things; angiogram showed mild blockage; progressively been getting weaker/weakness; bones periodically get icy cold; had heavy breathing which was difficult to control even with her focusing on her breathing; This is a spontaneous report from a contactable consumer or other non hcp (patient). An 85-years-old female patient received bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot number: EN6201; Expiration Date: unknown), dose 2 via an unspecified route of administration, administered in Deltoid Left on 17Feb2021 at 03:00 as dose 2, single for COVID-19 immunisation. Medical history included atrial fibrillation. The patient's concomitant medications were not reported. The patient previously took BNT162B2 for covid-19 immunisation and experienced asthenia on 30Jan2021. Relevant medical history and concurrent conditions included a fib. The patient has allergy to iodine. The patient did not receive prior vaccinations within 4 weeks. The patient did not receive any prior vaccinations within 4 weeks of receiving covid-19 vaccine. The patient has been keeping a daily journal for over 20 years and she noticed a trend of her symptoms after the vaccines. On 29Mar2021, the patient experienced progressively been getting weaker/weakness, a feeling from the top of her head to her knees. In Mar2021, the patient experienced bones periodically get icy cold. On an unknown date, had heavy breathing which was difficult to control even with her focusing on her breathing; on an unspecified date, the patient experienced sore arm, urinary tract infection, limited her ability to do things and on 22Mar2021, the patient experienced angiogram showed mild blockage, so it does not require surgery. The patient knows there have been reports of body aches then you could say sensations numbness, tingling, etcetera. The patient wakes up and is good for about an hour at most and then she gets weakness. The patient went by ambulance to the emergency room on 1Mar2021, due to the weakness and was out on same day. The patient underwent lab test which included, COVID-19 virus test which was negative on 01Mar2021. On 22Mar2021 Angiogram showed mild blockage. On an unknown date, the white blood cell count was normal. Therapeutic measures were taken with a bag of Rocephin. The patient was on a recording monitor and it sends reports to her cardiologist every night and it has not noted an event in over 90 days. The clinical outcome of the events progressively been getting weaker/weakness was not recovered; bones periodically get icy cold, sore arm, angiogram showed mild blockage, had heavy breathing which was difficult to control even with her focusing on her breathing, limited her ability to do things urinary tract infection was unknown. No follow-up attempts needed. No further information is expected.; Sender's Comments: Linked Report(s) : PFIZER INC-2021633718 similar report from same reporter

SUMMARY: New onset of arthritis-like joint pain affecting bilateral fingers, wrists, elbows, shoulders, and knees. Pain onset was temporally associated with the second COVID-19 vaccine shot. It began within one week of the shot and has persisted since then. "At times it is extremely painful and throbs. It affects me at night and sometimes the pain keeps me awake, but it is especially bad in the mornings. Sometimes I have pain both in pulling the blanket over me at night and taking it off in the morning. It has gotten so bad that I dread getting up each day. Some days I can barely get out of bed. I do feel better after I am up and moving around. Oddly, the pain moves from one area to another, affecting different joints in my body. It doesn't stay consistently in the same joint(s). It is really weird. I've had occasional aches before, such as in my lower back, but I have never felt anything like this. It is definitely new and came on all of a sudden. I believe that the vaccine triggered something in my immune system that has caused this new joint pain. CHRONOLOGY: I had my first Pfizer COVID-19 vaccine shot on February 10, 2021. Three weeks later, I had my second shot on March 4, 2021. Ever since then (beginning approximately on March 10, 2021), I have had these new and very bizarre aches in my joints. It started in my left fingers. They felt extremely stiff in the mornings and I had numbness and tingling in my hand. It felt like I couldn't even move it. It was weird. I have never felt anything like it before. It's not you usual "pins and needles" when your arm "goes to sleep." Shortly after that, it affected my right hand too. Some mornings it is almost impossible to straighten them. They are so stiff that I feel like I am going to break them if I move them. It didn't happen every morning at first, but it is becoming more consistent, over time. Once I get up and start moving in the morning, the joint pain usually goes away. Sometimes, I have a shooting pain in my hands and I think there may be nerve damage. I have also noticed that my grip strength in my hands has decreased. My hands are much weaker than they used to be. In addition to my bilateral fingers, this new arthritis has affected my bilateral wrists, elbows, and my right shoulder. When I saw my PCP on April 6th, 2021, my knees were not affected because I remember being able to get up from a seated position very easily. My doctor even commented on how agile I was. That has generally been true for me over the years. In the last month, though, since approximately June 15th, 2021 my knees have started to be affected by the same pain and stiffness. I notice it especially when I am getting up from a seated position. I have to hold onto something for support. Then, on approximately July 1, 2021, the pain and stiffness also started affecting my left shoulder. My right shoulder bothers me less now. It is very strange how the pain seems to move around from one area to another. So far, it has not affected my neck, my hips, or my feet. When I saw my PCP on April 6th, 2021, it was because I was having a lot of fatigue and I felt short of breath. I also told him about my joint pain and how I thought the vaccine caused it, since it seemed to start right after the second dose, but he dismissed it as being arthritis. I knew, however, that this was new for me and that I had never had it before. When I saw my Pulmonologist shortly thereafter, I told her about my symptoms and how I thought the vaccine had caused them. She said, "It absolutely could be." The most severe pain I have experienced to-date has been in my right wrist. I remember a sharp pain one day in February 2021, when I was trying to twist an ice cube tray. I do not recall if this was before or after my first vaccine shot on February 10, 2021. The tray was frozen pretty solid and it was hard to twist it to get the ice cubes out. I am left-handed and I remember that my right wrist was sore for several days afterwards. That right wrist pain still comes and goes. Sometimes I feel it every morning for a while, and then I won't. I have kept my wrist wrapped in a bandage and I am careful with how I use it, but I must have done something to aggravate it, because on Monday morning, May 24th, 2021, I got up to go to the bathroom and my right wrist hurt a lot. I had a hard time pulling up my underwear and pants. My right shoulder bothered me too. I got back into bed but I had a hard time pulling the covers back up over me. The pain worsened. It was almost unbearable and I was in tears. My husband got up a little later to go use the bathroom. He asked if I was okay and I said, "No, my wrist is killing me and I cant go back to sleep." He brought me hot washcloths to wrap around my wrist and this helped. He must have brought me fifty hot washcloths. The next morning, I called my PCP and asked for a referral to see a rheumatologist. I have an appointment pending on August 5, 2021. Then, on Wednesday, May 26, 2021, my right wrist pain was excruciating. I contacted my PCP and made an appointment for the next day. The pain subsided a bit and I kept my wrist wrapped. I was careful with how I used it, but the pain started up again in the morning after I got dressed. I was in tears because it hurt so much. I couldn't even touch it. It was swollen. I had trouble moving my right 4th and 5th fingers too. I used a heating pad and took Tylenol and they helped to take the edge off, but it still hurt. I wondered if I had a fracture or a torn tendon or ligament. I asked my doctor to give me an order for imaging so that I wouldn't have to go through the ER. The A.P. x-ray of my wrist did not show any fractures, but my doctor wrote in his note that there is a "deformity" in the wrist. I have tried a topical pain reliever, Aspercream, with minimal relief. I have not had the excruciating pain in my right wrist since May. I had hoped that the arthritis-like pain and stiffness would gradually go away with time, but it has persisted, off and on. Most mornings, I continue to have pain. I am now afraid to get a booster shot of the COVID vaccine if one is need because I don't want my pain to get worse."

bumps that itch/itching like hell; It is itching terrible; Itching all the time; they scab on my arms; bumps that itch/I am all broken up with little bumps all over my legs coded; I got more sores; It is driving me crazy; I started getting pimples; This is a spontaneous report from a contactable consumer. A 85-years-old female patient received second dose of bnt162b2 (BNT162B2; Batch/Lot Number: Unknown), via an unspecified route of administration, administered in Arm Left on 18Feb2021 13:30(at the age of 85-years-old) as single dose for COVID-19 immunisation. Medical history included hypothyroidism, hypersensitivity. Concomitant medications included levothyroxine sodium (SYNTHROID); hydrochlorothiazide. Historical vaccine included first dose of bnt162b2 (BNT162B2; Batch/Lot Number: Unknown), via an unspecified route of administration, administered in right arm on 28Jan2021, 01:15 PM as single dose for COVID-19 immunisation. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, has the patient has not been tested for COVID-19. On an unknown date in Feb2021 the patient experienced bumps that itch/itching like hell; it is itching terrible; itching all the time , they scab on my arms, bumps that itch/i am all broken up with little bumps all over my legs coded, I got more sores, it is driving me crazy, i started getting pimples. Clinical course reported as I had the shot 2 times and the 2nd time that I had the shot I am all broken up with little bumps all over my legs, all over my arms and itching like hell. Now the doctor gave me prednisone 2 times that didn't help and it helped me itching (Not cleared since there was distortion on line hence captured suspect conservatively). I asked the pharmacist, what she could give me. She didn't know. So I don't know what to do. It is itching terrible. It is driving me crazy. My legs, my arms and this happened right after I had the shot. That would be wonderful because this itch is driving me nuts. Itching all the time. This is terrible. Am I the only one that ever had this. I got to look that up. I don't have all those ready, had I known. I have no idea what I am going through. I should have never had it. I cannot find that card. I don't remember. I put the card. You know when you get old like I am, it is difficult to remember things. I try to keep everything in pack. I have tried to call so many times you people. I don't know. That was last month. It was a couple of days after I started getting pimples and it is itching so much like the bleedings. I have been taking Benadryl because itching was so bad. I just can't stand it and I have all sores on my arm, on my legs. He told me to take prednisone, but he only put like 6 pills and I had to take 2 a day. So it is 3 days. Name of medications: Benadryl, Prednisone. When probed as, improved, worsened or persisting, Consumer stated, ''It is the same way like it was when it started but now that I got more sores. I even asked the pharmacist yesterday and she can't tell me anything I could take and she said 'No. She didn't know. When paraphrased the concern, Consumer stated, ''Yes, I had it the 2nd time. This is what happened. Nobody knows what to do". Therapeutic measures were taken as a result of bumps that itch/itching like hell; it is itching terrible; itching all the time, they scab on my arms, bumps that itch/i am all broken up with little bumps all over my legs coded were Benadryl and Prednisone. The outcome of the events pruritus, scab, mass were not recovered, while other events was unknown No follow-up attempts are needed; information about lot/batch number cannot be obtained.

Client reported a headache. When she went to stand she said "she had an unusual feeling in her head. Blood pressure 140/88. Reports normally runs 130 's , stated it was in the 140's this am before coming.

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.

Like a truck hit me a day later BP up to 86/85; Like a truck hit me a day later BP up to 86/85; This is a spontaneous report from a contactable consumer (patient). An 86-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: El 3248), via an unspecified route of administration at the right arm on 13Jan2021 at 14:00 (02:00 PM) at single dose for COVID-19 immunization, administered in a hospital. The patient's medical history included breast cancer, thyroid low, and known allergies to bee sting, shellfish, codeine and sulfur. The patient's concomitant medication included thyroid (as reported) that the patient received in two weeks. The patient had no other vaccine in four weeks. The patient had no COVID prior to the vaccination and has not tested for COVID post vaccination. The patient is not pregnant. The patient experienced "like a truck hit me a day later bp up to 86/85" on 15Jan2021 at 09:15 AM. Treatment received for the events was reported as "Emergency" (pending clarification). The outcome of the events was recovered with sequelae (reported as recovered with lasting effects).

pain is excruciating, it has been terrible, the pain in left arm; she can hardly move her arm, she cannot dress, states she cannot do anything; she can hardly move her arm, she cannot dress, states she cannot do anything; This is a spontaneous report from a contactable consumer reporting for herself. An 86-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via intramuscular on 19Jan2021 at 13:30 (at the age of 86 years old) as a single dose in the left arm for COVID-19 vaccination. Medical history was not reported. Concomitant medication included tramadol 50mg tablet by mouth every 8 hours as needed for pain from 19Jan2021, and she stated it does not do any good. The patient did not receive any other vaccines within four weeks prior to the vaccination. On an unspecified date, the patient experienced excruciating pain in left arm, it has been terrible, the pain in left arm. The pain is between her elbow and shoulder, she can hardly move her arm, she cannot dress, states she cannot do anything. woke her up in the middle night hurting. The patient received treatment of excruciating pain in the left arm. The clinical outcome of excruciating pain in left arm was not recovered, and for she can hardly move her arm, she cannot dress, states she cannot do anything was unknown. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.

Patient became agitated approximately 15 minutes after giving her the first dose of covid-19 vaccination (Pfizer). Before giving her the vaccine she did seem nervous about it. While sitting in the waiting area after the vaccine was administered, the patient said that her angina was acting up. She did take 1 nitroglycerin tablet an got some relief. About 15 minutes later she became agitated again and took another nitroglycerin and again got some relief. She called a family member and explained what was happening. She did not feel that she needed an ambulance. After about an hour she was able to return to her room. I spoke to her on weekend and she felt better.

Extreme vertigo starting about 6:30 am on 1/21/2021, unable to get out of bed until 12:30pm on 1/22/2021 due to dizziness and nausea, hallucinations during this time, some low fever. Continued spells of weakness, dizziness and nausea for two weeks.

48 hours after the injection, patient had difficulty standing, walking, and had severe weakness. She was unable to stand for more than 5 minutes. Unable to put on her shoes, make her food, and needed assistance with dressing. She has improved over the week but still has difficulty with meals and dressing. Is able to walk for a few minutes and uses a walker and a wheelchair for longer trips.

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.

delirious: incapable of sleeping, insomnia and inability to be awake and aware; high, over the top blood pressure; Sweating; on and off chills; she gets warm and cold, hot and cold; concerned about one kidney/ was dehydrated; affecting her kidney; incapable of sleeping, insomnia; she was weak; feeling like she would slip onto the floor; she is still not clear headed; she is woozy, like foggy; she is still not clear headed, she is woozy, like foggy; arm is still sore from second vaccine; This is a spontaneous report from a contactable consumer (patient). An 86-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; lot number EL9262 expiry date 21May2021), via an unspecified route of administration on 12Feb2021 (at the age of 86 years old) at single dose in right arm for COVID-19 immunisation. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; lot number EL8982) on 22Jan2021 at single dose in upper right arm and on 22Jan2021 experienced severe headache and arm hurting. Relevant medical history includes ongoing compromised immune system diagnosed many years ago, and ongoing one kidney functioning. The patient received no concomitant medications. On 13Feb2021 the patient experienced high, over the top blood pressure, delirious incapable of sleeping, insomnia and inability to be awake and aware which both required hospitalization from 13Feb2021 to 14Feb2021. It was also reported they were concerned about one kidney/ was dehydrated in 13Feb2021. On 13Feb2021 unspecified blood labs showed kidney was extremely dehydrated and Chest X-ray was good. Clinical course was reported as follows: she was just released from hospital yesterday, she took the second Pfizer COVID shot, on 12Feb2021, and became so very very ill, she expected some side effects, the first shot wasn't bad, the first all she had was a severe headache and arm hurting, but that was 3 weeks ago, and the second one she can't say how horrible it was: she had to get the paramedics there, she was very very ill. It was the worst night she has had, and she is 86 years old, and has had a multitude of serious issues but that shot was the worst. It was a combination of high blood pressure, over the top, and insomnia like she couldn't budge and open her eyes, she couldn't see anything but squares, it was like a horrible, if there is such a thing as a trip, a horrible trip, something she can't imagine wishing on anyone. The county administered it, she has several doctor, she initially provides her primary care doctor, for consent to contact, but says her nephrologist would be better, as she hasn't seen her primary care doctor in some time. Her primary care doctor doesn't know she had this, another doctor gave her permission, her nephrologist. States they were more concerned in the hospital about her kidney, she has one kidney functioning and, on mistake of the hospital, they didn't connect her to hydration, the night nurse didn't, and she was dehydrated and it was affecting her kidney. Her husband tried to call Saturday, when she had this reaction at like 06:30/07:00, but there was a huge long wait, he was calling to see about side effects, but they were beyond waiting, had to get the paramedics, her blood pressure was 178/113 and heart rate was 103. First shot was 3 weeks back. It looks like she had it on 22Jan2021, the headache and arm hurting started towards the evening, the shot was taken earlier in the day, and they started in the evening, her headache was quite severe, but with Tylenol it went away, the arm is still sore from the second vaccine, but is slightly better. Clarifies she was hospitalized for the blood pressure and delirium, like, it is best explained, like delirious: incapable of sleeping, insomnia and inability to be awake and aware, all she could see was, like if she talked about people who did LSD and trips, it was a bad trip, it was squares, she wanted to open her eyes, but could only see squares. She fell asleep Friday night about 11PM, and felt this at 04:00, and she pulled off her sleep apnea mask, she had to run to the restroom, she was weak, feeling like she would slip onto the floor, and had to get right in bed, and the insomnia continued until about 7AM, that was when she started to be able to focus on like words, she was able to say words in her mind, it was like a bad nightmare. She was admitted to the hospital, she was in the emergency room (ER), the paramedics took her there Saturday, about 07:30, took her to the hospital after immediate heart checking, an intravenous (IV) of some kind, and brought her to the hospital and she was in X-rays and what not, they did procedures in the ER, and they suggested her to be observed overnight, they watched her and things started to become more normal, but she is still not clear headed, she is woozy, like foggy. High, over the top blood pressure outcome: It has been back to a good blood pressure. Insomnia is ok- she slept ok last night. What is left: the night she woke up, so early Sunday morning, in the hospital, she was profusely sweating like someone came to her room and showered her bed with water, her sheets and blankets were soaked and this morning she woke, she got up, was still very woozy, and asked her husband to help get her out of bed, and she changed her nightgown and after an hour she got in the shower, as she was sweating again, not sweating, but occasionally on and off chills, she is taking off her nightshirt and putting on a bed jacket, she gets warm and cold, hot and cold. She had blood labs a chest X-ray, heart monitor the whole time until she was discharged, and everything was good except the kidney was extremely dehydrated. This was all on Saturday as well. On her first visit to get the vaccine, at that time, the facility was a big mall, and they handed her what to look for after the injection, and she didn't notice until this morning, it says if you have an immune system that is compromised, it could affect it, and she has immune system that is compromised diagnosed many years ago. Over the top blood pressure and insomnia had resolved, arm sore was resolving, dehydrated and affecting kidney had not resolved, final outcome of the remaining events was unknown.

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.

Like I'm having a stroke; neck ache; nightmares; nervousness; Felt terrible with bad headache; This is a spontaneous report from a contactable consumer (patient). An 86-years-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number: EN6200) via an unspecified route of administration on 15Feb2021 13:00 at single dose in left arm for COVID-19 immunisation. She received the first dose of BNT162B2 (lot number: EL9262) on 18Jan2021 13:00 in left arm for COVID-19 immunisation. The patient medical history was not reported. The patient was not pregnant at the time of vaccination. The patient was allergic to Formaldehyde, Coumadin. Concomitant medication included levothyroxine sodium (LEVOXYL). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 15Feb2021, the patient felt terrible with bad headache. On 18Feb2021 also felt terrible. On 17Feb2021 08:00, Like she was having a stroke. Headache, neck ache, nightmares, nervousness. Blood pressure was ok. Oxygen was ok. Pulse was ok. No treatment received for the adverse events. Events outcome was not recovered.

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).

The patient developed acute shortness of breath, lethargy, and confusion the morning after the vaccination. EMS was called and she was brought to the emergency department. After evaluation and treatment, she was hospitalized. Hospitalization lasted two days. No other source of the acute symptoms were found besides the recent vaccination.

Resident describes localized pain to the injection site, stress incontinence, and exhibits an increase of confusion that occurred during the night time

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.

appt # 1507818 After my mother returned home approximately one hour after the vaccination, she suddenly did not feel well and lost most of her strength in her legs and could no longer stand. We placed her in a wheelchair and she then said that her throat was closing up. She said that it felt like someone was choking her. A moment later, she felt like her jaws felt huge. We quickly gave her about four or five large glasses of water (one right after the other) and quickly took her blood pressure which went up to 170/80. We then gave her one of her blood pressure pills. After this, she started to finally feel better.

within two days of first injection, patient woke with foggy mind that lasted about two weeks. Significant fatigue started a day after first injection became worse after second injection and that lasted until today.

Patient experiencing nausea anxiety SOB. On-site emergency response performed assessment. Vital signs all within normal limits; patient and husband advised to continue monitoring for life-threatening signs and symptoms; further medical transportation and treatment not advised; patient advised to hydrate and wait additional time. no transportation utilized RN

Felt spaced out/feels spacy; Tired; Achy; This is a spontaneous report from a contactable consumer. An 86-year-old female patient received first dose of bnt162b2 (BNT162B2; Solution for injection) via unspecified route of administration on Left arm on 28Jan2021 13.00 at single dose for covid-19 immunization. Relevant medical history and concomitant medications were not provided. It was reported that caller received the first dose of the Pfizer-BioNtech Covid-19 vaccine on 28Jan2021, this morning she felt spaced out, tired and achy. Caller would like to know if this normal 4 days after receiving the vaccine. From 01Feb2021 patient experienced Ongoing feeling spacy, tired and achy. Caller states she has a quick question, states she had second Pfizer vaccination last Thursday 28Jan2021, states she felt real well until today, states she feels spacy, tired, and achy. Wants to know if this is normal for four days later. States she got the vaccine in her left arm on 28Jan2021 at 1PM. Declined to provide HCP information. Does not have NDC, Lot, or Expiration Date to provide at this time. The caller was provided with a phone number of (phone ), option 3, and business hours prior to warm transfer to (name withheld), INT-#. The outcome of the event was "Not recovered". Information on the Lot/batch number has been requested.

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.

Per pt's caregiver, pt has been experiencing severe sleepiness/drowsiness following administration of covid (pfizer) vaccine. Caregiver reports pt is not coherent and presents with slurred speech.

Diarrhea; Vomiting; Weak; Found Slumped Against the Wall; Low Potassium; MRI Found Multiple Small Emboli in Brain; thrown more clots; Aphasia; Difficulty Walking; potassium dropped and she went into A-Fib and threw clots; potassium dropped and she went into A-Fib and threw clots; has problems with recent memories; confusion; food sensitivities; This is a spontaneous report from a contactable physician (patient's daughter). An 86-year-old female patient received her second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date were not provided) at the age of 86-years-old, via an unspecified route of administration on 24Mar2021 at 14:00 at single dose for COVID-19 immunization. Medical history included high blood pressure diagnosed in 1971 (reported as 50 years ago) and ongoing; type 2 diabetes in 2011 (reported as 10 years ago) which resolved in 2019 (about 2 years ago) after the patient lost some weight; she had an episode of A-Fib in 2019 when her potassium was low (lower than the current hospitalization), once the potassium was corrected, her A-Fib resolved. The physician stated that patient has shrunk and was now about 5 foot 2 inches. Clarified that this has not recently occurred since the vaccine; stated it was happening just with age. The patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date were not provided), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. The patient's concomitant medications were not reported. The patient did not have any issues with the first dose of the vaccine. She received her second vaccine dose on 24Mar2021. The physician spoke with the patient on Friday, 26Mar2021, and the patient was fine. On Saturday, 27Mar2021, the patient had an episode of diarrhea, vomiting and was weak. The lady cleaning the patient's house found her slumped against the wall. The physician met them at the hospital and said the patient seemed okay. They thought it was just an issue from her potassium being low on Mar2021, so they gave her that. The hospital did a CT scan that showed nothing on Mar2021. The hospital did an MRI of the head that showed multiple small emboli in the brain on Mar2021. The physician believed that the patient must have thrown more clots because she became aphasic on Mar2021 and could not name things. The patient also had difficulty walking on Mar2021. The physician felt it was important to call and report this since she has heard of people throwing clots with vaccines. The physician did not know if the events were related to the vaccine. The patient was in the hospital for 7 days (as reported). She was now able to walk with some assistance. The patient's son thought that the patient was okay when he went to see her. Since the reporter was a physician, she knew which questions to ask the patient and saw that she still had some problems. The patient could remember some things but has problems with recent memories on an unspecified date in 2021. She also has some confusion on an unspecified date in 2021, such as she thought she was in a boat hospital. The physician was uncertain if the vomiting and diarrhea was somewhat better. They were wondering if the patient has some food sensitivities (2021). The patient also had carotid studies done in the hospital on Mar2021 and they were fine. They believed that patient's potassium dropped, and she went into A-Fib and threw clots on Mar2021. The clots must have come from the heart valves since the carotid studies were fine and if the clots had been in her legs, they would've gone to her lungs not to her brain. The patient underwent lab tests and procedures which included CT scan: negative, potassium: low, carotid studies: fine, MRI of the head: multiple small emboli in brain, all on Mar2021; and potassium: low, height: 5 foot 2 inches (shrunk), and weight: lost, all on an unspecified date. The events diarrhea, vomiting, weakness and fall required emergency room visit. The outcome of the event difficult walking was recovering and unknown for all other events. The events diarrhea, vomiting, weakness, fall, potassium low, cerebral embolism, thrombosis, and "potassium dropped and she went into A-Fib and threw clots" were assessed as serious due to hospitalization and being life threatening; and the events aphasia and gait disturbance were assessed as serious due to hospitalization. All other events were non-serious. The patient was hospitalized from 27Mar2021 until 02Apr2021. Information about the lot/batch number has been requested.

Fell on day after due to dizziness, compression fracture resulted from fall, shortness of breath, delusional, depression, confusion, weak legs

This 86 year old female received the Covid shot on 2/07/21 and went to the ED on 2/12/21 and was admitted on 2/13/21 with a cerebrovascualar accident, weakness, encephalopathy and UTI and went to the ED a 2nd time on 2/24/21 and admitted on 2/26/21 with and went to the ED again on 3/22/21 with altered mental status and died in 4/2021. Please refer to the other details submitted within this report and contact the person who submitted this report via email for additional follow up details and investigation.

Patient with no reported past medical history or past surgical history presented to ED and found to have massive bilateral pulmonary embolism. Upon presentation, patient was confused and lethargic. The morning of the event, niece reports that patient was in her usual state of health this am and had gone downstairs to the kitchen this afternoon, when she was downstairs she began complaining of nausea and generalized back pain. Her niece went to grab her things to take patient to the hospital but when she returned she found the patient laying on the floor due to weakness and pain, no reported fall or trauma. Chest/Abd/Pelvis CT Angio was significant for large PE in R and L main pulmonary arteries. No family history of DVT/PE.

Same day as when patient received the 2nd vaccine, she was overcome with generalized fatigue and nausea. By the 4th day, her legs would not hold her when she tried to stand getting out of bed. She was nauseous to the point of not being able to eat or drink. Infact, she did not have the strength or desire to eat or drink. By the 5th day post vaccine (02/20/21), I took her to the Emergency room because she was so fatigued, she just slept, and couldn't stay awake to eat or drink. She was able to get to the car with a walker, but that was the last time she walked. After time at hospital and then Skilled nursing, she passed away on 03/21/21. She never regained the ability to toilet herself, eat on her own, failed to eat and drink, and eventually was put on hospice because she lost 30 pounds over the month from failure to eat or drink, even though I was there or the nurse was there to feed her every meal, and try to get her to take fluids. Her fatigue was just overwhelming. When she first arrived at the emergency room, she: ? Presented with 2 days of weakness and AMS; fever, nausea and generalized fatigue ? Word finding difficulty; without stroke or acute abnormal on CT or MRI; according to the Hospital

This 86 year old female received the Covid shot on 3/10/21 and went to the ED and admitted on 3/12/21 with the following diagnoses listed below. J18.9 - Pneumonia, unspecified organism D69.6 - Thrombocytopenia, unspecified Altered Mental Status

Presented to emergency department on 5/15/21 with weakness, lethargy, and increased confusion with onset approximately 4 to 5 days ago. She had a positive COVID exposure prior to presentation. Patient was admitted for further management of COVID-19 infection and acute kidney injury. Patient is admitted at time of writing.

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.

patient is very confused; arm hurting; body pain; fatigue; uncomfortable feeling; fell; sick; fell asleep; unconscious; vomited all over herself; urinary tract infection; 'weakened state'; muscle aches; This is a spontaneous report from a contactable other hcp. A 86-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration, administered in Arm Left on 15Jun2021 (at the age of 86-years-old) as DOSE 1, SINGLE for covid-19 immunisation. Medical history included covid-19 from Jan2021 to Feb2021, callers mother had covid back in Feb2021. The patient's concomitant medications were not reported. Patient had not received any other vaccines within 4 weeks prior to the COVID vaccine. On 16Jun2021 11:00 wednesday, the patient was found unconscious in the living room floor by a neighbor, had vomited all over herself, her arm hurting, muscle aches, body pain, very weak, was diagnosed with a UTI and patient was confused on an unspecified date. She has since been discharged home, is in a weakened state and was advised not to get the 2nd shot. Caller concerned that 2 individuals came over to her mothers house to administer the vaccine. Patient was advised no to receive the second dose Pfizer Covid 19 Vaccine by the doctor. Yesterday (16Jun2021), the caller's mother ended up in the emergency room with an adverse reaction: clarified her mother was discharged from the emergency room. The patient arm was still hurting. When asked if the arm hurting is improved, worsened or persisting, the caller replies it is probably about the same. Stated she was informed on Tuesday evening 15Jun2021 that an individual came to her mother's home and administered the first dose Pfizer Covid 19 Vaccine to the patient. The caller said she spoke to her mother at 11:00 on Wednesday 16Jun2021, had an uncomfortable feeling that someone came to her mother's home and administered her mother the first dose Pfizer Covid 19 Vaccine. At this time on 11:00 on Wednesday, 16Jun2021 was when the caller mother told the caller about her symptoms. The caller clarified the mother's symptoms all began less than 24 hours after the mother received the first dose Pfizer Covid 19 Vaccine. Patient has fatigue, body pain is persisting and being very weak is persisting. The caller has reached out to the doctor and had tried to get home healthcare in to help her mother get her strength back up. The caller said when her mother had come to with the neighbor, her mother said she was in the kitchen and fell and crawled into the living room and that was when the patient got sick all over herself. The caller mother just fell asleep and the caller believed her mother was unconscious at that point. Time the Vaccination was given in mid-afternoon. Patient was on the fence about receiving the Pfizer Covid Vaccine. Patient antibodies were probably just as good as the Pfizer Covid 19 Vaccine. Due to the patients age, she was capable of handling any possible side effects from the Pfizer Covid 19 Vaccine. The patient went ahead and set up to receive the Pfizer Covid Vaccine.The patient underwent lab tests and procedures which included blood test: normal, chest x-ray: normal on 16Jun2021. Events resulted in emergency room visit. The seriousness of unconscious was medically significant. The outcome of all events were unknown. Information on Lot/Batch number has been requested.

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.

Within several minutes after receiving the 2nd Pfizer vacinne injection the patient experienced severe dizziness and was taken by medical personnel to a medical tent for continuing observation and was offered food and liquid. After approximately 45 minutes she was released by the doctors and returned home. Within days of the 2nd injection the patient, at home, exhibited random brief periods of hallucidations. This issue continued periocically for 2-3 weeks. After this 2-3 week period, the caregiver (her husband) abruptly became aware, during numerous conversations, that the patient referred to her husband (Me) and his name, as in fact being 2-4 different persons, all of whom had the same name and appearance and identity. After many attempts, due to the Neurologist dr busy schedule, the patient was finally seen by a neurologist, on 04/30/2021. Neurology Dr ordered a MRI Brain Scan which was conducted at the Hospital on 06/03/2021. The MRI report showed only normal age-related degeneration, but no other brain modifications or deterioration. At the follow-up visit with neurologist, on 07/01/2021, the patient was diagnosed with Capgras Syndrome, an extremely rare variant of dementia. A treatment regimen for this diagnosis is currently being sought; as controlled clinical studies of potential treatments have never been undertaken due to its rarity. Due to the unique and comparative time-frame of the onset of the rare dementia disorder and her 2nd vaccination shot, I believe that the 2nd shot of the Pfizer vaccine could be the root cause of the dementia. We will be additionally contacting Pfizer about this adverse event.

Verbalize to feel anxious and nervous. Was evaluated onsite by Fire Rescue and released home at 9:32 am.

Admitted 1/10 for GI bleed; treated and discharged 1/12/21. Returned to ED 1/17/21 for spell of altered consciousness and tested positive for COVID. Vital signs stable, afebrile. No STEMI. Daughter and patient wishing to go home as she was just in the hospital; not admitted.

about 1 hour after shot, I got very cold and chilled, then that night or following day, I felt like I had a cold and sore throat and congested. Each day it got a tiny bit worse, I was soo sick but lethargic and unwell. It got a tiny bit worse the next day but I am hoarse and my throat feels annoyed and I don't feel like me. Even though all this happened I would go through with it again. The injection site hurt the next day and it went away.

1840 NSG staff notified that resident had fallen and was unable to get up. Upon arrival to resident, resident was lying on her right side outside of her room. Resident was severely diaphoretic and unable to state what had occurred. Resident had a blue tinge to her lips, wheezing bilaterally, equal strength bilaterally and very weak. BP 143/74, HR 66, 02 80%, temperature unable to read temporally due to diaphoresis. respirations equal and labored at 22 breaths per minute. EMS called. RN and CNA staff stayed with resident while waiting for arrival of EMS. During this time, son called resident's phone and he was updated of the situation. Upon EMS arrival at 1700, resident was regaining orientation and was no longer diaphoretic. EMS bs was 143. 02 placed on resident by EMS with 12 lead to be done on transport. EMS left with resident at approximately 1907. SJH ED called and given report to RN. DON notified.

Pfizer-BioNTech COVID-19 Vaccine EUA Severe pain from area of injection to neck - inability to move and difficulty sleeping as a result. Started to improve after 12 hours or so. but still in pain. Now able to move.

Cosign Needed Expand All Collapse All Patient 87 y.o. female who was seen at COVID Vaccine Clinic today for her first dose of the COVID 19 vaccination. She was given the Pfizer vaccination in the right deltoid muscle. During her 15 minute waiting period after the injection, the patient began to experience burning in her throat. She denied difficulty breathing, difficulty swallowing and throat tightness. This provider was notified of patient reaction and she was then assessed in the emergency room. Monitored patient for severe reaction symptoms, including but not limited to rapid progression of symptoms and respiratory distress. ALLERGY REVIEW OF SYSTEMS: Patient complains of sore throat Patient denies chills, facial swelling, chest tightness, shortness of breath, wheezing, dizziness and headaches Previous Reactions: Denies Objective Vitals Vitals: 01/25/21 1341 01/25/21 1350 BP: (!) 164/105 (!) 148/74 Pulse: 76 79 SpO2: 97% 98% Physical Exam Constitutional: Appearance: Normal appearance. HENT: Head: Normocephalic and atraumatic. Cardiovascular: Rate and Rhythm: Normal rate and regular rhythm. Pulmonary: Effort: Pulmonary effort is normal. No respiratory distress. Breath sounds: Normal breath sounds. No wheezing or rales. Skin: General: Skin is warm and dry. Neurological: General: No focal deficit present. Mental Status: She is alert and oriented to person, place, and time. Assessment/Plan Treatment included: antihistamines Follow up response to treatment: good. Patient discharge: Stable to go home and follow up with PCP. Differential Diagnosis: Vaccine-Related Anxiety (include misc mental health) Patients symptoms completely resolved prior to discharge. BP decreased throughout her stay.

30 minute episode of temporary confusion, hallucination followed by headache. Prior to that only fatigue, myalgia.

rash that looks like measles; rash on right side that goes around to back looks like diaper rash; This is a spontaneous report from a contactable pharmacist. An 87-year-old female patient started to receive bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, batch/lot number EK9231), via an unspecified route of administration on 08Jan2021 at single dose for covid-19 immunisation. Medical history was none. There were no concomitant medications. The patient stated she had this injection 08Jan2021, states the following Thursday, 14Jan2021, she broke out with 2 different reactions, a rash that looks like measles all over, the second reaction is part on her back looks like a little kid has not had their diaper changed, like diaper rash, like half a belt from the right side to the back. States she is very concerned, the patient went to a dermatologist who she had a lot of faith in, doctor met her at the door, read about it but has never seen a reaction like this. States that they injected her with something and it worked in two different places. States she did a biopsy on her hip and took movies to show her students, called her and stated she need to report this event. The patient states she wants to know if she should get the second vaccine. States she used to be 5 foot 2 inches, shrunk prior to vaccine. The patient last night to report but she could not get through. Stated she got injection on right arm. The patient stated the rashes are trying to improve. States the rash that looks like measles started on the right side and now is all over. The patient stated she is allergic to bromines and swims in a bromine salt water heated swimming pool and this has nothing to do with it but the point she is saying is that she says your allergic to things and then not have reactions and sometimes you do. Both events were serious with criteria of medially signicant. The patient underwent lab tests and procedures which included biopsy: unknown results, body height: 5 foot 2 inches (States she used to be 5 foot 2 inches, shrunk prior to vaccine). The outcome of the event rash that looks like measles was not recovered, while the outcome of the other event was unknown.; 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.

like she was going to pass out; Weakness; pains in the stomach/stomach was acting up; can't get to feeling herself; getting dizzy/ lightheadedness / felt dizzy/ dizziness; She didn't feel good/sick; She wakes up in the night crying; feel like she was little warm; she felt like she was going to die; pain in her stomach was like she had an ulcer; This is a spontaneous report from a contactable consumer (patient). An 87-year-old female patient received bnt162b2 (UNSPECIFIED TRADE NAME, Solution for injection, lot number: EL3248), via an unspecified route of administration on 18Jan2021 at single dose in left arm for COVID-19 immunization. Medical history included leg problem, it's severe pain in the right leg in the back; very bad nerves. Concomitant medication included oxycodone hydrochloride, paracetamol (PERCOCET [OXYCODONE HYDROCHLORIDE;PARACETAMOL]) for pain in her right leg. The patient had severe pain in her right leg and she was going to pain clinic for that, he was giving 'Propacet' for that. Caller stated that she had the injection on Monday (18Jan2021) at fair grounds, its the Covid Vaccine. She didn't feel good the day she got it on Monday. Then Tuesday she felt good. Wednesday (20Jan2021) she was sick again, and having pains in the stomach, well she can't say stomach, but also towards the afternoon around 2'o clock, she got light headed and dizzy, she felt like she was about to pass out (21Jan2021), and she thought to herself she had to hurry and get something to eat and that feeling last 4-5 hours. She took a pain pill when she got something to eat, and thought to sit down watch a program to take her mind off of it because she felt like she was going to die (Jan2021). After the pain pill and the food it seemed to get better. She wakes up in the night crying (Jan2021), because she was scared if she didn't get better the shot would kill her. Maybe it's her nerves getting the best of her. Her son had the vaccine and had no side effects. She wanted to know if she is the only one having the side effects. While on the phone with this call handler, caller states that she was starting to get dizzy again but she just had breakfast. Her First Dose was on 18Jan2021 Mon, and on the way home she said to her son she was getting dizzy/ lightheadedness. Her son said to her its not from the shot, but she was getting dizzy. On 19Jan2021 Tuesday, she felt good that day. On 20Jan2021 Wednesday, she was Sick again, with weakness, dizziness, she can't get to feeling herself and she had Pain in the stomach. On 21Jan2021 Thursday she felt dizzy, like she was going to pass out. On 22Jan2021 Friday she was feeling dizzy again, and her stomach was acting up and she was weak again. Caller was dizzy and weak. The dizziness was a different each time, sometimes she has got it, sometimes she didn't, its intermittent, she would be doing something and then she needed to grab a hold of something when the dizziness come on. Her Weakness was about the same. She was not feeling the stomach pain right at this minute, when she woke up during the night with it and last felt it 5 or 6AM this morning, she had chores and tasks to do this morning, but her heads going at that time also around 5 or 6 o clock, it was about the same as Wednesday, she just felt like she needed to get something to settle her stomach down, like she needed something for the energy. When attempting to get the product details, caller states that she was getting old, she provided EL3248, she needed light to read it. The card did have an Expiry date but she can't read it, it's 20 something, she just can't read. She was on nothing new. She took a pain pill when she got home but it didn't help, she was still dizzy. The pain pill was Percocet, it was dispensed in a brown pharmacy vial. Medical Conditions: She has a leg problem, it's severe pain in the right leg in the back, she wears a back brace, she needed an MRI Monday. Caller stated the date 12Feb2021, but did not confirm what this date was for. She didn't know how she would get the MRI if she didn't feel better. They were trying to pinpoint the pain in the leg. They tell her that she was in good health for 87 years of age, when they put her in back brace she felt good. On Monday when she got up there she was a little weak and they put her in a wheelchair that day, this past Monday. She had No results to share but she had a X ray a couple weeks ago (Jan2021), and that would lead up to MRI she was going to have. Caller stated that she had very bad nerves, her husband passed away 2 years ago and she hasn't overcome that, she lived by her-self, and was wondering if some of this stress, would lead to the symptoms she was having right now. She wanted to know if these are normal side effects and if it safe to have the second dose. Caller stated that she was slow and old. Consumer further stated, she didn't know if she got the right party or not. She just want to know if she was having a reaction to the COVID-19 injection (COVID-19 Vaccine) that she had on Monday, she didn't have a (distorted voice) that serious, like the whole Monday she was sick, Tuesday she felt fine, yesterday she was so stressed she can't hold her head up today she felt good but about 2 o'clock, she had pain in her stomach and she had it all the time, the pain in her stomach was like she had an ulcer and all of sudden she feel like she was little warm (Jan2021) and had to pass out and then get something to eat and sit down and take something for pain and it last about two hours and then go away and about 4 hours later she got it right back. She just wanted to know if that has anything to do with (incomplete sentence). She was not sure if she should (incomplete sentence), she was scared to have a second injection. Second due date of vaccine was 08Feb2021. The outcome of the events getting dizzy/ lightheadedness / felt dizzy/ dizziness, Weakness, pains in the stomach/stomach was acting up was not recovered, of the other events was unknown.

Roughly 7 hours after receiving vaccine patient complained of difficulty breathing. Per patient's wife/caregiver, patient appeared anxious, skin color appeared abnormal, and pulse was weak and bradycardic (not unusual for patient). Albuterol nebulizer treatment attempted but patient was too anxious to complete. Gave 2 puffs albuterol oral inhaler, and repeated treatment 15 min later followed by a small glass of cola. About 30min later patient calmed, no longer short of breath and pulse strong but face remained flushed. Vitals at 9:20pm included BP 116/47, pulse 67. Following day patient had multiple involuntary diarrheal stools. Symptoms reported to provider 2/8 and noted to be resolved.

After only a couple days post-vaccine, patient was unable to sit up, walk or feed herself. Taken to ER via EMS on 2/7/21. Nothing remarkable discovered. Slight dehydration, scant UTI bacteria. She is now in the Hospice contracted bed at the hospital returning to hospice care at home with 24/7 aides to feed and car for her.

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.

stayed up all night, slept all day; Hallucinations/ just saw people but never heard voices; stayed up all night, slept all day; This is a spontaneous report from a contactable consumer (patient's daughter). An 87-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) Solution for injection (lot number: EN5318, expiration date unknown) via an unspecified route of administration on the right arm on 01Feb2021 at a single dose as vaccine for COVID-19. The patient had no medical history and no concomitant medications. On 01Feb2021 23:00, the patient experienced hallucinations. It was reported that patient started hallucinating on 01Feb2021 23:00 and just saw people but never heard voices. The reporter stated that her mom never had hallucinations ever. The patient feared people were in the house and stayed up all night (from 01Feb2021 23:00), slept all day (on 02Feb2021). The reporter wanted to know if they have ever heard of this happening. She has made an appointment with the patient's doctor. The outcome of the events was unknown.

Tiredness afternoon throughout following day, lower back pain began during late afternoon on right side, by next morning, across full lower back. Afternoon of day after (2/18/22) severe pain in left leg at hip joint at groin area. This pain was so severe had to have assistance walking, sitting and standing up, undressing. The day after vaccine also had chills causing shaking of hands in the mid-afternoon, relieved by adding blankets. Woke on Friday the 19th feeling normal

lightheaded; experience funny feeling in face; HA; Vaccine Related Anxiety; This is spontaneous report from a Non-contactable Other Health Professional. An 87-year-old female patient received first dose of COVID-19 vaccine (UNSPECIFIED TRADE NAME, lot# EM9809), intramuscularly in right arm on 04Feb2021 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. During her 15 minutes waiting period after the injection, the patient experienced funny feeling in face, lightheaded and HA (headache) on an unspecified date with outcome of unknown. The patient denied rash, hives, welts, difficulty breathing, difficulty swallowing, wheezing, throat tightness, hoarseness, stridor, itching, dizziness, facial swelling, lip swelling and tongue swelling. Treatment included: no therapy. Follow up response to treatment: excellent. Patient discharge: Stable to go home and follow up with PCP. Differential Diagnosis: Vaccine Related Anxiety (include misc mental health). Patient left at 15:40pm accompanied by husband. Follow up with PMP regarding blood pressure. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information expected.; Sender's Comments: Based on the very close temporal association, there was a reasonable possibility that the vaccination with BNT162B2 played a contributory role in triggering the onset of the reported events. 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.

delirium; fell in the night/fallen; extreme fatigue; memory loss/memory problem prior to getting the vaccine, however, now it was worse; memory loss/memory problem prior to getting the vaccine, however, now it was worse; This is a spontaneous report from contactable other healthcare professionals. An 87-year-old female patient received second dose of bnt162b2 (Pfizer-BioNTech COVID-19 mRNA vaccine; lot number: EN5318), via an unspecified route of administration in the left arm on 01Feb2021 14:00 at a single dose for covid-19 immunization. Medical history included blood pressure abnormal, glaucoma, thyroid problems, mild cognitive impairment and memory problem. Concomitant medication included amlodipine, atorvastatin and carvedilol for blood pressure, donepezil for mild cognitive impairment, ezetimibe, levothyroxine for thyroid problems and ongoing latanoprost for glaucoma. The patient previously received first dose of bnt162b2 (lot number: EL3246) on 11Jan2021 for covid-19 immunization. On an unspecified date in Feb2021, the patient had fallen, did not hit her head, but she has extreme fatigue, memory loss (she has seen some improvement now) unable to be by herself now and take her medications. The patient had a mild case of memory loss and had delirium. The reporter cannot say these events occurred from the vaccine of course. However, the work up that has been done has been negative and reporter was worried. It was reported that the patient had a little memory problem prior to getting the vaccine, however, now it was worse. It was like the patient cannot be alone now. The patient did not have a stroke. However, this like sent the patient over a cliff. This is a life changing event. If patient gets better it's all good, but if she does not they are in big trouble. Patient was previously able to care for self and now she was not able too. Patient underwent lab test (unknown result) in Feb2021. Patient was taken to Urgent Care, was seen by a physician and basic blood work was done and a urine test was done (unknown result). The outcome of event delirium was recovering; all other events was unknown. Information on Lot/Batch has been requested.

Hallucinations in the last month or so, mostly when waking up after falling asleep during the day. Just occurred after getting the first shot and have happened sporadically over the last month or so.

Patient presents to ER from EMS for SOB and confusion. Of note, patient's husband passed this morning. Troponins elevated. Chest xray shows edema and likely left lower infiltrate. Patient admitted and started on IV antibiotics, Lasix, aspirin, nitroglycerin, and albuterol nebulizers. Patient is currently still admitted.

Pt received initial dose on 1/5/21, diagnosed with COVID-19 on 1/8/21, treated with monoclonal antibodies on 1/13/21. Pt experienced CHF exacerbation, anasarca, and renal failure during acute illness. Pt also treated for pneumonia during this time. Pt was considered terminal status on 1/25/21. She received second COVID-19 vaccine on 2/15/21. Pt then experienced increased difficulty eating and taking medications this same day, in addition to hallucinations she was experiencing. Patient subsequently died on 2/16/21.

A-fib; AKI (acute kidney injury); AMS (altered mental status); Dehydration; Hyperkalemia; Urinary tract infection without hematuria, site unspecified

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

Thigh pain; Hip pain; Vomiting; Shaky/Real shaky; she collapsed because of weakness in her legs/Legs collapsed on her; pain in her legs/Leg pain; weakness/Real weak; fatigue; severe headache; This is a spontaneous report from a contactable consumer received via Medical Information Team. An 87-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in arm left on 05Feb2021 at 10:00 (Batch/Lot number was not reported) (at the age of 86-year-old) 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 VACCINE) on 15Jan2021 for COVID-19 immunisation and experienced urinary tract infection; the patient previously took clindamycin hydrochloride (DYNACIN) and experienced allergy, gabapentin and experienced allergy, doxycycline which made her pass out and lose complete control of muscles and everything and put her in the hospital for 3 days. The patient experienced severe headache on 14Feb2021; the patient collapsed because of weakness in her legs/ legs collapsed on her and experienced pain in her legs/leg pain, weakness/real weak and fatigue, all on 22Feb2021; shaky/real shaky on 24Feb2021, vomiting on 26Feb2021, thigh pain and hip pain on 27Feb2021. Clinical course: on 22Feb2021 she saw her primary care physician for leg pain, weakness, fatigue and the same severe headache that she was seen for on 14Feb2021. On 22Feb2021 she was prescribed cyclobenzaprine and tramadol as pain medication. Before she took any of the cyclobenzaprine or tramadol on the night of 22Feb2021 her legs collapsed on her. On 24Feb2021 they called the doctor and told them that she had collapsed again, and he said to stop the cyclobenzaprine and changed tramadol dose to half strength. She started being shaky. On 26Feb2021 they called the doctor back because she had the same symptoms with the addition of vomiting. They said to stop the tramadol and start taking TYLENOL. On 27Feb2021 they went back to the urgent care for the same symptoms as well as leg pain, thigh pain, hip pain, being really shaky and real weak. The patient underwent lab tests and procedures which included blood test: everything was ok (her bloodwork is fine) on an unspecified date, computerized tomogram (CAT scan): everything checked out just fine on 14Feb2021, Urine test: urinary tract infection on 04Feb2021 and worsened urinary tract infection on 16Feb2021. Therapeutic measures were taken as a result of the events and included treatment with cyclobenzaprine (strength: 5mg) as a muscle relaxer and tramadol (strength: 50 mg) as pain medication both from 22Feb2021, tramadol was stopped on 26Feb2021 and TYLENOL (every 8 hrs. strength: 650 mg, Lot Number: SBA002, Expiry date: Dec2022) was started on the same date. The patient outcome of the event was unknown. Information on the lot/batch number has been requested.

Caller stated that she drank water the next morning because she still did not feel the need to urinate/She had no need to go urinate/ did not feel urge to go to the bathroom; Caller stated that she slept through the night about 7-8 hours, which is rare for her; This is a spontaneous report from a contactable consumer (patient reported herself). A 87-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: EL8982, Expiry Date: Not Provided) via an unspecified route of administration on 04Feb2021 17:30 (0951 ET) at single dose to her left arm for Covid-19 immunization. The patient's medical history and concomitant medications were not reported. Historical vaccine details included: she had her first dose on 14Jan2021, Lot: EL1283, left arm. Caller reported side effects after receiving the first dose of the Covid vaccine and would like to know if there have been any reports like hers. Caller received the first dose on Thursday, 04Feb2021 at Hospital around 5:30 p.m. Caller stated that her significant other (87, male) and herself received the vaccine together, in which she reported on behalf of significant other, that he experienced injection site discomfort during administration of the vaccine. Caller stated that she slept through the night about 7-8 hours, which is rare for her, and did not have any feeling to urinate. Caller stated that she drank water the next morning because she still did not feel the need to urinate, in which she finally did later on. Friday night, caller reported sleeping through the night again with no inclination to go to the restroom. "Nothing happened for many hours." Caller reported that things were more normal, but not 100 percent normal on Sunday. Caller reported "today is the first morning she actually had the need to go and the amount of fluid that came out was normal." Caller reported that this has never happened to her before and nothing else happened the day of vaccination. Caller received an annual blood test yesterday, in which they took 5 vials of blood, and performed a urinalysis. Caller stated that they would not have those results back until Wednesday. Caller stated that she looked up a report and was able to find one case of someone else experiencing a bladder problem after the vaccination. Caller asked why she would react like she did to the vaccine. Caller asked if she could have a worse reaction with the second dose. It was reported that, she had no need to go urinate. She was 87 years old and had the second vaccine on Thursday, the 04Feb2021. She came home and felt fine and had dinner. She went to bed at the appropriate time. She slept through the night and that was unusual because normally she had to get up to go to the bathroom. She had no need to go urinate. She woke up at 8 AM. She drank water because she did not have to urinate. It did not happen for quite some time. The same thing happened on the fifth. She slept without needing to urinate. Saturday morning she had no need to go urinate. Now it was Monday and Sunday was normal. Caller confirmed product as COVID19 Vaccine. It was reported that on 05Feb2021, she did not feel urge to go to the bathroom. Caller stated she wanted to report that she had some strange issues concerning her bladder. Stated she had the vaccine injected on Thursday last week 04Feb2021, stated she felt fine in the evening and through the night, stated she got injection at 5:30 PM, had dinner with her family and was fine, that she was 87 years old and normally she gets up once or twice to go to the bathroom to urinate, stated that first night she slept for almost 8 hours, got up and had no feeling to go to the bathroom and kept drinking water and eventually went and had no pain with urinating, states on Friday night again she slept all night and did not have to get up to go to the bathroom and did not have to go in the morning. Caller stated she kept drinking water. Stated Sunday was the first day she felt normal. Stated even when she started to have normal bladder behavior, she was not releasing normal amount of fluid initially, stated today it was really back to normal. Stated it was just trickles at first, but felt she had a lot of fluid to come out. Caller states she saw her doctor yesterday, not about this but just for her annual visit, stated she had a normal yearly blood test done and also had a urinalysis done but well not have results until Wednesday. Declined contact of HCP. Caller stated her question was had anyone else reported this, stated the read about it everywhere on the sheet and on (withheld) and could only find one other report of bladder issues. States she felt no pain at all or anything with either injection. Got the vaccine at (Withheld) in (Withheld). States she did not feel the needles even going in, no pain, felt fine. Stated her husband complained that his arm was hurting, states not anymore. Stated his injection was done by a different nurse. Stated the same thing happened on the first shot, and he had a different RN then as well. Stated they had to stay 15 minutes to make sure they felt okay, were not allowed to leave until 15 minutes were over. Outcome of the event sleep disorder was unknown whereas other event was recovered on 07Feb2021. No PQC present.

I was fine friday, my arm never hurt...awoke at 3AM and could not sleep so read and fell asleep and awoke at 9:00AM...got up and proceeded to do daily chores....and sudenly i did not feel very good, had a head ache, chills, body aches, trouble catching my breath, stomach discomfort, (not an feeling like i was going to be sick to my stomach, but just did not feel like eating anything), was dizzy, and very tired....the worst was the disorintation....was afraid i was going to pass out....laid down and fell asleep...when i awoke an hour later i felt worse....fell back asleep for another couple of hours....drank a lot of water, ate some cheese and crackers late in the day....slept thru the night and woke up on Sunday morning feeling fine....again arm never was sore....I have described all the symptoms i had on Saturday April 3rd.....i do not know what else you want

Extreme lethargy; Exacerbated symptoms of peripheral neuropathy; Difficulty sleeping; This is a spontaneous report from a non-contactable consumer (patient) via a Pfizer representative. An 87-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number and Expiration Date were not reported), via an unspecified route of administration, on 28Mar2021, at a single dose, for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient previously took the first dose of BNT162B2 for COVID-19 immunization. On Sunday (28Mar2021), the patient had exacerbated symptoms of peripheral neuropathy throughout the evening with difficulty sleeping. Day 1 post-vaccination (Monday, 29Mar2021), the patient experienced extreme lethargy. The outcome of the events was unknown. Information about lot number and expiration date for the suspect product will be requested in follow-up attempts.

Patient received her 1st dose of Pfizer COVID vaccine on 3/29/21. On ~ 4/11/21, the patient developed weakness, fatigue, and confusion. She was brought to the ER by her daughter on 4/13/21 and was found to be febrile and hypoxic. CXR consistent with COVID pneumonia and COVID test came back positive as well. Patient was then admitted to the hospital for COVID treatment and was started on dexamethasone and remdesivir.

My mother received doses of the Pfizer vaccine. She received the first shot on Friday March 5, 2021 at 12:15 PM and the second vaccine on Friday March 26, 2021 at 11:45 AM. Both vaccines were administered at the pharmacy. Early Tuesday Morning she was incoherent and suffered a stroke. She was taken to the hospital and spent the entire week at the hospital. Her primary doctor, was out of town and Dr was the covering doctor. While in the hospital she was under the care of another Dr

PT STATES HE HAS SOME TIGHTNESS IN HER THROAT. SHE DENIES CHEST PAIN OR THE PAIN WORSENING. SHE ARRIVES AT THE MED OBS 1 VIA WHEELCHAIR AT 1502. SHE DID NOT WANT TO GET OUT OF THE WHEELCHAIR AND SHE DID NOT WANT VITALS TAKEN. HER FRIEND WITH HER STATED SHE IS VERY ANXIOUS AND NEEDS HER NERVE PILL. AT 3:08 HER PULSE WAS 65 OXYFEN SATS 99% ROOM AIR. SHE DENIES WANT FOR WATER OR SNACKS. 1521 PATIENT WAS TAKEN TO THE EXIT VIA WHEELCHAIR, HER FRIEND, AND STAFF

Client received 2nd COVID vaccine of Pfizer (Lot# EW0185 expiration date 06/24/2021). Caregiver of Client asked EMT and EMT to check her blood pressure and her injection site. At 1754, RN responded to this event. At 1754, vital signs are blood pressure 163/84, heart rate 70, oxygen saturation 99%. Client reports she was anxious. RN answered all concerning questions in regards to COVID vaccine. Client reported to have a thyroid disorder, hypertension, high cholesterol. Client reports in taking Levothyroxine, Aspirin, Cilostazol, Amlodipine, Hydrochlorothiazide, Atorvastatin, Lantoprost. RN educated Client about ED precautions and common adverse effects of the COVID vaccine. At 1800, vital signs are blood pressure 162/80, heart rate 72, oxygen saturation 98%. Client reports no chest pain, no shortness of breath, no dizziness, no blurred vision, no headache, no nausea. At 1810, vital signs are blood pressure 160/79, heart rate 72, oxygen saturation 98%. Client reports no new symptoms and that all concerns have been addressed. Client is talking to staff and caregiver. At 1830, Client stood up with no complaints. Client walked out of facility with a steady gait using her cane accompanied by caregiver.

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.

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.

she started really itching; red spots one on each finger and each arm; nausea; she can't really sleep; This is a spontaneous report from a contactable consumer (patient). via information team. An 87-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number and Expiry Date: Unknown), via an unspecified route of administration in the right arm on 28Jan2021 about 15:00 ( at the age of 87-years) as dose 1, single for COVID-19 immunisation. The patient medical history included allergy to penicillin. Patient had no concomitant medications. There was no history of any previous immunization with the Pfizer vaccine considered as suspect nor any prior vaccinations within 4 weeks or additional vaccines administered on same date of the pfizer suspect vaccines. After vaccination, the patient was doing fine until around 13Feb2021 when she started really itching, red spots one on each finger and each arm, nausea, and can't really sleep. The events did not require any emergency room or physician office visit or hospitalization. No relevant tests were done. She was due to receive her second dose of vaccine on 19Feb2021. She asked if this was normal side effect and whether she should receive her 2nd dose of the Pfizer Covid vaccine if she suspects a non-immediate allergic reaction about a week later. Outcome of the events was not recovered. Information on the lot/batch number has been requested. Follow-up attempts completed. No further information expected.

Patient reported one day post immunization to be experiencing extreme fatigue- unable to get out of bed for usual daily routine

1. Lower abdomen pain 2. Confused Attending physician requested resident be sent to ER for further evaluation

Extreme nausea, hot flashes, dizziness, strange head, fatigue, nasal congestion, sore throat, runny nose, sneezing, sore arm,

Vomiting; Diarrhea; Patient has become aggressive, combative; Short tempered; Up and down most of the night; delusional; confused; This is a spontaneous report from a contactable consumer. A 88-year-old female patient received the first does of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 10Jan2021 13:30 at a SINGLE DOSE for COVID-19 immunization. Medical history included dementia from an unknown date and unknown if ongoing and COVID-19 prior vaccination. Concomitant medication included gabapentin (GABAPENTIN), hydrocodone (HYDROCODONE), haloperidol (HALDOL), levothyroxine (LEVOTHYROXINE), insulin aspart (NOVOLOG) , lisinopril (LISINOPRIL), lorazepam (LORAZEPAM), sennoside a+b (SENNA [SENNOSIDE A+B]), trazodone (TRAZODONE). The night after the vaccine was administered (10Jan2021), the patient experienced a bad case of vomiting and diarrhea. The patient has become aggressive, combative and short tempered. She was up and down most of the night, delusional and confused. Therapeutic measures (Lorazepam) were taken as a result of the events. The outcome of the events was not recovered. Information on the lot/batch number has been requested.

Dizziness; Pain in the lower extremities; pain in feet; legs hurt; Felt poorly; Blood pressure which was up a little but not terribly; Left arm where she got the injection was sore (localized pain); This is a spontaneous report from a contactable consumer (patient's sister). An 88-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EL3249), via an unspecified route of administration in left arm, on 13Jan2021 07:45, at a single dose, for COVID-19 immunization. The patient's medical history included atrial fibrillation, hypertension, bypass in 2010, hearing is very bad on the phone, arthritis pain, headache, and blood thinner. The patient's concomitant medications included metoprolol for hypertension, quinapril for hypertension, acetylsalicylic acid (BABY ASPIRIN) for hypertension, ascorbic acid/ calcium/ minerals NOS/ retinol/ tocopheryl acetate/ vitamin B NOS/ vitamins NOS/ zinc (CENTRUM SILVER), calcium carbonate (CALTRATE), atorvastatin, warfarin as blood thinner, spironolactone, and paracetamol (TYLENOL) for arthritis pain and headache; all were ongoing. The patient received the first dose of the BNT162B2 vaccine on 13Jan2021 and had reactions to the vaccine or something else. That day, the patient's left arm where she got the injection was sore (localized pain), but that was expected, and it went away within 2 days (initially didn't report it because it was expected). Yesterday (18Jan2021), the patient experienced dizziness and pain in the lower extremities. Last night (18Jan2021; about 6 days after the injection), the patient woke up, felt poorly, and was very dizzy (feeling of dizziness), then, later on, had pain in both lower extremities. The patient took her blood pressure which was up a little but not terribly with result of 159. The patient's heart rate, temperature, and pulse oximetry were okay on 18Jan2021. She then walked to the bathroom, came back, and went back into bed. The second time she said her legs hurt but this morning she is feeling better than she was. Today (19Jan2021), the pain in feet is better, and the dizziness is gone. Pulse oximetry and temperature were okay this morning (19Jan2021). The patient was wondering if these effects could be related to the vaccine, since the dose was received 6 days ago. The patient was not sure if could possibly be related to the COVID-19 vaccine or if it was that she spent a lot of time doing paperwork on the computer yesterday (18Jan2021) and perhaps that caused some of the symptoms. The patient's sister called to ask if Pfizer has heard of any late adverse effects from the COVID-19 vaccine like this patient's, 6 days later. The patient was scheduled to get the second dose on 04Feb2021 (day 22) and her sister asked what if it's not available. The patient's sister was concerned about interval and potentially being unable to gain access to the second dose due to supply issues. The patient recovered from "Left arm where she got the injection was sore (localized pain)" on 15Jan2021; and from "Dizziness" on 19Jan2021. The patient was recovering from the other events.

1/27/2021 developed increased fatigue, required increased assistance with ADLs. Continued with functional decline and overall decline in mentation. Has impacted functional level (requiring increased assistance with feeding, bathing, dressing, toileting) and speech/swallow ability. Decreased ability to respond/converse with staff

Very dizzy when I got up at night. In morning somewhat nauseous, could not get out of bed. chills and light headed. general feeling terrible. felt somewhat better by around 4PM. but still a little headed the next morning. Took Aleve and 2 Magnesium pills

I had a violent reaction; lesion on my brain and found everything once I was in hospital; I am upset; Dizziness; Vomiting; the "rungs" (not clarified) and the stomach after giving me something it stopped. I went from both ends when I had to throw up I just went out from both ends, (it was) bad; This is a spontaneous report from a contactable consumer (patient). An 88-year-old female patient received first dose of bnt162b2 (BIONTECH COVID-19 VACCINE, lot number: EL9262), via an unspecified route of administration on 23Jan2021 at single dose for covid-19 immunization. Medical history included diabetes, blood pressure high, thyroid. Concomitant medication included amlodipine, valsartan (DIOVAN), metformin, levothyroxine sodium (LEVOXYL) for thyroid, atorvastatin (LIPITOR). The patient had the shot on Saturday and Sunday, she had a violent reaction and she just want to report it. It was first shot she had the first on Saturday and it happened (incomplete sentence). Her follow up was that she found other problems. She found lesion on her brain, she found everything else once she was in the hospital. So actually this reaction was (incomplete sentence). She known never she was little upset today. She was not right why not follow up latter she was little upset today, so she just want to let you know she had a problem. When probed for the vaccination date, consumer stated, the date was 23Jan2021. When probed for start date of the events, consumer stated, it was 24Jan. When probed for the side effects, consumer stated, she had extreme dizziness, she had extreme vomiting and "run" (not clarified) and that was about it Dizziness she went to 12 o'clock noon she started with the dizziness and it was over in about 5 in the afternoon and the "rungs" (not clarified) and the stomach after giving her something it stopped. She went from both ends when she had to throw up she just went out from both ends, (it was) bad. They did not give her anything for that. They did all sorts of test and found out that she had other problems. When probed for any Laboratory test, consumer stated, "Yes, she did it and she was fine." When probed for laboratory results, consumer stated, "No, she did not have the results. Her doctor just gave them to her over the phone and said that she was good. Her A1C was 5.9." The event lesion on her brain was reported as serious per hospitalization. The patient underwent lab tests and procedures which included glycosylated haemoglobin: 5.9 on an unspecified date. The outcome of events was unknown.

Systemic: Chills-Severe, Systemic: Fainting-Severe, Systemic: Other- High heart rate, 121 BPM, high anxiety, body shaking chills, passed out for about 30 seconds, was able to speak and breath normally

COULD NOT STAND OR WALK, KEPT HER EYES CLOSED, LEANING TO ONE SIDE, SHAKING, COULD NOT FEED HERSELF, COULD NOT UNDERSTAND COMMANDS OR CUES, COULD STAND TO CHANGE BRIEF OR PULL HER PANTS DOWN, COULD NOT DRINK...LIKE SHE FORGOT HOW, WOULD NOT STAND TALL WITH SOMEONE HELPING, DID NOT KNOW HOW TO PICKUP FORK. VERY AMBULATORY, FED YOURSELF, DRESSED HERSELF UNDERSTOOD COMMANDS BEFORE THIS HAPPENED

Patient started having fever 2 days after second dose of Pfizer mrna vaccine. First dose occurred January 19, 2021 and was uncomplicated. Fevers continued and she started to have delirium and increased neurologic symptoms that mimicked stroke 6 days after vaccination. She was admitted 6 days after vaccination with fever 102, delirium.

PATIENT BECAME SHORT OF BREATH AFTER VACCINATION. EMS PRESENT AND TOOK CARE OF PT. O2 SAT 91%, O2 ADMINISTERED, O2 SAT 97% ON 2L/MIN. PATIENT'S DAUGHTER STATED HER MOTHER WAS "VERY ANXIOUS ABOUT GETTING SHOT". PATIENT TRANSPORTED TO HOSPITAL.

PATIENT ON 2ND DAY AFTER VACCINATION COULD NOT STAND OR WALK, COULD NOT UNDERSTAND COMMANDS OR CUES, COULD NOT FEED HERSELF, PRIOR TO VACCINATION AMBULATORY AND FEEDING HERSELF.

During monitoring after vaccine, pt stated she was experiencing racing heart and feeling faint. BP was taken and found to be 174/97 with pulse of approximately 104. Pt was escorted to emergency room for eval and treatment.

Pfizer-BioNTech COVID- 19 Vaccine EUA Patient received COVID-19 Vaccine dose #2 on February 24, 2021. On February 25th at 10:36 AM,Patient's son called physician to report some side effects to second dose of Covid vaccine. She had diarrhea when she came home yesterday. Son has been up all night with her as patient has had a "hacking cough,feels terrible, and now has had diarrhea x2". Patient has taken Advil and will be taking tylenol periodically through out the day for her side effects. Patients son notified physician at 09:55 AM on February 26 that the patient has expired.

Pt c/o "feeling different". Paramedic assessed pt- HR- 49; B/P- 190/91; R-12; SpO2- 99%. Pt states she was nauseated. Per caregiver, pt tends to be hypotensive. Rechecked B/P- 180/80; P-42. Continued to talk with pt and caregiver. Pt requested PHN call her PMD. Attempted to call PMD- he was not in the office and staff didn't know what time he would be back. Decision made to send pt to ER for evaluation as B/P continued to be elevated and HR was low. Final vitals as leaving- B/P 191/91; HR-40. Pt given Zofran in ambulance for nausea.

1/29 /21 Increased fatigued, congestion, BP elevated Stat CBC/BMP/CXR. CXR. CXR-CHF with superimposed bilateral infiltrates and bilateral pleural effusions. N.O. Rocephin 1gm IM QD x 7 days. CBC am. Consult with cardiology. 2nd covid vaccine not given. 2/2-2/5 Sent to ER for ongoing significantly elevated BP's. Remains on Rocephin. Hospitalized 3 days for Acute on Chronic Diastolic and Systolic Heart Failure-Diuresed with IV Lasix, Multiple changes in medications by cardiology for poorly controlled HTN. Head CT negative, Covid negative. 2/5 Readmission from Facility-Followed closely by cardiology. Losartan was increased, Hydralazine was increased, Norvasc was increased. Continue Atenolol. Monitoring daily weights and vital signs. Resident with increased lethargy and then behaviors at times, and refusing meds. Oral intake poor. Continued on Coumadin for A-Fib with monitoring of INR. Palliative consult ordered. Continued to be followed by Mental Health and APRN in addition to PCP. 2/6 CBC/BMP/CXR-BUN/Creatinine elevated 44/2.2 and upon readmission to facility. MD changed from Lasix to Demadex. CXR-Continued PNA. Started on Rocephin 1gm IM x 7 days. 2/8 MD visit. Palliative consult ordered 2/11 Critical labs with elevated BUN/Creatine and Na level. MD ofered hospitalization to ADPOA who declined and wanted to pursue Hospice instead. Resident was seen by APRN from Home Health and Hospice Services who discussed plan of care with ADPOA requested comfort care and no further hospitalizations. 2/12 Resident admitted to Hospice Services. Compassionate visit with ADPOA 2/14 resident with further decline, periods of apnea evident, comfort maintained. 2/18 Passed at facility with Hospice services in place and compassionate visits with ADPOA

broken femur; early morning fall (maybe related); lethargy; memory issues (beyond normal for her); low grade fever; This is a spontaneous report from a contactable consumer. An 88-years-old (non-pregnant) female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number and expiration date unknown), via an unspecified route of administration on an unspecified date at a single dose for COVID-19 immunization. Medical history included chronic obstructive pulmonary disease (COPD). Concomitant medications included atorvastatin (ATORVASTATIN), gabapentin (GABAPENTIN), lorazepam (LORAZEPAM), losartan (LOSARTAN), metoprolol succinate (METOPROLOL SUCCINATE), pantoprazole (PANTOPRAZOLE), paroxetine (PAROXETINE), and zolpidem (ZOLPIDEM). The patient had no other vaccines in four weeks. The patient had no COVID prior vaccination. On 20Feb2021 at 12:00, the patient had a low-grade fever for 2 days, followed by lethargy and memory issues (beyond normal for her) on the 3rd day (23Feb2021). Finally, on the 4th day (24Feb2021), by early morning, the patient had a fall (maybe related) and a broken femur. The events resulted in emergency room/department or urgent care, hospitalization as the patient was hospitalized for two days due to the events. Treatment for the events was unknown. The patient underwent lab tests and procedures which included Blood test/viral RNA: Negative on 26Feb2021. The events had not resolved. Information on the batch/lot number has been requested.

She got the vaccine, and had no problems until Wednesday 3/17/21 at 3:00 AM she started coughing and could not coughing. She finally got up and went into the bathroom and by 3:30 had coughed up little round, clear jellyfish. Then she stopped coughing and went back to bed for 15 minutes, and then at 3:45 started getting diarrhea which she had until 10:30 AM. She called Pfizer and reported her reaction and talked to them. During that time she had a lot of diarrhea and her body was starting to ache, joints and muscles. She did not take her temperature and went back to bed, and slept until she could get up and go to the bathroom. She then took her temperature and it was 100.7, which her normal is 97. 3. She slept from 11:00 PM Wednesday until 11:00 AM Thursday. She could not stay awake for long before falling back to sleep. Yesterday she did sleep most all of the day, and did not eat anything since Tuesday evening and did have a piece of toast yesterday. Today, 3/19/21 she is able to get up, dressed and gotten downstairs to get something to eat and has lost 6# in this time period. She is feeling wimpy, and her temp is down to 97.3, her pulse ox is 98%, pulse in the 70s. She's achy, and has rubbed on Aspercreme and has taken Tylenol a couple of times. She is still very weak, probably dehydrated and going to get something to eat as she has just gotten up. She is foggy thinking, but feels that once she rests, eats and gets strength she will be fine.

patient describes feeling dizzy assessed by RN and paramedics, blood pressure 142/100, 105, 99% RA, patient given water and discussed her anxiety. Vitals reassessed 132/90, Patient refused hospital.

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.

hospitalized for acute pancreatitis; acute renal failure; fatigue; very poor appetite; abdominal pain; started having confusion; This is a spontaneous report from a contactable physician. A 88-years-old female patient (not pregnant) received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: EN6207), second dose via an unspecified route of administration on 24Mar2021,single dose for covid-19 immunisation. Medical history included chronic kidney disease from an unknown date and unknown if ongoing , atrial fibrillation from an unknown date and unknown if ongoing , pulmonary hypertension, allergies to medications, food, or other products: clindamycin, levofloxacin, sulfa drugs, penicillin from an unknown date and unknown if ongoing. Patient started having fatigue immediately after 2nd dose vaccination. 3 days later (27Mar2021), patient had very poor appetite, abdominal pain and started having confusion. 6 days later (30Mar2021), patient was hospitalized for acute pancreatitis and acute renal failure. Events resulted in going to the emergency room/department or urgent care. Treatment received for the adverse event was IV rehydration, levophed, vasopressin, dobutamine, cefepime and flagyl. The outcome of the events was unknown. No COVID prior vaccination. Patient had COVID test post vaccination (nasal swab) on 31Mar2021 with result of negative. No follow-up attempts are possible.; Sender's Comments: By close temporal relationship, the company cannot completely exclude a contributory role of BNT162b2 in the development of the reported diagnosis of acute pancreatitis and acute renal failure. Medical history including chronic kidney disease in the setting of elderly age, cannot be also excluded as confounding factors. The impacts 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.

GI Bleed Anticoagulant adverse reaction, initial encounter ALTERED MENTAL STATUS EXTREMITY WEAKNESS Angiodysplasia of colon with hemorrhage

Got a sensation in her nose, throat and upper chest like it was warm, and there was dryness; Got a sensation in her nose, throat and upper chest like it was warm, and there was dryness; Got a sensation in her nose, throat and upper chest like it was warm, and there was dryness; Lips felt funny; The arm that was a little sore; This is a spontaneous report from a contactable consumer (reporting herself). A 88-Years-old white female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EL9266, expiration date: 31 May 2021), via intramuscularly in left arm on 14Feb2021 at a dose of 0.3ml as a single dose for COVID-19 immunisation. The patient's history included allergies to Penicillin, Cortisone, and she thinks also to Lidocaine, maybe. The patient did not have any NDC numbers, Lot numbers or expiry to provide for any of these products, as it was years ago. The patient did not receive any other medications. On 14Feb2021 about an hour after she got her vaccine; the patient had waited 40 minutes after getting the vaccine shot, and nothing happened, so she left, and while she was on her way home, she got a sensation in her nose, throat and upper chest like it was warm, and there was dryness. The patient previously used to get allergy shots because she was allergic to horse flies, and within 24 hours of being bitten, she would have hives the size of dinner plates. The patient went through allergy shots for 10 years and then she moved away and was no longer near water, so she did not think she needed the shots anymore. The patient had been getting the shots for 10 years, she would start to get where her lips felt funny and stuff after getting the shot, and her reaction to the COVID vaccine, felt similar to that, but it had dissipated within a half hour. This was probably respiratory and was not major, her nose did not close up, but it did get dry. The event resolved within an hour. The patient inquired with three physicians about if she should get the COVID vaccine, because she had an anaphylactic experience 40 years ago, before she was going to the allergist, and she had to go to the ER (emergency room), and they gave her whatever they did, Epinephrine or whatever it was, but that experience felt like she was being blown up like a straw was in her body. The patient inquired with these different physicians about told them about her experience from years ago, and what their suggestion would be, and they told the patient to go for it with getting the COVID vaccine, because it anything were to happen, it would be within 15 minutes of getting the shot, but the patient's was more than 15 minutes after getting it. The patient got the hives to the horse flies, it was usually within 24 hours. The patient did take an EPIPen with her when she went to get the COVID vaccine, because she was concerned she would have a reaction, but did not end up needing to use it. The outcome of the events was recovered.

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.

Daughter in law states that within a few days after receiving the vaccine the patient's dementia symptoms became worse. States pt started to have worsening effects of forgetfulness, became more aggressive and becoming combative.

ED to Hosp-Admission: Discharged 4/9/2021 - 4/12/2021 (3 days) Admission Date: 4/9/2021 - Discharge Date: 4/12/2021- Presenting Problem/History of Present Illness/Reason for Admission- Intracranial mass [R90.0], Hyperglycemia [R73.9], Acute encephalopathy [G93.40], COVID-19 [U07.1]. COVID-19 infection: Despite patient's immunization history, patient did test positive for COVID-19 on presentation. She required supplementation with 2 L of oxygen to maintain oxygen saturations. Dexamethasone 6 mg daily and remdesivir were initiated and continued for four days. Patient did have mild sinus bradycardia (with heart rates in the 50s) towards the end of the hospitalization but remained asymptomatic. Oxygen was weaned to room air and patient remained stable for

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.

Patient got her vaccine then the next day developed weakness and knee pain. Later the daughter admitted that she had had increased weaknesss and confusion for a few weeks. She was seen in her PCP's office and diagnosed with a UTI and gout. The x-ray of her knee later showed a fracture of her proximal tibia. A few days later she was brought to the emergency department with a wide complex tachycardia and acute coronary syndrome. She had an 11 day stay complicated with congestive heart failure, hypoxia, aspiration pneumonia and metabolic encpehalopathy. Her daughter thinks that this was brought on by the vaccine, and asked us to fill out a vaers.

cough and had clear and sticky stuff that looked like jelly fish coming out; diarrhea; fever 100F; Tired; Chills/ has the shivers; feels really "limpy", "blah"; This is a spontaneous report from a contactable consumer (patient). An 88-year-old female consumer intramuscular BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) first dose on 15Mar2021 at 11:00 at single dose in left arm for COVID-19 immunisation at the age of 88-year-old. Lot number EN6207, expiration date was 31Jul2021. Medical history included blood pressure high, arthritis. Historical vaccine included first dose of bnt162b2 on 22Feb2021 for covid-19 immunisation at the age of 88-year-old (1st dose, Lot: EM9809, Expiry date: 30Jun2021, Route: Intramuscular, Anatomical Location: Right arm). On 17Mar2021 at 03:45, the patient experienced cough and had clear and sticky stuff that looked like jelly fish coming out, diarrhea, fever 100F, Tired, Chills/ has the shivers, feels really limpy, blah (as reported). On 16Mar2021, body temperature was 100 and 99 Fahrenheit, Oxygen saturation 95-98%. The outcome of the events was unknown. No follow-up attempts are possible. No further information is expected.

Fever chills; Weakness; Muscle soreness; Tiredness; Joint pain; Cough; Hurts to Breathe; Hives at Injection Site/hives all over; Skin and Eyes Burning and Itching/her whole body is hot and itching; Couldn't Sleep; sweating and felt hot; Skin and Eyes Burning and Itching; sweating and felt hot; Sinuses and Nose Plugged Up; Diarrhea and Upset Stomach; Stomach Hurting; Diarrhea and Upset Stomach; Stomach Hurting; No Appetite; Sinuses and Nose Plugged Up; Diarrhea and Upset Stomach; Stomach Hurting; sickness; This is a spontaneous report from a contactable consumer or other non hcp (patient). An 88-years-old female patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration, administered in Arm Left on 05Mar2021 13:30 (Batch/Lot Number: EN6202) as dose 2, single for covid-19 immunisation (reason: giving them and because she had bone marrow disease and doctor thought she should get it) at doctor office. Medical history included 2 aortic valve replacements (last one was replaced 3 years ago in May and the first one was replaced 5 years ago), ongoing autoimmune disease and ongoing acid reflux, bone marrow disease and Covid. Concomitant medication(s) included prednisone (5mg once a day by mouth; she had been taking it for a number of years for a condition auto immune disease and she has to take it for the rest of her life) taken for autoimmune disorder, and pantoprazole (40mg once a day by mouth; started probably 5years ago) taken for acid reflux, start and stop date were not reported. The patient previously took BNT162B2 (Lot: EM9809) as dose 1, single on 12Feb2021 for covid-19 immunisation; flu vaccine for asthma (when she got a flu shot years ago, she had to go to ER for an asthma attack from that; it was way back in the 1990s; NDC, Lot, Expiration: Unknown). No investigation assessment was done. No vaccines administered on same date of the Pfizer suspect. No Prior Vaccinations (within 4 weeks). Family medical history relevant to adverse event was none. The patient experienced sickness on 05Mar2021; fever chills on an unspecified date, sinuses and nose plugged up; diarrhea and upset stomach; stomach hurting; no appetite on 08Mar2021; sweating and felt hot; and skin and eyes burning and itching/her whole body is hot and itching; and couldn't sleep on 12Mar2021; hives at injection site/hives all over on 14Mar2021, hurts to breathe on 15Mar2021; cough on 17Mar2021; tiredness; joint pain on 21Mar2021; muscle soreness on 22Mar2021, weakness on 23Mar2021. Therapeutic measures were taken as a result of this with BENADRYL, Z PACK, MYLANTA AND TYLENOL. Clinical course was as follow: The patient stated that she wondered if should've even had the vaccine. The patient had Covid in Mar2020 (a year ago in March) and she had long haulers until Jan2021. In March, her hematologist called and said she could get vaccine and stated that she shouldn't have. She stated that the second one made her really sick. This sickness was getting too long. Her second dose of the vaccine was on 05Mar2021. She was so tired; stated she doesn't feel good. She stated that she felt like she has long haulers all over again, it was horrible. Stated she felt like she shouldn't have gotten the second one. States she was doing okay with first one. Caller states that she already gave up a whole year of her life because of this. She tried to call before, but she didn't wait to talk to someone, she had to go somewhere. The patient stated that she had hives, tiredness, problems with her intestines, got really sick, her skin and eyes started to burn, she felt like she had hives all over, her skin was burning, she was sweating and felt hot, stated on the 14th it really got bad, her whole body was hot and itching. States that she took a BENADRYL and felt better the next 2 days and then started getting sinuses and nose plugged up and it hurt when she was breathing, had a slight fever, and her skin was itchy. She states that she went to doctor on 15Mar2021 (physician office visit), and he didn't think too much of it because her oxygen was okay. States that she felt worse, she was coughing bad, felt terrible, her muscles ache, and when she was hot, she couldn't sleep, now all she wanted to do was sleep and she had fever and chills. She was supposed to do exercises, but she couldn't, and it started two days ago. States she was not coughing as much but it was still hard and hurting. It was some of her joints, not all of her joints were hurting like when she had long haulers. Fever and chills started when her sinuses started acting up. The fever and chills kept getting occasional slips in and out. Her fever was not high but enough to get the chills. Sinuses and nose plugged up: it came and went with MUCINEX and it helped a little. Her intestinal problems were diarrhea that started on 08Mar2021 and upset stomach. She had a problem and it hurt terrible for days after. No appetite lasted for one week, so probably ended 15Mar2021. Caller states that she felt a little better but can't get rid of her cough. Couldn't Sleep: started when she had the burning and lasted a little after because she had to get herself together again. She could only sleep three hours at time. Skin and Eyes Burning and Itching: The burning and itching went away for a while, but it was back again because she had been lying in bed and tired, stated that it was not so bad. The burning stopped 15Mar2021 when the hives were gone, but she stated that right now it was back, her skin gets hot and then starts burning and itching. Patient stated that she did not have too much problems with first but this second, oh my god. She thought she got it too soon after having long haulers. She got rid of that in Jan2021 and was feeling good but now she felt terrible again. States there were no tests, she didn't have any. She was so weak, and she was having a hard time now, and she was doing so good. She was worried about her heart and valves. She guessed that call handler couldn't help her either, she stated that she didn't know what to do to feel better. She thought she had better call and report it. She has already gone to doctor and had only gone to him for 2 years, but hopefully he knew enough about her. She states that she probably should call him because she wasn't getting any better. The outcome for hives at injection site/hives all over was recovered on 15Mar2021, skin and eyes burning and itching/her whole body is hot and itching was not recovered, muscle soreness was not recovered, weakness was not recovered, cough was not recovered, tiredness was not recovered, joint pain was not recovered, fever chills was not recovered, sinuses and nose plugged up was unknown, diarrhea and upset stomach; stomach hurting was recovered on 11Mar2021, hurts to breathe was recovering , couldn't sleep was unknown, no appetite was recovered on 15Mar2021, sickness was unknown, sweating and felt hot was not recovered , sinuses and nose plugged up was unknown, skin and eyes burning and itching was not recovered, sweating and felt hot was not recovered. No follow-up attempts are possible. No further information is expected.

Extreme fatigue continuing 1st,3rd.5th and 7th day after 2nd shot. Every time I thought I was recovering, the extreme fatigue came back the next day.; Fuzzy head; Headaches on and off; Pressure inthe head with the fatigue. ( no temperature); This is a spontaneous report from a contactable consumer, the patient. A 88-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: ER8727) via an unspecified route of administration in the left arm on 23Mar2021 at 13:45 (at the age of 88-years-old) as a single dose for COVID-19 immunisation. The medical history of the patient included hypothyroidism, and unspecified penicillin allergy. Concomitant medication included levothyroxine sodium (SYNTHROID) for hypothyroidism from an unknown date. The patient previously received aspirin (MANUFACTURER UNKNOWN) for unspecified indication and experienced drug allergy. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6205) via an unspecified route of administration in the left arm on 02Mar2021 at 14:00 (at the age of 88-years old). Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 24Mar2021, at 10:00, the patient experienced event extreme fatigue which continued on the 1st, 3rd, 5th and 7th day after the second dose of vaccination (on 23Mar2021). Every time, the patient thought she was recovering, and an extreme fatigue came back the next day. On the same day at 10:00, the patient had very fuzzy head, headaches on and off and pressure in the head with the fatigue (no temperature). The patient did not receive any treatment for the reported events. The clinical outcomes of the events extreme fatigue, very fuzzy head, headache on and off and pressure in the head were not recovered. No follow-up attempts are needed. No further information is expected.

Pt got second dose of Pfizer after unremarkable first dose. 2 hours later at home developed garbled speech and confusion. Taken to ED and evaluated for acute stroke, TPA given. CT was not definitive. Weakness was R>L. Pt confusion worsened a bit into evening of day of event, but by the following morning pt had returned to baseline. Is an independent 89 yo who otherwise lives at home alone and is highly functioning. Pt did have a recent kyphoploasty and SI joint injection (perhaps with steroids/lidocaine). Currently patient hospitalized, expected discharge soon, only complaint is tingling in fingers.... we believe this may have been coincidental, but due to time course are reporting here.

The next morning after receiving the vaccine I noticed that my mother she talking to me, as her primary giver she knows me and comfortable to me. She tells me the same story over the over with isn't abnormal. It was every 3-4 words she was jumbling her words. I didn't think anything of it at first. I just let it go. Early Wednesday morning 2:48am, I heard her in her bedroom. I went to check on her, I found at her dresser trying to put her watch on. She didn't know who was I or didn't know where she was. It took me about 40 minutes to calm her down. Now it was every 2 words that she was jumbling up. I finally got her back to bed. I went to send a message to her doctor. In the morning someone from the doctor's office called back I explained what was going on and they said get her to an ER. I took her to the hospital 01/27/2021. She was admitted to hospital for overnight observation. Still not been discharged. Patient was still confused when I had to left last night, did not understand where she was at or why she had to stay there. My mother was very angry when she woke up early Wednesday is not my mom she is very lovely. One year or two years she did have a TA or mini stroke.

arm is hurting so bad; could not move her arm, her left arm; it feels like lead; she got the injection in is like equalizing the pain she has; hurts all over; sleeps every 2 hours; This is a spontaneous report from a contactable consumer (patient). An 89-year-old female patient received the 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date), via an unspecified route of administration on the left arm on 13Jan2021 10:35 at a single dose for COVID-19 immunization. Ongoing medical history heart failure, kidney failure, scoliosis and strained hernia (causing pain down her right leg). Other medical history includes patient gave up her car and as a result she went from 5ft 4 inches to 5ft 1 inch and went from 150 pounds to 106 pounds (stated she loves this new weight. She looks fabulous and wonderful in clothes). The patient's concomitant medications were not reported. It was reported that the patient was a retired school teacher, called about the shot, the vaccine, clarified as the COVID Vaccine. She mentioned she has a history of heart failure, kidney failure, scoliosis, and hernias. She was concerned about getting the vaccine and did not think she should get it, but her doctor informed her she should get it so she did. Since getting it she is having a hard time. Stated it feels like lead. She contacted her doctor and was informed to wait it out 24 hours and it would be a lot better. It was reported that the patient got the COVID Vaccine shot yesterday (13Jan2021 10:35). She mentioned her arm is hurting so bad. She contacted her doctor's office and was informed to give it another 24 hours for the pain to go away. It was reported that the patient hurts so bad, she hurts all over. She added she guesses the arm where she got the injection in is like equalizing the pain she has. She stated as soon as she got the injection everything was wonderful. It was afterwards she felt like she could not move her arm, her left arm. She felt like at first she was having a stroke. She did some self testing and was happy she realized she was not having a stroke. It was reported that the patient provided conflicting details of when arm hurting started. She initially stated it started 13Jan2021. She then stated she did not feel it until 8am in the morning of 14Jan2021 (pending clarification) when she could not move her arm and thought she was having a stroke. She commented she sleeps every 2 hours. She would later mention in report she felt the arm pain starting yesterday (as reported). Attempts made to clarify start of arm hurting, but unable to clarify further. She is scheduled to get the second does on 03Feb2021. She commented even with her age she is still very useful. She was told to continue taking acetaminophen. She has the 1000 mg, take two pills every six hours. She was told if she continued to have pain to take Aleve. Treatment was given for the events. The outcome of the event was unknown. Information on the lot/ batch number has been requested.

aching in muscle of upper left arm. Hurts when I move the arm. Didn't sleep well last night due to the aching, and continue hurting all day.

Resident per her usual health when dietary staff were into apartment at 0730 with her breakfast. Resident conversing, appropriate, with no focal deficits with ADL. Resident baseline with mild confusion, generalized weakness, using a 4 wheeled walker when ambulating. Med care manager into room at 0830 with am medications. Resident was lying partially on her bed, non responsive. EMS was called immediately and resident was transported to Hospital ER. Wellness nurse was notified later that resident was admitted for rule out CVA.

My blood pressure has always been normal. On the Saturday following my shot on Wed. my blood pressure went to 157 over 125 . Felt terrible like (when you bend over and get up to quick) that feeling stayed constant also a feeling of a constant hot flash. Doctors at ER gave me a through checkup and everything checked out normal except blood pressure. They said be sure and notify you because they think it probably was the vaccination. I am making an appointment with my doctor today .

Confused; Disorientated; Sleeping a lot/Groggy; Headache; Felt very weak, felt very tired; felt very panicky; Dizziness; Felt like she had the flu; Chills; pain in her neck; she was cold; This is a spontaneous report from a contactable consumer (patient). This 89-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number PFREL1283, Expiration Date 30Apr2021), via intramuscular, on 15Jan2021 (at 12:00) at a single dose on the left arm for COVID-19 immunisation. Relevant medical history included ongoing lymphoedema (she gets water in her legs), ongoing severe arthritis of both knee caps (she had a cortisone shot and lidocaine in her knees), and dust allergy. Historical vaccine included flu vaccine received in Jan2020 and in Oct2020 (with terrible reaction: pain in arm, numb in arm and muscle pain arm for 6 weeks). Past drug history included allergy to lidocaine (her face swelled up), and hydrocortisone (CORTISONE). She was in a wheelchair. Surgical history included 2 hip replacements. Relevant concomitant medications included drug for lymphoedema. The patient stated she started having side effects almost immediately after receiving the COVID-19 vaccine. She felt very panicky, felt very weak, felt very tired. She had like a headache. Some of the symptoms started the day she got the shot and then more symptoms arose the day after. She was very tired and was sleeping a lot the next day. She felt very like groggy. In fact, she was so groggy, she pressed the wrong button in her chair. She clarified she has lymphedema and she has to be in a lift chair to keep her legs elevated. When she needs to get up, she presses a certain button to raise and lift the chair into a sitting position. However, that day, her doorbell rang (her meals are delivered to her) and she was so groggy and confused, that she pressed the button that put her straight out into a lying position instead of a sitting position. She ended up sliding off the chair and onto the floor. She had to call for assistance (there is an emergency button she can press). She had to be lifted off the floor. She explained to them she didn't end up on the floor from walking, she slid off the chair. She was so disoriented she pressed the wrong button. She felt like she had the flu, she was cold, she had the chills. She was laying down, covered up with 2 blankets. She couldn't move. It was terrible. At the time, she slid off the chair, she had to go the bathroom. She is on a water pill which makes things worse, but she has a bedside commode close to her lift chair. When she was trying to get off the chair go to the bathroom (which is only 4 or 5 steps away from the commode), she was so disoriented, she pressed the wrong button. She has had this chair for 5 years. She slid off the chair and ended up hitting the floor with her rear end. She remained on the nice cold floor (its a ceramic tile floor) until they came to pick her up. She mentioned she has had 2 hip replacements and once she is on the floor, she can't get up. Once assistance from where she lives came to pick her up, she was asked if she need to go the hospital or call ambulance. She explained to them she didn't fall. She slid off the chair. She is a very active person. Although she is almost 90, year is not senile. She slid off the chair, she didn't fall. The patient stated that she got the flu shot this past October and had a terrible reaction to that, too. Therefore, she doesn't know if it's just her system. She has had a flu shot every single year for the past 10-15 years and she has never had a reaction at all. She received the regular flu shot at her doctor's office in Oct2020 had a terrible reaction, she had severe pain in her arm where they gave her the shot, the pain wasn't at the injection site, the shot was high up the arm, her arm was numb and she couldn't raise it; she had muscle problems with the arm, she had trouble with her arm for 6 weeks. She has been taking naproxen sodium (ALEVE) for the headache. She has just been treating it symptomatically. No fever and she has just felt cold. The patient stated she really is not sick. She went to pick up dog medicine from the vet and when she leaves her facility, her temperature is always checked when she comes back. She was told her temperature was 97 something. So, she wasn't running any temperature prior to the vaccine. The patient was planned for the second dose on 05Feb2021. The patient stated her symptoms are not so severe it affects her breathing or something serious. It's just a pain in her neck to walk around with a headache. The outcome of the events was unknown.

Systemic: Body Aches Generalized-Medium, Systemic: Confusion-Medium, Systemic: Diarrhea-Medium, Systemic: Fever-Medium, Systemic: SLURRED SPEECH, INABILITY TO HOLD SELF UP IN CHAIR, INCONTINENCE-Medium, Additional Details: RN ADVISED PT HAD FEVER OF 101, DIARRHEA, WHOLE-BODY MUSCLE SORENESS, STROKE LIKE SYMPTOMS INCLUDING SLURRED SPEECH, INABILITY TO HOLD SELF UP WHILE SITTING IN A CHAIR, INCONTINENCE, AND CONFUSION ABOUT HER SURROUNDINGS, DATE, TIME, AND SITUATION. ALSO ADVISED THAT PT IS A GREAT HISTORIAN & NORMALLY KNOWS CURRENT DATE, TIME, AND SITUATION. SYMPTOMS LASTED ROUGHLY 72 HOURS, AND PATIENT DID COMPLETELY RETURN TO BASELINE AFTER 72 HOURS HAD PASSED

Hallucinations... Seeing things on the wall floor, couch... Thinking people that are elsewhere were at her house.

PFIZER-BIONTECH COVID-19 VACCINE EUA. PATIENT SENT TO HOSPITAL FROM NURSING HOME ON 3/15/21 WITH DIARRHEA, VOMITING AND AMS. ADMITTED AND REMAINS HOSPITALIZED ON 3/17. PATIENT TESTED POSITIVE FOR COVID-19 ON 3/15 AND HAS RECEIVED BOTH DOSES OF VACCINE MORE THAN 2 WEEKS AGO. HOSPITALIZATION REPORTED TO BE RELATED TO PATIENT SEPTIC WITH GI INFECTION. POSITIVE COVID INFECTION IS INCIDENTAL. PATIENT ON ROOM AIR. NO FINDINGS ON CHEST X-RAY.

lost control of the body she can't sit, stand straight without any support; She fell on the floor/carpet at least four to five times and can't get up either; lost control of the body she can't sit, stand straight without any support; Can't do her routine thing without support of two people; head is spinning; This is a spontaneous report from a contactable consumer (patient). An 89-year-old female non-pregnant patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: solution for injection, Lot number: EL1283), via an unspecified route of administration on 29Jan2021 at 10:30 (at the age of 89-year-old) in right arm as a single dose for COVID-19 immunisation and lorazepam (Manufacturer: unknown, Formulation: unknown, strength: 1mg) via unknown route of administration at a dose of 1mg unknown frequency for an unknown indication. The patient relevant medical history included asthma and She can't even walk with the walker too. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient had no allergies. The patient concomitant medication included fluticasone propionate, salmeterol xinafoate (COMBITIDE). The patient did not receive any other vaccine within 4 weeks prior to the vaccine. It was reported that on 04Feb2021, at 09:00, she lost control of the body she can't sit, stand straight without any support. She can't even walk with the walker too. Can't do her routine thing without support of two people. Seems like her head is spinning. At 16:00, she fell on the floor/carpet at least four to five times and can't get up either and can't do her routine thing without support of two people. The patient condition resulted in Emergency room, physician office visit. The patient was also hospitalized on an unknown date in Feb2021 for 5 days. The patient received Meclizine HCL Tab as a treatment. It was also reported that the patient adverse events resulted in disability or permanent damage. The seriousness of the events was reported as hospitalization (on an unknown date in Feb2021) and disability. The outcome of the events was not recovered.

within a few days my aunts parkinsons symptoms became so much worse. we contacted her neuro dr who said that if she had exp a fever or muscle pains after vaccination this was a temp issue. she is now at a month past first vaccine and still exp parkinsons symptoms that are far worse than before vaccination. such as "off times" meaning her parkinsons med will not stop the tremors and as of this past week she is exp parkinsons induced hallucinations. her general parkinsons health has gone down hill in last month. she was diag over 6 years ago and has maintained the same level of health since then. she decided to not take the second vaccine bc she couldnt handle worse parkinsons symptoms.

Nausea, upset stomach, no appetite, fever of 101.7 degrees F for 3 days (relieved by Tylenol), extreme fatigue for 4 days, depressed mood for several days.

been 5 days and still having tiredness headaches joint pain nausea and feeling annoyed; been 5 days and still having tiredness headaches joint pain nausea and feeling annoyed; been 5 days and still having tiredness headaches joint pain nausea and feeling annoyed; been 5 days and still having tiredness headaches joint pain nausea and feeling annoyed; been 5 days and still having tiredness headaches joint pain nausea and feeling annoyed; This is a spontaneous report from a contactable consumer (patient). A 89-year-old female patient received unspecified dose number of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; Formulation: Solution for injection) via an unspecified route of administration on an unknown date (at the age of 89-year-old) as single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient reported that she received the vaccine last Friday and it had been 5 days and still having tiredness headaches joint pain nausea and feeling annoyed. The outcome of the events were not recovered. Information on Lot/Batch has been requested. Follow-up attempts are completed. No further information is expected.

The son came on 05/06 to receive the 2nd dose of Pfizer vaccine and informed us that his mother passed away on 04/18 after 3 days of post vaccination. A home hospice patient with Stage 5 Chronic kidney disease and Stage 4 COPD (Oxygen dependent) came in on 04/15 around 4:30 pm to receive a first dose of Pfizer. After 15 mandatory waiting in the pharmacy, she went home. Around 5:00 pm, patient told her son that she is feeling nauseated. Hospice nurse was contacted. On 4/16, patient experienced hallucination. She told her son that her fingers were disappeared. Hospice nurse was contacted. Please note that vaccine adverse event is not clearly related to vaccine, since patient was on hospice, stage 5 CKD and stage 4 COPD.

Nurse did not believe my mother when told she already had both vaccinations (Pfizer-lot #EL5318-2/12/2021 and Pfizer-Lot#EN5318 3/5/2021. Nurse had my mother sign authorization form. She had immediate fatigue, weakness and exhaustion. This continued and her overall health declined until she was admitted to Acute Care Facility on May 25, 2021. She went from walking with a walker (50-60 feet with assistance) , to only walking 4 steps with max assistance.

Message received from the daughter of the patient, daughter states that the 3-4 days after the administration of the vaccine that she reported to feel unfocused and "out of it", falling asleep more, and was seen by physician who advised to keep an eye on her, then was later found slightly unresponsive, transported to hospital and found to be suffering from stroke. Patient later discharged from hospital to nursing home and stayed there until 3/28/2021, where she was later transferred to the care of the family and passed away on 4/6/2021. Daughter of patient

Slept for 15 hours a day; Extreme fatigue; A1C is 8.4/HAC1 were at 8.4 post-vaccination; This is a spontaneous report from a contactable consumer (nurse). This consumer reported for 89-year-old female patient (reporters godmother). A 89-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot number was not reported), dose 1 via an unspecified route of administration on 19May2021 (at the age of 89-year-old) as 1st dose, single dose for COVID-19 immunization. The patient medical history was not reported. There were no concomitant medications. Reported stated that patient received the first dose of the Pfizer-BioNTech COVID-19 vaccine 19May2021. The reporter stated that patient HAC1 were at 8.4 (2021) post-vaccination and she has been experiencing extreme fatigue on an unknown date on 2021. She described her godmother as 'active' and explained 'she works out, attends her physical therapies, and swims'. Reporter asked for the efficacy of a single dose of the Pfizer-BioNTech COVID-19 vaccine. Reporter again stated, she had extreme fatigue, her A1C is 8.4 and she doesn't have side effects listed. She slept for 15 hours a day (2021). She was scheduled for her next injection on Wednesday and they were concerned about the second injection. They didn't know if they could postpone it and if they did, does it affect the effectiveness. She wants to know the percentage of coverage after the first injection and how long she can wait. The events were reported as non-serious. The patient underwent lab tests and procedures which included A1C: 8.4 on 2021. The outcome of events were unknown. Information on Lot/Batch number has been requested.

arm became hurt; swollen like a size of her palm under the area where she got the shot; redness and feeling hot; redness and feeling hot; sometimes irritable when sleeping; This is a spontaneous report from a contactable consumer (patient herself). An 89-year-old female patient received BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- UNKNOWN) via an unspecified route of administration in arm on 09Jun2021 as 2nd dose, single dose (at the age of 89-years-old) for COVID-19 immunization. Patient medical history and concomitant medications were not reported. Historical vaccine included BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- UNKNOWN) via an unspecified route of administration on 19May2021 as 1st dose, single dose for COVID-19 immunization. Patient had no reaction on previous exposure to vaccine (first dose). Patient took the 2nd dose of the PFIZER COVID 19 vaccine on 09Jun2021. On the night, when she had the 2nd shot her arm became hurt, felt it was swollen like a size of her palm under the area where she got the shot, redness and feeling hot, sometimes irritable when sleeping. She wanted to know if these were the reported side effects of the vaccine. The outcome of the events was unknown. Follow-up attempts are possible. Further information is expected.

I got a blood blisters on my mouth and it is after 6 week I still have a spot on my lips where blood blister; I had loss of balance; I could not walk; I was short of breath/Trouble breathing; I had blotting stomach; I had pain in my head; I had trouble sleeping; I was very weak; I have a problem with my memory; I was so ill; I feared I would die I was so sick; This is a spontaneous report from a contactable consumer or other non hcp. A 89-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection; Lot Number: ER8733) via an unspecified route of administration on 06Apr2021 at the age of (89-years-old) as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. It was reported that the patient experienced that she had loss of balance, could not walk, short of breath, blotting stomach and trouble breathing, pains in my head and trouble sleeping and she got a blood blisters on her mouth and it was after 6 week she still had a spot on her lips where blood blister was it was not painful, but she was very weak. She had a problem with her memory. She took Benadryl first and it did not really help after 3 or 4 weeks and then did not help she visited the emergency room for two times and later she went to doctor cabin for several times. This was how ill she was and eventually she had problems with Prednisone (Not clear and not clarified). She informed that she was so ill and did not take the second shot. The patient stated that she was very very ill, and she and her husband went to cemetery, a place where she could be buried because she feared she would die she was so sick, and her husband had a shot, and he was absolutely fine. The patient reported that there were people like who did not help and actually made her very ill maybe it was her age maybe it was her chemistry but it was definitely not for every single person. The patient finished taking drugs as she took them for a period of time (completed the course). She was not taking any drug and she was recovered, and she was doing better and her health was better. The patient took treatment for all the events. The outcome of the event the problem with her memory was not resolved whereas other events were resolved on an unknown date. Follow-up attempts are completed. No further information is expected.