Pfizer

Arm soreness / soreness in the arm and shoulder; Arm soreness / soreness in the arm and shoulder; Emesis; Nausea; This is a spontaneous report from a contactable nurse. This nurse reported different events for 6 patients. This is the sixth of the six reports. A 76-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number and expiration date not provided) via an unspecified route of administration on 29Dec2020 at a single does in the left arm for COVID-19 immunization. Medical history included dementia from 10Mar2020 and ongoing. The patient's concomitant medications were not reported. The patient experienced arm soreness (soreness in the arm and shoulder), emesis and nausea on 01Jan2021. The patient received paracetamol (TYLENOL) for the soreness, nothing for the emesis and nausea. The events were all resolved on 01Jan2021. Information on the lot/batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021006274 same reporter/ drug , different patient /AE.

Extreme tiredness, headache, weakness in legs making walking uncoordinated, to the point of losing my balance on Sunday, January 3rd, could not do my regular jog my legs were so uncoordinated on Monday, January 4th, and I fell over on my side when I squatted to pick up my cat at the end of the jog, Difficult to climb my front steps. Tuesday , January 5th, similar leg weakness and lack of coordination, but milder. Less weakness on Wednesday, Jan 6th, when just walking. Thursday, January 7th, did a jog, almost normal, but my left ankle not as responsive as usual. Headache the whole time, and feeling like too much caffeine. I only have one black tea in am. Symptoms seemed most severe in AM. Headache eased up in evening of 1/7.

Fatigue, Chills, Low grade fever, Muscle aches. Resident also developed cellulitis to lower portion of arm in which vaccine was administered within 24 hours or less of receiving vaccine and had no previous indication of abnormalities to arm or s/s of infection to arm.

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

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

Shot about 11:30, Physical Therapy at 2:00 Substantial weakness in legs and core with difficulty getting out of car. Difficulty standing and walking, fell but caught by PT. Performed PT exercises ok. This report produced about 6:09.

On this last Friday I received my first shot. On Sunday I got a lot of groin pain on both sides that interfered with my ability to walk. It still greatly bothers me to the point I can not walk very much at the gym on the treadmill without pain. I regret getting the shot. When will this groin pain go away? Sincerely,

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

all of her joints that had been previously hurt in the past started killing her; This is a spontaneous report from a contactable consumer. A 76-year-old female patient received at a clinic the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on the left upper arm on 14Jan2021 08:15 (quarter of 8 in the morning) at a single dose for COVID-19 immunization. The patient's second dose was scheduled on 04Feb2021. Medical history hurtful joints, 2 bad knees she has had surgery, pain in her elbow that she had injured in the past, and unspecified reactions to a number of medications like penicillin she can't take, and severe arthritis. There were no concomitant medications. The patient previously took swine flu vaccine in 1976), and stated to have a terrible reaction, she has not had another vaccine since 1976, however she did have the flu shot last 2021 and she had no reaction to that, but in 1976 to the swine flu vaccine she ran a super high fever for a week, she did not get Guillain barre from it. Patient also previously took aspirin and ibuprofen (MOTRIN) and reported that she can't those. The patient stated that all of her joints that had been previously hurt in the past started killing her, she turned over and woke up with the pain on 14Jan2021 about 23:00 or 24:00. Patient further described that she started having pain in her elbow that she had injured in the past and also her wrists and it hurt so bad. The patient reported to take paracetamol (TYLENOL) as the remedy that took about 4-5 days for it to go away. The patient recovered from the event (reported as fine now) on 19Jan2021. Information on the lot/batch number has been requested.

headache, nausea, severe myalgia -cervical/thoracic; pt had to take Tylenol and when that didn't work she had to take hydrocodone to get some relief.

Chills, fever, muscle aches, weakness, fatigue, nausea lasted 24 hours, then fatigued for another 12 hours. Recovered completely within 36 hours. Arm red, sore and swollen for 36 hours

I have had a sore left arm since receiving the first dose on 1/16. VAERS report was put in and e-confirmation 294505. First dose was given in the right arm but caused pain in the left arm. With the 2nd dose due to the pain in the left arm, I got the 2nd dose in the right arm. There was just a sting when they put in the needle in. Today 2/10/2012 around 2-3 am I woke up and my arm is swollen. It is a little discomfort when I move my right arm.

slight headache, nausea, not being able to move-sit up, walk, muscle pain, joint pain extreme for one day then a tapering off for about 3 days, Took Tylenol 500mg 2 every 6 hrs for a few days, ONDANSETRON 4mg 1every 8 hrs as needed for nausea

Immediately, within 2 hours of the vaccination, I developed a severe headache, join pain (knees, elbows, mostly legs and lower extremities) which evolved into intense, burning abdominal pain. My blood pressure rose to 160; however, there was no fever, cough or shortness of breath. This condition lasted until the 7am on the morning of February 8th, but pains returned that evening (Monday 2/8) through Tuesday morning. Symptoms subsided during the day on Tuesday, yet on Tuesday evening (2/9, approximately 48 hours after the injection), severe symptoms returned, similar to the initial evening. I visited my Primary Physician on Wednesday afternoon (2/10) for a consult.

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

Washed out, just relaxed slight fever, and chills, muscle aches, joint pains, 1 Tylenol and went to bed

One week after the first vaccine, I had severe pain in my right arm. I could barely lift it. applied ice and pain lessened...Then other events followed...My left wrist became swollen and red. then a day later the severe pain was in my left arm and I could barely lift it. I then had a swollen right foot. Podiatrist gave me a shot of cortisone but continued to have the pain and swelling...Shoulder pain returned. 2nd vaccine was 02/03/2021...Feb 10...both hands were stiff and I couldn?t open them...Then the shoulder pain in my right arm returned . This lasted 4 days...with the most severe pain.

My reactions started on Feb 10, Wed nite, with pain going from the left shoulder to right shoulder. Next day pain was in the right lung, severe, (could not take a breath). Next day the pain and discomfort traveled dow my right leg, extreme cramps, soreness, etc. The next day it was my left lung in severe pain. By Monday my breathing is very shallow and my cough is much worse, each cough produces its own package of phlem. Breathing is diffiicult I HAVE AN APPOINTMENT TO RECEIVE SECOND SHOT ON FEB. 24. I DO NOT THINK I SHOULD

Patient on 02/09/21 starting having slow thought process and weakness in left arm and hand and had little strength in left hand and was dropping things. patient was scheduled for ct scan for headaches later that week. Called and got ct scan to be done state. Patient had a CT scan on 02/09/21 which was negative and saw the doctor on 02/12/21 and he ordered an MRI which showed patient had a CVA, cerebrovascular accident-stroke, MRI results revealed the CVA.

Developed shingles, given salves,valacyclovir, 1gm for 7 days, pain patches, gabapentin. Had very achy joints and very sore arm that was injection sight, which is still tender and still sore today and still suffering from shingles. Shingles rash appeared 6 days after shot. Sore arm began 11 hours after shot.

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.

After receiving her vaccine client stated that she has stiffness and redness in the right arm in which she had her vaccine was given. Vital signs obtained by EMS BP 115/73, HR=74, o@ sat 96%. Client states she feels better. Client declined to be transported to the ER. Discharged home by EMS.

Pt received dose #2 Pfizer COVID vaccine 1/29/21 @ MAC vaccine clinic. Reported flu like symptoms over the next two days (fatigue, nausea, anorexia). 2/2/21 awoke with abdominal pain and distension. Presented to MHN ED 2/2/21 @ 1100 for workup and initially declined admission and went home. Was called and asked to return for admission and further workup, admitted to MHN 2/2/21 @ 1750. Fever, myalgias, headache. CT abd/pelvis "There is mild diffuse mesenteric edema surrounding the abdominal aorta and proximal branches. Additionally, there is mild bowel wall thickening involving the stomach without discrete mass. This is nonspecific and may represent infectious versus inflammatory changes." Per provider note "flu-like sx over the weekend that easily coincide with the timing of the COVID Pfizer vaccine. In addition, I wonder if her CT scan findings might also be related to the vaccine." Discharged home the next day.

I was vaccinated on Feb 23, 2021, on the evening of Feb 24, 2021, I experienced soreness and swelling under my right arm pit. To date the swelling is still apparent, but most of the soreness and pain under the arm pit has improved.

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

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

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.

Arm swollen and turned red 3 inches above and below injection site; Arm swollen and turned red 3 inches above and below injection site; arm swollen and turned red 3 inches above and below injection site. She said it does not hurt, but just feels kind of heavy; This is a spontaneous report from a contactable consumer. A 76-year-old female patient received BNT162B2 (lot number: EN5318), intramuscular on 25Jan2021 08:30 at single dose in the right arm for Prevention. Medical history included diabetes diagnosed 10 years ago, acid reflux and cholesterol, all on unknown dates. Concomitant medication included esomeprazole sodium (NEXIUM) taking for 10 years for Acid Reflux, ongoing metformin for diabetes, "Sarxigo" taking for about 3 years for diabetes and unspecified cholesterol medication. On 26Jan2021 09:30, the patient experienced arm swollen and turned red 3 inches above and below injection site. She said it does not hurt, but just feels kind of heavy. The flu shot did that to her too, but not as bad. Flu shot turned her arm red this year also. She got it in Oct2020. She also got in the right arm in the muscle. She would like to know if she will she be safe to take second dose of BNT162B2. The patient did not receive any other vaccines within four weeks prior to the vaccination. The outcome of the events was not recovered.

headache; chills; muscle pain; tiredness; feeling unwell; 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: EL3302), via an unspecified route of administration at the left arm from 30Jan2021 3:00 PM at SINGLE DOSE for covid-19 immunization. The patient is not pregnant at the time. The patient was vaccinated at a Pharmacy/drug store. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Medical history included cancer cured. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. It was reported that there are other medications the patient received within 2 weeks of vaccination, however it was unspecified. The patient previously took demerol and experienced allergy. It was reported that the patient experienced headache, chills, muscle pain, tiredness, feeling unwell on 30Jan2021 09:00 PM. The outcome of the events was recovered. No treatment was received for the adverse events. The case/ events were reported to be non-serious.

Swollen Lympf Nodes(7 days), slight headache(two weeks) tiredness(1 week)muscle aches(1 week),severe itching on back (no rash(2 weeks)nausea(1 day) Tylenol for headache, rest for tiredness, caladryl, Zyrtec, Pepcid for severe itchiness, Dr visit on Feb.22 - had me take a flu/covid test came back negative.

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.

Experienced right side aside pain 3 days after vaccination and broke out with shingles rash 6 days after vaccination

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

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.

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

I developed arm pain, up my arm to my neck, Then 2 days later developed a rash on my wrist, arm and top of my back.

Started with upset stomach and achey body late afternoon on Friday (1 week after 1st shot). Then developed diarrhea at the same time extreme fatigue. Diarrhea only lasted about 1 day, but fatigue ( which demanded many naps) and achey body lasted until Monday night. Woke up Tuesday feeling stronger, but still had lower back ache and tiredness - not extreme fatigue, but still so very tired - fewer naps. Today is Thursday and I am still quite tired, lower sore back ache. Never had a fever.

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

Joint pain, muscle aches, right shoulder pain, fatigue night after shots and next day Lasted over a period of 2 days

tiredness; headache; nausea; feeling unwell; muscle pain; joint pain; This is a spontaneous report from a contactable consumer (self-reported) via medical information team. A 76-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: EL9261, expiry date unknown), via an unspecified route of administration, in arm left, on 30Jan2021 as single dose for COVID-19 immunization. The patient medical history included Obesity and difficult time metabolizing medications. Family history included her daughter and grand daughter have EDS. She would probably be the genetic carrier. The patient concomitant medication included ongoing esomeprazole sodium (NEXIUM) and she has been on it about 2years, ongoing valsartan and she has been on it about 2 years. It was reported that the patient had experienced Tiredness, headache, muscle pain, joint pain, nausea and feeling unwell; all events on 07Feb2021, and everything is ongoing. The outcome of the events was not recovered.

tiredness; headache; muscle pain; chills; feeling unwell; injection site soreness; This is a spontaneous report from a contactable nurse (patient herself). A 76-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: unknown), via an unspecified route of administration on 31Jan2021 at 08:00 AM (at the age of 76-year-old) at a single dose for COVID-19 immunisation. The patient's medical history included coronary artery disease (CAD), hypothyroidism, and sleep apnea. Concomitant medications included levothyroxine, carvedilol, latanoprost, and amlodipine besilate (AMLOD). The patient previously took meperidine (DEMEROL) and experienced drug hypersensitivity. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient experienced tiredness, headache, muscle pain, chills, feeling unwell, and injection site soreness on 31Jan2021 09:00 PM. The patient had not taken any other vaccine in 4 weeks. The outcome of the events was recovering. There was no treatment given due to the events. It was also reported that since the vaccination, the patient had not been tested for COVID-19. Information on the Lot/Batch number has been requested.

She reports, "I have no balance." She had second COVID-19 vaccine on 2/12/2021 and afterwards had myalgias. Over the next few days she felt like her balance was off, particularly on 2/15/2021 when walking on the beach. On 2/18/2021 she went to urgent care and was diagnosed with lumbosacral radiculopathy. She doesn't agree with the diagnosis and states, "I feel like I've had a stoke." She has trouble controlling her right leg. Her right arm is okay and she's had not trouble speaking or had a facial droop. She is taking the prednisone which was prescribed. She started using a cane on 3/10/2021 due to dysequilibrium with veering towards the right. She felt more stable this morning but this afternoon is again needing to use the cane. She denies vertigo, nausea, vomiting.

Pain and swelling (about the size of a boiled egg) on the shot site; Pain and swelling (about the size of a boiled egg) on the shot site; Cold hands and feet after receiving shot; My right hand also was numb and needed to be rubbed to increase circulation; Fever; joint aches; headache; This is a spontaneous report from a contactable consumer reported that: A 76-years-old female patient received bnt162b2 (BNT162B2; Manufacturer Pfizer-BioNTech), via an unspecified route of administration, administered in Arm Right on 26Jan2021 (Batch/Lot Number: EL9261) as SINGLE DOSE for COVID-19 immunisation. Medical history included cerebrovascular accident, allergic to sulfa drugs (drug hypersensitivity). The patient received concomitant medications included losartan (LOSARTAN), atorvastatin (ATORVASTATIN), vitamin b12 nos (VITAMIN B 12 [VITAMIN B12 NOS]), acetylsalicylic acid (BABY ASPIRIN) taken for an unspecified indication, start and stop date were unknown. The patient did not receive any other vaccines with in four weeks. 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 27Jan2021 03:00, the patient experienced Pain and swelling (about the size of a boiled egg) on the shot site. Cold hands and feet after receiving shot, including all night. My right hand also was numb and needed to be rubbed to increase circulation. Fever, joint aches, headache. The patient underwent lab tests and procedures which included body temperature: results unknown .Outcome of the events were recovered on unspecified date.

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.

diarrhea; color of the diarrhea looked red and looked like it had blood on it; she sat down in a chair and noticed that it had blood when she got up and suspects that she had hemorrhoids and bleeding because of the diarrhea/she has hemorrhoids from having babies years ago; she sat down in a chair and noticed that it had blood when she got up and suspects that she had hemorrhoids and bleeding because of the diarrhea/she has hemorrhoids from having babies years ago; shaking/trembling out of control; hurting from her neck down to her toes; joints were achy, hurt, and stiff; joints were achy, hurt, and stiff; her teeth were chattering and cant stop, and when she tried to stop that it made it worse; she had hard time walking/Her gait was off and she was kind of jerking; fell in the bathroom; she was too weak; hard time rolling and trying to get out of bed; Her gait was off and she was kind of jerking; little nausea; she sat down in a chair and noticed that it had blood when she got up and suspects that she had hemorrhoids and bleeding because of the diarrhea; she was kind of wiped out for a couple of days (in 2021) and it was all over now; 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, solution for injection, lot: EN6203), via an unspecified route of administration in left arm on 27Feb2021 (at the age of 76years) as single dose for covid-19 immunisation. Medical history included ongoing fibromyalgia diagnosed in 1999; Covid-19 from 23Nov2020 to Dec2020 (went to the hospital because of pain in her side at night. Was told she had pneumonia and pleurisy, she got it 2 days after her husband did, but hers was a mild case); her husband had Covid in Nov2020 and died in Dec2020 and hemorrhoids (from having babies years ago). Concomitant medication included acetylsalicylic acid, caffeine, paracetamol (EXCEDRIN). The patient had no investigation assessment. The patient scheduled her first dose for 27Dec2021. The patient had questions about it, but the person administering it did not speak English and she said that initially she did not have any reactions while she was there. The patient received the first dose of the vaccine on 27Feb2021 and has a lot of adverse events. After the getting the shot, she woke up at 0400 and experienced shaking (whole body was shaking), trembling out of control, hurting from her neck down to her toes, her joints were achy, hurt, and stiff, her teeth were chattering and couldn't stop, and when she tried to stop that it made it worse, when she got up she had hard time walking, so much that when she had diarrhea, she had diarrhea on the floor, she also noticed that the color of the diarrhea looked red and looked like it had blood on it but she was not sure. After that, she sat down in a chair and noticed that it had blood when she got up and suspected that she had hemorrhoids and bleeding because of the diarrhea. She thought it was a result of the reaction to the shot. She noted that that she had COVID on 23Nov2020 and that she heard that people who had COVID might not need to get the second shot but it was only speculation so she was asking if this was true. She mentioned that she waited 90 days before getting the vaccine as per CDC guidelines and knew that the 2nd dose can be given for 42 days after the first dose. The patient's daughter in law who was an occupational therapist volunteered to fly in and take care of her after the second shot on 27Mar2021 but her 2nd shot was due on 20Mar2021 so she wouldn't be there until then. The patient was having a hard time rescheduling her appointment so asked if there was anything can be done. The patient would prefer not to take the second dose due to the side effects. The patient also reported that it looked like someone who had a stroke trying to walk again, her gait was off and she was kind of jerking. As she would take a step her foot would go down on a slant like it was skidding. She said that this happened one other time to her. It was like she was leaning forward and could not stop herself. When she was able to get up, she went into the living room and sat in her husband's chair and fell asleep until 15:00. When she got up, she noticed a lot of blood in the chair. The patient asked if this was allowed. She went home and took a couple of acetylsalicylic acid, caffeine, paracetamol because she did not have paracetamol (Tylenol), and she went to sleep. She had a hard time rolling and trying to get out of bed. She turned on her electric blankety and her heat. She said that by 0600 most of the shaking had gone away. She felt a little nausea, but got some dry toast. She said that she wanted to take a shower, but she started getting diarrhea from the injection. She fell in the bathroom and could not get herself up for over an hour because she was too weak. When she fell on the floor, she tried to get on a rug because she was still having the diarrhea on the floor. She said that it was everywhere. The next day she called her son and his wife they said that she could be alone for her second shot. She was scheduled for 20Mar2021 for her second dose. The patient had a hard time changing the appointment and her son could not come to stay with her until 27Mar2021. A friend told the patient that on the news it said that a second shot may not be necessary for people who have had Covid-19 already and she wanted to know if Pfizer has heard of this. The patient said that she was kind of wiped out for a couple of days (in 2021) and it was all over now. The doctor's office was aware of what happened and she was told to take extra strength Tylenol before and after the second injection to address these symptoms. The consumer considered the case as non-serious. The outcome of the event fatigue was recovered in 2021 while for the remaining events was unknown.

Severe joint pain especially in feet, ankles, knees; Severe joint pain especially in feet, ankles, knees; chills; headache; Pain was severe enough as to interfere with sleep; This is a spontaneous report received from a contactable consumer (patient herself). A 76-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection and lot number: EL1283) via an unspecified route of administration to left arm on 18Jan2021 13:00 at single dose for COVID-19 immunization. Patient medical history included high blood pressure and Allergy to tomatoes/walnuts. Concomitant medications included Lisinopril, Metropolol and Hydrochlorothiozide. On 26Jan2021 patient experienced with severe joint pain especially in feet, ankles, knees; chills, headache. Pain was severe enough as to interfere with sleep. Patient did not receive any treatment for the events. Seriousness was reported as non-serious. Outcome of events was not recovered.

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

Headache and was hot; really hot at night; Really strong muscle and joint aches/pain; Really strong muscle and joint aches/pain; fever; White bump near injection site.; This is a spontaneous report from a contactable consumer (patient herself). A 76-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection, lot number: EL9262 and expiry date: 31May2021) via Intramuscularly to left arm on 22Jan2021 10:30 at single dose for COVID-19 immunization. Patient medical history included bladder infection, blood pressure, she has some old age stuff like blood pressure, and she had Thyroid removed and takes a thyroid pill every day and she tends toward GERD. Concomitant medications included she does take other medications, but they are not relevant. Patient previously took Shingles shot for Shingles (Had the first of the Shingles shot but it was before that. She is due for the second one but she is putting it off for the COVID second dose). Patient reported that she got the COVID vaccine and was really excited because seemingly, she had no side effects. The shot did not hurt. Ten days after she go the shot, she got really hot at night and really strong muscle and joint aches on 31Jan2021. She was up almost all night. It just kept waking her up. So, she took something, an Ibuprofen thing to reduce fever and pain. The next night she took one proactively and did not have pain. The third night, she had it again but it was a headache all night and she was hot on 02Feb2021. It only seemed to happen at night. She felt like it was from the vaccine. She was not worried she had COVID. She had no breathing problems and did not feel like she was going to pass out. They said she should wait 48 hours and take a test to see if she had COVID. She did and it was negative. She does not feel any negativity toward the vaccine. She went in for a bladder infection and it was from a doctor's appointment that she got information and they told her she could go ahead and get it. Since she got the vaccine, she got white bump in the vicinity of the vaccine like a while mole, and another in the vicinity of the area as well. It does not itch or hurt. She noticed it about a week after the shot. She does not know the date. She was still on medication for a bladder infection but it would not have done anything. When she had reaction to the vaccine, it was already 10 days after she got the shot. She had asked them at Kaiser, and they think it was unrelated to any other medication. Outcome of event fever was recovered on 01Feb2021, for white bump near injection site was not recovered and recovering for all other events.

heart pain; Shoulder pain; Neck ache; Stiff neck; severe chest pain; This is a spontaneous report from a contactable consumer (patient). This 76-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in arm left on 23Feb2021 15:15 (batch/lot number: EN6198) as a single dose for COVID-19 immunization. Medical history included heart attack approximately 20 years ago). Family history included heart problems. Patient received unspecified concomitant medications. No additional vaccines administered on the same date of the Pfizer suspect. Patient experienced some side effects after receiving the first dose of the Pfizer-BioNtech Covid-19 vaccine. About 3-4 hour after she received the vaccine, on 03Feb2021 19:00, she had heart pain for around 5 hours, she also experienced shoulder and neck ache. These symptoms have resolved. She would like to know if she should receive the second dose of the vaccine, if these symptoms would be worse. Treatment for side effects: she put Spikenard, an oil, on the chest for the heart. At 15:10, she was fine, went home, had dinner, and then she first got shoulder pain/shoulder blade pain and then a stiff neck. Then she thought, she will go to bed and then had severe chest pain most of the night. Patient has never had flu or any vaccines. AEs did not require a visit to emergency room/physician office. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Outcome of the event shoulder pain was recovering, of the event neck pain was recovered in 2021, and of the events heart pain, stiff neck, and chest pain was recovered on 23Feb2021.

Intense pain in left knee. Red and swollen. Reports that she was screaming in pain and couldn't put any weight on it. taken by ambulance to ER. They completed a CT Scan and an ultrasound but found nothing. No med given helped with pain. She sent us an email on 3-23 and I called her. She is still experiencing pain (better) but has to use a walker to ambulate.

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

chest, back underarm pain; chest, back underarm pain; back pain; adhesions; Inflammation numbers were high; Clotting numbers were way high over 2000; pneumonia; This is a spontaneous report received from a contactable consumer. A 76-year-old female patient received the first dose of BNT162B2, via an unspecified route of administration in right arm on 01Jan2021 11:45 at single dose for COVID-19 immunisation. Medical history included thyroid, pancreas, and known allergies: Sulfa, k-flex, macrobid, statins, and pork. Concomitant medications included levothyroxine sodium (L-THYROXINE CAMPUS), vitamin B3, magnesium sulfate, and unspecified blood thinners. The patient experienced chest, back underarm pain two week later and did not get better. Patient had some adhesions and thought maybe from that. Patient had surgery and did not help. Pain kept getting worse. ED visit. On 04Mar2021, patient was diagnosed with pneumonia and sent home. After antibiotic, patient was no better. Another ED visit on 08Mar2021, clotting numbers were way high over 2000. Inflammation numbers were high. Patient was admitted every test available. 3 days in hospital. Patient was no better. Pain was terrible. Chest underarms and upper back. Patient was in serious pain and afraid to get second shot. Patient had cancelled. These adverse events were result in emergency room/department or urgent care and doctor or other healthcare professional office/clinic visit. This case was reported as serious with seriousness criteria-caused/prolonged hospitalization. The patient underwent lab tests and procedures which included several computerised tomogram (CT scan): unknown results on an unspecified date, COVID test (nasal swab): negative on 08Mar2021, and X-ray: unknown results on an unspecified date. Patient was treatment for the adverse events. Outcome of the events was not resolved. Information on the lot/batch number has been requested.

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

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.

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

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

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

A few hours after injection, arm muscle started to hurt and it has never improved, I have used heat, muscle rubs, and pain relievers. It has been 6 weeks now with no improvement, Difficult to use that arm for many tasks

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.

On Sunday at 10:00PM she checked her temperature and it was 100.6 degrees; she was cold, and had her pajamas on, with a snuggly on top of her pajamas, and a blanket on top of her snuggly; she felt some slight joint pain in her left knee; she didn't feel good; she felt off balance after receiving her second COVID-19 Vaccine dose. She said she only felt off balance the first day after she received her second vaccine shot.; felt a little off; Chills; Ache; Headache; Injection site pain; soreness under her left arm; This is a spontaneous report from a contactable 76-year-old female consumer reported for herself that she received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/lot number: EL9264), via an unspecified route of administration on 06Feb2021 17:15 at single dose in arm left for covid-19 immunization. The patient historical vaccine included BNT162B2 on 16Jan2021 for COVID-19 immunization and he she had Injection site pain (Lot Number: EL3247, Expiry Date: Unknown, Route: Intramuscular, Anatomical Location: Arm, Left, No. of Previous Doses: None) and about 10 years ago she had a flu shot, and she had a reaction that felt like she got the flu for a day. On 07Feb2021, the patient woke up and she felt a little off in the morning. On Sunday afternoon, between 1:00-2:00PM, she had chills, felt achy, slight headache and she didn't feel good. She said she was cold, and had her pajamas on, with a snuggly on top of her pajamas, and a blanket on top of her snuggly. She said it dawned on her at 10:00PM Sunday night that maybe she had a temperature. She said she checked her temperature, and it was 100.6 degrees. She said she called to ask a nurse if she could take Tylenol for her fever. She said she had read about not taking Tylenol with the COVID-19 vaccine, but nurse told her it was OK to take Tylenol. She said she felt some slight joint pain in her left knee, too. The patient stated that she had a little bit of injection site pain with her first COVID-19 Vaccine shot. She said she thought the injection site pain was due more to where the COVID-19 Vaccine shot was given, and not from the COVID-19 Vaccine itself. She said with her second COVID-19 Vaccine shot, she had pain at the injection site and soreness under her left arm. The patient took the generic Tylenol Pain Reliever 325mg for her fever and chills. The outcome of the event felt a little off, ache and didn't feel good recovering on an unknown date, chills, headache, temperature was 100.6 degrees resolved on 08Feb2021 and she was cold, had her pajamas on, with a snuggly on top of her pajamas, and a blanket on top of her snuggly were resolved on 08Feb2021. injection site pain and soreness under her left arm resolved on 10Feb2021 and She said she only felt off balance resolved on 07Feb2021.

Diarrhea; Heart palpitation; occasional low pulse rate; sore joints; low grade fever; This is a spontaneous report from a contactable consumer (patient). A 76-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Formulation: Solution for injection), first dose on 14Jan2021 at 12:45 (lot number: EL0140 and expiration date was unknown) and second dose on 04Feb2021 at 12:45 (Lot Number: EL3302 and expiration date was unknown) both administered in Left Arm via an unspecified route of administration at a single dose for COVID-19 immunization. Medical history included diabetes, CAD (coronary artery disease), aortic stenosis, COPD (chronic obstructive pulmonary disease), arthritis. Concomitant medication was not reported. The patient was not received other vaccines within four weeks of vaccination. The patient received unspecified medications within two weeks of vaccination. On 05Feb2021, the patient experienced diarrhea, heart palpitation, occasional low pulse rate, sore joints, and low-grade fever. The patient not received treatment for the events. The patient not had covid prior to vaccination. The patient not tested for covid post vaccination. The outcome of all events was reported as not recovered.

has been experiencing high sugar level; having pain at tip of radius- sore to touch. Very sore; joint pain; This is a spontaneous report from a contactable consumer (patient) via Medical Information Team and via sponsored program . A 76-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration on 23Feb2021 at SINGLE DOSE for COVID-19 immunisation. Medical history included diabetic. The patient's concomitant medications were not reported. The patient previously took steroid shots that cause blood sugars to sky rocket, but that was expected. The patient stated, "about the time I got the shot, started having pain at tip of radius- sore to touch. Very sore. No trauma there. It doesn't comes and goes. I'm aware of it" on 23Feb2021. The patient also said she has had increased blood sugars since the vaccine (readings of 197, 147, 154) on 23Feb2021. The patient further stated that she was looking at book and has had higher numbers of 197,147 and 154. Stated that she was usually 120 or below. Stated that she does not know if it had anything to do with it. Stated that the tip of her radius was terribly sore to the touch. Stated that it said that joint pain was a side effect on an unspecified date in 2021. Patient wanted to know if it was a side effect or just her own aches and pains. The outcome of all events was unknown. Information on the lot/batch number has been requested.

muscle pain; lot of pain; stiffness in muscles; difficult to walk; This is a spontaneous report from a contactable consumer (patient reported herself). A 76-year-old female patient received second dose of BNT162B2 (Pfizer-BioNTech Covid-19 Vaccine, Formulation: Solution for injection) via an unspecified route of administration on 04Feb2021 at single dose for Covid-19 immunization. The patient's medical history included arthritis (history of arthritis/joint pain to begin). She got her first dose of the Pfizer-BioNTech Covid-19 on 15Jan2021. Concomitant medications were not reported. Call back made on 11Feb2021 at 11:51 AM and reached for discussion. She reported that "she thought she was having side effects from the second Pfizer-BioNTech Covid-19 shot". Patient stated she already reported it to Safety and was transferred to Medical Information. She got her first dose of the Pfizer-BioNTech Covid-19 on 15Jan2021 and second dose was on 04Feb2021. She was 76-year-old with a history of arthritis so she had joint pain to begin with but now she developed muscle pain, specifically after the second dose. She did not have it with the first dose. She currently had a lot of pain and stiffness in muscles, it was difficult to walk and she could not raise arms above shoulders without pain. It started about Sunday (07Feb2021), when this became more noticeable". She planned to discuss this further with her physician. No additional details. Outcome of the events was unknown. No PQC Present. Information on the lot/batch number has been requested.

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.

Bad headache on left side of head Teeth started chattering for 2 minutes, but didn't feel cold 100.4° fever Legs felt 'heavy'

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

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

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

For 3 days after I was so tired it was hard to get off couch. My Afib has been controlled but the afternoon of shot heart rate started to fluxuate. had appt with heart Dr. took EKG was ok but stated that there were several patients with same systems. by Thursday April 1st, heart rate was up to 143, called 911, by the time I got to ER it was going down. Had another EKG with in range and all other blood work was OK. Right ankle that swells because of arthritis swelling is now worse.

Painful swollen lymph nodes under left arm and close to breast. I keep my left arm in sling like position held close to my body to help alleviate pain. Left back shoulder aches. Sometimes painful when I breathe and feel pain under rib cage on left No fever

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.

Patient noted that 2 days after vaccination that her left shoulder became very sore and achy. She was unable to left her shoulder. She denied redness or swelling at the site. Used tylenol. Did not contact MD. States her shoulder hurt for approx. 3 weeks post vaccination. Was massaging her arm to help relieve pain and it eventually felt better. Also shared that her left thumb also was sore and reddened post vaccination but unsure if it was related. Does not recall an injury.

One week after last shot developed shingles. treatment to date consist of at home methods to reduce pain and itching along path from back to center to edge of right breast. All rash is on my right side. Seven days since beginning of rash which proceeded by five days of back pain before realizing what was happening. Tried acetaminophen for pain relieve but developed a rash on arms and legs with intense itching and had never had a reaction before to this medicine. My immune system is not acting as it normally does.

Petechiae below the right knee. Per the patient, she also experienced this same rash when she had COVID-19 disease back in December 2020.

FEELING VERY SICK. Pain is unbearable. arm is sore. Fast pulse. when I get up I feel like I am going to faint. Chills low fever, Pain in joints and muscles severe headache.

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

About three days after getting vaccine, I began having pain in my shoulders and neck. For three weeks I had sharp, nerve like pain on the top of my shoulder which kept me awake most of the night. I thought it would go away. The sharp pain went away after three weeks, but pain in shoulder and bilateral neck persists. I saw on 04/09/2021. She prescribed a muscle relaxant and physical therapy. The muscle relaxant didn?t help and I didn?t do the p.t. She offered to refer me to an orthopedist, which I declined.

Two weeks after receiving vaccine, experiencing severe pain in under left breast, radiating around to the back. Chest pain and some breathlessness. I took her to the ER , on March 27, 2021, thinking it might be her heart. She was admitted for observation. She broke out with a severe case of shingles the next day, 3/28/21. She had been fully vaccinated for Shingles two years before (Shingrix).

coughs it is like a bronchitis type thing; coughs it is like a bronchitis type thing; full of phlegm; back started to hurt; tingling to the bottom of her feet; tired; severely sick; she couldn't walk or talk; she couldn't walk or talk; She shrunk; This is a spontaneous report from a contactable consumer (reported for herself). This 76-year-old female BNT162B2 (Pfizer Covid-19 vaccine, solution for injection, Lot number: unknown), via intramuscular route on left arm as a single dose on 06Feb2021 12:15pm, for covid-19 immunization. Medical history included minimal (borderline high blood pressure (since 6 years prior to this report). Concomitant medication included Lisinopril 10 mg once a day orally. On 06Feb2021 About 4 hours later after she got the shot, the patient experienced some tingling to the bottom of her feet with and without walking and felt like needles, then it went away some but not totally, and her back started to hurt. On 10Feb2021, she was coughing and full of phlegm. On an unknown date, since getting the first dose of the covid vaccine she had been severely sick, she could not walk or talk, felt really tired, and she shrunk (weight about 130 pounds). The patient did not have any history of previous immunization with the Pfizer vaccine. She was not administered any additional vaccines on Same Date of the Pfizer Suspect. The events did not require emergency room/ Physician office visit. She did not receive any prior Vaccinations within 4 weeks. There were no relevant tests performed. The patient recovered from the event of tingling on 07Feb2021. The outcome of the event of was event of phlegm was recovering. The outcome of the events of coughing, severely sick, she could not walk or talk, felt really tired, and she shrunk was not reported. She had not recovered from the event of back started to hurt and it had worsened. Information about Batch/Lot number has been requested.

Blood clot in her lower abdominal area; had the worst pain through her side that ran down her left leg and to her ankle; had the worst pain through her side that ran down her left leg and to her ankle; nerves are all tangled up; This is a spontaneous report from a contactable consumer (patient). A 76-year-old female patient received the second dose of bnt162b2 (BNT162B2, Solution for injection, Lot Number: EN6207), via an unspecified route of administration, administered in Arm Right on 17Mar2021 13:50 (at 76-years-old) as single dose for COVID-19 immunisation. The vaccine was administered at a hospital. It was not administered at a military facility. Medical history included hip replacement four years ago in 2017 (First right then 2 months later left) and knee replacement six years ago in 2015 (both 2 months apart). There were no concomitant medications. The patient previously received the first dose of bnt162b2 (BNT162B2, Solution for injection, Lot Number: EN6203), administered in Left Arm on 25Feb2021 (at 76-years-old) for COVID-19 immunisation and experienced bad headaches. The patient received the second dose of vaccine on 17Mar2021. On 29Mar2021, she was not hurting and went to brunch with friends. Afterwards (on the same date, 29Mar2021), she was sitting and got the worst pain through her side that ran down her left leg and to her ankle. She drove herself home but was in such misery. She went to the emergency room the next day, on 30Mar2021, wherein she had a CT (computerized tomography) scan that showed a blood clot in her lower abdominal area. She was taking pain medication every 6 hours, or she could hardly stand it. On 08Apr2021, she went back to the emergency room because she could hardly stand it. She was kept in observation status but was not admitted. She was scheduled to have another CT scan on 06May2021. She is not sure what they will do because the nerves are wrapped around it. She also mentioned that her doctor wants to do a biopsy. The pain was also running down to her ankle. She stated that she has had both of her hips replaced in the past. She added that her doctor will do an MRI (magnetic resonance imaging). He will put in a drain if it has not shrunk. The doctor can't do anything because the nerves are all tangled up (2021). As corrective treatment, the patient was taking pain medication for the blood clot and pain through her side that ran down her left leg and to her ankle. Outcome of nerves are all tangled up was unknown, while outcome of the other events was not recovered.

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.

sore muscles, especially lower back; some shakes and/or chills; some shakes and/or chills; sore muscles, especially lower back; This is a spontaneous report from a contactable consumer, the patient. A 76-year-old female non-pregnant patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 2 via an unspecified route of administration, administered in in Arm left on 09Feb2021 14:30 (Batch was not reported /Lot number 2192050) (at the age of 76-years-old) as single dose for covid-19 immunisation. Medical history included breast cancer from an unspecified date in 2016, penicillin allergy and sulphate allergy. Concomitant medications included multi vitamin (unspecified), acetylsalicylic acid (ASPIRINE) and anastrozole. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 on an unspecified date, administered in arm left (Batch/Lot number was not reported) for covid-19 immunisation. On 10Feb2021 14:00, the patient experienced some shakes and/or chills, sore muscles, especially lower back. No treatment was given for the events. The outcome of the events was not recovered. Information on the lot/batch number has been requested.

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.

On April 1, 2021 I woke up with pain in my left hip. As the day went on it got much worse and the nausea started to the point where my husband had to take me to the ER . They gave me some pain medicine, nausea medicine and did a cat scan of my abdomen. Nothing was found and I was sent home. April 4th the pain got so severe and the dry heaving to the point where blood came out. Again I went into the ER this time by ambulance because I was so weak at that point where I couldn?t walk. Again they gave me pain medicine and nausea medicine along with prednisone. It took about a week to recuperate and now I have severe tinnitus.

Arm hurts a little bit, after first vaccine; Tiredness, after first vaccine; Chills; Back hurts a little; This is the spontaneous report received from a contactable consumer(patient). A 76-years-old female patient received 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) at single dose via an unknown route on an unknown date for Covid-19 immunization. Medical history included usually constipated, her doctor put her on magnesium and docusate sodium (COLACE). Concomitant drugs included magnesium and docusate sodium, both for constipated. She experienced tiredness, arm hurts a little bit, chills, back hurts a little. The clinical course was reported as follows: the tiredness did not start until a couple days later and eventually went away. The arm hurting did not happen the first few days, it was not as bad the second day. She added that she could not complain about it. She did not have a fever, her temperature was 97.5. Her back hurts a little, but it hurts a lot anyways. She did not like to sit a lot. She liked to be active because it helps, but it was too gloomy to do anything on 12Apr2021. The seriousness of the events was unspecified. Outcome of tiredness was resolved. Outcome of the other events was unknown. No follow-up attempts are needed; information about lot/batch number cannot be obtained.

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.

Throbbing pain arm of injection site. Muscle soreness inside of arm. Has continued for last two months.

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

Right knee pain; tenderness; swelling; Pain at injection site; 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: EN5318), on 26Jan2021 at 12:00 (at the age of 76-years-old) at 1st dose, single administered in left arm for COVID-19 immunisation. Medical history included allergies. The patient was not pregnant. No COVID prior vaccination and no COVID tested post vaccination. Concomitant medications included calcium, tocopherol (MEMORALL), cetirizine, KETO, unspecified (all reported as other medications in two weeks). The patient previously took ampicillin and experienced allergies. No other vaccine received in four weeks. The patient experienced right knee pain, tenderness, swelling, continued. Pain at injection site lasting 24 hours. The events occurred on 30Jan2021 at 8:00. No treatment was received for the events. The patient had recovered from pain at injection site on 31Jan2021 at 08:00, had not recovered from the other events.

uncomfortable shooting sensation down her arm repeatedly throughout the day every day since first shot. 5/4 entered the hospital and diagnosed with Sepsis and MRSA. They cannot explain the source of this infection and cannot get it under control

Soreness under her arm unsure if muscle or lymph nodes; Pain under the arm, under the injection site in which it was a soreness; Aching in arm; Achy; This is a spontaneous report from a contactable consumer. A 76-year-old female consumer (patient) reported that received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: EN5318; Expiration Date: May2021) via an unspecified route of administration, administered in right arm on 04Feb2021 at 10:30 as first dose,single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. No Prior Vaccinations within 4 weeks. On 04Feb2021, the patient experienced after is that she felt a little achy and 04Feb2021 at 8:00 pm that evening her arm was aching, patient took an Ibuprofen and had no problem afterward, On 05Feb2021, the day after patient mentioned had pain under the arm, under the injection site in which it was a soreness which had no lump. She cannot discern whether it was a lymph node or muscle, but is leaning more into it being a muscle because patient could feel a pulling sensation when patient raises her arm at the shoulder. Patient was asking if these are common side effects and for how long do these usually last. On 06Feb2021 soreness under her arm, unsure if muscle or lymph nodes. The outcome of the events achy, pain under the arm, under the injection site in which it was a soreness were unknown, soreness under her arm was recovering and aching in arm was recovered on 04Feb2021. Follow-up attempts are completed. No further information is expected.

Pt recivied her 2nd covid 19 vaccine on 3/26. Patient is a 76-year-old female with a past medical history significant for hypertension, depression, hypothyroidism 2nd covid 19 vaccine on 3/26 who presented on 5/18 to the ER with complaints of lightheadedness and nausea that occurred over the weekend and was diagnosed with new onset rapid atrial fibrillation. She denied chest pain or shortness of breath but noticed intermittent bouts of palpitations. She went to see her PCP who referred her to the emergency room. EKG and telemetry in the emergency room were significant for new onset rapid atrial fib. She was given diltiazem and admitted to the hospitalist service. CT of the chest was negative for pulmonary emboli or focal consolidation. She had no electrolyte derangements she has no history of sleep apnea and no history of obesity. Her troponin and delta were unremarkable. She was subsequently admitted to the hospitalist service. She was treated with metoprolol and amiodarone along with Eliquis. She was seen by her cardiologist. Her recent echocardiogram was normal. Her TSH was actually elevated at 11.0 so her levothyroxine dose was increased to 175 mcg daily with a TSH in 6 weeks. At this time patient's rate is much better controlled but she remains in atrial fib. She will be following up with her cardiologist closely post discharge. She is also complaining of persistent R shoulder pain and weakness since her vaccine. Her shoulder x ray showed arthritic changes. She also c/o the worst headache of her life that lasted a week starting on May 4th. CT head was neg.

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.

This is a spontaneous report from a contactable consumer or other non hcp. A 76-years-old female patient received bnt162b2 (COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 20May2021 as 1 st dose single for covid-19 immunization. The patient medical history and concomitant medications were not reported. Patient is a 76-year-old female patient who received her 1st dose of the COVID Vaccine a week ago today, 20May2021. She mentioned that she experienced basically every side effect on the fact sheet except nausea. She had fever, chills, injection site swelling. injection site redness and warmness, swollen lymph nodes under her left arm, body aches, joint pains, tiredness, headaches, and a general feeling of unwellness. She mentioned that this lasted for 5 days and all came in gradually and not all at once. She is better now as of calling. She was asking if this is to be expected with the 2nd dose as well. The patient enquired whether using a heating pad would affect the effectiveness of the vaccine. The outcome of the events fever, chills, injection site swelling, injection site redness and warmness, swollen lymph nodes under her left arm, body aches, joint pains, tiredness, headaches, and general feeling of unwellness were recovered. Information on the lot/batch number has been requested.

Extreme pain on left side of body knee, ankle, hipt side of body knee, angle, hip; Extreme pain on left side of body knee, ankle, hip side of body knee, ankle, hip; This is a spontaneous report received from a contactable consumer (Patient). A 76-year-old female patient received first dose of BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number: unknown, expiry date: unknown), via an unspecified route of administration, administered in Arm Left on 01Mar2021 at 10:45 as 1st dose, single dose for covid-19 immunisation. Patient medical history included torn meniscus injury left knee. Patient concomitant medication included Tramadol (50mg), Gabapentin (300mg). Patient was not allergic. The patient was not diagnosed with COVID-19 prior to vaccination. The patient had not been tested for COVID-19 since the vaccination. On 01Mar2021 at 16:00, the patient experienced extreme pain on left side of body knee, ankle, hip it had lasted 6 days already and not letting up. No treatment was received. The outcome pf event was not recovered. No follow-up attempts are needed. Information about lot/batch number cannot be obtained.

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

She has been experiencing hair loss for a while; had a little bit of muscle pain; This is a spontaneous report from a contactable consumer (patient) via medical information team. A 76-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EN5318) via intramuscular route of administration in left arm/shoulder on 02Feb2021 (at the age of 76 years old) in the morning as 1st dose, single dose and second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EL9266) via intramuscular route of administration in left arm/shoulder on 23Feb2021 (at the age of 76 years old) in the morning as 2nd dose, single dose both for COVID-19 immunisation. Medical history included psoriasis on legs. Concomitant medication included hydroxychloroquine sulfate (PLAQUENIL S) 200mg tablet by mouth once daily taken for psoriasis from 29Mar2021. The patient did not receive any additional vaccines on same date of the Pfizer suspect. The patient did not receive any other vaccines within 4 weeks prior to the first administration date of suspect vaccine. The patient experienced she has been experiencing hair loss for a while on 07Apr2021 and had a little bit of muscle pain on an unspecified date in 2021. It was reported as, patient received both doses of the Pfizer Covid 19 vaccine in February. She has been experiencing hair loss for a while. Her dermatologist told her it was due to the vaccine. She enquired whether this happened to anyone else or was there other reports also. She was getting treatment for psoriasis and thought it was due to it. She contacted the FDA and was told it would take 120 days for it to drop to a half dose in her system. She asked about contacting CDC to report it. She was so upset that this happened to her. The patient hair loss was almost gone now, her daughter said she had fuzzies instead of bald spots. She just had bloodwork a few weeks ago, and had regular meds she takes, but has been taking those for a couple years but they don't make a difference with the shot, she doesn't believe. Patient has psoriasis on legs and was taking a new drug her dermatologist provided and she called the FDA about this med and they said it could cause hair loss but probably not, her doctor said it was not the cause of it. Drug was Plaquenil, but she was taking the generic for that, she was taking hydroxychloroquine 200mg tablet by mouth once daily, she started, she believes 29Mar2021 for psoriasis on legs. She stopped it as soon as her hair was falling out, as she thought it was that originally, but her dermatologist said it was not, it was from the shot. Patient did not visit physician office but it was panic, she was crying for 2 weeks, her daughter informed there was nothing to do, it will just fall out. Patient informed that when she got the shots, she didn't have any kind of reaction, just the second, she had a little bit of muscle pain, but overnight it went away. The patient underwent lab tests and procedures which included blood test: unknown on an unspecified date. Outcome of the event hair loss was recovering and for muscle pain recovered on an unspecified date in 2021. Follow up attempts are needed. Further information has been requested.

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

Acute idiopathic Pericarditis with recent hx of new onset rapid atrial fib admitted from 5/18-5/21 thought to be a possible immune mediated side effect from her covid 19 vaccine .. since 5/9 she has been experiencing daily severe headaches, malaise, intermittent palpitations. Ct brain at that time neg for bleed but showed small/old b/l lacunar infarcts. cta was neg for pe/acute pathology. She was discharged out on amiodarone, metoprolol and eliquiss to follow up with cardiology.on follow up with him her amiodarone was dc'd and the plan was to see EP for possible cardioversion but She then was readmitted from 6/5 -6/8 with new pericardititis with new b/l pleural effusions, new chf and new cardiomyopathy. She c/o 2 days of sob, b/l shoulder pain, chest heaviness and pain, worsened while lying flat along with continued intermittent racing heart. cxr showed new Basilar predominant opacities in both lungs suggesting pulmonary edema and was admitted with new chf with bnp of 993. She was then noted to have an elevated wbc with left shift and a fever and her CRP was markedly elevated at 67. CT chest showing Nonspecific abnormalities including 1cm thick pericardial effusion, bilateral pleural effusions and mild right-sided ground-glass lung opacification. . She has had no recent infections, travel, cont meds, does not drink alcohol, smoke or use drugs or supplements covid 19 neg. She was started on colchicine 0.6mg bid and ibuprofen 600mg q8h on 6/6 and was discharged home to follow up again with cardiology. she has improvement in herwbc to normal, resolution of L shift, resolution of fever and only slight increased crp. She has also converted to sinus rhythm although still tachycardic around 110bpm. Her headache is gone and she is no longer vomiting. State echo done this am showing ef 55% and new hypokinesis of the basal inferior wall and a Small amount of pericardial effusion with out any doppler evidence of Tamponade She had an echo last month which was normal She was also started on antibiotics due to b/l effusions which were eventually stopped before discharge

I am having some long term achiness in my left arm it is gone into my shoulder and joint; I am having some long term achiness in my left arm it is gone into my shoulder and joint; the right side is hurting too; This is a spontaneous report from a contactable consumer (patient herself). A 76-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot Number: EW0150/Batch number was not reported), dose 2 via an unspecified route of administration, administered in arm left on 01Apr2021 at 14:00 (at the age of 76-years-old) as 2ND DOSE, SINGLE DOSE for covid-19 immunisation at Hospital. Medical history included diabetes mellitus from an unknown date and unknown if ongoing (Verbatim: Diabetes), hypertension from an unknown date and unknown if ongoing (Verbatim: high blood pressure), blood cholesterol increased from an unknown date and unknown if ongoing (Verbatim: High cholesterol). Concomitant medication(s) included metformin (METFORMIN) taken for diabetes mellitus, lisinopril (LISINOPRIL) taken for an unspecified indication, atorvastatin (ATORVASTATIN) taken for blood cholesterol, acetylsalicylic acid (ASPIRIN (E.C.)) taken for an unspecified indication, pravastatin (PRAVASTATIN) taken for an unspecified indication and insulin (INSULIN) taken for an unspecified indication. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot Number: EN6206/Batch number was not reported), dose 1 via an unspecified route of administration, administered in arm right on 10Mar2021 at 15:00 for covid-19 immunisation. Consumer stated that, patient having some long term achiness in his left arm it is gone into his shoulder and joint and he had Rotator pesto (Not alpha spelled, further clarification unknown) long time ago but he know its not torn he haven't done any thing, and the right side is hurting too, both arm kind of hot, he don't know if its the vaccine but its both arm, right one not too bad, left one so bad, applied cream with lidocaine on it. Consumer stated that, for the treatment of the events he taken Tylenol, and he put Aspercreme with lidocaine. The patient underwent lab tests and procedures which included blood test was unknown on an unspecified date. Therapeutic measures were taken for the events. The outcome of the events was unknown. Information on Lot/Batch number was available. Additional information has been requested.

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

Chills; Fever of 100 degrees; Soreness in shoulders; Soreness in neck; Mild stomach ache; Lingering tiredness; This is a spontaneous report from a contactable Consumer, the patient. A 76 years old non pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID 19 mRNA VACCINE; Lot no: EN6205) via an unspecified route of administration through the right arm for COVID 19 immunisation on 06Mar2021 at 15:30 PM. The patient past drug history includes BNT162B2 (PFIZER-BIONTECH COVID 19 mRNA VACCINE; Lot no: EN6201) received through the right arm. The patient medical history includes Afib (Atrial fibrillation), diabetes and Age (Acute gastroenteritis). 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 has not been tested for COVID 19 since the vaccination. On 07Mar2021 at 15:30 PM, The patient experienced chills, fever of 100 degrees, lingering tiredness, mild stomach ache, soreness in the neck, soreness in the shoulders. No treatment measures received for the adverse events. The clinical outcome of all events was recovered. No follow up attempts are needed. No further information is expected.

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.

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.

has trouble moving her arm/ received vaccine in left arm but right arm was hurting; muscles in her right arm to her elbow was hurting; Swelling; This is a spontaneous report from a contactable consumer (patient). A 76-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EL9246), via an unspecified route of administration, administered in left arm on 05Feb2021 02:55 (Age at Vaccination: 76 years) as 1ST DOSE, SINGLE for covid-19 immunisation. The patient medical history was not reported. Concomitant medication(s) included PRESERVISION (reported as eyes) for AREDS 2, 1 twice daily from Feb2021 to ongoing started a week ago; hair skin and nails (reported as stye) as 2 gummies daily on an unknown date in 2020 (reported as 3 to 4 months ago). On 06Feb2021, the patient experienced swelling. On 07Feb2021, the patient has trouble moving her arm/ received vaccine in left arm, but right arm was hurting. The patient reported that when she woke up on Saturday her right arm was hurting. She received the vaccine in her left arm. The muscles in her right arm to her elbow was hurting. She also has swelling in her arm. She used Hemp Pain Cream. She is asking if she can take any type of pain killers. She is also having trouble moving her arm. She confirms that this started after receiving the vaccine. There was no history of all previous immunization with the Pfizer vaccine considered as suspect. There were no additional vaccines administered on same date of the Pfizer suspect. The events did not require a visit to emergency room or physician office. There were no prior vaccines administered within 4 weeks. The patient still had pain even after using Hemp Vana Pain Cream. Patient received treatment as Hemp Vana Pain Cream (Lot number: 37455C, expiration date: Dec2021). The outcome of all the events was not recovered. Follow-up attempts are completed. No further information is expected.

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

Chills; Muscle and joint aches; Joint aches; Upset stomach; Tired; 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: UNKNOWN), via an unspecified route of administration in the right arm on 20Mar2021 at 09:15 (at the age of 76-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Allergies to medications, food, or other products that included sulphur drugs. Concomitant medications included Tylenol started on unknown date within 2 weeks of vaccination for unknown indication. The patient previously taken first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EP6955), via an unspecified route of administration in the right arm on 27Feb2021 at 09:15 (at the age of 76-years-old) as a single dose for COVID-19 immunisation. Prior to vaccination, the patient did not diagnose with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient received other vaccines within four weeks prior to the COVID-19 vaccine which are not specified. The patient experienced chills, muscle and joint aches, upset stomach and tiredness on 21Mar2021. The patient did not receive any treatment for events. The events didn't result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The outcome of the events chills, muscle and joint aches, upset stomach and tiredness were not resolved. Information about lot/batch number cannot be obtained. No further information is expected.

felt real weak in her legs; not feeling well; Stomach upset; felt weak; This is a spontaneous report from a contactable consumer (Patient, self-reported). A 76-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number, NDC number and expiry date was not provided), dose 2 via an unspecified route of administration on 03Feb2021 (at the age of 76-years-old), as dose 2, single for covid-19 immunization. Medical history included ongoing asthma diagnosed when she was a child. There were no concomitant medications. Family medical history relevant to ae was not provided. The patient had previously taken the first dose of the bnt162b2 (batch number: EL9263) on 13Jan2021 (at 13:30-16:00, as reported) for covid-19 immunization (Unknown dose shot in right shoulder once, as reported). Patient age at first and subsequent immunizations if dates of birth or immunizations not available was not provided. No other medication were administered within four weeks prior to the first administration date of the suspect vaccine. Prior vaccinations patient had no adverse event. The patient stated that she felt real weak in her legs. Clarified that it is for the Pfizer Coronavirus shot. Wanted to know what to do about it. It was reported that the patient feeling weak started 3 days ago and feeling week in her legs which started 2 days ago. The patient stated she is still doing what she has been doing. Vaccination facility type was nursing home. On an unspecified date, the patient experienced "felt real weak in her legs", not feeling well, on 07Feb2021 felt weak and at 20:00, stomach upset. The adverse events did not cause emergency room or physician office visit. Treatment was for taken with Pepto Bismol as a result of stomach upset. Outcome of the events were not recovered. Follow-up attempts completed. No further information expected.

Pain in left knee making it difficult to walk upon getting out of bed.; Pain in left knee making it difficult to walk upon getting out of bed.; 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, Solution for injection, Lot number: EM9810 and Expiry date: Unknown), via an unspecified route of administration, administered in Arm Left on 06Feb2021 13:00 (at the age of 76-years-old) as DOSE 1, SINGLE for Covid-19 immunization. Not pregnant at the time of vaccination. The patient medical history was not reported. Concomitant medication(s) included lecithin, hormone replacement, CA, D, levothyroxine. Patient had no allergy. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not received any treatment and diagnosed with Covid 19 and has not been tested for COVID-19 Since the vaccination. On an unspecified date the patient experienced pain in left knee making it difficult to walk upon getting out of bed. I had no previous problems with my knee. Patient did not received any treatment for the events. The most recent COVID-19 vaccine was administered at hospital. Non-serious report. The outcome of event was not recovered. Follow-up attempts are completed. No further information is expected.

secretions and vomitting at 11pm...suctioned. 2:25 am 6/30 vent alarm. pt pale, bp 72/38 pulse 46 , cyanotic lips, limp, resps 11. pt passed at 2:30

This is a non-interventional study report from the marketing program received from a contactable consumer (patient) based on information received by Pfizer. A 76-year-old female patient received BNT162B2 (Pfizer BioNTech covid-19 Vaccine, solution for injection, Batch/Lot number was not reported), dose 1 intramuscular on 12Apr2021 (at the age of 76-year-old) as dose 1, single for covid-19 immunisation. The co-suspect included upadacitinib (RINVOQ), oral from Oct2020 (Batch/Lot number was not reported) to an unspecified date, at 15 mg for moderate to severe rheumatoid arthritis. The patient's medical history included diabetes mellitus from 1960 to an unknown date, rheumatoid arthritis from 1987 to an unknown date, internal haemorrhage from 2018 to an unknown date, small intestinal resection from Dec2018 to an unknown date, abdominal hernia from 2019 to 02Jun2021, non-tobacco user from an unknown date and unknown if ongoing, knee arthroplasty from 15Feb2021 to an unknown date, difficulty in walking. It was unknown if she was enrolled in a COVID-19 vaccine trial. Concomitant medications included methotrexate taken for an unspecified indication, start and stop date were not reported; paracetamol (TYLENOL) taken for rheumatoid arthritis, start and stop date were not reported; gabapentin (NEURONTIN) taken for rheumatoid arthritis, start and stop date were not reported; prednisone taken for rheumatoid arthritis, start and stop date were not reported; flecainide taken for heart rate decreased, start and stop date were not reported; metoprolol taken for heart rate, start and stop date were not reported; warfarin sodium (JANTOVEN) taken for an unspecified indication, start and stop date were not reported; venlafaxine taken for pain, start and stop date were not reported. On an unknown date in Apr2021, patient experienced knee surgery. On 13May2021, patient had another procedure for her abdominal hernia. Patient mentioned that her hernia was located in five different places, there were two on her left lower abdominal area and three on the right lower area. She stayed in the hospital for six days until 20May2021 and was treated with unrecalled antibiotics and pain relievers. On 13May2021, the patient experienced could not open and close left hand and swelling of left hand. On an unknown date in 2021, patient stated that "Her first dose of Covid-19 vaccine that was caused pain in her rheumatoid arthritis and elevated blood sugar level with a result of over 400 milligrams per decilitre", knee osteoarthritis. The reporter causality for the events knee surgery, knee osteoarthritis was not reported, blood sugar abnormal was possible, joint range of motion decreased, peripheral swelling, arthritic pains were not related. The manufacturer causality for all the events were no reasonable possibility. The patient underwent lab tests and procedures which included blood glucose abnormal: unknown mg/dl on an unknown date, blood glucose abnormal: unknown mg/dl on 09Jun2021, blood glucose abnormal: over 400 mg/dl on an unknown date in 2021, computerised tomogram: unknown on an unknown date, international normalised ratio: unknown on 09Jun2021, x-ray: unknown on an unknown date. The outcome of the events "Her first dose of Covid-19 vaccine that was caused pain in her rheumatoid arthritis and elevated blood sugar level with a result of over 400 milligrams per decilitre" were not recovered. The outcome of the events, knee surgery, knee osteoarthritis, could not open and close left hand and swelling of left hand were recovering and the outcome of had another procedure for her abdominal hernia was unknown. No follow-up attempts are needed. No further information is expected.; Sender's Comments: As per the information provided in narrative, the events hernia repair, knee operation, Osteoarthritis is assessed as possibly related to the suspect drug BNT162B2 based on strong temporal association. The events hyperglycemia, joint range of motion decreased, peripheral swelling, and arthralgia is assessed as possibly unrelated to the suspect drug BNT162B2 since the reporter denies causality. Also, consider possible contributory effects from patient's medical history and/or concomitant medications. 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.

Intense lower back pain; could only sleep sitting up; This is a spontaneous report from a contactable consumer, the patient. A 76-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: EN6207), via an unspecified route of administration on the left arm on 16Mar2021 at 10:00 (at the age of 76-year-old), as a single dose for COVID-19 immunisation. The patient reported that no medical history. Concomitant medications included simvastatin (ZOCOR), Vitamin D (MANUFACTURER UNKNOWN) (not specified), 81 mg aspirin (MANUFACTURER UNKNOWN), calcium (MANUFACTURER UNKNOWN) and naproxen sodium (ALEVE) for unknown indication. The patient did not have any allergies to medications, food or other products. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 16Mar2021 at 15:00 (about 4 hours after shot), the patient experienced intense lower back pain which began. She could not stand up straight, walk at 45-degree angle for 3 days and could only sleep be sitting up. The patient did not take any treatment for the adverse events. The adverse event did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events intense lower back pain and sleep sitting up were resolving at the time of this report. No follow-up attempts are needed. No further information is expected.

Husband reported weakness in left arm the evening of vaccination. Patient's health has declined. She now needs assistance with moving from chair to bed. She can walk once she is on her feet, but cannot get to her feet by herself. Just very week.

Second dose: lymph nodes under jaw still swollen; Second dose: dizzy; Second dose: rapid heartbeat; Second dose: almost passed out; Second dose: throat tightened; Second dose: jaw was tender; Second dose: lymph nodes under jaw were tender; Second dose: jaw was tender/Second dose: lymph nodes under jaw were tender; Second dose: tired; Second dose: nauseous; Second dose: diarrhea; Second dose: muscle pain; Second dose: joint pain; Second dose: chills; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 76-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 2 via an unspecified route of administration, administered in Arm Right on 30Jan2021 (76-years-old at the time of vaccination), (Batch/Lot Number: EL9265, Expiry date May2021) as DOSE 2, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient previously took dose 1 PFIZER-BIONTECH COVID-19 VACCINE, solution for injection dose 1 via an unspecified route of administration, administered in Arm Right on 09Jan2021 12:30(76-years-old at the time of vaccination), (Batch/Lot Number: EL3248; Expiration Date: Apr2021) as DOSE 1, SINGLE for covid-19 immunisation and experienced throat started tightening, Lymph nodes under her jaw were sensitive to the touch, feeling more and more tired, entire body was leaden with lethargy, couldn't do anything, all her joints were aflame, nauseous, pain in muscles, pain in joints, couldn't raise either of her arms, chills, low grade fever of 99.2 degrees Fahrenheit, Fatigue. Patient was dreading getting the second Covid 19 vaccine. One of the questions on the questionnaire she filled out prior to getting her second dose was if she had a severe reaction to any vaccine. She answered yes but no one at the facility asked her about it. She put that she may have had a severe reaction with the first Covid 19 vaccine but no one at the facility questioned it. She put question marks on the questionnaire on that question to indicate she didn't know if she had a severe reaction for sure or not. She did want to have protection against the Covid 19 virus, so she did get the second Covid 19 vaccine. After getting the second Covid 19 vaccine she experienced the same thing going home. Her throat tightened. Her jaw and lymph nodes under her jaw were tender. She was tired but didn't feel the leaden feeling she had with the first Covid 19 vaccine. She was nauseous and had diarrhea. She had muscle pain and joint pain and chills. These symptoms went on for 5 days. She thought she would be ok after the 5 days like she was after her first Covid 19 vaccine dose. On the sixth day she almost passed out in the grocery store. She had to sit on the floor of the grocery store and put her head between her knees. She was dizzy. She was still having the diarrhea, nausea, and chills. It was like having influenza symptoms. She went home that day and got into bed. Then gradually she got better. Maybe around the 9th day after the vaccine she was able to do some things around her house and on the 10th day she was better. Her lymph nodes under her jaw were still swollen. She doesn't know if what she experienced were normal side effects. She found the Pfizer reporting website obtuse. The website indicates there was a time limit to finish a report. She did not file online because she wasn't sure she'd be able to finish in the time limit. She was grateful for protection against the Covid 19 virus and would get the Covid 19 vaccines all over again, but she was not looking forward to getting a Covid 19 vaccine booster. She reported she was very healthy and active. When probed if she had seen her primary care doctor or gone to the emergency department, she reports the hospital was far away. She was living in a rural area in the mountains and did not trust the closest hospital to her. Her doctor friend who was an ophthalmologist told her that her antibodies were really kicking in and that's why she had the reaction to the Covid 19 vaccine like she did. When probing adverse events following any other vaccines, she reports she hasn't had a vaccine since childhood and doesn't remember having any adverse events from her childhood vaccinations. The last vaccine she had prior to the Covid 19 vaccine was the cold vaccine she received in 1992. She'd like to add she also had a rapid heartbeat with the dizziness on the day she almost passed out in the grocery store. That was the sixth day after the second Covid 19 vaccine on 05Feb2021. Her heartbeat was rapid for about a week after starting on 05Feb2021. The clinical outcome of the events lymph nodes under jaw still swollen was not recovered, remaining all events was unknown. No Follow up attempts are possible: No Further information is excepted.

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

Couldn't raise either of her arms; Chills; Low grade fever of 99.2 degrees Fahrenheit; Sick for 5 days after receiving her first Covid 19 vaccine with flu like symptoms; Throat started tightening; Jaw was sensitive to the touch/tightening of her jaw; Lymph nodes under her jaw were sensitive to the touch; Jaw was sensitive to the touch/Lymph nodes under her jaw were sensitive to the touch; Feeling more and more tired; Entire body was leaden with lethargy; All her joints were aflame; Nauseous; Pain in muscles; Pain in joints; This is a spontaneous report from a contactable consumer or other non hcp (patient herself). A 76-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection) via an unspecified route of administration in Arm Right on 09Jan2021 12:30(76-years-old at the time of vaccination), (Lot Number: EL3248; Expiration Date: Apr2021) as dose 1, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. Historical vaccine included cold vaccine and experienced sickness for a week (The COVID 19 vaccine is the first vaccine she's had since 1992. The last vaccine she received was called the cold vaccine. Clarified this vaccine was for the common cold). The patient did not receive any other vaccines within four weeks prior to the vaccination. Patient reported that She was calling about the COVID 19 vaccine. On 09Jan2021, the patient experienced, throat started tightening, jaw was sensitive to the touch, lymph nodes under her jaw were sensitive to the touch, feeling more and more tired, entire body was leaden with lethargy, all her joints were aflame, nauseous, pain in muscles, pain in joints, chills, low grade fever of 99.2 degrees Fahrenheit, she was sick for 5 days after receiving her first COVID 19 vaccine with flu like symptoms and on 10Jan2021, experienced couldn't raise either of her arms. She wanted to report her side effects because her side effects were dramatic. She wanted to contribute to the research being done on the COVID 19 vaccine. She reported with the first dose of the COVID 19 vaccine she waited the 15 minutes after receiving the dose and got in her car. She lived about 20 minutes from the vaccine facility. Her throat started tightening and her jaw and lymph nodes under her jaw were sensitive to the touch. She had errands to run but she felt herself feeling more and more tired. She needed to eat something, but she hadn't. She couldn't do anything. It was like her entire body was leaden with lethargy. She went home and took a nap for a couple hours. When she woke up from her nap all her joints were aflame. She felt nauseous. She got up to go to the bathroom and went back to bed. The next time she woke up she had pain in her muscles and joints. She has a friend who is a doctor and he told her to take some Acetaminophen. She took the Acetaminophen and went back to sleep and woke up the next day. When she woke the next day on 10Jan2021, she couldn't raise either of her arms. She couldn't raise the arm she got the vaccine in or the other arm. She couldn't reach up to get things out of her cabinets. She also had chills the first night after getting the first dose of the COVID 19 vaccine. She took Acetaminophen again and it eased her muscle and joint pain. She also had a low-grade fever of 99.2 degrees Fahrenheit. Her normal body temperature is low around 97.8 degrees Fahrenheit. She reported she was sick for 5 days after receiving her first COVID 19 vaccine with flu like symptoms. She didn't feel like she could get up and do her normal life for 5 days. On the last day, day 5, most of the other symptoms had gone away. She only had fatigue. The lymph nodes were very slow going getting better as well as the tightening of her jaw, that lasted a long time. She was grateful for protection against the COVID 19 virus and would get the COVID 19 vaccines all over again, but she is not looking forward to getting a COVID 19 vaccine booster. The patient underwent lab tests and procedures which included body temperature: 99.2 degrees Fahrenheit on 09Jan2021 Normal body temperature is low around 97.8 degrees Fahrenheit. Therapeutic measures were taken as a result of, all her joints were aflame, pain in muscles, pain in joints, low grade fever of 99.2 degrees Fahrenheit as Acetaminophen. The clinical outcome of the events Jaw was sensitive to the touch/tightening of her jaw, Lymph nodes under her jaw were sensitive to the touch was recovering, Fatigue not recovered, remaining all other events were recovered on 14Jan2021. No follow up attempts are possible. No further information is expected

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.

-March 4, 2020 - Morning after vaccine - Ankles swollen. I never had swollen ankles in the past. Bumps under skin on right forearm - felt like sand pebbles under skin. That has continued and is present now also. - March 6, 2020 - Breathing became tight - remained that way for a good two months. Shortness of breath - Month of March - Rash was breaking out on lower right leg and lower back. itchiness ( But, I was unaware that it was Covid Vaccine related) Gradually became larger rash on right shin area. Right ankle and leg started to swell. - Last week of March, First Week of April - Right leg became more swollen and inflamed. Then became frighteningly swollen. Rash on arms increased. April 15, 2021 - Dermatologist appointment - He told me that the protective barrier on my skin had broken down. Prescribed Steroid cream, and CereVe moisturing cream morning and night. Cetaphil Gentle Skin cleanser used very sparingly on only parts of body absolutely necessary to wash, but not on rash area. No hot showers ever again. He said he would not need an antihistamine. Refused to address swollen leg and ankle. ( Your site tells me it is closing, so I do not have time to continue.)

I already have some muscle pain; 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, Batch/lot number: EL0142, expiry date not reported), via an unspecified route of administration on 07Jan2021 09:30 at single dose on right arm for COVID-19 immunization. Medical history included none. There were no concomitant medications. The patient reported that she received the first dose of the vaccine yesterday (Thursday, 07Jan2021) and is scheduled to have the 2nd dose on 28Jan2021. She is asking if she should delay her Aerobics class the next day after the 28th because she knows that there are flu like symptoms that are associated with the 2nd dose of the vaccine. The patient stated, "What are the side effects after the 2nd dose? I already have some muscle pain." The patient also denied having any problems or symptoms after yesterday's shot (as reported, pending clarification). No other vaccine received that day and none in the 4 weeks prior. Not had any problems with the vaccines in past. When looking for name of vaccine states it was the one from Pfizer that was frozen, 170 degrees below zero. Mentions she is not a flu vaccine person and did not know if that matters. The adverse event did not require a visit to the Emergency Room or Physician Office. No relevant tests done. The outcome of the event was unknown.

Severe pain deep in left buttocks hip area. Began 01/14/21 am and continuing Now. Taking Aleve every 12 hours for some relief Pfizer COVID Vaccination on 01/13/21 at 7:27 am at medical center. Vaccination in right arm. I am 77.5 years old. Is there a drug interaction between Valtrex and the COVID vaccine?? I take Valtrex daily. Help

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.

About 19 hours after receiving the Pfizer Covid-19 vaccine, I got a fever of 101 degrees. My left arm felt very heavy.

Nausea and violent vomiting for 2 hours. Upper back and neck pain for 36 hours. Chills and shaking for 12 hours. Urine is now colorless instead of yellow-orange. I have had no treatment. Urine remains colorless, but other symptoms are almost resolved.

After a few days, muscle/joint pain ....headaches.....Tiredness......injection sit pain.... all were bearable and strong to disappear when i waek after the short I got Horrible chills, completely out of control, had to wear my night guard to stop teeth from getting chipped, lasted 3 or four hours. Could not warm up, had two down comforters on. The chills eventually stopped but the headaches Intensified, also I could. Or move my near and shoulders. Went to the ER, they did not believe it had anything to do with the shot, I was there for 12 hours, had head exrays, spinal taps to test for meningitis, they searched for anything else I might have...nothing else.. they would not say if I should have the second shot, called pfiser this morning, they could not tell me if I should have the second shot, that I should aske my doctor.......If Pfiser doctor does not know if it is safe how could my country doctor.

Short lived but I thought you should be advised. Heavy feeling in legs starting around 4.5 hours after shot, lasted for approximately 24 hours. Also arm felt sorer that on first show. Now feeling fine

The shot was given in my left shoulder. Two days later the left shoulder blade became rather painful, making movement difficult. E.g. turning my head to the left was very uncomfortable. These symptoms lasted about two days -- by a week later they were gone I used a hot pad and tylenol to become more comfortable. Probably not a very significant issue, but it was uncomfortable, I wondered if I perhaps had "pulled a tendon" or something like that.

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.

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.

Increase in cardiac arrhythmia - a-fib and rapid pulse, up to 135bpm while asleep Muscle and joint pain Fatigue

About 12 hours after receiving my booster vaccine I started feeling chills, then fever and extreme muscle aches and headache. My fever lasted about 12 hours running between 100 and 102 (on tylenol) Headache continues. Muscle aches and fever subsided about 24 hours after onset.

Note:Tested positive to CV19 27th October 2020 Pharmacy. CV19 Symptoms: High fever and fatigue. No loss sense of taste and/or smell. No breathing problems. 5th February 2021 Pfizer 1st dose CV19 vaccine. Scary symptoms started in grocery store parking lot around 6PM (after vaccine at 8:35A) my legs felt like they were partially paralyzed and I would not be able to walk to the car. I struggled to walk. Got home and laid down. Thought it was side effects to vaccine and it would pass if I went to sleep. Woke up and felt totally paralyzed and it required a lot of effort to turn on my side to try to reach my phone. All my muscles and joints ached. I am never sick and not a complainer.

Severe all over muscle and joint ache, fatigue, dry cough, chills, dizziness and weakness. Began around 7 or 8 am February 5 and continued all day and evening. I slept most of the day. Around 11:30 that night I woke up feeling quite a bit better. I slept all night. The next morning, Saturday, the aches had gone away and I was alot better. The cough, however, continued. The cough continued through Sunday. Monday the cough happened only a few times and I felt energetic and completely back to normal.

chills, shakiness followed by feeling very warm, sweating and sweaty, Extreme fatigue, body aches, joint pain. Injection site pain. Muscle pain. Nausea--did throw up twice. General feeling unwell. The fatigue has gone on for two weeks now. Starting to get better.

Date and time of vaccination: (list both if they received both shots): 1/6/2021 (First dose) 1/27/2021 (second dose) redness, swelling at injection site, feels like fat hanging from the arm. still occuring

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.

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

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

On first day had chills, sore throat, both minor. Second day had fatigue, moderate joint and muscle pains. Third day, some muscle pain.

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.

Extreme shaking and chills, large lump appeared on left leg thigh, Pressure of top of head (left side) and painful throbbing on right side of neck.

This is a spontaneous report from a contactable healthcare professional. A 77-year-old female patient received her first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) on her left arm, via an unspecified route of administration on 28Jan2021 13:30 at a single dose for covid-19 immunization. Medical history included diabetes type 2 and neuropathy (reported as neuropothy). The patient experienced Upper and middle back severe pain, nausea, vomiting, diarrhea; all on 01Feb2021 04:00 AM. The outcome of the events was unknown. Information on the lot/batch number has been requested.

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

chills; slight headache; joints aching; muscles aching; fatigue; weakness; This is a spontaneous report from a contactable healthcare professional. A 77-year-old non-pregnant female patient received her second dose of bnt162b2 (BNT162B2 reported as PFIZER COVID-19 VACCINE; lot number: EL9262; expiration date: unknown), via an unspecified route of administration right arm on 06Feb2021 14:00 at a single dose for covid-19 immunization. The patient medical history was reported as none. The patient has no allergies to medications, food, or other products. The patient was not diagnosed with COVID-19 prior to vaccination. Concomitant medication included bupropion, levothyroxine, sumatriptan succinate (IMITREX) and vitamin nos (MULTIVITAMIN). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient had his first dose of bnt162b2 (BNT162B2 reported as PFIZER COVID-19 VACCINE; lot number: EL3246) at the age of 77-year-old via an unspecified route of administration right arm on 16Jan2021 14:00 at a single dose for covid-19 immunization. On 07Feb2021 11:00 PM (reported as 33 hours post [23:00] second vaccination), the patient had chills, slight headache, joints aching, muscles aching, fatigue and weakness. The patient has not been tested for COVID-19 since the vaccination. The events were non-serious, and the patient did not received treatment for the adverse events. The outcome of the events was recovered on Feb2021.

This was my second vaccination at the same site. I was fine with the first shot, and seemed fine with the second one until the next afternoon around 3:00 p.m. All of a sudden I could feel some aching in the back of my neck and just a feeling of aching down my back. Then I started to get the chills, chills that were so bad my body was almost convulsing with chills. I ended up going to bed and I turned my electric mattress pad on to warm up. I then slept very well and I don't think I moved all night. I woke up sort of achy, but not much to be concerned with.

on 2/11/2021 AT 5:30pm Evening of the vaccination, my neck aching, and slight headache, When I woke the next day my arms and legs and neck and head ached, like I was coming down with a flu bug. Slight headache, Lymph nodes in neck painful and sore, legs and arms aching, flu like symptoms

2/19/21 12:30 AM- slight headache, followed by chills and body ache-especially lower bac. Last until about 4 PM 2/19/21 2/19/21 2:00 AM - discomfort chest/heart- Thought maybe I should mention it to doc if continued. Lasted 20 min. max. 2/19/21 12:30 AM-lower abdominal discomfort, bowel movement did not relieve discomfort - intermittent for several days until 2/23/21. Did not interfere with activities. Since symptoms were mild, I "toughed" it out. No medication

Blinding headache/ severe headache; chills/ shivers; couldn't warm up; Whole body was shaking out of control/ She got the shakes so bad she shook for like 5 hours; Neck froze completely; She can't move her head up and down normal/ couldn't move her head; Pain in her neck; pulled muscles; Muscles were so sore; Fatigue/Extreme tiredness; Weakness; Muscle pain; Joint pain; 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: EL0140), via an unspecified route of administration at the right arm on 13Jan2021 at a single dose for COVID-19 immunization. The patient had anaphylactic shock in the past to a sulfur antibiotic. There were no concomitant medications. She stated she did not have an extreme reaction for the first 3-4 days, it was fine and went away. She had fatigue, joint pain, all the regular things and they were easing up. She had an appointment on the 20Jan2021 and thought things were going okay. On day 7, 20Jan2021, that night, she had an extreme reaction of blinding headache, the shakes, her whole body was shaking out of control for hours, her neck froze completely, and she can't move her head up and down normal (this is still occurring). The patient has had joint paint on 14Jan2021; extreme tiredness, weakness and muscle pain on 15Jan2021; chills, pain in her neck and muscles were so sore from 20Jan2021. She figured that was side effects, and she was handling, and then exactly a week after, she got the shakes so bad she shook for like 5 hours, she had to put nightguard in her mouth to stop from cracking, and severe headaches and her neck completely locked up, she couldn't move her head, and she still can't. She had extreme headache, and she went to the ER on 26Jan2021, since she was in really bad shape, they wouldn't believe her that it was a COVID reaction, she was there for 12 hours, they did every test, she had spinal taps, she had a head X-ray, everything, as they said she had meningitis, but then ruled that out, they wouldn't believe she was having a reaction to the COVID shot, she can't move her head, her joints and that are ok otherwise, but she can't move her head, she has pain in her neck, and she is taking Excedrin for that. She stated her doctor told her to go ahead and take the second dose of the vaccine and just take Tylenol after. She stated Tylenol has no effect whatsoever. If she takes Excedrin the headache will go away and Tylenol won't budge it. She stated she is taking Excedrin regardless of what the doctor says. When asked for age of onset, states she was on Valium and she was not thinking straight, and asked her husband her age. She was not sure why it was given, now provides name as Diazepam 5mg. Muscle pain is fine now, it went away. She went to the doctor on 20Jan2021, as she had a regular appointment for bloodwork to be done, and said she felt pretty good, she had some reaction but was fine, and that night is when she got shakes and shivers so bad, she had 3 quilts on and couldn't warm up, her body was out of control, she couldn't stop, now states for 3-4 hours. Severe headaches started the night of the 20Jan2021. Her neck pain started right after the shakes, so maybe she pulled muscles when she had the shakes, the muscles were so sore, and she couldn't move her head, like down or to the side, she couldn't move it, which is why she went to the hospital, to the ER. She was there for 12 hours. She started taking Excedrin, states she ignored what the doctor told her. She knows her body and she can take Tylenol and Ibuprofen like it is candy, and it does nothing, one Excedrin puts everything away, she swears by Excedrin. The outcome of the event shaking recovered on an unspecified date; Joint pain and Muscle pain recovered on 19Jan2021; Blinding headache/ severe headache, Fatigue/Extreme tiredness was recovering, chills/ shivers, couldn't warm up, Neck froze completely, pulled muscles, fatigue was unknown; she can't move her head up and down normal/ couldn't move her head, Pain in her neck, Muscles were so sore, Weakness was not recovered.

Tightening of neck, light headed- symptoms remained the same during monitoring. Did not get better of worse. Patient stated she took tylenol before vaccine and will take ibuprofen when she gets home. Water given.

Back pain, bilateral lower extremity neuropathy, paresthesias, lower extremity weakness, urinary retention, orthostatic hypotension

Two hours after injection severe pain in my right knee began and continues moderately today 3/3/2021. (injection given at 1452) The doctor suggested heat/cold, anti-inflammatory, brace and finally an x-ray which indicated nothing. Four days after the second injection I've experienced mild pain in my opposite thigh and fatigue. The second injection was given in the opposite arm (left). While chatting with others in recovery after second injection about knee pain, another woman said she was experiencing the same and thought it was her arthritis but it felt different.

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 was hospitalized 2.5 days after having symptoms of a "massive heart attack" 2 days after the vaccine; blood clot; pain on the left side/pain so bad/ pain was so severe couldn't bent over and couldn't get up; pain was in the heart and underneath the rib; pain was in the heart and underneath the rib; had a little trouble breathing; broke out in a sweat; This is a spontaneous report from a Pfizer-sponsored program Pfizer First Connect from a contactable consumer (patient). A 77-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number/expiration date unknown), via an unspecified route of administration on an unspecified date in Feb2021 at a single dose for COVID-19 immunization. Medical history included asthmatic, had double pneumonia years ago, has ongoing atrial fibrillation and a pacemaker to control it as the only problem she has in her heart. The patient's concomitant medications were not reported. On an unspecified date in Feb2021, the patient was hospitalized for 2.5 days after having symptoms of a massive heart attack two days after the vaccine. It was reported that two days post vaccination, the patient was rushed to the hospital by ambulance as they thought she was having a massive heart attack. She added her symptoms lasted for hours, she had pain so bad that she was bent over and had a little trouble breathing. She said the pain was in the heart and underneath the rib, on the left side. She later mentioned she did not feel like it was AFib. She said they did every test possible and listed the following ones: ultrasound, stress test, x-ray (unknown results), and blood work in Feb2021. She specified that her blood work indicated a blood clot. She mentioned she was told by her personal friend, who was a doctor, that by having the shot sometimes it indicated you have blood clots when you really don't. The patient also specified that she broke out in a sweat, the pain was so severe that she could not bend over and could not get up; therefore, they treated her as if she was having a massive heart attack for 12 hours at the hospital. It was reported that they kept giving her stuff to stop the effect with her heart. She mentioned her second dose was scheduled on 25Feb2021. She asked if her experience was reported as a side effect to the vaccine and should she get the second dose of the vaccine. She explained the doctors did not know what she had, and she needed to determine if she can receive the second dose. She also asked if we could notify her if a similar reaction is reported. The outcome of the events was unknown. Information on lot/batch number has been requested.

Mild headache, worse than normal fatigue, stiff neck, muscle ache, hot flashes, flushed cheeks, itching. Rash to antecubital area of right arm starting on Sunday night.

Pfizer-BioNTech COVID-19 Vaccine EUA: patient reports fatigue, myalgias, chills, and a swollen arm (at injection site) starting one day after receiving vaccination. Patient previously had COVID-19. During clinic visit three days after vaccination symptoms have resolved without intervention.

injection site pain; Nausea; fatigue; joint and muscle pain; joint and muscle pain; headache; chills; This is a spontaneous report from a non-contactable consumer (patient). A 77-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EN6201), via an unspecified route of administration on 20Feb2021 at 08:45 at a single dose in the right arm for COVID-19 immunization. Medical history included stage 4 breast cancer and thyroid cancer. Concomitant medications included levothyroxine sodium (SYNTHROID) and lorazepam. The patient previously took sulfur and experienced allergies and first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) for Covid-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. The patient was not pregnant at the time of vaccination. On 21Feb2021 at 04:30, the patient experienced injection site pain, nausea, fatigue, joint and muscle pain, headache, and chills. The patient did not receive any treatment for the reported events. The patient underwent lab tests and procedures which included Nasal Swab/COV-2 RNA (RT-PCR) NAAT with negative result on 09Oct2020. The outcome of the events was recovered. No follow-up attempts are possible. No further information is expected.

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.

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.

Pt. states she received vaccine and left the park but started to feel her jaw clenching and some tightness in the neck so she came back and was seen and assessed by EMT. Vital signs: BP 134/84, HR 78, O2 96%. 20 min. into observation she verbalized sensation began to decrease, When asked, she said that she could swallow. When asked if she had difficulty breathing, she said no difficulty breathing and felt no other symptoms at the moment. Pt. advised to contact PCP, go to the ER or an urgent care if any other symptoms arise. Client and daughter verbalized understanding of instruction and cleared to leave by EMT.

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

On the day after I had pain in my left side. On the following day, I went to the ER with severe sciatic. This recurred and on Feb. 24 I was admitted to the hospital with severe inflammation in my spine.

severe redness in upper arm, throbbing in wrist traveling upward to upper arm. Loss of strength/grip in arm/hand.

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

Right Arm and Shoulder Stiffened up while lap swimming at 07:00 am. Felt cold and felt pressure in my head. Came home and covered up as chills started. After 12 hours the fever gradually subsided as did the pain in my neck and shoulder. Was left with headache that remained overnight but the pressure was not like the day before. Saturday I was just tired, I think from the fever, but by the evening I was back to normal.

2/28/2021 DAY OF INJECTION #1 - HEAVY SENSATION IN UPPER LEFT ARM, LASTED LESS THAN 24 HOURS 2/18/2021 DAY OF INJECTION #2 - MILD SORE UPPER LEFT ARM RADIATED TO LEFT SHOULDER BLADE, USED TOPICAL ARNICARE FOR THE SORENESS WHICH LASTED ABOUT 24 HOURS 3/21/2021 VERY SORE UPPER LEFT ARM, SUDDEN "CHARLIE HORSE" RADIATED FROM THE INJECTION SITE TO THE LEFT SHOULDER BLADE, LUMP/KNOT UNDER THE INJECTION SITE ABOUT THE SIZE OF A WALNUT, USED ARNICARE AND MASSAGE, NO RASH OR VISIBLE BRUISING, SORENESS LASTED SEVERAL DAYS

Experienced soreness at injection sight, slight headache, fatigue, chills, weakness in legs, indigestion (sour stomach). I was diagnosed with having Covid-19 on Nov. 9, 2020. I had a mild/moderate case which lasted over 2 weeks. After receiving my first dose of the vaccine in the morning, I started experiencing the same symptoms (in the evening) that I had when I had the actual virus. One week later, I'm feeling better.

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!

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

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

Pain in left armpit and left breast. Entire left arm swollen and reddened. Upper arm covered with blue tiny veins extending into left chest area.

Pain in left left behind Calf also behind Thigh Swollen vein in left arm from wrist to high way up my arm . Some pain and lumps. Fast heart rate

Woke up with headache, sweats, chills, joint pain, and low grade fever. Stayed in bed for a day and a half the took it easy for the next two days. Back to normal the following day (Saturday).

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,

Severe muscle/nerve pain in neck, back, gluts, hamstrings while in bed from 3 am to 6 am. It has occured for four nights five days after the vaccine shot. Daytime okay. Taking Tylenol 625. Did not affect it. Need advice if this is a reaction or I should see a doctor.

Couldn't breathe/shortness of breath; Back pain; blood pressure was high; was just sick; This is a spontaneous report from a contactable consumer. A 77-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 1 via an unspecified route of administration, administered in Arm Right on 08Mar2021 (at the age of 77-years-old) (Batch/Lot Number: EN6199; Expiration Date: 30Jun2021) as SINGLE DOSE for covid-19 immunisation. Medical history included ongoing blood pressure abnormal, cancer in her left lung, ongoing blood cholesterol abnormal, ongoing gastric disorder, ongoing diverticulitis Verbatim: Virticulitis. Concomitant medication included acetylsalicylic acid (ASPIRIN 81) taken for blood pressure abnormal; atorvastatin (ATORVASTATIN) taken for blood cholesterol; hydralazine taken for blood pressure abnormal; lisinopril (LISINOPRIL) taken for blood pressure abnormal from Feb2021 and ongoing; pantoprazole taken for gastric disorder from 2020 and ongoing. The patient had her first shot and after that, a week after she experienced some adverse events like back pain and sickness. After the patient started experiencing back pain, and got progressively worse, she was having problem breathing/Shortness of breath was reported. The patient was ambulanced and mentioned she was brought to the hospital/stayed with her doctors overnight due to the experiences she had. She had blood work done and based on the results, they suspected a blood clot on her lung and her CT scan did show that she did not have a clot in her lung. It was also reported that they did blood test and urine test and that all that EKG because the patient had her blood pressure gone considerably high and in the blood test. She was prescribed to take Tylenol every 8 hours and a to put a back patch on the left side of her back where she is experiencing pain. Caller did not provide if she was admitted to the hospital, or if she just stayed in the ER overnight for observation. Now, she wants to know if she will still proceed with her 2nd shot on 29Mar2021. The patient underwent lab tests and procedures which included abdomen scan: normal, no indication of blood clot on 17Mar2021, angiogram: normal, no indication of blood clot on 17Mar2021, blood pressure measurement: high, blood test: a blood clot on her lung on Mar2021, computerised tomogram: normal, no indication of blood clot on 17Mar2021, covid-19: negative on 17Mar2021, x-ray of pelvis and hip: normal, no indication of blood clot on 17Mar2021. Therapeutic measures were taken as a result of back pain (back pain). The seriousness of the events back pain and Couldn't breathe/shortness of breath was hospitalization. The outcome of the events back pain was recovering. The outcome of the other events was unknown.

Diffuse body aches, muscle tenderness and neuropathic pain beginning 1 day following injection. No abnormal physical exam findings.

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

headache; fever; severe back and leg pain; severe back and leg pain; fatique; Extremely sore arm; chills; This is a spontaneous report from a contactable consumer. A 77-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; solution for injection), via an unspecified route of administration, administered in left arm on 23Mar2021 15:15 (Lot Number: ER8730 and expiry date not reported) as single dose for covid-19 immunisation. Prior to the vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Medical history included atrial fibrillation, hypersensitivity and diverticulitis (start and stop date was unknown for all). Concomitant medication(s) and patient received within 2 weeks of vaccination included: hydrochlorothiazide, losartan potassium (LOSARTAN HCT); dronedarone hydrochloride (MULTAQ); omeprazole (OMEPRAZOLE) and levocetirizine (LEVOCETIRIZINE) all taken for an unspecified indication, start and stop date were not reported. On 24Mar2021 at 01:30, the patient experienced extremely sore arm, chills, headache, fever, severe back and leg pain, fatigue. The patient did not receive any treatment for the adverse event. Outcome of the events was recovering. Additional information 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.

Extreme headache rot. Side of head, extreme back pain in left wing one , Runny nose, Chills took Tylenol and napped for hrs for two days. 2 heavynosebleeds right nostril one wk later. 2nd shot on 2-21-2021, Hot, 4 nights of night sweats, Two more bloody noses right nostril. Tired

Severe muscle pain in middle of night for two weeks. Went to clinic and got gabapentin. No effect. Went to ER and got muscle relaxer. Taking Tylenol for pain.

Developed massive Pulmonary Blood Clots in both lungs. First symptom was shortness of breath and feeling I would faint. Went to Hospital Emergency room and was admitted immediately spent 2 1/2 days in ICU for treatment to dissolve blood clots (TPA) Was discharged on third day as oxygen level, heart beat, breathing and blood pressure appeared normal. Took second COVID19 (Pfizer-BioNTec) shot on Monday, March 29, 2021 at 1:00 p.m. (Lot ER8732) No adverse reaction to second shot except some muscle paid in left leg (calf).

joints were sore; This is a spontaneous report from a contactable consumer (patient). A 77-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; Batch/Lot Number: EN9581), via an unspecified route of administration, administered in Arm Left on 22Feb2021 09:15 (at 77-year-old) as single dose for COVID-19 immunization. Medical history included ongoing AFib (She has had this condition for a about 6 years), ongoing getting anemic real easy (She says she has had this for the last 20 years), Glaucoma from 1998 (She says that in 1998 she had both eyes operated on and in 2016 she was operated on again), Cataracts from 2018, Pacemaker insertion (cardiac) (She states she has a pacemaker that controls her heart so the pulse does not drop below 65. She says that pacemaker was implanted, she thinks, 2014 maybe), Concomitant medications included metoprolol tartrate (METOPROLOL TARTRAS) taken for atrial fibrillation, blood pressure measurement from an unspecified start date and ongoing; warfarin (WARFARIN) taken for prophylaxis from an unspecified start date and ongoing; duloxetine (DULOXETINE) taken for anxiety from an unspecified start date and ongoing; montelukast (MONTELUKAST) taken for asthma from an unspecified start date and ongoing; folic acid (FOLIC ACID) taken for prophylaxis from 2015 and ongoing; ferrous sulfate (FERROUS SULFATE) taken for anaemia from an unspecified start date and ongoing; furosemide (FUROSEMIDE) taken for diuretic therapy from an unspecified start date and ongoing; baclofen (BACLOFEN) taken for muscle spasms from an unspecified start date and ongoing; hydrocodone bitartrate, paracetamol (NORCO) taken for arthritis from an unspecified start date and ongoing; calcium (CALCIUM) taken for arthritis from an unspecified start date and ongoing; ergocalciferol (VITAMIN D) taken for anaemia from an unspecified start date and ongoing; ongoing adult vitamins since her body doesn't absorb what she eats. The patient previously took BNT162B2 (Batch/lot number EL3246, Dosage text left arm) first dose on 04Feb2021 for COVID-19 immunization and experienced heart attack; must have passed out; the muscle that goes around her heart, it was having like a charley horse; heart rate, 102, 103, it went up to 200 in the ambulance; chest pain; Nausea; hard to breath; she didn't remember all the tests; 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. The patient said she has to leave in 20 minutes to a doctor's appointment. She says her second shot was on 22Feb2021 and the only reaction was it felt like a truck hit her, all her joints were sore (unspecified date), it lasted 2 days then went away, she feels good. Patient was hospitalized. She says she got the second dose to make sure she gets all the doses so she doesn't get sick. The outcome of the event was unknown.

PFIZER-BIONTECH COVID-19 VACCINE EUA. Patient received vaccination on 2/10/21. No adverse reactions reported following vaccination. Patient had unplanned weight loss x 1 month of 14.1% and 6 month loss of 20.8% according to nursing nutrition notes. HT: 60in Wt 122lb. Patient died on 2/12/21.

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

bone very painful for 24 hours; Extreme fatigue; weakness; muscle and bone very painful for 24 hours; swelling at the entry of the injection; knot at the entry of the injection; just feeling unwell; Night sweats; lethargic; This is a spontaneous report from a contactable consumer(patient). A 77-years-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: EL9246), via an unspecified route of administration, administered in left arm on 02Feb2021 23:15 as SINGLE DOSE for covid-19 immunization. The patient's medical history included knee replacement, 3 times pneumonia, surgery for mitral valve repair ablation and atrial fibrillation, all from an unknown date and unknown if ongoing. On 25Jan2021 at 2:00 pm patient received first dose of Bnt162b2 (Lot no: EL3249) in left arm. On 11Feb2021 10:30 pm patient experienced bone very painful for 24 hours, extreme fatigue, weakness, muscle and bone very painful for 24 hours, swelling, knot at the entry of the injection, just feeling unwell, night sweats and lethargic. Outcome of the events was not recovered.

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.

Started feeling like kind of small lumps in that muscle or little below; redness; Muscle soreness; itching; This is a spontaneous report received from a contactable consumer (patient) via Medical Information Team. A 77-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Batch/Lot Number: EN6201, expiry date: unknown), via an unspecified route of administration on 06Feb2021 (at the age of 77-years-old) at a single dose for COVID-19 immunisation. The patient's medical history was not reported. Concomitant medication included DILTIAZEM. Patient stated I take Tiadylt and it is, I think maybe to dilate blood vessels and rest of the stuff is over the counter. The patient received the vaccine on 06Feb2021 and experienced some muscle soreness. Patient stated, I just wanted to report that I received a Pfizer Covid vaccine on February 6th and experienced some muscle soreness. But on the 12Feb2021, I started feeling like kind of small lumps in that muscle or little below and some redness and by Saturday, redness was about three and a half inches in length and two inches wide and lumps are still there, you could see the lumps. Also, I could feel that knot, it is probably like an inch and a half big knot. I am just thinking if it was reaction. It itched a lot but I didn't really have any pain or discomfort with it, it just was red and little warmer to touch. No treatment was received for the events. The outcome of redness and vaccination site lump was reported as recovering, while the outcome of itching and muscle soreness was unknown. Follow-up attempts are completed. No further information is expected.

Patient presented with acute onset neck pain radiating into her arms bilaterally on 4/25. On 4/27 she acutely became paralyzed in her lower extremities and lose sensation over her abdomen completely and decrease sensation in her legs bilaterally. MRI confirmed large spontaneous epidural hematoma in cervical and thoracic spine.

Uncontrollable body shaking, high fever, cold and hot sweats, was not aware at times of where I was or what day it was, my husband had to hold me to help stop the shaking.....NOT CHILLS, could not walk, diarrhea. This happened also on March 31st, my FIRST injection.....My heart was beating out of my chest.... very scary. Please don't tell me this is NORMAL!!! I've lost at least 5 lbs. I am petrified to get the booster, if there is one, I WILL NOT GET IT... ANY SUGGESTIONS.

sore throat; swollen glands; she said her throat felt swollen, and like it was closing up; Feeling unwell; Weakness; light headed/weak when standing up; polymyalgia; sick; This is a spontaneous report from a contactable nurse (patient). A 77-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EL9284; Expiration Date: 31May2021), dose 2 via an unspecified route of administration, administered in Arm Left on 11Feb2021 14:30 as single dose for covid-19 immunisation. Medical history included polymyalgia rheumatica, Giant Cell Vasculitis from 2020 (Verbatim: Giant Cell Vasculitis, Reported she started taking Prednisone about a year ago for Giant Cell Vasculitis. She said she started at Prednisone 60mg a day, and now is down to Prednisone 10mg a day), Congestive Heart Failure, COPD, Hypertension, Pulmonary Hypertension. There were no concomitant medications.The patient previously took first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EL1283, Expiry Date: 30Apr2021) on 21Jan2021 via Intramuscular, anatomical location was arm left, prednisone for Giant Cell Vasculitis (she started taking Prednisone (60mg a day)about a year ago for Giant Cell Vasculitis and was down to Prednisone 10mg a day.her side effects are not that bad. She said she just expected to feel better.), flu vaccine (She gets temperature 101 and sick from the flu vaccine, so she doesn't get the flu vaccine anymore and it had been quite a few years since she took the flu vaccine.), pneumonia vaccine (got a pneumonia vaccine about a year or so ago).On 12Feb2021, patient had been on the couch and watching television. She was fine laying down, but when she got up, she was lightheaded and didn't feel well and had weakness when she got up. Patient had a sore throat with swollen glands in her neck, her throat felt swollen and like it was closing up and glands started hurting on 15feb2021. She was sick when got up, but when lay down she was fine. she had polymyalgia was doing better before the vaccination. She was wondering if it was normal for the COVID-19 Vaccine side effects to last that long or were the COVID-19 Vaccine side effects expected to last that long. Wanted to know if because she was taking Prednisone, her COVID-19 Vaccine side effects were lasting longer. Patient stated she always thought she was 5'5", but the last time she was measured at the doctor she was told she was 5'. No further details provided. her shortness of breath is worse since she got the COVID-19 Vaccine. She said she was doing better before she received the COVID-19 Vaccine. She took 1 Tylenol on 11Feb2021 and again on 15Feb2021 (Lot Number: 06V1489, Expiration Date: May2022). She said she took 2 Equate Brand Tylenol 500mg tablets because her throat felt swollen, and the throat swelling went away on 16Feb2021. Patient had severe pulmonary hypertension until she had a cardiac catheterization. She said she was told from the cardiac catheterization that she had the potential for pulmonary hypertension but did not have severe pulmonary hypertension. She said prior to the cardiac catheterization she had years of cardia echos performed, and the cardiac echos were not correct. The outcome of the event throat felt swollen was recovered on 16Feb2021, for feeling unwell, lightheadedness, weakness it was not recovered and sore throat, swollen glands it was recovering.

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

Headache; Backache; fever; nausea; exhaustion; sore throat; dry cough; bronchitis; This is a spontaneous report from a contactable consumer (patient). A 77-year-old female non-pregnant patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection, Batch/Lot Number: EL9263, Expiration date not reported), via an unspecified route of administration in left arm on 31Jan2021 09:30 (at the age 77-year-old), as a single dose for COVID-19 immunization. Medical history included Type 2 Diabetes. The patient previously took ondansetron (ZOFRAN) and experienced allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19. Concomitant medications included insulin degludec (TRESIBA), insulin aspart (NOVOLOG), Bupropion, Alprazolam and Estradiol. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 03Feb2021 14:00, the patient experienced headache, backache, fever, nausea, exhaustion, sore throat, dry cough and bronchitis. The events resulted in doctor or other healthcare professional office/clinic visit. The patient was tested for COVID twice by covid test type: one Nasal Swab test, on 08Feb2021, the result was negative. The treatment received for the events were antibiotics and steroid. Outcome of the events were reported as recovering.

sx: headache the day after vaccination and local pain in the opposite shoulder (right shoulder) from where she was vaccinated (left arm). headache resolved with apap dosing. but rt shoulder pain/tightness has persisted on and off for the last 9days. pt said she is not using apap on regular basis. and also admitted to doing light gardening during this time.

headache; sweats; Chills, so bad that my teeth were rattling; fever; muscle aches; exhaustion; This is a spontaneous report from a contactable consumer (patient). A 77-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection) dose 1 via an unspecified route of administration, administered in left arm on 10Feb2021 02:15 PM (Batch/Lot number was not reported) as single dose for covid-19 immunization. Patient was non-pregnant at the time of vaccination. Medical history included neuropathy and diabetes. The patient's concomitant medications was not reported. On 11Feb2021 patient experienced chills, fever, headache, muscle aches, sweats and exhaustion which lasted until Saturday 13Feb2021 and then patient was fine for several days but on the night of 17Feb at 8PM, again with the chills, so bad that patient's teeth were rattling, headache and sweats all this lasted until 3 AM then patient had aches and exhaustion for several days". The treatment was not received for the adverse events. Outcome of headache and sweats was recovered on an unspecified date and rest of the event was recovered on 13Feb2021. No follow up attempts are needed. No further information is expected.

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.

headache; chills; fever; sore muscles; This is a spontaneous report from contactable Consumer (patient).A 77-years-old (non-pregnant) female patient received BNT162B2 (COMIRNATY, Solution for injection, Batch/Lot Number: BN5318 and expiry date was not reported) dose 2 via an unspecified route of administration in left arm on 12Feb2021 12:00 (at 77-years age) as a 2nd single dose for COVID-19 immunisation and received BNT162B2 (COMIRNATY, Solution for injection, Batch/Lot Number: EL8982 and expiry date was not reported) dose 1 via an unspecified route of administration in left arm on 22Jan2021 12:00 as a 1st single dose for COVID-19 immunisation. The patient medical history included AFib and latex allergy. Concomitant medication(s) included rivaroxaban (XARELTO); flecainide (FLECAINIDE); amlodipine (AMLODIPINE). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 13Feb2021 at 01:00 AM the patient experienced with headache, chills, fever and sore muscles. The patient had no covid tested post vaccination. The patient did not receive any treatment medication for the events. The outcome of the events was recovered.

Had a stroke from blood clot; she lost weight; This is a spontaneous report from a contactable consumer (mother) that: A 77-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: ER8272) via an unspecified route of administration on 31Mar2021, as a single for COVID-19 immunization. Previously patient received first dose of BNT162B2 (covid-19 vaccine, Batch/Lot Number: not clear) via an unspecified route of administration on 10Mar2021 as single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. Reporter stated, "I don't know so I just was try to find out or who I report or ask about. I convinced my mother to get her Covid vaccine, so she got her second shot on 31Mar we got it together. Yesterday (17May2021 ) my mom had a stroke from blood clot, and I was just asking myself if it could have had anything to do with from Pfizer shot as she never had any problem like that and now, she was in the hospital from the stroke, and I was just wondering if me talking her and getting her vaccine could possibly had to do with this. Reporter further stated, Absolutely, I have question as far as if that was the cause, was there any special treatment that she should be getting maybe I can at least inform the doctor about that anything. I am out of my mind right now because I felt that I talk to her getting the vaccine because I want to her to be safe, she was 77 yrs. old (Not clarified) she never had any medical problem I feel guilty. Height and weight: Reporter stated, She was approximately 5'6. I don't know the weight as she lost weight, she was not obese or anything like that, but I honestly don't know her weight. The outcome for the events was 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.

5:42 PM Note Telephone call with patient, she has been sick with intermittent fever, runny nose, back pain and leg pain for the past week. Does not seem to be getting any better but also not getting any worse. She has a procedure that is supposed to be done on 4/30. Patient states that she did have her 2 Covid vaccinations and the last vaccination was 5 weeks ago. She plans on canceling the procedure. Care Coordination Progress Note RN (Registered Nurse) COVID 19 Infusion Navigator Post Infusion Outreach #1 Infusion Date: 4/30/21 Medication ? bamlanivimab/etesevimab ? casirivimab ? bamlanivimab

she may have gained weight; nausea; a real bad headache; This is a spontaneous report from a contactable consumer (patient herself) via Medical Information Team. A 77-year-old patient received BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- UNKNOWN) via an unspecified route of administration in left arm on 02Feb2021 as 2nd dose single and had previously received BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- UNKNOWN) via an unspecified route of administration on 12Jan2021 as 1st dose (at the age of 77-years-old) for COVID-19 immunization. Patient had no other vaccines on the same day as her COVID vaccine. Patient medical history and concomitant medications were not reported. Patient woke up this morning (03Feb2021) with nausea and a real bad headache and wanted to know if she can take Tylenol but she is wondering if it is contraindicated with the product. Patient stated that the first dose did not do anything to her like this second dose has done. Patient further stated that she believes her symptoms are listed on her fact handout sheet as known side effects of the product. Patient lab data and procedures included patient weight as 265 or 270 pounds, she believes she might have gained weight during the pandemic. The outcome of the events was unknown. Follow-up (03Feb2021): This is a follow-up spontaneous report from a contactable consumer. This 77-year-old female consumer reported that included patient's complete age, description about the adverse event with the onset date.

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.

Hyperoxia; could not move her body or a finger or anything; Her arm was starting tingling; Tiredness for a few days after second shot; she was frozen; Blood oxygen level was at 163; This is a spontaneous report received from a contactable consumer (patient) via medical information team. A 77 years old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number and expiry date were unknown) via an unspecified route of administration, administered in left arm on an unknown date at 10:45 AM (3 weeks after 1st dose) as 2nd single dose for COVID-19 immunisation. The patient received glycopyrrolate (batch/Lot Number and expiry date were unknown) via unspecified route of administration on an unknown date at a dose of 2 mg tablets daily (once daily in the morning) orally for peptic ulcer. The patient stated that she guesses glycopyrrolate would be expired when the 30 days are up. The patient did not have glycopyrrolate during reporting. The patient had just called the office and ordered a new refill when the freezing thing started. The patient was blind, so she could not read the label and batch number. The patient medical history included blindness called retinitis pigmentosa, diagnosed at 43 years old, she did not take anything for retinitis pigmentosa and it was genetic, ongoing and low thyroid (for several years). Family Medical History was mentioned as none. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number and expiry date were unknown) via an unspecified route of administration in left arm in Jan/Feb2021 at 10:45 AM. The patient's concomitant medications included unspecified thyroid medications (for several years) and unspecified sleeping pill daily. On 25May2021 at 08:45, the patient went for her physical exam, the patient's blood oxygen was up to 163. The patient added high blood oxygen levels could affect the heart. The patient never had blood oxygen over 98. The consumer clarified she meant low oxygen and not low blood pressure. The patient had the writing on the tape recorder. Recorder spelled the term as Hyperoxia. The patient stated that a week and a half ago, she was sitting in a chair after both of her vaccines but that she started those pills again and felt tired. Tiredness was first noticed after second shot that evening and it lasted for some days. She was taking a nap while watching tv and that lasted couple of days. She would be tired and then have to take a nap, but did not feel bad. The patient sat in the recliner and went to sleep and when she woke up, she was frozen and could not move her body or a finger or anything. She went in around 1400 and had no idea how long she was asleep but her mind was working. The patient stated she told herself to concentrate and to move but could not. She had no idea how long she was in that state but kept concentrating on trying to move a finger and was able to get a finger to move. Her arm was starting tingling like when it falls asleep and she was just cautious when she finally got up to walk. The patient did not visit emergency room/physician office. The patient told that she did not feel this bad before the vaccines and that was why she thought it was the medication (glycopyrrolate) that caused it. The patient started back taking the medication a few weeks after and did not know what it was for and that was why she thought it was this medication. The patient underwent lab tests and procedures which included high oxygen level 163 on 25May2021 and blood pressure was 133/64 on an unknown date. The outcome of the event blood oxygen was up to 163 was not recovered, Hyperoxia, could not move her body or a finger or anything, Her arm was starting tingling, she was frozen was unknown, Tiredness for a few days after second shot was resolved. Information on Lot/Batch number has been requested.

sore shoulder; Shoulder discomfort (Musculoskeletal discomfort); sleepy; This is a spontaneous report from non-contactable consumer via two different programs. A 77-year-old female consumer reported that she received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; formulation: Solution for injection, Lot number and expiry date was not reported) dose 2 via an unspecified route of administration on 08Apr2021 (at the age of 77-year-old) as 2ND DOSE, SINGLE for covid-19 immunisation. On 02Apr2021, female patient initiated Tymlos (abaloparatide) 80mcg daily subcutaneous injection, Lot# unknown, for the treatment of osteoporosis.Medical history included , intervertebral disc protrusion from an unknown date and unknown if ongoing verbatim: 4th disc slipped on 5th disc and pinched a nerve, and surgery (unspecified) , nerve compression from an unknown date and unknown if ongoing verbatim: 4th disc slipped on 5th disc and pinched a nerve, and surgery (unspecified). Surgery from an unknown date and unknown if ongoing verbatim: 4th disc slipped on 5th disc and pinched a nerve, and surgery (unspecified), tooth injury from an unknown date and unknown if ongoing. verbatim: Teeth were clear after one year of therapy. The patient's concomitant medications were not reported. Historical drugs included Fosamax (alendronate sodium) and Forteo (teriparatide). Relevant surgical, social, or substance-usage history was not provided Relevant concomitant medications were not provided. The patient previously took first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; formulation: Solution for injection, Lot number and expiry date was not reported) via an unspecified route of administration on an unknown date as single dose for covid-19 immunisation. The patient experienced dizziness (start/stop date 02Apr2021, duration just a few minutes also reported as less than an hour), product use omission (did not use Tymlos on 08Apr2021) (start/stop date 08Apr2021), and intentional product misuse (took two doses of Tymlos on the same day) (start/stop date 09Apr2021). No treatment was reported. 09Apr2021, patient experienced sleepy and shoulder discomfort (musculoskeletal discomfort). On an unspecified date, patient had sore shoulder. Diagnostic tests included a bone mineral analysis; per patient, results were 3.6 (units not reported). The action taken with Tymlos was dose not changed. The outcome of events was unknown. Additional information has been requested. Information on the lot/batch number has been requested.

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

weakness; muscle pain; tiredness; has not been feeling well; headache; nausea; vomiting; some difficulty with breathing; This is a spontaneous report from Medical information team. A contactable consumer (patients daughter) reported that a 77-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: unknown) via unspecified route of administration on 01Jun2021 as single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. Patient previously took first dose of BNT162B2 on an unspecified date for COVID-19 Immunization. It was reported patient experienced side effects include, weakness, muscle pain, tiredness. Her mother has not been feeling well. She does not feel 100% today. She was calling to see if these symptoms are related to the shot. Her mother has experienced tiredness, headache, muscle pain, nausea, feeling unwell, vomiting, some difficulty with breathing. She was sitting up currently and was fine but was not 100%. She also has weakness. Outcome of the events was unknown. Information about batch/lot number has been requested.

seronegative rheumatoid arthritis seemed to flare after her vaccines; This is a spontaneous report from a contactable physician. A 77-year-old female patient received bnt162b2 (Pfizer), dose 1 via an unspecified route of administration on 01Mar2021 (Lot Number: EN6205), dose 2 via an unspecified route of administration on 22Mar2021 (Lot Number: EN6205) as single doses for COVID-19 immunisation. Medical history included ongoing seronegative rheumatoid arthritis. The patient's concomitant medications were not reported. The patient experienced seronegative rheumatoid arthritis seemed to flare after her vaccines on an unspecified date with outcome of not recovered. The event was reported as non-serious. The patient was not pregnant. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19.; Sender's Comments: Based on the information currently available,The casual association between the reported event and suspected vaccine BNT162B2 cannot be completely excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.

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)

I'm experiencing muscle and joint pain on the right side arm and hands. On the left side inside muscle of the arm. Pain in right leg that is severe knee joint and the muscle behind the knee. Left leg pain in joint and muscle. Prescribed Ibuprofen 600mg that is not helping.

2/22/2021 - Tested positive for Covid 3/9/2021 - found down at her SNF, taken to ER. complains of lower back pain, left hip pain, bilateral knee pain, low O2 sat Dx: Aspiration pneumonia of both lower lobes (HCC), *Left lower lobe pneumonia, History of COVID-19, Urinary retention, Diarrhea C diff negative. 3/22: placed on palliative care after speaking with family 3/23: Expired

she had 5 days of exhaustion where she felt like she couldn't get out of her chair; she was also very aware of her stomach; two twinges in her arm; she couldn't even stand clothes on her legs; skin on her left leg started to hurt so much that it reminded of her of having a neuralgia; She had stinging on the top and behind her knee and it traveled down towards her ankle and up towards her upper thigh/stinging in certain parts of her leg; skin on her left leg feels burning; left leg felt like it needed cold and not heat; 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 mRNA VACCINE, Solution for injection, Batch/Lot Number: EW0178; Expiration Date: 31Aug2021), via an unspecified route of administration, administered in left arm on 25May2021 at 14:30 (at the age of 77-year-old) at a single dose for covid-19 immunisation at Clinic. Medical history included ongoing high blood pressure, high cholesterol and it runs in her family (She has tried all the different "statin" medications and she couldn't tolerate any of them. Her cardiologist told her there was an injection she could take for her cholesterol every two weeks and it was supposed to be like a "liquid plumber" for your veins. She is so sensitive to medications including all these "statin" medications, there is no way she can take the bi-weekly injection. It might have a much more profound negative affect on her. She was so leery of taking medications, even over the counter medications), gastrooesophageal reflux disease (GERD), 4 cardiac stent placements in 2015, blood pressure abnormal, allergies (unspecified), sinus are swollen, neuralgia, cataract surgery (a year and half ago), retina had swelled and sensitivity to heat. Concomitant medications included acetylsalicylic acid (ASPIRINE) chewable tablets at a dose of 81 mg daily for sinuses are swollen (her sinuses are not swollen at this time), loteprednol etabonate (LOTREL) for blood pressure abnormal. The Lotrel keeps her blood pressure around 120/70mmHg, famotidine (PEPCID) for gastrooesophageal reflux disease. The patient previously took tylenol and experienced allergy and giant hives. Aspirin give her hives but usually a hive here or there, not real big hives, ilevro for retina swelling and affected her skin on her face (She did have a problem while she was taking the steroid eye drops. They made her feel very unwell. She does not take Prednisone for the same reason. She had tried many different steroid eye drops and so many of them gave her a problem. She ended up taking Ilevro. She had no choice but to take it. The Ilevro affected the skin on her face. Her retinas had to stop swelling. Everything is fine now. She has no glaucoma or macular degeneration. This occurred a year and half ago when she had her cataract surgery). She had given the nurse who gave her the injection a list of all her allergies and sensitivities and the nurse reviewed the list and didn't see anything in the Covid 19 vaccine that would cause the caller harm based on her list of allergies and sensitivities. The caller took a deep breath and prayed while she received the Covid 19 vaccine. After the vaccine she waited at the facility and she was fine and then she left to go home. She ever had an adverse event with any other vaccines she reports she has not been vaccinated with anything since she was a child. She didn't even have the Polio vaccine. The patient did not receive any other vaccinations within four weeks prior to the first administration of the suspect vaccine. After getting the Covid 19 vaccine, on an unspecified date, the patient had 5 days of exhaustion where she felt like she couldn't get out of her chair and she was also very aware of her stomach. Her stomach wasn't upset but she was aware of it. That slowly passed and she started doing the things she needed to do. She needs to walk because of her heart stents. She had been fine after the Covid 19 vaccine until last night on 10Jun2021 at 21:30 the patient skin on her left leg started to hurt so much that it reminded of her of having a neuralgia. She provides an example of her sometimes feeling a draft and she can develop a neuralgia from the draft for a day or two. That's what her leg felt like initially. As the night wore on, around 22:00, she realized she couldn't even stand clothes on her legs. She wears nightgowns, not pajamas and she had to take her nightgown off her leg. The sensation in her leg started changing, she could feel that she not only had the skin hurting sensation but now she had stinging in certain parts of her leg. She had stinging on the top and behind her knee and it traveled down towards her ankle and up towards her upper thigh. It was bizarre. She thought about it this morning, 11Jun2021, what it felt like. She remembered way back, long ago, and she was not a sun person, but it felt like how a sunburn would feel. The skin on her left leg feels burning. She used Aspercreme on her leg thinking it will help with the pain. She wiped all the Aspercreme off her leg. She could not cover her left leg. Her left leg felt like it needed cold and not heat. She does have a history of sensitivity to heat. She runs her air conditioner, and she had a ceiling fan above her bed. She had her left leg exposed and out of her bed covers to try and get the cold air on her hot leg. Finally, around 23:30, her leg still bothered her, but she was able to go to sleep. She twisted and turned at night but was finally able to put her bed cover back on her leg but lightly. The sensation was still there in her leg. She was so sensitive. On an unspecified date, the patient had two twinges in her arm and then her arm never hurt again. The events did not result in emergency room or Physician Office. She is due for her second Covid 19 vaccine on 15Jun2021. The outcome of the events she had 5 days of exhaustion where she felt like she couldn't get out of her chair, she was also very aware of her stomach, two twinges in her arm was unknown and the rest of the events was not recovered. Information on lot/batch number was available. Additional information has been requested.

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

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

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.

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.

cramps in stomach; chills; aches in joints; Diarrhea; This is a spontaneous report from a contactable consumer, the patient. A 77-year-old non-pregnant female patient received unknown dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6207) via an unspecified route of administration in the left arm on 10Mar2021 at 08:45 (at the age of 77-year-old), as a single dose for COVID-19 immunisation. Medical history included osteoporosis, hypertension, restless legs and low thyroid. Concomitant medications included levetiractan (MANUFACTURER UNKNOWN), ropinirole (MANUFACTURER UNKNOWN), baby aspirin (MANUFACTURER UNKNOWN) and valsartan (MANUFACTURER UNKNOWN) taken within last two weeks of vaccination for an unknown indication from an unspecified date. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested positive for COVID-19. 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 AM, the patient experienced chills, aches in joints, cramps in stomach, and diarrhoea. The patient did not receive any treatment for the adverse events. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events chills, aches in joints, cramps in stomach, and diarrhoea was recovering. No follow-up attempts are possible. No further information is expected.

very weak/wrung out in morning. Happened two more mornings over next two weeks. My heart normally beats irregularly due to mitral valve prolapse. But for about 3 weeks lying down particularly on my right side it was practically continual. Also my back started hurting. Also there was family stress. Also I was concerned when they weighed me at the doctor's office that I had lost 3 pounds. My weight had previously gone down from 130's to 129. But it went down to 126 at the office. Doctor did thyroid and liver blood tests. All was normal and stable. I have gotten the weight up to almost 128 since then.

Flare of her RA/ rheumatoid arthritis really got bad and painful in joints; 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 mRNA VACCINE, Solution for injection, Lot number- EM9809) via an unspecified route of administration in left arm on 04Feb2021 at 12:30 as dose 1 single (at the age of 77-year-old) and also received second dose of BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- EN6200) via an unspecified route of administration in left arm on 25Feb2021 at 14:00 as dose 2 single (at the age of 77-year-old) for COVID-19 immunization. Medical history included illness at time of vaccination, rheumatoid arthritis, blood pressure, cholesterol, occasional spastic bowel, blood type: Rh-Negative. No investigation assessment was reported. History of all previous immunization with the Pfizer vaccine considered as suspect, additional vaccines administered on same date of the Pfizer suspect, prior vaccinations (within 4 weeks), adverse events following prior vaccinations, family medical history relevant to adverse event were reported as none. Concomitant medications included methotrexate 2.5 mg, weekly (2.5 mg tablets orally. Takes 9 tablets by mouth once a week) for Rheumatoid arthritis from 23 years, atorvastatin 40 mg, daily for Cholesterol (had been taking 10-15 years), atenolol 25 mg, daily for Blood pressure (Had been taking 10-15 years), hydrochlorothiazide, triamterene (TRIAMTERENE & HCTZ) daily (37.5/25 mg) for fluid retention and blood pressure (Had been taking 10-15 years). The patient experienced flare of rheumatoid arthritis, it really got bad and pain in joints lasted about 5 weeks before she contacted the rheumatologist, started around 17Feb2021 or 18Feb2021 and had subsided. She had flares on occasions and when agent asked her about documenting the experience, she added that there was no way to be proven whether it was due to the shot or that she came off her medication. Patient stated it subsided within a couple days of going on the prednisone, some time in Apr2021. Patient stated it took about six weeks to get back. Patient stated she had both vaccine shots from Pfizer back in Feb2021 and a couple weeks ago, she heard on the news, and some friends have told her about it since, and she did check it out online, that a study was done at the same time, on the effectiveness of the Pfizer vaccine on patients who had been on methotrexate. Patient stated the findings were that those patients, in four control groups, were 62% covered on the vaccine versus the 95%. Patient added that means some were above 62%, and some were below. Patient stated she was curious because she's been on methotrexate for 23 years, she did stop it the week before and after each shot. Patient asked was there any way of finding out her own personal protection. Patient stated she did call her doctor about antibody testing, and the doctor told her she was not sure what it would show her, since she's not under a controlled situation, with exact dates that she stopped taking and retook it, also she had a flare at that time, about two weeks after the shot, where her rheumatoid arthritis really got bad and painful in joints. Patient stated it took about six weeks to get back. Patient stated she would have the flares on occasions anyway. Patient clarified this was not why she called and adds that when she mentioned it to her rheumatologist, she was told insurance would not cover it because she was not classified under any research program. Patient stated she did not go to the doctor, she suffered with it until her primary said call your doctor, call you rheumatologist for the pain. Did not go to the doctor, only called because it was covid time and everything was either via phone or video. Stated her rheumatologist has known her long enough to feel safe diagnosing. Not required to visit Emergency Room and Physician Office. Patient again stated she was not sure the event reported was from the vaccine. Patient reported an AE/PC for Methotrexate reports she's been on methotrexate for 23 years, she did stop it the week before and after each shot. Patient stated she would have the flares on occasions anyway. Relevant tests were reported as none. Product strength and count size dispensed: 2.5 mg tablets. Treatment medication included Prednisone: 5 mg tablets, started with four tablets once a day for two days, then three tablets for two days, then two tablets once a day for two days, then one tablet once a day for two days. Took a total of eight days. The outcome of the event was recovered in Apr2021. Information on the lot/batch was available, Additional information has been requested.

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

RIGHT ARM HURT THE NEXT MORNING. LEFT ARM HURT THE 2nd MORNING. A WEEK LATER MY BLOOD PRESSURE WENT UP ABOUT 40 POINTS AND I WENT TO DR AND HE RAISED MY BLOOD PRESSURE DOSE. THEN BOTH MY KNEE JOINTS SWELLED FOR A WEEK. THE SWELLING LEFT MY KNEES AND WENT DOWN TO MY ANKLE BONES. IT HAS BEENOVER A MONTH AND I CAN BARELY WALK.

Apr 28th began noticing right upper abdominal pain, from the sternum area, down and around base of right lower rib cage and toward my back. A tightness feeling going also toward my back. Interfering with breathing because pain increase with deeper breath but did not feel short of breath. Area became tender to touch. Felt like muscle spasms in "bread basket" area. These cont'd off and on - affecting size of meals I would eat - too much increase the discomfort. Self exploring lead me too exercising and deep breathing to advice via website. Provided some relief and improved breathing ability. By May 2th things became more severe- 3 morning episodes of severe gripping pain, sweats, chills ,nausea, vomiting, weakness - Husband took me to Emerg May 4th. Bld in urine. Kidney scan - no stones; Bld work - normal. Agan in Emerg June 29th. No medical reason given for the severe pain. Sent home.

Pericarditis S/S: actue chest pain or pressure, Chest pain made worse bu lying down, deep inspiration or cough, Pain Hx from 3 providers Patient presents for CP that started on Sunday night. Worse with inspiration states she feels like she has to breath shallow. Reports at 3:30 this morning pain was worse. Developed this retrosternal pleuritic chest pain late Sunday that has worsened over the course of the day yesterday and early this morning. She describes it as radiating up into her neck at times. No shortness of breath or cough. The pain encompasses a large area of her central chest which can radiate up the center of her neck. It is worse with deep breaths but not worse with walking. Initial Admit for Chest pain, developed A Fib during ED admission. Seen by Cardiology. Admitted 2/16-2/18. Neg CT pulm angiogram. Disch Diag including Cardiology 1. Pleuritic chest pain, 02/17/2021 2. Atrial fibrillation, 02/18/2021 3. NSTEMI (non-ST elevated myocardial infarction), 02/17/2021 4. Pleural effusion, bilateral, 02/18/2021 Pt readmitted 2/19/21. Troponin neg at that admit. D Dimer, Quantitative: 2.62 mcg/mL FEU Troponin I: <0.030 ng/mL BNP: 227 pg/mL Cardiology consult 2/20/21 called it pericarditis On 3/10/21 admitted for salicylate toxicity (on ASA for AFib) and ED provider stated that 2/16/21 admit for chest pain states that cardiology note at 3/10/21 stated the prior admit included diagnosis of pericarditis

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

During 15 minutes post observation period, patient c/o mild posterior headache and neck pain. BP 166/103, HR 124, SaO2 99%. Pt taking HCTZ antihypertensive but missed medication today. Patient received IV hydration at treatment center.

Injection site pain,tiredness,headache,muscle pain,chills, joint pain,nausea,feeling unwell, temperature 99.6

7 am. 1/13/2021 increased poly arthritis joint pain Chills Headache Malaise . Tylenol every 6 hours 1/14/2021. headache , malaise, hyper skin sensitivity on back arms; felt like sunburn 1/15/2021 increased pain on skin especially on back headache increased malaise ; joint pain subsided, Malaise and headache has lasted for 3 full days

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.

Intense headaches starting night of injection, lasted for days. I felt weak, pains in my legs ankles and arches. Stomach pain, and feeling lethargic. I took Tylenol but i think that disturbed my stomach. Still having soreness in my legs and ankles and still don't have energy today.

Body aches, low gr. temp. aches into her buttocks area down back of post. thighs. She did have Covid infection in Sept 2020. Meds admin - NaCl 0.9% I.V. bolus. 500 ml. Tyl. + Hydrocodone 650/25 - Labs - UA. lactic acid, SARS antigen, BMP, CBC, CXR - revealed pneumonia - F/U with family practice on Monday. In addition to above - numbness from waist down to toes, loss of bowel + bladder. T-102.F. Unable to walk - this lasted for 17 hrs.

Patient received Shingles Vaccine on 01/6/2021 and COVID-19 Vaccine on 01/26/2021. Pt began with rash on 01/27/2021, rash is located on the center of her back. She began with pain on 01/26/2021 in the morning, reports her pain is located beneath her armpit radiating both toward the front and back

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.

Pt alerted circulating RN that she was feeling tightening in her throat. Pt mentioned that she wanted to walk to the room because she was not feeling dizzy. Pt was asked about any heart problems and she responded that she has a pacemaker. Pt was taken to a private room for further monitoring and observation. Patient asked about history of this problem, to which she replied that this has never happened before. Patient mentioned that her allergic reactions typically consist of a rash or hives. Vitals were taken and recorded. BP was initially high at 180/80. Pt declined admission to the emergency department. Pt awake and alert, good historian. No difficulty speaking or breathing. No shortness of breath, denied chest pain, reported "tightness" and pointing to neck area. Pt described, "feels like I have phlegm there." Denied water. No drooling & speech clear. No numbness to extremities or aching to shoulders, no nausea, no dizziness. Pt ok to sit up and accepts water at 11:38AM (20 minutes following initial incident), denies food and juice. Swallows multiple sips without difficulty. Pt denied throat tightness or pain. EMTALA Form completed. Pt education performed regarding potential side effects of COVID-19 vaccine and sources of information going forward. 11:43AM pt feels comfortable to walk and wants to go home. Pt discharged to home ambulatory, stable VS and states understanding of plan of care after COVID 19 vaccine today.

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

accute hypothermia (93.3 degrees),pounding headache, pain from base of neck all down spine. temp came up gradually in 2 hrs. head and back pain continued 2 days. Temp continued low 95.5 and up every am and came to normal. returned to without head pain 5 days later. still have lingering symptoms thru today, ie temp is normal than low, than normal after arising in morning, still have moderate back pain and slight headache but nothing debilitating now. never had anything like this before. quite healthy and athletic ie running half-marathons til covid hit.

Mild headache; chills; some joint pains; This is a spontaneous report from a contactable consumer (patient). A 78-year-old non-pregnant female patient received first dose of BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine; lot number: EL8982), via an unspecified route of administration in the left arm on 26Jan2021 11:15 at 0.3 mL, single for COVID-19 immunization. Medical history included hypertension and known allergies to penicillin. The patient is not pregnant at the time of vaccination. The patient has no COVID prior vaccination. The patient has not been tested for COVID post vaccination. Concomitant medications included atenolol, chlorthalidone, felodipine, losartan, and potassium acetate (POTASSIO ACETATO). On 26Jan2021 15:00, the patient experienced mild headache, chills, and some joint pains. The patient did not receive any treatment for the adverse events. The outcome of the events was not recovered.

Exhaustion onset about 8:00 PM 1/26/21 lasting over 36 hours before starting to feel better. I literally slept all of the next day only getting up occasionally and most of the day after that. I started to become more normal feeling the late afternoon of 1/28/21. I also felt very stiff and uncomfortable. Sore neck and joint pain and a slight headache. I had a sore area across my arm (felt like a bruise although there was no discoloration) about 1 inch inch below the injection sight which was on my upper left arm. That persisted for several days. I slept and took 1 800 mg Ibuprofen (on 1/27/2021). Am feeling better but still not feeling 100 %. That may be due to increased allergies due to time of year of etc a

Fever over 100 degrees, muscle aches and joint pains, general weakness and malaise, at approximately 20 hours after injection, until about 30 hours after.

Very High Blood Presser---Concerned about a Heart Attach--Teeth Aching--Back Pain--Chest Pain--Feeling like a heavy object was on her chest or stomach--Pain from back moved to her sides.

Pfzer-BioNTech Covie19 Vaccine EUA. Joint and muscle pain in neck, shoulders, lower back, buttocks, legs.

I have osteoarthritis, with Heberden's nodes on all of my fingers. 3 days ago the two nodes on the most affected finger (and the first that showed the arthritis) turned bright red. Now the whole joint is red and a few of the other nodes have turned red. Except for binding the first finger with the hope it would help (it didn't), I'm not treating them, since of course one can't do anything about osteoarthritis except ease the pain.

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.

Extreme pain and burning sensation in abdomen (Day 4-6), extreme pain (bone/joints/muscles) in left arm (Day 6-8)

"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.

Severe headache; Feeling unwell; Joint pains; Muscle pains; Difficulty breathing; Chest pain; Tiredness; She felt a "little bit of nausea, very slight"; This is a spontaneous report from a contactable consumer (patient). A 78-year-old female patient received the first dose of bnt162b2 (BNT162B2 also reported as PFIZER-BIONTECH COVID-19 VACCINE, lot EL3302), via an unspecified route of administration in the left arm on 23Jan2021 11:00 at single dose for Covid-19 immunisation. Medical history included blood pressure abnormal, thyroid disorder and high cholesterol. Concomitant medications included levothyroxine, lisinopril and rosuvastatin. The patient experienced severe headache, feeling unwell, joint pains, muscle pains, difficulty breathing, chest pain, tiredness on 24Jan2021 and little bit of nausea, very slight on unspecified date in Jan2021. The outcome of headache was recovered on 24Jan2021; for difficulty breathing was recovered; for chest pain and fatigue was recovering; for other events was unknown.

itching, swelling and rash in the genital and anal area, itchy also on her legs, was sore in the gluteus area Has not seen the doctor yet (2/26/2021)

lost 3 pounds; chills; Sheets were soaking wet, she kept having to urinate; Kept having to urinate; Diarrhea; Getting very hot and cold; This is a spontaneous report from a contactable consumer. A 78-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) second dose, lot number: EL9262, via an unspecified route of administration on 07Jan2021 at a single dose in the upper part of left arm for COVID-19 immunization. The patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) lot number: EJ1686, expiry Mar2021, on 07Jan2021, she had no reaction or anything. The patient had no medical history. The patient's concomitant medications were not reported. The patient was calling about the second shot, Pfizer asked if there were side effects on the second one, and there were, she can't say what went on yesterday, it was that bad. She was a volunteer at the hospital. She lost 3 pounds in the last few days from this. She was in no condition to talk to anyone yesterday, and in fact, she was getting hot now. Yesterday (26Jan2021) was the worst, she doesn't know how to describe, but her sheets were soaking wet, she kept having to urinate, and she's ashamed, she almost couldn't make it to the bathroom, her aide said to not be ashamed, and she had a lot of diarrhea. It was around 2am she noted her sheets were soaking wet, and it started going away at 5AM. She was still having effects from the shot: she was still getting very hot and cold. Getting very hot and cold started 12:00PM Monday (25Jan2021) night. Getting hot and cold was like the chills. She has 27 chronic illnesses but doesn't think they have anything to do with the shot. She was grateful she got the shot and hopes everyone at Pfizer was able to get the shot. The outcome of the event 'sheets were soaking wet, she kept having to urinate' was recovered on 27Jan2021, diarrhea and getting very hot and cold was recovering, lost 3 pounds and chills was unknown. No follow-up attempts are possible, information about batch number cannot be obtained.

Neurology consult 2/13/21: This is a 78-year-old female we were consulted by Dr. for possible guillian barre s/p COVID vaccine. The patient tells me that she was in her normal state of health, and she received her 1st dose of the COVID-19 vaccineseen 7 days ago. Subsequent to that, the next day she developed chills, fatigue that continued for approximately 2 days. She states that 3 days ago, she woke up and was unable to lift her legs or get herself out of bed on her own. She felt weak in her proximal lower extremities and her trunk. She denied any bandlike sensations or paresthesias. She cannot tell me that she developed any distal lower extremity weakness initially but felt that it was the acute onset. She needed some help her out of bed when she was upright, she was able to use her walker to slowly get to the factor. She may have had some urinary incontinence, she does complain of diarrhea now. Denies any tingling sensation, no bulbar symptoms. This is a 78-year-old female who we were asked to evaluate for possible Guillain-Barre syndrome. She had acute onset of lower much greater than upper extremity weakness without any definite ascending features, of relevance, is that she received the COVID-19 vaccine 3 days prior to the onset of her symptoms. She did exhibit flu-like symptoms prior to this. Given that she does not have any specific area of intrathecal enhancement to suggest Guillain-Barre or other areas of radiculitis, I think it is reasonable to proceed with lumbar puncture to look for any other source. --Given the findings on the MRI cervical and lumbar spine including enhancement of the bilateral sacral S1 region, I would like Neurosurgery to further evaluate. -- would likely benefit from CT chest abdomen pelvis to rule out any underlying occult malignancy particularly if workup remains unremarkable. -- continue supportive care, monitor for shortness of breath, new vital capacities Patient remains admitted to the hospital with continued weakness at the time of this report

Headache; pains in knee and muscle above knee; pains in knee and muscle above knee; Fever; This is a spontaneous report from a contactable consumer. A 78-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) lot number: EN5318 expiration date: 31Jan2021, via an unspecified route of administration on 31Jan2021 12:20 at a single dose in the right arm for COVID-19 immunization. The patient had no family medical history and no concomitant medications. The patient had her first dose yesterday (31Jan2021), and she had some reactions to it last night 31Jan2021, had fever, headache and pains in knee and muscle above knee. She knows some of the side effect was normal. She was wondering more so, when is it ok to take a pain reliever for it, like aspirin or Ibuprofen. She went online and it said not to take anything, so she did not. She imagined her fever went away sometime during the night, she took it (unspecified) twice last night. This morning when she woke up, she had the headache, and it's gone now. Her pain in the knee started 4 hours after the injection, it was still sore but much better. The events did not require a visit to the emergency room. The patient had no prior vaccinations within four weeks. The outcome of the event fever was recovered on 31Jan2021, headache recovered on 01Feb2021 and for events pains in knee and muscle above knee was recovering. Information on the lot/batch number has been requested.

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

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

Patient experienced bad back pain, stomach spasms on night of vaccine. Starting on 2/28 hives and welts covered entire body. Very itchy. When she called to report on 3/4, reported they come and go and are not as severe as at onset.

Mild diarrhea, loss of appetite, back ache, and hip ache. All were mild and lasted two to six days. This happened only after shot number two.

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.

Reported after receiving the first COVID-19 Vaccine dose she had muscle pain that lasted about 2 weeks; I couldn't lift my arm for 3 weeks; Exacerbated her arthritis in her left shoulder; This is a spontaneous report from a contactable consumer. A 78-year-old female patient (consumer) received first dose BNT162B2 (Pfizer-Biontech Covid-19 Vaccine, Solution for injection, lot number: EJ1284, expiry date: 30Apr2021) via Intramuscular, Arm Left on 12Jan2021 at 13:00 at single dose for COVID-19 immunization. Patient medical history and concomitant medications were not reported. States she received her 1st Pfizer vaccine on 12Jan2021. "she couldn't lift her arm for 3 weeks on an unspecified date in Jan2021." When she received her 2nd dose 02Feb2021 the Pharmacist at the vaccinating site told her it was "ok to get her shot subq." Was this ok to not get the injection IM? "she even went back and asked the Pharmacist again if this was allowed and he said yes." Reported she received her first Pfizer COVID-19 Vaccine about 3 weeks ago (clarified as 12Jan2021, between 1:00-1:30PM, intramuscularly, in her left arm). She said she received her second COVID-19 Vaccine dose 2 days ago (clarified as 02Feb2021 between 1:00-1:30PM, subcutaneously, in her left arm). She said the COVID-19 Vaccines were administered by (Speciality pharmacy name). Reported after receiving the first COVID-19 Vaccine dose she had muscle pain that lasted about 2 weeks on 12Jan2021. She clarified she couldn't lift her left arm. She said the first COVID-19 Vaccine exacerbated her arthritis in her left shoulder on an unspecified date in 2021. She said the funny thing was when she received her second COVID-19 Vaccine dose subcutaneously on 02Feb2021, her left shoulder now feels better, like the second COVID-19 Vaccine treated her left shoulder arthritis. Treatment: Reported she started physical therapy for her left shoulder about 2 weeks after getting her first COVID-19 Vaccine shot. Reported she was a healthy individual and takes no medications. Reported she recently had routine blood tests performed. She said she tested for negative for Rheumatoid Arthritis. Outcome of event Muscle pain and Limb discomfort was recovered on an unspecified date in Jan2021, while with other event was unknown.

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

Severe migraine headache and multiple joint pain until steroids Mar 21, now slight headach. Swollen face Mar 20, 21, 22. Fatigue and brain fog for 10 days. Went to emergency room twice. Mar 18 and 21.

A week later, flu like symptoms: slight fever ( 99-100)r joint and muscle aches and pains, fatigue, poor appetite, chills intermittent sharp pain jabs throughout body and head. Rx: one dose of extra str. Tylenol, inc. fluids and sleep/ rest. Feel better tonight: took a shower after 3 days and am able to eat better.

The injection was given high up on my arm and was very painful. About an hour after receiving the shot my arm felt weak and my hand and fingers felt numb. I could not raise my arm. This lasted into the next day, when my shoulder began to hurt. The feeling returned to my hand but I started getting drawing pains in my arm, and increasing pain in my arm when raising it.

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.

Moderate to severe bilateral wrist pain; Moderate to severe bilateral hand pain; This is a spontaneous report from a contactable 78-year-old female consumer reported for herself that: A 78-years-old female patient received bnt162b2 ((PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot Number: EN6198),dose 1 intramuscular, administered in Arm Left on 20Feb2021 13:00 as SINGLE DOSE for covid-19 immunisation .The patient medical history was not reported. The patient's concomitant medications were not reported. The patient experienced moderate to severe bilateral wrist pain on 21Feb2021 15:00 and, moderate to severe bilateral hand pain on 21Feb2021 15:00 and Day 5 of Moderate to severe bilateral hand and wrist pain following Pfizer 1st COVID-19 injection 0n 21Feb2021. 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. and outcome of the event was not recovered.

pt stated that about an hour after she got the vax she had severe headache, extremely tired and pain in right leg muscle. On 2/20/21 all symptoms were gone except the pain the the right leg between her hip and knee on the outside of the leg. On 2/26/2021 she went to the ER. They did Covid Test, EKG, Chest X-ray and blood work. All test were negative. She was released to go home. On 3/4/2021 she woke up and her right leg had turned black and blue. She call 911 and taken to the ER where they did blood test, EKG, Chest Xray, CT, Spine Xray and US to see if she had any blood clots. She did not have any blood clots and all test were negative. Pt was released to FU w/ her PCP on 3/12/21. He took more blood work. Pt was told to drink water take more vitamin D. Pt still has some pain.

cannot take good deep breaths because of the soreness in her ribs; soreness in her ribs; She had no urge to eat/Has no desire to eat or drink; lost 10 lbs; feel ill; General feeling of the flu; had a slight sore arm; nausea; severe pain, her hip and knee were killing her; was having major problems, a delayed immune response; Rash covering her entire body; acute pain and with deep breaths; low grade fever; cough/Cough was a dry, tight, non-productive cough; Weakness; Chronically dehydrated; the COVID Vaccine wasn't working; the COVID Vaccine wasn't working; This is a spontaneous report from a contactable nurse. This nurse (patient) reported that a 78-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, batch/lot number: EN6204) at the age of 78-years, via an unspecified route of administration on 04Mar2021 at single dose; first single dose of BNT162B2 (lot: EM9810) on 11Feb2021; both for COVID-19 immunisation. Medical history included osteoarthritis (having aches and pains) had for 20 years; large sliding hiatal hernia was diagnosed from an EGD six months before, didn't want surgery to fix it; heartburn (last five years); fatty liver, was not from drinking alcohol; generalized anxiety; was tuberculosis positive only because she was exposed years ago. Concomitant medications included pantoprazole started four to five years before at 40 mg twice a day for heartburn; escitalopram (tablet) been on for 15 years or longer at 10 mg 1 DF every day for generalized anxiety; clonazepam 0.5 mg nightly at bedtime for anxiety (been taking for last ten years or more, stops her from worrying about her kids and stuff like that). The patient experienced on 07Mar2021, low grade fever, weakness, chronically dehydrated and cough; on 15Mar2021, rash, acute pain and with deep breaths; on an unspecified date, no desire to eat or drink. Seriousness criteria of these events were reported as disabling. Patient reported that was having major problems, a delayed immune response. Told everybody if this keeps up she was not going to make it. It was wearing her down and she was not going to survive. Occurred after second COVID vaccine. She is active, goes to pool, and does different things. Had vaccine on Thursday and was ok until Sunday. Started Sunday with low grade fever. Kept being low grade and never got to 101, 102, or 103. She didn't take ibuprofen. Usually takes ibuprofen once a day for routine aches and pains. Having weakness. Had no desire to eat or drink. She waited a couple days, but then called her doctor. Doctor's office wouldn't give her an appointment. Stated this wasn't the routine and has been going on for 10 days. This was too much. Two days later, caller's daughter-in-law took her to a place like an ER. A bunch of tests were done. She asked for an IV because she was chronically dehydrated. Weakness was getting to her. After seeing the doctor in the mini surgical ER, she didn't feel any better. She felt the same. Same nausea, weakness, low grade fever, the whole thing. Decided to see her regular doctor. Stated it wasn't her chest. Wanted to be told what was going on. Her regular doctor didn't order any labs. She was given a steroid shot. Thought she was in deep doo-doo. Stated this was not a good sign and she was not going to make it. She woke up yesterday with a rash covering her entire body. She had no clue she had the rash. Never saw the rash. Rash didn't itch, but she still had it. After steroid shot from doctor, she felt a little bit stronger and thought maybe she was going to make it, but then started getting severe pain. Patient was used to having aches and pains that went along with old age and her osteoarthritis. This was severe pain as if she fell and hurt her ribs. It hurts to take deep breaths. Her hip and knee were killing her. It was acute pain, not normal pain. This morning stated she couldn't take it and was going to take ibuprofen, which was not the best for her. She didn't want to eat, but tried to have food in her stomach to take the ibuprofen. She cannot take good deep breaths because of the soreness in her ribs. Thought something in her body was having a delayed immune response and her gut told her it was not good. For low grade fever, did not take ibuprofen, 07Mar2021 was when she started feeling yucky, she wanted to see how she felt and her temperature never really got up, stuck it out, normal temperature for her was 97 or lower, her temperature once in a while would range from 98 to 100.3 or 100.8, she cannot take paracetamol (TYLENOL). For weakness, noticed right away, felt a little better after steroid, had not been out of her door except to the ER. For chronically dehydrated, clarified she had no desire to eat, usually drinks coffee and tea in the morning, but now had no desire, was making herself drink, felt something wasn't right beginning on 07Mar2021, everything went south and got worse, clarified it really wasn't nausea, but no desire to eat or drink, doctor today gave her ondansetron (4mg) which didn't help and made it worse, eating and drinking didn't make her sick, just didn't want it. She had labs done in the ER and was told her labs weren't really that off for her to be that dehydrated. Asked for an IV because she was not drinking what she normally drinks, didn't feel any better after the IV. Rash covering her whole body, but didn't itch. Acute pain and with deep breaths began evening of 15Mar2021, seemed the same today, she just took an ibuprofen a little while ago and was feeling better. Patient also mentioned that realized her body was trying to get monoclonal antibodies and resistance to build up her immunity so that if she ever got infected with COVID virus she could fight it, it was just not working, it was not doing its thing, she was having a delayed immune response, was very worried about that, going on 8-9 days and it was weakening her by the day, didn't think she could take this too much longer. Clarified the COVID Vaccine wasn't working and her body couldn't get its act together. Patient had a slight sore arm after the second dose, never reacted at the injection sight, it was strictly internal, which kind of scares her, something was not right, was having the rash, pain, and severe weakness. Was not expecting any kind of problem. Didn't think too much about the second COVID Vaccine. Stated people were like "oh that second shot." If she didn't get better soon she is not going to do well. Cough was a dry, tight, non-productive cough, lungs were checked yesterday and were clear, felt like all of a sudden she has an urge to cough and nothing comes up. For steroid shot, didn't know if it was dexamethasone (DECADRON) or not, made her feel a little stronger for the day, but then brought on severe aches and pains in her joints and ribs, did not have this until the steroid shot. Patient said that didn't take ibuprofen the first couple days because she didn't want to mess up the immune response starting in her body, asked doctor about immune globulin for her delayed immune response, but doctor shook his head, knew that people with autoimmune are ordered IGE or IGG to test the immune system, asked doctor about this, but he shook his head. Stated she didn't think a CBC with different was performed at the ER, confirmed she was only in the ER after the second dose and was not admitted to the hospital. As of 17Mar2021, she stated then two to three days after that she woke up with rash over her entire body that showed up overnight, that alarmed her even more of course, no itch or nothing, no clue it was there until she washed off and could see it, she had never had a rash before, her arm never got red, but she had a low grade fever, stated now didn't know if good or bad, cough, not productive, some urge to cough, no appetite, not eating or drinking, and increasing weakness, today she couldn't say anything was different about her rash maybe slightly faded but she didn't feel any better, she did get a steroid shot when she went to doctor yesterday and that made her feel less weak. As of 18Mar2021, patient stated that had no reactions for the 1st 2 days following her 2nd dose however she started to feel ill, low grade fever that never went above 100. General feeling of the flu; aches and pain, which she had before but more than usual. She had no urge to eat. Tried to see her doctor when it had been going on for 5 days but they were not concerned. By that Friday, she went to the hospital. They found nothing wrong in her lab tests but she asked them for I.V fluids since she hadn't eaten or drank anything. On Monday, she went back to her initial doctor because she had a rash all over her body, it did not itch and her injection site had no redness. She was given a steroid shot, today she might be feeling a bit better. She lost 10 lbs. She had to stay inside for the past 10 days, except for doctor visits, although she was usually an active person. She would like to know how long the side effects would last. Outcome of the events low grade fever/ wasn't working, weakness, rash and acute pain and with deep breaths, cannot take good deep breaths and soreness in her ribs was not recovered/not resolved while of remain was unknown. Relatedness per primary source reporter via global introspection of BNT162B2 to events low grade fever, weakness, chronically dehydrated, no desire to eat or drink, acute pain and with deep breaths and cough were related.; Sender's Comments: Based on a temporal association and the known drug safety profile, the reported events are considered possibly related to BNT162B2. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.

Back pain; leg pain; general rib pain; This is a spontaneous report from a contactable consumer (patient). A 78-year-old non-pregnant female patient received the first dose of (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in left arm on 24Jan2021 as single dose for COVID-19 immunization in an public health department. The patient's medical history was not reported. The patient has no concomitant medications. No other vaccine was given within four weeks. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, has the patient has not been tested for COVID-19. The patient experienced back pain, leg pain and general rib pain for the last 3 days on 24Jan2021 12:00. No treatment was received. The events were considered non-serious since it did not result in death, life threatening, caused/prolonged hospitalization, disabling/incapacitating, congenital anomaly/birth defect. The outcome of the event was not recovered.

Trembling; muscle weakness; palpitations; light headed, dizziness; slight headache; This is a spontaneous report from a contactable other HCP. This 78-year-old female other HCP (patient) reported that she received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number; EN6201) via an unspecified route of administration from 08Feb2021 at 1:00 pm to 08Feb2021 at 1:00 pm at single dose on right arm for covid-19 immunisation. Vaccine facility type vaccine was doctor's office/urgent care. The patient was 78 years old and not pregnant at the time of vaccination. Patient's medical history included hypothyroid, hypertension, elevated cholesterol, possible heart condition, obesity, known allergies: shellfish, MSG (dates unspecified). Concomitant medications included Losartan, hydrochlorothiazide, triamterene (Dyazide), Levothyroxine, Pravastatin via an unspecified route of administration from unspecified date to an unspecified date at unknown dose and frequency for an unknown indication. If other vaccine in four weeks: No. Patient experienced trembling, muscle weakness, palpitations. light-headed, dizziness, slight headache on 08Feb2021 at 01:15 pm. AE resulted in: Doctor or other healthcare professional office/clinic visit. If treatment AE: no, If covid prior vaccination: no, If covid tested post vaccination: no. The outcome of events was recovered on an unknown date.

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

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.

Weight: She has gained weight since covid; 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: EL3246), via intramuscular, administered on Right arm on 12Jan2021 11:30 (at the age of 78-years-old) at single dose for COVID-19 immunization. Medical history included breast cancer (19 radiations and they took out three lymph nodes on the left, she was diagnosed 3 years ago); blood pressure abnormal (Additional Information for Concomitant Products Losartan: she has been taking for years and Additional Information for Concomitant Products Amlodipine besylate: added about a year ago); vein disorder (She clarifies that she had vein issues in her legs had vein injections to dispose of the larger veins. She was asking if it is possible that may have anything to do with it. She has had the vein injection a number of times throughout the years. The last time she had it done again was in Sep2020) and herpes zoster. No additional Vaccines Administered on Same Date of the Pfizer Suspect reported. Concomitant medication(s) included losartan (MANUFACTURER UNKNOWN, Formulation: tablet), orally at 100 mg, 1x/day (once a day) for blood pressure abnormal; amlodipine besilate (MANUFACTURER UNKNOWN, Formulation: tablet), orally at 5 mg, 1x/day (once a day) for blood pressure abnormal; and tamoxifen (MANUFACTURER UNKNOWN, Formulation: tablet), orally at 20 mg, 1x/day (once a day) for breast cancer. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced weight since COVID-19 infection on an unspecified date. She clarifies that she had vein issues in her legs had vein injections to dispose of the larger veins. She has had the vein injection a number of times throughout the years. The last time she had it done again was in Sep2020. Reports she had the shingles shot a few months ago. She will call her doctor to see if she should get a sonogram or x-ray of her calf to check for blood clot. The patient underwent lab tests and procedures which included that she was 136 pounds and she weighed herself and weighs 142 pounds. The outcome of event was unknown. No follow-up attempts are possible. No further information is expected.

gained weight since COVID,she was 136 pounds and she just weighed herself and weighs 142 pounds; she could not step down on her left leg; Charley horse; This is a spontaneous report from a contactable consumer (patient) reporting for herself. A 78-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: EN5318), dose 2 intramuscular route of administration, administered in Arm Right on 02Feb2021 17:00 as SINGLE DOSE for covid-19 immunization. Medical history included breast cancer (additional Information for Other Conditions: 19 radiations and they took out three lymph nodes on the left, she was diagnosed 3 years ago), blood pressure, 19 radiations, shingles shot. Reports she had the shingles shot a few months ago, vein disorder from Sep2020 to an unknown date. Patient was not sure if vein injections might be indicative of something and clarifies that she had vein issues in her legs had vein injections to dispose of the larger veins. She has had the vein injection a number of times throughout the years. The last time she had it done again was in Sep2020. Concomitant medications included losartan; taken for blood pressure abnormal; amlodipine besilate taken for blood pressure abnormal; tamoxifen taken for breast cancer. It was reported that, she has been taking losartan for years for blood pressure and amlodipine besylate about a year ago. The patient previously administered first dose BNT162B2 on 12Jan2021 11:30 (Lot number:EL3246), intramuscular injection in right arm for covid-19 immunization On 03Feb2021, patient experienced charley horse, gained weight since covid, she was 136 pounds and she just weighed herself and weighs 142 pounds, she could not step down on her left leg. Clinical course of events includes, patient was curious, she had her second shot at 5pm on Tuesday. Yesterday morning when she woke up at 6:30 or 7 in the morning, she could not step down on her left leg. For the last day and a half, she has had what had a bad charley horse behind her knee on the upper part of the calf. She was asking if the vaccine has any indications of a blood clot. Reports she was sitting in a car for 5 hours waiting to get the vaccine. She plays golf, stays busy, she does a lot, she was not someone that is very stagnant normally. When she went to get out of bed, she could not put her foot down, she was limping. She cannot step down without being in pain. She was trying to walk now. Therapeutic measures were taken as a result of charley horse, she could not step down on her left leg. She read walking was good and drinking water, drinking tea, she did a warm compress four times this morning. The outcome for the charley horse, she could not step down on her left leg was recovering and outcome for gained weight since covid, she was 136 pounds and she just weighed herself and weighs 142 pounds and was unknown.

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

On day 12 muscle discomfort in quadriceps; discomfort in lower back; This is a spontaneous report received from a contactable consumer (patient). A 78-years-old non-pregnant female patient received bnt162b2 first dose (BNT162B2, Solution for injection, lot Number: EN5318) via an unspecified route of administration, on left arm on 30Jan2021 13:00 at single dose for an unspecified indication. Relevant medical history and concomitant medications were not provided. Since the vaccination, the patient had not tested positive for COVID-19. Patient has not had symptoms associated with COVID-19. The patient previously received sulfa [sulfadiazine] and experienced drug hypersensitivity. On 10Feb2021 12:15, the patient experienced on day 12 muscle discomfort in quadriceps and discomfort in lower back gradually worsening each day. The outcome of the events was not recovered.

Sore neck was reported as worsened; Sore neck; sore arm; This is a spontaneous report from a contactable consumer (patient). A 78-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection), intramuscular, administered in Arm Left on 17Feb2021 12:08 (Batch/Lot Number: EM9809; Expiration Date: 30Jun2021) as single dose for covid-19 immunisation. Medical history included stiff neck. There were no concomitant medications. The caller explains the arm soreness developed on 17Feb2021 after she got home from receiving the vaccine. She couldn't sleep on her left side, which she is used to doing that. She hasn't slept on her left side still. Right now, where the needle went is a little sore, but her arm is okay. Her neck just hurts. The caller states her neck started to get sore probably last night while she was sleeping. She had a little bit of sore neck yesterday (18Feb2021) and last night. But, she woke up this morning and it was worse. She could move her neck and everything up until this morning. The outcome of the events sore arm was reported as recovering. The outcome of the event Sore neck was reported as not recovered. The outcome of the event Sore neck was reported as worsened was reported as unknown.

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

Pt states that 3 days after her Pfizer covid vaccine, she developed swelling and pain of left hand. Doctors notes state she was diagnosed with gout with a Uric acid of 8. The doctor states the covid vaccine could trigger gout and that she is taking HCTZ which can predispose. This was the pt's first episode of gout. She was treated with a medrol pak. Doctor's notes state that pt improved 1 day after taking steroids. she has not had any recurrence of gout.

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

passed out for a very short period of time; was awakened by total body shaking and it was not just shivers but was uncontrollable shaking; her body felt warm but then she was freezing; her body felt warm but then she was freezing; was sick and was different and very weak; muscles were sore; This is a spontaneous report from a contactable consumer. A 78-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 17Mar2021 12:10 (Batch/Lot Number: EN6207; Expiration Date: 31May2021) as a single dose for covid-19 immunization. The patient's medical history was not reported. There were no concomitant medications. The patient received her first dose of the Pfizer BioNTech COVID19 vaccine on 23Feb2021 (lot number: EN6198 with expiry date 31May2021) for Covid-19 immunization. The patient experienced passed out for a very short period of time and awakened by total body shaking and it was not just shivers but was uncontrollable shaking on 18Mar2021; her body felt warm but then she was freezing, she was sick and was different and very weak, and muscles were sore in Mar2021. It was further reported that the patient got the 2nd dose of the Pfizer BioNTech vaccine that day on 17Mar2021 and about 12:45am or 1:30am the next morning she was awakened by total body shaking and it was not just shivers but was uncontrollable shaking; the shaking has resolved completely but she is not sure when it resolved but she was shaking for a good while because she can remember being so uncomfortable with her body moving so much which went on for maybe 20 minutes or so when her husband woke up.Patient's husband then woke up and got Ibuprofen and gave it to her and that stopped the shaking which surprised her and she did not know the Ibuprofen would work to stop the shaking that well and the Ibuprofen did work in stopping the shaking. The Ibuprofen stopped the shaking and she can remember to touch her body felt warm but then she was freezing and she does not know what this means but this was not ongoing and resolved when her husband gave her the ibuprofen and she stopped shaking right away which always amazed her that the Ibuprofen worked. She stated fortunately the Ibuprofen stopped her from shaking and she was able to sleep until early morning when she woke up and knew she was sick and was different and very weak; states the weakness was not ongoing and the approximate time the weakness resolved was unknown but she was down the rest of the day and after that she passed out for a very short period of time and held her head up and stood up and thought wow something was going on and asked where was this coming from and it was not nausea but she was just weak. She has not passed out for a huge amount of time but fortunately she had some towels laying close by and was able to use a towel; states after that she stopped for the rest of the day and only got up to go to the potty and was just so weak and heard that from many people that they just slept afterwards.Caller states her muscles were sore and she realized that was just normal and after the 2nd dose of the vaccine she knew her muscles would probably be sore and this was resolved. She came downstairs and was sitting on a chair and then stood and no longer sat in the chair and her husband knew things were not right with her and her eyes looked funny and she passed out and that never happened to her before and she was passed out for a few moments. Other than the Ibuprofen she did not have treatment and did not go to the emergency room or the HCP office. Patient only took one Ibuprofen and she has a very small body and her husband sometimes takes 2-3 Ibuprofen and she thinks wow that is so many but she herself does not have any medication and she just took one Ibuprofen and it worked; She took the Ibuprofen on 18Mar2021 in the early morning. Fortunately she was in good health. Outcome of the event passed out for a very short period of time, was awakened by total body shaking and it was not just shivers but was uncontrollable shaking and muscles were sore was recovered in Mar2021, and unknown outcome for the remaining events.

Critical Limb Ischemia Symptoms: Progressive BL lower extremity and back pain starting on 3/20/2021. She presented to the ED twice and DVT ultrasound and lumbar spine CT showed no acute findings. Symptoms progressed to the point of severe pain on 4/1/2021 with toe numbness and paralysis. CTA of BL lower extremities was performed showing bilateral arterial thrombus. She underwent bilateral common femoral artery thromboembolectomy with vascular surgery. Of note, patient was on eliquis 5 mg BID given history of PE in 2018. She was compliant with this medication.

After 5 minutes of receiving vaccine, patient became nauseous. Once home, she complained of dizziness. Around 4am, patient was awakened with strong heart palpitations. She noticed ankle and foot swelling after about a day. She also noticed a rash on the vaccine arm, neck and under chin. She experienced severe nausea and vomiting over the next 3 days and could not eat food. She did not seek medical attention and chose to stay in bed to recover. As of today, the patient says she is almost recovered from these events.

injection site pain; tiredness; joint pain; slight fever (<100F); chills; nausea; feeling unwell; This is a spontaneous report received from a contactable consumer or other non hcp reporting for herself. A 78-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EL9262), via an unspecified route of administration, in left arm on 28Jan2021 19:15 at a single dose for COVID-19 immunization. Medical history included hypertension and thyroidectomy. Concomitant medications included sertraline, pravastatin, cranberry and losartan potassium.T he patient experienced injection site pain, tiredness, joint pain, slight fever, chills, nausea and feeling unwell on 29Jan2021. The patient underwent lab tests and procedures which included body temperature as less than 100 Fahrenheit on 29Jan2021. The outcome of the event was not recovered. No follow-up attempts possible. No further information expected.

Extreme joint and muscle pain, extreme fatigue I took tyleno, tramadol and advil at the appropriate time periods, Very sore injection site; became very, very red swollen and went down my arm almost to my elbow, around to underside of my arm. The pain and fatigue lasted 1 week and I stayed in be most of the time as I felt terrible. The arm lasted approx 3 weeks, I used benadryl and over the counter cortisone cream.

aftereffects lingered for over 2 weeks and I am still somewhat compromised; headaches; weak legs- arms and shoulders more dominant on left side.; weak legs- arms and shoulders more dominant on left side.; This is a spontaneous report received from a contactable consumer (patient). A 78-years-old female patient received bnt162b2 (BNT162B2), dose 2 intramuscular, administered in Arm Left on 17Feb2021 14:15 (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunisation.Age at vaccination:78 years.Medical history included guillain-barre syndrome from Oct1986 and ongoing. The patient's concomitant medications were:None.The patient received first dose dose of the same vaccine 27Jan2021 at 01:45 P.M on left Arm via IM and developed headache and very weak legs on 27Jan2021 at 1:45 P.M. Vaccination Facility Type where the vaccine was administered was reported: Nursing Home/ Senior Living Facility. No other vaccines were received in the previous 4 weeks. The patient reported : Both shots resulted in days of headaches and very weak legs- arms and shoulders more dominant on left side. Second shot's aftereffects lingered for over 2 weeks and I am still somewhat compromised although, much, much improved. Onset date /time of the events was reported:17Feb 02:15. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on 2020 (Between summer and winter of 2020). Outcome of the events was recovering; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021245697 Same reporter,patient/different dose

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

severe pain; joint pain; headache; fever; nausea plus heavy chest feeling; Have persistent cough; Heavy chest feeling; This is a spontaneous report from a contactable consumer or other non hcp. A 78-years-old female patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration, administered in Arm Left on 15Feb2021 13:15 (Batch/Lot Number: EL3248) as SINGLE DOSE for covid-19 immunisation. Medical history included gastrooesophageal reflux disease. Concomitant medication(s) included vitamin d3 (VITAMIN D3) taken for an unspecified indication, vitamin b complex (B COMPLEX [vitamin b complex]) taken for an unspecified indication, fish oil (fish oil) taken for an unspecified indication, biotin (BIOTIN) taken for an unspecified indication, start and stop date were not reported; famotidine (PEPCID [FAMOTIDINE]) taken for an unspecified indication. The patient previously took covid-19 vaccine for covid-19 immunisation. On 15feb2021, at 18:30 the patient experienced severe pain, joint pain, headache, fever, nausea plus heavy chest feeling and have persistent cough. The patient was recovering from the events. The action taken in response to the event(s) for bnt162b2 was not applicable. No follow-up attempts are possible. No further information is expected.

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.

left arm feels "heavy", warm to touch and continued redness at injection site. No pain or tenderness voiced.Patient has antihistamine cream, advised to apply anti histamine cream to affected area.

she just felt dizzy so fast and passed out; passed out; She hurt her ankle from it; 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), dose 2 via an unspecified route of administration, administered in Arm Left on 05Apr2021 08:45 (Batch/Lot Number: EP7534) as SINGLE DOSE for covid-19 immunisation. Medical history included ongoing hypertension, atrial fibrillation from Aug2020 and ongoing , cystitis. Concomitant medications included sulfamethoxazole, trimethoprim taken for cystitis from 27Mar2021 to 02Apr2021; apixaban (ELIQUIS) taken for atrial fibrillation from an unspecified start date and ongoing; atenolol (ATENOLOL) taken for Blood pressure from an unspecified start date and ongoing. The patient received first dose of bnt162b2 for COVID-19 immunization on 15Mar2021 lot number: EN6202, Expiry date: 30Jun2021. The patient received the second dose of the Covid vaccine around 8:45 a.m. and states that she "felt fabulous." On 06Apr2021 she felt fabulous. She said that she had a doctors appointment at 1200 06Apr2021 and her blood pressure was good. She said that she was also taking an antibiotic prior to that week. She asked the doctors about taking vaccines after taking the antibiotic since the medication said that you should avoid vaccines while taking the antibiotic, and they all said that it was fine. She came home about 1330 06Apr2021 and she passed out while making her lunch. She hurt her ankle from it and she is not a happy camper. She said that all her vitals were good and her blood was good. That was all taken 2 hours before she passed out. The weird thing was she never felt better that day after she passed out. She said that she had no reaction after the first shot. Prior to this she felt good and there was no warning, she just felt dizzy so fast and passed out. Caller said that her ankle is getting better and she hurt her toe too, but it is getting better. She treated the ankle with ice. She said that it could have been worse. She said that she did not understand this and had no side effects previously. The event passed out was assessed as serious (medically significant). The patient underwent lab tests and procedures which included blood test: good on an unspecified date her blood was good. Therapeutic measures were taken as a result of she hurt her ankle from it (arthralgia). The outcome of the event passed out was recovered with sequel on 06Apr2021, unknown for the other events.

Client received the COVID vaccine (Pfizer dose 2, lot #EW0179, expiration date 4/28/2021) at 1330. At 1345, the client reported right sided numbness and bilateral jaw tightness; RN, PHN; RN responded. Vital signs were as follows: blood pressure 140/75, heart rate 83, respiratory rate 14, O2 97%. The client stated that she has no allergies, takes lipitor, eliquis, and "colon medication," and she has a medical history of COPD, asthma, cardiac arrhythmia, and high cholesterol. At 1350, 50 mg of Benadryl PO was given and water was given. The client's color was within normal limits, she was neurologically intact (alert and oriented) and in no visible distress. The client denies shortness of breath and her lungs were clear to auscultation bilaterally. At 1355, the client's vital signs were: 96% O2, heart rate 89, temp 98.5, At 1401, the client stated that the numbness had decreased. Her blood pressure was 130/66, O2 99%, heart rate 92, respiratory rate 16. The client stated she did eat and drink today. At 1410, the client's blood pressure was 135/72, O2 96%, and heart rate 75. The client stated her symptoms had resolved at this time. Education provided regarding v-safe, emergency management, and AMR activation. At 1420, the client's vital signs were as follows: blood pressure 122/65, heart rate 72, and O2 96%. The client left at this time, ambulating to her car with a steady gait.

hips were hurting; having hard time getting up and down; This is a spontaneous report from a contactable consumer (Patient). A 78-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), formulation: Solution for injection, Batch/Lot Number: EN6201, expiration date: unknown, via an unspecified route of administration in Arm Right on 22Feb2021 11:00 as single dose for covid-19 immunisation. The patient medical history included atrial fibrillation from Jan2020 and ongoing and breast cancer about 8-9 years ago in the left breast. The patient concomitant medication included apixaban 5mg twice a day by mouth taken for atrial fibrillation, diltiazem hydrochloride 180mg once a day by mouth, lisinopril 20mg twice a day by mouth taken for blood pressure measurement and was ongoing, hydralazine 25mg twice a day by mouth taken for blood pressure measurement and all were ongoing. The patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), formulation: Solution for injection, Batch/Lot Number: EL3247, expiration date: unknown, via an unspecified route of administration on 01Feb2021 as single dose for covid-19 immunisation and had soreness in her arm for a couple of days. The patient clarified that she had the first dose on 01Feb2021. She said that her arm was sore for like a day and a half, but she had no other reactions with the first vaccine. On 23Feb2021, after second dose, the patient stated that her hips started hurting around 3 and then they hurt all night and have hurt ever since. She is having a hard time getting up and down. She said that around 14:00-15:00 her hips started hurting and got progressively worse. She said that she kept a hot water bottle on it. She said that it is hard to get up and down, especially off of the toilet. She took a Tylenol at 0900 23Feb2021. She said that she has had no problem with her hip prior to this. Her pain in her hips has improved since she took a Tylenol. She said that she does have a sensitivity to medication. She said that she had no reaction except for soreness from the first shot. Her arm is a little sore now, but it is her hip that is bothering her now. She said that she does not have any artificial hips or anything. She said that she has all of her body parts. Outcome of the event hips were hurting was recovering and having hard time getting up and down was not recovered.

urgent continuous diarrhea, abdominal cramps, weight loss (5 lbs) in 3 days, dehydration, low blood pressure. clear liquid diet, blood pressure medications adjustment

Patient experienced an arthritis flare after the 1st dose, and this became much more intense after the 2nd dose. She had increased weakness, abdominal pain, loss of appetite (not eating/drinking much), falls, and failure to thrive x3 weeks after the second dose which all ultimately got her admitted to the hospital (4/6/21). Upon admission, her blood counts were found to be dangerously low.

Pain; a lump down from where the injection site was/ lump in the arm, 4 inches down from the shoulder where she got the shot; her shoulder aches; shoulder aches and the feeling goes into the arm; This is a spontaneous report from a contactable consumer (patient). A 78-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration at age of 78-years, at single dose in left arm on 03Mar2021 10:00 (Lot number was not reported) for covid-19 immunisation. Medical history included type 2 diabetes that diagnosed about 3 years ago, this year makes 4 years, and she took medications for it. And she was a little overweight, supposed to drop some but gained some back that because of diabetes. Historical Vaccine included the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) also at age of 78-years, at single dose in left arm on 02Feb2021 13:00 for covid-19 immunisation and she had no problem with that one. Another Historical Vaccine included flu shots, it just lasted a day or two, maybe that's it, never had problems before. The patient's concomitant medications were not reported. The patient reported side effects from the Pfizer COVID vaccine. Her arm was still bothering her. There was a lump down from where the injection site was and that she kept rubbing it but it won't go away and that she still had pain. She was told she should go to the doctor, but she thought she would call to see what was best to do. She had not a fever, just the lump on the arm, 4 inches down from the shoulder where she got the shot. The patient stated that both Pfizer COVID vaccines were in her left arm, she should have gotten it in the other arm. The patient stated she heard about blood clots and thought she'd better check it out. The patient stated that she had the lump and her shoulder aches; not the shoulder the upper arm. The lump was on the inside and she kept rubbing it but it didn't go away. The patient had the second Pfizer COVID vaccine in the morning around 10:00 AM on 3Mar2021. The pain started the same day on 03Mar2021, then stated that night after midnight and that she thought it would go away. The lump in the arm started a couple of days after the Pfizer COVID vaccine, she thought it was a couple of days but maybe sooner, she didn't pay too much attention. The patient stated the lump felt like it was the size of a nickel, she was pushing to try to feel it and that maybe the lump was a little larger than a nickel. Her shoulder aches and the feeling went into the arm and it started the same week she had the shot but that she didn't pay any attention so is not sure exactly when it started. It was best to check it out with her doctor. The outcome for event pain and vaccination site lump was not recovered, while for remains event was unknown. Information on the lot/batch number has been requested.

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

intestinal problems after she eats, and feels like intestinal flu; Balance is off; feeling unwell, just didn't feel good/just hasn't felt right; bursitis in her hands./both of her arms that felt like bursitis; feeling weak, her legs, she could barely stand she had to go to bed; feeling weak, her legs, she could barely stand she had to go to bed; problems with her stomach, intestinal things, intestinal problems; problems with her stomach, intestinal things, intestinal problems further described as lower intestinal; joint pain/shoulders, knees and wrists hurt; Muscle pain; Tenderness; fever; weak; tired; Left arm hurt, injection site pain/tenderness at the injection site; This is a spontaneous report from a contactable consumer (patient) A 78-years-old female patient received the first dose bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration, administered in Arm Left on 05Apr2021 at 13:37 (Batch/Lot Number: EW0150; Expiration Date: 31Jul2021) as SINGLE DOSE for covid-19 immunization. The facility in which the vaccine was given was . Medical history included ongoing arthritis (If she does much your arms will ache/Doesn't take anything for her arthritis, her fingers and joints), hypersensitivity from an unknown date and unknown if ongoing allergy to milk , urticaria from an unknown date and unknown if ongoing (When she gets stressed she gets hives if she does not take her liquid Benadryl she will swell up) , covid-19 from Nov2020 to an unknown date Sick for 3 weeks/intestinal flu, diarrhea, couldn't eat anything/ test oxygen level; knuckles are so big it was registering like 76. Patient's doctor recommended the vaccine since she had Covid virus in Nov2020. Concomitant medication(s) included takes cholesterol and thyroid medication (details not provided); vitamin c [ascorbic acid] (VITAMIN C [ASCORBIC ACID]) taken for an unspecified indication from an unspecified start date and ongoing; vitamin d [vitamin d nos] (VITAMIN D [VITAMIN D NOS]) taken for an unspecified indication from an unspecified start date and ongoing; calcium (CALCIUM) taken for an unspecified indication from an unspecified start date and ongoing. The patient previously took influenza vaccine and experienced influenza, Previously took Aspirin and experienced angioedema. The patient experienced left arm hurt, injection site pain/tenderness at the injection site on 05Apr2021, fever, weak on 06Apr2021, weak, tired on 06Apr2021; joint pain/shoulders, knees and wrists hurt, muscle pain, tenderness on 08Apr2021, problems with her stomach, intestinal things, intestinal problems on 12Apr2021, intestinal problems after she eats, and feels like intestinal flu, balance is off, feeling unwell, just didn't feel good/just hasn't felt right,bursitis in her hands./both of her arms that felt like bursitis, feeling weak, her legs, she could barely stand she had to go to bed on an unspecified date. The adverse events did not require a visit to the Emergency Room or Physician's Office. The patient underwent lab tests and procedures which included body temperature: '100.57 ' fahrenheit on 06Apr2021. Clinical course was reported as follows the patient received the first Pfizer-BioNTech Covid-19 Vaccine on 05Apr2021. On the same day 05Apr2021 her left arm hurt, injection site pain. On 06Apr2021 in the afternoon she had a fever of 100.57 Fahrenheit. She was also very weak and had to lay down because she was tired. She had site pain, joint pain, and muscle pain. With the joint pain her wrists hurt, it was her shoulders, knees and wrists hurt. The tenderness at the site didn't go away until Sunday. She reported her problems with her stomach, intestinal things, intestinal problems, further described as lower intestinal. She started feeling weak, her legs, she could barely stand she had to go to bed. She was tired, started to get joint pain and feeling unwell, just didn't feel good. She felt that just to stand she would fall down, so she had to lie down. Her balance is off, and she felt weak for about 2-3 days, weak is not completely gone but noticed her balance is off a little bit which is ongoing. She just hasn't felt right since she's had the shot. With the muscle pain it felt like she had bursitis in her hands. She had tenderness at the injection site as well as in both of her arms that felt like bursitis, which went away on 12Apr2021 or 13Apr2021. She has intestinal problems after she eats, and feels like intestinal flu. Someone saw her and said she looks tired. On 7Apr2021, she had a visit from the the insurance company doctor and he recommended her not to take the second shot, and that's why she called Pfizer. The second dose of Pfizer-BioNTech Covid-19 Vaccine is due on 26Apr2021 but she's not sure she wants to because she is still recovering from the first one. The clinical outcome of the events Joint Pain, Muscle pain recovered on 12Apr2021, Vaccination site pin Recovered 10Apr2021, Fever recovered 06Apr2021, Weak, tired, balance is off, feeling unwell, just didn't feel good, intestinal problems after she eats, and feels like intestinal flu was unknown, Tenderness was recovered Apr2021, problems with her stomach, intestinal things, intestinal problems was not recovered

2 1/2 hours after receiving 2nd shot, I developed total stiffness in back could barely stand up straight and had a stabbing, electric nerve pain down the L leg that was causing me to walk with a cane and take pain pills. I am still with pain, can walk only short distances and feel fatigue and L leg shakes . My gait is unsteady.

WOKE UP NEXT DAY WITH ACHING IN MY LEFT HIP AREA, CONTINUED TO GET WORSE THAT DAY AND NEXT DAY TO THE POINT I WAS HAVING TROUBLE MOVING AND BREATHING BECAUSE OF THE PAIN. EARLY MORNING THURSDAY HAD MY HUSBAND TAKE ME TO ER AS THE PAIN HAD MOVED UP MY BACK ON THE LEFT SIDE. ER TOOK X-RAY AND SAW NOTHING, GAVE ME PAIN MEDICATION, PRESCRIBED PREDNISONE AND THE PAIN STARTED TO SUBSIDE. TOOK PREDNISONE FOR A WEEK AND THE PAIN DISAPPEARED.

About 45 minutes after 2nd shot I had very odd feeling of lightheaded and dizzy. Also felt like a tight band around chest and difficulty in a deep breath. This lasted about 20 minutes. Since then a lot of joint pain and fatigue

1 week later - aches (arthritis was worse), leg cramping, general feeling of being unwell seems to come and go still having pain in arm where injection was

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.

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.

She also is diabetic and has high eye pressure.; The pain is going to her neck and does not let her raise her arm. She also mentions that she also have a sharp pain in her belly and she did not have it before.; Feeling that her shoulder is killing her.; The pain is going to her neck and does not let her raise her arm. She also mentions that she also have a sharp pain in her belly and she did not have it before.; she also have a sharp pain in her belly; This is a spontaneous report from a contactable consumer (patient). A 78-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: unknown), via an unspecified route of administration on 30Apr2021 as a single dose for covid-19 immunization. Patient's historical vaccine included first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: unknown) via unspecified route on an unspecified date. The patient's medical history included diabetes. The patient's concomitant medications were not reported as single dose. It was reported that the patient felt that her shoulder was killing her. The patient stated that the pain was up to her neck and does not let her raise her arm. The patient also stated that she also had a sharp pain in her belly which did not had it ever before all on 19May2021. The patient also stated that she was also a diabetic and has high eye pressure. Patient called her doctor this morning and could not find him so she she left a message. Patient did not want to go to the ER and she wanted to know why she was having these adverse reactions after 20 days of taking the vaccine. The patient was explained about the reports of muscle pain and pain in the injection site, the possible duration and being more intense after the second dose. The patient was recommended to consult her physician to determine the cause of her pain. Therapeutic measures were not taken as result of AE. The outcome of the events was unknown. Information on lot number/batch number was requested.

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.

Left arm was sore when received the vaccine which she expected. Then it started traveling and now it is completely up to the shoulder area and she is in extreme pain. Her doctor told her to call local DOH to report adverse effects.

right knee arthralgias and effusion started day after, persistent at office visit 6/15 concerning for reactive arthritis

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.

Lips tingling/Tongue started to tingle; Face red which felt like swollen; Face red which felt like swollen; Her face "felt tight"; This is a spontaneous report from a contactable consumer (patient). A 78-years-old female patient received bnt162b2 (PFIZER- BIONTECH COVID- 19 VACCINE, Solution for injection), dose 1 via an unspecified route of administration, administered in arm left on 26Jan2021 14:00 (Batch/Lot number was not reported) as 1st dose, Single Dose for Covid-19 immunisation. Medical history included Von willebrand's disease Von Willebrand syndrome and Glanzmann's disease and allergies. Family history included bleeding disorder. She was poisoned by pesticides and formaldehyde years ago and they burned her entire respiratory system. There were no concomitant medications. The patient never had a reaction to a vaccine. No vaccines administered on same Date of the Pfizer suspect. No prior vaccinations were given within 4 weeks and no adverse events following prior vaccinations. On an unspecified date of Feb2021, the patient experienced lips tingling, face red which felt like swollen, tongue started to tingle, her face felt tight. The events lasted about 1- 2 hours. Patient wanted to know; can she take a Benadryl before the vaccine. The second dose is due on 16Feb2021 so the first dose was 3 weeks before that one was due. After getting the shot, her lips started to tingle, tongue started to tingle, and her face felt real tight. When the nurse came out to check on her, she was told by the nurse her face was really red. The nurse was going to get an EpiPen and wanted to call EMS. The reporter states she told her to just give her a Benadryl, she normally has them in her car but had run out. Patient stated she was allergic to everything. Anything coming in contact with her respiratory system such as hair spray, scents, any chemical causes her problems. The patient explained that she was re-reading the information about telling the vaccination provider about medication conditions including allergies and bleeding disorder, both of which she has. She was concerned about getting the second dose. She wants to know if the first dose will offer any protection. She had the first dose of the covid shot on 26Jan2021. She started feeling funny. The patient called the nurse and reports her lips were tingling and her tongue was starting to tingle. Her face was really red. Her face felt like it had pressure like it was blowing up but it did not feel swollen, it was tomato red. The patient queried if she does not get the second dose what will that do. She knows there needs to be given a certain amount of time between the doses. She heard on the tv that it can be given up to 45 days and still be effective. She heard all kinds of information, she heard that someone should get the second dose within 28 days and the paperwork states something different. Asked if her reaction will be worse with second shot. She was supposed to go back on 16Feb2021 for the second dose. Patient stated she took Benadryl after her reaction from the vaccine. She wanted to know if this affects the vaccine. Patient mentioned the fact sheet states that patients should tell the vaccination provider if they have a bleeding disorder or are on a blood thinner. She states she has a bleeding disorder. Therapeutic measures were taken as a result of the events. She took a Benadryl for treatment. The outcome of the event was resolved on an unspecified date of Feb2021. Information on the lot/batch number has been requested. Follow-up attempts completed. No further information expected.

Swelling, pain and weakness in right arm. The symptoms were diagnosed as lymphedema. Treatment consisted of 2 weeks of antibiotics and steroids and, eventually PT with a specialist in lymphedema swelling. This side of the patient has many of her lymph nodes removed in conjunction with a surgical removal of a right breast cancer lump removal some 25 years ago. No lymphedema symptoms had ever incurred in the patient prior to the covid vaccination. PT is ongoing but little improvement after 2 weeks of treatment.

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

day after getting the 1st dose she got a headache/chills/low temp/couldn't more left arm/arm, neck and shoulder pain

Beginning approximately two days after my first vaccine shot, I have experienced joint pain and stiffness. It is most prevalent in my left shoulder and the middle finger of my right hand. I have not had pain in these places before. I have also had pain and stiffness in my knees and lower back, and I have had problems in these places before. The pain is not debilitating and is relieved with Advil and Tylenol. I expected it to just resolve itself, but it has not. I have communicated this to my health care provider, Dr. , by telemedicine.

joints are very sore and achy/Joints really hurt after second dose; This is a spontaneous report from a contactable consumer (patient). A 78-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 13Jun2021 (at the age of 78-year-old) as 2nd dose, single for COVID-19 immunization. Medical history included lung cancer (she was diagnosed with lung cancer about a year ago and was still in treatment). The patient's concomitant medications were not reported. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Batch/Lot number was not reported), dose 1 via an unspecified route of administration on an unspecified date, 1st dose, single for COVID-19 immunization and was ok. The patient stated that she received the second dose of the Pfizer BioNTech Covid-19 vaccine on 13Jun2021. On an unspecified date, the patient experienced joints are very sore and achy. She had an effect from the second dose. She did not know what to take and wanted to ask Pfizer what she could take. The patient stated that now her joints are very sore and achy. The patient stated that her HCP referred her to Pfizer to see what she can take for joint soreness. The patient asked what she can take for soreness in her joints. The patient stated that first one was ok, and with the second one, her joints really hurt. The patient declined to receive any further information over the phone regarding her side effects in relation to the Pfizer Covid-19 vaccine. Referred to healthcare professional for further guidance. The outcome of the event was unknown. Information on the lot/batch, further information has been requested.

itching; Rash; fatigue; joint pain; low blood sugar; This is a spontaneous report from a contactable consumer (patient). A 78-year-old non-pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EM9809/Expiry date: unknown), via an unspecified route of administration on 04Feb2021 at 11:00 AM in the left arm (at the age of 78-years-old) as single dose for COVID-19 immunization. The patient medical history included ongoing diabetes from 2000 and hysterectomy in the year 2000. The patient had received some other medications within 2 weeks of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No pre-disposing factors was reported. Follow up received on 21Apr2021, it was confirmed that on 27Feb2021 at 10:00, the patient experienced rash, fatigue, joint pain and low blood sugar (previously reported as, 05Feb2021, 12:00 AM, the patient experienced rash, fatigue, joint pain, and low blood sugar. Adverse event resulted in Doctor or other healthcare professional office/clinic visit. The patient was given advice and reassurance for the treatment of the adverse event). The patient had received treatment for rash. No treatment medication for received for events fatigue, joint pain, and low blood sugar. The patient was not hospitalized as a resulted of these events. Patient reported that the Doctor suggested taking benadryl for itching due to rash. The patient reported that she required a virtual visit to Physician office. It was unknown if the patient had any primary infection site. No culture was performed. The patient reported that she was fine now at the time of reporting. The clinical outcome for the event itching was unknown and the outcome of other events had recovered. Information on the lot/batch number has been requested. Follow up(21Apr2021): This is a follow up-spontaneous report from a contactable consumer received in response to Non-HCP letter via follow-up letter which included: Added patient's age at vaccination, medical history, suspect drug details (Lot number, Time of vaccination), updated event details (onset date and outcome), clinical course and narrative updated accordingly. Follow-up attempts completed. No further information expected.

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.

neck spasms; diarrhea; the urge to go to the bathroom all day long; a bloating abdomen with a lot of gas; a bloating abdomen with a lot of gas; feeling severe muscle pain in the stomach; This is a spontaneous report from a contactable consumer. This 78-year-old female consumer (patient) reported. A 78-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 05Feb2021 (at the age of 78-years-old) as dose 2, single for COVID-19 immunization. The patient's medical history and concomitant medications was not reported. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as dose 1, single for COVID-19 immunization. The patient called to report her symptoms after the administration of the second dose of the Pfizer's COVID-19 vaccine. On 06Feb2021, the patient started having neck spasms, diarrhoea, and the urge to go to the bathroom all day long, also a bloating abdomen with a lot of gas, feeling severe muscle pain in the stomach. She stated her symptoms were not putting her on risk based on the information that she received about the vaccine when it was administered to her. Outcome of the events was unknown. Information on the lot/batch number has been requested. 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".

polymyalgia rheumatica; Patient received the vaccine in left arm on 03Apr2021. On 05Apr2021 he experienced muscle pain in upper right arm. Once he received second dose it became worse.; Patient received the vaccine in left arm on 03Apr2021. On 05Apr2021 he experienced muscle pain in upper right arm. Once he received second dose it became worse.; This is a spontaneous report from a contactable consumer (reported for herself). A 78-years-old female non-pregnant patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Batch/Lot number was not reported), dose 2 via an unspecified route of administration, administered in arm left on an unspecified date (at the age of 78-years-old) as dose 2, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient previously received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot number: ER8737/Batch was not reported), dose 1 via an unspecified route of administration, administered in arm left 03Apr2021 (at the age of 78-years-old) as dose 1, single for covid-19 immunisation and experienced muscle pain in upper right arm on 05Apr2021. The reporter stated that patient received the vaccine in left arm on 03apr2021. On 05apr2021 he experienced muscle pain in upper right arm. Once he received second dose it became worse and contacted her physician. Physician ran multiple blood work, ruled out possibilities and gave me a diagnosis of PMR (polymyalgia rheumatica). Started prednisone 30 msg on 24May21 in decreasing doses. Pain was relieved and she still on the medication. The reporter stated that patient have never experienced such intense pain in her life. Physician attributed her pain to the vaccine. The event polymyalgia rheumatica assessed as serious. The patient underwent lab tests and procedures which included blood test: unknown on an unspecified date. The reporter stated the events result Doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of patient for the events with prednisone 30 msg started on 24May2021. The outcome of the events pain in extremity, condition aggravated was resolving and polymyalgia rheumatica was unknown. Information about lot/batch number has been requested.

Headache; Chills; Muscle ache; Joint ache; Left arm pain; Feeling "sick"; Slight fever; This is a spontaneous report from a contactable consumer, the patient. A 78-year-old non pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE BIONTECH, Lot number: EN6207), via an unspecified route administration in the left arm on 19Mar2021 at 12:45 (at the age of 78-years-old), as a single dose for COVID-19 immunisation. Medical history included allergy to mites, grass pollen, cats and latex (skin contact). Concomitant medications included multiple vitamins (MANUFACTURER UNKNOWN), losartan potassium (MANUFACTURER UNKNOWN) and bifidobacterium infantis; lactobacillus acidophilus (PROBIOTICS); all from unknown dates for unspecified indications. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE BIONTECH, Lot number: EN6205), via an unspecified route administration in the left arm on 26Feb2021 at 00:15 (at the age of 78-years-old), as a single dose for COVID-19 immunisation and received doxycycline hyclate (MANUFACTURER UNKNOWN) and potassium dichromate (MANUFACTURER UNKNOWN); both on unknown dates for unspecified indications and experienced drug allergy. On 19March2021 at 14:00, the patient experienced headache, chills, muscle ache, joint ache, left arm pain, feeling sick and slight fever. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive treatment for the reported events. The clinical outcome of the events headache, chills, muscle ache, joint ache, painful left arm, feeling sick, fever was recovering at the time of this report. No follow-up attempts are needed. No further information is expected.

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.

Pfizer COVID 19 Vaccine EUA Pfizer Dose 1 2/26/21 (EN6198) Pfizer Dose 2 3/18/21 (EP7534) COVID Positive 7/6/21 7/6/21: The patient presents to ED with diarrhea and Pt is 78 y/o female who presents to the ED complaining of chronic diarrhea onset since March that worsened over the last two weeks. Pt has had a cough as well. Pt has had a previous colonoscopy, but was told by GI that it was "too soon to have another." Pt denies any recent antibiotics, recent sick contacts, or recent travel. Pt states she is diabetic and her sugars have been 112 in the morning and 150 in the evening. Pt denies any abdominal surgery. Pt admits to cough, nausea and back pain, but denies vomiting, bloody stools, fevers, chest pain, shortness of breath, and abdominal pain aside from a pain that occasionally radiates down to her pelvic which she does not have currently. Pt denies a bowel movement today. Pt admits to both Covid-19 vaccine doses in March. Pt received the Pfizer vaccine.. The onset was chronic. The course/duration of symptoms is worsening. The character is not bloody. Risk factors consist of not recent antibiotic use, not infectious exposure and no recent travel. Associated symptoms: abdominal pain, nausea, cough, denies vomiting, denies fever, denies chest pain and denies shortness of breath. Patient seen examined emergency department for chief complaint of diarrhea that has been present for several weeks. Patient has seen her GI doctor. She states that stool cultures were obtained. Stool cultures reviewed, which demonstrated all negative stool cultures. Due to patient's persistent diarrhea, workup was obtained to rule out acute dehydration verses AKI verses electrolyte abnormality. Workup obtained demonstrates no acute findings. Patient was updated results. On reexamination, patient states he has had no episodes of diarrhea in the ED. This juncture, I believe patient is stable for discharge home with close follow-up with GI. Patient is agreeable. Return precautions are discussed, including change in mental status, decreased urinary output, or any other concerns..

Colon cancer metastatic; Lung disorder; Kidney stones; Kidney cancer; Vomiting; Pain worsened; Back ache; Thyroid nodule; Lung nodule; sciatica; Nauseous; Light-headed; Feelings of weakness; Difficulty in walking; This is a solicited report from a marketing program received from a contactable consumer (patient). A 78-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), first dose via intramuscular on 29Mar2021 (Batch/Lot Number: ER8733) at age of 78 years old as single dose for covid-19 immunisation; upadacitinib (RINVOQ), oral from Dec2019 (Batch/Lot number was not reported) and ongoing, at 15 mg, once per day for moderate to severe rheumatoid arthritis. Medical history included non-smoker: secondary tobacco exposure, abstains from alcohol, high blood pressure, glaucoma, rheumatoid arthritis, muscle cramps in legs, cholesterol, acid reflux, and dry eyes. The patient had a relevant medical history of osteoporosis, hiatal hernia, DURICEF allergy manifested by pseudomembranous colitis. The patient had secondary tobacco exposure. She had history of usage of Remicade for unknown indication. Concomitant medications included amlodipine taken for hypertension; vitamin D3 taken for supplementation therapy; ciclosporin (RESTASIS) taken for dry eye and glaucoma; latanoprost taken for eye disorder; folic acid taken for rheumatoid arthritis; methotrexate taken for rheumatoid arthritis; magnesium taken for muscle spasms; fish oil taken for blood cholesterol; omeprazole taken for gastrooesophageal reflux disease; all start and stop date were not reported. Solicited report by a consumer of a female with events of colon cancer metastasize to the liver, kidney cancer that possibly moved onto liver, vomiting, back ache, pain worsened, spot on the lung and kidney stones and non-serious lightheaded, felt weak, could hardly walk, nodule on thyroid and right lung and nauseous with RINVOQ (upadacitinib). On unknown dates, the patient experienced kidney cancer that possibly moved onto liver and nodule on thyroid and right lung. On 29Mar2021, the patient experienced lightheaded, felt weak, could hardly walk and nauseous. On 29Mar2021, the lightheaded, felt weak, could hardly walk and nauseous resolved. In May2021, the patient experienced back ache. On 29May2021, the patient experienced vomiting and pain worsened. On 02Jun2021, the patient experienced kidney stones. On 03Jun2021, the patient experienced colon cancer metastasize to the liver and spot on the lung. On 03Jun2021, the vomiting resolved. On 17Jun2021, the kidney stones resolved. PFIZER BIONTECH COVID-19 VACCINE (TOZINAMERAN) was also considered suspect. On 27May2021, she was sent to the emergency room because of back ache and was given prednisone. In Jun2021, she had a terrible back ache. She thought she had sciatica. In Jun2021, she went to the doctor, physician pressed on her back and she went through the roof. She was vomiting and had pain in her back and her daughter took her to the emergency room and did x-ray and cat scans and she had kidney stones and she was having an ultra sound. Went back to the emergency room from 02Jun2021 until 04Jun2021 because of vomiting and pain. She also had kidney cancer that had possibly moved onto her liver. She had an endoscopy done. The biopsy and other tests to decide what was going to happen. There was a nodule on her thyroid and her right lung. She felt ok and had a little backache at times, but she was taking. She already had the COVID-19 vaccines first dose but was advised not to had the second dose because of the adverse events she experienced after the first dose. It was unknown if she was enrolled in a COVID-19 Vaccine Trial. On 29Mar2021, she received 1st dose COVID-19 Vaccine manufactured by Pfizer, lot number ER8733. The patient was treated with PREDNISONE. Relevant laboratory and other diagnostic tests included: 17Jun2021 abdominal ultrasound: No more kidney stones; Unknown date biopsy: Unknown; Jun2021 CAT scans: Kidney stones; 03Jun2021 chest X-RAY: Spot on the lung; 04Jun2021 colonoscopy: Colon cancer; 03Jun2021 computed tomography scan: Colon cancer metastasize to the liver; 04Jun2021 endoscopy: Hiatal hernia; Jun2021 endoscopy: Unknown; Unknown date lab tests: Unknown; Unknown date ultrasound: Unknown; Jun2021 X-RAY: Kidney stones. The action taken in response to the events for suspect product upadacitinib was dose not changed. The outcome of events colon cancer metastatic, kidney cancer, and lung disorder was not recovered, events vomiting was recovered on 03Jun2021, kidney stones was recovered on 17Jun2021, light-headed, feelings of weakness, difficulty in walking, and nauseous was recovered on 29Mar2021, events back ache, and pain worsened was recovering, of other events was unknown. Causality for RINVOQ(UPADACITINIB): The reporter's causality for the event(s) of colon cancer metastasize to the liver, vomiting, back ache, pain worsened, spot on the lung, kidney stones, lightheaded, felt weak, could hardly walk, nodule on thyroid and right lung unknown onset, nodule on thyroid and right lung unknown onset and nauseous was not provided. The reporter's causality for the event(s) of kidney cancer that possibly moved onto liver with RINVOQ(UPADACITINIB) was no reasonable possibility. (Withheld) opinion is that the events of colon cancer metastasize to the liver, kidney cancer that possibly moved onto liver, spot on the lung, nodule on thyroid and right lung unknown onset and nodule on thyroid and right lung unknown onset are not assessable. (Withheld) opinion is that there is no reasonable possibility that the events of vomiting, back ache, pain worsened, kidney stones, lightheaded, felt weak, could hardly walk and nauseous are related to RINVOQ(UPADACITINIB). The reporter's assessment of the causal relationship of the events with the suspect vaccine 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. No further information is expected.; Sender's Comments: Considering the close temporal association, a causative role of BNT162B2 vaccine for the reported Light-headed, Feelings of weakness, Difficulty in walking, and Nauseous cannot be excluded. All other events are considered unrelated to BNT162B2 vaccine.

severe heartburn; Headache; Chills; joint pain; muscle aches and pains; Fatigue; This is a spontaneous report from a contactable consumer, the patient. A 78-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Unknown) via an unspecified route of administration in the left arm on 03Feb2021 at 10:45 (at the age of 78-years-old) as a single dose for COVID-19 immunisation. Medical history included osteopenia, breast cancer in 2010, hearing impairment. The patient was allergic to NSAID. Concomitant medications included ibandronate (MANUFACTURER UNKNOWN), niacinamide (MANUFACTURER UNKNOWN) and vit D (MANUFACTURER UNKNOWN) received within 2 weeks of vaccination. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Unknown) via an unspecified route of administration in the left arm on 13Jan2021 at 10:00 (at the age of 78-years-old) as a single dose for COVID-19 immunisation. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Since the vaccination, the patient had not been tested for COVID-19. On 03Feb2021 at 22:00, the patient experienced severe heartburn, headache, chills, joint pain, muscle aches and fatigue. No therapeutic measures were taken as a result of the events. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events heartburn, headache, chills, joint pain, muscle aches and fatigue were recovered with sequelae on an unknown date. No follow-up attempts are needed; Information about lot number cannot be obtained.

I am a very active 78 yr old women. Ever since I had the vaccine, my joints and muscles in legs and arms are extremely painful especially when I first wake up. This pain has limited my active life almost completely. Without Alieve or Tylenol, I would not have been able to function without pain.

shoulder blades started hurting/then the pain went down to both hips and her back too; collar bones they started hurting like hell; then the pain went down to both hips and her back too; pain all over the body; could not move there left arm or neck; Physician instructed patient not to get second dose of Pfizer Covid Vaccine so patient did not get second dose as scheduled for 18Jun2021; pretty bad headache/headaches; severe chills and temperature; severe chills and temperature/chills; move her left arm where she had gotten the shot and couldn't move it/ arm was paralyzed; This is a spontaneous report received from a contactable consumer (patient). This is report 1 of 5. A 78-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: not reported), dose 1 via an unspecified route of administration in left arm on 28May2021 at 17:30 as single for covid-19 immunization (at the age of 78years). The patient medical history included First serious fall from May2021 to an unknown date-Shattered left hip that was May2019; shattered left hand and wrist; When shattered left hip they had to fix the shattered hip then they put a metal rod from the hip to the kneecap inside the femur bone. Second serious fall from 27Nov2019 to 27Nov2019, fell again in her home and that time she shattered the left knee, hip fracture- Broke right hip 4 or 5 times, shoulder arthroplasty- On the right arm. She broke that right before get to the shoulder, the upper arm and the shoulder and everything was all mangled, stevens-johnson syndrome from on an unspecified date in 1954 and ongoing-very severe autoimmune disease she got at age of 12, in roughly 1954. It is also called Erythema bullosum-that's what it starts out as-then becomes Stevens-Johnson Disease, then Stevens-Johnson syndrome. Affects mucus membranes in body and appears to be rejecting the eyes-this is relative to her blindness. When contracted had 108 degree fever, implantable defibrillator insertion from on an unspecified date in 2015 and ongoing- installed back about 6 years. She was taking some kind of, the numbers are way down now, she does not think there's a problem but they were thinking she was prediabetic which was probably attributed to her diet. The day before they did the blood test she had ice cream for lunch and for dinner. Then she had the blood test taken the next morning which could have set the numbers off the chart; since then the numbers have gone down. glucose tolerance impaired. They were thinking she was prediabetic and blind from an unknown date and unknown if ongoing, wheelchair user from an unknown date and unknown if ongoing. She only has 1 eye now-left eye; has been legally blind since age 24 years; now left eye is just about gone. She was the 5th person in the world to have Stevens-Johnson syndrome with blindness that could still see and lived. First 3 people with Stevens-Johnson syndrome died-4th lived but was blind. Concomitant medication's included sertraline hydrochloride (ZOLOFT), diazepam (VALIUM), hydrocodone bitartrate, paracetamol (VICODIN), cholesterol (CHOLESTEROL) taken for an unspecified indication and Unknown product: Some kind of stomach pill, does not know, it is the size of caraway seed in rye bread. Regarding concomitant medications caller reported she has no idea. She is taking products that the drug store puts a bubble pack for her. She was taking high blood pressure but her blood pressure was never high, it always ran on the low side; but they started giving her that when she had a pacemaker and defibrillator 2-in-1 installed back about 6 years ago. Otherwise unknown. Cholesterol meds but those numbers are all under control. She has been having trouble; so she thinks this is the last months she is getting her meds after that she thinks she is stopping everything. There's 5 or 6 meds in the morning and 2 at night, one is cholesterol from #. She cannot provide further information for her concomitant products as she is blind-Lots/NDCs/Expiries: Not provided, She cannot provide further information for her concomitant products as she is blind. With the old flu vaccines with the live viruses she was always coming down with the flu after getting the injections. Patient was not diagnosed with COVID-19 prior to the COVID vaccine and since the vaccination. Patient did not receive other vaccine within 4 weeks prior to the COVID vaccine. Patient did not visit emergency room or physician office. Adverse reaction was very bad: Started out with pretty bad headache around noontime, 12:00 on 29May2021 with the most severe part of event starting probably about 22:00. From there it went to severe chills and temperature. Then she went to move her left arm where she had gotten the shot and couldn't move it; she tried to move her fingers and make a fist but couldn't do it; the arm was paralyzed. Then her shoulder blades started hurting like hell, like incredible. If she had a gun she would have put it to her head. Then where the neck connects to the body, collar bones she guessed; in between like if she had an adam's apple it would be on both sides of those bones that are right beside the neck, they started hurting like hell. The paralyzed arm the pain coming from that was incredible; then the pain went down to both hips and her back too; but back wasn't as severe as the bones. All of Saturday, 29May2021 into Sunday, 30May2021 she was unable to get out of bed. This whole thing just intensified, she had nobody there; she lives in senior housing, they are confined to their quarters, to their apartments, the whole thing. She did not have access to anyone, had problems with her phone with no dial tone, nothing. Finally on Sunday, 30May2021 early evening she was able to, she would say, slither out of bed on her back and drop her feet over the edge of the mattress so those are kind of like on the floor. Her wheelchair is next to her; she has to get her upper body upright to be in seated position to be able to get into the wheelchair which was damn near impossible to do. She never knew that kind of pain existed. She was then able to get into the bathroom and use that. She had nothing to drink because obviously if you drink have to urinate and use the bathroom there was no way she was going to go through that again. She thought at that time she might as well go and unlock the door so if an ambulance does come they can haul her to the hospital or they could retrieve her body. She was totally convinced she was going to die on Sunday night into Monday morning, 30May2021-31May2021. She was up until 04:30 on Monday morning, 31May2021 because she was so scared if she fell asleep she would pass away in her sleep. The pain she could not describe how bad that was. That was Monday morning, 31May2021, all of this interim information she is discussing here; basically she was a total mess until it started backing off on Wednesday, 02Jun2021. She was told by the commission for the blind, that they were able to set up the appointment with # because she was due for in-home inoculation with J&J but when they had trouble with that it was pulled and the appointments were cancelled. The commission for the blind took it upon themselves to set up appointment for her Pfizer Covid Vaccine which was given at # on 8 #. #-that was where her Pfizer Covid Vaccine was administered. She did not call anyone or go to the doctor, emergency room or hospital; she has life alert but thought it was in God's hands so if he takes her he takes her. She did not call her daughter. She did call her doctor the early part of last week; he wants her to have a blood test to check for antibodies to see how much of the vaccine is in her or how much she is covered. Once he sees those numbers he says maybe she should get the J&J Covid Vaccine, but if she already got the Pfizer Covid Vaccine and with the J&J trouble with that too, that does not even make sense. She asked for information about that. She was due for a physical about a week ago but her daughter was unable to take her to her physical appointment because she had to take granddaughter to hospital because granddaughter has a hole in her heart and they had to do some testing on her. The patient underwent lab test which included body temperature of 108 degree on 29May2021. The outcome of events were unknown. Information about lot/Batch has been requested.

I had no issues with 1st dose. After taking the 2nd dose, I played golf afterwards. By the end of the round, I was having pain in my left foot. The pain got worse to where I couldn't walk on it. The pain went up my leg to my knees. The next day, I went to the Ortho Indi facility. They did an x-ray on me that indicated that there was no structural damage to cause pain. The doctor recommended me to put on a boot that go up to my knees and to ice it. I did that from Wednesday through Sunday. The pain went away. Every now and then I would get a sharp pain in my left foot, but then it goes away.

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

high fever; joint pain; some weakness in her legs/severe muscle weakness; headache; nausea; she was very ill / She said she was pretty sick for 10 days; diarrhea; muscle pain; This is a spontaneous report from a contactable Nurse (patient). A 78-Year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: EW0173, expiry: 31Aug2021), via an unspecified route of administration on 19May2021 (at the age of 78-year-old) as single for COVID-19 immunisation. Medical history of the patient included borderline multiple myeloma [had borderline multiple myeloma for 10-15 years], monoclonal gammopathy [MGUS, she had it for a while. there are periods of time when her protein was elevated making her borderline for myeloma], patient has had a couple rounds of prednisone to suppress the protein and has a positive ANC. Patient has a multitude of issues, severe allergies, COVID-19 in Mar2020 [had an antibody tested 3 months later and 6 months later that both showed no antibodies], diagnosed with sarcoidosis [in 1970 bust is in remission; tested regularly for sarcoidosis and patient thinks she might be having a gallbladder attack now], Russian flu [in 1988 and was in hospital for two weeks and almost died from that], was having a lot of immunology problems going on (immunocompromised patient), anaphylaxis (had 5 episodes of anaphylaxis), 9-10 episodes of total body hives, has been resuscitated twice, B-cell blood malignancy. Concomitant medications were not reported. Patient previously received hepatitis and tuberculosis vaccine and later discovered that she was a non-responder to hepatitis and TB. Patient previously received swine flu vaccination on an unspecified date in the 70s. Patient was having a lot of immunology problems going on and the doctor recommended her not get a flu vaccine. Patient has had no flu vaccine since swine flu in the 70s. Patient was allergic to over 30 drugs (unspecified). Immunologist did an immunology review of her allergies and prior vaccination problems before determining if patient could get the COVID vaccine. Physician wrote her a letter that said patient had to get the vaccine in a room with an IV ready and the defibrillator ready as well. On an unspecified date in 2021, after the first dose, patient was very ill, had a high fever, diarrhea for 6 days, severe muscle weakness/some weakness in her legs, muscle pain, joint pain, also had nausea and a headache that lasted about 2.5 weeks. She was reticent to get the second dose because she had barely recovered from the first dose when she was due for her second dose. Patient was pretty sick for 10 days. Outcome of the event nausea, headache (duration 2.5 weeks) and diarrhea (duration: six days) were resolved on an unspecified date in 2021 and for other events were unknown.

and really horrible radiating pain down both of her legs, front and back.; She also said there was numbness in her leg; swelling in her sacrum; headache; nausea; She said she had severe joint pain; severe muscle weakness, and pain; she did not have any appetite; and had troubles staying awake.; HCP said that she also had neurological problems; had a fever of 102 for 5 days; diarrhea; dizzy; severe muscle weakness, and pain/ weakness in legs; She said she had a severe bilateral leg and sacral pain to the point where she had difficulty walking; She said she had a severe bilateral leg and sacral pain to the point where she had difficulty walking; She said she had a severe bilateral leg and sacral pain to the point where she had difficulty walking; This is a spontaneous report from a contactable other HCP (patient). A 78-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), at same age, dose 2 via an unspecified route of administration on 09Jun2021 (Batch/Lot Number: EW0182; Expiration Date: 31Aug2021) as DOSE 2, SINGLE for covid-19 immunisation. Medical history included ongoing Borderline multiple myeloma (Borderline Multiple myeloma for 10-15 years), ongoing Monoclonal gammopathy, covid-19 from Mar2020, Severe allergies, ongoing having a lot of immunology problems going on/ immunocompromised, sarcoidosis from 1970, Russian flu, 5 episodes of anaphylaxis, had 9-10 episodes of total body hives, has been resuscitated twice, B cell blood malignancy, allergic to over 30 drugs and lingering COVID symptoms: dry cough, muscle and joint pain, headache, dizziness, and diarrhea. The patient's concomitant medications were not reported. Patient previous received hepatitis vaccines and TB for immunization and experienced did not respond/ nonresponsive, received Swine Flu for immunization and received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EW0173, expiry: 31Aug2021), on 19May2021 (at the age of 78-year-old) as single for COVID-19 immunisation and experienced high fever, joint pain, some weakness in her legs/severe muscle weakness, headache, nausea, she was very ill / She said she was pretty sick for 10 days, diarrhea and muscle pain. The patient experienced dizzy, and severe muscle weakness, and pain/ weakness in legs, both on 10Jun2021 with serious criteria of disability, diarrhea, and had a fever of 102 for 5 days on 10Jun2021. Her immunologist cleared her for the vaccine because she has an unsettling allergy history. He did an immunology review of her allergies and prior vaccination problems before determining if she could get the COVID vaccine. He wrote her a letter that said she had to get the vaccine in a room with an IV ready and the defibrillator ready as well. Her immunologist thought it was prudent she try the first dose. She did have COVID already in 2020. She ended up in the emergency room from the vaccine. She was reticent to get the second dose because she had barely recovered from the first dose when she was due for her second dose. The second dose reaction was different. The day she got the second dose 09Jul2021, she got home okay without problem and went to bed. When she got up in the morning she had trouble getting out of bed. She had difficulty walking. She said she had a severe bilateral leg and sacral pain to the point where she had difficulty walking (10Jun2021). She also said there was numbness in her leg, swelling in her "sacrum," and really horrible radiating pain down both of her legs, front and back. She was fine the day she received the shot, but had great difficulty getting out of bed the next day. She said she still could not drive because she was still dizzy and nauseated. She added that she had headache, nausea, and diarrhea. She said she had on and off diarrhea for 6 or 7 days, and couldn't keep anything down without having it. She said she had severe joint pain, severe muscle weakness, and pain, and had a fever of 102 for 5 days (from 10Jun2021 to 15Jun2021). On the 5th day of her having fever, she said she was struggling to put one foot in front of the other in terms of walking. She said she was also starting to feel as if she was paralyzed. She was having troubles trying to walk normally since there was weakness in her legs. She also said she did not have any appetite. She spent a lot of time in bed, sleeping, and had troubles staying awake. She said she had a bad headache. She said she called 911, and went to the hospital. She stayed there for 2 days. She said it was very unpleasant. She also had neurological problems as well such as extreme difficulty in walking, standing up, and profound leg weakness. However, she said that her neurologist assured her that it would go away within 4 to 5 weeks. She said it has already been 5 weeks since her 2nd dose, but she was still not feeling well. She was improving, but not well. She said she was physically not much better. She was having severe bilateral leg and sacral pain. Her sacrum was hot and swollen so she called the ambulance. She went to the ER because she had difficulty walking. She went to the ER. After five days of the second dose she still had a fever and trouble walking. The ER did multiple scans including a CAT scan of her abdomen and pelvis, an x-ray of her pelvis, and MRI of her upper and lower spine. She also had blood cultures and multiple lab work done. They were trying to rule out Guillain-Barre. She was in the ER for 2 days. She was very sick. The second day she was in the ER they told her she could go home. She thought it was because they were busy. No one explained to her the results of her tests or what was going on. Once her fever was done they didn't have to deal with her anymore. They sent her home when she was still sick with leg pain, trouble walking, and still had diarrhea. She was still nauseated, and was just eating jello. It is week 5 and she is really physically not much better. She can't drive because she was still dizzy and nauseated. She has leg pain, trouble sleeping, and muscle weakness in her legs. She is not recovered from the second dose. She thought she was going to die from it. It took a lot to call 911 especially as a nurse, but the numbness and pain in her legs was really severe. She had such weakness that she had trouble standing up and navigating through her apartment without falling down. She had made slight improvement. She mentioned that she had the flu back in 1988, so she felt very ill, and was in the hospital for 2 weeks. She was a long haul COVID patient who is enrolled in a long haul COVID program. She has been sick for a year and a half now since having COVID. She got COVID in Mar2020, and did not recover well. that is one of the reasons why they delayed her vaccination. She had to do prednisone during that time, and had to wait 6 weeks after completing the Prednisone to get the vaccine. Her baseline was a subnormal temperature of 96.1 because of her immunology issue. So 102 is really high for her. She had lingering COVID symptoms, and was a long haul patient. She had a cyclic problem with dry cough, muscle and joint pain, headache, dizziness, and diarrhea. She would have it bad for 7 days, and then recover a couple of days, and then it repeats itself. She couldn't drive because she was too dizzy and weak to drive. It was not safe to drive. She didn't have enough strength in legs to stop the car. She was seen by a neurologist several days after her emergency room visit. He examined her, and asked her reaction to the Pfizer vaccine. He said he had other patients with similar outcomes. She was immunocompromised . She has had borderline Multiple myeloma for 10-15 years. She has Monoclonal gammopathy, MGUS, she had it for a while. There are periods of time where her protein is elevated making her borderline for myeloma. She has had a couple rounds of prednisone to suppress the protein. She has a positive ANC. She has a multitude of issues. She was diagnosed with sarcoidosis in 1970 bust is in remission. She is tested regularly for sarcoidosis. She thinks she might be having a gallbladder attack now. In the past, she has been a non responder to vaccines. She got out of healthcare for that reason. She did not respond to hepatitis vaccines. She doesn't have NDC/lot/expiration for those vaccines. The infectious disease doctor at the time told her she shouldn't be a nurse for that reason because it put her at risk for hepatitis. She was also nonresponsive to TB. She doesn't have NDC/lot/expiration to any of the ones she has been non responsive to. Last time she was vaccinated she had Swine Flu. She was having a lot of immunology problems going on. The doctor recommended her not get a flu vaccine. It was later discovered that she was a non responder to hepatitis and TB. She has had no flu vaccine since swine flu in the 70s. In 1988 she had the flu, and was in hospital for two weeks and almost died from that. One of the doctors she worked with died from flu. He was a surgeon. He died so she thought she was going to. She barely squeezed by. She was allergic to over 30 drugs'. No information on those drugs provided. She has had 5 episodes of anaphylaxis. She had been resuscitated twice. She has had 9-10 episodes of total body hives. The COVID vaccine knocked her down to 0. She has had to cancel her last 5 weeks of life. She was homebound. She couldn't get out of bed and get dressed. When she had COVID in Mar2020, she had an antibody tested 3 months later and 6 months later that both showed no antibodies. She has a B cell blood malignancy, and the b cells pump up the immune system. So she wasn't surprised she didn't have antibodies. Events caused emergency room visit and physician office visit. The outcomes of events dizzy, severe muscle weakness, and pain/ weakness in legs, She said she had a severe bilateral leg and sacral pain to the point where she had difficulty walking, nausea, diarrhea, had a fever of 102 for 5 days were recovering while other events were unknown.; Sender's Comments: Based on the information in the case report and a plausible temporal relationship, a possible causal relationship between the events "dizziness and muscular pain" and suspect drug BNT162B2 cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.

Sx onset 7/15/21 with cough, chills & muscle aches. Visited son, his wife & newborn. Son and DIL are both + cases. Tested on 7/26/21 which resulted as positive.

Sx onset 7/15/21 with cough, chills & muscle aches. Visited son, his wife & newborn in another location. Son and one other are both + cases. Tested on 7/26/21 which resulted as positive.

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

Resident had seizure like activity followed by a vagel response with large bowel movement. Resident then began to show signs of blood clot to left lower extremity. No pedal pulse, area on leg warm to touch. Left lower leg now cold to touch, stiff, purple and white in color. No other signs of modeling, body warm to touch, no fever noted. Respirations and pulse increased with low oxygen levels. Resident not responding to stimuli.

muscle pains-runs down left leg/thigh, chills, arm pain soreness after vaccination along with itching, frequent urination

Swollen right index finger and joint. Quite painful - most pain is subsided but swelling is still there on joint.

right arm unusable for 48 hours following injection, high blood pressure (200)4th day, TMJ 4th and 5th days, joint pain in both shoulders 3rd day

Severe chills/shaking cold Severe body/muscle aches Day of/could not walk unassisted Severe nausea/throwing up Fever No appetite

Started on 1/25/2021. Patient developed palpable purpura and petichia to bilateral lower legs. Platelet count transient drop to 126k, then back up to 150k.

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.

Cough, shortness of breath, fatigue, body aches, headache, runny nose, congestion Today 1-30-2021 headache is finally gone, lingering cough, congestion is better, some aches in my shoulders

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

Severe headache 4 hours after shot, generalized muscle weakness all over 12-15 hours after shot (felt paralyzed), fever (100.5) 12-15 hours after shot, nausea and moderate abdominal cramping morning after shot, extreme fatigue for 1 week following shot

According to patient he began having intense shoulder pain 2 days after his Covid vaccine. 1 week ago he saw Dr. (orthopaedic physician) who diagnosed him with SIRVA. He was told that the injection was given too high in his arm. HIs arm is improving, but he does continue to have some discomfort.

Burning sensation on skin on Feet on Back; Burning sensation on skin on Feet on Back; Burning sensation on skin on Feet on Back; This is a spontaneous report from a contactable 79-year-old female consumer (patient). A 79-years-old non-pregnant female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number EL3247), via an unspecified route of administration in left arm on 28Jan2021 10:45 at single dose for covid-19 immunisation. Medical history included embolism in 2012 and cardiac pacemaker insertion in 2019. Concomitant medication included warfarin (unknown manufacturer), levothyroxine sodium (THYROXIN) and lisinopril (unknown manufacturer). The patient previously took lidocaine and ciprofloxacin and experienced drug hypersensitivity. The patient previously received the first dose of bnt162b2 for covid-19 immunisation and experienced four small raspberry type "burn" left arm and small taste in mouth. The patient experienced burning sensation on skin on feet on back on 28Jan2021 with outcome of recovering. The patient was not treated for the event. The patient did not have COVID-19 prior to vaccination and was not covid tested post vaccination.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021112990 Same reporter/patient/drug, different events

Swollen knee right, Difficulty up and down stairs especially up. Initial trouble standing.. Lifting leg to out in pants. Tx: ice, elevate, rest. Water exercise, Tylenol at night.

I received my vaccine on Sunday, work up Monday with sore arm which I expected. Monday night around 9pm I had a fever 101.3, my normal pain lever increased bad, and my balance of worse than normal, to walk 20 yards I had to stop at least 5 times because my back was hurting so bad. The next day, I woke up with normal fever but there was redness on the injection site a little larger than a silver dollar, around 8 my fever went up to 100. The next night, Wednesday night my fever was at 99.6, the next day my temp was normal and continued to be the rest of the time. The redness on my arm started fading and has continued to fade but I can still see where it is.

After two days, had sore arm, sore shoulder and neck. 4 days after very tired,, and felt like had flu for 5 days. Had rash on left arm ob 6 day, still tired but better. 7 day ok.

to ER on 2/19/21 breathing difficulty, hoarse voice , chest pain, skin itchy, headache, edema, body joint pain, elevated B/P

When making way to the bathroom, patient got dizzy and fell head first onto hardwood floor injuring her face and her knees. This bruised her entire face except a portion of her left cheek. She had already been having muscle and joint pain in her arms and shoulders and had been light headed since her 2nd vaccination. Patient did not make appointment.

Sore throat, headache, muscle aches and fatigue for two (2) days then gone. No treatment was sought.

chills for 2 days, then itchy for several days, then urine burning, then nerve jumping in arms, then clammy all separate in afternoons 2nd shot was 2 weeks ago

When I started to get ready for bed I was overcome with fatigue, and I went to sleep and I woke up two hours later with terrible pain in my muscles and joints, and the injection site was sore. I woke up two other times throughout the night. I was weak, and yesterday the pain was somewhat lessened, but I had an intermittent mild head ache throughout the day, and I went to bed early last night. This morning the ache was still a little achy and tired, but that had cleared up by noon.

pain in the injection site and arm/pain at injection site all the way to her elbow; pain in the injection site and arm/pain at injection site all the way to her elbow; felt like someone stuck a knife in her muscle; 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 A3249 and expiry date unknown, via unspecified route of administration at the left arm on 21Jan2021 at single dose for Covid-19 immunization. The patient's medical history was not reported. Concomitant medications included other medications. The patient had the first dose of the Pfizer vaccine on 21Jan2021 and the following day (22Jan2021), she experienced pain in the injection site and arm. The patient informed that it felt like someone stuck a knife in her muscle. The patient informed that the pain was improving and not sure if she wanted to get the second dose. The patient informed that she had a dental procedure done and was taking pain medication to help with that but it didn't help with her pain in her arm from the shot. The patient has been having pain at injection site all the way to her elbow. The patient informed that the first day they it was like she had a shot. The patient informed that it felt like a knife was being stuck in her muscle the second day (22Jan2021). The patient informed that today it felt like pressure. The patient informed that at night time that she sleeps perfect and when she gets up in the morning that it was bad pain. The patient informed that she was leery about getting her second shot. The patient informed that she had two teeth pulled on Friday (unspecified date) after she got the vaccine. The patient informed that they redid her partial for those teeth. The patient informed that they had prescribed 800 mg of ibuprofen for her teeth. The patient stated that she thought it would help the pain in her arm but it did not. The patient was told to keep taking it but she stopped. The patient informed that she has to take antibiotics for her teeth until they were all gone. Therapeutic measures was received by the patient due to the events. The outcome of the events was recovering.

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

pain in her hand/ lower part of each finger hurt; joint pain in right hand; bled quite a bit; This is a spontaneous report from a contactable consumer (patient). A 79-year-old female patient received dose 1 of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot number EL9263), intramuscular on 27Jan2021 (at the age of 79-years-old) as a single dose in the left shoulder for COVID-19 vaccination. Medical history included shoulder surgery about 10 years ago and she lost use of her thumb and index finger, the nerve comes from the shoulder; her hand might be numb and stiff, often but not every morning from an unknown date. Concomitant medications were reported as she is on medication but nothing she feels is relevant. On 03Feb2021, the patient experienced pain in her hand and all the lower part of each finger hurt for about 5-10 seconds, joint pain in her right hand lasting 10-15 seconds, it did not last very long; and she bled quite a bit stating she thinks she got it right in the vein on 27Jan2021. The pain happened about four different mornings but has not had pain "since Friday" and that was lighter sharp pain with no numbness. The clinical outcome of the event bleeding was unknown; pain in extremity and joint pain was recovered on 12Feb2021.

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.

She did have an inflamed shoulder prior, it has been pretty good lately but flared up after the vaccine/She does have rheumatoid arthritis in right shoulder and arm; right shoulder and right arm felt sore and achy/ right arm and shoulder were aching; right shoulder and right arm felt sore and achy/ right arm and shoulder were aching; 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: EN6201), intramuscular at upper left arm on 17Feb2021 10:15 at a single dose for COVID-19 immunization. Medical history included ongoing Rheumatoid arthritis (arthritis in right shoulder and arm gets inflamed and sore; rheumatoid arthritis in right shoulder and arm. It sometimes flares up and gets sore) diagnosed in late 2019, ongoing Autoimmune deficiency disease diagnosed in late 2019 and lower left eyelid which was inverted. There were no concomitant medications. No prior vaccinations (within 4 weeks). The patient previously took Shingrix vaccine (Shingles vaccine) at left arm last year-2020 and she felt soreness and achiness in right shoulder and arm. The patient received the first dose of the Pfizer COVID-19 vaccine yesterday on 17Feb2021 at her left arm. A few hours later her right shoulder and right arm felt sore and achy. On 18Feb2021, the patient's right arm and shoulder were aching. The patient mentioned that this has also happened last year when she had a Shingrix vaccine. She was also injected in her left arm but her right arm got sore and achy. She felt soreness and achiness in right shoulder and arm. She wanted to know if this is a normal reaction from the vaccine. The patient stated that it was weird. On unspecified date, when she lifts her arm up high it hurts, she stated that she does have an inflamed shoulder. She did have an inflamed shoulder prior, it has been pretty good lately but flared up after the vaccine. During the night it was very bad. She does have rheumatoid arthritis in right shoulder and arm. It sometimes flares up and gets sore. She was wondering if there is a relationship with the COVID 19 vaccine because she felt like she got the COVID 19 vaccine in the right arm, she asked if she's reacting to the medication. No treatment was administered for right shoulder. Routine lab work done on 02Feb2021 but it has nothing to do with this. The events did not require a visit to Emergency Room or Physician Office. The patient is also scheduled to have Botox in her lower eyelid for her left eye to release the nerve muscle. She asked if it is ok since she just had the Pfizer COVID-19 vaccine. She is scheduled to get botox injection next week for lower left eyelid which is inverted, it was bothering her. They have to release the muscle by getting an injection of botox. She was receiving conflicting information from her PCP, who says wait a month and her ophthalmologist who says its ok to get the COVID 19 vaccine. She thought she heard something about not mixing botox with the vaccine. The outcome of the event "She did have an inflamed shoulder prior, it has been pretty good lately but flared up after the vaccine/She does have rheumatoid arthritis in right shoulder and arm" was unknown; and other events was recovering.

Patient presented to ED o 2/13 for right knee pain post fall (pain level 10/10) starting 11/3/2020 post rehab. Right knee x-ray showed extensive osteoarthritis with periarticular calcification, intra-articular loose bodies, no fracture. Pain initially managed with Percocet. PT/OT recommended outpatient physical therapy and NSAIDS. Patient stable and discharged for further rehab 2/15. Per , hospitalizations are to be reported irrespective of attribution to the vaccine. This hospitalization does not appear to be related to the vaccine.

At approximately 8PM I began to have significant chills. They lasted most of the night. By morning I knew I wasn't feeling well. I wan not hungry and as a result only had a cup of tomato soup with cracker that day. Later in the evening I had a cup of warm milk. Periodically I would have chills and muscle aches especially in my legs. I went to bed early and am much better today. I am also getting my appetite back.

Three days after second vaccine, I started to get sore in left shoulder, two hours later the pain had moved up my neck. By nighttime I could barely move my head to the left and pain was severe. i was very chilled and could hardly stop shivering until I took a heating pad and dressed warmly and went to bed. Sunday, still have a lot of pain and taking aspirin for the pain. Also will use SalonPas for the painful areas to see if that helps. Still cannot move my head to the left without pain.

At about 4:45 AM the following day after receiving my second Covid-19 vaccine shot, I experienced a reaction including itchiness all over my body, redness all over my body, abdominal discomfort, diarrhea, vocal changes, lightheadedness, felt hot (but didn't have a temperature, 97.4 degrees Fahrenheit), joint pain. Took Benadryl, and symptoms resolved after about an hour.

Patient had shot Tue. eve.2/9. Woke up Sat AM with sever lower back pain to where she could not stand up without help. Specifically complains of pain in her tail bone, especially when she sits. Went to ER on Sun. AM (2/15) . (diag. Lumbosacral Strain). Saw GP (2/17) ordered PT. Started PT 2/19. 2/23 pain in tailbone gets worse, went to Urgent care, had X-ray of tail bone (OK). Diagnosed with UTI on 3/1, put on Levofixacin 500mg. Received 2nd vaccine 3/3, RT on 3/5 patient walking better. patient on 3/6 complaining of pain getting worse

pt stated that several days later she started having trouble with her left leg, hip and foot. Pt went to her PCP after she got these symptoms and they did xrays on her leg which showed no breakage. He prescribed her anti-inflammatory and pain pills. She has been applying ice to affected areas. She has been referred to an orthopedic doctor but is waiting for them to contact her. She has also been to a message therapist and a Chiropractor with no help for the pain. Pt states that the pain is not getting any better.

Quivering muscle pain when attempting to stand and to sit; Thigh muscles still feel quivering and tight/tight and unstudy; This is a spontaneous report from a contactable consumer (patient). A 79 -year-old female patient received her first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number:EL9262), via an unspecified route of administration (on left arm) on 29Jan2021 (at the age of 79 -years-old), single dose for COVID-19 immunization. Medical history included Mech. Valve/ Arthritis from an unknown date. Concomitant medication included warfarin, bempedoic acid, hydrochlorothiazide, losartan potassium. The patient previously took ciprofloxacin and experienced drug allergy. The patient experienced quivering muscle pain when attempting to stand and to sit. Occurring upper thighs in front and under buttocks in rear. Similar feeling across groin area when sitting. Began the 2nd day after vaccine shot on a Sunday. Now, on Wednesday still occurring . however, not as pronounce. I still push myself up from sitting as well as sitting down as thigh muscles still feel quivering and tight and unstudy. No treatment for the adverse events. The outcome of the events was recovering. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The events were assessed as non-serious.

Patient presented to the ED 3/11/2021 after rolling out of bed and landing on her right knee. Patient reported pain of the right knee but denies any other symptoms.

muscle tendon pain on the left side of neck/pain went to right side of neck/pain appeared both sides and still persisting; muscle tendon pain on the left side of neck/pain went to right side of neck/pain appeared both sides and still persisting; pain on the shoulder area; stiff neck; This is a spontaneous report from a contactable consumer, reporting for herself. A 79-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), lot number: EL9263, via an unspecified route of administration on 09Feb2021 at 16:30 (at the age of 79 years old) as a single dose in the left arm for COVID-19 vaccination. Medical history included atrial fibrillation diagnosed about 15 years ago. Concomitant medications were not reported. . The patient did not receive any other vaccines within four weeks prior to the vaccination. On 10Feb2021, the patient experienced muscle pain and tendon pain. It was reported that she experienced a pain on the shoulder area and a "muscle tendon pain" on the left side of the neck the next day. The pain then went to her right side of her neck the day after. The day after that, she mentioned that the pain appeared on both sides of her and is still persisting until now. She mentioned she had a real stiff neck that she could barely turn her head without having great amount of pain. She could only align her ear to her shoulder on that range. She is not 100% sure it's related to the vaccine but she mentioned that this has never happened before. She is asking if this a normal side effect and how long should this last. It was "Reported she got her first COVID-19 Vaccine shot last Tuesday, 09Feb2021. She said on Wednesday, 10Feb2021, she developed a cramp on the left side of her neck (clarified as more of a muscle or tendon pain) She said the area from where her left bra strap sits to her left ear was sore. She said she got her COVID-19 Vaccine administered in her left shoulder. She said she didn't think anything about the left neck pain at first. She said she put cream on her neck and took some Tylenol as needed. She said the following day, Thursday, 11Feb2021, the left side of her neck was fine, but the right side of her neck had the same muscle pain or tendon pain. She said both the right and left sides of her neck hurt now. She said she can barely turn her head in either direction due to the pain. Caller asked if her neck pain is some kind of reaction to the COVID-19 Vaccine." She had blood work done on Oct2020 with unknown results. As treatment, she has been taking Extra Strength Tylenol ever since she developed neck pain and arnicare cream for muscle and tendon pain. The clinical outcome of muscle pain and tendon pain was not recovered. The outcome of stiff neck and pain on shoulder area was unknown.

swelling in her right knee, not sore or hurt, just swelling.; This is a spontaneous report from a contactable consumer (patient reported herself) via sponsored Program . A 79-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number: Unknown, NDC number: Unknown) via an unspecified route of administration on 14Jan2021 at single dose to avoid COVID 19. The patient's medical history and concomitant medications were not reported. It was reported that, "caller received the first dose of the Pfizer vaccine on 14Jan2021. Caller reports swelling in her right knee, not sore or hurt, just swelling. Caller wanted to know if that was anything she needed to be concerned about. Caller already reported to DSU. Potential duplicate AE. A little bit of swelling in knee after she had first dose of the Covid-19 vaccine". She has had swelling in her right knee. "Caller is calling about Pfizer shot. She got it about two weeks ago and she was waiting for the second shot 04Feb2021. She has had swelling in the right knee and she was wondering if that would be anything she should be concerned about. Later on today she could answer some questions. She said she could answer some now if it did not take too long. She thinks it was on 14Jan2021. When she got her first dose. She noticed her right knee was swollen about a week ago. It was slightly swollen, just a little bit, it was not hurting, just swollen. It had improved since it began. Product details: She confirmed she got the Pfizer COVID-19 vaccine. All she had was a doctors office card that had a date and time for her to be back. She saw her name and the date and time she was supposed to be there. It was just the name of her primary care doctor then it had their name and address and the phone number and they told to her to bring it back with her. She did not see any NDC, lot number, or expiration date. She said it was just a doctors office card like they use to write you an appointment reminder. History and investigations: She did not think there was anything that needs to be added. There was nothing that she had not been taking all along". Outcome of the event was recovering. No PQC present. Information on the lot/batch number has been requested.

It started with a feeling as though I was getting a sore throat. I took an Emergen-C drink and went to bed at normal time. I also had more drainage than normal from my head. During night I felt a fierce sore throat. Next day, sinus headache, slight sore throat, additional drainage from head. Last meal that day was lunch. Going to bed, I vomited. Next day, sinus headache, drainage, cough and yellow phlegm from lungs--a cough. Took Tylenol during these times. Vomited before bed. Next day I took Alka-Seltzer Plus Cold meds in a.m. and again in afternoon. Felt better. Ribs very sore from coughing. Appetite began returning. Congestion much improved. Following day (today) still congested but improved. No meds so far today.

Stood up to go to the bathroom and could not put her right leg down; thought she was having a heart attack or a stroke or something; Fell on her right side; Cerebrovascular accident; Diarrhea; Nose running; Her calves were so sore, like having charley horse where her calf muscles were so tight it hurt; like having charley horse where her calf muscles were so tight it hurther calf muscles were so tight it hurt; her calf muscles were so tight it hurt; This is a spontaneous report from a contactable consumer. A 79-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in right arm on 18Feb2021 (Batch/Lot Number: EN6201) as single dose for COVID-19 immunisation. Medical history included family history of glaucoma from 2019 (Her mother has Glaucoma); memory ain't that good (she puts everything on her calendar because her memory ain't that good); ongoing irregular heart beat since 2006 (periodically when she goes to the doctor they have her walk the treadmill and stuff like that); ongoing diabetes since 2011; and was allergic to Penicillin (as a kid she was bitten by a dog, she must have been about 12 years old, went to hospital they gave her a shot of penicillin, her head blew up, she looked like a monster, she went back they gave her Streptomycin). Concomitant medication(s) included brimonidine taken for glaucoma from 21Feb2021 to 01Mar2021; latanoprost taken for glaucoma; apixaban (ELIQUIS) taken for arrhythmia, and dyspnoea from 2019 and ongoing; and metoprolol taken for arrhythmia. The patient was administered with her first dose of COVID-19 vaccine on 18Feb2021. It went beautiful, she did not have any aftereffects or anything initially. On 01Mar2021, while in her own apartment she stood up to go to the bathroom and could not put her right leg down; she thought she was having a heart attack or a stroke or something and she fell on her right side. She went to the hospital where she was hospitalized overnight for observation and testing. MRI performed during that hospitalization had result of Cerebrovascular Accident-CVA. She also reported onset of diarrhea and nose running around 01Mar2021. When she went to the hospital on 01Mar2021 she was laying down, and when the doctor moved the blanket to test her legs her calves were so sore, like having charley horse where her calf muscles were so tight it hurt. The events were reported to have required a visit to the emergency room. They did not find anything else during hospitalization with testing. The only thing she can think of related to these events was the COVID-19 vaccine. She called to ask if she should or should not get the second dose of the COVID-19 vaccine as scheduled for 11Mar2021 relative to these events. She was scheduled for second dose on 11Mar2021, but she is scared because of events that occurred 01Mar2021. The outcome of the events diarrhea, "Nose running", "Her calves were so sore, like having charley horse where her calf muscles were so tight it hurt", "her calf muscles were so tight it hurt" was recovering, and for other events was unknown.

AFTER THE FIRST SHOT ABOUT 10 DAYS LATER MY RIGHT KNEE AND RIGHT HIP (BOTH HAVE BEEN REPLACED ) WERE REALLY HURTING ME AND I THOUGHT I DID SOMETHING TO HURT IT. AFTER THE SECOND SHOT ON 3/21/2021 I GOT SHINGLES ON 2 DAYS AFTER THE SHOT.

Initial rash on forehead after first injection. After second dose several weeks later she immediately (next day) had hip pain and difficulty walking. It continued to worsen every day. On the 9th day after the second dose she started vomiting. Currently she has joint and muscle stiffness, extreme weakness and fatigue. She can hardly lift up her toilet seat. Her PCP started her on oral prednisone and she is now on 10mg qod.

Joint pain 1st day to present, deep red skin lesions 3rd day to present, welts, head blisters4th day to present, nausea 2nd day, extreme fatigue 1-4 days,

Pain when using my left hip which was replaced more than five years ago and has not given me any problems until now.

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)

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.

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

muscle in the crock of my arm is swollen; This is a spontaneous report from a contactable consumer or other non hcp. A 79-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 Left on 28Jan2021 17:00 (Batch/Lot Number: EN9581) as SINGLE DOSE for covid-19 immunisation. Medical history included non-hodgkin's lymphoma Mother with non-hodgkin's lymphoma. It was reported that patient had the Pfizer first dose a week ago today. She did not have a specific reaction but the muscle in her arm, the crook of her arm, is swollen. She didn't know if this was a side effect of the vaccine or not. Clarifies she received the first dose of the Pfizer COVID 19 vaccine 28Jan2021 1700PM in the left arm. She noticed maybe about five days after the vaccine, noticed the swelling in her arm by the muscle in the crook of her arm. She is unsure if she pulled her arm. Mentions she does not have lymphedema. She is scheduled 18Feb2021 for the second dose. Patient states height is 5 foot 1 inch or 5 foot tall. She used to be 5 foot 2 inches; states she shrunk from natural aging. Outcome of the event was recovering.

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

severe pain, swelling of Right DIP joint right index finger, thumb and wrist. Acute onset. No fever. Responded to 400 mg oral ibuprofen.

suspected COVID-19 with symptoms; suspected COVID-19 with symptoms; exploding diarrhea; extreme tiredness she could hardly walk; muscle aching; Joint pain; felt very sick and couldn't really function; could hardly walk; stayed in bed all day; This is a spontaneous report from a contactable (patient). A 79-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 2nd via an unspecified route of administration, administered in Arm Right on 11Feb2021 09:00 (Batch/Lot Number: GL9269) as single dose, dose 1st via an unspecified route of administration, administered in Arm Right on 21Jan2021 (Batch/Lot Number: el8982) as single dose for covid-19 immunization. Medical history included apnoea from 2019 to (Verbatim: Apnoea, Diagnosed 2 years ago) , hypertension ( Verbatim: Blood pressure high, diagnosed 15-20 years ago). The patient's concomitant medications were not reported. Family Medical History Relevant to adverse event was none. On 10Mar2021 the patient woke up to a big reaction. The patient had exploding diarrhea, extreme tiredness she could hardly walk, muscle aching, joint pain, felt very sick and couldn't really function, she stayed in bed all day, got better in the late afternoon. It was as if the patient had covid, then it disappeared. The outcome of the events was recovered.

Adverse Event: Intense achy pain near left armpit Treatment: Moist heating pad Outcome: Pain lessened; 20 minutes x2 with heating pad

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.

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

left arm soreness; Lack of energy; This is a spontaneous report from a contactable consumer (patient). A 79-years-old female patient received second dose of bnt162b2 (BNT162B2 Pfizer-BioNTech COVID-19 Vaccine; Solution for injection), via an unspecified route of administration on 11Feb2021 as single dose for covid-19 immunization. Medical history included bronchitis and illness from Dec2019 to an unknown date. Concomitant medications were not reported. The patient experienced left arm soreness, lack of energy on an unspecified date. The reporter said that she become very ill in dec2019 while on vacation in (place name), went to walk-in clinic twice. no pneumonia though coughing, horrible wheezing, told me it was probably bronchitis. given numerous drugs, still doctoring when and returned home. more drugs. no energy for 2-3 months. had been told lots of sickness in (place name) when she was there. heart and lungs checked and ok. often wondered if she had covid. woman across aside from me on plane coughed all the way to (place name). 3 days later she was sick. The outcome of the events was unknown.

headaches; pretty serious muscle aches; projectile vomiting; fever; chills; massive diarrhea; tiredness; 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, Formulation: Solution for injection, Lot Number: EL8982; Expiration Date: May2021) on 27Jan2021 15:20-15:30 (at the age of 79-year-old) intramuscularly administered in Arm Left as single dose for prevention. The patient medical history were not reported and no concomitant medications. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. AE following prior vaccinations was reported as none. Vaccination facility type was reported as hospital and not a military facility. The patient called for information about if her symptoms could be related to the administration of the Pfizer's COVID-19 vaccine. The patient reported that she has massive diarrhea (08:30), projectile vomiting (10:00), fever (10:00), pretty serious muscle aches (11:00), tiredness (07:30), headache (13:00) and chills (08:30) on 10Feb2021. Events fever, Pretty serious muscle aches and tiredness were reported as worsened. The patient reported that she was administered with the first dose of the vaccine 2 weeks ago and she was feeling fine starting with the symptoms today (10Feb2021). The patient reported that she thought it was possible that she has been infected of COVID-19 virus. The patient reported that she considered herself a healthy 79-year-old woman. Received call from the patient regarding the Pfizer COVID 19 vaccine. She had the first vaccine two weeks ago today (10Feb2021). She was having massive Diarrhea, Chills, projectile vomiting, fatigue, muscle aches and fever. She started out with her normal body temp of 97.3 and this morning it was 98.2. She took it an hour later, and it was 98.4 and then it was 100 and now it was 100.2. That was why she was calling. She would like to know if these were side effects. She said she cannot think. She filled out two forms on the second day after the shot. It came up on her email and it listed the symptoms and said have you had any today. She was kind of fatigued today (10Feb2021). A week later she had pretty serious muscle aches and one more thing. The diarrhea was one massive one this morning and it got rid of everything. It was liquid. She has not had one since. Projectile vomiting was twice within 10 minutes of each other. It happened pretty fast at 09:30-10:00 this morning. She has not eaten anything at all. Muscle aches started at 10:00. The tiredness started before diarrhea and was progressively getting worse. Headache started an hour to hour and a half ago. Chills started at 08:00 and were worse for 2 hours and then got better. She could take off gloves and scarf around her neck but does not have chills now. Outcome of the events massive diarrhea, projectile vomiting and chills was reported as recovering. Outcome of the events fever, pretty serious muscle aches, tiredness and headache was reported as not recovered.

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.

Developed significant bruising within minutes/hours and has had significant limb pain for 11 days. Also radiating down arm and up into chest and back

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.

Severe back and leg pain lasting at least 6 weeks; still continuing, but now about 60% better than it was. Must use a walker due to pain Saw neurologist's Nurse Practioner and am receiving Physical Therapy 2x weekly. Scheduled to see doctor at pain clinic about injection in low back.

1st dose 1/28, second dose 2/21; each time had injection site soreness. 3/26/2021 had onset of pain, joint pain, neck pain, right knee swelling and fever.

left leg went to sleep and when I stood up I fell on my left foot; Maybe I have just sprained my ankle and there was extreme swelling has moved up to my calf area and feels like there is water in the leg and it's throbbing; left leg went to sleep and when I stood up I fell on my left foot; Maybe I have just sprained my ankle and there was extreme swelling has moved up to my calf area and feels like there is water in the leg and it's throbbing; left leg went to sleep and when I stood up I fell on my left foot; Maybe I have just sprained my ankle and there was extreme swelling has moved up to my calf area and feels like there is water in the leg and it's throbbing; left leg went to sleep and when I stood up I fell on my left foot; Maybe I have just sprained my ankle and there was extreme swelling has moved up to my calf area and feels like there is water in the leg and it's throbbing; left leg went to sleep and when I stood up I fell on my left foot; Maybe I have just sprained my ankle and there was extreme swelling has moved up to my calf area and feels like there is water in the leg and it's throbbing; left leg went to sleep and when I stood up I fell on my left foot; Maybe I have just sprained my ankle and there was extreme swelling has moved up to my calf area and feels like there is water in the leg and it's throbbing; little bit of soreness on my left arm where the injection went; This is a spontaneous report from a contactable consumer (Patient). A 79-years-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm Left on 09Feb2021 (Batch/Lot Number: EL9269) as SINGLE DOSE for covid-19 immunization. Medical history included blood cholesterol, glucose tolerance impaired, pre-diabetic with HbA1C 6.1. Patient was allergic to Penicillin (swell), Metformin (swell), Sulfa (breathing trouble) and Allegra (headache). Concomitant medication(s) included rosuvastatin, calcium, vitamin D3, vitamin B complex. On 09Feb2021 (Monday, same day of vaccination, patient experienced little bit of soreness on my left arm where the injection went, on 10Feb2021 (Wednesday) left leg went to sleep and when stood up i fell on my left foot; maybe i have just sprained my ankle and there was extreme, swelling has moved up to my calf area and feels like there is water in the leg and it's throbbing (Throbbing pain). The patient was treated with Ibuprofen 200 mg (Intent: Advil) and Aspirin but it was not doing anything to the patient. Patient states that she was usually very healthy and dont have problem with blood pressure. She was prediabetic and just taking care with diet and exercise. Patient was worried if this affect heart in anyway. There was a heart disease on her mother's side of the family, everybody on her side of the family died of a heart attack and patient younger brother has a stent put in and seen other people who have heart problems, and they have the swollen legs and feet and just wondering if that's the same thing that's happening to her. The second dose of vaccine was scheduled for 03Mar2021. The outcome of the events was unknown.

I went to the hospital with palpitations; lightheadedness; She had terrible back pain in center of back; She felt achy; fatigued; back discomfort; she had a lot of shoulder, under arm, and left breast swelling; she had a lot of shoulder, under arm, and left breast swelling; she had a lot of shoulder, under arm, and left breast swelling; Her breast felt like it weighed 60 pounds and ached.; had the worse headache; Her shoulder blade was tender; neck pain; achy feeling was ongoing with her muscles; achy feeling was ongoing with her legs; legs felt rubbery; short winded; sweaty; she felt clammy and hot.; she felt clammy and hot.; This is a spontaneous report 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 in left shoulder on 11Feb2021 at age of 79-year-old at single dose for COVID-19 immunization; methylprednisolone (MEDROL, Tablet), orally from 20Feb2021 to 26Feb2021, at 4 mg, by mouth, frequency was different based on the day, from 27Feb2021 to an unspecified date, at unspecified dose for swelling, the back. Medical history included thyroid and pericarditis fluid. Family history included brother had heart disease. There was no prior vaccinations within 4 weeks. Concomitant medication included levothyroxine sodium (SYNTHROID) ongoing for thyroid for 20 years. Historical vaccine included first dose of bnt162b2 in left shoulder on 21Jan2021 (Batch/lot number: EN6201) for COVID-19 immunization with no side effects. The patient had her 2nd Pfizer vaccine dose on 11Feb2021 and received a "medrol pack" on 20Feb2021 for "shoulder, back and neck pain. She have felt lousy for 4 weeks. She went to the hospital with palpitations and it probably was from the 2nd pack of methylprednisolone, she was prescribed after the 1st pack did not really help her pain. She haven't been sick or had a cold for 25 years and the 2nd dose through her for a loop. She stated her daughter called her and she said that her doctor told her that her vaccine may not be effective and she may not be protected because she took methylprednisolone. The patient received the second vaccine on 11Feb2021 and she had a lot of shoulder, under arm, and left breast swelling. The patient mentioned she went to her doctor because after calling the COVID hotline they said they had cases where some of the vaccine had seeped into the lymph nodes. She was told to have her lymph nodes. No patient demographic details provided regarding those other patients who had the vaccine seep into lymph nodes. She went on to explain she went to the doctor, but the doctor said there were no problems with the lymph nodes. On 13Feb2021, she felt achy and fatigued, back discomfort. The lightheadedness occurred on 18Feb2021. The doctor gave her a high dose of the methylprednisolone 4mg pack for a week. 16 days later on 27Feb2021 it had not touched the discomfort in back, fatigue and lightheadedness and gave her another pack of methylprednisolone. She also had heart palpitation, was sweaty and went to the Emergency Room. The patient mentioned she took a low dose of levothyroxine sodium (SYNTHROID). She asked the doctor about the methylprednisolone being taken after the shot. The patient heard it diminished the effect of the shot, that she may not have as much protection. She had called the COVID hotline to address this issue and they said people who were on chronic steroid therapy had no problem as far as they know. The patient asked if she was protected because she had the methylprednisolone pack the first one within 9 days after shot and a second pack 16 days later. She took a low dose of generic levothyroxine sodium every day. She commented she was concerned with the drug interaction and wanted to make sure still protected. She was informed by individual who answered COVID hotline she felt like she was still protected because others have been on chronic steroid therapy. Shoulder swelling started a couple day after the second shot, explained it was there or about around 13Feb2021. Her shoulder blade was puffy and tender. The swelling went into the arm and breast. Her breast felt like it weighed 60 pounds and ached. That took a while to go away. The patient explained initially it was also there or about around 13Feb2021 when she noticed she was so fatigue and had the worse headache (Feb2021), she never got nauseous. Her shoulder was still swollen a week ago as of 09Apr2021. She went to a chiropractor for an adjustment and the chiropractor said shoulder was still a little swollen. She had terrible back pain in center of back on 18Feb2021. It was so much that she was afraid something else was going on. The patient stated the swelling it was ongoing up until a few days ago as of 09Apr2021. She still had puffiness around that area when went to chiropractor. For the back discomfort she went to chiropractor for adjustment. She was unsure when that discomfort went away. The achy feeling was ongoing with her muscles and legs until last week as of 09Apr2021 when she started to feel better. Her legs felt rubbery. Her muscles felt achy. She felt better as of 09Apr2021. It had gotten better within the last week as of 09Apr2021. The fatigue was ongoing until last week as of 09Apr2021. The patient felt so bad for month and had no idea what was going on. Her lightheadedness went away last week as of 09Apr2021. She commented she did not want to blame all of this on the shot because she did not know what methylprednisolone did to her. The patient confirmed she had back discomfort. She still had some back discomfort. She started to fell short winded a week before the heart palpitations appeared really bad on 21Mar2021. She did not feel short winded anymore, but she was unsure when that stopped. With her heart palpitation she felt clammy and hot. Therefore, she wen to the ER. The heart palpitations gradually got better, and probably stopped totally last week as of 09Apr2021. She mentioned she had a headache for a good month after the second shot. It started either the 13Feb2021 or 14Feb2021. She stated all her symptoms were getting much better since last week as of 09Apr2021. There was no other treatment beside the methylprednisolone for her symptoms. Therapy start and stop date of methylprednisolone captured as confirmed by reporter in formal field, unable to clarify further. The patient confirmed all had been discarded and no lot/exp/NDC to provide. When she was in Emergency room, they did two EKG, drew blood work for the heart, chest x-ray back and front, and verified vital signs which were all good. She went home that same night on 21Mar2021. She went back to doctor on 05Apr2021 and did another chest x-ray and another echocardiogram and everything was fine. The event heart palpitation required a visit to emergency room, the patient was not sure if from the vaccine or methylprednisolone. The patient's heart rate got to 120, her normal was 80. The relevant Tests on 21Mar2021 they did Chest x-ray back and front, a couple EKG and blood work. The patient went back about a week ago as of 09Apr2021 because she was still not feeling great. They did an EKG, ordered echocardiogram and chest x-ray which were done on 05Apr2021. Test results came back on 08Apr2021. She had pericarditis fluid in the past and that's what they were checking for with the echocardiogram. The lab tests and procedures for investigation on 21Mar2021 included: chest X-ray: negative, EKG: negative, blood work: negative, negative. The action taken in response to the events for the methylprednisolone was unknown. The outcome of achy, back discomfort, back pain was resolving, the outcome of short winded was resolved in 2021, outcome of headache was resolved in Apr2021, the outcome of other events was unknown. Information on the batch number has been requested.

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.

Experiencing progressive weakness and numbness in arms and hands. Legs feel heavy. Hands become stiff and freeze in position, occasionally cramping. I've described the arm and leg sensations as "dead arm" and Heavy legs. Also have a feeling in them that I can't describe. I started paying attention to this in early March. Now it is frequent…several times a day lasting for 15 to 20 minutes.

past medical history significant for coronary artery disease s/p PCI, chronic hypoxic respiratory failure on 2L, hypertension, multinodular goiter who presents to ED on 4/25/2021 with symptoms of progressive shortness of breath, dysphagia and neck pain. Labs showed elevated BNP of 3000 and a hemoglobin of 8.5. Patient was incidentally positive for COVID-19 pneumonia

Shoulder joint pain; muscle pain in left and right arms from my shoulder down to my hands; muscle pain in left and right arms from my shoulder down to my hands; This is a spontaneous report from a contactable consumer, the patient. A 79-year-old non-pregnant female patient received first dose of bnt162b2 (Solution of injection, Lot Number: EI8982), via an unspecified route of administration, administered in left arm on 11Feb2021 12:30 (at an age of 79-years-old) as single dose for covid-19 immunisation. Medical history included lumpectomy from 17Nov2020, type 2 diabetes mellitus, hypertension, heart attack 20/12, 2 stents. The patient's concomitant medications were not reported. On 11Feb2021 14:30, the patient experienced shoulder joint pain, muscle pain in left and right arms from my shoulder down to my hands. The clinical outcomes of the shoulder joint pain, muscle pain in left and right arms from my shoulder down to my hands were not recovered. No follow-up attempts are possible.

painful muscle; joint aching; temperature of 99.4; injection site pain; dizziness; general feeling of malaise; This is a spontaneous report from a contactable consumer (patient). A 79-year-old non pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL9263), via an unspecified route of administration, administered in left arm on 18Feb2021 at 10:15 (at the age of 79 years old) as a single dose for COVID-19 immunisation. Medical history included osteoarthritis and fibromyalgia. 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 allergic to penicillin. Concomitant medications included Levothyroxine .075MG, Losartan 25MG and Eye vitamins. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously took historical vaccine on first dose of BNT162B2 (PFIZ-ER-BIONTECH COVID-19 VACCINE, Lot number: EL1283) in left arm on unspecified date for covid-19 immunisation. On 19Feb2021 at 12:30 the patient experienced 15 hours after the second dose COVID 19 vaccine I had painful muscle and joint aching, temperature of 99.4, injection site pain, dizziness and general feeling of malaise. The patient did not receive any treatment for the events. The patient underwent lab tests and procedures which included body temperature 99.4 on 12Feb2021. The outcome of the events was recovering.

Severe Lethargy, Muscle aches and pains constantly, Color Blindness to certain colors. Failed the color dot test

muscle pain; joint pain; tiredness; feeling unwell; a little bit of dizziness; losing strength in her hands; fingers are swollen up; achiness and pain are more pronounced than usually; This is a spontaneous report from a contactable other hcp. A 79-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: not reported), dose 2 via an unspecified route of administration on 14Apr2021 at SINGLE DOSE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date, the patient experienced muscle pain, joint pain, tiredness, feeling unwell, a little bit of dizziness, losing strength in her hands, fingers are swollen up, achiness and pain are more pronounced than usually. Patient received the first dose of the Pfizer-BioNtech Covid-19 vaccine on 18Mar2021 and the second dose on 14Apr2021, about 2 and a half weeks ago or 3 she started experieinced side-effects, she had this side-effects in the past also and they include: muscle pain, joint pain, tiredness, feeling unwell, a little bit of dizziness, she's also losing strength in her hands because her fingers are swollen up. She states that this time the achiness and pain are more pronounced than usually. She would like to know if this could possibly be side-effects from the vaccine. She would like to know what are the recommendations. She would like to know how far after vaccination the side-effects were reported (onset). She would like to know how long this side-effects can last. The outcome of the events was unknown. No follow-up attempts are needed; information about lot/batch number cannot be obtained.

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.

Pfizer-BioNTech COVID-19 Vaccine EUA - admitted to hospital 04/5/2021with covid-19 after one dose of Pfizer Covid-19 vaccine on 3/18/2021. 79 yo Female received 1st dose of Pfizer Covid-19 vaccine on 3/28/2021. Reactions reported were body aches and soreness at the injection site shortly after vaccine injection. After vaccination, patient found out that 2 of her family members that she lives with had positive Covid-19 tests (health status of these family members unknown). Patient got a covid-19 test on 3/30/21 and it was positive. On 4/2/2021, pt had a telemedicine visit for fever and dry cough. Azithromycin and albuterol prescriptions were given because of concern

Arrival Date: 2/14/2021 Discharge Date: 2/18/2021 Primary Discharge Diagnosis: Principal Problem: Sepsis (HCC) POA: Yes Active Problems: GERD (gastroesophageal reflux disease) POA: Yes Portal hypertension (HCC) POA: Yes Thrombocytopenia (HCC) POA: Yes Esophageal varices (HCC) POA: Yes Chronic systolic heart failure (HCC) POA: Yes Essential hypertension POA: Yes Hyperlipidemia POA: Yes Operations/Procedures: None Pertinent Diagnostic Studies: Xr Chest 1 View-portable Result Date: 2/15/2021 Portable chest at 0039 hours HISTORY: New left internal jugular catheter. AP sitting portable chest compared to February 14, 2021 and shows introduction of a left internal jugular catheter with the tip doubled back on itself possibly in the distal brachiocephalic vein. No evidence of pneumothorax. There is a coarse appearance to the pulmonary interstitium bilaterally some of which may reflect chronic disease though the possibility of a very small infiltrate at the left base retrocardiac cannot be excluded and has not changed. No significant pleural effusion or definite acute vascular congestion. The heart, mediastinal and hilar structures are not enlarged or changed. Degenerative disease of the spine is noted with a mid thoracic scoliosis convexity to the right. Left internal jugular catheter in place with distal tip curved back on itself possibly in the distal brachiocephalic vein. Chronic interstitial lung disease bilaterally as well as what may be a small focal infiltrate at the left base unchanged. Xr Chest 1 View-portable Result Date: 2/14/2021 PROCEDURE: XR CHEST 1 VIEW-PORTABLE HISTORY: cough COMPARISON: 9/27/2020 Impression: Limited portable view obtained. Heart mediastinum stable There is mild central vascular and interstitial prominence which could reflect developing mild interstitial edema or interstitial pneumonitis. No severe CHF. Some slightly more focal patchy increased interstitial airspace opacity in the left lower lobe retrocardiac region is identified and could represent a developing infectious inflammatory infiltrate. Clinical correlation and follow-up advised Incidental findings: CXR- Chronic interstitial lung disease bilaterally as well as what may be a small focal infiltrate at the left base unchanged. Test Results Pending at Discharge: Pending Labs Order Current Status Microscopic Urinalysis In process Blood Culture Peripheral Preliminary result Blood Culture Peripheral Preliminary result Active Issues Requiring Follow-up: ISSUE- Needs to follow up with PCP Discharge Medications: Discharge Medications New Medications Sig cefpodoxime 200 MG tablet Commonly known as: VANTIN Start taking on: February 19, 2021 Take 1 tablet (200 mg total) by mouth daily. Do not start before February 19, 2021. Quantity: 6 tablet Discharge Disposition: Home Or Self Care Code Status: DNR Details of Hospital Stay History of Present Illness (from the H&P) CHIEF COMPLAINT: Chills fever, nausea, vomiting, diarrhea after receiving Covid vaccine #2 (Pfizer) HPI: This is a 79 y.o. female with a past medical and surgical history as below-most significant for breast cancer that was diagnosed in 2017, portal hypertension secondary to fatty liver in 2019, resultant esophageal varices that bleed presents with the following chronological history: Approximately 9 AM yesterday morning she went to the clinic for her second Covid vaccination. At that time her temperature was 97.3. She felt fine the rest the day. At 1 AM she woke up with shakes. She continued with nausea and that resulted in vomiting and then diarrhea. She also had severe pain in her thighs. This was severe enough that she called the ambulance. Patient also relates later that she had had some burning on urination 2 days prior to the vaccination. She had leftover Macrodantin that she took 9 PM yesterday. Also relates back in December she was seen by Dr for vaginal infection and 2 times a week she has to administer intravaginal antibiotics. She has had multiple GI bleeds secondary to esophageal varices and is followed regularly by Dr who has had to do multiple banding procedures on her. She also relates she has an enlarged spleen and is followed by Dr. In the emergency room she was noted to be febrile and hypotensive. She received a total of 5 L of normal saline in the ER to bring her pressures up with a systolic below 100. She has a very elevated procalcitonin as well as lactic acid. Urine is positive for large amount of blood and small leukocyte esterase Hospital Course 79 y.o. year old female with HTN, infiltrating ductal carcinoma of the right breast stage I status post lumpectomy with positive margins was on anastrozole but taken off secondary to abnormal liver enzyme testing, CLL/thrombocytopenia stage I with no treatment needed, fatty liver complicated by portal hypertension/splenomegaly resulting in bleeding esophageal varices, history of viral cardiomyopathy in 2006, B12 deficiency, history of admission for septic shock, chronic diarhea, presented to the emergency room on 2/14 complaining of fevers, myalgias fatigue nausea and vomiting 24 hours after having a second dose of COVID-19 vaccine. She was admitted for septic work-up and later found to be hypotensive after 7L of fluids and was transferred to the ICU for septic shock, left IJ was placed. Source of infection found to be septic from UTI. Urine culture sterile with less than 1000 colony forming units and blood cultures no growth to date. On the day of discharge. Shock resolved. Her procalcitonin trended down. Wonder whether she had an exaggerated response to the Covid vaccine given that today the urine culture shows no growth. Regarding acute on chronic diarrhea she had unremarkable GI PCR and diarrhea improved after starting Imodium. She is had extensive work-up for this with GI as outpatient and days colonoscopy planned in the near future. CLL with splenomegaly/nodular hyperplasia of the liver with noncirrhotic portal hypertension/neutropenia/thrombocytopenia/hyperbilirubinemia/esophageal varices requiring banding in the past -Was restarted on propanolol and midodrine prior to discharge. -Chronic stable anemia/B12 deficiency-getting supplementation every 3 months Thrombocytopenia -she did have drop in platelet counts during admission while being on pantoprazole and Lovenox and these were discontinued and platelet count stabilized. She can have repeat CBC as outpatient to document improvement in platelet count. She was not noted to have any platelet type bleeding. History of right-sided breast cancer status post lumpectomy was on anastrozole but stopped secondary to liver disease Lab Studies: Lab Results Component Value Date GLUC 86 02/18/2021 CALCIUM 8.4 (L) 02/18/2021 NA 149 (H) 02/18/2021 K 3.8 02/18/2021 CO2 23 02/18/2021 CL 114 (H) 02/18/2021 BUN 18 02/18/2021 CREAT 0.9 02/18/2021 Results from last 7 days Lab Units 02/16/21 0702 MAGNESIUM mg/dL 1.9 Lab Results Component Value Date CALCIUM 8.4 (L) 02/18/2021 PHOS 2.4 (L) 02/17/2021 Results from last 7 days Lab Units 02/18/21 0724 02/14/21 1855 WHITE BLOOD CELL COUNT Thou/uL 4.1 < > 2.9* HEMOGLOBIN g/dL 10.0* < > 8.8* HEMATOCRIT % 30.0* < > 27.7* PLATELET COUNT Thou/uL 33* < > 37* NEUTROS PCT % -- -- 84.7 NEUTROS ABS Thou/uL -- -- 2.40 LYMPHS PCT % -- -- 10.9 LYMPHS ABS Thou/uL -- -- 0.30* MONOS PCT % -- -- 3.1 MONOS ABS Thou/uL -- -- 0.10* EOS PCT % -- -- 0.8 EOS ABS Thou/uL -- -- 0.00 BASOS PCT % -- -- 0.5 BASOS ABS Thou/uL -- -- 0.00 < > = values in this interval not displayed. Lab Results Component Value Date ALT 28 02/18/2021 AST 15 02/18/2021 GGT 22 09/09/2019 ALKPHOS 116 02/18/2021 BILITOT 1.0 02/18/2021 Physical Exam at Discharge Last Vitals: BP 117/70 (BP Location: Left arm, Patient Position: Lying) | Pulse 73 | Temp 98.1 °F (36.7 °C) (Tympanic) | Resp 18 | Ht 1.626 m (5' 4") | Wt 73.2 kg (161 lb 6 oz) | SpO2 94% | BMI 27.70 kg/m² Patient was seen and examined by me on the date of discharge. General Appearance: Alert, Awake, not in acute distress. Cardiovascular: S1-S2 regular, no murmurs present. Respiratory: Bilateral air entry present, no added sounds heard Gastrointestinal: soft, non-tender, non-distended, bowel sounds present. Extremities: B/l LE edema I spoke with the patient regarding the discharge plan. The discharge plan was discussed with the case management and the nursing staff. Patient verbalzied understanding of the discharge and was agreeable for the discharge plan. Called pt;s husband to give update on care plan but got voice mail. Condition on Discharge: Improved

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

ED Discharged 4/4/2021 (2 hours) Hospital ED MD Last attending ? Treatment team Acute cystitis without hematuria +1 more Clinical impression Sore Throat ? Fever ? Back Pain Chief complaint ED Provider Notes MD (Physician) ? ? Emergency Medicine Expand AllCollapse All HPI Chief Complaint Patient presents with ? Sore Throat ? Fever ? Back Pain 80-year-old female with multiple complaints. Patient states she had her second Covid vaccine yesterday. Since then she is complaining of having generalized weakness, headache, body aches, back pain, cough, nausea, generalized weakness and dizziness. No abdominal pain. She has nausea but no vomiting or diarrhea. No dysuria. Denies any chest pain.

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.

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

no strength at all in her legs and her arms, muscles didn't work at all; Nauseas; Temperature of 100.6 degrees; Headache; her joints swelled; her hands were swollen and tight; 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 MRNA VACCINE, Solution for injection), an unspecified route of administration, administered in Arm Right on 25Feb2021 at 10:30 (Batch/Lot Number: EL9267) as 1st dose, single for covid-19 immunization.Concomitant medication(s) included warfarin sodium (COUMADIN), she takes a 5mg tablet, by mouth, once daily on tuesday, thursday and saturday's. The rest of the days she takes a half of a 5mg tablet confirmed as a 2.5mg dose, by mouth once daily. Indication: She had 2 strokes about 12 years ago, so it keeps her blood regulated, not too thick or too thin, usually it's right on. When probed for any product information, the caller made the comment let her get in some light so she can see better. She confirms the bottle is dispensed in a pinky peach pharmacy vial. She sees an Rx number, Use by date: 26Jan2022 and losartan potassium (COZAAR) taken for blood pressure measurement was the generic for Cozaar, Losartan potassium. She takes a 25mg, tablet, by mouth, once daily for her blood pressure. She verifies this medication is also dispensed in a pharmacy bottle. She mentioned she takes both medications, Coumadin and the Losartan potassium, at night time because it's easier for her to remember. The patient stated she takes a blood pressure medication and a coumadin tablet, She clarifies she has been on these medications for a long time, more than the 2 week time period leading up to receiving the COVID-19 vaccine. She went to bed early on Friday night, 26Feb2021, because she had issues all day long and she forgot to take these medications. She only takes 2 pills at night but she forgot all about them because she had all that stuff going on during the day. o prior vaccinations within 4 weeks. Medical history included cerebrovascular accident (She had 2 strokes about 12 years ago). O 25Feb2021, the patient experienced headache and on 26Feb2021, the patient had asthenia, nausea , pyrexia (temperature was 100.6 degrees), joint swelling and peripheral swelling. It was reported that patient had a really crazy experience, She received her first dose on 25Feb2021 at around 10:30 am afterwards, she had just a regular headache and then the next morning, she tried to get out of bed and had no strength at all in her legs and her arms. She got up out of bed, and her legs would not hold her up so she collapsed on the floor. She mentions her husband is hard of hearing and she was calling for his name to help her. She could not even scoot on the floor, her muscles just did not work at all. The caller states her husband came in and got her up. She went to the bathroom and then for the rest of the day, she stayed in the recliner. Really, the next day, she got back her strength in her shoulders. She clarifies on Saturday, 27Feb2021, she started to get back her strength. She also read in the newspaper to not get a mammogram and a COVID-19 vaccine on the day and she did because they didn't know. She confirms her mammogram was scheduled on 25Feb2021 at 2pm, which was after when she received the COVID-19 vaccine, so her mammogram might not be right. The outcome of events recovered on 27Feb2021. No follow-up attempts are needed; information about lot/batch number cannot be obtained.

3/11 woke up with severe chills, joint pain and headache 3/25 experienced numbness down my entire left side, had a severe headache and difficulty walking

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 had pain on the left side of my head above the ear; I was freezing; had terrible chills; completely exhausted; My stomach hurt; couldn't eat; lost 2 1/2 lbs; This is a spontaneous report from a contactable consumer (patient). A 79-year-old non pregnant female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection, Lot number: EN6198, Expiration Date: not reported) via an unspecified route of administration in left arm on 05Mar2021 at 13:30 (at the age of 79-year-old) as a single dose for COVID-19 immunization at pharmacy or Drug Store. Medical history included an unspecified allergy. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medication included atenolol at a dose of 50 mg twice daily, received in two weeks. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number PAA156051, Expiration Date: not reported), via an unspecified route of administration, in right arm on 10Feb2021 at a single dose for COVID-19 immunization and experienced very tired for over a day. On 05Mar2021 after the second shot at 18:30 (reported as within 6 hrs), the patient experienced pain on the left side of her head above the ear and was freezing, had terrible chills for 2-3 hrs and had to be covered with several blankets. Patient did warm up, but completely exhausted into Sunday AM (as per report), her stomach was hurt, couldn't eat and patient lost 2 1/2 lbs. Patient did not receive any treatment for the events. The outcome of the events was recovering. No follow-up attempts are possible. No further information is expected.

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

thyroid pain; low grade fever; joint pain; headache; acute thyroid inflammation; This is a spontaneous report from a contactable consumer (patient herself). A 79-year-old female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number EN6201) via an unspecified route of administration in arm (unclear whether left or right) on 30Jan2021 03:30 PM at single dose for COVID-19 immunisation. It was unclear whether the patient received the first or second dose. Relevant medical history included allergy to penicillin and sulfur drugs, breast cancer in 2018, surgery, chemo and radiation. The patient had no COVID prior to vaccination. The patient did not receive any other vaccine in four weeks. Concomitant medications included anastrozole (ARIMIDEX) and multimineral supplement. The patient developed acute thyroid inflammation 10 days after her second shot with thyroid pain (thought it was a sore throat), low grade fever, joint pain and headache. It lasted for 3 weeks, diagnosis was made two weeks after onset of symptoms. Onset date for acute thyroid inflammation was Feb2021, while onset for the other events was 23Feb2021. No treatment was received. Acute thyroid inflammation was serious due to disability, while other events were non-serious. The patient was tested for COVID post vaccination: nasal swab was negative on 05Mar2021. The events resolved with sequelae (lasting effects). Information on Lot/Batch number was available. Additional information has been requested.

headache; some soreness in her arm and it kind of went up to her shoulder; little bit of soreness in her arm; This is a spontaneous report from a contactable consumer (patient). A 79-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Batch/Lot Number: EW0153) via an unspecified route of administration, administered in left arm on 03Jun2021 13:00 (at the age of 79-years-old) as 1ST DOSE, SINGLE DOSE for covid-19 immunization. Medical history included her first cataract surgery on her right eye, and they found out she had glaucoma. She got a slight infection which is unusual after cataract surgery. She weighs around 188. She is trying to be healthier in general. She had so much going on in 2020, like everybody else. Her sister was really ill and she passed away She and her daughter were planning to fly in August and wanted to be fully vaccinated before they fly. She had been through this before as a child when she had the polio vaccine and there are people she knows got polio who are still affect by it as adults. She is also on blood thinners. She got good reports from her eye doctor. She had no eye pressure. A couple days later she saw her primary doctor and everything was good there. She sees her cardiologist on 17Jun2021. The main thing is she had been on blood thinners since Apr2017. She hopes she doesn't have to be on them for the rest of her life, but it's a possibility. She has to take that twice a day. She also takes a high blood pressure medicine and thyroid medication. She was told to tell the nurse to use a smaller needle. She has arthritis in both of her knees which is kind of hereditary. She had a fall after the campfire. They evacuated, and when they came back and fell in a store. She is getting physical therapy. The Pradaxa is quite expensive. She takes it twice a day. She keeps a log. This medication can't have air reach it, so she can't use a pill box with that. She keeps a journal and logs her medicines. She takes eye drops for her glaucoma. She takes a drop in both eyes before bedtime. It gives it a chance to rest and for the drops to absorb. She stated that diabetes runs in her family. On 20Mar2021 she had her first cataract surgery, so they gave her anesthesia for that. Glaucoma, cataract, arthritis, fall. Concomitant medication(s) included dabigatran etexilate mesilate (PRADAXA) taken for anticoagulant therapy from Apr2017 and ongoing, unspecified high blood pressure medication, thyroid medication and eye drops for glaucoma in both eyes before bedtime which would give a chance to rest and for the drops to absorb. Historical vaccination included polio vaccine. On 03Jun2021, It started that day she had the vaccine. Her vaccine was at 13:00. It was 104 that day so she stayed hydrated and drank a lot of water. She came home and had a little soreness. She was surprised she didn't have any big noticeable difference. With her arm soreness she was surprised it hurt in her shoulder. If she touches the site she can feel that, but she was okay and was well. On 04Jun2021 she had a headache the next day, and she did take Tylenol. She tried to prolong taking the Tylenol because she heard not to take Tylenol before the vaccine or too soon afterwards to give the vaccine a chance to do its thing. She went ahead and took Tylenol and it worked. It kicked in, and her headache went away the same day. She heard from other people that is was a classic symptom. Her symptoms weren't something she had to stay in bed for. She had a little anxiety before she had the vaccine. She read up as much as she could and decided on Pfizer because she had spoken with other people who had Pfizer. She will continue to wear a mask, she is really good at that. Outcome of the event headache was recovered on 04Jun2021. Outcome of other events it was recovering. Information on Lot/Batch number was available. Additional information 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.

headache; low temperature, temperature was 97 degrees and went up 101 at one point; stomach cramps; bad backache; This is a spontaneous report from a contactable consumer (patient). A 79-years-old female patient received BNT162B2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, solution for injection, batch/lot number: EN5318, expiration date and NDC number was unknown), via an unspecified route of administration, administered in left arm on 22Jan2021 at 16:00-16:30 hours as dose 1, single dose (at the age of 79-years-old) for COVID-19 immunisation. The patient had no medical history and relevant family medical history. There were no concomitant medications or other products used by the patient. Patient had no other vaccinations within four weeks prior to the first administration date of the vaccine. On 24Jan2021 at 07:30 hours, patient had bad backache, stomach cramps and low grade temperature. Patient stated that she was in bed for three days with a bad backache, stomach cramps and low temperature, temperature was 97 degrees and went up 101 at one point. Patient stated that on the information sheet paperwork that it stated that if she had a reaction with that one that she should not get the second vaccine, so patient wanted to know what to do. On 26Jan2021, at 10:00 hours, patient had a headache the last day. Patient took Tylenol, as treatment. Patient had no emergency room and physician office visit. No relevant lab tests were performed. The outcome of all the events was resolved on 26Jan2021. Lot/batch number was not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information was expected.

muscle aches and pain; headaches; migraine; This is a spontaneous report from a contactable consumer (patient) reported for herself. A 79-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number: EW0169) via an unspecified route of administration (at the age of 79 years) on left arm on 26May2021 as dose 2, single for COVID-19 immunization. Medical history included, diabetes mellitus, high blood pressure, depression, thyroid disorder, all from an unknown date and unknown if ongoing. Past drug event was on Metformin for two years. Has been taking maybe 6 months, just refilled the second time, and it is every 3 months; Metoprolol ongoing has been taking quite a while, about 10 years, maybe not that long, so 5 years. Concomitant medications included chondroitin sulfate, glucosamine hydrochloride, manganese ascorbate (COSAMIN) taken for arthralgia from an unspecified start date and ongoing (It doesn't work right away, have to keep taking it. Has been taking a while and starts and stops taking it when she needs to. Generic, from (Withheld). It does work); hydrocodone (HYDROCODONE) taken for back pain from an unspecified start date and ongoing (Started quite a few years ago. Only takes a half of one, depending on the rate of pain. It is powerful stuff. Gets the prescription from the pain doctor and is monitored through the state of (withheld), sitagliptin phosphate (JANUVIA [SITAGLIPTIN PHOSPHATE]) taken for diabetes mellitus from an unspecified start date and ongoing (Has not been taking that long); ascorbic acid, ergocalciferol, folic acid, nicotinamide, panthenol, retinol, riboflavin, thiamine hydrochloride (MULTIVITAMINS [ASCORBIC ACID;ERGOCALCIFEROL;FOLIC ACID;NICOTINAMIDE;PANTHENOL;RETINOL;RIBOFLAVIN;THIAMINE HYDROCHLORIDE]) taken for an unspecified indication from an unspecified start date and ongoing, curcuma longa (TURMERIC [CURCUMA LONGA]) taken for an unspecified indication from an unspecified start date and ongoing, (VITAMIN C [ASCORBIC ACID]) taken for an unspecified indication from an unspecified start date and ongoing; carbinoxamine maleate (OMEGA 100) taken for an unspecified indication from an unspecified start date and ongoing, fish oil (FISH OIL) taken for an unspecified indication from an unspecified start date and ongoing; cyanocobalamin (B12 [CYANOCOBALAMIN]) taken for thyroid disorder, start and stop date were not reported. Historical vaccination includes the patient received bnt162b2 on 03May2021 (1st dose Lot: ER8736 Anatomical Location: Arm left around 10:30 or 11:00) for COVID-19 immunization which caused mild pain after first shot. Patient is scheduled for a steroid shot 14Jun2021 and was told it was a two-week waiting period to obtain the steroid shot after receiving the second dose of the vaccine. The patient asked how long she should wait and stated she usually receives steroid injections and in which she tried to schedule her injections and was told to wait two weeks and do not want it to weaken my immune system. On an unspecified date May2021, about 4 or 5 days after second dose patient experienced muscle aches and pain It was maybe 4 or 5 days after the second shot. It lasted for about a week and was very painful. Thinks it may be an everyday thing with elderly people., headaches, she woke up on the 4th or 5th day with it. She does have headaches but not like that one. It was like a migraine type of headache. The muscle aches and headaches occurred at the same time. She takes supplements as treatment and is supposed to get another shot this week. She will go with the one that hurts the most. The patient was scheduled to have a steroid shot 14Jun2021(Monday) and asked how long she should wait for the steroid shot and her knees have been bad, so she is going in for steroids. The patient had blood work every 3 months for diabetes and have been normal. The patient underwent lab tests and procedures which included blood test result as normal. Referred caller to HCP and provided information that it is not a contraindication to receiving the vaccine. The clinical outcome of the event was unknown.; Sender's Comments: Linked Report(s) reporter/drug, different AE/ patient

It started with a "tingling" feeling starting at the top of my head and going down to my feet. For a period of time, I was unable to move - my legs week; could not stand. I could not move my fingers and hands. I felt like I was "out of my body" It was very frightening.. After about an hour, all my feeling came back to my body; I was able to walk (not very confidently yet)). I was weak for several hours.

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.

Chills, fever, dehydration, intense bone pain, intense fatigue diarrhea, nausea, then pneumonia, then pleural effusion, then extreme hypothyroidism, then multiple episodes of elevated pulse/heartbeat. Over a 2 month period.

Well like I said, I woke up and my arm after the shot was sore. The joint was bothering me, and I thought that it was a side effect of the shot and after about a week I had a little bit of movement but still pain. So later in May I finally called the orthopedic doctor. I got an MRI and he said it was a significant tear to the rotator cuff. I did not do anything so I do not know what or how it happened. I just figured it was the COVID vaccine, although the doctor thought it was highly unlikely. I had surgery to repair it on May the 20th 2021, at local hospital. I came home that night after the surgery. The doctor gave me tramadol for the pain as well. I will have another MRI next week, in mid-July 2021.

she can't lift anything/Patient states she couldn't even roll over in bed, she just laid there like she was dead; muscle and body pain; body pain/ in a lot of pain; shortness of breath; headaches; lightheadedness; weakness; tiredness; chills; joint pain; nausea/Really Bad Nausea; it feels like her throat and neck are swelling and tight; it feels like her throat and neck are swelling and tight; it feels like her throat and neck are swelling and tight; weird bumps on her arms that were itchy but now are not; sore throat; she feels like her throat and neck is swelling and tight; weird bumps on her arms that were itchy but now are not/weird bumps on her arm; bone pain; This is a spontaneous report from a contactable consumer or other non-healthcare professional. A 79-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection, batch/lot number: EW0171) via an unspecified route of administration, administered in Arm Left on 09Jun2021 (79-year-old at the time of vaccination) as dose 1, single for covid-19 immunisation. Medical history included ongoing she is disabled and has been disabled for 27 years. Patient states she lost 14 pounds in the last 3-4 weeks, but that was before the shot. The concomitant medications were unspecified. Historical vaccine included flu shot When she gets the flu shot, she can get symptoms for about a week. History of all previous immunization with the Pfizer vaccine considered as suspect was none. Additional Vaccines Administered on Same Date of the Pfizer Suspect was None. No prior vaccination within 4 weeks. The reporter reported that, she received her first dose of the Pfizer Covid-19 vaccine on 09Jun2021, and then on 10Jun2021 she experienced Muscle and Body Pain, bone pain, sore throat, shortness of breath, headaches, light headedness and dizziness Really Dizzy; didn't know if she was walking forwards or backwards, Weakness; she can't lift anything. Patient states she has to have 3 sips of coffee in a cup and she still needs 2 hands to hold it; couldn't hold a pencil, tiredness, chills, joint pain and in a lot of pain, and Really Bad Nausea. The reporter stated that when the patient lays down it feels like her throat and neck are swelling and tight, and she also has weird bumps on her arm, the itching is gone but she can still feel the bumps. she couldn't even roll over in bed, she just laid there like she was dead. The reporter stated the patient is not getting the second dose and not going to the hospital. The reporter asked how long do these symptoms normally last, it's already been two weeks. The reporter asked, "If she can't take the second shot, can the doctor give her a clearance for that, Some places are forcing people to take this." Patient is in the background on speakerphone and states she is not going to the hospital, so forget that. The reporter stated the patient also has weird bumps on her arm, the itching is gone but she can still feel the bumps. The reporter stated that the side effects started on 10Jun2021. Patient states the bone pain lasted a week and a half and then every day something new came, they were kind of sporadic. Patient stated that she has the bumps on her arm, and everything except vomiting, if vomits she is in trouble. Patient states her bones are better some, but the weakness is there, she can't lift anything. Patient states she has to have 3 sips of coffee in a cup and she still needs 2 hands to hold it and she still gets dizzy. The reporter stated there are so many different side effects that they are unsure of when each one started and stopped, but most of the side effects are ongoing. Patient stated there is no way anyone will get her to go to the hospital but she just wanted to know how much longer is this going to go on. Patient stated last night she didn't know if she was walking forwards or backwards and she was so weak she couldn't pick up a pencil. Patient stated in the morning she thought she is still alive, she couldn't believe it. Patient stated she will not have the second shot, she cannot. Patient states she can't go through that again, she would rather die. Patient stated she couldn't even roll over in bed, she just laid there like she was dead. Patient states she has had a hard life but never like this. Patient stated she takes a lot of medications but she has been taking them for years and there are no medications or medical conditions that she feels are relevant. No treatment received for events. The outcome of the event muscle and body pain, body pain/ in a lot of pain, weird bumps on her arms that were itchy but now are not, bone pain were resolving and events were not resolved. Information about lot/batch number was provided. Additional information has been requested.

Tiredness; Some achiness; Muscle aches more tenseand uncomfortable; Queasiness; This is a spontaneous report received 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: EN6204), via an unspecified route of administration in the left arm on 11Mar2021 at 09:45 (at the age of 79-years-old) as a single dose for COVID-19 immunisation. Relevant medical history included prediabetes and rheumatoid arthritis. Concomitant medication included omeprazole (MANUFACTURER UNKNOWN) taken for an unknown indication from an unspecified date. The patient previously received penicillin and sulphonamide and experienced an allergy. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN), via an unspecified route of administration on an unknown date 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 4 weeks prior to the COVID-19 vaccine. On 11Mar2021, the patient experienced tiredness, some achiness and muscle aches. On 12Mar2021, the patient reported that the muscle aches were more tense and uncomfortable. On an unspecified date in Mar2021, the patient experienced queasiness. Therapeutic measures included intake of VICKS flu syrup for the adverse events experienced. The events did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcomes of the events tiredness, aches, muscle aches and queasiness were resolved on 13Mar2021. No follow-up attempts are needed. No further information is expected.

Patient reports started having weakness and numbness in feet in mid March 2021. She reports she saw a neurologist and was diagnosed with Guillian Barr Syndrome on 06-15-2021. She reports her weakness is improving with Physical Therapy. She received her first dose of COVID 19 Pfizer vaccine on 01/25/2021.

Pt w/ gradually increasing fatigue, multiple joint pain and swelling, and muscle pain over the following weeks. This is did not subside but increased in April and May, becoming severely painful. Began to self treat pain/swelling with OTC po and topical pain relief of joints/muscles, contemplated ER visit multiple times and finally decided to seek medical care early June. CPK over 900, ESR and CRP also elevated. CPK 2 weeks later 1,256 and pt started losing muscle mass, lost 7 lbs in 3 weeks, is exhausted and in pain. Waiting on Rheum consultation. No family history of ALS or other typical associated diseases w/ these labs.

shot was given around 11am and around 1-2 she began to get chills and body aches worse than covid, exhausted, several weeks later she began to having issues with walking, she will get pains in her knees and legs, its hard to walk she begins to walk like a penguin, she is now using a cane.

Severe headache; Muscle aches; Feeling of unwell; Fatigue; Chills; Hot flashes; Nausea; This is a spontaneous report from a non-contactable consumer, the patient. A 79-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN), via an unspecified route of administration in the arm left on 12Mar2021 at 10:00 (at the age of 79-years-old), as a single dose for COVID-19 immunisation. Medical history included chronic fatigue and grave's disease. The patient had unspecified allergy to medications, food, or other products. Concomitant medications were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 12Mar2021 at 10:15, the patient experienced severe headache, muscle aches, feeling of unwell, fatigue, chills, hot flashes and nausea. It was reported that, the headache was absolutely severe to the point that it was hard to keep eyes open and see. The adverse events did not result in a visit to the doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for headache, muscle aches, feeling of unwell, fatigue, chills, hot flashes and nausea. The clinical outcome of events severe headache, muscle aches, feeling of unwell, fatigue, chills, hot flashes and nausea were resolved on an unknown date in Mar2021 (lasted 3 and half days). No follow-up attempts are possible; information about lot/batch number cannot be obtained.

freezing with chills, and turned up the heat.; node on my arm; Adds her arm at the place where the gave her the shot has a knot and it is slightly red and has fever in it.; Adds her arm at the place where the gave her the shot has a knot and it is slightly red and has fever in it.; Adds her arm at the place where the gave her the shot has a knot and it is slightly red and has fever in it.; freezing with chills; freezing with chills; Nausea; slight headache; 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: EN6205 and expiration date was not reported), via an unspecified route of administration, administered in Arm Left on 29Mar2021 12:30 (at the age of 79 years) as single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. Historical vaccine included first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number and expiration date was not reported), first dose via an unspecified route of administration, administered on 01Mar2021 as single for COVID-19 immunisation. Patient states she had the second shot yesterday and adds she didn't have any side effects from the first one. After the second one, by 20: 00PM she had nausea for about an hours and a slight headache that went away by the time she went to bed. Then early the next morning she was freezing with chills, and turned up the heat. Adds she didn't have all that with the first one. Adds her arm at the place where the gave her the shot has a knot and it is slightly red and has fever in it. She is asking is all this a normal side effect. Mentions she took her temperature and she doesn't have a fever. Patient Clarifies she received the first dose of the Pfizer COVID 19 vaccine on 01Mar2021 in the afternoon in the left arm and the second dose on 29Mar2021 at 12: 30PM in the left arm. Patient further stated that "I got a node on my arm and it has fluid in it and I didn't have that before, so I'm concerned about it." The outcome of the events Nausea, slight headache was recovered on 29Mar2021 while the freezing with chills was recovered on 30Mar2021. While the outcome of the rest of the events were unknown. No follow-up attempts are needed. No further information is expected.

RA Flare Up that affected all joints of my body for approximately 5 hours beginning around 12 Noon to 1 PM.. Had taken my regular dosage of Celebrex 200 mg at around 10 AM. Took Tylenol 500 mg. Bed rest with warm blankets. Had never had a flare-up that affected all my paired joints at once. 8 hours later I had no symptoms other than fatigue.

Developed a stiff neck after a week or so and thought nothing of it until now because it is not going away. Also , I developed an itchy pimply rash on my lower back that is troublesome and for which I am using benedryl. The asprin nor the aleve seem to help the neck. The itchy is driving me nuts--benedryl helps a little. SHOULD I GET MY SECOND DOSE WHICH IS DUE FEBRUARY 10?

Nerve pain day 2&3 Arthritic pain day 3&4 Sick sick sick day 4-6 oxygen level 75 percent Headache day 10

Extreme intensification of fibro and polymyalgia symptoms (almost unable to do anything). Need to use a walker and still do. Also leg and foot swelling

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.

Pt rec'd vaccine two days ago and was sick a day later, light fever, chills, joints hurt, headache, having a hard time raising the arm, it's very sore, nauseated, lasted 1 day.

Vaccine administered on 2/11/21. Presented to emergency department on 2/18/21 following an episode of syncope and collapse at home. Patient reports becoming dizzy and diaphoretic at home and passed out in bathroom. Presented with left-side rib pain and headache attributed to hitting door and ground during fall. Was checked for COVID19 prior to transferring to observation unit and was found to be positive. Patient was discharged home in stable condition from observation on 2/19/21.

injection site pain; tiredness; headache; muscle pain; chills; joint pain; fever 99-101 degrees; medical history of myasthenia gravis was given Pfizer-Biontech-Covid-19 Vaccine; medical history of myasthenia gravis was given Pfizer-Biontech-Covid-19 Vaccine; This is a spontaneous report from a contactable consumer (patient). An 80-year-old non-pregnant female patient received her first dose of bnt162b2 (BNT162B2 reported as PFIZER-BIONTECH-COVID-19 VACCINE; lot number: EL1289; expiration date: unknown) was 80-year-old at the time of vaccination via an unspecified route of administration right arm on 26Jan2021 09:30 at a single dose for covid-19 immunization. Medical history included myasthenia gravis, bipolar disorder, chronic obstructive pulmonary disease (COPD), hypothyroidism, high cholesterol and allergies to ACE inhibitors. The patient was not diagnosed with COVID-19 prior to vaccination. Concomitant medication included fluticasone furoate, umeclidinium bromide, vilanterol trifenatate (TRELEGY), fluticasone propionate (ALLER FLO), cetirizine hydrochloride (ALLER TEC), aspirin [acetylsalicylic acid] (ASPIRIN), clonazepam and ipratropium bromide (IPRA). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously took ciprofloxacin (CIPRO) but had allergies. The patient received the most recent COVID-19 vaccine in a hospital. On 28Jan2021 07:00 AM, the patient had injection site pain, tiredness, headache, muscle pain, chills, joint pain and fever 99-101 degrees. The patient who has a medical history of myasthenia gravis was given Pfizer-Biontech-Covid-19 Vaccine on 26Jan2021 with unknown outcome. The patient did not received treatment from the adverse events and the events was considered as non-serious. The patient has not been tested for COVID-19 since the vaccination. The outcome of all the other events was not recovered.

Systemic: Joint Pain-Mild, Additional Details: At the end of the 15 minute observation time after the patients COVID shot, she complained of leg soreness from her preivously diagnosed arthrtitis. She did not have any further questions or comments or concerns about the injection and did not think the soreness was from the shot. She felt healthy to go.

Systemic: Joint Pain-Mild, Additional Details: Patient was being observed, at the 15 minute mark the pharmacist asked how the patient was doing and to see if she had any issues or comments or concerns after the injection, she complained of pain and soreness in her leg but this was from previously diagnosed arthritis and it happens when she sits for long. She had no further questions and felt healthy to go.

Got 2nd vaccine on Monday morning. On Tues (2/23) I had extreme fatigue about 4:30 PM. By the time I went to bed , all my bones and muscles ached and I had a headache. I had a very slight fever that Tylenol took care of .Wed. morning I was OK but it happened again Wed. afternoon.

No adverse events following the first dose on 02.05.2021 The second dose on 02.26.2021 : fever - highest 101.2 degrees; slight headache; nausea; deltoid pain; anorexia; loose stools; fatigue I was pleased to have a reaction suggesting to me that some immune response was being generated.

I am 4 months out from spinal surgery including 3 fused vertebrae. One day after receiving the 2nd dose I experienced severe pain in the fused area

Feet felt stiff and bone in right leg felt strange; Feeling dizzy and faint like; tired; Sinuses started to drain; itching on the right shoulder (where she had the vaccine); Itching on right side of arm near elbow, middle part of stomach and neck; pain in the shoulder; This is a spontaneous report from a contactable consumer, the patient. AN 80-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot number: EN6201, Expiry date: 30Jun2021) intramuscularly in the right arm on 11Feb2021 at 13:00 (at the age of 80-years-old) as a single dose for COVID-19 immunization. Medical history included highly sensitive and highly allergic to everything from food to medicine; had been through near death with allergies; allergic to penicillin, iodine and shellfish; high blood pressure, eye disorder (unspecified), allergies with her sinuses. Concomitant medications were not reported, but the patient took unspecified high blood pressure and eye medication. The patient previously took dextropropoxyphene hydrochloride (DARVON), ether and castor oil and experienced allergies; sulfamethoxazole and trimethoprim (BACTRIM) for severe acute sinusitis on Jan2021 (about a month ago). On 11Feb2021 at 13:20, the patient start feeling dizzy and faint like, and felt a little tired. She came home and went to bed and on 11Feb2021, had itching on the right shoulder (where she had the vaccine) and on the right side of the arm near the elbow, the middle part of the stomach and the neck (itching came and went) and later, her sinuses started to drain. On 12Feb2021, the patient's feet felt stiff and the bone in the right leg felt strange. On an unspecified date in Feb2021, the patient had pain in the shoulder. The patient queried if she can take aspirin for the pain in the shoulder and diphenhydramine (BENADRYL) if the itching comes back. The clinical outcome of pain in the shoulder was unknown, of "itching on right side of arm near elbow, middle part of stomach and neck", "feeling dizzy and faint like", tired, sinuses started to drain, "feet felt stiff and bone in right leg felt strange" and "itching on the right shoulder (where she had the vaccine)" was resolving.

Patient had her second COVID vaccine on 2/20/21. The next day she developed diffuse body aches. She went on to develop worsening dyspnea and fever to 103°F on February 23. She had a fever again on February 24. The patient also experienced a few episodes of vomiting and diarrhea but no abdominal pain and had pain of the legs, right greater than left. Blotchy red patches of the hands and arms developed. She therefore presented to the ER on 2/25/21. See full history below from infectious disease note on 3/1/21: Patient is an 80 year old female who has a past medical history notable for hypertension, dyslipidemia, and hypothyroidism. The patient was diagnosed with a high-grade lymphoma of the retroperitoneum in 2004 and completed 4 cycles of multi-chemotherapy (Cytoxan, Adriamycin, vincristine, methotrexate, and IT chemotherapy (Magrath-like regimen)). She completed 4 cycles with complete remission on PET scan. The biopsy of a left cervical lymph node in 2007 revealed follicular lymphoma and she completed radiation therapy to the neck with complete remission. A left axillary lymph node biopsy in 2016 revealed grade-3 follicular lymphoma with mixed follicular and diffuse histology. Chemotherapy was pursued. The biopsy of a pelvic lymph node in 2019 was consistent with G1-2 follicular lymphoma.  She completed radiation to the pelvis in May of 2019.  She developed progressive pelvic adenopathy in April of 2020 and received 5 cycles of chemotherapy. Subsequent CT showed improvement in the adenopathy.  Her course was complicated by pulmonary emboli (September 2020).  In November of 2020 she was started on maintenance Rituxan every 2 months.  She received the 2-dose Pfizer COVID vaccine series on 1/29/21 and 2/20/21. With the above background, the patient presented to the emergency room on February 25, 2021 with complaints of diffuse body aches, which had developed that day after receiving her second dose of COVID-19 (SARS-CoV-2) vaccine.  She went on to develop worsening dyspnea and fever to 103°F on February 23.  She had a fever again on February 24. The patient also experienced a few episodes of vomiting and diarrhea but no abdominal pain and had pain of the legs, right greater than left. Blotchy red patches of the hands and arms developed.  She called Oncology on February 20 and it was recommended that she go to the emergency room for evaluation.   She was afebrile on presentation to the emergency room.  She was tachycardic, however, with a pulse rate of 117 bpm.  She was breathing at 48 breaths per minute.  Blood pressure was 105/80 mmHg.  Oxygen saturation by pulse oximetry was 96%. Examination was notable for paraspinous muscle tenderness, tachypnea, mild respiratory distress, and a mildly distended abdomen.  Mild erythematous patches of the feet and forearm were noted, as well as evidence of edema of the right leg from the knee to the lower leg. The peripheral blood leukocyte count measured 0.8x10e3/µL.  ANC was 0.48x10e3/µL.  Platelets measured 96x10e3/µL.  Creatinine was 0.97 mg/dL.  AST was 86 and ALT 20 U/L. The lactic acid level of the venous blood was 3.6 mmol/L. The procalcitonin level of the blood measured 28.37 ng/mL. The C-reactive protein level was 313.7 mg/deciliter. The creatine kinase (CK) level was 4023 U/L.  LDH measured 314 U/L. Troponin was 3.22 ng/mL.  Urinalysis showed 6-10 wbc?s, 0-2 rbc?s/hpf, 3+ blood, negative nitrites, hyaline and granular casts as well as amorphus crystals. A chest radiograph showed possible, but not definite, mild atelectasis or infiltrate at the left lung base.  A radiograph of the right tibia/fibula showed circumferential soft tissue edema seen within the knee and upper to mid aspect of the lower leg.  EKG showed sinus tachycardia but no evidence of arrhythmia or ischemia. Cultures of specimens of the blood were obtained.  The patient was started empirically on vancomycin and cefepime and was admitted.   Faint erythema and ecchymosis of the right leg extending to the dorsal right foot and right wrist erythema were noted following the patient?s admission.  Her condition subsequently destabilized with increased respiratory rate, worsening pain, and hypotension, so she was transferred to the ICU. An abdominopelvic CT on February 25 revealed a small amount of free fluid in the abdomen around the liver, cholelithiasis with no evidence of acute cholecystitis or biliary dilatation, a nonobstructing 5-mm stone of the mid pole of the left kidney, coronary artery calcifications, mild infiltration of the fat in the inferior retroperitoneum and along the right common iliac region with small nodes in this region, similar compared with September 24, 2020, but improved compared with April 30, 2020, and consistent with response of lymphoma to chemotherapy; a myomatous uterus. A CT scan of the right lower extremity showed extensive edema about the subcutaneous tissues of the right lower leg and infiltration of the fat about the muscles of the right lower leg, likely representing cellulitis and fasciitis, and possible myositis. However, there was no air within the subcutaneous tissues or muscles to suggest necrotizing fasciitis and no evidence of abscess.     The patient?s antibiotic treatment was later changed to vancomycin, piperacillin-tazobactam and clindamycin. Cultures of specimens of the blood were later reported as being positive for methicillin-susceptible Staphylococcus aureus on 2/2 sets. Repeat blood cultures (February 26) were positive as well. Her antibiotics were modified to cefazolin monotherapy. Repeat blood cultures on Feb 27 and 28 were negative.   TTE completed 2/27/21 without obvious vegetation.   TODAY (3/1/21): Cultures negative 2/27 and 2/28. Remains on IVIG. Afebrile. She complaints of continued pain in the Right leg and swelling at that left arm. Exam GENERAL: NAD EYES: Sclera and conjunctiva clear NECK: no adenopathy LUNGS: Breath sounds normal and symmetric. No rales or wheezes. HEART: regular rhythm, no murmur appreciated ABDOMEN: Soft without mass, tenderness, organomegaly or hernia. EXTREMITIES: RLE with ecchymosis, slight overlying erythema and anterior blister: blistering more pronounced today. left foot with plantar erythema, some tenderness today. LUE fullness with some heat/tenderness SKIN: No other rashes or other abnormalities are noted. NEUROLOGICAL: alert, appropriate Assessment 1. MSSA septicemia with shock. Positive blood cultures 2/25 and 2/26 thus far. Negative since 2/27. 2. Multifocal cellulitis and interstitial infective myositis of LE- suspect related to above. CT scan was negative for apparent necrotizing infection. 3. Elevated CK due to above- improving 4. Recurrent lymphoma- has been on maintenance rituximab (11/2020). Immunocompromised state. 5. Low immunoglobulins- remains on IVIG 6. Positive urine cultures with Staph aureus- this is typically secondary seeding from bacteremia rather than primary staph uti. CT abd/pelvis negative for nidus of infection along GU track (no renal abscess for example) 7. LUE swelling/tenderness.   Plan 1. Cont Cefazolin without change: goal dosing 8gm/24hr 2. Following repeat blood cultures, negative thus far (tentative D0= 2/27/21) 3. Pending course, anticipate likely TEE--- > presently precluded due to thrombocytopenia 4. Will obtained LUE doppler for completeness given pain/swelling here. Down the line, may need to consider additional imaging (CT?) if concern for abscess, etc). 5. ID will follow along with you. Please call if any questions/concerns. Patient is still admitted, and is in the ICU.

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

red blotches; felt sensation at her foot for that she could not walk; experienced chills; hands were shaking; right foot and ankle swelling; right foot and ankle swelling; pain; This is a spontaneous report from a contactable consumer (reporting for herself). An 80-year-old female patient received her first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3249, expiration date: 31May2021), via an unspecified route of administration on her left arm on 30Jan2021 to 30Jan2021 at single dose for covid-19 immunization. The patient's medical history was not reported. There were no concomitant medications. The patient previously took phenytoin sodium (DILANTIN) and carbamazepine (TEGRETOL) and experienced allergy as her reaction to those were sometime between 2010 and 2012. On 30Jan2021 after three and a half hours, the patient felt sensation at her foot for that she could not walk, experienced chills, hands were shaking, had a swollen ankle and foot and pain. Around 5 o clock, the patient stated that it was like a strange sensation in her foot and she also got chills. By 7 o clock, she was in pain. The patient stated that she took two Tylenol. The patient stated that at around 9 o clock, she noticed that her ankle and foot were swollen with red blotches on it so she took two Benadryl and then slept until noon. The patient stated that Benadryl actually gave her some relief, although the pain didn't completely subside, but it subsided a little so that it was more tolerable. The patient stated that she had been debating if she should have gone to the emergency room (ER), but she didn't because she has a high pain tolerance. The outcome of the events was unknown.

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

hand felt like it was sleeping especially her finger tips it felt like neuropathy; Joint pain; Exhaustion; same arm that she broke, it seemed weaker now which it seemed like the side effects go to areas that were weakened before; with the arm the pain and movement in that arm has worsened since the injection; with the arm the pain and movement in that arm has worsened since the injection; with the arm the pain and movement in that arm has worsened since the injection; with the arm the pain and movement in that arm has worsened since the injection; This is a spontaneous report from a contactable consumer (patient). An 80-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) lot number EL9266 and expiry date 31May2021, via unspecified route of administration on 15Feb2021 at single dose for Covid-19 immunization. Medical history included, broke her elbow from 04Dec2020 and surgery from 12Dec2019 and second surgery was from 15Jul2020; the patient thought that the second surgery on her arm was in 2020 and she actually broke her arm in 2019. She thinks it was actually Dec2019 when she broke her arm and the second surgery was on 15Jul2020; ongoing with the arm the pain and movement in that arm (movement disorder) and arm; weakened (same arm that she broke). There were no concomitant medications. The patient was taking the same medications she always takes, and she waited until after the dose to take them. Historical vaccine included first dose of BNT162B2 lot number EL02162, expiry date 31May2021 for Covid-19 immunization. The patient was calling about the vaccine, the second Pfizer COVID 19 vaccine. She experienced some side effects, there was joint pain on 15Feb202 later that nigh and the most obvious thing was exhaustion that began later the same day as well; but one thing was unusual, the strange side effect that has happened on 16Feb2021 was that her hand felt like it was sleeping especially her finger tips it felt like neuropathy but it was much better now, it was the same arm that she broke, it seemed weaker now which it seemed like the side effects go to areas that were weakened before. The patient stated that the main thing was the neuropathy thing, it felt like she was sitting on her hand and that persisted, but it was 90 percent better and she thinks it will go away. The neuropathy feeling was ongoing but much less, it was improved it happens only if she squeezes her hand so it was much less and she hoped it just dissipates. The patient's main concern was the neuropathy and it has improved a great deal. The patient mentioned with the arm the pain and movement in that arm has worsened since the injection (Feb2021). The worsened pain and movement has persisted about the same since she noticed it. The patient informed that was the joint she guessed, because she broke the elbow. The outcome of the events hand felt like it was sleeping especially her finger tips it felt like neuropathy, joint pain, exhaustion was recovering, same arm that she broke, it seemed weaker now which it seemed like the side effects go to areas that were weakened before was unknown, while not recovered for the rest of the events.

Patient presented with back pain for 2 weeks, with fall prior to arrival. Patient had evidence of discitis and UTI on admission. ID felt that the seeding of the discitis was related to cholangitis from recent cholecystectomy. Treated with IV antibiotics with plan for 6 weeks duration and discharged to SNF. Patient had significant pain treated with Percocet and Dilaudid with dramatic but incomplete esolution of pain. Per EAU, hospitalizations are to be reported irrespective of attribution to the vaccine

3/3/21 er to hospital admission: 81 y.o. female with a history of Parkinson's in previous stroke. The patient basically is maintained in the nursing home in this state of being bed-bound and nonverbal. She was recently transferred to Rehab after she developed a stage IV sacral ulcer at a previous nursing home. The patient had been seeing wound care and doing very well. Her stage IV sacral ulcer had been healed to a stage II. She had been gaining weight. Unfortunately, at her wound care appointment yesterday the wound had decompensated a little bit and had started to drain some purulent material. It also enlarged in size a little bit. I was called yesterday afternoon and the nursing home reported the patient was not wanting to eat or drink. Lab work showed a sodium of 170 and creatinine consistent with acute kidney injury. She also appeared to have a urinary tract infection. Because of her critical labs she was sent to the nursing home. The patient was evaluated in the nursing home and then admitted to the floor. She was given Zosyn and vancomycin and started on IV fluids. The emergency room physician did counsel the family that the prognosis was very grim. The patient has done reasonably well overnight. She has been grimacing quite a bit and the family has decided they just want her kept comfortable comfort care during admission

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

Very high glucose + 300 with need for more than 10 extra units insulin per day for 4 days; Diarrhea; Vomiting day 4 to day 6; Continuing nausea; Continuing nausea with loss of 5 lbs; 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, Solution for injection, Lot number: EM9810), via an unspecified route of administration, right arm on 14Feb2021 12:15 PM at single dose for covid-19 immunisation at Doctor's office/urgent care. The patient wasn't pregnant at the time of vaccination. The patient's medical history included Allergies to medications, food, or other products included Sulfa, gluten and cortisone meds, diabetes since age 5 and heart failure. List of any other medications the patient received within 2 weeks of vaccination included Thyroid, metoprolol succinate (TOPROL XL), KCL, furosemide (LASIX [FUROSEMIDE]) (reported as Lasux), spironolactone. The patient didn't received any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced very high glucose + 300 with need for more than 10 extra units insulin per day for 4 days on 17Feb2021 12:00 PM, diarrhea and vomiting day 4 to day 6 and now continuing nausea with loss of 5 lbs because of nausea at day 11 on Feb2021. The patient received additional insulin as a treatment and call to cardiac physician. Prior to vaccination, the patient wasn't diagnosed with COVID-19. Since the vaccination, the patient hasn't been tested for COVID-19. The outcome of the event Blood glucose increased, Diarrhea, Vomiting, Weight loss was recovering and outcome of event Nausea was not recovered. Information regarding lot/batch number has been requested.

slight sore shoulder; This is a spontaneous report from a contactable consumer (patient reported herself). A 80-year-old female patient received first dose of BNT162B2 (Pfizer COVID-19 VACCINE, Formulation: Solution for injection, Lot number: EL3247) via an unspecified route of administration on 21Jan2021 at single dose to her left arm for Covid-19 immunization. The patient's medical history included stroke (caller said this was diagnosed 5 years ago), blood pressure high (caller said this was diagnosed 5 years ago), asthma and obesity. Caller said that she had a stroke five years ago, which she had been taking medication for that for a while. No further details provided about this medication. She said obesity was there, and she also had high blood pressure which was also diagnosed five years ago. She said that sometimes she had a slight case of asthma, which she used to get frequently but while wearing masks she did not get infections like that anymore. Concomitant medications were not reported. Caller said she had not had any other recent vaccinations or started any new medications. On an unspecified date, the patient experienced slight sore shoulder/shoulder soreness. Consumer called about the Pfizer COVID-19 vaccine who said she had a fever of 101 degrees Fahrenheit, sometimes a little higher, and she wanted to make sure there was nothing wrong with that. She said she got her second dose yesterday, and her first dose was 21Jan2021. Pfizer COVID-19 vaccine: Caller said that the vaccine card was handwritten, the NDC/EXP were not provided. Caller provided ID number and unknown number from the vaccine card. She said her first dose was given on 21Jan2021, with LOT El3247 or EL3247, she said that the way it was written she would guess the second letter is an I or a L. She said that her second dose given 11Feb2021 was LOT EM9809. Caller said her fever started this morning, on 12Feb2021, after her first dose she had no fever just a slight sore shoulder, and this time it hurt more. She said today she had also had chills, and she took her temperature and it was 101 degrees Fahrenheit and this afternoon it was almost 102 degrees Fahrenheit, she said she always took her temperature to make sure she was ok, and not getting COVID, which she asked if she had COVID after getting the shot. Caller said that she took two paracetamol (TYLENOL) last night and two today, though she usually took two every day. Unknown male took over the call briefly for caller and was given recording notification. He provided clarified product name of Acetaminophen Extra Strength 500 mg, and said she took two before getting the shot, two last night, and two this morning so she has had 6 in the last 24 hours by mouth. UPC: Unknown, they do not see a barcode on the bottle. LOT: 0DE2408A, EXP Jan2022. . Caller said she would just like to make sure she was not doing anything wrong. Product strength and count size dispensed: not provided, two doses. Was a sample of the product available to be returned, if requested (Y/N): not provided. Packaging sealed and intact: not provided. Outcome of the event was unknown.

she experienced Diarrhea; she had muscle weakness in both legs and back; legs felt weak; 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 VACCINE, Solution for injection), via an unspecified route of administration, administered in Arm Right on 05Feb2021 13:40 (Batch/Lot Number: EM9810) as single dose for covid-19 immunisation. Medical history included Diabetes from Mar1964, she does some exercise after the shower for the hip surgery done prior to the vaccine. Concomitant medication included insulin lispro (HUMALOG) uses with a pump taken for diabetes mellitus. Caller stated she received her first dose of the Pfizer covid vaccine on Friday, and yesterday morning 09Feb2021 she experienced Diarrhea and then later on she had muscle weakness in both legs and back. She does some exercise after the shower for the hip surgery done prior to the vaccine and uses a cane to walk. She said she is a little better today and wanted to know if that was due to the vaccine. Outcome of the event she had muscle weakness in both legs and back was unknown. Outcome of the other events was recovered on 10Feb2021.

pain in the neck/pain down her neck on her right side; hard for her to move it from side to side; This is a spontaneous report from a contactable consumer (patient). This 80-year-old female patient received first dose of BNT162B2 (Covid shot, PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/lot number: EL3246; NDC number: Unknown; Expiry Date: Unknown) from an intramuscular route of administration via left arm on 02Feb2021 as single dose for covid-19 immunisation. Patient's medical history included ear ache in right ear and cold. She explained she did have an ear ache in right ear, she figured she must have had a cold. She was using ear drops and it just sort of went away. She clarified this was prior to the vaccine. It started over a week or 10 days ago, she guesses. She doesn't recall. She believes the ear ache was cleared by Tuesday before receiving the vaccine. The patient was received unknown concomitant medications. No other vaccines administered on same date of the Pfizer suspect. No prior vaccinations (within 4 weeks). The patient experienced pain in the neck that makes it hard for her to move it from side to side and pain down her neck on her right side on 04Feb2021. The patient had the first COVID-19 shot last Tuesday evening and everything was fine. Probably on Thursday she started getting pain down her back, clarified as her neck, on her right side. Like, she can't hardly turn her head left or right without turning her whole body. Patient declined to include a healthcare professional for the report. She confirms she started having pain in her neck on the right side. She clarifies she had an ultrasound last Friday because they were concerned with her liver. They called that night and that was fine. However, Friday morning when she went in for that appointment, she really didn't have any pain in her neck. Therefore, it had to have been after. It must have actually started either Friday night or Saturday. Caller explains she paid no attention to the pain until yesterday so she thought she would call today. She was not sure about vaccination time stated had a 7 o'clock appointment, so maybe by 7:30-7:45PM. The outcome of events was reported as not recovered.

On or about March 16, 2021, my left ankle swollen and hot to touch; sought and received medical treatment on March 25, 2021, and after a dobbler and ct scan was diagnosed with bilateral pulmonary emboli. Treated at Emergency Department and placed on Eliquis 5mg x 2 @ day for 7 days and then for 23 day - 1tab x 2 a day.

2 days after receiving vaccine - pain above kidneys on right side back continuing for 5 days, then next day stabbing pain starting above right kidney in back and shooting up to base of right shoulder, then next day stabbing paid on right side starting at the waist and shooting up ribs, then next day rash appeared on back and right side continuing to front to belly button. Turned out to be severe case of shingles. I had the shingles vaccine several years earlier.

high blood pressure; cholesterol; flutter; her hands were red and felt warm; heart pains; she wakes up groggy; pain in middle of her chest; she felt tired/she feels worse; her arm hurt; her hands were red and felt warm; her legs felt heavy; This is a spontaneous report received from a contactable consumer, the patient. A 79-years-old female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6202), via an unspecified route of administration, administered in Arm Left on 04Mar2021 at 17:15 (at the age of 79-years-old) as a single dose for COVID-19 immunisation. Medical history included blood cholesterol increased from 2011 and ongoing; diagnosed 10 years ago, hypertension from 1991 and ongoing; diagnosed 30 years ago, chest pain from an unknown date and unknown if ongoing. Concomitant medications included atenolol taken for blood pressure from an unspecified start date and ongoing; benazepril hydrochloride, hydrochlorothiazide taken for blood pressure from an unspecified start date and ongoing; nifedipine taken for blood pressure from an unspecified start date and ongoing; simvastatin taken for blood cholesterol increased from an unspecified start date and ongoing. The patient experienced she was having issues with her heart/she also has pain in middle of her chest like heart pains/seems like more pressure and sort of constant, her hands were red and felt warm, high blood pressure, cholesterol, flutter, her legs felt heavy on 04Mar2021, she felt tired/she feels worse on 06Mar2021, she wakes up groggy, her arm hurt on 04Mar2021, she was having issues with her heart/she also has pain in middle of her chest like heart pains/seems like more pressure and sort of constant. Her hands were red and felt warm, had high blood pressure, cholesterol, flutter, her legs felt heavy, she felt tired/she feels worse, she wakes up groggy, and her arm hurt. She states that she could hardly sleep on the left side, so she is going to have it on the right next. The chest pains started a few weeks ago and it started before the vaccine but now it seems like more pressure and sort of constant, not a pain, pain but a pressure that she knows is there. Now and then she feels a flutter. Clinical outcome of heart pain was not recovered, for hands were red and felt warm, high blood pressure, cholesterol, flutter, she felt tired, she wakes up groggy, pain in middle of her chest was unknown, her legs felt heavy, her arm hurt was recovered. The lot number for the vaccine, BNT162b2, was not provided and will be requested during follow up.

March 21 was supposed to be the "end" of the final period after my 2nd shot -- On March 21st I started developing aching muscles, joints and neck and waves of nausea along with intermittent muscle wekness & extreme fatigue. It became worse on the 22nd & 23rd so for safety on the 24th I had a "nasal Covid-19 test" done at a Urgent Care facility to determine if I had possibly contracted the Covid-19 virus. The test came back 'negative' -- I did not have an active case of Covid. The symptoms I was experiencing finally calmed down about Friday - the 26th and by Sunday, they were over. It was almost like a further delayed adverse reaction to my final March 6th 2nd dosage shot although the muscle & joint aches and fatigue were worse than just after the 2nd shot?

Starting 4 days following my 2nd vac. dose, I've had episodes of unusual inflammation in my knees or ankles at different times and lasting for a week at a time, causing pain, stiffness and swelling. This has continued for six weeks though there were also periods when I was symptom free. I hope that my immune system has returned to normal. I have not heard of these symptoms reported previously.

Blood in left leg. Hospitalized for 3 days. Now on Eliquist. Couldn't walk on left leg. Had to pull the cord and maintenance called the ambulance. Still having pain in left leg even after a cortisone shot still not better and they don't know why. Next appoint is on Thursday. There is another appoint at the pain clinic for her back pain tomorrow

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

body aches everywhere; severe headache; bones and joints were hurting so bad she couldn't barely walk much; bones and joints were hurting so bad she couldn't barely walk much; bones and joints were hurting so bad she couldn't barely walk much; Nausea; by 10 her mom had hard cramping, that it started at 8:30 with cramping in her abdomen and severe bloating; bloating; could still void but it was pressure tying to go/severe pain and abdominal pain was causing pain to void; couldn't eat or anything; intestinal cramping/severe gut, lower abdominal, intestinal pain; This is a spontaneous report from a contactable consumer via An 80-year-old female patient received the second dose of bnt162b2, via an unspecified route of administration, administered in arm on 04Apr2021 15:00 (Lot number was not reported) as single dose for covid-19 immunisation. Medical history included Ehlers-Danlos syndrome (states she was diagnosed about 40 years ago), Allergies, lung collapses (due to Ehlers-Danlos syndrome), preemie, no fusion in her eyes (States she sees out of one eye most of the time), does not retain sodium and potassium (related to Ehlers-Danlos syndrome), egg allergy. The patient previous received pneumonia and shingles vaccine for immunization and was fine, the first dose of the bnt162b2 via an unspecified route of administration in arm on unspecified date as single dose for covid-19 immunisation and fine. Concomitant medication included potassium as does not retain potassium; spironolactone; a list of medications. Her mom got her 2nd dose on Sunday and is in the process of needing to report that. She ended up with severe gut, lower abdominal, intestinal pain and bloating along with other normal things. States she saw her doctor yesterday and he believes it could be caused by the Propylene Glycol in the vaccine. Her mother received her shot at 3pm on 4Apr2021 and does not know which arm. Her symptoms started around 8:30 with body aches everywhere, a severe headache, her bones and joints were hurting so bad she couldn't barely walk much, she made it to the bathroom and that was it, and nausea. Caller states by 10 her mom had hard cramping, that it started at 8:30 with cramping in her abdomen and severe bloating. States her mom could still void but it was pressure tying to go and caused severe pain and abdominal pain was causing pain to void. Caller provides that her mom continues the same until Tuesday morning and then the intestinal cramping and bloating is still continuing now and it's more primarily her lower left area as of Wednesday. She has a big history of Ehlers-Danlos syndrome and her doctor that she met with yesterday feels this is probably from the propylene glycol component that caused the flare up, as she usually doesn't have this and he is hoping it will calm down in about a week. Her mom also couldn't eat or anything until Tuesday. She was down all of Sunday night and Monday for about 36 hours. Stated the voiding is somewhat better but not much better and the rest of the symptoms are consolidated and persisting. Reporter stated her mom can't go without her medications. Her mom did a virtual doctor visit and will follow up later this week. Her mother got the second dose of the vaccine and had severe intestinal pain, headache, joint pain, nausea, abdominal pain. The outcome of the event Dysuria was recovering, Unable to eat was recovered on 06Apr2021, other events was not recovered. No follow-up attempts are needed. Information about lot/batch number cannot be obtained.

The caller reports that approximately one week after her second COVID19 Pfizer vaccine, she experienced swelling of her left axillary lymph node with related discomfort and pain. She reports the symptoms resolved in about 1-1.5 weeks without further complication.

She had a back ache; Her neck and shoulder ached; Her neck and shoulder ached; This is a spontaneous report received from a contactable consumer (patient). An 80-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in arm right on 17Mar2021 14:30 as single dose for covid-19 immunisation. Medical history included covid from Nov2020, and lost there sense of taste and smell. The patient's concomitant medications were not reported. The patient experienced she had a back ache, and her neck and shoulder ached on 17Mar2021. The outcome of event back ache was unknown, while other events were recovered on 24Mar2021. Information on the lot/batch number has been requested.

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

Sever muscular pain and disability in arms and left upper thigh. Ability to walk diminished. Lasted 4 days and disappeared suddenly after 4 days.

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.

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.

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

big itching in the body/strong itching; pain in the back and stomach/hurts in her upper back; pain in the back and stomach/hurts in front of her upper stomach; broke out in rash all over her body; This is a spontaneous report from a contactable consumer or other Non-health care professional. An 80-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 25Jan2021 as 2ND DOSE, SINGLE for indication of COVID-19 immunization. The patient medical history was not reported. The patients concomitant medications were not reported. The following 4 days patient was fine and after that she described her side effects as big itching in the body, pain in the back and stomach - She went to Hospital and doctors were not able to give any treatment recommendations. She wants to consult with Pfizer about her condition and seek for recommendations. patient broke out in rash all over her body and she was concerned about it. Patient stated that she had a strong itching for three days. Reported that hurts upper back and front of upper stomach. Has insurance and no one answered what she needs. Stated that she is in the shower every half hour. Stated that the itching is bad and she wanted to know what to do. Stated that she is healthy and has no problems and she had the vaccine a week ago and did not have any symptoms until three days ago when the itching started very hard then her back thing and then her stomach thing. Stated that she had no symptoms from the first one. Patient had taken her second dose of vaccine a week ago and did not have any symptoms until three days ago when she experienced, strong itching (pruritis), hurts in her upper back/front of her upper stomach (abdominal pain upper), rash all over her body. Stated that she called Medical Information before and they did nothing. Case number not provided. Outcome of events was unknown. 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.

started of with just muscle pain in left arm, as time went on, both arms,shoulders, legs, are all quite painful. they get worse when not moving,move arms hard to stand up, or

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

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.

On Tuesday, May 20th, about two and half weeks after the first dose, my mom felt listless, tired, run down. She developed a cough, a lot of throat pain, headache, back pain, body aches. About a week after she began to feel sick, she developed shingles on Thursday, May 29th. She knew what it was immediately because she had shingles previously. She started anti-viral medication on Friday, May 30th.

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.

severe headache on 2nd day, exhausted for 3 weeks, mild chills, extreme burning in chest, passed within 12 hours, tingling in hands and arms and itching, low blood pressure, sporaitic left arm and elbow pain, lower stomach cramps, diarrhea, out of breath

had a red patch that was hot around the site; The muscles in her entire right arm are very sore and says that it's painful; had a red patch that was hot around the site; red patch on my arm was just red and hot and hard; The muscles in her entire right arm are very sore and says that it's painful; This is a spontaneous report received from contactable consumer (patient). An 80-year-old female patient reported for herself that she received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot Number: EL9267, and Expiration date: Unknown), via an unspecified route of administration, administered in upper right arm on 25Feb2021 as 2nd dose, single dose for COVID-19 immunization. The patient's medical history included psoriatic arthritis, Deaf (I am on a 'casting' call phone because I am deaf) and the patient also took Penicillin (I was three years old saved my life). The patient's concomitant medications were not reported. The patient stated that she took lot of medications (unspecified) she had a set of "tremor", it was a long list. The patient previously took BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot Number: EL9269, and Expiration date: Unknown) in left arm on 04Feb2021 as 1st dose, single dose for COVID-19 immunization. The patient had infusion of Simponi on 04Feb2021 the same day she took first dose of vaccine. No other vaccine was administered prior to first dose of COVID vaccine. It was reported that the patient experienced a side effect after getting the second dose of the Pfizer-BioNTech COVID-19 Vaccine on an unspecified date in 2021. Originally, she had a red patch that was hot around the site in the hand for about two weeks. The muscles in her entire right arm are very sore and said that it's painful when she reached. The entire arm was painful and uncomfortable, and it was getting worse. On an unspecified date in 2021, the patient was recovered from the event "red patch on my arm was just red and hot and hard" and outcome was unknown for the event "the muscles in her entire right arm are very sore and says that it's painful" Follow up needed, further information has been requested.

Both knees started aching, they were painful at the same time and My knee still aches at times in the beginning it was very painful and it is less painful today; This is a spontaneous report from a contactable consumer (patient). A 80-years-old female patient received second dose of bnt162b2 (PFIZER-BIONTEC COVID-19 VACCINE, Solution for injection Batch/lot number: Unknown and expiry date was not provided), via an unspecified route of administration, in the left arm, on 05Apr2021 at 13:10 (at the age of 80-years-old) as a single dose for covid-19 immunisation. Medical history and concomitant medication were not reported. Patient had previously taken first dose of vaccine on 14Mar2021 at 10:00. No other vaccine has been administered within 4 weeks prior to COVID shot. On 19Apr2021, patient had both knees started aching, they were painful at the same time and for his knee still aches at times in the beginning it was very painful and it was less painful today. They slowly started getting better but they aren't 100 percent yet patient was little concerned that will never get back to normal. Patient still experiencing less pain, both knees are the same slightly improved but not completely. On 18May2021, patient had complete blood count as routine lab tests and result was normal. Reporter seriousness for both knees started aching, they were painful at the same time and for my knee still aches at times in the beginning it was very painful and it was less painful today was unspecified. No treatment was received. The outcome of event was recovering. Information about batch/lot number has been requested.

She is shrinking.; left shoulder was causing her trouble; This is a spontaneous report from a contactable consumer. A 80-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EN6199), via an unspecified route of administration in the right arm, on 04Mar2021 (at the age of 80-years-old) as, single dose for COVID-19 immunisation. Medical history included ongoing high blood pressure (she has had it for years), ongoing diabetes (she has had it for years), ongoing uses a continuous positive airway pressure (CPAP) (she has only used it for the last 3 years), pain in her shoulder and glenohumeral arthritis. Concomitant medication was not reported. Historical vaccine included first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EN6201), via an unspecified route of administration in the right arm, on 11Feb2021 as, single dose for COVID-19 immunisation and experienced left shoulder was causing her trouble and Received Cortisone shot 2 days before receiving the Covid vaccine. The patient previously took cortisone on 02Mar2021, received at doctor's office administration in the right arm for shoulder pain. The patient had she is shrinking and left shoulder was causing her trouble on an unspecified date in Mar2021. It was reported that the patient had both doses in her right arm because her left shoulder was causing her trouble. It was reported that the patient tooks a lot of medications but nothing she thought it was relevant. On 02Mar2021, the patient received cortisone shot to the right arm for shoulder arm. The patient was considered high risk and she did not worry as much about that as she did about the Cortisone. The patient wanted to know if she would negated her second dose by agreeing to the cortisone shot. she stated her physician assured that her there would be no problem. On an unknown date, before vaccination the patient underwent lab tests which included X-ray and resulted with glenohumeral arthritis in her shoulder. The physician stated that because of glenohumeral arthritis, the patient was having shoulder pain and it was started about 8 or 9 months ago. On an unknown date in Mar2021, the patient experienced freezing up. The patient also would like to know if booster doses of the Pfizer-Biontech Covid19 vaccine are recommended. She wanted to know if it was safe for her to go to a party with other fully vaccinated people, without masks. When the Patient took the Covid vaccination, the whole thing turned into a big circus. It was snowing and she had postponed her appointment with her physician for terrible pain in her shoulder. She had to cancel the appointment 4 times because of snow but she finally went on 02Mar2021 and got a Cortisone shot. She thought she should wait and come back to get the Cortisone shot because she was going to get her second Pfizer vaccine in 2 days, but her physician assured her that nothing would happen. After he gave her the Cortisone shot, she did research and it said she shouldn't do it. The patient called Pfizer and a woman said to take the shot anyway because it was better to take it on time than to wait. The patient question was how good was her immunity and she asked how good her protection would be. She called when she did not know whether to postpone or take the vaccination and the woman suggested to take the shot. The woman said the scheduling of the shot was more important since they had no research on how the Cortisone affected the shot. She was wondering in order to research if Pfizer would want to take a test to see her coverage. The outcome of the events was unknown.

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

neck felt really weird, her whole neck was hurting; very tired; Fever; pain in the stomach; Dry heaves; back was hurting; no energy; knee hurting; got so sick; delusional; This is a spontaneous report from a contactable consumer (patient). A 80-year-old female patient received first dose of bnt162b2 (BNT162B2, Solution for injection, Lot: EL2346) via unspecified route of administration on 15Jan2021 09:57 as single dose in arm right for COVID-19 Immunization. Medical history reported was thyroid, blood thinner and degenerative disc disease, all ongoing. Concomitant medications reported was rivaroxaban (XARELTO) ongoing as blood thinner taking for many years, levothyroxine ongoing for thyroid it was 25 and they no product taking for 5 years and prednisone from 21Jan2021 till 26Jan2021 for degenerative disc disease as Blister pack take six, then five, and down to one daily by mouth for six days. No prior vaccinations within 4 weeks was reported. Consumer called to report side effects. Stated she received the first dose of the Pfizer COVID 19 vaccine 15Jan2021 at 09:57AM in the right arm. Six days later all of the sudden in the evening she got so sick with pains in her stomach; dry heaves but she didn't throw up; felt horrible with no energy. She didn't even brush her teeth or undress to go to bed. In the night she had a fever, but she was so sick she couldn't reach overtake her temperature. She heard a voice saying, "what is your temperature". She thought she was delusional. She woke up and her knee was hurting, and her back was hurting. She had a knee replaced in Jul2020 and sometimes has trouble with it. She was diagnosed with degenerative disc disease and the doctor put her on prednisone pack for her back pain. The next day she felt better but her stomach was still bothering her, and she was so very tired. She hasn't been out, and it wasn't like she picked up anything. The next night Saturday her neck felt really weird, her whole neck was hurting. She was tired until Wednesday. Outcome of the event pain in the stomach was recovered on 24Jan2021, Dry heaves recovered on 21Jan2021, no energy, neck felt really weird, her whole neck was hurting was recovered on 22Jan2021, very tired was recovered on 27Jan2021, back was hurting, knee hurting, fever was recovering and for remaining events its unknown. Follow-up attempts are completed. No further information is expected.

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.

Immediately I had "funny bone" pain in the opposite arm (right) of the injection. That comes and goes at night but less as time goes on. Left arm still hurts at the injection site. Main Problems: Headaches and extreme dizziness. I thought the dizziness was a UTI problem. I took 14 pills twice to get rid of the "UTI" effect as per my GP. The dizziness and headaches started after the vaccine and is getting worse and worse. The room is spinning when I get up at night or lay down to sleep and many times during the day. My husband cannot drive anymore and this problem is scary. I wish I did not get the vaccine. I believe I had Covid after holidays of 2019 and into Jan. of 2020. Serious coughing and could not breath. We we

hurting so bad shoulder across shoulder to neck; hurting so bad shoulder across shoulder to neck; This is a spontaneous report received from a contactable consumer. This consumer (patient) reported for herself that an 80-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EW0186) at the age of 80-years, via an unspecified route of administration, administered in left arm on 26Jun2021 at 10:10 at single dose for COVID-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. Consumer stated that she was just calling to report her side effects from first Pfizer shot, she got her shot on Saturday and then on 28Jun2021 (Monday) it hurts so bad, 28Jun2021 (Monday) 29Jun2021 (Tuesday) and 30Jun2021 (today) she was hurting so bad her shoulder across her shoulder to her neck and she didn't know what could be to ease the pain, she would tell that she had tried heat, she have tried cold little wash cloth, she was taking paracetamol (TYLENOL) with codeine, she was taking the muscle relaxant (unspecified medication), rubbed it with this diclofenac sodium topical gel, she had rubbed it as per cream nothing does any good, patient wanted to know what she can do for. Consumer stated it was just severe pain from her shoulder. The adverse events occurred on 28Jun2021. Outcome of the events was not recovered/not resolved Follow-up attempts are completed. No further information is expected.

Muscle pain left hip; This is a spontaneous report from a contactable consumer (patient). An 80-years-old non-pregnant female patient received first dose of bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number and Expiry date was not reported), via an unspecified route of administration on 15Feb2021 at 01:00 PM as single dose for covid-19 immunisation at doctor's office/urgent care. The patient had penicillin allergy and other relevant medical history was reported as none. Concomitant medications included budesonide, omeprazole, hydrocodone bitartrate, paracetamol (NORCO), lovastatin and metoclopramide (METROPRASIL) all received within two weeks of vaccination. The patient did not have covid prior to vaccination and was not tested for covid-19 post vaccination. Patient did not receive any other vaccine in four weeks. On 15Feb2021, at 05:00 PM, the patient experienced muscle pain left hip. The event resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of muscle pain left hip included chiropractor adjustment. The outcome of the event muscle pain left hip was recovering. Follow-up attempts completed. No further information expected.

Pain in lower ribcage. Plus long-term continuing inflammation felt in lungs, primarily. But also full body inflammation.

Headache; Right arm funny bone nerve pain that would go all the way up and down arm; nerve pain; UTI; she is still dizzy and having bad effects for the UTI; This is a spontaneous report from a contactable consumer (patient). A 80-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot/NDC number: Unknown; Expiry date: Unknown) via an unspecified route of administration in left arm on an unknown date in 2021 14:00 (at 80-year-old) on left arm as single dose for COVID-19 immunization. The patient's medical history thyroid issues was over 30 years ago, penicillin allergy (since 1964) that gave her hives so bad. loaded with hives and was a pimply mess, ongoing doxycycline allergy that gave her severe diarrhea, sulfonamide allergy, iodine allergy, fever and could not breathe/extreme difficulty breathing. The past drug event included tetracycline, arithromycin, Levaquin, ceftin, Zithromax that caused drug allergy (ongoing). Concomitant medications included levothyroxine (Other products: Yes) taken for thyroid disorder (had it for 30 years or more and had been taking for the same then). The patient previously took doxycycline and experienced diarrhoea, tetracycline and experienced drug hypersensitivity, erythromycin and experienced drug hypersensitivity, levaquin and experienced drug hypersensitivity. It was mentioned that no investigation assessment was done. She came home on an airplane on 03Jan2019, the year COVID started. When she got back, she told her doctor she thought she had gotten Covid, so they tested her, but she was negative. She thought she had it and volunteered for antibodies. She did not get over it until mid Jan2019. They told her she was over it for too long though if she had it. It was mentioned that history of all previous immunization with the Pfizer vaccine, prior vaccinations (within 4 weeks) if applicable, list any other vaccinations within four weeks prior to the first administration were reported as none. Received call from consumer regarding the Pfizer COVID vaccine. She has ongoing symptoms that started after she received the vaccine. She only got the first dose. On an unknown date in 2021, she started having headaches that she never knows when they are going to come on and they are continual. She did not have them before she got the vaccine. She did not remember the start date and said it was right away after the first dose that she received about a month and a half ago. It started right away. She was not getting the second one because the headaches would not go away. They become more continuous and more often. She was hesitant to get the vaccine because she was allergic to just about all antibiotics. She does not have names, lot or expirations for any. She later provided that Penicillin gave her hives so bad. She was loaded with hives and was a pimply mess. She also said that Doxycycline gave her severe diarrhea. She then found her list and also provided allergies to the following: Tetracycline, Arithromycin, Sulfa, Levaquin, Ceftin, Zithromax, and no contrast Iodine. She does not remember the exact reaction. It is either severe hives or severe diarrhea. She does not have the lot or expiration for any of them. No further details provided. She had another issues immediately after the shot. She had funny bone pain in the right arm but she got the shot in the left arm. This pain was described as a nerve pain that would go all the way up and down her right arm. It would come at night after the shot but then it went away. She does not have it right now. Right now she was trying to get rid of a UTI. It was recently within the last 2 weeks ago. She started medication for it and they did not help. She had a call into the doctor and she was still dizzy and had bad effects for the UTI. She took the medication and had to refill it. Medication was Nitrofurantoin Mono Mcr 100 mg. One capsule every 12 hours. It was in a pharmacy vial with unknown lot or expiration. She did a refill and took it twice. She finished them and has none left. Her friends were upset because she would not get second shot and certainly not a third because of these headaches. She felt she may take a chance at getting something worse than these headaches. She does not feel she should get them or anymore. The patient did not require emergency room and physician office visit. She had been to her doctor since and she mentioned the headaches, and all they say was to take Advil. Outcome of the events headache, urinary tract infection and dizzy was not recovered, whereas other events were recovered on an unspecified date in 2021. Description of Product Complaint: Description of complaint: Right now she is trying to get rid of a UTI. It is recently within the last 2 weeks ago. She started medication for it and they did not help. She had a call into the doctor and she is still dizzy and having bad effects for the UTI. She took the medication and had to refill it. Medication is Nitrofurantoin Mono Mcr 100 mg. One capsule every 12 hours. It is in a pharmacy vial with unknown lot or expiration. She did a refill and took it twice. It was mentioned that product strength and count size dispensed: 100mg, 14 count. Information on lot/batch number had been requested.

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

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

Friday afternoon ... headache and right thigh muscle discomfort . Saturday ... headache and more thigh muscle discomfort. By night, muscle ache was continual and continued throughout the night. Very difficult to walk. Sunday ... called Telehealth around noon, They triaged me into Dr.'s office. By Sunday afternoon, less discomfort, but still a headache. During this discomfort time, I would take 2 Tylenol (500 mg), which relieved it. Before I settled down for the night, I took 1 Tylenol and when I woke up at 3:00 a.m., the ache was not there (the Tylenol would have worn off by then). Monday a.m. ... could walk much better. The headache and the constant muscle ache are gone. Nurse called; I am to keep watch, and if there are any changes for the worse, I will go into the Dr.'s office.

Muscle pains; Joint pains; This is a spontaneous report from a contactable consumer. An 81-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number EL1284/expiration date unknown), dose number 1, via an unspecified route of administration on 05Jan2021 at a single dose on the left arm for vaccination. The patient had no relevant medical history and no concomitant medications. The patient volunteers at a local hospital. She reported muscle pains and joint pains after Pfizer COVID-19 vaccine. She had onset of muscle pains and joint pains around 1:00am on 06Jan2020. Muscle pains and joint pains worsened around 5:30am on 06Jan2021. She was taking 500 mg of Equate Acetaminophen every 4 hours for the muscle pains and joint pains, but the Equate Acetaminophen does not seem to be helping the muscle pains and joint pains. Her second dose was scheduled on 26Jan2021. The outcome of the events was not recovered.

She complained that after receiving the vaccine her arm felt heavy and sore to movement. She was evaluated EMT and released home feeling better at 1:39 pm.

slight temp elevation, severe hip joint pain extending into 3rd day -- first the left hip, then the right hip by 2nd day; also muscle aches in left arm and leg.

weakness/feeling weak; Dizziness/head was dizzy; nausea; Neck was sore; discomfort; 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 number: EK9231, Expiry Date: Apr2021), via an unspecified route of administration at right arm on 08Jan2021 13:00 at single dose for covid-19 immunization. Vaccine was not administered at military facility. Vaccination facility type was health department. The patient got the flu shot every year and never had a problem. There were no concomitant medications. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 13Jan2021, the patient experienced severe dizziness/head was dizzy, feeling weak, nausea, neck was sore. The events did not require a visit to emergency room or physician office. She was very dizzy and laid back down. Today (14Jan2021) was better but she felt weak and wanted to figure out what was going on. She took it to make sure she felt better but the only thing she's had was discomfort. No treatment, not contacted the doctor. The outcome of events weakness/feeling weak, dizziness/head was dizzy was recovering. The outcome of events nausea, neck pain was not recovered. The outcome of event discomfort was unknown.

When I got out of bed Saturday morning, Jan. 16, 2021, or Sunday, Jan. 17, both of my hips were extremely painful. I had never felt pain in my hips and was alarmed by it. I didn't associate the pain with the COVID-19 vaccination until Jan. 22, when I heard a doctor in a video from the Health Department talking about the vaccinations. The city communication system had sent the link to me, unrequested, in an email. The doctor listed possible side effects, including hip pain. I searched the internet for lists of side effects, although I had read them in newspaper reports and had heard them in coverage of the pandemic and vaccines. I was unaware of hip pain specifically or joint pain being on the list.

I think its arthritis and it's very painful today; She was not sure if she had twisted it or if it was arthritis; She confirms it is her knee, she thinks its arthritis, it has swelled up before but it was very painful.; She confirms it is her knee, she thinks its arthritis, it has swelled up before but it was very painful.; This is a spontaneous report from a contactable consumer (patient). An 81-year-old female patient received the first dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EL3249, expiration date: 31May2021), via an unspecified route of administration on 15Jan2021 at single dose for covid-19 immunization; ibuprofen, and paracetamol (TYLENOL), both via an unspecified route of administration from an unspecified date at unknown dose for an unspecified indication. Medical history included knee pain from an unknown date. The patient clarified she had been dealing with this knee pain prior to receiving her first dose of the vaccine. The patient's concomitant medications were not reported. The patient got the vaccine on Friday (15Jan2021) and she had a knee that was giving her a fit. She was not sure if she had twisted it or if it was arthritis. She just wanted to know if there were any over the counter medications she can take such as Tylenol or Ibuprofen that she could take for knee pain that will not interfere with vaccine. She confirmed it was her knee, she thought its arthritis, it had swelled up before but it was very painful, and she was wondering if there was any medications that might be in fair with this vaccine such as Tylenol or Ibuprofen or anything like that. She said this morning it was a little better after being off it last night, it was not as painful this morning. She said previously she had been taking Tylenol or Ibuprofen and it would help it a great deal but she wanted to check since she had the first shot Friday to see if taking that would interfere with anything. The action taken in response to the events for ibuprofen and paracetamol was unknown. The outcome of the events was unknown.

Cough (mild - no trouble breathing) & Diarrhea 1.30 / chills 1.31 / leg & back pains 1.31-2.1 / continuing cough

Around 1/27/21 patient noticed numbness of bilateral legs and progressive weakness. Admitted to hospital 1/29/21 and diagnosed with Guillen Barre. Initially paresthesia was from feet to groin and has been improving.

severe back and leg pain and paresthesias bilaterally; severe back and leg pain and paresthesias bilaterally; severe back and leg pain and paresthesias bilaterally; This is a spontaneous report from a contactable other hcp. A 81-years-old female patient (not pregnant) received bnt162b2 (BNT162B2, manufacture: Pfizer), via an unspecified route of administration on 04Jan2021 at SINGLE DOSE for covid-19 immunisation. Medical history included Known allergies: sulfa. No covid prior vaccination. No covid tested post vaccination. The patient's concomitant medications were not reported. The patient experienced severe back and leg pain and paresthesias bilaterally on 05Jan2021. The events resulted in hospitalization. The outcome of the events was unknown. Information on the Lot/Batch number has been requested.; Sender's Comments: Based on a drug-event chronological association, contributory role of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) to the onset of reported events severe back and leg pain and paresthesias cannot be completely excluded. The case will be reevaluated should additional information become available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.

Big toes hurt, gout; Big toes hurt, gout; Glands in her neck on the right side swollen; Arm is very sore; This is a spontaneous report from a contactable consumer (patient). A 81-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EL8982) via an unspecified route of administration in left arm on 20Jan2021 mid-afternoon at single dose for COVID-19 immunisation. Medical history included ongoing atrial fibrillation diagnosed about 25 years ago, Canker sore on 18Jan2021 (she did go the doctor for that and the doctor urged her to rinse it with salt water to she's been doing that), some soreness in her month on 18Jan2021, gout reaction. The patient concomitant medications were not reported. No Pfizer vaccine was administered on the same date. Prior Vaccinations (within 4 weeks) was none. The patient got a reaction that she thought should be noted. She has had a very slight history of gout. She woke up this morning on 21Jan2021 and her big toes hurt. She knew that this was a symptom of what she had had in the past which was gout. The patient confirmed her big toes hurting was pretty much staying the same. It's not that uncomfortable. She knew from past experience that this was what happens, like when she ate certain foods like seafood or whatever, she would have this kind of gout reaction. This morning on 21Jan2021, she also felt the glands in her neck on the right side were swollen. The swelling seemed to have gone down. Her army was also very sore. She stated the soreness began last night, in the evening on 20Jan2021. The soreness had pretty much stayed the same. She expected the soreness, but she didn't expect her toes to hurt. It was important to note "she is able to able the gout". She had only had gout really bad time once and then she's had a little bit every so often. The gout just seems to be connected to the vaccine- she could not say nothing that she ate would indicate other wise. The events did not require visit Emergency Room or Physician Office. She had an appointment for 10Feb2021 to get the second COVID-19 vaccine. The outcome of event glands in her neck on the right side swollen was recovering, outcome of events was not recovered.

Extreme headache, neck ache, for five days; elevated BP 180/90. 160/88, etc. De. prescribed additional BP medication after a week, and BP is gradually coming down...I hope.

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.

Within 15-minutes of vaccination, the patient reported that their "arm was getting tight and tingling". EMS evaluated patient on-site. Patient was hypertensive (160/86), but otherwise vitals were WNL. Patient refused transport to hospital.

About 2:00 PM noticed swelling and discomfort in the left shoulder and was tired. Went to sleep. The symptoms went on for the next couple of days but resolved by Thursday. the arm was stiff and quite sore, felt a little swollen. The fatigue was gone by Wednesday. Had the typical shortness of breath from her asthma. Did not take anything other than her usual Tylenol.

her equilibrium was off; She said feels cold all the time now; bone and muscle in her body hurt; hands and body were jerking; she ached all over; she felt tired; rigors; shaking; muscle and joint aches/her muscles hurt; muscle and joint aches/her joints hurt; 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, Batch/lot number: EL3247), via an unspecified route of administration at left upper arm on 21Jan2021 08:00 at single dose for covid-19 immunization. Medical history included lymphoma from 2018. The patient's concomitant medications were not reported. There were no additional vaccines administered on same date of the Pfizer. The patient previously took rituxan for lymphoma (Reported she had been in remission for a little over a year. She said she had received only 4 Rituxan infusions for the lymphoma before she went into remission). 12 hours post injection: she "experienced significant rigors and shaking, muscle and joint aches, her equilibrium was off at some point, she was tired, had generalized pain, and chills". She also confirmed feeling better. She stated she heard the the second dose of the vaccine caused more reaction than the first dose and would like to validate the information. She explained the first instance she experienced rigors was after a lymphoma treatment. She believed the rigors lasted "12 hours" but was not certain because she "fell asleep and got warmed". The patient felt great all day on 21Jan2021 after receiving her first COVID-19 Vaccine dose. She said almost exactly 12 hours later, she started to have rigors. She was shaking so hard that her hands and body were jerking. Her muscles and joints were hurting, her equilibrium was off, she ached all over, she had pain, felt tired, and she had chills. The rigors started first. She said she felt really cold at the same time, so she went to bed and covered up, trying to get warmed. She fell asleep for awhile, and then woke up and went to the bathroom. When she went to get out of bed to go to the bathroom, she stood up, and every bone and muscle in her body hurt. She said she was aching all over, and her equilibrium was off. She didn't feel like getting up, and finally went to sleep to get the rigors to stop. She felt cold all the time now, but the rest of her symptoms had improved. She said it seemed like the muscle in her right leg was still pretty sore. She said she recovered from the rigors completely. She had rigors once before when she had an infusion. She clarified the infusion was Rituxan. She said she had a reaction to her first treatment of Rituxan. She said she had rigors when the Rituxan infusion was first started. She was given a couple things (but she didn't know what those things were), and she stopped shaking. She said the infusion staff waited a few minutes and tried to restart the Rituxan infusion, but she would have rigors again. She said the infusion staff tried slowing down the Rituxan infusion rate, as well. She said the Rituxan infusion normally takes 2 hours, but after 8 hours, she had only got about 20% of the Rituxan infusion, before the Rituxan infusion was stopped. She stated she had 3 subsequent Rituxan infusions at later dates, and did not have any problems with those infusions. Her first dose of the COVID-19 Vaccine was administered high up in the muscle of her left arm, close to the shoulder joint. She said the COVID- 19 Vaccine injection didn't hurt, and her left arm never got sore. She said on 30Dec2020 she had lab work done for her oncologist. She went about every other month for blood work to make sure she was still in remission. She saw her oncologist on 06Jan2021, and her oncologist said her blood work looked pretty good and was better. She asked her oncologist about the COVID-19 Vaccine, and her oncologist said she definitely wanted her to get the COVID-19 Vaccine. Her next appointment with her oncologist was in Mar2021. She said she had been seeing her oncologist every month, but her oncologist this time, wanted to try seeing her after 2 months. The events did not require a visit to emergency room or physician office. The outcome of events rigors, shaking was recovered in Jan2021. The outcome of events muscle and joint aches/her muscles hurt, equilibrium was off, aching all over, tired, bone and muscle in her body hurt, hands and body were jerking was recovering. The outcome of event feels cold was not recovered.

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.

As I washed up in the morning, about 8 a.m., I noticed my underarm was sore. As I examined the area several times during the next couple of hours I noticed a lump. The lump was moveable, but seemed about the size of a nickle. It scared me even though it was not actually in my breast. The doctor told me since it was moveable and felt smooth he thought it to be a reaction to the Covid vaccine, but ordered a mammogram. I called for the mammogram and was told I could not have one until 4 weeks after the 2nd shot. I have a mammogram scheduled 3/26/2021.

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.

diarrhea and it was just all bright red fresh blood/bright red blood with diarrhea; bright red blood coming from her anal area; feel heaviness, she just feels that heaviness.; she lost weight; This is a spontaneous report from a contactable consumer (patient). A 81-year old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE lot number EM9809) (at the age of 81-years-old), via an unspecified route of administration on 06Feb2021 between 12:30 and 1PM as a single dose for covid-19 immunization. The facility where COVID-19 vaccine was a doctor's office and administered anatomically located on the right arm. The patient medical history included: She has been diagnosed years ago 10 years ago, which was since she smoked with COPD and she is on breathing medication, but she has not had it due to getting in a donut hole with insurance and she cannot afford it, her hands also won't let her use it, She hasn't had it for 2 months. Arthritis. She has had no other vaccines on the same day or in the past 4 weeks, she had the flu shot back in Oct2020. Family Medical History: Her dad had heart problems and cancer. Her brother had cancer. Her mother had heart conditions. Concomitant medications included: Acetaminophen and Naproxen sodium. She was taking a lot of acetaminophen and Naproxen sodium for arthritis pain, but she has not had any since Friday night 05Feb2021. She did not want to take anything before the shot. She hasn't been weighed in a while, she lost weight. On 06Feb2021, at 8 o clock on the night, she experienced bright red blood coming from her anal area; then, she had diarrhea and it was just all bright red fresh blood, it was fresh new blood not dark at all. Today she is still having bright red blood with diarrhea; the blood seems like it is decreasing, it's being colored by diarrhea. She felt maybe in so many years is like when you have a period at times and feel heaviness, she just feels that heaviness. Caller reports that she does have a standing appointment with her provider tomorrow. The clinical outcome of the events bloody diarrhea and anal bleeding was not recovered, heaviness and weight decreased was unknown. She is scheduled for the second dose on 10Feb2021.

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.

Two minutes post . vaccination Pt reponed neck pain. Pain level 5 out of 10. V/S taken BP 152/74 HR 95 Spo2 93 o/o RP 18. Patient observed for an additional 15 minutes. Prior to discharge v/s retaken BP 136/79, HR 86 Spo2 96o/o. Patient reponed pain level 2 out of 10

woke up in the middle of the night sweating; whole left shoulder, arm and hand was very sore and achy; whole left shoulder, arm and hand was very sore and achy; This is a spontaneous report from a contactable consumer (patient). An 81-year-old female patient received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, lot number and expiry date unknown), via an unspecified route of administration on 21Jan2021 at a single dose on the right arm to be inoculated against the virus. The patient has no medical history and there were no concomitant medications. The patient reported that she got the Pfizer vaccine shot last Thursday, 22Jan2021 and while she was there she didn't have any reaction. She had the vaccine in her right arm because she was left handed and by the time she got home, her whole left shoulder, arm and hand was very sore and achy. She had trouble with her left shoulder, she didn't know if it was the co-incident (as reported) or not and then it kind of then the patient took some Tylenol and it kind of eased up. The patient then reported that on 22Jan2021, Friday night, she woke up in the middle of the night sweating and that happened during the night and in the morning it went, but it is still there but she still has soreness in her left shoulder, arm and hand and it kept her up last night. She didn't know if this was going to be a symptom of the vaccine. She wanted to know that when she will get the second one, is it going to be worst and what she was supposed to do. The patient was scheduled to get the second dose on 11Feb2021. The patient reported unspecified labs with unknown results. The outcome of the events whole left shoulder, arm and hand was very sore and achy was not recovered while the outcome of woke up in the middle of the night sweating was unknown. Information on the lot/batch number has been requested.

Completed 15 min observation; as exiting felt flush, and hot wanted to sit; sat down and slumped over; Daughter called help; No Bp or O2 measurable; felt cool and clammy to touch; chest rises with breathing; eyes open and blinking but not responding to questions asked; performed sternal rub, did not react; Rapid response notified;Connected to monitor; aganol respiration noted,Transferred to stretcher. lips turned purple; bag mask placed and bagged respirations; approx 15 chest compressions performed, responded to compressions; Started to breath and color returned to face. Immediate transfer to ED.

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

She 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

Developed pain Lt axilla with swelling of 1 lymph node this lasted for 3 d then the swelling of the lympn was no longer apparent, the pain in the axilla persists. I then developed pruritus generalized without rash or uticaria. This lasted for 10 d

Got intense pain in upper thigh, right leg, so bad I could barely walk. Had to told onto walls. Went on all night. Next morning I also had bad, but not AS bad, pain in upper left thigh, closer to groin. It went away completely by 2pm on 3/5. Had made with apptmt with my PCP for getting bloodwork and xrays. When pain was mysteriously gone, I canceled. But pain was incredibly intense on 3/3 and into morning.

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

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.

Trouble breathing. Taken to ER. Diagnosis Congestive Heart Failure. No Previous such diagnosis. Admitted for 6 days with Metropolo benign only new prescription. After 2nd shot on February 2 had follow up visits but started experiencing light headless. On February suddenly went limp with loss of pulse and breathing. Taken to Hospital ER, admitted without neurological responses. Died on February 22.

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

Headache, heaviness in head. I was able to concentrate and do my work but head felt heavy and cloudy (?) when standing. Was okay when doing work a my desk. An extreme and unusual fatigue. Some occasional weakness in legs especially when getting up. Some interior shaking. It happened 4-5 times over 10 days. Did not last more that 30 seconds to 1 minute. Had absolutely no symptoms after vaccine. Symptoms started about 4-5 days after vaccine.

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.

Couldn't control leg muscles for 2 days, knee aching on right side, couldn't stand or walk for two days.

Polyarthritis affecting hands, wrists, shoulders, knees - significant pain and inability to ambulate without significant pain; behaves like reactive arthritis/autoimmune disease, intermittent fever, CRP markedly elevated at 133 (normal < 10); requiring Prednisone for treatment; unresolved as of 3/3/1/21

inflammation/inflammation on her right side of waist and in the back down in to pelvis, ovary and groin area; pain in her arm; muscle pain; pain; Her arm bothered her: she could not lift her arm; 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 VACCINE), via an unspecified route of administration, administered in Left Arm on 29Jan2021 (Batch/Lot Number: EL9262) as single dose for covid-19 immunisation (Indication: Felt that getting COVID at her age would be worse than getting a possible reaction to the vaccine). Patient had an allergic reaction to the swine flu vaccine in 1979-1980. Patient had muscular problems that resulted from the Swine Flu shot. She had weakened muscle. Most of the time she was okay, but she was more prone to getting back pain and stuff, not pain on her side and on the front side like she has now. Patient wanted to know if the swine flu shot and the covid 19 vaccine had similar ingredients. The Swine Flu shot was back in 1979 or 1980. This is the only type of flu vaccination she has ever had. She did not take more after that. She does not have a lot number to provide. She does know though, that a lot of people at that time came down with (Name) from that vaccine. With this vaccine, nobody seems to be getting strong side effects from it. No Other Products. Patient History reported as No. No Investigation Assessment. The patient medical history and concomitant medications were not reported. The patient experienced pain in her arm statin she could not raise her arm for a day. Her arm bothered her: she could not lift her arm on 30Jan2021and recovered on 31Jan2021. The patient experienced a day later pain and inflammation on her right side of waist and in the back down in to pelvis, ovary and groin area muscle with not recovered (reported as worsened). Caller stated that it was quite painful describing the pain as muscle pain and inflammation. Caller stated that this pain had not gone away. Caller stated she was due for her second dose and wanted to know if she should get the second dose based on her side effects to the first dose. The patient was having to take anti-inflammatory medications for the pain associated with her side effects to the covid 19 vaccine. Patient thought she had a reaction to the Pfizer COVID Vaccine. The day after she had the usual side effect of her arm bothering her. Then she started to experience pain and inflammation around her right side from the waist area down to the front of her pelvis to her groin muscle. It seems like pain and inflammation. It has not gone away. If patient stays home and did nothing she felt a little better. If she took an anti inflammatory she also felt a little better. If she was going out and doing something it flares up. That was why she felt it was muscular, it felt inflamed. Caller stated that it overall had gotten worse in the last few days. She was doing more things than the first couple of days. Treatment: The anti inflammatory was Diclofenac 25mg. She had also been taking Tylenol at night. She said that it does not make the pain completely go away, but it helps keep the pain tolerable. Did not have either of these medications on hand to provide the lot numbers. The outcome of event Her arm bothered her: she could not lift her arm was recovered on 31Jan2021, of other events was not recovered.

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.

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..

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

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.

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

Pt relays that 4 hours after she received the vaccine, she developed acute bilateral weakness in the legs and had to crawl up the stairs. "legs were not working"

I started feeling fatigued, and my joints started aching Having arthritis; I started feeling fatigued, and my joints started aching Having arthritis; This is a spontaneous report from contactable consumer (patient) reported for herself. A 81-year-old non-pregnant female patient received second dose of BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EN6202), via an unspecified route of administration in the left arm on 17FEB2021 10:00 as a SINGLE DOSE and previously received first dose of BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EL9265), via an unspecified route of administration in the left arm on 01FEB2021 13:00 for COVID-19 immunization. Medical history reported as penicillin allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Concomitant medication was not reported. Patient's medications received within 2 weeks of vaccination olmesartan 40mg, multivitamin, Omega 3, D3, Tumeri. On day after second shot patient started feeling fatigued and joints started aching. Having arthritis used to some joint discomfort, but this went beyond want was normal to patient. The fatigue was so encompassing that patient lay on the couch and watch tv most of the day, interspersed with naps. The pain and fatigue lasted from 25Mar2021 until 10Mar2021 when it has begun to ease. Patient still nor back to where she was but feel better. Not being sure why reaction was so bad and glad she had the vaccine and would repeat it even knowing how I would react. The patient did not receive any treatment for the events. The clinical outcome of the events was recovering. Information on the lot/batch number is requested.

After the first vaccine she experienced pain in arm and pain between the eyes. She also had flu like symptoms for approximately 3 days, and unusual bowel movements not diarrhea, not constipated, but not normal and painful. After second dose had similar reaction bowel issues are still bad and very painful (to the point of vomiting during bowel movements due to pain). She saw her primary care doctor and was Rx'd a cream. This has caused her to decrease her eating. This did not help and she was having loss of visual acuity and started not being able to speak properly so went to the ED for concern over Strokes. had 2 MRIs, and determined not to be having a stroke so was released to home. Sxs seemed to resolve ( like a spell) . Was still having bowel issues and she also developed a rash from the neck to the groin. So she went to a specialist. The Rash cleared after about 3 days. Specialist advised that the sxs were all due to the COVID Vaccine. Flank pain under the right ribs has also been present, this is not improving, it is a dull pain that seems to be worsening ( the bowel seems to be about back to normal now) She is planning on speaking with her PCP about the right flank pain.

She got the vaccine, and had no reactions at all other than perhaps a chill. About 2-3 weeks later on 3/7/21 she started experiencing what they are calling muscle confusions. She feels a tapping sensation on her biceps and triceps and then starts with muscle cramps running down her right arm creating her fingers to cringe or come together or contract. This then travels down to her right leg to her quadriceps which cramps and convulse and travels to her calves which tighten up like a Charlie Horse and down her toes to where they contract as well. They are intermittent, scattered and sporadic. Sometimes she will get 2-3 a day, and then none at all and then a few days later a couple more. These contractions last 3-5 minutes. She had COVID back in April of 2020 and was hospitalized until August of 2020 with that. During that time she was on a ventilator for 60 days and on a breathing tube and coded and was out for about 30 minutes. She had an EEG of her brain in September and told that she was fine. her neurologist felt she should have another one due to these symptoms, and she had that and everything was normal. The doctor prescribed 500 mg twice a day of Levetiracetam. The seizures kind of regress a little and then they came back and he upped that medication to 1000 mg twice a day. The seizures still continue and have continued but is still taking the medication. He felt that she should know see an epileptic specialist and they have an APT for 5/27/21. These episodes are exhausting and wear her out. She was going to PT due to the weakness from being in the hospital for so long, and now she is fearful if she is going to fall and uses a walker and is having a setback in that progress. She is to continue therapy at home for now and to follow up with the Epilepsy specialist.

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.

Muscle ache in my arms; This is a spontaneous report received from a contactable consumer (patient) reported for herself. This is the second of two report. A 81-years-old female patient received second dose of bnt162b2 (Pfizer-BioNTech COVID-19 Vaccine), at the age of 81-years-old, via an unspecified route of administration, administered in upper left arm on 16Mar2021 (Lot Number: CN6205) as single dose for covid-19 immunisation. Medical history was none. The patient's concomitant medications were not reported. patient received first dose of bnt162b2 (lot number: EL9267) at the age of 80-years-old on 15Feb2021 for covid-19 immunisation. Patient got the second shot and about 10 days later and started having a muscle ache in arms and neither one is gone away yet. Patient was just rubbing some Benadryl on arms because, because it hurts she was thinking about going to doctor make an appointment with the doctor and yet I was hoping it'd go away but so far not. Event outcome was not recovered. No follow-up attempts are needed. No further information is expected. ; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021427428 Same patient, different dose and event.

3/6 I woke up with a nerve pain the size of a silver dollar at top center of right thigh where it joins my torso and i still have that pain, 3/9 under distress because of the pain I had a venous ultrasound on both legs with Dr., then I noticed on 3/13 rose pink flesh on both lower calves, 3/18 Dr sent me for an MRI Imaging of my lower back because of the pain. 3/19 I saw Neuro Dr for Botox on left side of face, I was told that they thought a nerve crossed a vein that caused a tremor on the left side of my face. 3/23 Dr. had an audio apt. 3/29 I had a full breakout of cellulitis on my lower left leg and it was a deep deep purple red and it itches. 3/30 I was sent to Dr assistant to see if I had extensive back and hip trouble and I was examined physically with movement, they offered a shot at nerve point and water therapy. I put arnicare on the spot and it makes the pain manageable. 4/7 cellulitis, 4/9 I tried to be seen, 4/10 my heart beat irregular, then the rash appear and there was acute pain at the top of my head. ValACYcalovir 500 tab (valtrex) 4/19 Sonogram for arteries in my legs and I was given the doxycycline and prednisone, and today I still have a bright red and swollen ankle on the right and I still have some dried up shingles on my chin and head. I have photos that I took of my reaction to the vaccine.

shingles; burning bumps; rash/breaking out spot; back ache; This is a spontaneous report from a contactable consumer (patient) and additional consumer (patient's daughter). An 81-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 1 intramuscular, administered in right arm on 26Feb2021 13:45 (lot number: EN6198) at the age of 81 years old, as single dose for COVID-19 immunisation. Medical history included osteoporosis and macular degeneration in both eyes. The patient's concomitant medications were not reported. Historical vaccination included shingles vaccine (SHINGRIX) on an unspecified date (about 5 years ago) for immunization. The patient did not receive any other vaccine four weeks prior to COVID vaccine. Patient mentioned she received her first COVID-19 vaccine on 26Feb2021. Then on 02Mar2021, she started having a back ache. Then by Friday, 05Mar2021 she started breaking out on her right side. She thought at first it was due to her using a heating pad for her back which was sore. Then on Sunday morning on 07Mar2021 she noticed a new breaking out area on her stomach. She thought she might have shingles. She was seen at her primary care doctor on 08Mar2021 and was told it was shingles. She was prescribed an antiviral drug now. She wanted to know if she should get the second COVID-19 shot and if the antiviral drug affect her getting the second shot. Patient noticed the breaking out on her right side towards her stomach and it may have started a day earlier. If it started on her back, she wasn't aware and she didn't feel it until Friday 05Mar2021. The breaking out started on her right side around towards her torso and a little backwards towards her back. On her waistline, lower than her waistline, a little bit lower. Right where her thigh meets her torso. Like her hip kind of like a crack there. The backache she can't feel any more, she wondered if the backache was a precursor to shingles or not. Referring to the backache, maybe she didn't notice it, maybe it was on 08Mar2021 that she didn't notice the backache anymore. Patient's daughter mentioned her mom was still on 07Mar2021. On Friday 05Mar2021 at bedtime she noticed the breaking out area, and it still burns, the bumps. The rash/breaking out spot is still there and hurts. They are bumps not blisters. When she looked at it this morning 09Mar2021 after taking three of the anti-viral pills the breaking out area is not as bright, maybe a little duller red color. She uses a magnifying glass when probed for details from the Patient Vaccination Card. She has low vision in both eyes due to macular degeneration. She went to the doctor on 08Mar2021. She was prescribed antiviral, Valacyclovir 1 gram tablet, take 1 tablet by mouth 3 times daily. She started taking this on 08Mar2021, was prescribed 21 pills for 7 days. NDC/Lot#/Expiry unknown, discard after Mar2022. Did not see on bottle to provide. When asked about if print was small it was clarified this was a blue bottle filled by the pharmacy. It is not a manufacturer bottle. She first saw the breaking out area on Friday 05Mar2021 night and didn't think anything about it until Sunday 07Mar2021 when she had a new break out. Her second COVID-19 injection is scheduled for 19Mar2021. She did have shingles shot about 5 years ago. And she knows they have a new one, but she has not taken the new one. Her doctor told her yesterday 08Mar2021 to get the shingles vaccine. She hasn't decided if she's getting the shingles vaccine or not. The event shingles required visit to Physician office. The patient recovered from backache on 08Mar2021; recovering from shingles; while outcome of the remaining 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.

"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

Office Visit 5/4/2021 screening laboratory testing for COVID-19 virus +1 more Dx Cough ? Diarrhea ? Fatigue Reason for Visit ED to Hosp-Admission Discharged 5/5/2021 - 5/17/2021 (12 days) Last attending Treatment team Pneumonia due to COVID-19 virus Principal problem Hospital Problems POA * (Principal) Pneumonia due to COVID-19 virus Yes Asthma without status asthmaticus Yes Systemic lupus erythematosus (CMS/HCC) Yes Overview Signed 12/1/2020 7:46 AM Note: Document: 08/22/19 - Consults Rheumatology Paroxysmal atrial fibrillation (CMS/HCC) Yes Atrial fibrillation with RVR (CMS/HCC) Yes Esophageal stricture Yes Hospital Course HPI: patient is an 81 y.o. female with pmh of COPD and HTN presented to the ER with complaint of palpitations. She reports since her second covid short on 4/29, she's been feeling "ill." she states she's been having diarrhea, chills, fatigue, and cough. In the ER, she was found to be in afib with RVR. She was given a one time dose of cardizem but then spontaneously converted to NSR. She is not hypoxic but admits to increased cough and occasional dyspnea. CTA was done in the ER due to elevated D dimer. Pulm embolism was ruled out, however, she was found to have bilateral infiltrates concerning for viral pna Hospital Course: Please send details from consultation note from hematology gastroenterology 81-year-old Caucasian female she had a history of COPD hypertension she was admitted through the emergency room on May 6 with a chief complaint of palpitation chest discomfort. She was found to have A. fib with RVR with underlying history of paroxysmal atrial fibrillation. Patient was admitted and atrial fibrillation is rate controlled in maintain with increase his Lopressor. ACS is ruled out by cardiac enzyme patient was found to have a COVID-19 pneumonia fortunately patient oxygen saturation remained good continue having mild cough. And initially she was not started any dexamethasone or any antiviral remdesivir. But over the time patient actually having mild wheezing shortness of breath but oxygen saturation remained stable so then dexamethasone was started. Heart rate was pretty controlled with current medication Lopressor anticoagulation did not start since patient was found to have a severe thrombocytopenia. Patient was seen by hematologist recommend to bone marrow biopsy thought that the sudden drop possible from infectious source. So then that point Heparin Olympic Eliquis was not started. Over the time patient platelet count back to normal platelet count 1 75,000 Eliquis started 2 days ago. Since she looked tolerating Eliquis heart rate is well controlled after adding dexamethasone she is underlying history of COPD her wheezing is much improved and she is currently on DuoNeb. In the history of asthma without status asthmaticus patient will be discharged home with continue current medication Decadron for 5 more days started Eliquis 5 mg 2 times daily since she is tolerating and platelet count is normal I recommend to check CBC for platelet count in 5 days. This patient will benefit to see hematologist outpatient although she refused to do a bone marrow biopsy. She is having chronic low back pain and currently on narcotics recommend to follow-up with PCP to change his narcotic medication.. Initially she had a CTA chest done which was normal although D-dimer was mildly elevated negative for pulmonary embolism and a mild infiltration concerning viral pneumonia so bacterial antibiotic was not started. Stable to be discharged home she was having intermittent low-grade fever for almost like 5 to 10 days. The fever is totally gone now. She is clinically stable new medication is adjusting increase Lopressor 50 mg 2 times daily. Eliquis 5 mg p.o. twice daily and she is going to go home with Decadron only for 5 days.. Patient also have underlying history of chronic dysphagia patient was seen by gastroenterology recommend to follow-up outpatient in 2 to 3 weeks Follow-up PCP in 5 days, follow-up with hematology as scheduled

Severe headache; Fever; Muscle and joint pain; Muscle and joint pain; Lethargy; This is a spontaneous report from a contactable consumer (patient) reported. An 81-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number was not reported) via unspecified route of administration, administrated in left arm on 03Feb2021 at 15:00 as 2nd dose single for COVID-19 immunization. The patient medical history included fibromyalgia, arthritis. Allergies to medications, food, or other products: amoxicillin. Patient received first dose (BNT162B2, Batch/Lot no: EL0140) via an unspecified route of administration, administrated in right arm on 01Jan2021 at 10:00 for COVID-19 immunization. the patient concomitant medications were not reported. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. Facility where the most recent COVID-19 vaccine was administered in hospital. On 04Feb2021 at 03:00am, patient experienced severe headache, muscle and joint pain, fever, lethargy. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not tested for COVID-19. The outcome of the events was recovering. No follow-up attempts are possible; information about lot/batch number cannot be obtained.

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

My mother presented with lower back pain several days post first dose of vaccine. Three days after the pain started, she developed a rash that was diagnosed by her general practitioner as shingles. The pain and rash lasted for 5 weeks. The rash was extremely painful the first week and she was very fatigued. She was given a prescription for Valacyclovir at the time of diagnosis which was a week after the pain started and 3 days after the rash erupted.

A whole-body rash was evident 2-3 weeks after the first vaccine dose. Subject was unsure at the time if it was vaccine related. Severe swelling of hands and legs began the same day after the second vaccine dose with general malaise and concerns about fainting. Oral steroids were prescribed for 2 weeks, and progression of the symptoms seem to stabilize during steroid treatment. After steroid treatment, the symptoms resumed at full strength with swelling in the hands and legs causing the superficial skin to peel off and split down into the dermis with bleeding and pain. Joints in the hands and legs were painful. Severe swelling and pain in the hands and legs persisted for at least 6 weeks after the second vaccine dose. A diuretic was prescribed at about 4-5 weeks after the second vaccine dose. The subject is currently reporting improved symptoms.

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

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.

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.

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

Painful ribs ,profound fatigue,- frontal headaches, muscle pain, chills , loss of apatite .joint pain , nausea .

Polymyalgia; inflammation of the muscles throughout the body/ all systems in the body, Her arm, leg, torso, everything; this is so dramatic and so painful; an autoimmune attack on her body; This is a spontaneous report from a contactable consumer or other non hcp. An 81-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: Unknown), via an unspecified route of administration, administered in Arm Left on 28Mar2021 (at the time of vaccination 81-years-old), as a SINGLE DOSE for COVID-19 immunization. The patient previously received first dose of BNT162B2 via an unspecified route of administration, administered in Arm Left on 07Mar2021 (at the time of vaccination 81-years-old), as a SINGLE DOSE for COVID-19 immunization. The patient's medical history included Guillain-Barre; when she was 19 years old, she was paralyzed; she has never been able take a flu vaccine until about two years ago she had her first one and a year ago she had her second one; and compromised immune status. The patient's concomitant medications were not reported. The patient did not have any vaccine prior vaccination within 4 weeks. On 20May2021, the patient experienced polymyalgia, and inflammation of the muscles throughout the body/ all systems in the body, her arm, leg, torso, everything; on an unspecified date 2021, this is so dramatic and so painful, and an autoimmune attack on her body. The patient underwent lab tests and procedures which included blood test: unremarkable on 28May2021, and blood test: sedimentation rate went down on 04Jun2021. The outcome of the events polymyalgia, inflammation of the muscles throughout the body/ all systems in the body, her arm, leg, torso, everything was not recovered; this is so dramatic and so painful, and an autoimmune attack on her body was unknown. VACCINE SUPPLEMENTAL FORM: Details coded in narrative. Information on the lot/batch number has been requested. No follow-up attempts are completed; information about lot/batch number cannot be obtained.

This is a spontaneous report received from a contactable nurse (patient). A 81-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number: EN6201; expiration date: 30Jun2021) via an unspecified route of administration, administered in deltoid left on 02Mar2021 11:00 as single dose for COVID-19 immunization. Medical history included Neuropathy, Diabetes, AFib, Anemia, bleeding ulcer, Rectal bleeding, Hypertension, knee bleed, osteoarthritis in hands, Bursitis, Cataracts, arthritis in knees, Stroke, hearing impairment, Diverticulitis, Internal hemorrhoids, Bunionectomy, Fall, broke her ankle, device implant, Transfusion, retinal surgery, Cataract surgery, had a positive COVID test, Cholesterol, Weak and cracked fingernails and keep blood thin, to prevent clots. Concomitant medications included Onglyza for diabetes mellitus, Pantoprazole for ulcer. Fish oil for blood cholesterol abnormal, Atorvastatin for blood cholesterol abnormal, Zocor, Colecalciferol (VITAMIN D 3), Biotin, Cyanocobalamin (Vitamin B12) for hypoaesthesia, ubidecarenone (COQ-10), macrogol 3350 (Miralax), acetylsalicylic acid (Baby Aspirin) for anticoagulant therapy, fexofenadine hydrochloride (Allegra). On an unspecified date, the patient experienced had sore arm and on 02Mar2021 had strong headache, stiffness/neck stiffness, chills, weakness, soreness all over the body, moderate soreness at the injection site after covid 19, joint pain, felt cold, tiny red spot at injection site about the size of a dime, back pain. The events were considered as non-serious by the reporter. Reporter stated that she was a Retired RN, and she had her first dose of the Pfizer Covid vaccine on 02Mar2021 at 11am, and she was scheduled for her second covid immunization on 23Mar2021. Caller has questions about side effects she experienced after the first dose and whether or not she should get the second immunization. Caller states she had a pretty strong reaction to the first injection. Caller states that she had the COVID disease in 22Oct2020, the caller went to the ER and had a positive COVID test because she had a fever, but she was sent home because her lungs were clear. She reported that both her son and her husband also got COVID around that time, but none of them had to be hospitalized. Stated that about an hour after her first injection, some soreness developed at the injection site. Later that afternoon she started to get a strong headache and her arm was getting sorer; in the evening, she started developing more joint pain in multiple joints, all over including, and especially, on her toes and feet; and her left arm was getting more sore, she got the chills, and she felt cold all the time, her temperature was 96.4; caller states that she also developed a tiny dime sized red spot at the injection site. Caller states that she also was thirsty, but she was a diabetic and that might have something to do with it. By the time it was time for her to go to sleep she was stiff and weak all over. She had neck stiffness, the feeling of being kind of stooped over. Caller was worried she would be unable to straighten up. The next morning, she still had weakness, stiffness and soreness, could hardly take a shower. She had to sit on side of tub and had to have her husband help her to get dressed. By about 10am the next day, everything started going away and by noon everything had pretty much cleared up completely and was gone. The pain in caller's feet and joints was gone by lunch and she did not have a fever. Caller states that at dinner that night, she was still weak though, and at the evening meal, she was so weak that she couldn't get up from the chair at the kitchen table alone. Once she was on her feet, she was okay, she could walk, but she uses a cane, especially when she was sick. About an hour or two later, she had a temperature of 99.4. But the next day, she didn't have a fever, and she could use that same chair without help. Caller states that she was fine by Friday and her blood sugar was 95, which was good. Caller states that she had a backache a few days following, but she has had backache before. Caller states that this was her history, she had the COVID, and she had a bleeding ulcer over a year ago now. Caller also saw a Cardiologist and had the watchman device implanted at the end of Sep2020, caller had this procedure to try and help get her off the Eliquis, which she had been on since having the stroke. Caller reports that she also had a Rectal bleed when she was put back on the Eliquis, and her doctors kept her on it because of the stroke. Caller states that she has silent A. Fib and that can throw little clots, so the doctors wanted her on a low dose of Eliquis but apparently that was too much for the caller too. Caller thinks the heart procedure is doing great and doing its job, but she was unable to go in for her follow up to the procedure, because she needed an esophageal echocardiogram to see if the device was sealed over by the heart muscle, and she couldn't have that until Jan2020, because she had to test negative for COVID twice. Caller states that her hemoglobin never really recovered more than 10 since her bleeding ulcer. But her hemoglobin went down to 7.4 and she was sent to the ER at the end of Jan2021, and she had two transfusions, and the next morning her hemoglobin went down to 7, the hospital staff thought that she must be bleeding. So the caller saw a GI doctor who said that the caller needed an endoscopy and colonoscopy to see where this was coming from, to make sure she was not bleeding from the ulcer. They saw the ulcer was healed but irritated, and the colonoscopy removed a couple polyps. The polyps were negative for cancer cells. After the caller had the COVID injection, she had blood in her stool. Caller went to the ER in the evening of 08Mar2021, and she stayed in the ER until the next morning. Caller states that the stool sample did show that there was some blood in her urine (captured as provided by the caller), and the ER did a CT of her abdomen, and they didn't see blood or diverticulitis. Caller does have a history of diverticulosis or internal hemorrhoids. Because things were going on last Fall, and things were rescheduled with the COVID disease, and things, the caller did not get her regular flu shot until 12Jan2021, because she needed two negative COVID tests prior to being able to get the Flu shot. She got two negative COVID tests on 24Dec2020 and 06Jan2021. Caller does not know if having had her flu shot in Jan2021, could have affected it. Caller was concerned and was wondering if she should take the second dose of the COVID vaccine or not. HCP Details: Caller hasn't spoken to her PCP since she was last in the hospital. She tried to call her HCP, but that office was getting a new computer system and they were having a high call volume for COVID stuff, so caller could not get through to them. Caller plans to email her doctor today. Everything has been overwhelming with all these things and people for doctors to juggle. Event Details: Caller reports that the soreness at her injection site, by the next morning, was up into her shoulder. Caller states that her niece, who was not a nurse, called the caller and told her to get the injection three fingers below the shoulder joint, because there were some instances of people getting injected into the shoulder joint. So, caller had soreness at the injection site, but within 24 hours, states that she was just sore all over, but it all went away by the afternoon the next day. Caller states that, she was told that she would have reactions more to the second injection than the first, so that was her concern, was she does not want to get the second injection and then it be worse than what she experienced. Caller had a lot of pain in her toes following the COVID injection, but she has diabetes that was well controlled, and she has neuropathy, and probably arthritis. But caller states that the pain in her toes was worse than normal, following receiving the COVID vaccine. Caller has had a bunionectomy, so she always has some numbness in the toe, and she fell and broke her ankle a few years later. But caller states that the very concerning thing was, following the COVID injection, the joint pain and soreness all over and weakness that she experienced. Caller had the stiffness together with some of the other things from her low hemoglobin anyway, as she has not fully recovered from the blood loss, but she was much better, and after the transfusions she had a hemoglobin of 10. And when caller went to the hospital lately, her hemoglobin was 9.4, and she was having it tested Tuesday morning again. Caller states that it was hard to say that everything she experienced was from the COVID vaccine, as she has a history of some of these things, including weakness. Caller finally got off the Eliquis when the hemoglobin went so low, she stopped the Eliquis maybe on 29Jan2021. Caller states that she was told by her Cardiologist that her symptoms at the time were from low Hemoglobin. Caller states that she was probably walking around with that low hemoglobin for a few days. Weakness: Caller states that at times she gets very fatigued, but she was not so weak right now. But caller states that weakness has been an up and down thing for her for the past few months, even before the COVID vaccine. Treatment: Caller took her normal Aspirin, but she did not take Tylenol even though she was told she could, and she did not take Allegra. She just took her normal medicines. History: When caller had her rectal bleed, she went into the ER on 08Mar2021, and she was sent home the next morning. Caller states that the ER was busy that evening and did not see the doctor until 10 or 11 that evening. But when the tests were finished up around 3am, the caller was told that she could go home or be admitted. Caller asked to go home but not until a little later in the morning, so she could call her family. Knee Bleed: Caller confirms it was aspirated and treated in the ER; she did not have to stay overnight. Caller saw orthopedic doctor a day or two later, and he did not order anything else. Caller walks with a cane now most the time because she is trying to avoid falling. Eliquis: Caller reports that the Eliquis was held for a few days after her GI bleed. She was taking 5mg twice a day from April or May2018. Caller had the GI bleed and the Eliquis was held for a few days and then she went back on it, then had rectal bleeding again. So, after that, caller's dose was reduced to 2.5mg twice day. The doctors did not want to take her off the Eliquis because of her prior stroke, so they just reduced her dose. The Eliquis had been preventing little TIAs and stuff in her hand and mouth and stuff. And that reduced dose was okay for a while. But caller states that she started getting those symptoms back, and several times a day she was getting the numbness, and she was scared she was going to have a stroke, so she said maybe because she was previously on mg twice a day, maybe she should up her dose to 7.5mg, and that worked well. So, caller took 5mg in the morning and 2.5mg in the evening. This was over a weekend, and on Monday the caller wrote her cardiologist, who said this dosing was not normally recommended, but if it was working for the caller, then that is okay. But then in July, the caller got the knee bleed. So, the doctors thought the caller's knee bleed was from the 2.5mg knee bleed but caller thinks she started to get that earlier because she had an episode that was similar before that, caller thought that episode in May or so was just arthritis. But, in Jul2020 her knee became swollen, very painful, and she could not get out of bed. Caller states that her son who was a weightlifter could not get her out of bed. She went to hospital via ambulance where her knee was aspirated. Caller reports that the Eliquis was not stopped due to the knee bleed, she was just told to go back to 2.5mg twice daily. Caller states that her heart doctor said that because she has had a stroke, she has to take the Eliquis to prevent stroke. Caller reports that she initially was not interested in the Watchman implant, but after all this, she decided to get that procedure so she could stop the Eliquis because she was a bleeder. The patient underwent lab tests and procedures which included colonoscopy: the ulcer was healed but irritated, endoscopy: the ulcer was healed but irritated, haemoglobin: 7.4 on Jan2021, haemoglobin: 7 on Jan2021. The outcome of sore arm and weakness was unknown, headache, stiffness/Neck stiffness, chills, soreness all over the body, moderate soreness at the injection site, Joint pain, felt cold, tiny red spot at injection site about the size of a dime were recovered on 03Mar2021 and back pain recovered on 09Mar2021.; Sender's Comments: Based on the information currently available, a possible contributory role of the suspect vaccine BNT162B2 in triggering the onset of pain in arm,toe,headache,stiffness,chills,weakness,pain,joint pain,feeling cold,vaccination site erythema,pain and pain in toe. But also consider relevant medical history and concomittant drugs . The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate

My arm has been sore; It has just been over my neck; my arm, shoulder was swollen; my arm, shoulder was swollen; I got up and my arm, shoulder was swollen, that hurt and then it stop hurting; This is a spontaneous report from a contactable pharmacist (patient).A 81-year-old female patient received unknown dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration, administered in Arm on 11Jun2021 (Lot Number: EW2178) at the age of 81-year-old as a single dose for covid-19 immunisation. Medical history included back injury from an unknown date and unknown if ongoing and patient on morphine for back injury. The patient's concomitant medications were not reported. The patient's arm has been sore which just been killing her and pain was also over her neck. patient was on morphine but that morphine did not even touch this and her neck is about to kill her. On 12Jun2021 patient's arm, shoulder was swollen and that hurts. The outcome of events pain in arm, shoulder pain was recovered and event pain neck, swollen arm, joint swelling was unknown. No treatment received for the events..

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

ALS. My mother was perfectly healthy for her age which can be attested to by her Internist noted here in. Within 10 days of the vaccine the symptoms of Bulbar onset ALS started appearing. However, no one in the family knew what it was.

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.

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

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

I have felt horrible; Every bone in my body ached except my eyebrows and eyelashes; I am so weak I have no energy; I can hardly walk; 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 08Jan2021 at single dose for COVID-19 immunization. The patient medical history included autoimmune disease and "bad back", both from an unknown date and ongoing. The patient's concomitant medication included prednisone for autoimmune disease and tramadol 75 mg daily for back pain. On an unspecified date, the patient reported that: "I felt horrible, every bone in my body ached except my eyebrows and eyelashes, I am just wiped out when does this go away, I am so weak I have no energy, I can hardly walk". The patient underwent lab tests and procedures which included blood test: unknown result, on an unspecified date. The patient outcome of the events was unknown. The information on the batch number has been requested.

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

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

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

has a very stiff neck; 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 MRNA VACCINE), via an unspecified route of administration on 20Jan2021 (at the age of 82-years-old) as a single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), on an unspecified date (at an unspecified age). On an unspecified date in Jan2021, the patient had a very stiff neck. The reporter inquired if the patient can take over the counter pain medication for the very stiff neck. The clinical outcome of the very stiff neck was unknown. Information on the lot/batch number has been requested.

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,

had the worst backache; muscle soreness; muscle soreness at the injection site; The initial case was missing the following minimum criteria: no adverse effect. Upon receipt of follow-up information on 27Jan2021, this case now contains all required information to be considered valid. A contactable consumer (patient) reported that an 82-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EJ1686, expiry date not reported), via an unspecified route of administration at the right arm on 21Jan2021 at single dose for COVID-19 immunization. Medical history included autoimmune haemolytic anaemia (reported as immune system attacks red blood cells). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was vaccinated at a hospital. Concomitant medications included prednisone for red blood cells from Dec2020 and ongoing, folic acid from Dec2020, and omeprazole from 05Nov2020. The patient did not have any symptoms the day she received it except for muscle soreness at the injection site on 21Jan2021. On the night of 26Jan2021, she had the worst backache. Her son went to the store and bought Lidocaine patches for it. Clinical outcome of the event muscle soreness at the injection site was recovered on 22Jan2021 while for the worst backache was not recovered.

1/22 8:000 PM had 3 jerks quick jerks of left arm, 1/23 around 11:30 when laid down on and off little jerks from head to toe on and off. When I woke up around 8:30 could feel some. During day some little ones mostly arms or hands, once in a while legs, Monday 1/23 around 9:00 PM a hard jerk on left shoulder and at night kind of a hard one on left arm. Seemed to have seattled down to mostly subtle ones in hands or arms on and off. Legs feel kind of stiff or tight. Once in awhile felt pulsating through out, but that seems to have gone away. Mild pain feeling around shoulder blades on and mostly off. Never had before.

I had my 2nd Pfizer vaccine , Lot:EL9264 at 10:30 on Feb. 13, 2021 at MC. I was beginning to get slight pain in my back by late afternoon the same day. By bedtime, it was much worse. I woke up around 2:am to go to the bathroom. I couldn't even stand up. My husband was able to help me and get me back to bed. I had excruciating pain with every step. I couldn't bend, turn, etc. I spend all of the next 2 days in bed. Yesterday, on the 3rd day, I was able to sit in a chair for a short time. Today I am better and can get along without assistance.

There were no adverse reactions to the first dose, EL9261. In the hours immediately after the second shot, EN6200, there also were no reactions. However at approximately 1915 of the date of administration, several worrying effects presented, including; * strong headache * reaction site pain, though not redness * generalised weakness, but especially noticeable in legs * mild fever at 99.9 consistently for over 12 hours

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

Third day symptoms after first shot, extreme muscle pain , upper leg ,knee, foot, and groin! Pain level aroun 7 for two weeks ,on and off ,nights mostly. Pressure excellent the pain. Tylenol, Tramadole , no help. Dr visit on the 23 th , question of taking the second shoot.

sometimes the pain in her neck affects her ear and swallowing; sometimes the pain in her neck affects her ear and swallowing; it was shooting pain up into her skull and the top of her head; neck pain on the left side; her skin on the left side of her neck is sore to touch; This is a spontaneous report from a contactable nurse (patient). An 82-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL9269, expiration date was not reported) (at 82 years of age), via an unspecified route of administration in the left arm on 06Feb2021 15:40 at a single dose for COVID-19 immunisation. Medical history included diabetes mellitus and hypertension. There were no concomitant medications. The patient did not take any other vaccinations within four weeks prior to the first administration date of the vaccine. She had no adverse events prior vaccinations and no illness at time of vaccination. The patient received her 1st dose on Saturday (06Feb2021). On Sunday (07Feb2021), she had neck pain on the left side, which was the same as she got the vaccine, and it was shooting pain up into her skull and the top of her head. She stated that her skin on the left side of her neck was sore to touch on 07Feb2021. Sometimes it affects her ear and swallowing on 09Feb2021. She stated that he looked in her throat and it looked okay. She wanted to know if this was from the vaccine. She stated that the shooting pain was killing her today. She had been using Bengay, heat, and Tylenol which lasts about 8hrs. States that the pain woke her up last night, so she took 2 Tylenol Arthritis. Her 2nd dose of the vaccine is scheduled for 27Feb2021. Her husband kept saying it was from the shot, but she doesn't know. She asked if it was then what is she going to do with the 2nd one? The patient did not go to the emergency room nor visit a physician's office for the events. The outcome of the event neck pain was not recovered while recovering for other events. The events neck pain on the left side, skin on the left side of her neck is sore to touch, and sometimes the pain in her neck affects her ear and swallowing are reported as medically significant events.

Fever 101+ for two days, severe aches in hips and pelvis, loss of appetite, loss of energy which is continuing. Intestinal upset which is continuing.

some pain in my left shoulder; severe pain in my lower back; significant nausea; This is a spontaneous report from a contactable physician (patient). An 82-year-old female patient received second dose of bnt162b2 (BNT162B2) , via an unspecified route of administration on 10Feb2021 12:00 at single dose on right arm for covid-19 immunisation. Medical history included ongoing allergy to perfumes/scents, ongoing allergy to linseed oil, ongoing chronic osteoarthritis (six joint replacements), GERD, hypertension. Concomitant medication included duloxetine hydrochloride (CYMBALTA), enalapril, ferrous sulfate, gabapentin. The patient previously received first dose of bnt162b2 on 20Jan2021 11:00 for covid-19 immunisation and experienced no adverse event. The patient stated that, "I had no reaction, not even a sore arm, after the first shot. However, for two days (Feb2021) so far after the second shot I have severe pain in my lower back, some pain in my left shoulder, and significant nausea." No treatment received for the adverse events. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. Patient was not pregnant at the time of vaccination. The outcome of the events was not resolved. Information on Lot/Batch number has been requested.

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

Increased blood pressure; Pain breathing; felt some discomfort in her hand; This is a spontaneous report from a contactable Physician. A 82-years-old female patient received the first dose of bnt162b2 (BNT162B2) vaccine , via an unspecified route of administration on 08Feb2021 at 0.3 mL, single for Covid-19 immunisation . Medical history included ongoing cardiac disorder (she has had five bypasses ten years ago) , ongoing lung disorder, ongoing osteoporosis , she has had three operations on her spinal cord. She has a neurologic compression fracture from ages ago , seasonal allergy, nitrate compound therapy, hypertension, anticoagulant therapy, electrolyte imbalance. Concomitant medication included ranolazine (RANEXA), isosorbide (ISOSORBIDE), gliclazide (DIAZIDE [GLICLAZIDE]), apixaban (ELIQUIS), magnesium (MAGNESIUM) , ubidecarenone (Q-10 CO-ENZYME). The patient experienced increased blood pressure on 09Feb2021 with outcome of not recovered , pain breathing on 09Feb2021 with outcome of not recovered , felt some discomfort in her hand on 09Feb2021 with outcome of unknown. The patient underwent lab tests and procedures which included blood pressure measurement: increased on 09Feb2021 166/100 and pulse 65. The 100 was alarming to her. The patient would notice the increase in blood pressure and pain breathing when walking longer distances Information on the lot/ batch number has been requested.

Patient presented to ED with chest pain on her right breast radiating to the back intermittently. No associated N/V, diaphoresis, or SOB. Pt was started on a heparin drip but was later discharged home after being cleared by cardiology. Per the EUA, hospitalizations are to be reported irrespective of attribution to vaccine.

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

upon rising from a sitting position my legs would not hold me up. I could not walk without someone helping to keep me from falling. My legs around the knees and lower thigh area were having spasms just momentarily. I went to bed, slept well and next day everything was fine. No pain associated with episode.

a bad stiff neck on my left side; one of my lymph nodes were swollen; the pain on my left side of my neck; This is a spontaneous report from a contactable consumer (the patient). A non-pregnant 82-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 left arm on 30Jan2021 at 10:45 AM (at the age of 82-years) as a single dose for COVID-19 immunization. Medical history included asthma, and hypertension. The patient did not have any known allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medication taken within two weeks of vaccination was not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 03Feb2021 at 05:00 AM, the patient woke up with a bad stiff neck on her left side. When she touched her neck, she realized that one of her lymph nodes were swollen, and pain on her left side of my neck. The patient was not sure whether the pain on her left side of her neck had anything to do with this swollen node. After four days, she still had the swollen node and a lot of pain on her left side of her neck. No treatment was given. The clinical outcome of bad stiff neck on my left side, one of her lymph nodes were swollen, and pain on her left side of my neck was not recovered. It was also reported that since the vaccination, the patient had not been tested for COVID-19. Information on lot number was requested.

Fever; feeling unwell; muscle pain; chills; injection site pain; This is a spontaneous report from a contactable consumer (patient). An 82-year-old female patient (not pregnant) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number: EN5318) via an unspecified route of administration in right arm on 05Feb2021 17:15 at single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient previously took bacitracin and experienced allergies, nalidixic acid and experienced allergies. The patient experienced fever, feeling unwell, muscle pain, chills, injection site pain, all in Feb2021. No treatment received. No other vaccine in four weeks. No covid prior vaccination. No covid tested post vaccination. The outcome of the events was not recovered.

woke wet from sweat; Nausea; neuropathy was elevated to an unbearable level /neuropathy flared up; body aches; severe muscle ache; This is a spontaneous report from a Pfizer-sponsored program received from a contactable consumer (patient's daughter-in-law). An 82-year-old female patient received her first dose of bnt162b2 (BNT162B2 reported as PFIZER COVID-19 VACCINE; unknown lot number and expiration date) at 82-year-old vaccination age via an unspecified route of administration in the right arm on 11Feb2021 15:30 as a single dose for covid protection (covid-19 immunisation). Medical history included transient ischaemic attack (TIA) which she has had this happen twice, thyroid removal in 1970, stroke (last doctor screwed up her medications and could have caused a stroke), has been losing a lot of weight (prior to vaccination) and neuropathy. Concomitant medications included influenza vaccine (FLU) on an unspecified date for an unspecified indication, blood pressure medicine, and hormone medication since she had her thyroid removed in 1970. The patient did not receive vaccinations within 4 weeks prior. The reporter mentioned that the patient has experienced body aches on 12Feb2021, nausea on 13Feb2021 and she woke wet from sweat on 16Feb2021. It was mentioned that her neuropathy was elevated to an unbearable level on 12Feb2021. She didn't feel it the first day. When talking about the neuropathy, the reporter stated that it was like something stabbing her from the knees to the toes. She has to lay in bed. Her legs hurt so bad she is unable to stand and can't sit for long. She woke wet with sweat twice. The first time was on 16Feb2021 and again on 19 or 20Feb2021. She had a flu shot on an unspecified date when they came out. The events did not require emergency room or physician's office visit. The reporter mentioned that her mother in law who was due tomorrow for the second dose and wanted to cancel because their doctor advised them to wait for at least a month to receive the second dose. According to her, her mother in law was sick for almost 3 weeks after the first dose, her mother in law experienced severe muscle ache and her neuropathy flared up on an unspecified date in 2021. The outcome of the events sweaty was recovered on an unspecified date in 2021, as for the event nausea was recovered on 01Mar2021 while muscle ache was unknown. The outcome of the other events was recovering. The following information on the batch/lot number has been requested.

muscle pain; she did not feel good; tiredness; joint pain (thigh/hip/went down to her both legs)/all over body; pain in her back/pain right side of her back; injection site pain; chills; This is a spontaneous report from a contactable consumer (Patient herself) via medical information team. A 82-year-old female patient received first dose of BNT162B2 (Pfizer-BioNTech COVID-19 Vaccine, solution for injection, Lot Number: EL322/9, Expiration date: Not provided, NDC number: Not provided), via unspecified routed of administration (Anatomical location: Arm Right) on 27Jan2021 12.10 as single dose for Covid-19 immunisation. The patient medical history included on May2020 she had emergency gallbladder surgery and she had a severe low sodium level. Adds she is still taking gatorade for the sodium level (still low sodium level; doesn't even come to the bottom range) and her doctor told her not to take free water, on 9Mar2020 she had a total knee replacement, she had a hysterectomy 10 years ago She had ongoing Urinary incontinence, ongoing urinary tract infection in Jun2020 or Jul2020, patient family history includes husband passes and she is alone. The patient had no Prior Vaccinations within 4 weeks. The patient concomitant medications included vitamin d3 at 50 mcg orally once a day, oxybutynin orally 5mg twice a day, diphenhydramine hydrochloride orally 25mg once a day for allergy, cephalexin orally 250mg once a day, amitriptyline 10 mg thrice a day orally for urinary incontinence all concomitant medications are ongoing. It was reported that on 27Jan2021 2 hours later patient experienced pain in her back, injection site pain, tiredness, chills, muscle pain, and joint pain ("upper joint of both legs, 1st one leg, then 2nd leg, then both"), also stated that almost two hours to the date she felt pain 7 inches by 9 inches on the right side of her back. Eventually it went away, she also had injection site pain, tiredness; muscle pain really really bad chills; joint pain; but she had no fever; Adds she did not feel good and these effects just came one after the other. Adds she was so cold besides four sweaters and her heating blankets she was still so cold, she does get chilled a lot but this was so obvious, States she had the joint pain all over her body but especially in the joint of her thigh/hip and it went down to her legs. She is not sure when went away because she took two extra strength tylenol and it got better. Adds she lives alone because her husband passes, and she had to use a cane and it was really difficult. The outcome of the event back pain recovered on 31Jan2021, injection site pain recovered on 28Jan2021, chills recovered on 30Jan2021, Fatigue, muscle pain, Arthralgia, she did not feel good recovered on 01Feb2021.

tired; fever; general malaise; diarrhea; sweating; muscle aches; headache; 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, Solution for injection, Lot Number: EL9262; Expiration Date: May2021), intramuscularly, administered in left arm on 04Feb2021 12:15 pm as SINGLE DOSE for covid-19 immunisation. Medical history included neuroendocrine tumour of the lung and ongoing chronic obstructive pulmonary disease (Diagnosed 15 or so years ago). There were no concomitant medications. 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): N/A. Additional Vaccines Administered on Same Date of the Pfizer Suspect was None. Any AE(s) did not require a visit to Emergency Room and Physician Office. It was nothing severe. Prior Vaccinations (within 4 weeks) was None. AE(s) following prior vaccinations: n/a. The patient experienced headache (non-serious) on Feb2021, fever (pyrexia) (non-serious) on 06Feb2021, general malaise (malaise) (non-serious) on 06Feb2021, diarrhea (diarrhoea) (non-serious) on 06Feb2021, sweating (hyperhidrosis) (non-serious) on 06Feb2021, muscle aches (myalgia) (non-serious) on 06Feb2021 and tired (fatigue) (non-serious) on 08Feb2021. The caller is 82 years old. She received her first COVID-19 vaccine on 04Feb2021. She was fine 04Feb and 05Feb2021. On the 6th and 7th, she had muscle aches, fever, she was sweating and had general malaise. These symptoms felt important enough to report, she doesn't know if Pfizer is keeping track of it or what. When probed for consent to contact, the caller explains the doctor she had been seeing is no longer practicing, and she just started seeing this doctor. She doesn't know how much this new doctor is going to help. Caller adds that she also experienced diarrhea. She was a little bit better yesterday, but she feels fine today. She states she maybe a little tired today, but nothing else. She is fine. Her daughter had a question that she wanted the caller to ask. These symptoms do not mean she should not get the second shot? These are pretty normal side effects, aren't they? From what she has read they are. She is scheduled for her second vaccine on 26Feb2021. Vaccination Facility Type: there is a special area roped off just giving shots to public. The outcome of events was recovered on 08Feb2021 and for event (tired) was unknown.

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.

jerks left arm next day, next day small jerks fr head to toe at night. have lessened but still minor jerks especially arms and hands; stiffness in legs and back; This is a spontaneous report from a contactable consumer (patient). An 82-year-old female patient (not pregnant) received BNT162B2 (lot number: em9809) second dose on 10Feb2021 10:30 at single dose on left arm for COVID-19 immunisation. Medical history included sleep apnea. Concomitant medications included lisinopril, acetylsalicylic acid (BABY ASPIRIN) and paracetamol (TYLENOL). The patient had allergies to Levaquin. The patient previously took BNT162B2 (lot number: el9261) first dose on 20Jan2021 (at the age of 82-year-old) on right arm for COVID-19 immunisation. Facility type vaccine was Hospital. Jerks left arm next day, next day small jerks from head to toe at night. have lessened but still minor jerks especially arms and hands. stiffness in legs and back. AE resulted in Doctor or other healthcare professional office/clinic visit. The outcome of the events was not recovered. No treatment. No covid prior vaccination. No covid tested post vaccination.

soreness started at the injection site; moved into this joints in the elbow and shoulder area; This is an initial spontaneous report from a contactable nurse (patient). An 82-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, lot number; NDC number; Expiry Date: Unknown) via an unspecified route of administration, administered in right arm on 03Feb2021 14:15 as single dose for COVID-19 immunization (at hospital). The patient medical history was none. The concomitant medications were not reported. History of all previous immunization reported none. Patient not provided the family medical history. Patient reported that both she and her husband received their first Pfizer COVID-19 vaccine shots 8 days ago (clarified as 03Feb2021). She said her arm was sore for 3 days, and then the arm soreness was gone. She said her husband's arm has been sore for 8 days, clarifying it was 8 days ago that her husband got the COVID-19 vaccine. She said her husband has tried Advil, Tylenol, hot packs, cold packs, and nothing seems to help his pain. Reported that she and her husband both received their first COVID-19 Vaccines on the same day and time, and the COVID-19 Vaccines were administered at the same facility. Treatment declined due to the reported stated that she did not need to take anything for her COVID-19 Vaccine injection site pain, saying the vaccine injection site pain went away on its own after 3 days. On 03Feb2021 the patient reported that she experienced soreness started at the injection site, moved into this joints in the elbow and shoulder area. The reaction of duration reaction/event: 03 days. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine The term highlighted by the reporter. The reporter classified the event as Non-serious and assessed the causality between the event and the vaccines as Related. The outcome of the events was recovered on 06Feb2021. Information about lot and batch number was requested.

severe chills; muscle aches; fever; arm "a little sore"; freezing to death; she is very tired; joints bothering her; This is a spontaneous report from a contactable Consumer (Patient) via Medical information team. An 82-year-old female patient received the first dose of bnt162b2 (BNT162B2, Pfizer-BIONTECH covid-19 vaccine, Formulation: Solution for injection, Lot number: EN9581, Expiration date: May2021, NDC number was not provided) via an unspecified route of administration, in arm right on 06Feb2021 18:00 as single dose for covid-19 immunisation. Medical history included thyroid condition and covid-19 from 29Jun2020 to an unknown date. Concomitant medication were not reported. Patient got 1st dose of vaccine on 06Feb2021. After dose experienced severe chills, muscle aches on 07Feb2021, fever, arm "a little sore", "freezing to death" on Feb2021, patient says, "the same symptoms like I had covid" patient tested positive for covid 19 in Jun, antibodies present before vaccine (in Dec). Patient was calling about the Covid 19 Vaccine. She had the first shot on Saturday at 6 o clock. She then woke up at like 3 or 4 in the morning with severe chills. Patient states that she had covid back Jun2020, on 29Jun2020 she was diagnosed as positive, she took herself to the hospital. She recalls getting the test 4 days later. The back around Christmas 2019 she a lot of similarities to it. After 4 days she recalls during a weekend she got sick. She recalls going on a Monday to get her test done, it did come back positive, she served her time, and proceeded to get better. Patient confirms that her First Dose of the covid vaccine was on Saturday 06Feb2021 at 6PM. Then at 3 or 4AM on 07Feb2021 she began to notice chills. Patient has the side effect list she had all of them, on Sunday she just slept all day long, her back and head was killing her, patient states that it felt as if she had covid again, patient experienced the same symptoms as when patient had covid. Patient no longer has the severe chills, that was Sunday into Monday. Patient then clarifies that she did not mean her back and head killing her, its more muscle aches and joints bothering her, and patient had a fever, patient is not having muscles aching at the moment, it normal very minimal, she is very tired on Feb2021. Patient second dose is on 27Feb2021. Patient takes a thyroid pill but doesn't know what name of her thyroid condition is. patient blood pressure is good. Patient explains that back in Jun2020, she was Sick for 4-5 days she then took a covid test, tested by Nasal Swab and then got the results the next day. 29Jun2020 is the day of the test, on the same day she went to the hospital but got sent home in 6 hours. In Dec2020 she had a positive antibody covid test. The outcome of the event severe chills was recovered on 08Feb2021, muscle aches was recovering and unknown for other events.

4 a.m. 2/25/21, 1-degree fever lasting 4 days, swollen face 1 hour, joint pain first day, weakness 10+ days, diarrhea for 3 days starting 1 week after shot,

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

Patient developed diffuse arthralgias and myalgias associated with left arm weakness starting 2-3 weeks after but becoming unbearable at 4 weeks from 2nd dose. pain was resistant to NSAIDs.

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

On April 12th, she began to notice increasing pain around the right shoulder blade, this rated around to the front of the chest over the next few days. On April 15th, she noted a rash developing in this region. She sought evaluation / treatment in the Emergency Department on April 17th, where the vesicular rash was felt to be consistent with shingles.

vertigo; Fatigue; muscle pain; stomach cramps; Diarrhea; mucus from sinus; This is a spontaneous report from a contactable other Non- HCP. A 82-Year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number EL9261) via unspecified route of administration in left arm on 06Feb2021 (at the age of 82-Year-old) for COVID-19 immunization. Medical history included diabetes, high blood pressure, overweight. The patient was not pregnant. Concomitant medication included ezetimibe 10 mg once daily; metformin 1000 mg twice daily; acetylsalicylic acid (ASPIRIN) 81 mg once daily; chromium picolinate, cinnamomum verum bark, colecalciferol (CINSULIN ADVANCED STRENGTH) (medications in two weeks). No other vaccine in four weeks. The patient previously took first dose of BNT162B2 ((PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number EL1283) in left arm on 16Jan2021 for COVID-19 immunization. On 06Feb2021, patient experienced muscle pain, fatigue, stomach cramps and diarrhea, mucus from sinus, vertigo. No treatment was received for events. No COVID prior vaccination. Patient has not tested COVID post vaccination. The outcome of events was recovered. No follow-up attempts are possible. No further information is expected.

I had a lot of reaction from the COVID shot. I had a bad bad flare with my arthritis by being off of the Xeljanz; I have been extremely fatigued; I had a few headaches which is extremely rare for me to have a headache; Can't use left hand/Painful to sit down and straighten the leg up; Right leg and knee and joints are so swollen; A lot of pain; Hard to get up from a chair or get in and out of bed; This is a spontaneous report from Pfizer Sponsored Program. A contactable 82 year old female consumer (patient) reported for herself, took BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE Solution for injection, lot number EN6206, Expiration date were unknown), via unspecified route anatomical site of injection administration stated by the patient was Left upper arm on 18Mar2021 for COVID-19 immunization and had a co suspect as Tofacitinib Citrate( XELJANZ) as prescribed 5 mg tablets which was stopped by the patient to take BNT162B2. The patient's medical history reported was rheumatoid arthritis, Chronic kidney disease, AFibrillation and unspecified allergy. The concomitant medications included were Paracetamol(TYLENOL) was taken for pain whenever she needed. Apixaban(ELIQUIS) as 5mg twice daily, Bumetanide(BUMETANIDE) as ongoing, VITAMIN D3 as 1000 units daily, Ubidecarenone (COQ-10) 30mg once daily, Metoprolol(METOPROLOL)50mg twice daily, Prednisone(PREDNISONE) 5mg once a day, Cyanocobalamin(VITAMIN B12 CYANOCOBALAMIN) ongoing, Digoxin(DIGOXIN) 0.125mg once daily tablet ongoing. She had to take anit-histamines at this time of the year. They said she should not take Covid 19 BNT162B2 and Tofacitinib Citrate( XELJANZ) at the same time. She had been off it for two weeks and she had a lot of reaction from the COVID shot. She had a bad flare with her arthritis by being off of the XELJANZ but she was back on it for a little while. She had to delay her second dose of the vaccine because of it and that she would have to go off of it for another two weeks when she get the second dose for 8Apr2021. She was not sure if she should try as her right leg was in bad pain. stated that she had been off XELJANZ to take the COVID 19 shot. Patient was afraid to take that second shot. She had been extremely fatigued and had a few headaches which was extremely rare for her to have a headache. They did not last very long, they were more of like just pain in her head and uncomfortable for a few minutes and it went away. Her main concern was that her hands were so swollen, that it was very difficult to take care of herself. And her legs as well as it was hard to get up from a chair or get in and out of bed as it was painful. She did not know what to do as to go off of the XELJANZ for two weeks, which unfortunately both are Pfizer medications. She could not use her left hand and her right leg, knee and joints were so swollen. It was painful to sit down and straighten the leg up and she was in a lot of pain. She was supposed to stay off of this XELJANZ right after taking the first shot which she did, did not take XELJANZ until 3Apr2021 which was a full two weeks period, that was her Rheumatoid Arthritis. Outcome of the events was unknown. Additional information has been requested.

Severe nausea; weight loss; stomach pain; bladder infection; This is a spontaneous report from a contactable Nurse (patient). An 82-year-old female patient not pregnant received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Left on 25Mar2021 13:30 (Lot Number: EN6208) as single dose (at the age of 82-years-old) for covid-19 immunisation. Medical history included tachycardia, hypothyroidism and Covid prior vaccination (date unknown). Concomitant medications in two weeks prior to the vaccination included metoprolol succinate (TOPROL), levothyroxine sodium (LEVOXYL). The patient previously took sulfamethoxazole, trimethoprim (BACTRIUM DS) and experienced drug hypersensitivity. Patient did not receive other vaccine in four weeks prior to the COVID vaccine. On 30Mar2021 patient experienced severe nausea, weight loss, stomach pain and bladder infection. Patient had three visits to primary care doctor (dr), one clinic visit for intravenous (iv) fluids, emergency room (ER) Visit and hospital admission. Patient was admitted for three days in response to the events (dates were not provided). 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 underwent laboratory tests and procedures which included sars-cov-2 test (Nasal Swab) negative on 14Apr2021 and sars-cov-2 test (Nasal Swab) negative on 16Apr2021. Patient had not recovered from the events, at the time of the report.; Sender's Comments: Based on the available information it is unlikely that BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) contributed to events occurrence. The reported events more likely represent intercurrent medical conditions unrelated to Covid-19 vaccination. 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 a week after taking 1st dose of covid vax her left knee became stiff and painful with swelling. She has been applying ice and taking Tylenol which seems to help but has had these symptoms going on 3 weeks. She recently had her 2nd dose on 4/21/21 with no reactions but continues to have swelling and pain in her left knee.

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

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.

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,

Left knee started to swell and reports that it is painful; Left knee started to swell and reports that it is painful; It is is stiff; This is a spontaneous report from a contactable consumer (patient). A 82-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, lot number and expiry date unknown), via an unspecified route of administration on an unspecified date (at the age 82-year-old) as a single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient states that about a week and a half to two weeks after, her left knee started to swell and reports that it is painful. She states that it is not an "excruciating" pain but does report that it is really bothering her and that it is stiff. She is concerned that this may be an autoimmune response to the vaccine. She also mentions that she received her second dose of the vaccine the day before yesterday. The patient states that when she took Tylenol and placed ice on it, the swelling seemed to go down a little bit and does not know if she should continue with icing it and resting it, or if she should see her doctor. Outcome of the event was not reported. No follow-up attempts are needed. Information about lot/batch number cannot be obtained.

Patient started to experience left arm pain hours after the vaccination on 05/04/2021, and the pain gradually moved to the patient's left chest wall, anterior chest and right chest wall, patient was having shallow breathing limited by pleuritic pain, presented to the ED on 5/10/2021 and was diagnosed with acute bilateral nonobstructive pulmonary emboli based on CT angiogram chest.

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.

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

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

headache; muscle pain; chills; Joint pain; injection site redness swelling & pain; injection site redness swelling & pain; injection site redness swelling & pain; This is a spontaneous report from a contactable consumer or other non-HCP (patient). This 82-yerar-old non-pregnant female received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; lot number: EN6198; expiration date: unknown), via an unspecified route of administration in right arm on 24Feb2021 09:00am, as a unknown single dose for COVID-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient's medical history included hypertension, arthritis and patient had known allergy's adverse reaction to compazine. The patient's concomitant medications were metoprolol, spironolactone, HCTZ, Azelastine nasal. On 24Feb2021, the patient experienced headache, muscle pain, chills, joint pain, injection site redness, swelling & Pain. No treatment was received in response to the adverse events. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, patient was not tested for COVID-19. The outcome of events was recovered on an unspecified date of 2021. No follow-up attempts are possible. No further information is expected.

pain in her lower back that is "a lot stronger" than what it normally is/She said that the pain in her lower back is a little stronger than it normally is; She gets pain all the time.; muscle pain; This is a spontaneous report from a contactable consumer (patient). An 82-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 30Apr2021 (Batch/Lot number was not reported) as single dose for COVID-19 immunisation. Medical history included osteoporosis, sciatica, pain in extremity, back pain. The patient's concomitant medications were not reported. The patient experienced pain in her lower back that is "a lot stronger" than what it normally is/she said that the pain in her lower back is a little stronger than it normally is (non-serious) in May2021 with outcome of not recovered, she gets pain all the time (non-serious) in 2021 with outcome of unknown and muscle pain (non-serious) in 2021 with outcome of unknown. The patient stated that she normally suffers from osteoporosis and sciatica where the pain goes to her legs. However, since receiving her first dose, she has been experiencing pain in her lower back that is "a lot stronger" than what it normally is (she specified that she noticed the back pain getting worse around 5 days after the vaccine). Caller mentions that she has taken injections for the pain in the past and now feels that she is going to have to go back to get them again. Caller states she read that muscle pain and joint pain can occur with the vaccine but she is not sure if that is what is happening to her and would like to know if this is a side effect of the vaccine. She stated also that it can cause joint pain and muscle pain and said that this was muscle pain. She states that she is unsure about getting her second dose of the vaccine because of her side effects. Caller mentions that she has taken the flu vaccine for years and never had any side effects. The patient had not recovered from the back pain aggravated; the outcome of the other events was unknown. No follow-up attempts are needed; information about lot/batch number cannot be obtained.

fever of 101; joint pain; diarrhea; This is a spontaneous report from a contactable consumer. An 82-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EN5318), via intramuscular route of administration on 26Jan2021 at 10:00 (at the age of 82-year-old) as first dose, single in left arm (shoulder) for COVID-19 immunization. The patient's medical history included breast cancer. Concomitant medications were not reported. Patient was healthy before vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 28Jan2021 at night, on the day of vaccination, the patient had diarrhea. On Wednesday she felt fine. On 28Jan2021 Thursday, the patient experienced joint pain, on only her thigh in the left leg and noticed fever which was at 100.1 on 31Jan2021, Sunday morning. Patient took aspirin and it went down. On 01Feb2021, her temperature was normal and was 97.5 degrees Fahrenheit. The patient underwent lab tests and procedures which included body temperature: 100.1 Fahrenheit on 31Jan2021, body temperature: 97.5 Fahrenheit on 01Feb2021, which was normal. The clinical outcome of the event joint pain was recovering and outcome of all other events was recovered. Follow-up attempts are completed. No further information is expected.

Shortness of breath.; pain in left shoulder/arm/breast; pain in left shoulder/arm/breast; pain in left shoulder/arm/breast; This is a spontaneous report from a contactable consumer (patient). This 82-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in arm left on 25Feb2021 14:30 (Lot Number: EN6200) as single dose (at 82 years old) for COVID-19 immunisation. Medical history included complex regional pain syndrome, scoliosis, primary biliary cholangitis, hypersensitivity. On 26Feb2021 00:30, the patient experienced shortness of breath, pain in left shoulder/arm/breast with outcome of not recovered. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient had not been tested for COVID-19. No follow-up attempts are possible. No further information is expected.

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

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.

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.

Day 2, pain left arm. Could not lift coffee cup. Lower back pain off & on. Gone on Day 4, but now am nauseous and light headed and back pain is back but higher up.; Day 2, pain left arm. Could not lift coffee cup. Lower back pain off & on. Gone on Day 4, but now am nauseous and light headed and back pain is back but higher up.; Day 2, pain left arm. Could not lift coffee cup. Lower back pain off & on. Gone on Day 4, but now am nauseous and light headed and back pain is back but higher up.; Day 2, pain left arm. Could not lift coffee cup. Lower back pain off & on. Gone on Day 4, but now am nauseous and light headed and back pain is back but higher up.; This is a spontaneous report from a contactable consumer (patient). An 82-year-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number: EL9262) via an unspecified route of administration, administered in left arm on 29Jan2021 at 12:00 (at the age of 82-year-old) as 1st single dose for COVID-19 immunisation. Patient medical history included high blood pressure (HI BP), osteoporosis, blood cholesterol increased, all from an unknown date and unknown if ongoing. Patient had no known allergies. The patient concomitant medications taken in two weeks of COVID-19 vaccination included pravastatin (PRAVASTATIN), hydralazine (HYDRALAZINE), hydrochlorothiazide (HYDROCHLOROTHIAZIDE), all taken for an unspecified indication. 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. It was reported that on Day 2, 30Jan2021 at 05:00, the patient had pain in left arm, could not lift coffee cup, lower back pain was off and on. Event gone on Day 4, but 'now' patient was nauseous and lightheaded and back pain was back but higher up. Patient received no treatment for the events. The patient had not been tested for COVID-19 since the vaccination. The outcome of the events was reported as resolving and outcome of the event pain left arm was resolved on 01Feb2021. Follow-up attempts are completed. No further information is expected.

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.

Patient came to emergency department with complaints of midsternal chest pain radiating to the back that started on 6/13/21. Patient discussed pain as severe sharp chest pain that worsens with taking a deep breathe, movement, and coughing, Patient was diagnosed with pericarditis. Patient was admitted to the hospital for observation, monitoring, and evaluation. Patient was given Toradol 15mg IV and monitor chest pain.

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

Chills; fever; severe fatigue; headache; nausea; joint pain; trouble breathing; One week very sick; Was bed ridden since 01Mar2021; This is a spontaneous report from a contactable consumer (Patient). A 83-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Lot number: E L3302) via an unspecified route of administration in left arm on 01Mar2021 at 00:00 (age at vaccination 83-year-old) at single dose for COVID-19 immunization. Medical history included chronic obstructive pulmonary disease, heart disease, cancer survivor, fibromyalgia and high blood pressure. Patient had known allergies. The patients concomitant medications were not reported. Patient did not receive any other vaccines within 4 weeks prior to covid vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 01Mar2021, at 00:00 patient experienced chills, fever, severe fatigue, headache, nausea, joint pain and trouble breathing. Patient was bedridden since 01Mar2021 the day of the shot and was very sick for one week. Therapeutic measures were taken as a result of chills, fever, severe fatigue, headache, nausea, joint pain, trouble breathing, one week very sick, was bed ridden since 01Mar2021. The outcome of event was recovering at the time of reporting. No follow-up attempts are possible. No further information is 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

My left hip was very sore and it got worse; My left hip was very sore and it got worse; The pain was so bad I couldn't move and I also had a lot of pain in my right shoulder; The pain was so bad I couldn't move and I also had a lot of pain in my right shoulder; I think it exacerbated, it kicks in my immune system; Pfizer shot affected my immune system and started this but this is my guess; This is a spontaneous report from a contactable consumer (patient). An 82-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: Solution for injection, Batch/Lot Number: EM9809), via an unspecified route of administration on 26Feb2021 as 2nd dose, single for COVID-19 immunization (age at the time of vaccination was 82-year-old). The patient's medical history included blood pressure and arthritis. Concomitant medications included hydrochlorothiazide (HYDROCHLOROTHIAZIDE) taken at 12.5 mg for blood pressure. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: Solution for injection, Batch/Lot Number: EL9264), via an unspecified route of administration on an unspecified date as 1st dose, single for COVID-19 immunization vaccination. On an unspecified date in 2021, the patient stated after the second shot I got some side effects and a few days after it began, and it was my left hip was very sore and it got worse. The patient made an appointment with the orthopaedist but before she could get to see him, she had to go to the Hospital in the ambulance because the pain was so bad she could not move and she also had a lot of pain in my right shoulder which went on a couple of weeks, just beginning to light up a little bit that day. So, she thought it was a side effect because I thought it was exacerbated, it kicked in my immune system so that was what I was thinking it was and I just reported it. The patient stated regarding outcome as yes but it has alleviated quite a bit I mean it was very bad , quite a lot actually today anyways it's pretty good and I have been on Prednisone (treatment), I am in the middle of taking that. I started taking it (Prednisone) 10 days ago. I have another week to go on it's a reduce dose you know you take 2 a day to 5 days, when you take you take two twice a day for five days then you take one twice a day for five days and you take one a day for five days." When probed if consumer is taking any medication other than Prednisone, consumer stated, "Not for the pain, I mean I do have other medications beside Prednisone. I am taking Hydrochlorothiazide (Clarified as concomitant medication) and nothing else. "Regarding start date of event the patient stated, "I can only give you an approximation it was about maybe four or five days later approximately. I started felling sore on my hip and then it gone worse. From 02Mar would be a good guess. She was guessing that the Pfizer shot affected her immune system and started but this is my guess, I am not a doctor. Treatment medication included Prednisone for all the events expect I thought it exacerbated, it kicked in my immune system. Outcome of all the events was reported as recovering and unknown for the event I thought it exacerbated, it kicked in my immune system. No follow up attempts are possible. No further information is 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.

Systemic: SWELLING OF THE HAND-Severe, Additional Details: PT DIAGNOSED WITH RHEUMATOID ARTHRITIS FOLLOWING VACCINE

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

atrial fibrillation; Headaches everyday, after first vaccine; Rapid heartbeat for a week and a half, after first vaccine; Very weak legs, after first vaccine; Extremely tired, after first vaccine; This is a spontaneous report from a contactable consumer (patient). An 82-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), 1st dose via an unspecified route of administration on 24Jun2021 (Batch/Lot number was not reported, expiration date not provided) at age of 82 years old as a single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced atrial fibrillation, headaches everyday, after first vaccine, rapid heartbeat for a week and a half, after first vaccine, very weak legs, after first vaccine, extremely tired, after first vaccine, all on an unspecified date. Clinical course: Caller stated a few days later, she had some reactions to her first shot. Caller reported that she had headaches everyday, a rapid heart beat for a week and a half, very weak legs, and she was extremely tired. Caller states her Cardiologist knows about her health concerns, and she did go into atrial fibrillation, but he didn't give her any specific answers. Caller did not specify when she went into atrial fibrillation. The outcome of the events was unknown. Information on the lot/batch number has been requested.

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.

Vaccine administered to pt at 1805. Pt observed for 30 minutes due to history of allergies. AT 1835 pt reported feeling "cold, nauseous" and reported feeling "every side effect on the handout." Staff provided juice and graham cracker and assessed vitals. Vitals within patient's baseline. Pt then reported "back pain" and described ita s "squeezing" Staff performed 12 lead EKG. EKG results within patient's baseline. Pt kept for another 10 mins and observed. Staff advised pt to contact doctor and go to ER if symptoms persist. Pt reported feeling better and comfortable with going home. Pt went home after a total of 45 minutes of observation with daughter.

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

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.

Extreme pain in right knee joint which has had a total knee replacement which was done almost 2 years ago. The pain subsided after about 2 days. I always have some discomfort of this knee, but the pain I experienced after the vaccine was much different.

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.

My mom received the Covid 19 vaccine on Jan 5, 2021 and became very about a week later. I was informed that she tested positive for Covid 19 on January 14th. One January 17th she became very tired and weak and would not eat. Hospice called me and told me that she was in a decline state. I saw her on January 25 and 26 and she was just sleeping and could not open her eyes. Her vitals were good and she seemed to understand when I talked to her - she would squeeze my hand and moan but she could not talk or open her eyes. My mom passed away on January 27, 2021 just 22 days after receiving the Covid 19 vaccine. She was very think to begin with and being to weak and tired to eat resulted in her losing even more weight. Some of the other residents were given fluids to help and they recovered. My mom was not given fluids. I believe there were 20 deaths in her care home for the month of January when they vaccinated. This was an alarming number of deaths for the home. The facility had very few Covid deaths in 2019 and 2020. I asked every week if they had any Covid and or Covid deaths and this amount was shocking to me and the workers there.

developed a back ache; pain under her arm; armpit pain; a rash from her elbow up; This is a spontaneous report from a contactable consumer (patient) via Pfizer sponsored program. An 83-year-old female consumer received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 13Jan2021 at 12:30-13:00 at single dose in left arm for COVID-19 immunisation (over the age, senior citizen). Lot number was EL8982. Medical history included diagnosed allergies, Compromised immune status, respiratory illness, genetic / chromosomal abnormalities, endocrine abnormalities (including diabetes) and obesity), high blood pressure, cholesterol. Concomitant medications included medicines for high blood pressure and cholesterol. Patient reported that she took suspect vaccine and for 4 days she felt fine but then in Jan2021 she developed a backache (just below the shoulder; it was really bad and very uncomfortable, on 17Jan or 18Jan, as reported), pain under arm, ache under arm pit (reportedly as worsening) and a rash from her elbow up. Patient thought after a couple days pain would be gone; it was just as bad as when it started. The patient received TYLENOL in Jan2021 and ongoing for pain, but it did not work. The patient did not visit emergency room or physician due to the events. The outcome of rash was unknown, the patient did not recover from other events.

Grossly swollen legs and feet and ankles BP RISING TO 202/ 86 . i NEVER HAD THAT LEVEL OF HIGH BP BEFORE and it still is persisting up until today. highest BP for years was usually in the 130 range or rising a few times into the 150's when greatly stressed

Very sick feeling, muscle aches, chills, sleepy, tired, arm pain for 28 hours after vaccine. In bed all day.

RECEIVED PFIZER COVID VACCINE ON 02/04/2021 REPORTED TO ED ON 02/13/2021 WITH NECK/BACK PAIN, DIFFICULTY SWALLOWING, SORE THROAT, SOA, WEAKNESS/TINGLING IN BLE. ADMITTED ON 02/13/21 FOR DIAGNOSIS OF WEAKNESS, HYPOKALEMIA, CARDIAC ENZYMES ELEVATED, CHF, AND LEUKOCYTOSIS.

Days 3, 4, 5, 6: Inability to move head in any direction (up/down or L/R) without SEVERE pain. Neck unable to support head unless directly above shoulders. Leaning forward slightly to sit or stand up caused unbearable pain. Unable to lift head from pillow to roll over. Could only swallow food, if neck muscles held tightly with hand to prevent movement. Severe pain caused Vasovagal syndrome fainting. Asymptomatic fever 99.7-100.5 for Days 3, 4, 5. No chills, weakness or aching. Day 7: In A.M., slightly increased head movement possible for first time without pain. By P.M. even better, but still only very limited movement of a few inches possible. Improved daily thereafter. Day 15 (today): Mild stiff neck persists.

Injection pain, tired, chills, joint pain, nausea, and didn't feel well. I had diarrhea. I had COVID in November and the symptoms were pretty much the same. Feeling much better today.

Shooting-sharp pains above the L elbow lateral/posterior ; lasts a few minutes then subsides. Not aggregated with movement nor relief with repostioning. Occurs randomly several times through the day.

Weak mussels, particularly legs. Fell down, even using a walker. X-ray of possible broken collarbone showed only a bruise. This was done at hospital emergency room. Also very tired and slept most of day. Was getting up for supper when fall occurred.

Sharp pain behind right knee. Subsided by evening. Went to The ER Sunday morning, Feb. 21. They x-rayed leg and found nothing unusual for a woman my age. Then they conducted a scan and discovered a blood clot behind my knee. Since then, I have had intermittent pain. The Doctor referred me to a hematologist which I will see this week. Prior to the vaccination have never had a blood clot. It occurred three days after the vaccination. Coincidence? I think not.

I have a muscle disease, Polymyalgia Rheumatica ; side effects : extreme muscle pain when standing , and walking experienced with both doses of vaccine (2/3/21 and 2/24/21) (usual prednisone 8mg does not help the pain) went to urologist Mon Feb 8 for burning, urinary tract, no infection; (nurse practitioner said was side effect of another patient. ) this burning I experienced with the first dose of vaccine (2/3/21); burning lasted two weeks Muscle pain experienced with both doses of vaccine took AZC pills for urinary tract burning.

Patient received the injection approximately 1:27PM on Friday, February 26, 2021. She felt fine until about 8PM Friday, Feb 26. At that time, she had feeling of malaise but did not check for fever. She went to bed and fell asleep. Upon arising on Saturday, February 27, 2021, she felt feverish and had a backache. Her fever was first checked about 11:30AM by her son and it was 101 degrees. During the afternoon, about 3PM, she ran a higher fever (102 degrees). The family consulted her primary care physician, who advised hydration and a Tylenol. After talking with the physician, about 4pm, the family gave her a 500 mg Tylenol, which brought the fever down to just under 100 degrees by 8pm Saturday night. She also had aching legs at that time. but no longer had a backache. She slept Saturday night and awakened on Sunday, Feb 28, with a fever of 99 degrees. Around Noon another Tylenol 500 mg tablet was administered. During Sunday afternoon, the fever dropped to around 98.2 (Patient has a normal temperature of 97.3 or 97.4, well documented). On Monday, March 1, 2021, at 11:00am, her temperature was normal, 97.4. She said she still felt tired and her legs "don't feel quite right". However, our family feels she is doing much better and she has enough energy to do some of her normal activities and participate in conversation.

Patient describes body aches in arms after vaccine. The pain is the same as her previously diagnosed polymyalgia rheumatica which had been in remission for 2 years

diarrhea; injection site pain; tiredness; headache; muscle pain; chills with elevated temp; chills with elevated temp; joint pain; injection site swelling and redness; injection site swelling and redness; nausea; feeling unwell; 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, solution for injection, lot number: EL9265), via an unspecified route of administration at the left arm on 28Jan2021 at 08:00 AM (at age of 83 years old) at a single dose for COVID-19 immunisation. The patient was not pregnant at the time of vaccination. The facility where the most recent COVID-19 vaccine was administered was reported as "Other". The patient's medical history included stage 3 kidney, prediabetes, and allergies to sulfa. The patient was not diagnosed with COVID-19 prior to vaccination. The patient received unspecified concomitant medications (patient received other medications within 2 weeks of vaccination). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously took hypromellose (GENTEAL; reported as "gen-teal") and experienced allergy. On 29Jan2021 at 02:00 AM, the patient experienced diarrhea, injection site pain, tiredness, headache, muscle pain, chills with elevated temp, joint pain, injection site swelling and redness, nausea, and feeling unwell. The patient did not receive treatment for the events. The patient has not been tested for COVID-19 since the vaccination. The events were reported as non-serious. The outcome of the events was recovering.

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

headache; tiredness; muscle pain; fever; nausea; feeling unwell; Injection site pain; This is a spontaneous report from a contactable consumer. An 83-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; Batch/lot number: EL9262;) via an unspecified route of administration on 26Jan2021 at single dose for covid-19 immunisation. Medical history included parkinson's disease ongoing. Concomitant medication included carbidopa monohydrate, levodopa (CARBIDOPA + LEVODOPA) for Parkinsons disease, clonazepam. The patient previously received first single dose of bnt162b2 for Covid-19 immunization (she had no side effects after the first dose of the vaccine). Patient had Parkinsons disease received the second dose of the Pfizer COVID-19 vaccine yesterday, 26Jan2021, and today she was experiencing most of the symptoms listed including: injection site pain in Jan2021, on 26Jan2021, had tiredness, headache (Had a headache, headache for the most part gone but still lingering), muscles pain, fever, nausea and feeling unwell. The caller states that she had no side effects after the first dose of the vaccine. The caller wants to know how long her symptoms are going to last. The outcome of the event Injection site pain was unknown, rest of the events was not recovered.

Soreness in joints and pain in arm from shoulder to elbow. Soreness is going into upper portion of back and neck on right side. Very hard to lift arm.

Ground Glass Opaque lung problem; Weak; nausea; diff.breathing; pain on rt.side waist around to back,down to lower belly; slight temp almost 100; pain on rt.side waist around to back,down to lower belly; pain on rt.side waist around to back,down to lower belly; This is a spontaneous report from a contactable consumer. A 83-year-old female patient received first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EL3247), via an unspecified route of administration, administered in Left Arm on 22Jan2021 10:45 am as SINGLE DOSE for covid-19 immunisation. Medical history included overweight, sleep apnoea syndrome and ongoing shortness of breath. Concomitant medication included levothyroxine strength 125 mcg; triamterene; colecalciferol (VIT.D3) and thiamine (VITAMIN B1). The patient previously took tylenol and experienced drug intolerance (Known allergies: Cannot tolerate anything but Tylenol). No other vaccine in four weeks. Facility type vaccine was Workplace clinic. The patient experienced weak (asthenia) on 23Jan2021 15:00, nausea on 23Jan2021 15:00, diff. breathing (dyspnoea) on 23Jan2021 15:00, pain on rt.side waist around to back, down to lower belly (pain) on an unspecified date in 2021, ground glass opaque lung problem (lung opacity) on an unspecified date, slight temp almost 100 (body temperature increased) on an unspecified date in 2021 and pain on rt.side waist around to back, down to lower belly both on an unspecified date in 2021. AE resulted in [Emergency room/department or urgent care]. Treatment was received for these events (Levofloxacin 500mg). It was reported that Weak, nausea, diff. breathing, urgent care on Fri. 05Feb2021, with pain on rt. side waist around to back, down to lower belly. Contrast Cat Scan showed no signs where pain was, but found Ground Glass Opaque lung problem. Is it safe to take #2 vaccine I'm on oxygen now, slight temp almost 100, usually 97. There was no covid prior vaccination. Patient has covid tested post vaccination as SARS-COV-2 test: negative (Nasopharyngeal) on 05Feb2021. The outcome of events was not recovered.

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

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

polymyalgia rheumatica; RS3PE including elevated ESR and CRP; RS3PE including elevated ESR and CRP; RS3PE including elevated ESR and CRP; This is a spontaneous report from a contactable physician. An 83-year-old female no pregnant patient received first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration at single dose for COVID-19 immunisation. No pregnant at time of vaccination. Medical history included Hypothyroidism, known allergies: Morphine. No covid prior vaccination. Concomitant medications included Levothyroxine. No other vaccine in four weeks. In Feb2021, since receiving vaccination, patient developed symptoms consistent with polymyalgia rheumatica and RS3PE including elevated ESR and CRP. Responded to prednisone. Patient insists no symptoms until she received first dose. AE resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Hospitalization for 2 days. Lab data included Nasal Swab in Mar2021: Negative. Medrol/prednisone were received. Outcome of the event was recovering. Information about lot/batch number has been requested.; Sender's Comments: A possible contributory effect of suspect BNT162B2 on reported events cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.

Developed symptoms consistent with polymyalgia rheumatica and RS3PE including elevated ESR and CRP that have significantly worsened after 2nd dose of vaccine; Developed symptoms consistent with polymyalgia rheumatica and RS3PE including elevated ESR and CRP that have significantly worsened after 2nd dose of vaccine; Developed symptoms consistent with polymyalgia rheumatica and RS3PE including elevated ESR and CRP that have significantly worsened after 2nd dose of vaccine; Developed symptoms consistent with polymyalgia rheumatica and RS3PE including elevated ESR and CRP that have significantly worsened after 2nd dose of vaccine; Developed symptoms consistent with polymyalgia rheumatica and RS3PE including elevated ESR and CRP that have significantly worsened after 2nd dose of vaccine; This is a spontaneous report from a contactable physician. An 83-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot umber ad expiration date were not reported) as a single dose, with route of administration and therapy date unspecified, for COVID-19 immunization. Medical history included hypothyroidism. Concomitant medications included levothyroxine. The patient previously took morphine, and had allergies; and the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number and expiration date were not reported) on an unspecified date for COVID-19 immunization, and had polymyalgia rheumatica, RS3PE, elevated ESR and elevated CRP. On an unspecified date in 2021, after the second dose of vaccination, the patient's developed symptoms consistent with polymyalgia rheumatica and RS3PE including elevated ESR and CRP have significantly worsened. The reported events have resulted into doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. The patient was hospitalized on an unspecified date in 2021 for two days due to the reported events. The patient had received methylprednisolone (MEDROL) and prednisone as treatment for the reported events. The outcome of the events, 'developed symptoms consistent with polymyalgia rheumatica and RS3PE including elevated ESR and CRP have significantly worsened', was recovering. The patient was not diagnosed with COVID-19 prior to vaccination; and had a nasal swab test in Mar2021 that was negative post-vaccination. Information about lot/batch number has been requested.; Sender's Comments: Considering the plausible temporal association, a causal association between the reported 'polymyalgia rheumatica and RS3PE including elevated ESR and CRP ' (aggravated, already reported after the first dose of vaccine) and BNT162B2 cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.

3/30/21 AM = (Patient's notes) "Chest/breast PAIN throughout night and (previous) day. Pain continuously in back last two (2) days. Nauseated, weak bladder every hour or so. No appetite. 1st Covid shot 3-27.

pain in rt shoulder, unable to lift arm above head without pain..tried moist wrap; Tylenol, but not much relief. the symptoms are more severe in the early A>M>, but is much less in the midafternoon;

This was my second shot. With the first I had sore arm for 2 days and joint point at left hip. A few days prior to second shot i developed irritation on 2 days of left foot. Following second shot, I had sore arm for a day and a half, joint pain at left hip that extended all the way down my leg which caused difficulty walking. That pain lasted for 2 full days. The toe irritation developed into painful blisters and extended to 3 toes on my left foot. I am currently using Hydro cortisone cream on them.

Pain in right knee started several days after receiving second shot. Knee had a total replacement several years ago.

After several days of pain in left shoulder, on the morning of 4/11/21 a harsh rash was noted on the back next to the shoulder blade as well as a similar bright red rash on the thorax front. A visit to a Now Care facility on that Sunday morning confirmed a diagnosis of shingles, and Valacyclovir was prescribed, 1 gm. tablet every 8 hours for 7 days. In the following 4 days, as the medication was taken, the rash gradually spread around the side of the thorax from front to back and under the left arm. The pain remains as of 4/22/21.

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

Severe Sore Throat; Stiff neck; Shortness of breath; Back ache; every bone and every part of her body hurt; every bone and every part of her body hurt; pain under her ribs; weak and shaky; weak and shaky; biceps ached; Fatigue; tremendous headache; This is a spontaneous report from a contactable consumer (patient). An 83-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), first dose via an unspecified route of administration on 28Mar2021 14:00 (Batch/Lot number was not reported: did not get a card that lists NDC, Lot, Expiration) as SINGLE DOSE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient had no history of all previous immunization with the Pfizer vaccine considered as suspect. It was also reported that no additional vaccines were administered on the same date. The patient did not require visit to Emergency Room and stated that she was desperate and would've gone but she didn't have a ride and added she is worried about the second. Also, the patient did not required visit to the physician's office. No prior vaccinations (within 4 weeks). No family medical history. The patient reported that she received the first dose of the vaccine and 5 days later she got a terrible reaction. She did not expect it. She had a terrible reaction and thought she was going to die. She stated she wanted to report this because the TV says you should expect some kind of reaction after the second dose but does not say after the first and she said that Pfizer needs to know about this reaction. She stated she heard the second dose is worse. The patient asked if she has to get her second dose and if she needs to report this anywhere else? The patient added "what should I do about side effects?" It was reported that the patient (reported as is almost 84) had the first shot on Sunday 28MAR2021 and everything was fine by Friday she was in terrible trouble really really bad. States she has never heard of this, they say the first is easy and everything was terrible. States every bone and every part of her body hurt on 02Apr2021. She states after 24 hours (03Apr2021) it did go away. The patient asks does this happen to other people? It was stated that her symptoms came on suddenly and she had a severe sore throat, stiff neck, back ache, pain under her ribs, very very weak and shaky, shortness of breath, biceps ached, fatigue, and a tremendous headache. It was stated that started on Friday 02Apr2021 12:00 like a hurricane and after 24 hours they subsided on Saturday 03Apr2021. The patient added that she doesn't remember getting a card and didn't know that she should have a card until she saw something about it on TV, and thought well she didn't get a card. The patient also asked what does she do about that? The patient states she takes medication but not that affects this. The outcome of the events recovered on 03Apr2021. Additional information has been requested

muscle pains and soreness that started with her left arm and kind of settled on her left shoulder blade.; muscle pains and soreness that started with her left arm and kind of settled on her left shoulder blade.; muscle pains and soreness that started with her left arm and kind of settled on her left shoulder blade.; This is a spontaneous report from a contactable consumer(patient). An 83-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number Unknown), first dose via an unspecified route of administration, administered in left arm on 31Mar2021 as single dose for covid-19 immunization. Patient was 83 years old at the time of vaccination. Patient's medical history and concomitant medications were not reported. On an unspecified date reporter mentioned that muscle pains and soreness that started with her left arm and kind of settled on her left shoulder blade. She puts rubbing alcohol, a Salonpas patch, and extra stregnth Tylenol for it. She is not associating it with the vaccine, but would like to know if she can receive her 2nd dose on her right arm. She is scheduled for it on Wednesday, 21Apr2021. Therapeutic measures were taken as a result of events. Outcome of the events was unknown. No follow-up attempts are needed; information about lot/batch number cannot be obtained.

Nauseated and threw up and then later in the day the same thing happen to me. I nauseated and threw up; Nauseated and threw up and then later in the day the same thing happen to me. I nauseated and threw up; Tired; Muscle pain in my left thigh; This is a spontaneous report from a contactable consumer (the patient). A 83-years-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number- EN5318 and expiration date was not reported), via an unspecified route of administration, administered in right arm on 30Jan2021 (age at the vaccination 83-years-old) as single dose for covid-19 immunization. Medical history included rheumatoid arthritis. Concomitant medications include hydroxychloroquine, methotrexate. The patient received first shot on the 30Jan, and I was okay until 01Feb, and I woke, and I got nauseated and threw up and then later in the day the same thing happened to me. I nauseated and threw up and I had muscle pain in my left thigh. The next day, I was just extremely tired, and I didn't do any more throwing up because I do have Rheumatoid Arthritis and I was already compromised, I wonder should I take the 2nd shot which I due to have on 22Feb. Patient just took Tylenol for the pain in my leg and nothing else, I didn't want to start up again by taking something. Outcome of the events was unknown. Follow-up attempts are completed. No further information is expected.

Fever; lack of appetite/ lost her appetite, she is having a hard time eating and very rarely felt like eating anything; weight loss/ lost 8 pounds; Headaches; This is a spontaneous report from a contactable consumer or other non-healthcare professional. A 83-years-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Batch/Lot Number: EL9269) via an unspecified route of administration in right arm on 11Feb2021 at 17:00-18:00 and received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Batch/Lot Number: EN6198) via an unspecified route of administration on 03Mar2021 at 12:00, both as single dose for COVID-19 immunization. The patient's medical history included flu vaccination for years and pneumonia vaccine. Concomitant medication(s) included Vitamin D 2000. On 25Feb2021, patient had headaches starting 2.5 weeks after her first shot. On 15Mar2021, patient experienced weight loss/ lost 8 pounds, patient also stated she was between 129-130 pounds when this started. On 15Mar2021, patient experienced lack of appetite/ lost her appetite, she was having a hard time eating and very rarely felt like eating anything. Patient also stated that she used to enjoy breakfast and lunch but then she was forcing them down, sometimes she could eat dinner. On an unspecified date, patient experienced fever. Patient mentioned that one night she felt like mashed potatoes and so her husband made her mashed potatoes and she ate a lot of them. Also mentioned that she forced herself to eat because she knows she had to. Patient was not losing anymore weight but she was not putting any back on like she thought she should be either. In the evening, she tried to eat pasta or potatoes. Patient mentioned that she had been to the doctor on 10Mar2021 and he gave her a B12 shot for her lack of appetite and said if she doesn't improve, to come back; she had been to the doctor twice. Patient stated that she lived on Tylenol and started taking it every 7-8 hours then down to every 4 hours because she needed relief. Her temperature would go from 97.1 to 99. Patient reported that no fever now and the highest it got was 99.8 and as soon as she took Tylenol, her temperature would go down. Patient wanted to know if anyone else has had this reaction. Outcome of the fever was recovered on an unspecified date, headache was recovered on 14Mar2021 while the events; lost her appetite and weight loss was not recovered. No follow-up attempts are needed. No further information is expected.

may be blood clot; Something happened with my knee and it has just got worse; I was thinking maybe it is a pulled muscle or something but it is very bad now; This is a spontaneous report received from a contactable consumer (patient). An 83-year-old female patient (5 feet 1 inches, about 120 pounds) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EN6198, patient was not sure) via an unspecified route of administration at left arm on 22Feb2021 (83-year-old at time of vaccination), at single dose; the second dose of BNT162B2 (lot number: unknown) via an unspecified route of administration on 15Mar2021 (83-year-old at time of vaccination), at single dose, for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Patient stated she has got both the shots of Pfizer (Covid-19 vaccine) and at the end of the first one or it is like eighteen days, just before the second shot, something happened with her knee and it has just got worse (from 12Mar2021). She did not connect that with the Pfizer shot and I was thinking maybe it is a pulled muscle or something but it is very bad now. She would like to know what she can do. Also, she is thinking may be blood clot at this point and she would like to have it checked. She thinks that she should be able to contact somebody to actually get some physical test on this. She tried heat and cold alternate and Absorbine Jr. and Aspirin. It varied with the days, she thinks she has taken Aspirin about twice a day and it is a tablet and it was 325 mg and she took two of those, orally. Therapeutic measures were taken as a result of the event and included "heat and cold alternate and Absorbine Jr. and Aspirin". The outcome of the event was not recovered. Information on the lot/batch number has been requested.

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.

Six days after the second dose of Pfizer I started experiencing shortness of breath so I went to the ER and took a chest x-ray and had fluid in my lungs. Doctors discovered I had Atrial Fibrillation. In January I had an Echo Cardiogram and none of the previous described diagnoses were present then. I was admitted; doctors attempted to shock my heart back into rhythm several times but were unsuccessful. Therefore, I was put on Eliquis (5mg) and a water pill to get rid of the fluid in my lungs (and swollen ankles). I was hospitalized for 9 days where I was evaluated through numerous tests. Eventually it was suggested that I undergo the Watchman's Procedure to get off blood thinners. Everything went well with that surgery on Thursday May 20th; complications arose after the surgery: heart rate and blood pressure spike, lungs started filling up with fluid. Ended up in ICU for four days. I still have a problem with my lungs despite having no history of lung problems and I am now dealing with AFIB. This all started 6 days after my second shot.

patient developed muscle and joint stiffness 5 days after vaccine administration that persisted, she was diagnosed with PMR on 3/24/21 when her symptoms were not resolving

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.

tiredness; little soreness; other day arm, her felt very heavy from the swelling; she felt a little bump over where her muscles; a red patch in little down from injection/it was itching a little bit and she noticed the patch and that her arm; itch/itching, it was itching a little bit down from the injection; swelling a little bit down from the injection; a red rash, down further, not around the vaccine itself; redness is not right on top of the needle mark, it is down a little bit from there.; Body chills; This is a spontaneous report from a contactable consumer (patient) and Other HCP. An 83-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EL3247 and expiry date was not reported), dose 1 via an unspecified route of administration, administered in arm right on 30Jan2021 13:30 single dose for covid-19 immunization. Medical history included COVID-19, she confirms that was before received the vaccine and She did get COVID back on 20Nov. Medical history included diabetes mellitus, blood pressure abnormal, thyroid disorder, blood magnesium decreased, and vitamin D decreased from an unknown date and unknown if ongoing. she was a little chubby. Concomitant medication(s) included insulin glargine (LANTUS) (reported as Lantus Solostar) taken 40 units once daily injection for diabetes mellitus, levothyroxine taken 75 mcg once daily by mouth for thyroid disorder, losartan potassium 50 mg once daily by mouth taken for blood pressure, magnesium oxide (Mag Ox) (2x/day (400 twice daily by mouth) taken since she was low on magnesium, cholecalciferol (3000IU) taken for low vitamin, and she taken 3000 units per day, there is 1000 units in her multivitamin and 2000 IU in her Vitamin D3. The patient reported that she received vaccine on 30Jan2021, and everything was fine until 31Jan2021 and said, 'Everything was fine until Sunday afternoon', she patient experienced itch and swelling, a red rash, down further, not around the vaccine itself. It's still there. She tried cold compresses yesterday which seemed to help. 'No fever, just tiredness.' A little soreness'. She stated that, the redness was not right on top of the needle mark, it was down a little bit from there. It was like a patch, a red patch and it was a little down from injection, because she put the needle high up on her shoulder and it was down a little further from there and it was a little red. She thinks it was about 3 inches wide, it looks like lighter now, but she can't see good in her room. She says the Tylenol seems to help it. She confirmed she got the first dose 30Jan2021 and she was supposed to get the second one 20Feb2021. She noticed the red patch the next day, 31Jan2021 and the itching, it was itching a little bit and she was just rubbing it and soothing it and she noticed the patch and that her arm was swollen a little bit in that area. It hasn't worsened; she was going to go to the bathroom because it was very sunny in the room and she can't tell how it was. It looks like its fading; the redness was fading she can still see the outline but it's very pale compared to yesterday. It has improved since the other day arm, her felt very heavy from the swelling, she didn't realize until she felt a little bump over where her muscles were, but it seems to be much better today. On unknown date in 2021, the patient also had body chills. She wants to know how long this will last and was she still eligible for the second shot. Patient used Tylenol & cold compresses for adverse events. The patient did not require medical intervention/ emergency department visit/ hospitalization and intensive care unit admission. The outcome of the events was resolving except for "chills" which was found to be unknown. No PQC involved. No follow up attempts are possible. No further information is expected.

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

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.

Site: Pain at Injection Site-Medium, Additional Details: whole body tremor, lower back pain. Blood O2 was 99%, HR 76bpm. Unsure of the reaction, benadryl and epipen were given. Pt went home walking after 20 mins of the event. Paramedics did not arive on time and were cancelled after pt went home. Pt was advised to see PCP

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.

Labored breathing; chest pressure; fatigue; chest felt very tight; she is not planning to get her second vaccine; because has vertigo besides this; she can't swallow; Wheezing; got very sick; pains all over; headache; neck pain; arm pain; bone pain; 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, formulation: Solution for injection, lot number: GWO196), via an unspecified route of administration in Arm Left on 24Jun2021 at 04:00 (83-year-old at the time of vaccination) as dose 1, single for covid-19 immunisation. Medical history included bl high cholesterol; reported that her body makes cholesterol, it is not what she eats. It is 350 sometimes, 300 is high. Asthma, swollen, blood pressure, allergy with some soaps, adhesives they have to put one with cloth that does not have the same qualities as adhesive or otherwise she gets a rash, history of stents for heart attack, couple of arteries clogged but not showing any signs of causing problems, cancer. The patient had allergy with some medicines like clindamycin, Percocet, Percodan, penicillins. Concomitant medications included amlodipine (AMLODIPINE, dose: 5 mg, 1x/day) taken for blood pressure; atorvastatin (ATORVASTATIN, dose: 40 mg (she has been taking for years)) taken for blood cholesterol; furosemide (LASIX [FUROSEMIDE, dose: 20 mg (for three years. Not every day)]) taken for when her legs get swollen; salbutamol sulfate (VENTOLIN ACCUHALER) taken for asthma. It was reported that amlodipine was taken 3 or 5 years she has been on, but does not remember off hand, atorvastatin was taken maybe 8 years, it runs in her family everybody has it. She has been taking all her medications 50 years but not her cholesterol medication, for Lasix she is running like a chicken with her head cut off because everything that has happened to her. She takes 20, her daughter takes 40 mg not every day, for Ventolin when foggy outside she gets wheezy and when she is outside walking, she does one spray once and that is it. Years ago, she had bad asthma but not in the last 5 years except with weather. The patient previously took flu vaccine vii every year and experienced her arm hurt a little bit, coughing, chest hurt, did not have breathing thing, she got the flu, fainted. Reported that she was getting the flu vaccine every year, she takes it, and was okay the first time but her arm hurt a little bit and it never hurt. Two years ago, she took it and 2 weeks later felt sick like coughing and her chest hurt and she did not have breathing thing. Coughing and chest hurting led to her going to the emergency because she also fainted, so she called # and they took her to the hospital. She did tests and it was not her heart. They tested her for the flu and she said oh I already got my flu shot and they said well good thing you did. Caller confirms she got the flu after getting the flu shot. Reported that after experiencing labored breathing, chest pain, she called a cardiologist and went to the doctors and was admitted to the hospital for cardiac testing, and complains of labored breathing and fatigue. She wants this documented and has a history of stents in the past but hospital workup was negative. She had a heart attack 3 years ago and has stents in her heart. What happened when she called, she had cancer 5 years ago, when she called the oncologist and told him he said call cardiologist and she told her that she had the vaccine. She was taken by ambulance to the hospital and they did a bunch of tests and electrocardiogram and xrays and put her on monitor. After a few hours, they sent her to the cardiac floor where they gave her an injection, more blood tests, more of everything. The next day, nuclear testing of the heard and all of that stuff and sent her home and said it was not her heart and it was fine. She still had a couple of arteries clogged but not showing any signs of causing problems so they do not have to put a stent in. Caller confirms this was prior to receiving the vaccine because she has arteries clogged but only one with a stent and she still does not need a stent. No history of previous immunization with the Pfizer vaccine considered as suspect. No prior Vaccinations within 4 weeks. Reported that after vaccination they left her there for the 15 minutes and she had no reaction and came home and said my God, I should have done this a long time ago, because her arm was perfect and did not hurt and she had no symptoms till 2 o'clock in the morning. Reported that she is not planning to get her second vaccine. The second one she hears has worse and more side effects. She does not know what is going to happen if she only has one. She is supposed to have one 15Jul2021 in a couple days and right now she cannot take it if she is feeling this way because it is impossible and how should she do it if she is sick. Reported that Dr was afraid she was having a heart attack because she felt think someone was squeezing her chest and her breathing wasn't normal, so the hospital did all kinds of cardiac evaluation and they admitted her to the cardiac floor and continued to have all kinds of cardiac testing done, turns out her heart was okay, even though she has a stent in her heart and has 2 arteries that are clogged but they do not need to be fixed because there are not clogged to the point where it would cause her any problems, All the test showed that she did not have a heart attack. She has a lot of fatigue, if she walks from the bedroom to the kitchen, she really tires and feels like her breathing is labored, it's awful, and pains in the neck, even though before used to have a little pain in the neck, because has vertigo besides this but now has to be putting Ice packs constantly on the neck, waits and hour and then again and takes Motrin for the pain. Also the muscles, the doctor says the muscle in the chest, not in her heart and when she touches it hurts. Also having episodes where she can't swallow like she used to and had Asthma but kinda went away and now has started the past 2 days having Asthma, always has a pump with her because when it is foggy out she gets a little wheezing since yesterday, when she wakes up in the morning she hears the wheezing so will take a puff from the inhaler, so she would like this to be registered because she is 84 year old lady and has some issues that she never had other than when she had a heart attack, to which she had to change her medication. On 26Jun2021, the patient experienced labored breathing, chest pressure, fatigue, chest felt very tight, on an unspecified date, the patient experienced she is not planning to get her second vaccine, because has vertigo besides this, on 07Jul2021, the patient experienced wheezing, on 24Jun2021, the patient experienced got very sick, pains all over, headache, neck pain, arm pain, bone pain. It was reported that some term highlighted by the reporter as Labored breathing, chest pressure, fatigue. It was reported that it was not chest pain but it was pressure like somebody was squeezing her heart or had a rock on it and it weighed 100 pounds. It has gotten worse now that she is having wheezing in the morning. She had to use an inhaler for asthma yesterday. It has not gotten worse but it is the same. AE(s) require a visit to emergency Room and physician Office and hospitalized for one day. The patient was hospitalized for labored breathing, chest pressure and fatigue and chest felt very tight from 30Jun2021 to 01Jul2021. The patient underwent lab tests and procedures which included blood test resulted as unknown results, height resulted as 149.86 cm which she think shrunk and got fat, she used to be 4'11", electrocardiogram resulted as unknown results, nuclear testing of the heard resulted as it was fine, weight resulted as 100 lbs on 26Jun2021 which rock on it and it weighed 100 pounds, x-ray resulted as unknown results. Reported that all tests were negative but they put her in for her heart and no other reason to keep her because she did not need any kind of procedure done. Once they found it, she went home. Patient received treatment for events (labored breathing, chest pressure, fatigue, chest felt very tight, wheezing, pains all over, neck pain. The outcome of events Labored breathing, chest pressure, fatigue, chest felt very tight, Wheezing was not recovered, the outcome of events she is not planning to get her second vaccine, got very sick, pains all over, headache, neck pain, arm pain, bone pain, because has vertigo besides this and she can't swallow was unknown.

bilateral lower extremity weakness following 2nd dose leading to a fall. Hospitalized same day and found to have right bundle branch block on EKG.

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

Lost 5 pounds; one bout of diarrhea; night sweats so bad; nausea and vomiting; headaches; nausea and vomiting; diagnosed with bronchial pneumonia; This is a spontaneous report from a Pfizer Sponsored Program. Information was received from a contactable nurse (the patient). A 83-years-old female patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration, administered in Arm Left on 19Mar2021 12:30 (Batch/Lot Number: EL6204) as single dose for covid-19 immunisation (Age at vaccination 83 years) . Medical history included mycobacterium avium complex infection. On 24Feb2021 the patient received the first dose of BNT162B2 vaccine. Concomitant medications included multivitamin (MULTIVITAMIN) taken for an unspecified indication from 19Mar2021 12:30 to 19Mar2021 12:30; calcium (CALCIUM) taken for an unspecified indication, start and stop date were not reported; vitamin b complex (B COMPLEX (B50)) taken for an unspecified indication, start and stop date were not reported. The patient was diagnosed with bronchial pneumonia (medically significant) on Mar2021 with outcome of recovered , lost 5 pounds (non-serious) on an unspecified date with outcome of recovered , headaches (non-serious) on Mar2021 with outcome of recovered , nausea and vomiting (non-serious) on Mar2021 with outcome of recovered , one bout of diarrhea (non-serious) on an unspecified date with outcome of recovered , night sweats so bad (non-serious) on Mar2021 with outcome of recovered. Therapeutic measures were taken as a result of diagnosed with bronchial pneumonia and included antibiotics, albuterol and cough medicine. Course of the event. Caller states that she then had a sore throat and nasopharynx and throat felt like she was breathing fire. It got worse and worse. Caller states that within 48 hours of receiving the vaccine, she also began coughing and coughing. She had headaches, nausea, vomiting, one bout of diarrhea, and night sweats so bad that she had to change her pillow and bedding and was soaked from the waist up. Caller adds she was diagnosed with bronchial pneumonia. She had an appointment with a pulmonologist doctor and was seen at the clinic. They did x-rays, cat scans, and she was unable to do a breathing test because she could not quit coughing. Caller does not have additional details. Gave her antibiotics for 21 days, a nebulizer of albuterol and saline and they gave her cough medicine. It was the same cough medicine with codeine. She spent 6 days just at the clinic with tests in the doctor and came home from the train. Caller adds she was not admitted. This all stretched out over 3 weeks and gradually increased. Follow up information has been requested.; Sender's Comments: As there is limited information in the case provided, the causal association between the event and the suspect drug cannot be excluded. The case will be reassessed once new information is available. The contribution of patient's age cannot be completely ruled out in the occurrence of the events. The impact of this report on the benefit/risk profile of the Pfizer drug is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.

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

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.

Per husband: "Wife developed severe chicken pox all over body. Wife got shock- for two days, she had sore shoulder, on the 3rd/4th day she starting developing rash on site where she got the shot. Then rash spread to her other side and now rash has spread all over the body. Thought it would go away in a day or two, but hasn't. She has had the rash for 8 days." Further investigation on interview: It started approximately 3-4 hours after vaccination. First a sore arm then it felt itchy. She then noticed red raised spots. This rash has resolved slowly but "almost back to normal" as of Feb. 1. She still wants to get her second dose on Feb. 2 as scheduled.

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

On 1/21/21 she received her 2nd dose of the vaccine and she said she was fine until 1/30/21 and she had the agonizing back pain again and stiff neck. Then on Sunday 1/31/21 she had a fever of 100.8. Dr. started her on prednisone yesterday. She said she isn't sure if they are truly reactions to the vaccine but it was just strange that it happened both times.

She received her first dose on 12/31/20 and she stated everything was fine until 1/11/21 and she had a backache in her lower back. On 1/14/21 it was agonizing.

left arm was blue from her shoulder to her elbow almost whole circumference going under arm /left arm discoloration is what she calls "puce", clarifying hers is a purple, black, and blue color; slight left arm swelling; left arm discomfort; This is a spontaneous report from a contactable nurse (patient). An 84-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EK9231, expiration date: Apr2021), via an unspecified route of administration in the left deltoid on 12Jan2021 14:45 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On Jan2021, her left arm was blue from her shoulder to her elbow and almost the whole circumference going under her arm. On Jan2021, she has a slight left arm swelling and left arm discomfort. The discomfort was bearable. The discoloration of her left arm has become bad. She was at the COVID-19 vaccine clinic, some nurses looked at her arm, and insisted she contact Pfizer and her doctor to report what happened to her arm. She has an appointment with her doctor the afternoon of 20Jan2021. Her second COVID-19 vaccine dose is scheduled on 02Feb2021. Her left arm swelling and discomfort is the same now, but her left arm discoloration is awful. Her left arm discoloration is the only change she has experienced since her first report. Her left arm discoloration is what she calls "puce", clarifying hers is a purple, black, and blue color. The discoloration of her left arm is uncanny. The discoloration stops before her left elbow like a completely straight line drawn by a ruler. The discoloration continues from her left elbow up to her left shoulder for which the discoloration spreads out unevenly. Outcome of the events was not recovered.; Sender's Comments: A possible contributory role of the suspect products cannot be excluded for the reported events based on the known safety profile and temporal association The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators as appropriate.

Sore arms and hands. Sore stomach muscles........during the night after the shot ....by morning all aches were gone

pain in her knees that went down to her feet; pain in her legs/ went down to her feet; maybe it was arthritis; can't hardly walk; This is a spontaneous report from a contactable consumer (patient). An 84-year-old female patient received first dose of bnt162b2 (Pfizer-BioNTech COVID-19 mRNA vaccine, Lot Number EL1284 and Expiration Date unknown) via an unspecified route of administration on 09Jan2021 (vaccine location: left arm) at single dose for COVID-19 immunisation. The patient's medical history and concomitant medications was reported as none.On Monday (11Jan2021) morning she had a lot of pain in her legs and knees that went down to her feet. She thought maybe it was arthritis, but it was still there and it still hurts. She can't hardly walk real good cause it hurts. She was wondering if it could be a side effect from that vaccine. She wanted to know if there been a reaction like this in other people. Supposed to get her second dose on 30Jan2021. The outcome of events was not recovered without treatment involved. No follow-up attempts are possible. No further information is expected.

"Started to have a rash on rt side of her face, along with dizziness, weakness and tingling in her rt arm. Rapid response team called and came, RRT took her to ED"

Patient was brought in by ambulance on 01/28/2021 with complaints of fever, chills, myalgias, shakiness, and severe hypotension. Patient was treated for severe sepsis and acute kidney injury. Patient was given fluid resuscitation, but unresponsive to treatment; NE+ vasopressin, hydrocortisone IV, along with empiric antibiotic regimen were initiated. Patient later on developed pulmonary edema, Non-ST elevation MI with no chest pain and new onset of cardiomyopathy with EF 40-45% and clean coronary arteries shown on cardiac catheterization. Physician suspected cytokine release syndrome related to the COVID vaccine and congestive heart failure. Naranjo scale score of 2 indicates possible ADR. MD indicated vaccine reaction unlikely.

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.

UKNOWN BRAND OF VACCINE; lightheadedness and arm "heaviness" status post receiving the first COVID vaccine 30 minutes PTA.

CHEST TIGHTNESS, CHEST PAIN, DYSPNEA, MYALGIA BEGINNING 48 HRS AFTER VACCINE WAS GIVEN, LASTING > 48 HOURS. GRADUAL DISSIPATION IS NOTED.

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"

Vaccine administered 2:30 pm March 4, 2021, March 6, 6:30 a.m. RIGHT hand was red and swollen could not make a fist, Pain, in hand, wrist and elbow. March 7, 6:30 a.m. Improving. March 7, 4:30 PM could make a fist. March 8, 6:30 a.m. appears normal.

About 11 hours later, severe weakness in muscles causing her to fall in her apartment. She was admitted to hospital, and had fever and cough which progressed to pneumonia. Event further weakened already weak kidney function. After a week in hospital was transferred to nursing home long term.

sudden, severe leg pain, muscle weakness,pain on bending knees, worsened chronic back pain , tingling i n feet

3/13/21 Ferrell ER to admission hpi: 84 y.o. female presented to the emergency room with complaints of back pain, nausea, and abdominal pain. Patient approximately 1 week ago was bending over to pick something up and fell to the floor landing on her coccyx, and has had increased low back pain since that time. Patient does have a history of congestive heart failure and atrial fibrillation. Patient states that she had noticed increasing lower extremity edema and mild shortness of breath with exertion. The patient states that her back pain escalated and she was unable to stand or walk on her own. Patient was then brought to the ER for further evaluation per EMS. The patient did have a CT of the abdomen and pelvis which showed no definite acute intra-abdominal/pelvic abnormality, and mild acute during L2 superior endplate compression fracture with approximately 4 mm of displacement into the spinal canal. Patient also had a CT of the lumbar spine without contrast which showed acute appearing mild L2 superior endplate compression fracture with approximately 2 mm of displacement to the spinal canal, and multilevel degenerative disc disease. This morning upon entering the room the patient was standing with assistance of a walker and hospital staff. Patient tolerated fair. Patient does complain of severe pain with standing and movement. Patient does have 3+ pitting edema to bilateral lower extremities. Denies numbness or tingling to lower extremities. Bilateral lower extremity pulses are 1+ 1+, with CMS being less than 3 sec and skin is pink warm and dry. Patient's EKG in the emergency room did show atrial fibrillation with RVR with a rate of 137. Patient was given Cardizem IV in the emergency room, and then was started on Cardizem CD 100 80 mg p.o. daily. Patient's rate is controlled at between 92 and 96 beats per minute and continues to show atrial fibrillation on the telemetry. No shortness of breath is noted at this time. Patient did also have lab work drawn in the emergency room CBC: White count is 9.4, hemoglobin 14.4, hematocrit was 43.7, with a platelet count of 261. Patient's CMP showed a BUN of 21, creatinine 1.2, potassium was normal at 4.6, and her GFR was noted at 41. Patient also had a BMP drawn which was noted at 322. Patient also had a urinalysis performed which shows negative for leukocytes, nitrate negative. Patient was admitted to medical inpatient as it is deemed that she will need longer than a 2 midnight stay for cardiac monitoring and will work with physical therapy and occupational therapy for gait training and strengthening with relation to the compression fracture of her L2 fracture, and pain control.

Pt received her 1st Pfizer vaccine on 3/15/21 and was admitted to the hospital with sudden right hip pain on 3/20/21. she also tested positive for covid 19 during her admission. she was discharged on 3/22 feeling better with resolution of her pain and was told to watch closely for worsening s/s of covid 19

For 6 weeks she has had been nauseous, throwing up, -0- energy (like a limp dish rag--hard to sit up or hold her head up), severe chills, loss of appetite (lost 20 pounds)

Patient received 1st dose Pfizer COVID vaccine on 2/5/2021 and second dose on 2/26/21. She had no adverse reaction to either dose. Around 3/2/2021, she saw her physician complaining of pain in her arm, which was attributed to gout. At the time, she also had a nonproductive cough, generalized weakness and one episode of loose stool. She presented to the emergency room on 3/7/21 with significant hypoxia. She tested positive for COVID 19 by both rapid test and PCR. A quantitative test for COVID antibodies was sent out to a reference lab on 3/7/2021 and resulted on 3/11/2021 as >250 U/mL. Pt. required CPAP, BiPAP, High Flow Oxygen and ultimately intubation. Was not oxygen dependent before hospitalization. Pt. treated with dexamethasone, 2 doses of Remdesivir (then held due to acute kidney injury), tocilizumab X 1 dose, 1 unit COVID-19 convalescent plasma. Pt. expired on 3/19/2021. Sample sent for genome sequencing to check for variants of interest in joint effort between pathology and infectious disease. Report not yet available.

extremely ill; extreme fatigue; nausea; muscle aches; He is afraid she has COVID; have achy arm; This is a spontaneous report from a contactable consumer (patient reported herself). A 84-Year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/lot number: EL3949, NDC number: Unknown, Expiry Date: May2021) intramuscularly given very high in the top of left arm on 04Feb2021 9:20 AM at 0.3 ml single dose for Covid-19 immunization. The patient's medical history included fractured skull (five years ago), shingles (two years ago) and bleeding ulcers. Concomitant medications were not reported. Patient had the first dose of PFIZER-BIONTECH COVID-19 VACCINE last 04Feb2021 at 9:20 AM - Same day 6:00 PM started to have achy arm - After a few days developed symptoms like extremely ill, extreme fatigue, nausea, muscle aches. DSU potential duplicate AE Report E transmit - According to the patient she had already reported the side effects and transferred to our department. On 04Feb2021, the patient experienced arm started to ache like hell. Tiredness, muscle pain, nausea and feeling horribly ill. It was reported that, "she was having some symptoms. She got her vaccination on the 04Feb2021 and developed the symptoms yesterday. Her doctor was very alarmed that it was not just usual symptoms that go along with the vaccine because of the length of time between when she got it and when she developed symptoms. He was afraid she had COVID. She needed to know if that was normal so she could get back to him. Caller clarified that she meant side effects. She wanted to know whether it was normal to have gotten the vaccine on 04Feb2021 and not develop side effects until 09Feb2021. The vaccination was given in the morning at 9:20 AM and she did not have any symptoms until 6:00 PM that evening. Her arm started to ache like hell. That one showed up then, but cleared up in a couple of days. The arm got better and better. The other set of side effects started yesterday which was tiredness, muscle pain, nausea, and feeling horribly ill. She felt awful and did not want to go to a hospital if it was not necessary. HCP information included she had only seen him a couple of times. She had a long term doctor that retired and she got shifted over to him. They did not have a good relationship she must say. His whole group was associated with where she got the vaccine. They were all virtual now. She had been on lock down for a year. She did not have the doctor's address, phone number, or email. Tiredness, muscle pain, nausea, and feeling horribly ill: started yesterday morning when she got up between 4:30 AM and 5:00 AM. She was so woozy and thought it was left over sleep. She felt unwell all day. She had felt unwell today, but not as bad as yesterday. She had to get vaccination card out of hand bag and needs her glasses to read the small numbers. First dose was given on 04Feb2021. She had appointment on 25Feb2021 for second dose. Healthcare Provider who gave the vaccine was Hospital. They called her on the third at 5:00 PM to see if she could come the next day for the vaccine. They did a good job. Her brother was a retired anesthesiology and she called him this morning and he said to go to the hospital or testing center. Then he agreed that she should call Pfizer. History of all previous immunization with the Pfizer vaccine considered as suspect and additional vaccines administered on same date of the Pfizer suspect were none. She did not get her flu shot in anticipation of getting the COVID vaccine. Her brother and his granddaughter were both anesthesiologist. They get work up about not being able to breathe and ventilators. They gave advice. She was glad her brother approved for her to call Pfizer to find out. She wanted to believe it was side effects. She had been on lock down. Her brother said she could have been exposed at the vaccine site. Caller stated everyone had on a mask. She was not obese. She was not sure if it is relevant, but she would tell it anyway. She fractured her skull 5 years ago and was in Hospital because it was bleeding. That had resolved. She was in ICU and then six weeks of acute rehab. She had a bad case of shingles two years ago which led to bleeding ulcers. Again she went to the hospital, but she was scoped they found ulcers and treated. She went back for scope again and it had all healed up". Outcome of the event have achy arm was recovering whereas other events was unknown.

Severe muscle pain and stiffness in the neck, upper back, shoulders, arms, and legs. THIS HAS NOT ABATED AFTER TWO MONTHS. It is significantly affecting daily activities: walking is slow, painful, and unstable (leading to several near falls) ; painful head-turning prevents driving, and normal activities are restricted. Symptoms are worse in the morning but persist at some level all day. Patient has had fibromyalgia for many years and knows that pain well; this is distinctly different and more sustained.

Excruciating muscle pain; This is a spontaneous report from a contactable consumer or other non hcp. An 84-years-old female patient received bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection, Lot number: Batch/Lot Number: 610247; Expiration Date: Aug2022), dose 2 via an unspecified route of administration, in Arm Right on 11Feb2021 as single dose for COVID-19 immunization. The patient medical history was not reported. The patient's concomitant medications were not reported. 5 days after vaccination, the patient experienced Excruciating muscle pain in right thigh. Her daughter-in-law had Pfizer COVID-19 Vaccine and had the same symptoms of excruciating muscle pain for two weeks. The patient took acetaminophen 250mg, aspirin (two pills q5hours), caffeine: 85mg. The outcome of the event was unknown. No follow-up attempts are possible, and no information is required.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021208189 same drug/event, different patients.

Having pain in left shoulder, same site where the Pfizer Covid Vaccination was given; hardly feel hand; its stiff; can hardly move her shoulder; she can feel it in the muscle; 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) via an unspecified route of administration, administered in left arm on 31Mar2021 (Batch/Lot number was not reported) as single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. Patient reported she received the Pfizer Covid Vaccine on 31Mar2021. Patient was having pain in the left shoulder, same site where the vaccination was given. Patient could hardly feel her hand. Stated it goes and comes. 15Apr2021morning when patient woke up it was worse, it was stiff and patient could hardly move her shoulder. She could feel it in the muscle, since receiving the vaccination. Patient stated she needed help and was in pain. Patient asked what should be used for pain. Weight was 168 or 170, in between. Patient stated she wanted to call her doctor before it is too late. Outcome of the events was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained.

symtptoms started evening of vaccine dose. Felt fine in am. found on floor by family brought to hosp by EMS, seizure disorder; didn't have the strength to get to bed due to fatigue, which is history. Also abd pain and diarrhea and myalgias. Mottled reticular rash diagnosis identified: Abdominal pain; Acidemia; Acute kidney injury; Lactic acidosis; Mottled skin; NSTEMI (non-ST elevated myocardial infarction); Right hip pain; Tachypnea; Weakness

Severe muscle stiffness; pain in neck, shoulders, upper back, arms and shoulders; pain in neck, shoulders, upper back, arms and shoulders; pain in neck, shoulders, upper back, arms and shoulders; pain in neck, shoulders, upper back, arms and shoulders; affecting my walking; fallen several times; This is a spontaneous report from a contactable consumer (patient). An 84-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), dose 2 via an unspecified route of administration, administered in Arm Left on 16Feb2021 11:00 (Batch/Lot Number: EN6201) as SINGLE DOSE for COVID-19 immunisation. The patient was not pregnant at time of vaccination. Medical history included penicillin, sulfa, aspirin, anything related to horse serum, cats and insect bites allergy, fibromyalgia, irritable bowel syndrome and arthritis from an unknown date and unknown if ongoing. The patient previously took BNT162B2 (lot number: EL3247) dose 1 on 26Jan2021 10:45 AM at 84 years old in the left arm for COVID-19 Immunization. The facility where the most recent COVID-19 vaccine was administered was in the urgent care center. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. On 17Feb2021, severe muscle stiffness and pain in neck, shoulders, upper back, arms and shoulders the day after the vaccine. This has not abated after two months. The patient stated, "it is significantly affecting my walking, and I am unstable now and have nearly fallen several times. I cannot even move my head to read the paper without pain, and rarely drive anymore as well. I have had fibromyalgia for many years and know that pain well; this is different". The outcome of events was not recovered. The patient resulted in disability or permanent damage. No treatment was given to the patient for the events.

she couldn't put in any exercise up and down/ cannot hold her hand up and it got fall in; she couldn't feel any muscle. It is stiff; Left shoulder that is at the site I got the vaccine in pain.; Left shoulder that is at the site I got the vaccine in pain.; I have pain in muscle; I can not hold my hand up and it got fall in.; This is a spontaneous report received from a contactable consumer (patient) and a contactable other health professional. An 84-year-old female patient received second dose of bnt162b2 (Batch/Lot Number: ER8727), via an unspecified route of administration in left arm on 31Mar2021 as single dose for covid-19 immunization. Medical history included high blood pressure and high cholesterol from an unknown date and unknown if ongoing. Concomitant medications included ongoing amlodipine besilate (NORVASC) taken for hypertension; ongoing rosuvastatin taken for high cholesterol. The patient previous took the first dose of bnt162b2 on 10Mar2021 for covid-19 immunization. On 31Mar2021, she had pain in muscle, and she cannot hold her hand up and it got fall in. The muscle pain was so much. She cannot her hand up, she was in so much pain. Left shoulder that was at the site she got the vaccine in pain. She took 1st shot of covid vaccine on 10Mar2021. It is 31Mar2021 for second shot. Lab test: just blood test. She took for her heart and for lymph node. It was Biopsy. It was two weeks ago. She didn't remember the date. She took a nuclear test for her heart. Everything was negative. She got the vaccine in her arm and it wasn't that bad you know until I don't know. In morning she woke up and after the exercise pain in muscle and she couldn't feel any muscle. It is stiff, she couldn't put in any exercise up and down, her muscles she wanted to know what to do with it. She took paracetamol (TYLENOL) in this morning. The patient underwent lab tests and procedures which included biopsy: negative, nuclear test for heart: negative both on an unspecified date. The outcome of events for pain in muscle, Left shoulder that was at the site she got the vaccine in pain were not resolved, for other events was unknown. No follow-up attempts are needed. No further information is expected.

This is a spontaneous report from a contactable nurse (patient). An 84-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: ER8730), via an unspecified route of administration, administered in Deltoid Left on 26Mar2021 as 2nd dose, single for covid-19 immunisation. Medical history included cholesterol abnormal. Concomitant medications included cholesterol medication. The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN6202), administered in left arm on 26Feb2021 for COVID-19 Immunization. The patient states she had no immediate side effects. She states that two weeks, after the second dose (in Apr2021), she developed unbearable body aches, specifically in her arms and legs. The patient states she was unable to pick up her right leg and put it over her left leg. She states she is not getting better. The patient is asking if this is a side effect of the Covid vaccine, or is it from something else? She states she was healthy, she walked and was active, before the vaccine. The patient answers as there is very minimal improvement. She states that maybe there is some improvement because she has been taking Ibuprofen and Tylenol. The patient states her event has improved with the medications but they start to come back once the medications wear off. The patient stated she received her Pfizer Covid vaccine first dose in Feb and second dose in march. She stated 2 weeks after the second dose (in Apr2021) she is having terrible muscle aches in her arm and leg (calf muscle) she has to take ibuprofen to get through the day. The patient wanted to know about reports of it. She stated she has seen her doctor and done some tests. She has gone off her cholesterol medication and got checked for clots (no clots). The patient stated, "I got the vaccine in couple of week, I had no problem when I got the vaccine not even a sore arm. couple of weeks later I have developed excruciating pain and aching in my leg and my left arm. I went to the doctor and had whole panel of test and they ruled everything out I don't have Lyme, they took me of my cholesterol medication, I bought a new mattress, I am not sleeping in new mattress. I only take one medication cholesterol medication which I stopped and I am in agony and I wanted to know, if this is possibly connected to the COVID vaccine because I was really really healthy individual before they started." There is no additional Vaccines Administered on Same Date of the Pfizer Suspect, no prior Vaccinations (within 4 weeks), no AE following prior vaccinations, no patient's Medical History (including any illness at time of vaccination). The patient states she feels her medications are not relevant to the report. The outcome of the events was unknown.; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the reported events. There is limited information provided in this report. 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.

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.

she seems to have a cold with a runny nose; full of phlegm; Adds now she seems to have a cold with a runny nose; feeling tired/she is tired; extreme chills and freezing; she cut her lip in two places from her teeth chattering; Uncontrollable shaking/worst part was the chills, almost like a seizure'; she had extreme chills and freezing for 3 hours starting when she went to bed.; She started to feel nausea later on Monday; stiff neck on the right side of the back of her neck the day after the vaccine; headachy; Adds hers were like a fast flu; she was so sick she had to get back in bed yesterday; This is a spontaneous report from a contactable consumer (Patient). A 84-year-old female patient re-ceived first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for Injection, Batch/Lot Number: EL3247; Expiration Date: unknown), via an unspecified route of administration, administered in arm left on 21Jan2021 16:00 (at the age of 84-year-old) at a 1st dose, single for COVID-19 immuniza-tion. Medical history included thyroid disorder. No medical history (including any illness at time of vac-cination) was reported. None of the patient family medical history was reported. The patient did not receive any other vaccines prior to the COVID vaccine within 4 weeks. Concomitant medication includ-ed levothyroxine sodium (SYNTHROID) at a dose of 0.88 mg 1x/day (.088 mg; take once daily by mouth) via oral route of administration taken for thyroid disorder. Consumer states she received the Pfizer COVID 19 vaccine 21Jan2021 at 1600PM in the left arm. The effects didn't come until Tuesday night when she went to bed. The patient experienced worst part was the chills, almost like a seizure, headachy, she was so sick she had to get back in bed yesterday, hers were like a fast flu on an unspeci-fied date in Jan2021, she seemed to have a stiff neck on the right side of the back of her neck the day after the vaccine on 21Jan2021, she started to feel nausea later on Monday on 25Jan2021 and she had extreme chills and freezing for 3 hours starting when she went to bed on 26Jan2021. Adds she took two Advil, put on sweats and took a heating pad into bed then she was able to fall asleep. She cut her lip in two places from her teeth chattering and uncontrollable shaking Tuesday night on 26Jan2021. When she put the heavy clothes on and took that Advil the chills stopped, and she slept for four hours. she is tired on 27Jan2021, she seems to have a cold with a runny nose and full of phlegm on 28Jan2021. The patient received Advil as a treatment medication to the events extreme chills and freezing. The events were reported as non-serious. Outcome of the events she seems to have a cold with a runny nose, full of phlegm was not recovered; headachy, adds hers were like a fast flu, she seems to have a cold with a runny nose, worst part was the chills, almost like a seizure, she was so sick she had to get back in bed yesterday was unknown; she started to feel nausea later Monday, she cut her lip in two places from her teeth chattering, feeling tired/she is tired was recovering; stiff neck on the right side of the back of her neck the day after the vaccine was recovered on 25Jan2021, and re-maining other events extreme chills and freezing, she had extreme chills and freezing for 3 hours start-ing when she went to bed, uncontrollable shaking recovered on 26Jan2021. She was asking about getting the second dose considering her chills, Mentioned she talked to a few people who had the chills and were tired after the second dose but they were not as bad and every-thing was over in a day or so. Caller declined to report on anyone she knows who had chills and was tired after the vaccine. Adds she is scheduled to receive the next dose of the vaccine 10Feb2021. Adds it scares her a little bit because of the extreme chills. Follow-up attempts are completed. No further information is expected.

Shortness of breath; Joint pain; Feeling unwell; The initial case was missing the following minimum criteria: No adverse effect. Upon receipt of follow-up information on (24Feb2021), this case now contains all required information to be considered valid. This is a spontaneous report from a Pfizer sponsored program via contactable consumer (Patient) and in response to Non HCP letter sent. A 84-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: unknown, Lot number and Expiration date: unknown), via an unspecified route of administration on 10Feb2021 at 01:45 on Arm left (at the age of 84-year-old) as 2ND DOSE, SINGLE DOSE (1 shot) for COVID-19 immunisation in Hospital. Vaccine wasn't administered at a Facility. No other products were taken together. There are predisposing factors. The patients medical history was not reported. Concomitant medications was none. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: unknown, Lot number and Expiration date: unknown), via an unspecified route of administration on 20Jan2021 (at the age of 84-year-old) as 1ST DOSE, SINGLE DOSE for for COVID-19 immunisation. Patient had her 1st shot of the vaccine yesterday (20Jan2021). On the 03Feb2021, she is scheduled to have surgery on her head patient is aware that they will put a shot in it. On 11Feb2021 at 08:00, the patient experienced shortness of breath, Joint pain and feeling unwell. No admission to hospital was involved. No treatment received was received. Patient was feeling fine now. No visit to emergency room and Physician Office. No culture was performed. Outcome of the events was recovered on an unknown date in 2021. No follow-up attempts are possible, information about lot/batch number cannot be obtained. No further information is expected.

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.

leg weakness; This is a spontaneous report from a contactable physicians (one is the patient). An 84-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), at the age of 84-years-old, intramuscular on 23Mar2021 12:15 at 1st dose, single; then intramuscular on 13Apr2021 12:15 at 2nd dose, single in the left arm for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient has no family medical history. On 23Mar2021 at 1am, the patient experienced leg weakness. This event required visit to emergency room for 7 hours and was hospitalized on an unspecified date in 2021. The patient received no treatment for treatment and recovered on 23Mar2021. On 13Apr2021 12:15, the patient again experienced leg weakness. The patient was hospitalized for 2 days. It was unknown if the patient received treatment for this. It was also reported that a catheter was inserted for 3 days and repeated again on 26Apr2021. The event was assessed as serious due to disability and hospitalization. It was reported that the vaccine was not administered at military facility. Outcome of the event was reported as not recovered. Information about lot/batch number has been requested.; Sender's Comments: Based on the strong temporal relation (event occurred after first and second dose administration) there is reasonable possibility of causal association between the event lower extremity weakness and the suspect drug BN162B2. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.

She reported having injection site swelling; the second shot hurt her; her arm was swore 2-3 days/arm a little sore after second shot; and was tired after; right hand swollen/Her index finger on the left hand is swollen back to the palm; right ankle swollen/swollen down to her wrist; thumb swollen and stiff; left index finger swollen/thumb swollen/her middle finger swelled; This is a spontaneous report from a contactable consumer or other non healthcare professional. An 84-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection) via an unspecified route of administration in left arm on 30Apr2021 at 15:00 (Batch/Lot Number: ER8735) (at the age of 84 years) as 2nd dose, single dose for COVID-19 immunization. Medical history included arthritis, patient's mother had arthritis but she had it much younger than patient's age. Concomitant medication(s) included ubidecarenone (COQ 10) 100mg, once a day for health reasons and ongoing, acetylsalicylic acid (ASPIRIN (E.C.) 81 mg, once a day for heart and ongoing, losartan (LOSARTAN) for cardiac disorder and ongoing (Had been taking over 10 years), carvedilol (CARVEDILOL) for cardiac disorder and ongoing (Had been taking over 10 years). Patient previously took first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) via unspecified route of administration in the left arm 02Apr2021 (at the age of 84 years) as single dose for COVID-19 immunization. On 14May2021, patient experienced, left index finger swollen/thumb swollen/middle finger swelled. She went to the doctor on 14May2021, when she showed the doctor her finger they said it could possibly be arthritis. On an unspecified date, patient experienced injection site swelling, the second shot hurt her, her arm was sore 2-3 days/arm a little sore after second shot, was tired after, right hand swollen/her index finger on the left hand is swollen back to the palm, patient had to take her rings off, it hadn't gotten as bad as the index finger but it was swollen, it was not as stiff to bend as the index finger, it was hard to bend and was stiff when she got up right ankle swollen/ swollen down to her wrist, thumb swollen and stiff. She thought that the doctor said to take Tylenol as treatment, but she didn't care for Tylenol, so she didn't take anything. The outcome of the left index finger swollen/thumb swollen/middle finger swelled was not recovered while for the events was unknown. No follow-up attempts are possible. No further information is expected.

Come down with an infection, she is almost bed ridden; sick/his wife is sick/My wife is down with a sickness; Come down with an infection, she is almost bed ridden; She has lost some weight in the last couple of weeks; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer (Patient's husband) reported for a female patient. An 84-year-old female patient received first dose of BNT162B2 (Solution for injection, Lot number: EL9261 expiration date: unknown) via an unspecified route of administration on 21Jan2021, as a single dose for Covid-19 immunization. The patient did not have any medical history. Concomitant medications were not reported. On an unspecified date, the patient fell sick (reported as "My wife is down with a sickness"). On 04Feb2021, she was diagnosed with an infection (reported as come down with an infection). It was stated that she was almost bed ridden and on an unknown date in 2021, she had lost some weight in the couple of weeks prior to this report. It was stated that she had an appointment for second dose of vaccine scheduled on 09Feb2021, unfortunately she had come down with an infection 'chronic' (further not clarified), she had received the diagnosis from her doctor. She was almost bed ridden at the time of this report, hopefully improving. It was also stated that she would not be able to go for that second session on 09Feb2021, and needed to reschedule appointment a little later, the reporter asked could she go as far as a week beyond such as like 15Feb2021 or 16Feb2021. The reporter stated that do not know her weight, she has lost some weight in the couple of weeks but that was okay. She was taking an antibiotic Bactrim (Further clarified as treatment) for this infection, on a 5 day schedule which would end on a day next to this report. The patient went to the doctor on 04Feb2021 Thursday, underwent laboratory test blood work on 04Feb2021 the result showed the infection (unspecified). The reporter did not think this was a side effect from the vaccine, and stated this was, could be, reporter was guessing it could be. It was reported that, "I am going to say it's very much in the vicinity of 145 pounds. She has lost some weight in the last couple of weeks but that's okay, I would say that 140, I am going to say 140 instead of 145". The outcome of the events of fell sick, come down with an infection, almost bed ridden and lost some weight was unknown. Follow-up attempts completed. No further information expected.

Hives; Rash on my nose and below my nose and near bottom lip/ Facial rash; Back of my neck, I had a sharp little pain, stinging sensation; This is a spontaneous report from a contactable consumer (patient, self-reported). A 84-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number and expiry date were not reported), via an unspecified route of administration, in Arm Left, on 05Feb2021 at 13:30 PM (age at vaccination: 84 year), as a single dose for COVID-19 immunization at hospital or clinic. Vaccine was not administered at military facility. The patient's medical history included COPD, right sided congestive heart failure, pacemaker, AFib, and she has heart problems (she said that were usual for an old woman). Concomitant medications were not reported. The patient did not receive any other vaccine within 4 weeks prior vaccinations. There was no family medical history relevant to adverse event. The patient reported that on 07Feb2021, she had a rash on her nose and below her nose and near bottom lip. On the back of her neck, she had a sharp little pain, stinging sensation on an unspecified date in Feb2021 and she suspected it was the first sign of a rash. Not certain if there was a rash on her neck or not and asked was this a possible reaction to the shot. The patient stated that last night she noticed a scaly patch on her nose that she felt with her finger, then this morning she looked at it good and it was actually a rash, after washing her face she noticed it's not scaly it's a rash, today the rash was between the lip and nose on her face, and on the bottom part of lip, it was slightly tender, and was unusual. On 08Feb2021, she saw rash and hives on the other areas on the face. She assumed her rash was worsening as it was spreading. Her second dose was schedule for 26Feb2021. There were no relevant tests. Outcome of the events was unknown. Information on the lot/batch number has been requested. Follow-up attempts completed. No further information expected.

Redness; She her arm got stiff later in the afternoon; Right side was blood red like a rash; itched/itched in her midriff; This is a spontaneous report from a contactable consumer (patient). A 84-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection, Lot number and expiration date was not reported) via an unspecified route of administration in left arm on 09Feb2021 15:50 as dose 1, single for COVID-19 immunization. Medical history included allergies and heart problems. Concomitant medications included allergy shot every other Monday and heart medication every day by mouth. Prior Vaccinations within 4 weeks was none and No AE(s) following prior vaccinations. Patient did not received additional vaccines on same date of the Pfizer Suspect. There was no history of previous immunization with the Pfizer vaccine considered as suspect. Patient's Medical History and Family Medical History Relevant to AE(s) was none. The patient experienced itched/itched in her midriff on 09Feb2021, right side was blood red like a rash on 10Feb2021, redness and her arm got stiff later in the afternoon on an unspecified date. It was reported that, she stated that she would have a reaction when they would increase her allergy shot sometimes. No further details was provided. Patient enquired if she could have the second shot. She had an allergy shot on Monday with her allergy doctor. It was reported that she had no effects yesterday when she got it. Her arm got stiff later in the afternoon. She went to bed and itched in her midriff. This morning when she got out of the shower her right side was blood red like a rash that extended from her elbow to her waist. She said that she did not check the color of her arm and midriff last night it just itched. She was at her daughter's house and was fully clothed and was unable to provide the outcome of the redness and rash. She said that her rash felt better now. Adverse events did not required a visit to emergency room or physician office. The clinical outcome of the redness and her arm got stiff later in the afternoon was unknown and itched in her midriff and right side was blood red like a rash was recovering. Follow-up attempts completed. No further information expected. Information on the Batch/Lot number has been requested.

Legs are very heavy severe difficulty walking just in the house; Ankles hurt, can't get out of bed without physically lifting up her legs; This is a spontaneous report received from a contactable consumer. A 84-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6205), via an unspecified route of administration on the left arm on 26Feb2021(at the age of 84-year-old), at 09:00 as a single dose and also received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6208), via an unspecified route of administration on the left arm, on 19Mar2021(at the age of 84-year-old), at 09:00 as a single dose for COVID-19 immunisation . The patients medical history consisted of chronic obstructive pulmonary disease (COPD) and was a cancer survivor. The patient did not take any concomitant medication. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. Since the vaccination, the patient had not been tested for COVID-19. On 26Feb2021 at 09:00, the patient experienced heaviness in legs and pain in ankle. It was reported that the patients legs were very heavy and had severe difficulty walking just in the house. Her ankles hurt and she could not get out of bed without physically lifting up her legs and this had started happening after the first vaccine was administered. The adverse events had resulted in doctor or other healthcare professional office or clinic visit. The clinical outcome of the events heaviness in legs and pain in ankle was not recovered at the time of this report. No follow-up attempts are needed. No further information expected.

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.

Her ankle and hip joints pain started to worsen/Experiencing joint pain after first and second; A part of her hips started to hurt and went away; This is a spontaneous report from a contactable consumer or other non hcp (Patient). A 84-years-old female patient received first dose of bnt162b2 (BNT162B2, PFIZER-BIOTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration, administered in Arm Left on an unspecified date (age at vaccination: 84-year-old) as single dose for covid-19 immunization. Vaccination Facility: Hospital. Vaccine Administered at Military Facility: No. Medical history included ongoing arthritis, ongoing Dermographism Had since her 30s, ongoing cardiac disorder, ongoing thyroid disorder, ongoing Fibromyalgia Had since her 30s. Concomitant medication included atenolol (ATENOLOL), amlodipine besilate (NORVASC), furosemide (LASIX [FUROSEMIDE]), potassium (POTASSIUM), all taken for cardiac disorder from an unspecified start date and ongoing, levothyroxine sodium (SYNTHROID) taken for thyroid disorder from an unspecified start date and ongoing, cimetidine (TAGAMET [CIMETIDINE]) taken for mechanical urticaria from an unspecified start date and ongoing, Historical Vaccine included received flu shot and Got so sick and sick for over a year (Will never get flu shot again.) at the age 18 or 19 years. loratadine (CLARITIN [LORATADINE]) taken for mechanical urticaria from an unspecified start date and ongoing, prednisone (PREDNISONE) taken for rheumatoid arthritis from an unspecified start date and ongoing, paracetamol (TYLENOL) taken for pain from an unspecified start date and ongoing. It was reported that patient wanted to know if the joint pain she experienced is something caused by the Pfizer BioNTech Covid-19 Vaccine or caused by her history of arthritis and fibromyalgia. She experienced the worsened joint pain a few days after getting her 2nd shot of the Pfizer BioNTech Covid-19 Vaccine last 24May2021 and the pain persists until now. Also reported her ankle and hip joints pain started to worsen after the second shot of the vaccine last 14May2021. During the first shot, a part of her hips started to hurt and went away, on the following day another part of the hip started to hurt and went away again. She wanted to know how long her joint pain would last. She was quite displeased that she is unable to obtain medical recommendation as to managing her joint pain and how long the worsening would last. Upon date 24May2021 it was reported that stated after the first shot, she had joint pain, but it went away. Second shot was more pronounced pain. She has arthritis and fibromyalgia. Pain happened shortly after the shot. Today the pain is worse. Day before pain was not so bad. It is off and on. Caller states she doesn't want to worry. Caller states that her husband said that the person had trouble giving her second shot. She moved the needle around. Arm hurts a little bit. Getting better. She did not even feel the first shot. She did not even know that she had gotten it when it was already done. She then explains that this is getting better. She confirms her arm was hurting a little before the second shot because she had already had the first shot in that arm. It is worse with the second. With the first shot, she had hardly any problems at all. This is why she is hoping second shot is not a problem for her. Therapeutic measures were taken as a result of events with Tylenol for pain. Patient was not visited physician office or Emergency Room. The outcome for the event her ankle and hip joints pain started to worsen/experiencing joint pain after first and second was not resolved and for event a part of her hips started to hurt and went away outcome was resolved on 2021. Information on the lot/batch number has been requested.

chest pain; her arm went numb; she experienced deep pain above her knees on both sides; the knees, because of clotting or whatever so she tried to rub some alcohol on her leg; This is a spontaneous report from a contactable Other Health Professional (patient, Dentist). A 84-year-old female patient received BNT162B2 (Pfizer BioNTech Covid 19 vaccine, lot number EW0167), via an unspecified route of administration at left arm on 26APR2021 at the 84 years old at single dose for COVID-19 immunization. The medical history was ongoing high blood pressure, pain and allergic. The concomitant medications were none. The patient states she goes to the doctor for a checkup for almost 1 year but she cant go because she wasn't able to go anymore because of corona virus and she didn't go out to visit her doctor for almost one year. The patient states she has high blood pressure, but she doesn't have medicine, it was diagnosed a long time ago because the doctor said take this medicine but she wasn't able to get a checkup and wasn't able to get the medicine so she doesn't have medicine. The patient would like to report a terrible effect on herself by the Pfizer vaccine. The patient states she had her first vaccine 26APR2021 and after that she had chest pain on 27APR2021 that lasted for the next day and almost 2 days and then her arm was also numb on 27APR2021 and she just put some hot and cold compress on her chest and she just rested and it just went away, but last week the same thing, her chest became painful and she saw this number about the Covid 19 and that's why she's calling, what should she do should she get the second vaccine? The patient states she did not report to anybody yet, this is her first time. The patient states last week, it came back again and then on the next day 27APR2021, it was very deep and painful in her knees, both sides, left and right above her knees. The patient states yes, sometimes its very painful. The patient states not now, but last week the pain was in her chest and she put a cold compress on it. The patient states after the numb and pain, its not like pain, its deep pain, that's why she's bothered. The patient states it's really serious, the knees, because of clotting or whatever so she tried to rub some alcohol on her leg, that's what she did. Chest Pain; very deep and painful in her knees: The patient states it's slowly not pain, it's not very painful like before, the first and second time that it occurred. The patient states it's pain, but it's like better, it's getting better. The patient states she cannot say that it's recovered, she feels a little better. The patient confirms it is ongoing and it is persisting. The patient states it's not worsening, she just feels it sometimes then it goes away if she massage it or applies pain ointment.Chest Pain: The patient states her chest is painful, the left side of her chest is very painful. The patient states she doesn't like to receive it because she said she might be allergic because sometimes she's really allergic, but all her friends said she needs to go now, she will be protected and of course she knows that like from the flu vaccine so she searched before she was able to see and she was going to get Moderna so she said she would look for a nearer place near her and so her friend told her to go to pharmacy because she has friends there that would help her and she went there and she got the Pfizer vaccine. The patient states that's because she did not have the pain before that for a long time for many years and now after getting the vaccine, now, she experienced it. All of the events were assessed as Medically significant. The adverse events did not require a visit to Emergency Room or Physician Office.Prior Vaccinations (within 4 weeks), there was no any other vaccinations within four weeks prior to the first administration date of the suspect vaccine. The reporter considered the events were all related to Pfizer Covid 19 Vaccine. The outcome of the event was Numbness of upper extremities was not recovered ,the others was Recovering. The information on the batch number has been requested.; Sender's Comments: Based on the information provided and temporal association, a causal association between suspect drug and the reported events cannot be completely excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.

Left wrist became very sore and painful; This is a spontaneous report from a contactable consumer, the patient. A 84-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 30Apr2021 at 11:30(at the age of 84-year-old) as a single dose for COVID-19 immunisation. The patient no medical history. The patient did not take any concomitant medication. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 01May2021 at 11:30 about 24hours after the vaccination, the patient experienced Left wrist became very sore and painful started. Called for assistance and information but only received message that she was 'next party in queue' for over 45 minutes. The clinical outcome of the event Left wrist became very sore and painful was not recovered. No follow-up attempts are possible; information about lot/batch number cannot be obtained.

Back aches; Chills; Couldn't breathe; Couldn't walk; pain; This is a spontaneous report from a contactable consumer (patient). A 84-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Right on 20Feb2021 16:30 at 84-years-old (Batch/Lot Number: EL9264) as dose 2, single for COVID-19 immunization. Medical history included ongoing Thyroid issue, ongoing High blood pressure, Lung carcinoma cell type unspecified stage I (Lung cancer stage I, She hasn't had treatment for over a year. She had radiation.) Concomitant medications included levothyroxine taken for Thyroid issue from an unspecified start date and ongoing; losartan taken for High blood pressure from an unspecified start date and ongoing; aspirin [acetylsalicylic acid] taken for an unspecified indication from an unspecified start date and ongoing. The patient previously took first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EL9265), on right arm on 30Jan2021 at 84-years-old for COVID-19 Immunization. Patient had both Pfizer Covid Shots. She had side effects and had to be rushed to the hospital. They are sending her a bill, and she felt that she should not have to pay the hospital bill. Her insurance paid so much and the bill is for $250 that she doesn't have. It is for the ambulance. The vaccine was for Covid. She had the first dose on 30Jan2021 and the second on 20Feb2021. 2 days after the second one she had to be rushed to the hospital. She was getting chills, back aches, and all kinds of complications. She couldn't even move, and she called an ambulance. Her insurance left her with a $250 bill. She called the ambulance to say it is due to the Covid shot. Each time she called she waited over an hour. Yesterday she waited over an hour and a half. She is a little disgusted. Now she got a bill from the hospital, and she figured it was related to the Covid shot. She thinks they gave her a shot at the hospital. It was quite an experience. After she was admitted to the hospital for a couple hours that Saturday or Sunday so she thinks she was in the hospital on 21Feb2021, they gave her a shot and she started seeing things. It was an experience she doesn't want to go through again. She has no idea what the shot was, she thinks it was for the pain. They sent her home and gave her pills to take for the pain. She doesn't want to take too many pills for pain. The pills are Hydrocodone Acetaminophen, she takes one half to 1 tablet as needed for pain for up to 3 days. They are in an amber colored pharmacy bottle. It says OTY6. She couldn't walk 2 days after she had the second shot (22Feb2021). Back aches: She more of less ignored it. She took Tylenol and that didn't help. That Sunday she more or less started aching and couldn't breathe. She told her husband she had to get out of there. She just took regular Tylenol, expiration date: Nov2023. She does not see a lot number. Each one is 500mg. She has arthritis too. It is an over the counter medication. Couldn't breathe 2 days after she had the second shot. As a matter of fact, they had to lift her off of the bed. It was on and off for a couple of hours. She can't remember if she had any tests done. Adverse Event Chills, couldn't breathe, couldn't walk, and back aches time of onset (24-hour clock) was about 13:00 or 14:00. She did not take any other vaccinations within four weeks prior to the first administration date of the suspect vaccine. She asked the doctor before taking the vaccine, and he said it wouldn't affect her at all. On the paper it specifies if she has any side effect to call the ambulance which she did. She cannot get them on the phone and waited over an hour. The outcome of the events was unknown. No follow-up attempts are possible. No further information expected.

Generalized joint pain, abdominal cramping without nausea or diarrhea. Lasted 12 hours. Took 2 doses of Tylenol .

Woke up on Monday night with muscle pain in left shoulder, neck. Continues through Tuesday off and on.

stiff neck on right side extending down to shoulder started on 1/25/21 upon waking in morning and still stiff today 1/27/21

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.

Pt. was vaccinated and being monitored, 15 minutes after vaccination. Pt was injected @ the R DT. Pt reported pain to R side of neck, dizziness, and weakness. Pt's vitals were obtained all were WNLs, breathing was normal and unlabored. S/S subsided, pt denied any further issues. Pt was released to spouse.

the day after the vaccine was administered I had symptoms of: pain in my sides and lowerback, and I had hives on my arms, stomach, wrists, shoulders. the hives came and went and showed up in these places off and on from Saturday January 30th until monday February 1st. I took tylenol on saturday and I applied alcohol to the hives because they itched. The pain in my sides and lower back was very bad.

hurting/right arm and shoulder over to the left; hurts on both sides/right shoulder right above on the neck began to ache; hurting/right arm and shoulder over to the left; hurts on both sides/right shoulder right above on the neck began to ache; pain went across her face to the left side; pain in the right shoulder to above the neck; This is a spontaneous report from a contactable consumer (patient). An 85-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiry date unknown) via unspecified route of administration in the right deltoid on 14Jan2021 at single dose for Covid-19 immunization. The patient's medical history and concomitant medications were none. The patient informed that the hurting started when she was just talking with someone on 17Jan2021. The patient had taken ibuprofen and tramadol. The patient informed that her right arm and shoulder over to the left, it sort of rotated over to there and hurts on both sides and wanted to know if there was anything she could do to eliminate that or make it less consuming. The patient informed that she didn't notice any problems for a couple days, then her right shoulder right above on the neck began to ache. This pain went across her face to the left side, it has sort of stayed in this particular area. It has not stopped aching since then. The patient informed that she didn't know what to take. The patient informed that the pain in the right shoulder to above the neck started 3 days after, it went on to the face to left side, it was in the neck mostly, and the top part of the shoulder, it was a dull aching pain, sometimes it shrills, and she really felt like, it was like it really hits her. The neck shoulder pain all started on the same day. The patient informed that it was not quite as bad as before, she took ibuprofen. The patient took Tramadol after the onset of the neck/shoulder pain. The patient informed that the end of the second phase of the vaccine is coming on the 07Feb2021. The outcome of the events pain in arm, facial pain was unknown, while shoulder pain, neck pain was recovering. Follow-up activities are possible, information on the batch number has been requested.

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

Pt reported dizziness, flushing, numbness in both hands to patient monitor. This RN assessed pt, who also reported chest pain, described as "angina" but said she had not had this type of chest pain before. Said she takes nitro for other chest pain but that pain is sharp and stabbing. Pain today described as "dull" and on left side of chest. Also reported nausea. VS: BP 130/82, HR 86, SpO2 98%. EMS called due to chest pain. While waiting for EMS, patient reported that pain started radiating from chest around to left back. No SOB, talking in full sentences with RN and son. EMS arrived and brought patient to ambulance. Pt was not transported to ED, returned to car to go home (son driving). .

inflamed a little bit in the areas to the interior of my knee toward her upper leg; very painful to stand on or walk on; Very painful to stand on or walk on; left knee had some pain and like a swelling; left knee had some pain and like a swelling; This is a spontaneous report from a contactable consumer (patient). This 85-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 21Jan2021 at single dose for covid-19 immunisation. Medical history included blood cholesterol (abnormal) and psoriasis. Concomitant medications included ixekizumab (TALTZ) for psoriasis and statins for cholesterol. The patient took injection on Thursday (21Jan2021) morning. Yesterday (22Jan2021) the patient began to get, her left knee had some pain and like a swelling. The patient didn't know if that's related to the injection. It was not her right knee also, it was only her left knee and it looked like it's inflamed a little bit in the areas to the interior of my knee toward her upper leg. It was very painful to stand on or walk on. The patient did not have any pain at the injection site. She did not have any fever that she was aware of, she had no nausea, she was not dizzy. The patient wanted to know if the reaction that she had in her left knees was possibly connected to the injection. The patient put some ice on it and had no other treatment. Outcome of all events was unknown. Information on the batch/lot number has been requested.

rheumatoid and osteoarthritis. Always have some pain but it increased dramatically; rheumatoid and osteoarthritis. Always have some pain but it increased dramatically; This is a spontaneous report from a contactable nurse (patient). An 85-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: not reported), via an unspecified route of administration on right arm on 29Jan2021 08:00 at single dose for covid-19 immunisation. Medical history included ongoing rheumatoid arthritis, ongoing osteoarthritis, CAD (coronary artery disease), hypertension, GERD (gastrooesophageal reflux disease), osteoporosis, lumbar stenosis, lumbar degenerative disc and Allergies: Sulfa. Concomitant medication included carvedilol (COREG), prednisone, methotrexate, adalimumab (HUMIRA), fluoxetine hydrochloride (PROZAC) and risedronate sodium (RISEDRIN). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine and not diagnosed with COVID-19 prior to vaccination. On 29Jan2021, 12:00 patient had rheumatoid and osteoarthritis. Always have some pain but it increased dramatically and almost unbearably. The patient pain med did help some. Lasted about 11 hours. The seriousness criteria were considered as non-serious. Since the vaccination, the patient been not tested for COVID-19. The outcome of the events was recovering. Information on the lot/batch number has been requested.; Sender's Comments: A possible contributory effect of suspect drug on reported Rheumatoid Arthritis aggravated 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.

Nausea, Throwing up, Chills, fever, Happened on days 1-5 after vaccine. Diarehia, cramps..painful to rib cage & Pelvis, Bone pain, cannot walk, loss of appetite & loss of balance I feel now!

Severe headache and muscle/joint pain that began about 15 hours after injection. Trying Tylenol but it doesn't help very much.

1st Dose vaccine 1/29/21; Admitted to Hospital from ED 2/1/21-2/4/21 Dx PNA, d/c'd home. ; 2nd dose vaccine 2/19/21; seen in ED 2/22/21 for SOA, congestion, N/V, and Left flank pain x 3 days; admitted to hospital from ED 2/22/21 Dx: 1. Epigastric pain R10.13 789.06 2. Elevated brain natriuretic peptide (BNP) level R79.89 790.99 3. Dyspnea, unspecified type R06.00 786.09 4. Abnormal CT of the abdomen R93.5 793.6 5. Hypomagnesemia E83.42 275.2 6. Hypokalemia E87.6 276.8 Currently still admitted to hospital at time of this report.

left arm swelling, appeared within one hour of second vaccine dose. Swelling progressed with soreness of arm. Swelling worse day after. Started abating by Thursday 2/25/21 evening. Advised ice pack on arm, but pt. said it was too sore on day after dose given (Wednesday) to apply. Pt. took one aspirin on Wednesday morning. Advised her she could take a second later in the day. (Yesterday pt. stated she had taken a Tylenol. Today upon review she realized that she took an aspirin. Ibuprofen is also available. Advised pt. take an ibuprofen now over the phone as I waited. Taken at 8:13pm EST. No further medication taken on Wednesday. (Also encouraged ice pack on neck Wednesday for ongoing strong headache / neck pain yesterday. Pt. does not remember if she tried that. Head/neck pain resolved today.) Pt. states swelling today (Thursday) is mild-to-moderate, less than yesterday, but still noticeable. Doesn't hurt as much as it did yesterday, she says. She can now lift her arm without pain.

Developed 101.1 fever starting 12 hours after injection. Went from 99.9 at first onset. Next day grew to 101.1 degrees. Finally fever broke in early morning hours after 1-1/2 days of feeling ill. Stayed hydrated with 7-up and water every hour or so, no food. Slight bit of nausea. Normal temperature is 97.6. Some aches in neck area, slight hurt at injection site.

Systemic: RHABDOMYLOSIS-Medium, Additional Details: AFTER RECEIVING THE VACCINE PATIENT HAD MUSCLE WEAKNESS AND FELL DOWN. PATIENT WAS TAKEN TO DOCTOR AND DIAGNOSED WITH RHABDOMYLOSIS

Post injection Day 1, merely lethargic & painful arm. Day 2, absolutely PERFECT. Day 3, low-grade fever, uncomfortable arm but never inspected Day 4 (today): Noticed redness on arm, reaching 4-1/2 inches in length below site of injection, warm to the touch. Low grade fever of 98.1 when normal is in the 97.1 area.

was in so much pain she was crying; Right ankle and foot was swollen and shiny/wrist was swollen and shiny/knee was swollen and shiny; knee was shiny with a lump she did not have before; arm, hand was swollen and shiny/foot was swollen; right elbow is messed up/its swollen and stiff; right elbow is messed up/its swollen and stiff; This is a spontaneous report from a contactable consumer. An 85-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot and expiry not reported), first dose on 28Jan2021 at 12:30 then second dose at 18Feb2021 at 11:25, both via an unspecified route of administration at a single dose on left arm for COVID-19 immunisation. Medical history included diabetes mellitus (diagnosed 40 years ago) and a heart condition (had 5 stents, angioplasty, open heart surgery, clarified as triple bypass, in 98, 7 heart caths- 2 of them in one day, a stroke and a heart attack) from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. The patient had the vaccine, the second one on 18Feb2021, last Thursday. She was in the hospital yesterday. On 21Feb2021, the patient experienced her right ankle and foot was swollen and shiny, her knee was swollen and shiny and knee was shiny with a lump she did not have before, arm, hand and wrist were swollen and shiny and her shoulder, and her right elbow was messed up. The doctor is the current county health advisor, he said to report all these things. On 21Feb2021, the patient was in so much pain she was crying. She went to the emergency room because it hurt so bad and then was admitted and kept overnight. The patient was put on prednisone to help with swelling. The patient's right elbow being messed up is improved and persisting, its swollen and stiff. The outcome of the events knee was shiny with a lump she did not have before and pain was recovering, right elbow messed up was not recovered, while of the rest was unknown. Information on the lot/ batch number has been requested.

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.