Pfizer

Muscles & bones symptom reports

Female, 76 - 89 years

Age Reported Symptoms Notes
76 2021-01-07 joint pain Arm soreness / soreness in the arm and shoulder; Arm soreness / soreness in the arm and shoulder; Em... Read more
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.
76 2021-01-09 muscular weakness Extreme tiredness, headache, weakness in legs making walking uncoordinated, to the point of losing m... Read more
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.
76 2021-01-17 muscle pain Fatigue, Chills, Low grade fever, Muscle aches. Resident also developed cellulitis to lower portion ... Read more
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.
76 2021-01-21 joint pain, muscle pain high fever 102, fatigue, no energy, aches in muscles in joints, nauseous
76 2021-01-23 muscle pain, joint pain injection site pain/arm hurts tiredness headache slight muscle pain/joint pain ***nausea feeling lou... Read more
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
76 2021-01-24 joint pain Joint pain. Subsided they reoccurred with much more intensity. Could barely walk my right knee hut s... Read more
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
76 2021-01-26 muscular weakness Shot about 11:30, Physical Therapy at 2:00 Substantial weakness in legs and core with difficulty get... Read more
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.
76 2021-02-01 groin pain On this last Friday I received my first shot. On Sunday I got a lot of groin pain on both sides that... Read more
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,
76 2021-02-02 joint pain Anaphylaxis symptoms started three day after the shot I started having chills, trembles, sore throat... Read more
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,
76 2021-02-03 joint pain all of her joints that had been previously hurt in the past started killing her; This is a spontaneo... Read more
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.
76 2021-02-07 muscle pain headache, nausea, severe myalgia -cervical/thoracic; pt had to take Tylenol and when that didn't wo... Read more
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.
76 2021-02-08 muscle pain fever, fatigue, nausea, muscle aches
76 2021-02-08 muscle pain Chills, fever, muscle aches, weakness, fatigue, nausea lasted 24 hours, then fatigued for another 12... Read more
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
76 2021-02-09 limb discomfort I have had a sore left arm since receiving the first dose on 1/16. VAERS report was put in and e-con... Read more
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.
76 2021-02-10 muscle pain, joint pain slight headache, nausea, not being able to move-sit up, walk, muscle pain, joint pain extreme for on... Read more
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
76 2021-02-12 joint pain Immediately, within 2 hours of the vaccination, I developed a severe headache, join pain (knees, elb... Read more
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.
76 2021-02-13 joint pain extreme Chills followed by being very Hot and then chills again , headache , teeth hurt , eyes sensi... Read more
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.
76 2021-02-14 joint pain Washed out, just relaxed slight fever, and chills, muscle aches, joint pains, 1 Tylenol and went to ... Read more
Washed out, just relaxed slight fever, and chills, muscle aches, joint pains, 1 Tylenol and went to bed
76 2021-02-15 joint pain, joint swelling, musculoskeletal stiffness One week after the first vaccine, I had severe pain in my right arm. I could barely lift it. applie... Read more
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.
76 2021-02-18 joint pain My reactions started on Feb 10, Wed nite, with pain going from the left shoulder to right shoulder. ... Read more
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
76 2021-02-18 muscular weakness, grip strength decreased Patient on 02/09/21 starting having slow thought process and weakness in left arm and hand and had l... Read more
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.
76 2021-02-19 joint pain Developed shingles, given salves,valacyclovir, 1gm for 7 days, pain patches, gabapentin. Had very ac... Read more
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.
76 2021-02-22 joint pain Fever 100 Achy joints Chills
76 2021-02-22 muscle pain Pfizer-BioNTech COVID-19 first dose, 1/23/2021, little reaction. second dose, 2/13/2021: headache on... Read more
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.
76 2021-02-23 musculoskeletal stiffness After receiving her vaccine client stated that she has stiffness and redness in the right arm in whi... Read more
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.
76 2021-02-25 muscle pain Pt received dose #2 Pfizer COVID vaccine 1/29/21 @ MAC vaccine clinic. Reported flu like symptoms ov... Read more
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.
76 2021-02-26 armpit pain I was vaccinated on Feb 23, 2021, on the evening of Feb 24, 2021, I experienced soreness and swellin... Read more
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.
76 2021-02-26 muscle fatigue, muscle pain, joint pain Within an hour, I felt like I had been hit by a tank; difficulty breathing, dysequilibrium, problems... Read more
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
76 2021-02-26 muscle pain, joint pain After 12 hours, extreme fatigue, headache,tinnitus, chills then joint and muscle pain I took Aleve a... Read more
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.
76 2021-03-01 joint pain Injection site pain, tiredness, headache slight, joint pain, fever up to 101.6, feeling unwell
76 2021-03-02 joint pain head hurt; pain in all of her joints/couldn't move fingers; felt numb; Nauseous; felt unstable; ligh... Read more
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.
76 2021-03-02 limb discomfort Arm swollen and turned red 3 inches above and below injection site; Arm swollen and turned red 3 inc... Read more
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.
76 2021-03-02 muscle pain headache; chills; muscle pain; tiredness; feeling unwell; This is a spontaneous report from a contac... Read more
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.
76 2021-03-03 joint pain Every joint in my body hurts. No apparent rash. Headache but no fever
76 2021-03-03 muscle pain Swollen Lympf Nodes(7 days), slight headache(two weeks) tiredness(1 week)muscle aches(1 week),severe... Read more
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.
76 2021-03-07 back pain, musculoskeletal stiffness, muscular weakness, joint pain Within 8 hours of the vaccine, I experienced severe muscle weakness (could not lift arms above head;... Read more
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.
76 2021-03-08 flank pain Experienced right side aside pain 3 days after vaccination and broke out with shingles rash 6 days a... Read more
Experienced right side aside pain 3 days after vaccination and broke out with shingles rash 6 days after vaccination
76 2021-03-08 muscle pain Extreme fatigue, muscle pain, headache. Difficulty getting out of bed. Slept 23 hours a day for 6 da... Read more
Extreme fatigue, muscle pain, headache. Difficulty getting out of bed. Slept 23 hours a day for 6 days. Increasing muscle pains for 3 weeks.
76 2021-03-09 joint pain, limb discomfort Heavy, aching legs from the knee down. Knees throb. Right shoulder intermittent aching. Walking affe... Read more
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.
76 2021-03-09 armpit pain Sore arm, extreme fatigue, fever 101.9 and loss of appetite for 2 days following vaccine. aching beh... Read more
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.
76 2021-03-09 neck pain I developed arm pain, up my arm to my neck, Then 2 days later developed a rash on my wrist, arm and ... Read more
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.
76 2021-03-10 back pain Started with upset stomach and achey body late afternoon on Friday (1 week after 1st shot). Then dev... Read more
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.
76 2021-03-13 bone pain, muscle pain ACHY MUSCLES, BONES HURT/ACHED, FATIGUE FOR ABOUT 24 HOURS.
76 2021-03-14 musculoskeletal stiffness Terrible nightmare during night of injection. Smothering and paralyzed feeling. Shouting out in my ... Read more
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
76 2021-03-14 muscle pain, joint pain Joint pain, muscle aches, right shoulder pain, fatigue night after shots and next day Lasted over a... Read more
Joint pain, muscle aches, right shoulder pain, fatigue night after shots and next day Lasted over a period of 2 days
76 2021-03-14 muscle pain, joint pain tiredness; headache; nausea; feeling unwell; muscle pain; joint pain; This is a spontaneous report f... Read more
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.
76 2021-03-14 muscle pain tiredness; headache; muscle pain; chills; feeling unwell; injection site soreness; This is a spontan... Read more
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.
76 2021-03-14 muscle pain She reports, "I have no balance." She had second COVID-19 vaccine on 2/12/2021 and afterwards had my... Read more
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.
76 2021-03-15 joint pain Pain and swelling (about the size of a boiled egg) on the shot site; Pain and swelling (about the si... Read more
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.
76 2021-03-15 joint pain Headache first and 2nd day. A week later woke me up 2 nights in a row but only lasted 12-15 minutes.... Read more
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.
76 2021-03-17 muscle rigidity tremor and chills onset last night, body rigid, could not sleep
76 2021-03-18 joint pain, neck pain diarrhea; color of the diarrhea looked red and looked like it had blood on it; she sat down in a cha... Read more
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.
76 2021-03-20 joint pain Severe joint pain especially in feet, ankles, knees; Severe joint pain especially in feet, ankles, k... Read more
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.
76 2021-03-20 joint pain Fine after shot and evening; went to bed approximately at 9pm and got so cold, put 3 blankets on an... Read more
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.
76 2021-03-20 muscle pain, joint pain Headache and was hot; really hot at night; Really strong muscle and joint aches/pain; Really strong ... Read more
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.
76 2021-03-22 joint pain, neck pain, musculoskeletal stiffness heart pain; Shoulder pain; Neck ache; Stiff neck; severe chest pain; This is a spontaneous report fr... Read more
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.
76 2021-03-23 joint swelling, joint pain Intense pain in left knee. Red and swollen. Reports that she was screaming in pain and couldn't pu... Read more
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.
76 2021-03-24 joint pain, neck pain, back pain Back hurt a tremendous amount; Lower back, hips, knees, neck pain; Lower back, hips, knees, neck pai... Read more
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.
76 2021-03-24 back pain chest, back underarm pain; chest, back underarm pain; back pain; adhesions; Inflammation numbers wer... Read more
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.
76 2021-03-24 muscular weakness 3/5 Anxiety attack with increased heart rate ...lasted about 20 minutes after taking one half of a ... Read more
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.
76 2021-03-24 musculoskeletal stiffness I think I am having a bad reaction to my covid shots. The first shot was 1/31; a week later on 2/7 ... Read more
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
76 2021-03-26 muscle pain Headache, nausea but no throwing up, tiredness, lack of energy, soreness at the sight of the injecti... Read more
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.
76 2021-03-27 limb discomfort she did not have a reaction to first. After the second she got very cold and felt miserable like her... Read more
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
76 2021-03-27 muscle pain After 2nd shot, started from day 3, I have muscles aches.
76 2021-03-28 joint pain 1st dose, none Second dose administered 02/18/2021, 11:00 AM 1st 10 days: lymph node swelling of le... Read more
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
76 2021-03-28 back pain, joint swelling Pt is presenting today for Shortness of Breath (pt reprted soa, back pain ( due to rehab 2 weeks ago... Read more
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
76 2021-03-28 muscle pain A few hours after injection, arm muscle started to hurt and it has never improved, I have used heat,... Read more
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
76 2021-03-30 joint pain, armpit pain, muscle pain she felt like she was dying, it was a strange feeling, like out of body feeling, she knew she was fe... Read more
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.
76 2021-03-30 joint pain On Sunday at 10:00PM she checked her temperature and it was 100.6 degrees; she was cold, and had her... Read more
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.
76 2021-03-30 joint pain Diarrhea; Heart palpitation; occasional low pulse rate; sore joints; low grade fever; This is a spon... Read more
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.
76 2021-03-30 joint pain has been experiencing high sugar level; having pain at tip of radius- sore to touch. Very sore; join... Read more
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.
76 2021-03-30 muscle pain, musculoskeletal stiffness muscle pain; lot of pain; stiffness in muscles; difficult to walk; This is a spontaneous report from... Read more
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.
76 2021-03-31 joint pain, muscle pain, neck pain transferred from shoulder to her neck; shoulder was in pain/ elbow and shoulder were in pain; inject... Read more
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.
76 2021-04-04 limb discomfort Bad headache on left side of head Teeth started chattering for 2 minutes, but didn't feel cold 100.4... Read more
Bad headache on left side of head Teeth started chattering for 2 minutes, but didn't feel cold 100.4° fever Legs felt 'heavy'
76 2021-04-05 joint swelling Pfizer-BioN Tech COVID-19 Vaccine EUA: Swelling in mouth/lips, severe itching (all over, especially... Read more
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
76 2021-04-06 neck pain Pain in left side of Neck and Ear and both eyes ,Then on the second night the pain moved to the rig... Read more
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
76 2021-04-07 muscle pain, joint pain Total fatigue and lack of energy; pretty motionless, could take a shower & read but that was about ... Read more
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.
76 2021-04-10 joint swelling For 3 days after I was so tired it was hard to get off couch. My Afib has been controlled but the a... Read more
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.
76 2021-04-10 muscle pain Fever, headache muscle ache for two days. Yook Tylenol
76 2021-04-11 back pain, musculoskeletal chest pain, joint pain Painful swollen lymph nodes under left arm and close to breast. I keep my left arm in sling like pos... Read more
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
76 2021-04-12 muscle pain is here today for ED follow-up on A-fib. Patient stated she is not taking Eliquis. She had no sid... Read more
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.
76 2021-04-13 joint pain Patient noted that 2 days after vaccination that her left shoulder became very sore and achy. She wa... Read more
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.
76 2021-04-13 back pain One week after last shot developed shingles. treatment to date consist of at home methods to reduc... Read more
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.
76 2021-04-13 limb discomfort Petechiae below the right knee. Per the patient, she also experienced this same rash when she had CO... Read more
Petechiae below the right knee. Per the patient, she also experienced this same rash when she had COVID-19 disease back in December 2020.
76 2021-04-14 joint pain, muscle pain FEELING VERY SICK. Pain is unbearable. arm is sore. Fast pulse. when I get up I feel like I am goin... Read more
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.
76 2021-04-17 back pain BODY ACHES; FEVER; NASTY TASTE; dark urine; backache; heartburn; fatigue; This is a spontaneous repo... Read more
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.
76 2021-04-19 joint pain, neck pain About three days after getting vaccine, I began having pain in my shoulders and neck. For three wee... Read more
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.
76 2021-04-21 back pain Two weeks after receiving vaccine, experiencing severe pain in under left breast, radiating around ... Read more
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).
76 2021-04-23 weight decreased, back pain coughs it is like a bronchitis type thing; coughs it is like a bronchitis type thing; full of phlegm... Read more
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.
76 2021-04-27 joint pain Blood clot in her lower abdominal area; had the worst pain through her side that ran down her left l... Read more
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.
76 2021-04-27 muscular weakness, musculoskeletal stiffness Her legs got weak; she lost coordination; anxiety was exacerbated by her terrible fatigue; depressio... Read more
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.
76 2021-04-27 muscle pain, back pain sore muscles, especially lower back; some shakes and/or chills; some shakes and/or chills; sore musc... Read more
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.
76 2021-04-27 weight increased Headache; Shrunk; Weight gain; Not feeling that great; Dizziness; Felt weird when went for walk; Thi... Read more
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.
76 2021-04-28 joint pain On April 1, 2021 I woke up with pain in my left hip. As the day went on it got much worse and the na... Read more
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.
76 2021-04-30 back pain Arm hurts a little bit, after first vaccine; Tiredness, after first vaccine; Chills; Back hurts a li... Read more
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.
76 2021-05-02 muscle pain 03/09: presents to the ED with palpitations that began 90 minutes prior to arrival. The patient has... Read more
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.
76 2021-05-04 bone pain she has a little bit of skin that is very dry; Pain under breastbone; Welts; lumps in her skin under... Read more
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.
76 2021-05-04 muscle pain Throbbing pain arm of injection site. Muscle soreness inside of arm. Has continued for last two mo... Read more
Throbbing pain arm of injection site. Muscle soreness inside of arm. Has continued for last two months.
76 2021-05-07 joint pain tinnitus; joint pain; headache; extreme fatigue; chills; then fever; This is a spontaneous report fr... Read more
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.
76 2021-05-12 joint pain Right knee pain; tenderness; swelling; Pain at injection site; This is a spontaneous report from a c... Read more
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.
76 2021-05-13 limb discomfort uncomfortable shooting sensation down her arm repeatedly throughout the day every day since first sh... Read more
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
76 2021-05-17 armpit pain Soreness under her arm unsure if muscle or lymph nodes; Pain under the arm, under the injection site... Read more
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.
76 2021-05-21 joint pain, arthritis Pt recivied her 2nd covid 19 vaccine on 3/26. Patient is a 76-year-old female with a past medical hi... Read more
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.
76 2021-05-28 back pain, neck pain very exhausted; sleeping a lot/sleeping all the time; bottom neck area to ache; not able to eat anyt... Read more
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.
76 2021-06-01 joint pain This is a spontaneous report from a contactable consumer or other non hcp. A 76-years-old female pa... Read more
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.
76 2021-06-03 joint pain Extreme pain on left side of body knee, ankle, hipt side of body knee, angle, hip; Extreme pain on l... Read more
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.
76 2021-06-03 muscle pain pt says that she has a tremendous amount of body and muscles aches with extreme fatigue. She alread... Read more
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.
76 2021-06-07 muscle pain She has been experiencing hair loss for a while; had a little bit of muscle pain; This is a spontane... Read more
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.
76 2021-06-07 weight increased She had high Blood pressure yesterday; Second dose administered on the Left Arm, her arm did hurt a ... Read more
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.
76 2021-06-09 joint pain Acute idiopathic Pericarditis with recent hx of new onset rapid atrial fib admitted from 5/18-5/21 t... Read more
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
76 2021-06-10 joint disease, musculoskeletal discomfort I am having some long term achiness in my left arm it is gone into my shoulder and joint; I am havin... Read more
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.
76 2021-06-12 muscular weakness, joint pain, muscle pain Pain in joints, muscles and muscle weakness
76 2021-06-13 joint swelling, arthritis Arthritis, body aches, swelling in joints, felt groggy or in a fog.
76 2021-06-14 joint pain Heart pounding, palpitations day 3-4. Decreased hearing after shot #2 given on 03/29/2021. Incre... Read more
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.
76 2021-06-16 joint pain, neck pain Chills; Fever of 100 degrees; Soreness in shoulders; Soreness in neck; Mild stomach ache; Lingering ... Read more
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.
76 2021-06-22 joint pain Within a few days, I had some joint pain, headaches and fatigue. I was also disoriented. Those sympt... Read more
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.
76 2021-06-24 muscular weakness, neck pain She has also has dizziness; She is pitching forward like vertigo; The dizziness got much worse this ... Read more
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.
76 2021-06-24 muscle pain has trouble moving her arm/ received vaccine in left arm but right arm was hurting; muscles in her r... Read more
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.
76 2021-06-24 weight decreased chills; the glands in her neck, under her chin were swollen and hurt a little; below knee and feet a... Read more
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.
76 2021-06-29 joint pain, muscle pain Chills; Muscle and joint aches; Joint aches; Upset stomach; Tired; This is a spontaneous report from... Read more
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.
76 2021-06-29 muscular weakness felt real weak in her legs; not feeling well; Stomach upset; felt weak; This is a spontaneous report... Read more
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.
76 2021-06-30 joint pain Pain in left knee making it difficult to walk upon getting out of bed.; Pain in left knee making it ... Read more
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.
76 2021-06-30 decreased muscle tone secretions and vomitting at 11pm...suctioned. 2:25 am 6/30 vent alarm. pt pale, bp 72/38 pulse ... Read more
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
76 2021-07-01 joint pain This is a non-interventional study report from the marketing program received from a contactable con... Read more
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.
76 2021-07-08 back pain Intense lower back pain; could only sleep sitting up; This is a spontaneous report from a contactabl... Read more
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.
76 2021-07-14 muscular weakness Husband reported weakness in left arm the evening of vaccination. Patient's health has declined. She... Read more
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.
76 2021-07-17 joint pain, muscle pain Second dose: lymph nodes under jaw still swollen; Second dose: dizzy; Second dose: rapid heartbeat; ... Read more
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.
76 2021-07-17 joint swelling, joint pain Since February 19th I have been in constant pain. Difficulty in walking, exercising, and every day a... Read more
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
76 2021-07-17 muscle tightness, joint pain, muscle pain Couldn't raise either of her arms; Chills; Low grade fever of 99.2 degrees Fahrenheit; Sick for 5 da... Read more
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
76 2021-07-19 armpit pain headache; dizziness; fever; chills; Strong stomach pains; nausea; vomiting; distorted taste; new bli... Read more
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.
76 2021-07-20 muscle pain Fever or Chills Fatigue Muscle or body aches Headache Congestion or running nose
76 2021-07-22 joint swelling -March 4, 2020 - Morning after vaccine - Ankles swollen. I never had swollen ankles in the past. Bum... Read more
-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.)
77 2021-01-13 muscle pain I already have some muscle pain; This is a spontaneous report from a contactable consumer (patient).... Read more
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.
77 2021-01-16 joint pain, musculoskeletal pain Severe pain deep in left buttocks hip area. Began 01/14/21 am and continuing Now. Taking Aleve every... Read more
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
77 2021-01-20 muscle pain sore arm, chills, low-grade fever, muscle aches, foot pain (arthritis?), loss of appetite, fatigue (... Read more
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.
77 2021-01-23 limb discomfort About 19 hours after receiving the Pfizer Covid-19 vaccine, I got a fever of 101 degrees. My left a... Read more
About 19 hours after receiving the Pfizer Covid-19 vaccine, I got a fever of 101 degrees. My left arm felt very heavy.
77 2021-01-24 back pain, neck pain Nausea and violent vomiting for 2 hours. Upper back and neck pain for 36 hours. Chills and shakin... Read more
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.
77 2021-01-24 muscle pain Sore arm and muscle aches less than 24 hours
77 2021-01-26 muscle pain, joint pain After a few days, muscle/joint pain ....headaches.....Tiredness......injection sit pain.... all were... Read more
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.
77 2021-01-26 muscle pain Tiredness, sleeping more, headache, muscle pain, mild chills, feeling unwell
77 2021-02-01 limb discomfort Short lived but I thought you should be advised. Heavy feeling in legs starting around 4.5 hours a... Read more
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
77 2021-02-02 joint pain The shot was given in my left shoulder. Two days later the left shoulder blade became rather painf... Read more
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.
77 2021-02-03 neck pain Itching/She was itching on her knee, leg, arm, neck, and ears.; She had hives on the knee; The two t... Read more
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.
77 2021-02-05 muscle rigidity Patient complained of dizziness and said she was going to pass out. Observation nurse called site cl... Read more
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.
77 2021-02-06 joint pain, muscle pain Increase in cardiac arrhythmia - a-fib and rapid pulse, up to 135bpm while asleep Muscle and joint p... Read more
Increase in cardiac arrhythmia - a-fib and rapid pulse, up to 135bpm while asleep Muscle and joint pain Fatigue
77 2021-02-06 muscle pain About 12 hours after receiving my booster vaccine I started feeling chills, then fever and extreme m... Read more
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.
77 2021-02-07 joint pain, muscle pain Note:Tested positive to CV19 27th October 2020 Pharmacy. CV19 Symptoms: High fever and fatigue. No... Read more
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.
77 2021-02-08 joint pain, muscle pain Severe all over muscle and joint ache, fatigue, dry cough, chills, dizziness and weakness. Began ar... Read more
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.
77 2021-02-08 neck pain Shingles break out 10 days after first injection, pain and pox on neck and head
77 2021-02-10 joint pain, muscle pain chills, shakiness followed by feeling very warm, sweating and sweaty, Extreme fatigue, body aches, j... Read more
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.
77 2021-02-10 limb discomfort Date and time of vaccination: (list both if they received both shots): 1/6/2021 (First dose) 1/27/2... Read more
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
77 2021-02-10 muscle pain, joint pain dont want to eat anything; hot and cold chills; headaches; muscle pain; fever; joint pain; injection... Read more
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.
77 2021-02-10 neck pain Pain in the jaw, neck, throat, bilateral lymph pain/swelling, sweating, chills, weakness - neck pain... Read more
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.
77 2021-02-13 joint pain 02/05/21 6:00PM total exhausion, chills, headache, joint pain, felt like I had the flu. Also, m... Read more
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
77 2021-02-13 muscle pain, joint pain On first day had chills, sore throat, both minor. Second day had fatigue, moderate joint and muscle... Read more
On first day had chills, sore throat, both minor. Second day had fatigue, moderate joint and muscle pains. Third day, some muscle pain.
77 2021-02-13 muscle pain Maybe this is not what is qualified as "adverse", but i have not been able to get out of bed, eat, ... Read more
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.
77 2021-02-16 neck pain Extreme shaking and chills, large lump appeared on left leg thigh, Pressure of top of head (left s... Read more
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.
77 2021-02-17 back pain This is a spontaneous report from a contactable healthcare professional. A 77-year-old female patien... Read more
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.
77 2021-02-17 weight decreased Severe virtigo and intractable nausea requiring ER admission. Sxs ameliorated with Ativan, meclizine... Read more
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
77 2021-02-21 muscle pain, joint pain chills; slight headache; joints aching; muscles aching; fatigue; weakness; This is a spontaneous rep... Read more
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.
77 2021-02-21 neck pain, back pain This was my second vaccination at the same site. I was fine with the first shot, and seemed fine wi... Read more
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.
77 2021-02-21 neck pain on 2/11/2021 AT 5:30pm Evening of the vaccination, my neck aching, and slight headache, When I woke... Read more
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
77 2021-02-23 back pain 2/19/21 12:30 AM- slight headache, followed by chills and body ache-especially lower bac. Last unti... Read more
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
77 2021-02-28 joint pain, muscle strain, musculoskeletal stiffness, muscle pain, neck pain Blinding headache/ severe headache; chills/ shivers; couldn't warm up; Whole body was shaking out of... Read more
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.
77 2021-02-28 muscle tightness Tightening of neck, light headed- symptoms remained the same during monitoring. Did not get better ... Read more
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.
77 2021-03-01 muscular weakness, back pain Back pain, bilateral lower extremity neuropathy, paresthesias, lower extremity weakness, urinary ret... Read more
Back pain, bilateral lower extremity neuropathy, paresthesias, lower extremity weakness, urinary retention, orthostatic hypotension
77 2021-03-02 joint pain Two hours after injection severe pain in my right knee began and continues moderately today 3/3/202... Read more
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.
77 2021-03-02 muscular weakness, joint pain severe chills, usually after getting up in mornings weakness muscle and joint soreness pain
77 2021-03-02 muscular weakness Shortly after vaccination, upper legs felt weak and head felt as if she was "floating" similar to b... Read more
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.
77 2021-03-02 musculoskeletal chest pain she was hospitalized 2.5 days after having symptoms of a "massive heart attack" 2 days after the vac... Read more
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.
77 2021-03-02 musculoskeletal stiffness, muscle pain Mild headache, worse than normal fatigue, stiff neck, muscle ache, hot flashes, flushed cheeks, itch... Read more
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.
77 2021-03-04 joint pain fatigue, headache, hip pain, site redness - all 8 hours - no treatment
77 2021-03-05 muscle pain Pfizer-BioNTech COVID-19 Vaccine EUA: patient reports fatigue, myalgias, chills, and a swollen arm (... Read more
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.
77 2021-03-07 joint pain, muscle pain injection site pain; Nausea; fatigue; joint and muscle pain; joint and muscle pain; headache; chills... Read more
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.
77 2021-03-07 back pain I have been having excruciating stabbing pain between T5 and T 6 on the right side of my back.; have... Read more
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.
77 2021-03-09 muscle tightness little tight around my neck and throat, like a tightness; Tightening in my neck and around my mouth ... Read more
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.
77 2021-03-10 neck pain, muscle pain The next morning, she could hardly wake up and had no appetite. Saturday still no appetite but did d... Read more
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.
77 2021-03-11 muscle tightness Pt. states she received vaccine and left the park but started to feel her jaw clenching and some tig... Read more
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.
77 2021-03-12 joint pain March 3, 2021-Sore injection site of right arm March 4th- Injection site slightly sore March 5th -so... Read more
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.
77 2021-03-14 back pain On the day after I had pain in my left side. On the following day, I went to the ER with severe scia... Read more
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.
77 2021-03-14 muscle pain pain, arm swelling, fever, chills, fatigue, muscle aches, and headache for 36 hours.
77 2021-03-14 muscle pain myalgia, facial and hand swelling, body aches requiring more than Tylenol/ibuprofen.
77 2021-03-15 grip strength decreased, joint pain severe redness in upper arm, throbbing in wrist traveling upward to upper arm. Loss of strength/gri... Read more
severe redness in upper arm, throbbing in wrist traveling upward to upper arm. Loss of strength/grip in arm/hand.
77 2021-03-15 muscle pain, joint pain, neck pain Severe plantar fasciitis onset first week of February. By February 14, severe bilateral trapezius pa... Read more
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.
77 2021-03-16 joint pain, neck pain, musculoskeletal stiffness Right Arm and Shoulder Stiffened up while lap swimming at 07:00 am. Felt cold and felt pressure in m... Read more
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.
77 2021-03-21 joint pain 2/28/2021 DAY OF INJECTION #1 - HEAVY SENSATION IN UPPER LEFT ARM, LASTED LESS THAN 24 HOURS 2/18/2... Read more
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
77 2021-03-21 muscular weakness Experienced soreness at injection sight, slight headache, fatigue, chills, weakness in legs, indiges... Read more
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.
77 2021-03-22 gout Extreme Fatigue -falling asleep whenever I sit down up to 20 hours in one day. Memory loss includin... Read more
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!
77 2021-03-24 back pain, joint pain Severely sore left arm; chills, headache; fever; severe back and knee pain; fatique
77 2021-03-24 neck pain, joint pain severe pain emanating from injection site; traveled upward over shoulder; continued up right side of... Read more
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.
77 2021-03-24 neck pain She has constant spiking of her blood pressure (BP) and lack of sleep/She has been in and out of the... Read more
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.
77 2021-03-25 armpit pain Pain in left armpit and left breast. Entire left arm swollen and reddened. Upper arm covered with bl... Read more
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.
77 2021-03-26 limb discomfort Pain in left left behind Calf also behind Thigh Swollen vein in left arm from wrist to high way up m... Read more
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
77 2021-03-26 muscle swelling, joint swelling Swelling, joints and muscles, all over body
77 2021-03-27 joint pain Woke up with headache, sweats, chills, joint pain, and low grade fever. Stayed in bed for a day and ... Read more
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).
77 2021-04-01 grip strength decreased The 2-3 days after the shot my mom got a fever (over 100 degrees) and the chills which we were able ... Read more
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,
77 2021-04-04 muscle pain, back pain, neck pain Severe muscle/nerve pain in neck, back, gluts, hamstrings while in bed from 3 am to 6 am. It has oc... Read more
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.
77 2021-04-06 back pain Couldn't breathe/shortness of breath; Back pain; blood pressure was high; was just sick; This is a s... Read more
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.
77 2021-04-06 muscle pain Diffuse body aches, muscle tenderness and neuropathic pain beginning 1 day following injection. No ... Read more
Diffuse body aches, muscle tenderness and neuropathic pain beginning 1 day following injection. No abnormal physical exam findings.
77 2021-04-07 back pain fever up to 101 F; itching; severe head and spine pain; severe head and spine pain; Extreme fatigue;... Read more
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.
77 2021-04-08 back pain headache; fever; severe back and leg pain; severe back and leg pain; fatique; Extremely sore arm; ch... Read more
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.
77 2021-04-09 muscle pain sciatic nerve just blow up. This time it quickly turned into tremendous pain; no energy; I slept mos... Read more
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.
77 2021-04-12 back pain Extreme headache rot. Side of head, extreme back pain in left wing one , Runny nose, Chills to... Read more
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
77 2021-04-12 muscle pain Severe muscle pain in middle of night for two weeks. Went to clinic and got gabapentin. No effect. W... Read more
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.
77 2021-04-13 neck pain right ear and right neck pain.right foot pain and swelling.fatique. dysequilibrium. diffuse pruritis
77 2021-04-16 muscle pain Developed massive Pulmonary Blood Clots in both lungs. First symptom was shortness of breath and fe... Read more
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).
77 2021-04-17 joint pain joints were sore; This is a spontaneous report from a contactable consumer (patient). A 77-year-old ... Read more
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.
77 2021-04-19 weight decreased PFIZER-BIONTECH COVID-19 VACCINE EUA. Patient received vaccination on 2/10/21. No adverse reaction... Read more
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.
77 2021-04-21 muscle pain Patient tested for COVID-19 PCR on 4/10/21; >2 weeks after fully immunized w/ Pfizer on 3/18/21. Pat... Read more
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.
77 2021-04-23 muscle pain, bone pain bone very painful for 24 hours; Extreme fatigue; weakness; muscle and bone very painful for 24 hours... Read more
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.
77 2021-04-26 joint pain, neck pain Client c/o sore LD. Minutes later c/o neck and shoulder pain. Nurse called EMT to do vitals on cli... Read more
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.
77 2021-04-26 muscle pain Started feeling like kind of small lumps in that muscle or little below; redness; Muscle soreness; i... Read more
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.
77 2021-04-29 neck pain Patient presented with acute onset neck pain radiating into her arms bilaterally on 4/25. On 4/27 s... Read more
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.
77 2021-04-29 weight decreased Uncontrollable body shaking, high fever, cold and hot sweats, was not aware at times of where I was ... Read more
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.
77 2021-04-30 muscle pain sore throat; swollen glands; she said her throat felt swollen, and like it was closing up; Feeling u... Read more
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.
77 2021-05-01 back pain Burning back pain in the first lumbar dermatome distribution starting on 3/10. Drop attack on 3/17 ... Read more
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
77 2021-05-04 back pain Headache; Backache; fever; nausea; exhaustion; sore throat; dry cough; bronchitis; This is a spontan... Read more
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.
77 2021-05-06 joint pain sx: headache the day after vaccination and local pain in the opposite shoulder (right shoulder) from... Read more
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.
77 2021-05-10 muscle pain headache; sweats; Chills, so bad that my teeth were rattling; fever; muscle aches; exhaustion; This ... Read more
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.
77 2021-05-13 joint pain headache; Exhausted; Chills; Joint Pain; achy pain; Flu; Eye floaters; Feeling Strange; Nauseaus; Di... Read more
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.
77 2021-05-13 muscle pain headache; chills; fever; sore muscles; This is a spontaneous report from contactable Consumer (patie... Read more
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.
77 2021-05-21 weight decreased Had a stroke from blood clot; she lost weight; This is a spontaneous report from a contactable consu... Read more
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.
77 2021-05-23 muscular weakness She got her vaccine, a little diarrhea, a slight headache, foggy brain, overwhelming fatigue, slight... Read more
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.
77 2021-05-25 back pain 5:42 PM Note Telephone call with patient, she has been sick with intermittent fever, runny nose, ... Read more
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
77 2021-05-31 weight increased she may have gained weight; nausea; a real bad headache; This is a spontaneous report from a contact... Read more
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.
77 2021-06-03 joint pain Horrible feeling; Blood pressure goes high; Joint hurt; Fever/ very low temperature; This is a spont... Read more
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.
77 2021-06-04 frozen shoulder Hyperoxia; could not move her body or a finger or anything; Her arm was starting tingling; Tiredness... Read more
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.
77 2021-06-08 joint pain, musculoskeletal discomfort sore shoulder; Shoulder discomfort (Musculoskeletal discomfort); sleepy; This is a spontaneous repor... Read more
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.
77 2021-06-09 musculoskeletal stiffness Benign Essential Blepharospasm; her eyes were red and irritated when she was in for her treatment; h... Read more
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.
77 2021-06-09 muscle pain weakness; muscle pain; tiredness; has not been feeling well; headache; nausea; vomiting; some diffic... Read more
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.
77 2021-06-10 rheumatoid arthritis seronegative rheumatoid arthritis seemed to flare after her vaccines; This is a spontaneous report f... Read more
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.
77 2021-06-11 neck pain, joint pain Soreness at injection site (3 days) Swollen lymph glands (2 days) Lethargy (2 days) Fever spikes (da... Read more
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)
77 2021-06-16 joint pain, muscle pain I'm experiencing muscle and joint pain on the right side arm and hands. On the left side inside musc... Read more
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.
77 2021-06-16 back pain, joint pain 2/22/2021 - Tested positive for Covid 3/9/2021 - found down at her SNF, taken to ER. complains of lo... Read more
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
77 2021-06-16 limb discomfort she had 5 days of exhaustion where she felt like she couldn't get out of her chair; she was also ver... Read more
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.
77 2021-06-24 joint pain, neck pain, tendonitis Head pain; Pain on jaw bone; Pain on both sides of the nose; Pain in neck and shoulders; Froze up he... Read more
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.
77 2021-06-24 limb discomfort hard time walking; tiredness; foot swollen; foot hot to touch; Since receiving the vaccine she has b... Read more
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
77 2021-06-24 muscle pain Little bit weak today; sore muscle; body ache; had chills too; I would feel bad.; if I smell food, i... Read more
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.
77 2021-06-29 joint pain Difficulty breathing/she could barely breathe; felt like her "left lung is made of stone"/felt like ... Read more
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.
77 2021-06-29 joint pain cramps in stomach; chills; aches in joints; Diarrhea; This is a spontaneous report from a contactabl... Read more
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.
77 2021-07-05 back pain, weight decreased very weak/wrung out in morning. Happened two more mornings over next two weeks. My heart normally ... Read more
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.
77 2021-07-06 rheumatoid arthritis Flare of her RA/ rheumatoid arthritis really got bad and painful in joints; This is a spontaneous re... Read more
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.
77 2021-07-12 neck pain, joint pain I first lost my nail. It was unusual because there was no trauma to the nail. I was reaching for som... Read more
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.
77 2021-07-15 joint swelling RIGHT ARM HURT THE NEXT MORNING. LEFT ARM HURT THE 2nd MORNING. A WEEK LATER MY BLOOD PRESSURE WEN... Read more
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.
77 2021-07-15 muscle tightness Apr 28th began noticing right upper abdominal pain, from the sternum area, down and around base of ... Read more
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.
77 2021-07-21 neck pain Pericarditis S/S: actue chest pain or pressure, Chest pain made worse bu lying down, deep inspiratio... Read more
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
77 2021-07-28 joint swelling, joint pain July 28 2021 woke up with slight cough , sore throat, also had some knee pain July 29 woke up 4;30 a... Read more
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
78 2021-01-09 muscle pain, joint pain Tiredness, headache, muscle pain, chills, joint pain, fever, feeling unwell, nausea, weakness
78 2021-01-13 neck pain During 15 minutes post observation period, patient c/o mild posterior headache and neck pain. BP 166... Read more
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.
78 2021-01-14 joint pain, muscle pain Injection site pain,tiredness,headache,muscle pain,chills, joint pain,nausea,feeling unwell, tempera... Read more
Injection site pain,tiredness,headache,muscle pain,chills, joint pain,nausea,feeling unwell, temperature 99.6
78 2021-01-15 joint pain 7 am. 1/13/2021 increased poly arthritis joint pain Chills Headache Malaise . Tylenol every 6 hour... Read more
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
78 2021-01-17 joint swelling Three Swollen left fingers Swollen left knee
78 2021-01-28 weight decreased She has shrunk; weighs less. Maybe 154 pounds. She was 170; she got first dose of Pfizer COVID vacci... Read more
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.
78 2021-01-31 joint pain Intense headaches starting night of injection, lasted for days. I felt weak, pains in my legs ankles... Read more
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.
78 2021-01-31 musculoskeletal pain Body aches, low gr. temp. aches into her buttocks area down back of post. thighs. She did have Covid... Read more
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.
78 2021-02-01 armpit pain Patient received Shingles Vaccine on 01/6/2021 and COVID-19 Vaccine on 01/26/2021. Pt began with ras... Read more
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
78 2021-02-01 weight increased she had a wave that started at the top of her head and felt like she was losing consciousness and th... Read more
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.
78 2021-02-03 muscle tightness Pt alerted circulating RN that she was feeling tightening in her throat. Pt mentioned that she wante... Read more
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.
78 2021-02-07 musculoskeletal stiffness, muscle pain Severe muscle pain/stiffness in right side mid back, right thigh, right arm.
78 2021-02-07 muscle pain Severe Muscle ache over entire body. 1st day bedridden. 3rd day improving. 1st evening trying to ... Read more
Severe Muscle ache over entire body. 1st day bedridden. 3rd day improving. 1st evening trying to sleep I had very vivid, realistic dreams.
78 2021-02-08 back pain accute hypothermia (93.3 degrees),pounding headache, pain from base of neck all down spine. temp ca... Read more
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.
78 2021-02-10 joint pain shoulder soreness and fever
78 2021-02-10 joint pain Mild headache; chills; some joint pains; This is a spontaneous report from a contactable consumer (p... Read more
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.
78 2021-02-10 musculoskeletal discomfort, musculoskeletal stiffness, joint pain Exhaustion onset about 8:00 PM 1/26/21 lasting over 36 hours before starting to feel better. I lite... Read more
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
78 2021-02-13 muscle pain muscle aches, tired
78 2021-02-15 muscle pain, joint pain Fever over 100 degrees, muscle aches and joint pains, general weakness and malaise, at approximately... Read more
Fever over 100 degrees, muscle aches and joint pains, general weakness and malaise, at approximately 20 hours after injection, until about 30 hours after.
78 2021-02-16 back pain Very High Blood Presser---Concerned about a Heart Attach--Teeth Aching--Back Pain--Chest Pain--Feeli... Read more
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.
78 2021-02-19 muscle pain Swelling. And pain injection site, severe muscle pain whole body
78 2021-02-19 neck pain, joint pain, back pain, musculoskeletal pain, muscle pain Pfzer-BioNTech Covie19 Vaccine EUA. Joint and muscle pain in neck, shoulders, lower back, buttocks,... Read more
Pfzer-BioNTech Covie19 Vaccine EUA. Joint and muscle pain in neck, shoulders, lower back, buttocks, legs.
78 2021-02-21 joint pain Low grade fever which reached 99.8 degrees joint ache
78 2021-02-24 joint pain I have osteoarthritis, with Heberden's nodes on all of my fingers. 3 days ago the two nodes on the... Read more
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.
78 2021-02-24 joint pain Day 5 of Moderate to severe bilateral hand and wrist pain following Pfizer 1st COVID-19 injection 0n... Read more
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.
78 2021-02-24 bone pain, joint pain, muscle pain Extreme pain and burning sensation in abdomen (Day 4-6), extreme pain (bone/joints/muscles) in left ... Read more
Extreme pain and burning sensation in abdomen (Day 4-6), extreme pain (bone/joints/muscles) in left arm (Day 6-8)
78 2021-02-26 joint pain "Pfizer-BioNTech COVID-19 Vaccine EUA" My left arm/shoulder had pain shortly after the vaccination. ... Read more
"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.
78 2021-02-28 joint pain, muscle pain Severe headache; Feeling unwell; Joint pains; Muscle pains; Difficulty breathing; Chest pain; Tiredn... Read more
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.
78 2021-02-28 muscular weakness Immediate weakness in right arm, flushing of face and chest, minor shortness if breath
78 2021-02-28 musculoskeletal pain itching, swelling and rash in the genital and anal area, itchy also on her legs, was sore in the glu... Read more
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)
78 2021-02-28 weight decreased lost 3 pounds; chills; Sheets were soaking wet, she kept having to urinate; Kept having to urinate; ... Read more
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.
78 2021-03-01 muscular weakness Neurology consult 2/13/21: This is a 78-year-old female we were consulted by Dr. for possible guill... Read more
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
78 2021-03-02 muscle pain, joint pain Headache; pains in knee and muscle above knee; pains in knee and muscle above knee; Fever; This is a... Read more
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.
78 2021-03-04 muscular weakness, joint pain, muscle pain Excessive shivering/shaking; weakening of lower legs; spiked high temp during the night into the n... Read more
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.
78 2021-03-07 joint pain Extreme fatigue, lightheaded and dizziness, extreme joint pain, vision blurryness and sore eyes, ... Read more
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.
78 2021-03-07 back pain Patient experienced bad back pain, stomach spasms on night of vaccine. Starting on 2/28 hives and w... Read more
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.
78 2021-03-08 back pain, joint pain Mild diarrhea, loss of appetite, back ache, and hip ache. All were mild and lasted two to six days.... Read more
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.
78 2021-03-13 muscle pain, joint pain I was vaccinated with Pfizer for the first time 11 days ago. Within a few minutes of being vaccinate... Read more
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.
78 2021-03-14 limb discomfort No discomfort in arm for 2 weeks after vaccination. Full pain in most of left arm
78 2021-03-15 limb discomfort, arthritis, muscle pain Reported after receiving the first COVID-19 Vaccine dose she had muscle pain that lasted about 2 wee... Read more
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.
78 2021-03-20 muscle pain Lightheadedness; tired; aches in her hands; corner of her eye and around it was itching really bad; ... Read more
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.
78 2021-03-24 joint pain Severe migraine headache and multiple joint pain until steroids Mar 21, now slight headach. Swollen ... Read more
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.
78 2021-03-27 joint pain, muscle pain A week later, flu like symptoms: slight fever ( 99-100)r joint and muscle aches and pains, fatigue, ... Read more
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.
78 2021-03-27 muscular weakness, joint pain The injection was given high up on my arm and was very painful. About an hour after receiving the s... Read more
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.
78 2021-03-28 muscle pain, muscular weakness Migraine 10 hours? Headache and foggy head on and off for four weeks? Muscle pain and weakness upper... Read more
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.
78 2021-03-29 joint pain Moderate to severe bilateral wrist pain; Moderate to severe bilateral hand pain; This is a spontaneo... Read more
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.
78 2021-03-29 muscle pain pt stated that about an hour after she got the vax she had severe headache, extremely tired and pain... Read more
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.
78 2021-03-30 joint pain, weight decreased, musculoskeletal chest pain cannot take good deep breaths because of the soreness in her ribs; soreness in her ribs; She had no ... Read more
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.
78 2021-03-30 back pain, musculoskeletal chest pain Back pain; leg pain; general rib pain; This is a spontaneous report from a contactable consumer (pat... Read more
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.
78 2021-03-30 muscular weakness Trembling; muscle weakness; palpitations; light headed, dizziness; slight headache; This is a sponta... Read more
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.
78 2021-03-30 neck pain Swelling on her right ear; Symptoms of the flu/side effects like the flu; Diarrhea/bad diarrhea; Uri... Read more
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.
78 2021-04-02 joint pain, muscle pain Headache at base of skull 1st night (Sun), next morning all muscles ached, significant pain in many ... Read more
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.
78 2021-04-03 weight increased Weight: She has gained weight since covid; This is a spontaneous report from a contactable consumer ... Read more
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.
78 2021-04-03 weight increased gained weight since COVID,she was 136 pounds and she just weighed herself and weighs 142 pounds; she... Read more
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.
78 2021-04-05 muscular weakness PROGRESSIVE LEG WEAKNESS, CONCERN FOR GUILLIAN BARRE
78 2021-04-06 joint pain pt states that she has sore left arm. Pt has metal screws and plates in her left ankle and later th... Read more
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.
78 2021-04-07 back pain On day 12 muscle discomfort in quadriceps; discomfort in lower back; This is a spontaneous report re... Read more
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.
78 2021-04-07 neck pain Sore neck was reported as worsened; Sore neck; sore arm; This is a spontaneous report from a contact... Read more
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.
78 2021-04-08 joint pain, neck pain 3/27 got 1st pfizer vaccine in her right arm had injection site pain for a week and finally resolv... Read more
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
78 2021-04-08 gout Pt states that 3 days after her Pfizer covid vaccine, she developed swelling and pain of left hand. ... Read more
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.
78 2021-04-09 joint pain, muscle swelling, back pain 2/24/2021 thru 3/1/2021 - Left Arm pain and tenderness at injection site - less pain each day. Trea... Read more
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
78 2021-04-12 muscle pain passed out for a very short period of time; was awakened by total body shaking and it was not just ... Read more
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.
78 2021-04-14 back pain Critical Limb Ischemia Symptoms: Progressive BL lower extremity and back pain starting on 3/20/2021... Read more
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.
78 2021-04-14 joint swelling After 5 minutes of receiving vaccine, patient became nauseous. Once home, she complained of dizzines... Read more
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.
78 2021-04-15 joint pain injection site pain; tiredness; joint pain; slight fever (<100F); chills; nausea; feeling unwell; Th... Read more
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.
78 2021-04-17 joint pain, muscle pain Extreme joint and muscle pain, extreme fatigue I took tyleno, tramadol and advil at the appropriate ... Read more
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.
78 2021-04-17 joint disease, muscular weakness aftereffects lingered for over 2 weeks and I am still somewhat compromised; headaches; weak legs- ar... Read more
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
78 2021-04-20 neck pain Acute headache radiating to neck and right shoulder and right eye. Acute hypertension with hypertens... Read more
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
78 2021-04-23 joint pain severe pain; joint pain; headache; fever; nausea plus heavy chest feeling; Have persistent cough; He... Read more
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.
78 2021-04-24 joint pain, muscle pain Sundowning/sundowners; feel tired/Tiredness; headache on right side of head/not terrible, not like a... Read more
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.
78 2021-04-25 limb discomfort left arm feels "heavy", warm to touch and continued redness at injection site. No pain or tenderness... Read more
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.
78 2021-04-26 joint pain she just felt dizzy so fast and passed out; passed out; She hurt her ankle from it; This is a sponta... Read more
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.
78 2021-04-26 muscle tightness Client received the COVID vaccine (Pfizer dose 2, lot #EW0179, expiration date 4/28/2021) at 1330. A... Read more
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.
78 2021-04-27 musculoskeletal discomfort hips were hurting; having hard time getting up and down; This is a spontaneous report from a contac... Read more
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.
78 2021-04-27 weight decreased urgent continuous diarrhea, abdominal cramps, weight loss (5 lbs) in 3 days, dehydration, low blood ... Read more
urgent continuous diarrhea, abdominal cramps, weight loss (5 lbs) in 3 days, dehydration, low blood pressure. clear liquid diet, blood pressure medications adjustment
78 2021-05-02 arthritis Patient experienced an arthritis flare after the 1st dose, and this became much more intense after t... Read more
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.
78 2021-05-04 joint pain Pain; a lump down from where the injection site was/ lump in the arm, 4 inches down from the shoulde... Read more
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.
78 2021-05-10 bone pain, joint pain, muscle pain muscle and joint aches; muscle and joint aches; teeth and bones hurt; teeth and bones hurt; chills; ... Read more
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.
78 2021-05-10 muscular weakness, joint pain, muscle pain intestinal problems after she eats, and feels like intestinal flu; Balance is off; feeling unwell, j... Read more
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
78 2021-05-16 musculoskeletal stiffness 2 1/2 hours after receiving 2nd shot, I developed total stiffness in back could barely stand up stra... Read more
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.
78 2021-05-21 joint pain, back pain WOKE UP NEXT DAY WITH ACHING IN MY LEFT HIP AREA, CONTINUED TO GET WORSE THAT DAY AND NEXT DAY TO TH... Read more
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.
78 2021-05-22 joint pain About 45 minutes after 2nd shot I had very odd feeling of lightheaded and dizzy. Also felt like a t... Read more
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
78 2021-05-24 joint pain 1 week later - aches (arthritis was worse), leg cramping, general feeling of being unwell seems to c... Read more
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
78 2021-05-24 muscle tightness, joint pain feeling a click right before her fast heartbeat then drink water and slows it down/something clicks ... Read more
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.
78 2021-05-24 neck pain The patient called in around 1:00 pm on 5/25/21 to report symptoms after vaccine. She said that she ... Read more
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.
78 2021-05-25 joint pain, musculoskeletal stiffness, groin pain back was so stiff; extremely difficult to stand; When I was in a standing position, an Electric bolt... Read more
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.
78 2021-06-07 weight decreased very serious extreme anxiety; nausea, severe nausea, where she couldn't eat; Severe Headache; Abdomi... Read more
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.
78 2021-06-08 joint pain, neck pain She also is diabetic and has high eye pressure.; The pain is going to her neck and does not let her ... Read more
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.
78 2021-06-10 musculoskeletal stiffness Pain and stiffness in hands. Pain and stiffness all the time.
78 2021-06-13 muscular weakness 12 hours after vaccine patient developed bilateral lower extremity "paralysis". She felt feverish a... Read more
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.
78 2021-06-14 joint pain Left arm was sore when received the vaccine which she expected. Then it started traveling and now i... Read more
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.
78 2021-06-14 joint pain right knee arthralgias and effusion started day after, persistent at office visit 6/15 concerning fo... Read more
right knee arthralgias and effusion started day after, persistent at office visit 6/15 concerning for reactive arthritis
78 2021-06-14 muscular weakness I woke up the next morning with a very soar arm, a fever, chills and so achy. The next day, the fev... Read more
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.
78 2021-06-15 musculoskeletal stiffness Lips tingling/Tongue started to tingle; Face red which felt like swollen; Face red which felt like s... Read more
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.
78 2021-06-16 muscular weakness Swelling, pain and weakness in right arm. The symptoms were diagnosed as lymphedema. Treatment consi... Read more
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.
78 2021-06-18 musculoskeletal pain, joint pain Pain in the shoulder; Hurt when I take a deep breath (lasted for days), pain radiated around my brea... Read more
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.
78 2021-06-23 neck pain, joint pain day after getting the 1st dose she got a headache/chills/low temp/couldn't more left arm/arm, neck a... Read more
day after getting the 1st dose she got a headache/chills/low temp/couldn't more left arm/arm, neck and shoulder pain
78 2021-06-24 joint pain, musculoskeletal stiffness Beginning approximately two days after my first vaccine shot, I have experienced joint pain and stif... Read more
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.
78 2021-06-24 joint pain joints are very sore and achy/Joints really hurt after second dose; This is a spontaneous report fro... Read more
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.
78 2021-06-24 joint pain itching; Rash; fatigue; joint pain; low blood sugar; This is a spontaneous report from a contactable... Read more
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.
78 2021-06-24 musculoskeletal stiffness, limb discomfort spasms; her arms "tightens up" during the night; having trouble sleeping/she barely sleeps 3-4 hours... Read more
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.
78 2021-06-29 muscle pain neck spasms; diarrhea; the urge to go to the bathroom all day long; a bloating abdomen with a lot of... Read more
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.
78 2021-06-29 weight decreased, muscular weakness Individual contacted 06/27 to report event s/p 2nd Pfizer COVID-19 injection. Caller shared she exp... Read more
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".
78 2021-06-30 polymyalgia rheumatica polymyalgia rheumatica; Patient received the vaccine in left arm on 03Apr2021. On 05Apr2021 he exper... Read more
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.
78 2021-07-01 joint pain, muscle pain Headache; Chills; Muscle ache; Joint ache; Left arm pain; Feeling "sick"; Slight fever; This is a sp... Read more
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.
78 2021-07-06 joint pain, joint swelling, back pain Nausea; Flu like symptoms; a flare with hands and achiness/sitting for long times everything started... Read more
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.
78 2021-07-06 back pain Pfizer COVID 19 Vaccine EUA Pfizer Dose 1 2/26/21 (EN6198) Pfizer Dose 2 3/18/21 (EP7534) COVID Pos... Read more
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..
78 2021-07-06 back pain Colon cancer metastatic; Lung disorder; Kidney stones; Kidney cancer; Vomiting; Pain worsened; Back ... Read more
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.
78 2021-07-08 joint pain, muscle pain severe heartburn; Headache; Chills; joint pain; muscle aches and pains; Fatigue; This is a spontaneo... Read more
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.
78 2021-07-12 joint pain hives, vertigo, dizziness, knee pain, paralysis of knees down. severe stomach pain.
78 2021-07-15 joint pain, muscle pain I am a very active 78 yr old women. Ever since I had the vaccine, my joints and muscles in legs and ... Read more
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.
78 2021-07-17 back pain, bone pain, joint pain shoulder blades started hurting/then the pain went down to both hips and her back too; collar bones ... Read more
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.
78 2021-07-20 joint pain I had no issues with 1st dose. After taking the 2nd dose, I played golf afterwards. By the end of th... Read more
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.
78 2021-07-21 joint pain same pain feeling in bladder and pelvis; Sore arm; had pain that was just in the knee replacements, ... Read more
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
78 2021-07-27 joint pain, muscular weakness, muscle pain high fever; joint pain; some weakness in her legs/severe muscle weakness; headache; nausea; she was ... Read more
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.
78 2021-07-27 muscular weakness, muscle pain, back pain, joint pain and really horrible radiating pain down both of her legs, front and back.; She also said there was n... Read more
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.
78 2021-07-28 muscle pain Sx onset 7/15/21 with cough, chills & muscle aches. Visited son, his wife & newborn. Son and DIL are... Read more
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.
78 2021-07-28 muscle pain Sx onset 7/15/21 with cough, chills & muscle aches. Visited son, his wife & newborn in another locat... Read more
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.
79 2021-01-04 armpit pain, back pain, musculoskeletal stiffness pain under right arm pit; very stiff neck; pain radiating into ear; pains radiating down right arm, ... Read more
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.
79 2021-01-10 musculoskeletal stiffness Resident had seizure like activity followed by a vagel response with large bowel movement. Resident ... Read more
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.
79 2021-01-17 muscle pain muscle pains-runs down left leg/thigh, chills, arm pain soreness after vaccination along with itchin... Read more
muscle pains-runs down left leg/thigh, chills, arm pain soreness after vaccination along with itching, frequent urination
79 2021-01-18 muscle pain, musculoskeletal stiffness, joint pain Tired, headaches, muscle pains, chills, stiff neck, overall unwell feeling, joint pain, nauseous
79 2021-01-20 joint swelling Swollen right index finger and joint. Quite painful - most pain is subsided but swelling is still t... Read more
Swollen right index finger and joint. Quite painful - most pain is subsided but swelling is still there on joint.
79 2021-01-22 joint pain right arm unusable for 48 hours following injection, high blood pressure (200)4th day, TMJ 4th and ... Read more
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
79 2021-01-23 muscle pain Severe chills/shaking cold Severe body/muscle aches Day of/could not walk unassisted Severe nausea/... Read more
Severe chills/shaking cold Severe body/muscle aches Day of/could not walk unassisted Severe nausea/throwing up Fever No appetite
79 2021-01-27 limb discomfort Started on 1/25/2021. Patient developed palpable purpura and petichia to bilateral lower legs. Plate... Read more
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.
79 2021-01-28 muscle pain, back pain Vaccine at 11:;50 am. 9:30 pm severe pain in left leg with cramps. then right leg but not as severe... Read more
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.
79 2021-01-29 joint pain Cough, shortness of breath, fatigue, body aches, headache, runny nose, congestion Today 1-30-2021 he... Read more
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 2021-01-29 muscle pain Flu like symptoms for approximately 24 hours. Headache, muscle aches. Course of action Tylenol.
79 2021-01-31 musculoskeletal stiffness Left side of neck has been very stiff since the shot was given.
79 2021-02-01 joint pain Arm pain to shoulder, chills, flu kind symptoms. Body ache.
79 2021-02-03 muscle pain, muscular weakness 79 yo female with past medical history only significant for endovascular coiling of cerebral aneurys... Read more
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.
79 2021-02-04 muscular weakness Severe headache 4 hours after shot, generalized muscle weakness all over 12-15 hours after shot (fel... Read more
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
79 2021-02-05 joint pain According to patient he began having intense shoulder pain 2 days after his Covid vaccine. 1 week a... Read more
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.
79 2021-02-05 joint pain EXTREME BODY AND JOINT PAIN, CONSTANT,
79 2021-02-14 back pain Burning sensation on skin on Feet on Back; Burning sensation on skin on Feet on Back; Burning sensat... Read more
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
79 2021-02-14 joint swelling Swollen knee right, Difficulty up and down stairs especially up. Initial trouble standing.. Lifting ... Read more
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.
79 2021-02-17 back pain I received my vaccine on Sunday, work up Monday with sore arm which I expected. Monday night around ... Read more
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.
79 2021-02-21 joint pain, neck pain After two days, had sore arm, sore shoulder and neck. 4 days after very tired,, and felt like had fl... Read more
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.
79 2021-02-21 joint pain to ER on 2/19/21 breathing difficulty, hoarse voice , chest pain, skin itchy, headache, edema, body... Read more
to ER on 2/19/21 breathing difficulty, hoarse voice , chest pain, skin itchy, headache, edema, body joint pain, elevated B/P
79 2021-02-24 joint pain Headache, stomach cramps, dizziness, shaking, fatique, joint pain, nausea
79 2021-02-24 muscle pain, joint pain When making way to the bathroom, patient got dizzy and fell head first onto hardwood floor injuring ... Read more
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.
79 2021-02-26 muscle pain Sore throat, headache, muscle aches and fatigue for two (2) days then gone. No treatment was sought... Read more
Sore throat, headache, muscle aches and fatigue for two (2) days then gone. No treatment was sought.
79 2021-02-28 limb discomfort chills for 2 days, then itchy for several days, then urine burning, then nerve jumping in arms, the... Read more
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
79 2021-02-28 muscle pain, joint pain When I started to get ready for bed I was overcome with fatigue, and I went to sleep and I woke up t... Read more
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.
79 2021-02-28 muscle pain pain in the injection site and arm/pain at injection site all the way to her elbow; pain in the inje... Read more
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.
79 2021-03-01 joint pain shoulder and arm sore, rt arm, drowsiness, memory issues
79 2021-03-01 muscle pain tingling lips, itchy red cheeks - on the way home Saturday muscle aches from neck to ankles - during... Read more
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
79 2021-03-02 joint pain pain in her hand/ lower part of each finger hurt; joint pain in right hand; bled quite a bit; This i... Read more
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.
79 2021-03-02 muscle pain CHILLS 3-4 HR DURATION,FATIGUE.AND MUSCLE ACHES
79 2021-03-02 muscle pain shaking chills (rigor) 12H post shot; muscle aches; headache; fatigue (slept all next day); brain fo... Read more
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.
79 2021-03-02 rheumatoid arthritis, joint pain She did have an inflamed shoulder prior, it has been pretty good lately but flared up after the vacc... Read more
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.
79 2021-03-03 back pain, weight decreased Achy body, backache, neck ache, weak, low appetite, losing weight, no energy
79 2021-03-04 joint pain Patient presented to ED o 2/13 for right knee pain post fall (pain level 10/10) starting 11/3/2020 p... Read more
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.
79 2021-03-04 muscle pain At approximately 8PM I began to have significant chills. They lasted most of the night. By morning I... Read more
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.
79 2021-03-06 joint pain, neck pain Three days after second vaccine, I started to get sore in left shoulder, two hours later the pain ha... Read more
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.
79 2021-03-06 joint pain At about 4:45 AM the following day after receiving my second Covid-19 vaccine shot, I experienced a ... Read more
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.
79 2021-03-06 back pain, muscle strain Patient had shot Tue. eve.2/9. Woke up Sat AM with sever lower back pain to where she could not stan... Read more
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
79 2021-03-07 joint pain pt stated that several days later she started having trouble with her left leg, hip and foot. Pt we... Read more
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.
79 2021-03-07 muscle tightness, muscle pain Quivering muscle pain when attempting to stand and to sit; Thigh muscles still feel quivering and ti... Read more
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.
79 2021-03-08 musculoskeletal stiffness Headache, stiff neck, left arm hurt to use it.
79 2021-03-11 joint pain Patient presented to the ED 3/11/2021 after rolling out of bed and landing on her right knee. Patien... Read more
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.
79 2021-03-11 muscle pain severely cold, short of breath, exhaustion, muscle pain, nausea, fast heart rate, dizzy, weak
79 2021-03-15 muscle tightness leg cramps and tightness walking.
79 2021-03-18 muscle pain, joint pain, musculoskeletal stiffness muscle tendon pain on the left side of neck/pain went to right side of neck/pain appeared both sides... Read more
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.
79 2021-03-20 joint swelling swelling in her right knee, not sore or hurt, just swelling.; This is a spontaneous report from a co... Read more
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.
79 2021-03-22 musculoskeletal chest pain It started with a feeling as though I was getting a sore throat. I took an Emergen-C drink and wen... Read more
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.
79 2021-03-23 muscle pain Stood up to go to the bathroom and could not put her right leg down; thought she was having a heart ... Read more
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.
79 2021-03-24 joint pain AFTER THE FIRST SHOT ABOUT 10 DAYS LATER MY RIGHT KNEE AND RIGHT HIP (BOTH HAVE BEEN REPLACED ) WERE... Read more
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.
79 2021-03-25 joint pain, musculoskeletal stiffness Initial rash on forehead after first injection. After second dose several weeks later she immediatel... Read more
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.
79 2021-03-25 joint pain Joint pain 1st day to present, deep red skin lesions 3rd day to present, welts, head blisters4th day... Read more
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,
79 2021-03-26 joint pain Pain when using my left hip which was replaced more than five years ago and has not given me any pro... Read more
Pain when using my left hip which was replaced more than five years ago and has not given me any problems until now.
79 2021-03-28 joint pain Very severe malaise, nausea, lack of appetite, weakness, urinary frequency (every 15 min x 2 days - ... Read more
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)
79 2021-03-29 joint pain Headache; very sore joints; so weak had trouble walking; so weak had trouble walking; went to bed ni... Read more
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.
79 2021-03-29 musculoskeletal stiffness, muscle pain, joint pain Very sore arm. Achey joints muscles, extreme fatigue, stiff neck, "fuzzy" thinking. Most gone afte... Read more
Very sore arm. Achey joints muscles, extreme fatigue, stiff neck, "fuzzy" thinking. Most gone after one day. Arm still a little sore.
79 2021-03-29 muscle pain sore arm, all muscles ached, wierd, dreams couldn't sleep
79 2021-03-30 back pain, joint pain Pain in both shoulders and back. Onset day after 1st vaccine and still continues.
79 2021-03-30 muscle swelling muscle in the crock of my arm is swollen; This is a spontaneous report from a contactable consumer o... Read more
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.
79 2021-03-30 weight decreased This is a spontaneous report from a contactable consumer (patient). A 79-year-old female patient rec... Read more
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.
79 2021-03-31 musculoskeletal stiffness, muscle pain Severe headache; muscle aches and stiffness; dizziness; elevated BP (related???)
79 2021-04-01 joint pain, joint swelling severe pain, swelling of Right DIP joint right index finger, thumb and wrist. Acute onset. No fever.... Read more
severe pain, swelling of Right DIP joint right index finger, thumb and wrist. Acute onset. No fever. Responded to 400 mg oral ibuprofen.
79 2021-04-06 joint pain, muscle pain suspected COVID-19 with symptoms; suspected COVID-19 with symptoms; exploding diarrhea; extreme tire... Read more
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.
79 2021-04-06 armpit pain Adverse Event: Intense achy pain near left armpit Treatment: Moist heating pad Outcome: Pain lessene... Read more
Adverse Event: Intense achy pain near left armpit Treatment: Moist heating pad Outcome: Pain lessened; 20 minutes x2 with heating pad
79 2021-04-08 joint pain 2ND DAY AFTER 2ND SHOT, EXTREME PAIN IN HIP JOINT YOU SIT ON; NO UPPER BACK PAIN. TOOK 2 EXTRA STRE... Read more
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.
79 2021-04-08 musculoskeletal stiffness Pt had fever 102; stiff neck; blinding headache; vomit for 14 hours
79 2021-04-09 joint pain couldn't walk straight; use a cane; Guillain-Barre syndrome; left knee and left hip were so painful;... Read more
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.
79 2021-04-09 limb discomfort left arm soreness; Lack of energy; This is a spontaneous report from a contactable consumer (patient... Read more
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.
79 2021-04-09 muscle pain headaches; pretty serious muscle aches; projectile vomiting; fever; chills; massive diarrhea; tiredn... Read more
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.
79 2021-04-10 joint pain Vomiting and diarrhea two hours after shot. Foggy head for 4 days. Severe joint pain for for 3 days... Read more
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.
79 2021-04-20 back pain Developed significant bruising within minutes/hours and has had significant limb pain for 11 days. A... Read more
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
79 2021-04-20 bone pain Onset of chills, fever, deep ache in bones of face, jaw, neck, upper arms, chest and back. Restlessn... Read more
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.
79 2021-04-21 back pain Severe back and leg pain lasting at least 6 weeks; still continuing, but now about 60% better than i... Read more
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.
79 2021-04-22 joint pain, joint swelling, neck pain 1st dose 1/28, second dose 2/21; each time had injection site soreness. 3/26/2021 had onset of pain,... Read more
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.
79 2021-04-23 joint swelling left leg went to sleep and when I stood up I fell on my left foot; Maybe I have just sprained my ank... Read more
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.
79 2021-04-24 joint swelling, neck pain, muscle pain, musculoskeletal discomfort, muscular weakness, back pain, joint pain I went to the hospital with palpitations; lightheadedness; She had terrible back pain in center of b... Read more
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.
79 2021-04-28 neck pain, muscle pain, joint pain hallucinations; Headache; chills; fever; sweats; diarrhea; got ill/not feeling well; Pain behind eye... Read more
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.
79 2021-05-01 limb discomfort, musculoskeletal stiffness Experiencing progressive weakness and numbness in arms and hands. Legs feel heavy. Hands become sti... Read more
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.
79 2021-05-02 neck pain past medical history significant for coronary artery disease s/p PCI, chronic hypoxic respiratory fa... Read more
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
79 2021-05-04 joint pain, muscle pain Shoulder joint pain; muscle pain in left and right arms from my shoulder down to my hands; muscle pa... Read more
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.
79 2021-05-04 muscle pain, joint pain painful muscle; joint aching; temperature of 99.4; injection site pain; dizziness; general feeling o... Read more
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.
79 2021-05-08 muscle pain Severe Lethargy, Muscle aches and pains constantly, Color Blindness to certain colors. Failed the c... Read more
Severe Lethargy, Muscle aches and pains constantly, Color Blindness to certain colors. Failed the color dot test
79 2021-05-09 muscle pain Cough SOB Muscle or body aches, New loss of taste or smell, Congestion or runny nose and Diarrhea
79 2021-05-10 joint pain, muscle pain, muscular weakness muscle pain; joint pain; tiredness; feeling unwell; a little bit of dizziness; losing strength in he... Read more
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.
79 2021-05-10 armpit pain, joint pain, neck pain vary sore arm; pain in part of the neck; bad headache; Injection site swelling; Injection site redne... Read more
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.
79 2021-05-13 muscle pain Pfizer-BioNTech COVID-19 Vaccine EUA - admitted to hospital 04/5/2021with covid-19 after one dose of... Read more
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
79 2021-05-13 muscle pain Arrival Date: 2/14/2021 Discharge Date: 2/18/2021 Primary Discharge Diagnosis: Principal Problem: ... Read more
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
79 2021-05-18 joint pain shortness of breath; experienced white and pink bumps on her face around her lips; experienced white... Read more
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.
79 2021-05-18 back pain ED Discharged 4/4/2021 (2 hours) Hospital ED MD Last attending ? Treatment team Acute cystitis wit... Read more
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.
79 2021-05-25 neck pain tired; cold; head was in a fog; Staggering; Diarrhea; ears were ringing; arm was sore; body ache; ne... Read more
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.
79 2021-05-28 joint pain, back pain, muscle pain a few little chills; I started shaking violently from chills; severe muscle pains all through my bac... Read more
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.
79 2021-05-28 joint swelling no strength at all in her legs and her arms, muscles didn't work at all; Nauseas; Temperature of 100... Read more
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.
79 2021-06-01 joint pain 3/11 woke up with severe chills, joint pain and headache 3/25 experienced numbness down my entire le... Read more
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
79 2021-06-07 joint pain Depressed/depression; It has caused diarrhea that has persisted for 8 weeks; Soreness/her shoulder w... Read more
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 depresse