Pfizer

Nervous system symptom reports

Male, 76 - 89 years

Age Reported Symptoms Notes
76 2021-01-11 pain in extremity mild elevation of his sed rate and leukocytosis; mild elevation of his sed rate and leukocytosis; my... Read more
mild elevation of his sed rate and leukocytosis; mild elevation of his sed rate and leukocytosis; myalgia (was reported as worsened); Arthralgia; Ten days later and still having pain/started in neck and migrated to his back, the buttocks and gluteal and quadriceps area; Ten days later and still having pain/started in neck and migrated to his back, the buttocks and gluteal and quadriceps area; Ten days later and still having pain/started in neck and migrated to his back, the buttocks and gluteal and quadriceps area; Ten days later and still having pain/started in neck and migrated to his back, the buttocks and gluteal and quadriceps area; This is a spontaneous report from a contactable physician (patient). A 76-years-old male patient received bnt162b2 (Pfizer-Biontech Covid-19 Vaccine), via an unspecified route of administration on 23Dec2020 at single dose on deltoid Right for covid-19 immunisation. Medical history included ongoing type 2 diabetes mellitus (diagnosed about 8 years ago). There were no concomitant medications. Patient developed myalgia on 27Dec2020 and arthralgia on 28Dec2020. Patient also experience ten days later and still having pain/ started in neck and migrated to his back, the buttocks and gluteal and quadriceps area in Dec2020. He had labs a few days ago. He had a mild elevation of his sed rate and leukocytosis. Events myalgia and arthralgia considered serious due to medically significant. Outcome of events myalgia (was reported as worsened) and arthralgia was not recovered. Information about batch/lot number has been requested.; Sender's Comments: Based on the time association, the events myalgia and arthralgia are possibly related to suspect bnt162b2 administration. 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 2021-01-13 tremor, seizure Two seizures of Left arm shaking and non-responsiveness with urinary voiding and post-ictal state th... Read more
Two seizures of Left arm shaking and non-responsiveness with urinary voiding and post-ictal state the day after vaccination
76 2021-01-14 bell's palsy morning of 01/13/2021 awakened with early Bell's Palsy on right side
76 2021-01-15 pain in extremity, tenderness Sore and tender right arm, chills, muscle ache, joint pain, some nausea, fatigue starting at about 6... Read more
Sore and tender right arm, chills, muscle ache, joint pain, some nausea, fatigue starting at about 6 PM EST on 1/13/21, worse on 1/14/21 until around 5 PM EST, better on 1/15/21 with some fatigue, but all symptoms recurring again that evening starting around 7 PM EST. I took Tylenol 325 mg around 10 PM EST and went to bed and feel normal so far today 1/16/21.
76 2021-01-15 pain in extremity Sore arm
76 2021-01-25 weakness, feeling cold Weak; Chills and completely ice cold; Chills and completely ice cold; Really sore in injection arm; ... Read more
Weak; Chills and completely ice cold; Chills and completely ice cold; Really sore in injection arm; Joints hurt; This is a spontaneous report from a contactable consumer (patient). This 76-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 11Jan2021 12:00 on arm Left at single dose for covid-19 immunisation. Lot number is EL3, then a number he cannot read, followed by 46. Medical history included type 2 diabetic. No concomitant medications. His joints hurt on 11Jan2021 in later afternoon. It is not worse, but not better. On 12Jan2021, chills and Woke up during night completely ice cold. Had to get a blanket and finally went back to sleep. Feels weak. Doesn't know what happened. Still feels chill. After midnight on the 12Jan2021. Is a little bit better. He was really sore in injection arm on 11Jan2021. Outcome of the event Joints hurt was not recovered. Outcome of the events Chills and completely ice cold was recovering. Outcome of the event Really sore in injection arm was not recovered. Outcome of the event Weak was unknown. Information about lot/batch number has been requested.
76 2021-01-25 pain in extremity Fatigue; mild soreness/arm sore/soreness in the arm; This is a spontaneous report from a contactable... Read more
Fatigue; mild soreness/arm sore/soreness in the arm; This is a spontaneous report from a contactable consumer. A 76-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EJ1686), via an unspecified route of administration on 04Jan2021 15:00 at a SINGLE DOSE for covid-19 immunisation, naproxen sodium (ALEVE), via an unspecified route of administration on 04Jan2021 at an unspecified dose and frequency for an unspecified indication. Medical history included blood pressure abnormal, blood uric acid abnormal, hypersensitivity, blood cholesterol abnormal, all from an unknown date and unknown if ongoing. Concomitant medication included alopurinol (ALOPURINOL), 300mg take once daily by mouth for Uric acid, amlodipine besilate (AMLODIPINE BESILATE) 10mg; take once daily by mouth for blood pressure, atorvastatin calcium (ATORVASTATIN CALCIUM) 20mg; take one half daily by mouth for cholesterol, cetirizine (CETIRIZINE) 10mg take once daily as needed for allergy, omeprazole (OMEPRAZOLE) 20mg; take one twice daily by mouth for uric acid, losartan (LOSARTAN), 100mg; take once daily by mouth for Blood pressure. The patient called regarding the Pfizer COVID 19 vaccine. He received his first dose of the vaccine at the a Hospital. He added he had just taken Aleve before the vaccination. Then he was reading in his heart magazine and it said it could effect the efficacy of the shot if you take aspirin or ibuprofen. He was asking for more information about that and was it okay that he took Aleve. He clarified he received the first dose of the Pfizer COVID 19 vaccine on 04Jan2021 at 15:00 PM in the left arm. He took the Aleve at 08:00 04Jan2021. He reports he had no pain the first day, no soreness in the arm or anything. The next day he had mild soreness in arm like the flu or pneumonia shot. On the third day he was a little fatigued. But by the fourth day he was able to take his usual walk of three or four miles without being winded and he was fine. He was planning for the second dose 25Jan2021 at 15:00. The outcome of the event pain in extremity was recovered on 06Jan2021 and the event fatigue was recovered on 07Jan2021.
76 2021-01-25 pain in extremity He is also experiencing coughing; all I wanna do is sleep; Had aches and pains; He also has joint pa... Read more
He is also experiencing coughing; all I wanna do is sleep; Had aches and pains; He also has joint pain and pain in his right arm, hand, and wrist area; He also has joint pain and pain in his right arm, hand, and wrist area; Diarrhea; He is also very fatigued and does not want to get out of bed and that he is so tired; off and on headaches; This is a spontaneous report from contactable consumers. A 76-year-old male patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EK4176), intramuscular on 06Jan2021 11:28 (also reported as about 1130) at a single dose on left arm for COVID-19 immunization. Medical history included pulmonary fibrosis from 2014 and ongoing, ongoing type 2 diabetes mellitus (Diagnosed probably in 1996-1997; under control). The patient previously had pneumonia shot in 2020 and flu shot in 2020 (few months ago in Oct2020/Nov2020) both for immunization. The patient's concomitant medications were not reported. The patient experienced diarrhea, very fatigued and does not want to get out of bed and that he is so tired, and off and on headaches, all on 07Jan2021. He also has joint pain and pain in his right arm, hand, and wrist area on 11Jan2021. He experienced coughing, somnolence, and had aches and pains on an unspecified date. Patient received the vaccine last Wednesday. He experienced diarrhea (on Thursday and Friday, went away then came back on Yesterday), had aches and pains, and severe fatigue (all I wanna do is sleep). Today he said that he wasn't having diarrhea that can be attributed to him not eating much yet, a few aches and pains, very tired, and a minor headache. He was asking how long do these symptoms usually last. Patient received it last Wednesday 06Jan2021 at about 1130. He said that he has been experiencing side effects, not severe, but on Thursday 07Jan2021 and Friday 08Jan2021, he had diarrhea. He said that on Saturday 09Jan2021 the diarrhea let up and Sunday 10Jan2021 was ok, but yesterday 11Jan2021 the diarrhea was bad. He said that he is also very fatigued ("severe fatigue (all I wanna do is sleep)") on 07Jan2021 and does not want to get out of bed and that he is so tired. He has had no fever, but has had off and on headaches. He said that he also has joint pain and pain in his right arm, hand, and wrist area. He said that it is hard to pick up a cup or glass because of the pain. He said that he got the injection in the left arm. He said that he is also experiencing coughing, but stated that he does have pulmonary fibrosis and it could be that. Diarrhea: patient said that his diarrhea is improved as of today 12Jan2021. Fatigued: he said that he noticed it on 07Jan2021, it subsided Saturday 09Jan2021 and Sunday 10Jan2021, but yesterday and today 12Jan2021 it is very prominent and he is very tired. Headaches: He said that the headaches are not severe, but they were there. He said that the headaches are not there today. Pain in the arm, hand, and wrist area: He said that he noticed the pain yesterday and stated that it is slightly worse. Coughing: He said that he coughs due to the pulmonary fibrosis too and sometimes it is a lot and sometimes it is a little bit. He said that he has to get his second dose on 27Jan2021 at 1500. He stated that his brother died of Covid last Thursday. The outcome of event diarrhea was recovering, of "he is also very fatigued and does not want to get out of bed and that he is so tired", "he also has joint pain and pain in his right arm, hand, and wrist area", and "coughing" was not recovered, of "off and on headaches" was recovered on 11Jan2021, of the events "all i wanna do is sleep" and "had aches and pains" was unknown. No relevant tests. No prior vaccinations within 4 weeks. No family medical history relevant to AE.
76 2021-01-28 tremor, feeling jittery Shakiness; Chills; Feeling jittery; This is a spontaneous report from a contactable consumer. This c... Read more
Shakiness; Chills; Feeling jittery; This is a spontaneous report from a contactable consumer. This consumer reported for self that the 76-year-old female patient received first dose of bnt162b2 (BNT162B2, Pfizer BioNtech Covid-19 vaccine) via unknown route of adminsitration on 15Jan2021 11:30AM on left upper arm at a single dose for covid-19 immunization(lives in senior center and because of his age). Medical history and concomitant medications were none. He is a little shaky, but not had any dizziness or anything. He wanted to make sure it's okay and not interfere with him getting the next dose. Is this normal. Has also had a few chills, but not feeling too bad. Is a little jittery, but is staring to feel better. He did not receive any other vaccines the same time or 4 weeks prior. Did get a flu shot last October (Oct2020) with no problems or reaction. States no history of problems with vaccines in past. Vaccination Facility Type was unknown. No Vaccine Administered at Military Facility. History of all previous immunization with the Pfizer vaccine considered as suspect (or patient age at first and subsequent immunizations if dates of birth or immunizations are not available) was none. Additional Vaccines Administered on Same Date of the Pfizer Suspect was none. No AE(s) require a visit to Emergency Room or Physician Office. Prior Vaccinations (within 4 weeks prior to the first administration date of the suspect vaccine(s)) was none. AE(s) following prior vaccinations was none. Patient's Medical History (including any illness at time of vaccination; Provide other relevant medical history including but not limited to these conditions: diagnosed allergies, compromised immune status, respiratory illness, genetic /chromosomal abnormalities, endocrine abnormalities (including diabetes) and obesity) was none. Family Medical History Relevant to AE(s) was none. Relevant Tests was none. The events started from 15Jan2021 with outcome of not recovered. Information on the lot/batch number has been requested.
76 2021-01-31 weakness Lightheaded, Nauseous and weakness. Hypotensive
76 2021-02-01 numbness, tingling Tingling, numbness in face, arms, hands and down front of both legs. Started second day after shot a... Read more
Tingling, numbness in face, arms, hands and down front of both legs. Started second day after shot and starts first thing in morning, continues throughout day and subsides in evening. I?m in my eight day and problem continues. Made calls to my oncologist and MD and solution or advice received as of this time.
76 2021-02-02 weakness Wife states day after injection client began coughing, weak, pain in joint, tires easily. Returns t... Read more
Wife states day after injection client began coughing, weak, pain in joint, tires easily. Returns to bed at least two times per day, feel rested but upon rising to side of bed becomes weak again. Complaining of shortness of breath. Concerned about COVID infection; states had three negative tests with last test being in December. Was evaluated by Dr. with Family Medicine (his primary care provider was not available) and was prescribed Prednisone 20 mg QD x 5 days and Erythromycin 250 mg QD x 5 days; both have been completed. During office visit lungs were evaluated and reported as clear; physician mentioned a COVID test but none was obtained. Has continual cough with asthma, but feels symptoms have gotten worse since the COVID vaccine; "can't get his strength back". States the weakness, cough, shortness of breath, and joint pain have remained the same since first day noticed and has not seen any improvement since completing Prednisone and Erythromycin. Not on O2; states O2 sat is around 98 - 99%; uses a C Pap Machine. Wished to schedule a COVID test; appointment given for 2/3/2021. Denies dyspnea beyond usual SOB; instructed to seek emergency care if symptoms worsen; indicated understood and would do so if needed.
76 2021-02-02 cold sweat Chills, clammy, extremely fatigued
76 2021-02-02 feeling hot, flushing Immediate warm flushing sensation lasting a couple seconds/coincident with change in taste to a meta... Read more
Immediate warm flushing sensation lasting a couple seconds/coincident with change in taste to a metallic taste. Lasted only a few seconds.
76 2021-02-03 feeling hot Lost all recollection of time and memory for 12 hours. Body heat to severe sweating.
76 2021-02-03 myelitis transverse 1st dose of vaccine was 1/12/21, Lot number EK9231 2nd dose 2/2/21, Lot number EL8982 Patient was ... Read more
1st dose of vaccine was 1/12/21, Lot number EK9231 2nd dose 2/2/21, Lot number EL8982 Patient was feeling well the day of vaccine and reports no recent illness, no adverse events to first injection in COVID vaccine series. 20 minutes later developed dizziness and nausea. Within hours noticed LUE weakness. Weakness has progressed over last two days to severe left upper extremity and left lower extremity weakness with inability to walk. No sensory deficits. Some urinary retention. Hyperreflexia on examination with upgoing toe on left. Presentation consistent with transverse myelitis. Patient remains hospitalized at this time, starting treatment with IV solumedrol for clinical transverse myelitis. Workup remains in process
76 2021-02-03 unresponsive to stimuli Pt son, reports patient passed away on 2/1/21 in the early hours. Pt wife, told Pt's son that patien... Read more
Pt son, reports patient passed away on 2/1/21 in the early hours. Pt wife, told Pt's son that patient started feeling "bad" with common cold like symptoms on 1/31/21, had a temp of 99.0. Pt's wife went to take a shower, when she got out patient was unresponsive. She called EMS, they pronounced patient deceased upon arrival. Pt's son also reports patient and Pt's wife both had their 1st COVID-19 vaccine 13 days prior. He was told by EMT on sight to notify the facility where they received their vaccines. He did contact them and was told to notify PCP.
76 2021-02-04 weakness Severe headache, body aches, slight nausea,, complete fatigue unable to function, chills, fever101.6... Read more
Severe headache, body aches, slight nausea,, complete fatigue unable to function, chills, fever101.6 (highest) total feeling of unwell
76 2021-02-04 bell's palsy BELLS PALSY SYMPTOMS ON LEFT SIDE OF FACE . Start PredniSONE Tablet, 20 MG, 3 tablets, Orally, Once... Read more
BELLS PALSY SYMPTOMS ON LEFT SIDE OF FACE . Start PredniSONE Tablet, 20 MG, 3 tablets, Orally, Once a day, 7 days, 21 Tablet, Refills 0 Start Valacyclovir HCl Tablet, 1 GM, 1 tablet, Orally, Three times a day, 7 days, 21 Tablet, Refills 0
76 2021-02-04 flushing diaphoresis, flushing, anxiety Narrative: Began feeling symptoms during monitoring period-mildly di... Read more
diaphoresis, flushing, anxiety Narrative: Began feeling symptoms during monitoring period-mildly diaphoretic, dizzy, flushing upon standing. Was anxious about second vaccine. Received monitoring of vital signs for additional 15 min and water provided. Released to home.
76 2021-02-04 night sweats little bit of fever; sluggish; Feeling unwell; he lost some weight; perspiring quite a bit at night;... Read more
little bit of fever; sluggish; Feeling unwell; he lost some weight; perspiring quite a bit at night; allergies due to the pollen; This is a spontaneous report from a Pfizer sponsored program via a contactable male consumer reporting for himself. A 76-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number unknown), via an unspecified route of administration on 15Jan2021 at SINGLE DOSE for COVID-19 immunisation. Medical history reported as none. Family history included wife who passed away 2.5 years before, on an unspecified date and his daughter and her (daughter) son, who lives with the patient, tested positive for COVID virus. There were no concomitant medications. The patient experienced little bit of fever, allergies, and feeling unwell, but described as not horribly bad. Patient stated he is ok and doesn't think it has anything to do with the COVID-19 Vaccine. He stated that he thinks it is just allergies due to the pollen. Patient was taking two to three Ibuprofen once or twice a day when he goes to sleep. He has been perspiring quite a bit at night, which he stated was ok. Aside from that he was pretty much ok. He doesn't get second dose until 15Feb2021. Stated we have come a long way from beginnings of time where people would just die. He asked if he should get tested. Patient was advised to follow up with his primary care physician. He stated his symptoms began in the evening of 16Jan2021 at 8pm. He started getting a little feverish and sluggish. He took three Ibuprofen. He thought he lost some weight with the COVID-19 Vaccine. Weight was between 169-170lbs on 16Jan2021. The patient operates a daycare center with children. He was not taking any medication except for the Ibuprofen. He is very active and runs a business. Only thing is, he is sad because he does not have his wife with him. He stated everything was fine. He wanted to know if it was possible one can get the COVID virus even with the injection. He asked about the second COVID-19 Vaccine and what does the first dose do. Treatment included ibuprofen for little bit of fever, sluggish, and Feeling unwell. Outcome of the events was unknown. Information on the Lot/Batch number has been requested.; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the reported events of fever, sluggish, weight decreased, night sweats and feeling unwell due to temporal relationship Based on the information provided by the reporter, it appears unlikely that subject drug contributed to the event of pollen allergy, which likely represent intercurrent medical condition. There is limited information provided in this report. This case will be reassessed upon receipt of follow-up information.
76 2021-02-05 pain in extremity 1. At approx 11PM , Tues. my left arm started to hurt and was a bit stiff. By 6AM, my neck was stif... Read more
1. At approx 11PM , Tues. my left arm started to hurt and was a bit stiff. By 6AM, my neck was stiff and I could not move left arm because of pain. I went to bed and when I got up Wed at about 1:30pm, I experienced a lot of pain in my joints and I could not get out bed. I also felt light headed. This lasted the whole day and night. I slept most of the day. The next day, Thur, I was better however, my joints were still hurting. Saturday morning it appears that I was ok.
76 2021-02-05 tremor Fever to 100 degrees F., shaking teeth rattling chills, headache , myalgia, sore muscles, fatigue, j... Read more
Fever to 100 degrees F., shaking teeth rattling chills, headache , myalgia, sore muscles, fatigue, joint pains and insomnia
76 2021-02-07 bell's palsy, facial paralysis Patient went to Emergency Room @ 5PM day following vaccine with difficulty moving eyes and drooping ... Read more
Patient went to Emergency Room @ 5PM day following vaccine with difficulty moving eyes and drooping cheek.
76 2021-02-07 facial paralysis Bell's palsy; This is a spontaneous report from a contactable physician reported for self. This 76-y... Read more
Bell's palsy; This is a spontaneous report from a contactable physician reported for self. This 76-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 04Jan2021 10:50 on Arm left at single dose (Lot # EK5730) for covid-19 immunisation. None additional vaccines administered on same date of the Pfizer suspect. Medical history included ongoing Cardiac disorder from Jun1990, Type 1 diabetes mellitus from 2000, Heart Attack from Jun1990. Concomitant drugs were none. He said he has a question. He stated he got his first dose of the COVID-19 Vaccine on 04Jan2021 and woke up 9 days later on 13Jan2021 with Bell's Palsy, which was medically significant. He said he was not sure if he should get his second COVID-19 Vaccine shot that was scheduled for Monday, 25Jan2021. He asked if Bell's Palsy has been a reported side effect of the COVID-19 Vaccine. He said he refuses to take steroids for the Bell's Palsy. He said he had an incident in 2019 where he was prescribed steroids for an arthritic condition, and he ended up septic. No treatments were received. Outcome of the event was resolving. Drug result by physician was related.; Sender's Comments: A possible contributory effect of suspect BNT162B2 on reported Bell's Palsy 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.
76 2021-02-08 unresponsive to stimuli Found unresponsive on the floor 19 hours after receiving the vaccine. Transported to hospital.
76 2021-02-09 burning sensation Burning sensation on upper right back which moved to shoulder and right front upper chest. Elevated ... Read more
Burning sensation on upper right back which moved to shoulder and right front upper chest. Elevated blood pressure. Went ER on 01292021. Resolved on own by 01312021
76 2021-02-09 unresponsive to stimuli HPI Patient is a 77 y.o. male who presents with in full cardiac arrest. Patient is resident of loca... Read more
HPI Patient is a 77 y.o. male who presents with in full cardiac arrest. Patient is resident of local nursing home. According to nursing home staff, a tech was in his room talking with him as patient was laying in bed. Tech began walking out of patient's room and turned around to tell him one last thing when the tech noticed patient had gone unresponsive. Patient had no spontaneous respirations or pulse, subsequently CPR was started immediately. 911 was called. This occurred around 5:30 a.m.. Upon EMS arrival on scene, they found a male unresponsive with CPR being performed. There was no spontaneous respirations or circulation. Thus, ET tube was placed and ACLS guidelines initiated. Patient was found to be in PEA, and according to EMS, patient was given a total of 6, 1 mg epinephrine IV push and 1, 1 Amp sodium bicarb. Patient was worked on at the scene for approximately 40 min before being transferred to ER. Upon arrival to ER trauma room 1 patient is still in full arrest. ET tube in place with good ventilation. Patient remains in PEA. Chest compressions and ACLS guidelines initiated. In reviewing patient's chart and nursing home notes, patient is a full code. Patient has a significant cardiac history including known coronary artery disease with 4 vessel CABG. Patient also has history of 3rd degree heart block and pacemaker placement. Patient has history of ischemic cardiomyopathy but last echo performed in 2020 shows ejection fraction of 45%.
76 2021-02-11 discomfort On Saturday 2/6/21 in the morning on the left side under armpit felt like he had a pulled muscle or... Read more
On Saturday 2/6/21 in the morning on the left side under armpit felt like he had a pulled muscle or something. It eventually radiated over up into the left quadrant of his chest where he could not push down on it. It was extremely painful by Monday. He has a history of esophageal spasms and exacerbated them to where he thought he was having a heart attack. He called his Cardiologist and told him to go to the ER. He went to the hospital Monday evening, he had two EKG's, had blood drawn 3 times, did sonograms looking for blood clots. He did inform them that he had the vaccine on Friday and they told him it was due to that. He went to nuclear medicine to get his lung checked for blood clots as well. All tests were negative. He saw his PCP today who told him that the lymph nodes were affected due to the vaccine. He has improved greatly, still has some slight discomfort which his PCP said would go away in time.
76 2021-02-11 pain in extremity Pain the underneath part of left arm, pain in tendon of left ankle and rash on left side around to t... Read more
Pain the underneath part of left arm, pain in tendon of left ankle and rash on left side around to the middle of back which itches severely and is very tired
76 2021-02-12 pain in extremity Sore arm General aches Chills Fatigue
76 2021-02-14 weakness very bad abdomen pain and back kidney area pain chills and weakness for 24 hours and still four day... Read more
very bad abdomen pain and back kidney area pain chills and weakness for 24 hours and still four days later very week and unable to do much activity
76 2021-02-14 flushing Pt sts feeling flush post receiving vaccinations. Pt vital signs were within normal limits. Pt ref... Read more
Pt sts feeling flush post receiving vaccinations. Pt vital signs were within normal limits. Pt refused treatement or tx.
76 2021-02-16 brain damage Following day after vac. resident had increased lethargy, nausea, altered mental stats, temp 100.1 b... Read more
Following day after vac. resident had increased lethargy, nausea, altered mental stats, temp 100.1 bp 96./52, hr 107. Sent to er 1/29, returned 1/31 diagnosis systemic inflammatory response syndrome. On 2/1 resident had temp and respiratory distress. Sent to er again. Returned 2/3 with diagnosis CHF. On 2/7 resident sent out again after stat labs and xray. xray showed infiltrates. Returned from er on 2/10 diagnosis acute encephalopathy and metabolic encephalopathy.
76 2021-02-16 facial paralysis Bells Palsy - Left sided; This is a spontaneous report from a contactable physician. A 76-year-old m... Read more
Bells Palsy - Left sided; This is a spontaneous report from a contactable physician. A 76-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number: EL9263) intramuscular in left arm on 23Jan2021 at single dose for COVID-19 immunization. Medical history included DMII (Type II diabetes mellitus), Parkinson's disease, and CAD (coronary artery disease). Concomitant medications were not reported. The patient previously took metformin and experienced allergy. Prior to vaccination, patient was not diagnosed with COVID-19; and since vaccination, patient has not been tested. Facility where the most recent COVID-19 vaccine was administered: Other (Public Health Department). On 24Jan2021, the patient experienced Bells Palsy - Left sided. The event required physician office visit (Doctor or other healthcare professional office/clinic visit). No treatment was received for the event. Outcome of the event was unknown.
76 2021-02-17 tingling, numbness dizzy; nauseous; left arm weakness/left leg weakness; numbness and tingling of his left fingers; num... Read more
dizzy; nauseous; left arm weakness/left leg weakness; numbness and tingling of his left fingers; numbness and tingling of his left fingers; lost balance; fell; This is a spontaneous report from a contactable physician. A 76-year-old male patient received 76-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; brand: Pfizer; lot number: 59267-1000-1) intramuscular at left arm on 02Feb2021 at 11:00AM at a single dose for COVID-19 immunization. Medical history included closed fracture of patella, coronary atherosclerosis, essential hypertension, malignant neoplasm of prostate, and known allergies: acetominophen, doxycycline, oxycodone-acetominophen, oxycodone hydrochloride/oxycodone terephthalate/paracetamol (PERCOCET). Historical vaccine included the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; brand: Pfizer, lot number: 59267-1000-1) intramuscularly at left arm on 12Jan2021 at 12:00PM for COVID-19 immunization. Other medications in two weeks included omeprazole (PRILOSEC, strength: 20 mg), CPD losartan potassium (COZAAR, 25 mg, tablet), simvastatin (strength: 20 mg, tabs), hydrochlorothiazide (strength: 25 mg, tabs). No other vaccine in four weeks. Facility type vaccine was at Doctor's office/urgent care. Adverse events were reported as follows: 20min after getting the 2nd dose, the patient became dizzy and nauseous. 20 min after that the patient developed left arm weakness and numbness and tingling of his left fingers. When trying to get out of his car, he lost balance and fell. He had no loss of consciousness or head trauma. He had progressively worsening left arm and left leg weakness. Adverse event start date was reported on 02Feb2021 at 11:30AM. AE resulted in Emergency room/department or urgent care, hospitalization for 3 days. Treatment received for AE included baclofen and methylprednisolone. The outcome of events was not recovered. No covid prior vaccination. Covid tested post vaccination included Nasal Swab (NAAT) on 02Feb2021 was negative.; Sender's Comments: A causal association between BNT162B2 and the reported events cannot be excluded based on a compatible temporal relation. 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.
76 2021-02-18 tremor BECAME VERY, VERY COLD AND HAD VERY BAD SHAKES. SIMILAR TO ANTIPHLAXIS REACTION I HAD TO 2 ANTIBIOTI... Read more
BECAME VERY, VERY COLD AND HAD VERY BAD SHAKES. SIMILAR TO ANTIPHLAXIS REACTION I HAD TO 2 ANTIBIOTICS- CIPRO & METRONADOZLE. WENT TO BED WITH CLOTHES ON AND SEVERAL BLANKETS. LASTED 5-6 HRS. NEXT DAY WORN OUT. 3RD DAY FEELING BETTER. I DID NOT HAVE SWELLING OR CLOSURE OF MY THROAT. I DID NOT SEE A DOCTOR .
76 2021-02-19 tremor High Fever, shakes, chills, headache Feb 17 p.m. - Feb 18 plus all over ache. Tylenol time releas... Read more
High Fever, shakes, chills, headache Feb 17 p.m. - Feb 18 plus all over ache. Tylenol time release. Felt good on Feb 19.
76 2021-02-20 weakness RECEIVED 1ST DOSE OF PFIZER COVID VACCINE ON 02/14/21. ON 02/20/21 REPORTED ED FOR GENERALIZED WEAKN... Read more
RECEIVED 1ST DOSE OF PFIZER COVID VACCINE ON 02/14/21. ON 02/20/21 REPORTED ED FOR GENERALIZED WEAKNESS, FATIGUE. , AND NAUSEA/VOMITING/DIARRHEA AND BEING UNABLE TO EAT SINCE YESTERDAY. ON 02/20/21 ADMITTED INPATIENT TO HOSPITAL WITH DIAGNOSIS OF ELEVATED TROPONIN AND GENERALIZED WEAKNESS.
76 2021-02-20 tremor, weakness, pain in extremity Severe shaking. Chills, headache,acute srvere sharp pain in both feet . Began after a short sleep pe... Read more
Severe shaking. Chills, headache,acute srvere sharp pain in both feet . Began after a short sleep period. Lasted for 3 hours. Then wesknesd and headache tiredness until bedtime the next eve. No isdued after 2nnd night sleep.
76 2021-02-21 numbness, pain in extremity Developed quite a bit of pain in the tip of left index finger. Also, have slight numbness feeling t... Read more
Developed quite a bit of pain in the tip of left index finger. Also, have slight numbness feeling there.
76 2021-02-23 weakness Patient felt achy, tired starting the day after the vaccine. Per his wife, he was very tired and "... Read more
Patient felt achy, tired starting the day after the vaccine. Per his wife, he was very tired and "losing stamina". On 2/13/21, he woke up feeling dizzy and weak. His wife asked him if he wanted to go to the doctor and he declined. He ate breakfast and went to rest in his easy chair. He passed away an hour later.
76 2021-02-24 discomfort Left deltoid nodule s/p vaccination. Ice pack applied. Pt tol well. Decreased discomfort to sit
76 2021-02-25 facial paralysis Bell's Palsy - L facial droop; This is a spontaneous report from a contactable physician. A 76-year... Read more
Bell's Palsy - L facial droop; This is a spontaneous report from a contactable physician. A 76-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: EK4176), intramuscularly on 22Jan2021 at 08:00 am on the left arm at single dose for COVID-19 immunization. Medical history included type 2 diabetes mellitus (DM 2), hypertension (HTN), hypersensitivity lung disease (HLD), and hepatitis C (Hep C) s/p treatment, all from an unknown date. Patient had no known allergies. Concomitant medication included acetylsalicylic acid (ASA), gabapentin, lisinopril, and an unspecified statin from unknown dates and indication. No other vaccines were received in four weeks. On 27Jan2021, it was reported that the patent experienced Bell's palsy - L facial droop which resulted in emergency room visit and required treatment of "Pred". The patient had no COVID prior to vaccination and was tested post vaccination on 27Jan2021 via nasal swab which had a negative result. The patient received the vaccine in a hospital. The outcome of the event was reported as recovering.; Sender's Comments: A possible contribution role of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) to the onset of event Bell's palsy cannot be excluded, due to temporal relationship. The case will be reassessed should additional information become available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
76 2021-02-25 pain in extremity 18-20 hours after receiving the injection he noticed that "his heart would beat "hard"/heart beating... Read more
18-20 hours after receiving the injection he noticed that "his heart would beat "hard"/heart beating fast; about 18 to 20 hours later the next morning he was experiencing something like a palpitation; arm hurt that night and the next morning/sore arm of course; This is a spontaneous report from a contactable consumer (patients wife). A 76-years-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot Number: EL9261) , via an unspecified route of administration on 21Jan2021 at 14:30 (at the age of 76-years-old) in the left arm as SINGLE DOSE for covid-19 vaccination. Medical history included cardiac murmur and Type 2 Diabetic. There were no concomitant medications. On 21Jan2021 the patient experienced arm hurt that night and the next morning/sore arm, and On 22Jan2021, 18-20 hours after receiving the injection he noticed that 'his heart would beat hard' /heart beating fast/he was experiencing something like a palpitation. Report described that it is like when you get scared. This Happens 2-3 times a day and it is not constant. The patient went to his primary care physician on Friday for a 'routinely scheduled annual check up' and mentioned this to her at his appointment. His provider encouraged him to call Pfizer and report these symptoms. His doctor is going to continue to follow up with him and if the problem persists do further tests. Lab data included heart rate on 22Jan2021 18-20 hours after injection his heart would beat hard /would be fast/something like a palpitation. The clinical outcome of heart beating fast was not recovered while palpitations and arm pain were unknown.
76 2021-02-27 bell's palsy Bell's Palsy
76 2021-02-28 tremor Fever; belly is swollen; hurting; hard for him to breath/moves and exerts, his breathing is labored;... Read more
Fever; belly is swollen; hurting; hard for him to breath/moves and exerts, his breathing is labored; extremely tired; muscle pain, aches; extreme chills/shivering; shaking; Joint pain; This is a spontaneous report from a contactable consumer. A 76-years-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, solution for injection, lot number: EL3248, expiry date not reported), via an unspecified route of administration on 02Feb2021 11:00 at a single dose in the left arm for COVID-19 immunization. Medical history included ongoing atrial fibrillation (reported he has had no occurrence for 3-4 years); and high blood pressure and high cholesterol, both from an unknown date and unknown if ongoing; and pneumonia. Concomitant medications included that patient was also taking high blood pressure medication and high cholesterol medication. When asking for the Lot number, reporter explained "his card was in his wallet but she gave her lot and said it was the same, they got the shot at the same time, within 5 minutes of each other". Patient previously took amoxicillin for pneumonia from 09Jan2021 to 13Jan2021, reported as he took this for 5 days and stopped. This was reported as "It was noted that he had pneumonia and got an antibiotic that he took for 5 days. It was amoxicillin and was started on 09Jan2021" (pending clarification). Reporter also stated that she was not sure if it was a Pfizer vaccine but patient did have a mild reaction to the first shingles vaccine (unspecified) but this lasted only 24 hours. Reporter, a wife calling for her husband (patient), was reporting on the COVID vaccine and who explained he was having symptoms and wanted to report this but also has a question on what to do. Patient was extremely tired. This was noticed on the 3rd day after the shot. This would be Friday 05Feb2021 and it was the same since starting. There were moments when he has rested and showered where he felt better but then it went down again. The patient had muscle pain, aches on 05Feb2021, this would be Friday, and it came and went but was about the same. Patient had extreme chills on 05Feb2021, and he was still shaking now (05Feb2021). It was a little better during the day, maybe because he was moving around but last night he was shivering and shaking for 3 hours and she could not get him warm even with the heating pad. Patient also had joint pain on 05Feb2021 and it was the same since starting. Patient had fever that probably started Sunday, 07Feb2021 wherein few hours ago, it was 102.00 but she got it down to about 100.2 now, it has increased and was the reason she called today. Patient's belly was swollen since 05Feb2021 and it was the same since starting. She remarked she was not sure if this was where lymph nodes were or not and the cause of the swelling. It was also explained that due to hurting, it was hard for him to breath. When he moved and exerted, his breathing was labored. This would be Friday, 05Feb2021 and it is the same since starting. Yesterday, patient went to his primary doctor. He was supposed to do blood work but couldn't due to his fever. The doctor prescribed him an anti-inflammatory called Etodolac 500mg. It was by Taro Pharmacutal US (there was no Lot or expiry). He took one at 7pm and was to take them twice a day, took another a little while ago. Reporter explained she has heard stories where the second dose is worse, and wanted to know if that is true. She also wanted to know if the product Etodolac, has side effects that are similar to what patient was experiencing, and wouldn't taking that make the side effects double worse. Therapeutic measures were taken as a result of the events extreme chills/shivering, shaking, joint pain, and fever. The events extremely tired, muscle pain, aches, extreme chills, shaking, joint pain, fever, belly was swollen, hurting, and "hard for him to breath/moved and exerted, his breathing was labored" were not recovered
76 2021-03-01 weakness, numbness Weak clogged up, my hands were numb and chills, fever, nausea, feeling unwell, my nose feels swoll... Read more
Weak clogged up, my hands were numb and chills, fever, nausea, feeling unwell, my nose feels swollen, runny nose, my lymphoids are swollen, im tired. Joint pain, and just drowsy, slight headache at time. Slight case of constipation
76 2021-03-01 weakness Chills; Headache; extremely weak; has not felt like eating anything; This is a spontaneous report fr... Read more
Chills; Headache; extremely weak; has not felt like eating anything; This is a spontaneous report from a contactable nurse reporting for her husband. A 76-year-old male patient received the 2nd dose of bnt162b2 (BNT162B2, Manufacturer Pfizer-BioNTech, lot# EL9264), via an unspecified route of administration in the deltoid right, on 03Feb2021 at 15:00, at single dose, for COVID-19 immunisation. Medical history included cardiac disorder from 2007 and ongoing, cholecystectomy on 21Dec2020, stent placement from Dec2020 to Jan2021 (stents placed on 27Dec2020 or 28Dec2020, in Jan2021 it was removed), hospitalisation from Dec2020 to Jan2021 (for 11 days), ongoing weakness (weakened state). The reporter explained that her husband had some big issues from Nov2020 to Jan2021 which ended in the removal of a dead gallbladder that was gangrene and had to have stents placed. He was in a weakened state already. There were no concomitant medications. No other vaccines were administered on the same date or 4 weeks prior. Previously the patient received the 1st dose of bnt162b2 (BNT162B2, Manufacturer Pfizer-BioNTech, lot# EL1283) on 13Jan2021, for COVID-19 immunisation, with no adverse effect. The patient experienced chills on 08Feb2021 with outcome of not recovered, headache on 08Feb2021 with outcome of not recovered, extremely weak on 08Feb2021 with outcome of not recovered, has not felt like eating anything in Feb2021 with outcome of not recovered. The events chills, headache and extremely weak were considered medically significant. Therapeutic measures were taken as a result of chills and included treatment with Tylenol. The reporter assessed the events as related to vaccination.
76 2021-03-02 weakness, facial paralysis Bell's Palsy/drooping of his face and mouth; Bloody nose; vertigo (dizzy / lightheaded); vertigo (di... Read more
Bell's Palsy/drooping of his face and mouth; Bloody nose; vertigo (dizzy / lightheaded); vertigo (dizzy / lightheaded); swallowing issues; Chewing issues; weak; tired / does not have stamina; This is a spontaneous report from a contactable consumer (the patient's wife). A 76-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot: EL9264), via an unspecified route of administration in the right arm on 09Feb2021 at 12:30 (at the age of 76-years-old) as a single dose for COVID-19 immunization. Medical history included vertigo (before the 2nd dose all the time), diabetic type 2 due to exposure to Agent Orange, stent in Dec2019, sulfa allergies, blood pressure abnormal. Concomitant medications included metformin, buspirone, sitagliptin phosphate (JANUVIA), hyoscyamine sulfate (OSCIMIN), doxepin, lisinopril for blood pressure, silodosin, simvastatin (ZOCOR), exenatide (BYDUREON) for diabetes, fish oil, zinc tablet in the morning, ubidecarenone (COQ-10), vitamin D3, cyanocobalamin (VIT B12), allium sativum bulb (GARLIC EXTRACT), ascorbic acid/ betacarotene/ biotin/ calcium/ chloride/ chromium/ copper/ folic acid/ iodine/ lycopene/ magnesium/ manganese/ molybdenum/ nickel/ nicotinic acid/ pantothenic acid/ phosphorus/ potassium/ pyridoxine hydrochloride/ riboflavin/ selenium/ silicon/ thiamine/ vanadium/ vitamin b12 nos/ vitamin d nos/ vitamin e nos/ vitamin k nos/ xantofyl/ zinc (CENTRUM SILVER FOR MEN 50+). The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot: EL3247) on 23Jan2021 at 10:30 (at the age of 76-years-old) in the right arm and experienced pain in arm and fatigue. On 09Feb2021, the patient developed a bloody nose that was unstoppable at home. The reporter took the patient to the emergency room (ER), where his nose was packed, and he was kept overnight. The following day, while his nose was being unpacked, drooping of his face and mouth was observed. Tests for a stroke were negative on Feb2021. The patient was kept in the hospital for three days and was diagnosed with Bell's Palsy on 11Feb2021. The events "Bell's Palsy/drooping of his face and mouth" and bloody nose resulted in hospitalization/prolonged hospitalization in Feb2021 for 3 days. The patient's wife reported that as of 09Feb2021, he had swallowing issues when it came to solid foods and was looking for suggestions on what he can eat. The tongue was not swollen, and he was breathing better since the packing had been removed. As of Feb2021, the patient had chewing issues and cannot take solid food. The patient had vertigo before the second vaccination dose all the time, and experienced it again last night on 16Feb2021, he was dizzy and lightheaded. As of an unspecified date in Feb2021, the patient was weak and tired (did not have stamina). The patient was treated for "Bell's Palsy/drooping of his face and mouth" with prednisone 20 mg 2 tablets once a day and valacyclovir 500 mg 2 tablets twice a day. The patient was not treated for bloody nose and swallowing issues. The clinical outcome of " Bell's Palsy/drooping of his face and mouth", swallowing issues, chewing issues, weak, "tired / does not have stamina" was not resolved; bloody nose was resolved on Feb2021; "vertigo (dizzy / lightheaded)" was resolved on 17Feb2021.
76 2021-03-02 pain in extremity Within 1 hr pain in right leg above knee; This is a spontaneous report from a contactable consumer (... Read more
Within 1 hr pain in right leg above knee; This is a spontaneous report from a contactable consumer (patient). A 76-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 12Feb2021 07:45 at single dose for at left arm covid-19 immunisation. Medical history included type 2 diabetes, heart surgery in 2017, spinal stenosis, high blood pressure. Concomitant medications within 2 weeks of vaccination included metformin, metoprolol, gabapentin, glipizide, warfarin, acetylsalicylic acid (ASPIR). The patient experienced within 1 hr pain in right leg above knee on 12Feb2021 08:30 with outcome of not recovered. Patient didn't receive treatment for the event. Patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, patient had not been tested for COVID-19. The report was considered as non-serious. Information on the lot/batch number has been requested.
76 2021-03-03 tremor Low grade fever: 99.8; chills and shaking; extreme fatigue
76 2021-03-04 weakness Patient was vaccinated tihe Pfizer #1 2/12/21. Started feeling weak 2/13 and presented to ED on 2/14... Read more
Patient was vaccinated tihe Pfizer #1 2/12/21. Started feeling weak 2/13 and presented to ED on 2/14. Was admitted to Hospital. Found to be COVID +, required O2 per NC 2-3 L for approx 24 hours. Was found to have NSTEMI. Was transferred for speciality/cardiology care at General Hospital. Was on heparin gtt. Cardiology-no intervention. Was not treated for COVID and was discharged to home on 2/16. Was unable to care for himself at home and was readmitted with in hours. He has failed discharge twice and is being now discharged to SNF
76 2021-03-04 weakness he violently threw up/vomiting; lost control of all of his extremities; acute pancreatitis; had no s... Read more
he violently threw up/vomiting; lost control of all of his extremities; acute pancreatitis; had no strength; affected his memory; barely moving; balance was horrible/his whole balance everything was off; lost his appetite right away; not eat; This is a spontaneous report from a contactable consumer reporting for the husband. A 76-year-old male patient received the first dose of bnt162b2 (Batch/lot number: EL3302), via an unspecified route of administration on 21Jan2021 at single dose for COVID-19 immunisation. Medical history included Allergy from an unknown date, blood pressure abnormal from an unknown date, ongoing kidney patient and was on dialysis three times a week. Concomitant medication included insulin aspart (NOVOLOG), insulin glargine, vitamin b complex (SUPER B COMPLEX), acetylsalicylic acid (BABY ASPIRIN), vitamin d3, ascorbic acid, biotin, folic acid, mecobalamin, nicotinic acid, pantothenic acid, pyridoxine hydrochloride, riboflavin, thiamine (DIALYVITE), atorvastatin, cetirizine for Allergy, fish oil, docusate, amlodipine besilate for Blood pressure and other medications as the patient was kidney patient. For Concomitant medication amlodipine besilate, the consumer stated, Right now at this time he was not supposed to take them on his dialysis days. So, he took one tablet on Saturday & Sunday, Tuesday & Thursday. The patient had his first shot of the Pfizer on 21Jan2021, he lost his appetite right away and wasn't eating. And then on 29Jan2021 he took 2 bites of a meal, and had extremely volatile vomiting and lost control of all of his extremities. He violently threw up on the 29Jan2021 and from that's when on he had no appetite, she couldn't get him to eat anything. Her daughter had to help her pick him up of the floor, the Friday night 24 hours it was just horrible. The consumer stated, Saturday morning (30Jan2021) he had gotten use of extremities back but barely moving and still very, his whole balance everything was off. He was able stand up and use the restroom by himself. This had all affected his memory, he couldn't do his medications alone anymore and he couldn't take care of himself. And then on the 12Feb2021 the consumer took him over to the hospital because after when he vomited on the 29Jan2021 he lost all use of his extremities. They diagnosed him with acute pancreatitis, but he still, he was in the hospital from Friday 12Feb2021 and they released him on the 17Feb2021. And he still had no strength. His balance was horrible. It was affecting, whatever it was affecting his memory. The consumer stated they had no idea why he came down with acute pancreatitis and he never had any pain with it. They said they were amazed that he was not in severe pain, never any pain. The outcome of events had no strength and balance was horrible was not recovered. The outcome of the other events was unknown.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021187441 Same reporter/patient/product, Different dose/AE
76 2021-03-04 pain in extremity Loss of taste and smell. Sore neck, shoulder, arm on side vaccination was given. Generalized body a... Read more
Loss of taste and smell. Sore neck, shoulder, arm on side vaccination was given. Generalized body aches. Congestion, extreme fatigue and chills all lasting for 3-4 days.
76 2021-03-05 cold extremities I felt great after my vaccine until midnight that same day. My legs from the knees down including m... Read more
I felt great after my vaccine until midnight that same day. My legs from the knees down including my feet were painfully cold as if they were on dry ice. I didn't get much sleep that night, but the next morning at 2:00 a.m. the pain was gone. I was just extremely fatigued which was a symptom I expected. I don't know what to think of the first symptom but wanted you to know. Thank you.
76 2021-03-07 weakness Client verbalized feeling very weak after receiving the vaccine. According to client he is diabetic... Read more
Client verbalized feeling very weak after receiving the vaccine. According to client he is diabetic and did not absorb anything to eat prior to receiving the vaccine. Client was given a bottle of water and evaluated by Fire Rescue. Client's spouse accompanied home and he was released by paramedic at 9:40 am. Per Paramedic no further evaluation needed.
76 2021-03-07 weakness chills,shortness of breath ,Brain fog, lack of energy
76 2021-03-07 tingling, cold extremities, numbness Numbness and tingling in right leg about 4 days after 2nd vaccination, moved to right foot. Then mo... Read more
Numbness and tingling in right leg about 4 days after 2nd vaccination, moved to right foot. Then moved to left foot but didn't affect left leg.. Feet are cold now, legs are okay now, just the feet. Hands, lips, & tongue, & face feel numb and tingly too. Spoke with Dr on phone. Client stated he took Tylenol for a couple of days after vaccination. Stated injection site is black & blue. Client still dealing with numbness & tingling. Waiting to speak with Dr again. Phone call to office.
76 2021-03-10 weakness Sudden loss of strength in left hand/arm involving wrist extention and radial deviation and grip str... Read more
Sudden loss of strength in left hand/arm involving wrist extention and radial deviation and grip strength. Normal range of motion is still present but stregth is significantly diminished and has reurtned only minimally. Right arm is normal.
76 2021-03-10 seizure Patient was admitted to the Neuro ICU in critical condition. He is there currently on 4 seizure medi... Read more
Patient was admitted to the Neuro ICU in critical condition. He is there currently on 4 seizure medications AND INTUBATED WITH GENERAL ANESTHESIA TO CONTROL THE SEIZURES. All diagnostic tests including MRI's, CT scans, laboratory tests, Spinal taps are negative. He was presented and they can arrive at no diagnosis!!!!! He has no history of a seizure disorder.
76 2021-03-10 tenderness I developed stomach, intestinal pain, cramps. A continuous aching with a sharp pain about every 20 -... Read more
I developed stomach, intestinal pain, cramps. A continuous aching with a sharp pain about every 20 - 35 minutes. Lasting 36 hours. This was in my lower abdomen below belly button on the left side. Really quiet frightening, in that this was not in any material regarding side affects. I considered the emergency room Saturday night but didn't t go. Began to subside Sunday afternoon, leaving me sore to the touch. Only a little tenderness remains in the area. I have seen no physicians. I cannot speak to any permanent damage.
76 2021-03-11 pain in extremity Right leg pain and swelling 8 days after second dose. Started on Eliquis in the ER following positiv... Read more
Right leg pain and swelling 8 days after second dose. Started on Eliquis in the ER following positive ultrasound exam.
76 2021-03-14 bell's palsy symptoms of bell palsy; Numbness of upper and lower lip on right side.; sore muscles in neck; sore m... Read more
symptoms of bell palsy; Numbness of upper and lower lip on right side.; sore muscles in neck; sore muscles in neck and shoulder; watery eyes; muscle aches; pains; problems in sleeping; This is a spontaneous report from a contactable consumer via the Pfizer sponsored program. This is a spontaneous report from a contactable consumer (the patient). A 76-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EL9264), via an unspecified route of administration, in the left arm on 01Feb2021 at 14:30 (at the age of 76-years) as a single dose for COVID-19 immunization. Medical history included chronic asthma, nasal polyps, vestibular schwannoma, alopecia, gastrooesophageal reflux disease. The patient did not have any known allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient's concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 23Feb2021 at 07:00 AM, the patient experienced symptoms of bell palsy, numbness of upper and lower lip on right side, sore muscles in neck and shoulder, watery eyes, muscle aches, pain, problems in sleeping. He felt the symptoms after the first dose. The patient visited the emergency room/ department or urgent care due to the events. The patient did not received treatment for the events. The clinical outcome of the events was not recovered.
76 2021-03-15 numbness 76 YO M C/O LEFT SIDE RING AND LITTLE FINGER HAS GONE NUMB AFTER COVID 19 SHOT (PFIZER) WHILE WAITIN... Read more
76 YO M C/O LEFT SIDE RING AND LITTLE FINGER HAS GONE NUMB AFTER COVID 19 SHOT (PFIZER) WHILE WAITING IN THE OBSERVATION AREA. PT HAS NO OTHER C/OOR SX. NUMBNESS IS IMPROVING AFTER MOVING ARM AROUND. DENIES ALL SX RELATIVE TO ALLERGIC/ANAPHYLACTIC REACTIONS.FOUND ABOVE PT SITTING A/O X4, NO DISTRESS, CX - GOOD RESP EFFORT, WITHOUT C/O. EXTREM - GOOD PMS X4 WITH EXCEPTION OF LITTLE AND RING FINGER OFLEFT HAND. R/O TEMPORARY NUMBNESS OF RING AND LITTLE FINGER OF LEFT HAND SECONDARY TO ULNAR NERVE COMPRESSION. EXAM, T&R WITH INSTRUCTIONS TO FOLLOW UP IF NUMBNESS DOESNT GO AWAY.
76 2021-03-15 pain in extremity Pain in left calf Had ultrasound on left leg 3-16-2021 DX: hematoma left leg Told to apply hotpack q... Read more
Pain in left calf Had ultrasound on left leg 3-16-2021 DX: hematoma left leg Told to apply hotpack q20 min off & on
76 2021-03-22 pain in extremity, numbness Left index finger suddenly developed considerable pain in the tip of the finger and a slight numbnes... Read more
Left index finger suddenly developed considerable pain in the tip of the finger and a slight numbness there as well; Left index finger suddenly developed considerable pain in the tip of the finger and a slight numbness there as well; This is a spontaneous report from a contactable consumer (the patient). A 77-year-old male patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN), via an unspecified route of administration in the left arm on 05Feb2021 at 13:00 (at the age of 76-year-old) as a single dose for COVID-19 immunization. Medical history included heart condition. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not have any allergies to medications, food, or other products. The patient's concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 19Feb2021, the patient experienced left index finger suddenly developed considerable pain in the tip of the finger and a slight numbness there as well. The patient did not receive any treatment for the events. The clinical outcome of the "left index finger suddenly developed considerable pain in the tip of the finger and a slight numbness there as well" was not resolved. The lot number for the vaccine, BNT162b2, was not provided and will be requested during follow-up.
76 2021-03-24 pain in extremity Unable to use legs Right thigh sore
76 2021-03-24 pain in extremity Pains in hips and hands, lesser pains and some stiffness in other joints and muscles. This is typic... Read more
Pains in hips and hands, lesser pains and some stiffness in other joints and muscles. This is typical of when I get viral diseases such as colds and flu, except that there were no cold symptoms in my head. First noticed when I awoke the day after my second shot and lasted into late afternoon. OK after that.
76 2021-03-24 unresponsive to stimuli Resident entered the Observation, with daughter at side and stated that patient is feeling dizzy, st... Read more
Resident entered the Observation, with daughter at side and stated that patient is feeling dizzy, staff lowered patient to chair in sitting position, BP 122/81, P64, R24, O2 sats 94 on room air, resident became slightly unresponsive, BS 109, EMS here, O2 at 100% Endtidal NC, with O2 sats at 92%, HR 42, BP 90/48, P45, IV fluids NS in progress flowing via 20 guage, 911 call. 14:42- 911 here, patient assessed, BP 92/51, P60, R22 patient fully aroused, was taken to hospital at 14:52, family will follow to ER.
76 2021-03-25 difficulty speaking Within 1/2 hour of vaccine, patient states he had fever, chills, shortness of breath, aches, through... Read more
Within 1/2 hour of vaccine, patient states he had fever, chills, shortness of breath, aches, throughout the body - "eyeballs hurt" - "hair hurts" loss of appetite, lost his sense of taste, increased hoarseness, decrease O2 saturations.
76 2021-03-26 tremor Total body pain followed by extreme chills then feverish then uncontrollable tremors accompanied by ... Read more
Total body pain followed by extreme chills then feverish then uncontrollable tremors accompanied by unable to keep my balance(had to hold on to desk )then massive amounts of nasal mucous all in about a 9 0 minute time period then just headache and fatigue - felt fine 90 mins after headache and fatigue
76 2021-03-27 pain in extremity 12h after COVID vaccination awoke with severe bilateral muscle/buttock/leg pain, nausea, vomiting an... Read more
12h after COVID vaccination awoke with severe bilateral muscle/buttock/leg pain, nausea, vomiting and ultimately some confusion and disorientation with possible left sided focal neurologic deficits. Sodium initially 127 on admission, but may have been artifact, as simultaneous venous blood gas electrolytes showed 135. On following day had platelet count of 115k, repeated at 90k
76 2021-03-28 seizure, inability to speak, muscle twitching 2/17 received 1st dose vaccine, Pfizer 2/20-3/9 admitted. Found to have seizures (twitching of upper... Read more
2/17 received 1st dose vaccine, Pfizer 2/20-3/9 admitted. Found to have seizures (twitching of upper extremities, aphasia). 2/24 RML pneumonia. Found to have MSSA bacteremia and bacteriuria. Transition from vanco/pip-tazo to cefazolin Mental status improved and he was sent on cefazolin which he was to complete on 3/26/21. Was not sent out on seizure prophylaxis. 3/23 second dose Moderna. Had recurrent seizure on 3/27. Evidence of post central stroke. Expressive and receptive aphasia.
76 2021-03-29 weakness Covid-19 weakness diarrhea pneumonia hypoxia Acute Kidney Injury Sepsis
76 2021-03-31 seizure Witness seizure activity by the patient's wife and observation clinical (RN) staff. Per the patient'... Read more
Witness seizure activity by the patient's wife and observation clinical (RN) staff. Per the patient's wife this type of seizure happens on a regular basis. The patient was seated at the time of the seizure and did not fall from the chair. The patient was transported to the ER for evaluation and post seizure activity monitoring.
76 2021-04-01 weakness onset of chills around 10 pm, poor sleep due to chills. next day weak, tired. achy. fever of 103. ch... Read more
onset of chills around 10 pm, poor sleep due to chills. next day weak, tired. achy. fever of 103. chills and fever continued through next day. feeling better on 04/02/2021. still weak. was hospitalized in October 2021 for five days due to COVID.
76 2021-04-04 burning sensation, tremor Blood pressure spike 10 minutes after shot. 6 hours later had intense burning of nerve bundles dow... Read more
Blood pressure spike 10 minutes after shot. 6 hours later had intense burning of nerve bundles down arms and legs for 2 hours. After that had 1 hour of uncontolled severe shaking and shivering . Next day felt fine. Afew days started noticing LOW FREQUENCY INTERMITTANT TINNITUS THAT IS A HUM, BUT ONLY IF I AM AROUND HIGH VOLTAGE POWER TRANSMISSION LINES AND POWER TRANSFORMERS . HEAR IT IN MY HOME WHICH IS 1000 FEET FROM HIGH VOLTAGE LINES 24/7 SINCE DAY 2-4 OF DOSE #1. Can hear it in other enclosed areas, but doesn't seem to happen AS MUCH outdoors, although if I am within 1000 feet of high voltage lines I will hear it UNLESS there are many trees to block the EMF's or HUM between me and the source. SOUNDS CRAZY, BUT IS TRUE FOR PAST 3 MONTHS 24/7 AND HAS RUINED MY LIFE BECAUSE I CANNOT SLEEP AND SLEEPING PILLS DON'T WORK. HAS DISRUPTED MY SLEEP CENTER SOMEHOW. ALL OF THIS IS SINCE FIRST COIVD19 SHOT ! HAVE HAD #2 SHOT AND WILL NEVER GET ANOTHER !
76 2021-04-05 inability to speak, tremor At 30 mins he began shaking and appeared to pass out for a moment. He became confused. This morning ... Read more
At 30 mins he began shaking and appeared to pass out for a moment. He became confused. This morning he had fever, oxygen was low, not speaking not walking.
76 2021-04-06 pain in extremity sore left arm, little bit swollen; sore left arm, little bit swollen; covid vaccine in the bicep are... Read more
sore left arm, little bit swollen; sore left arm, little bit swollen; covid vaccine in the bicep area/vaccine very low in the arm (into the bicep) and not the deltoid; This is a spontaneous report from a contactable other hcp (Nurse). A 76-years-old male patient received bnt162b2 (BNT162B2), dose 2 intramuscular, administered in Arm on an unspecified date (Batch/Lot Number: EM9809) as 0.3 mL, single for covid-19 immunisation. The patient medical history was not reported. There were no concomitant medications. The patient previously received first dose of bnt162b2 (Lot: EL3249) via intramuscular in left deltoid on 18Jan2021, unknown time as single dose for covid-19 immunisation. On 08Feb2021, covid vaccine was administered in the bicep area/vaccine very low in the arm (into the bicep) and not the deltoid and on 09Feb2021, sore left arm, little bit swollen. Clinical course of the events includes, someone at a vaccine clinic, the second dose of the covid vaccine was administered very low in the arm. States the injection probably did not go into the deltoid, probably went in the bicep. She is asking if the injection would need to be repeated. She wants to know if the vaccines will need to be repeated. She also had a sore left arm and it was little bit swollen which started on the morning of 09Feb2021. The outcome for the event covid vaccine in the bicep area/vaccine very low in the arm (into the bicep) and not the deltoid was unknown and for the events sore left arm, little bit swollen was not recovered.
76 2021-04-06 pain in extremity slightly sore arm; This is a spontaneous report from a contactable pharmacist in response to a healt... Read more
slightly sore arm; This is a spontaneous report from a contactable pharmacist in response to a healthcare professional letter. A 76-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; lot number EM9809) intramuscularly in the upper left arm on 10Feb2021 at 15:30 (at the age of 76-years-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient previously received the first dose of BNT162B2 (lot number EL1289) on 19Jan2021 at 10:30 (at the age of 76-years-old) for COVID-19 immunisation and experienced sore arm, headache, and slight sinus headache. On an unspecified date, the patient experienced slightly sore arm which lasted one day post-vaccination. The outcome of slightly sore arm was recovered on an unspecified date.
76 2021-04-06 restless legs syndrome Vaccine kicked my Restless Leg Syndrome into high gear, making it impossible to sleep. Did not sleep... Read more
Vaccine kicked my Restless Leg Syndrome into high gear, making it impossible to sleep. Did not sleep for 2 nights in a row, until finally the reaction started to subside. Also, the vaccine gave me a minor case of hives rash. This has not subsided yet. But the RLS is NOT a minor problem, it is major, to me.
76 2021-04-07 weakness, tingling, seizure like phenomena Vasovagal/pre-syncopal event. Accompanied by paresthesia/ weakness/ blurred vision/ lightheadedness.... Read more
Vasovagal/pre-syncopal event. Accompanied by paresthesia/ weakness/ blurred vision/ lightheadedness.;a seizure-like episode followed' patient was transported to ER via EMS.
76 2021-04-07 pain in extremity Fatigue; Pain in arm; This is a spontaneous report from a contactable consumer (patient's wife). A 7... Read more
Fatigue; Pain in arm; This is a spontaneous report from a contactable consumer (patient's wife). A 76-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number: EL3247), via an unspecified route of administration in right arm on 23Jan2021 at 10:30 as a single dose for COVID-19 immunisation. The patient's medical history included diabetic type 2, stent from an unspecified date in Dec2019, sulfa allergies. Concomitant medications included metformin (Strength: 500 mg) at four times a day, buspirone (Strength: 10 mg) at thrice a day, sitagliptin phosphate (JANUVIA, Strength: 50 mg), hyoscyamine sulfate (OSCIMIN, Strength: 0.125 mg), lisinopril (Strength: 5 mg) at once a day (bedtime) for BP (blood pressure), silodosin (Strength: 8 mg) at once a day (bedtime), simvastatin (ZOCOR, Strength: 40 mg) at once a day (bedtime), fish oil (Strength: 1000 mg) at twice a day, zinc (Formulation: Tablet) at once a day (in the morning), vitamin D3, cyanocobalamin (B12 20 MIL, Strength: 1000 mg) at once a day, allium sativum bulb (GARLIC EXTRACT) at 1 DF (Dosage Form), once a day (1 pill, once a day), ascorbic acid, betacarotene, biotin, calcium, chloride, chromium, copper, folic acid, iodine, lycopene, magnesium, manganese, molybdenum, nickel, nicotinic acid, pantothenic acid, phosphorus, potassium, pyridoxine hydrochloride, riboflavin, selenium, silicon, thiamine, vanadium, vitamin b12 NOS, vitamin d NOS, vitamin e NOS, vitamin k NOS, xantofyl, zinc (MEN 50+) at once a day, ubidecarenone (COQ-10, Strength: 200 mg) at once a day, exenatide (BYDUREON PEN, Formulation: Injection) at weekly (once a week on Monday) for diabetes, doxepin (Strength: 10 mg) at twice a day (bedtime). Family history was none. The patient did not receive prior vaccinations (within 4 weeks). The patient experienced pain in arm on 23Jan2021, fatigue on 24Jan2021. The patient did not require the initiation of new medication / other treatment / procedure for the events. Relevant tests was none. The outcome of the event fatigue was not recovered and recovered on an unspecified date in 2021 for the other event.
76 2021-04-07 pain in extremity It was itchy like crazy; both of his arms are as stiff and achy at the top; both of his arms are as ... Read more
It was itchy like crazy; both of his arms are as stiff and achy at the top; both of his arms are as stiff and achy at the top; This is a spontaneous report from a contactable consumer (patient). A 76-year-old male patient received bnt162b2 (BNT162B2, Solution for injection) via an unspecified route of administration on an unspecified date (Batch/Lot Number: EL9263) at single dose for covid-19 immunisation. The patient's medical history and concomitant medications was not reported. The patient had two side effects and the second shot would be coming up and he was nervous about what he should do. The main side effect is that they put a band aid on where injection was to protect site. The next morning, he took it off and on the edge of the band aid, there was a red dot about 1/8 to 1/4 inch around. It was itchy like crazy, he did not scratch it. That dot was staying there. The doctor told him not to do anything to it and just put a little bacitracin on it. He did not provide any information for the Bacitracin such as a dose, lot or expiration. The next side effect was both of his arms which was stiff and achy at the top. The injection arm feels exactly like the right, but only the left one got the injection. He would like to know if he should be concerned with second dose or not. The outcome of the events was unknown.
76 2021-04-08 bell's palsy paralysis of right side of face (Bell's Palsy); This is a spontaneous report received from a contact... Read more
paralysis of right side of face (Bell's Palsy); This is a spontaneous report received from a contactable consumer (patient himself). A 76-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EMe205) via an unspecified route of administration in left arm on 09Mar2021 at 17:15 (at the age of 76-year-old) as a single dose for COVID-19 immunization. The patient's medical history included ADM II. The patient did not have allergies to medications, food, or other products. Concomitant medications included insulin, carvedilol, furosemide, clopidogrel, simvastatin (SIMVAS); All received within two weeks of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. The patient has not been tested for COVID-19 since the vaccination. The patient experienced paralysis of right side of face (Bell's Palsy) on 11Mar2021. The adverse event resulted in doctor or other healthcare professional office/clinic visit. The event was considered as serious (disability or permanent damage) by the consumer. The patient was treated with physical therapy - heat, vibration for the adverse event. The outcome of the event was not recovered. Information on the lot/batch number has been requested.
76 2021-04-09 weakness 4/3 = SATURDAY - 12:30 AM , USED 2 ACETAMINOPHEN PM ( This what i use nightly ) 6:30 AM , CHILLS ... Read more
4/3 = SATURDAY - 12:30 AM , USED 2 ACETAMINOPHEN PM ( This what i use nightly ) 6:30 AM , CHILLS (FEVER) LASTED COUPLE OF HOURS TIRED NO ENERGY , NO FOOD UNTILL DINNER TIME , WAS TOLD I LOOKED PALE , ** THAT SATURDAY AFTERNOON I WAS SMELLING AN ODOR LIKE GARBAGE, WIFE SAID SHE DIDN'T SMELL ANYTHING, LASTED FOR A FEW HOURS.??? 4/4 = SUNDAY - STILL LOW ENERGY. EVERY MORNING FOR PAST 20 YEARS I RINSE EYES WITH SALINE SOLUTION. I SKIPPED SATURDAY, TRIED SUNDAY & MY EYES STARTED BURNING, TRIED A DIFFERENT BOTTLE STILL BURNING, HAD TO STOP. 4/5 = MONDAY - FEELING BETTER & EYES RINSED WITH NO PROBLEM .???
76 2021-04-09 weakness Diverticulitis; Worsening parkinson's symptoms.; cough lasted 3 weeks; headaches; feel week; imbalan... Read more
Diverticulitis; Worsening parkinson's symptoms.; cough lasted 3 weeks; headaches; feel week; imbalance; unable to move legs; This is a spontaneous report from a contactable consumer. A 76-years-old male patient received bnt162b2 (Pfizer, Formulation: Solution for injection), dose 2 via an unspecified route of administration, administered in arm left on 16Feb2021 06:00 to 16Feb2021 06:00 (at the time of 76-yers-old) as single dose for covid-19 immunisation. Medical history included ongoing parkinsonism, high blood pressure and asthma. Concomitant medications included fluticasone propionate/salmeterol xinafoate (ADVAIR); losartan, omeprazole, dopamine and silodosin (RAPAFLO). The patient previously took bnt162b2 for covid-19 immunisation (Covid 19;Pfizer,Lot unknown; time; 05:00 AM, Vaccine location; left arm, dose; 01). The patient had worsening parkinson's symptoms. 2 days post vaccine, unable to move legs. cough lasted 3 weeks, and experienced headaches. Patient continues to feel week and has imbalance. Also had a case of diverticulitis on 18Feb2021. The event diverticulitis was considered as medically significant. The patient not received treatment for the adverse events. The outcome of events was resolved with sequel on 2021 (unspecified date). No follow-up attempts are possible; information about lot/batch number cannot be obtained.
76 2021-04-11 breast pain Woke up with very stiff neck Neck sprain, subsequent encounter Breast pain in male Unclear etiolog... Read more
Woke up with very stiff neck Neck sprain, subsequent encounter Breast pain in male Unclear etiology, no obvious mass on exam no axillary adenopathy, mamogram pending Patient's axillary and shoulder pain may be secondary to Covid vaccination.
76 2021-04-12 mild one side paralysis, weakness CVA with residual hemiparesis - C-Diff, diarrhea, weakness. AKI
76 2021-04-14 severe one side paralysis, difficulty speaking, seizure, inability to speak Patient received 1st Covid-19 Pfiser Vaccine shot on Thursday February 11, 2021. Patient received th... Read more
Patient received 1st Covid-19 Pfiser Vaccine shot on Thursday February 11, 2021. Patient received the 2nd Covid-19 Pfiser Vaccine on Thursday, March 4, 2021. 7 days after second vaccine shot on Thursday, March 11, 2021, patient showed some symptoms of a itchy-horsed throat & a slight dry cough. Called doctors - they said nothing to worry about, drink hot fluids and take couch drops. It went away in 2-3 days. Exactly 4 weeks after second Covid-19 Pfiser vaccine on Thursday, April 1st 2021, patient was sent to the ER for a seizure.
76 2021-04-15 bell's palsy, numbness patient reported numbness in right side of face and tooth pain on the day after his covid-19 immuniz... Read more
patient reported numbness in right side of face and tooth pain on the day after his covid-19 immunization. His prescriber evaluated him today and said he has a sinus infection with mild bells palsey. Unsure if related to immunization.
76 2021-04-16 pain in extremity His arm was sore; Nausea; Headache; Fatigue; This is different feeling than what he normally feels; ... Read more
His arm was sore; Nausea; Headache; Fatigue; This is different feeling than what he normally feels; This is a spontaneous report from a contactable consumer (patient's wife). A 76-years-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: EL9264, Expiration Date: 31May2021) via an unspecified route of administration on 02Feb2021 as single dose for COVID-19 immunization. Medical history included diabetes mellitus. On 04Feb2021 the patient experienced his arm was sore, nausea, headache, fatigue. On an unspecified date Feb 2021, the patient experienced this is different feeling than what he normally feels. The reporter stated, Yes, he takes a lot, I would rather not because its lot he is diabetic and he takes blood thinner and statin and its very long list, but these are different so those, the reason I called because this is different feeling than what he normally feels when he gets ups in the morning, and that's why I thought maybe it because of Covid. The patient underwent lab tests and procedures which included glycosylated hemoglobin, diabetes, I do I have to look up the result and the date, the date was 30Jan and it was blood draw for his A1C. The outcome of event different feeling than what he normally feels was unknown and other outcome of the events was not recovered.
76 2021-04-21 bell's palsy BELLS PALSY diagnosed March 23, 2021 Treated with Prednisone and Valacyclovir Gradual improvement
76 2021-04-23 weakness Headache; nausea; diarrhea; weakness; fatigue; 99.5 temp; This is a spontaneous report from a contac... Read more
Headache; nausea; diarrhea; weakness; fatigue; 99.5 temp; This is a spontaneous report from a contactable consumer (patient). A 76-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL926), via unspecified route of administration in left arm on 18Feb2021at 08:30 as a single dose for COVID-19 immunization. The patient medical history included Hypertension, hyperlipidemia, acid reflux. The patient concomitant medication included fenofibrate, atorvastatin, atenolol, lisinopril. The patient was not diagnosed with COVID-19 prior to the vaccination. The patient had not been tested for COVID-19 since the vaccination. The patient has allergic to cephalosporins. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 18Feb2021, the patient experienced headache, nausea, diarrhea, weakness, fatigue, 99.5 temp. The patient did not receive any treatment for the events. The outcome of the events Headache, nausea, diarrhea, weakness, fatigue, 99.5 temp was recovered.
76 2021-04-23 pain in extremity Could not eat all next day - slept around the clock.; 27 hours later nausea; headache; muscle ache; ... Read more
Could not eat all next day - slept around the clock.; 27 hours later nausea; headache; muscle ache; temperature of 99.5; discolored (orange) urine.; 1st day - sore arm only.; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 76-years-old male patient received first dose of bnt162b2 (BNT162B2, Solution for injection, Batch/Lot Number: EK 32 48), via an unspecified route of administration, administered in Arm Left on 30Jan2021 at 17:45 as single dose for COVID-19 immunization. Medical history included high blood pressure. No known allergies were reported. Concomitant medications included atorvastatin calcium 40 mg, Metoprolol succinate 25 mg, Colecalciferol (D3) 25. 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. Since vaccination patient was not tested for covid-19. On 30Jan2021, first day after vaccination, the patient had sore arm only. On 31Jan2021 at 10:00 pm, 27 hours later of vaccination, patient experienced nausea, headache, muscle ache, temperature of 99.5 and discoloured (orange) urine. The events were considered nonserious. Patient could not eat all next day and slept around the clock, drank a little bit of bubbly water. After 48 he later patient began to feel a little better and ate some grapes. The patient had not yet recovered from the events.
76 2021-04-23 tremor stomach aches; he's got the shakes; his right back, shoulder and back of his neck, his legs, his tru... Read more
stomach aches; he's got the shakes; his right back, shoulder and back of his neck, his legs, his trunk of his body are sore, everywhere his muscle are sore; Diarrhea; This is a spontaneous report from a contactable consumer (Patient). A 76-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE: Solution for injection), dose 1 via an unspecified route of administration on 25Dec2020 (Batch/Lot Number: EL9261; Expiration Date: 31May2021) as single dose for an unspecified indication. Medical history included myocardial infarction from an unknown date and unknown if ongoing (He had 2 heart attacks and open heart surgery and he is sick of this already), cardiac operation from an unknown date and unknown if ongoing (He had 2 heart attacks and open heart surgery and he is sick of this already) rhinorrhoea from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. On 28Dec2020, the patient experienced diarrhea, stomach aches, he's got the shakes, his right back, shoulder and back of his neck, his legs, his trunk of his body are sore, everywhere his muscle are sore. Patient says the 25th of last month, 25Dec he got his first shot, that was 14 days ago and 3 days after he got diarrhea it was pretty severe but then that cleared up and he was ok for few days and then he got stomach aches, the stomach aches woke him up at 5o'clock in the morning and then he had the stomach ache 03Feb. It was 3 times he had the stomach aches. Today he's got the shakes but he also has Parkinson's so a lot of things amplify his Parkinson's, so he is not overly concerned about the shaky thing. shaky thing happens periodically to him but it is pretty bad today. What he did to rectify is he took his normal medicine and he has taken an antacid on those days when he had the stomach ache and one other thing, the second thing was the stomach aches and also his right back, shoulder and back of his neck, his legs, his trunk of his body are sore, everywhere his muscle are sore and he is having a runny nose, the runny nose is the last thing but at the same time the runny nose was happening prior to taking the shot so that might not be related. He is calling to see if those things are associated with the vaccine. During that time period of time he took his temperature and he did not have a fever at any time. The action taken in response to the events for bnt162b2 was not applicable. The outcome of events was unknown.
76 2021-04-25 severe one side paralysis, speech disorder Ischemic stroke with paralysis on left side of body, impaired speech, swallowing, cognitive function... Read more
Ischemic stroke with paralysis on left side of body, impaired speech, swallowing, cognitive functioning
76 2021-04-27 pain in extremity After the first vaccine: Leg pain, foot pain, chest pain. Four days after vaccine, the chest pain wa... Read more
After the first vaccine: Leg pain, foot pain, chest pain. Four days after vaccine, the chest pain was so bad that my dad went to ER and had a Pulmonary Embolism . He was hospitalized two nights. After the second vaccine: right leg pain, weakness in both legs. Three days after the second dose, my dad had a stroke.
76 2021-04-30 weakness I can barely walk for maybe for simple thing an hour and then I am wiped out and have to go to bed a... Read more
I can barely walk for maybe for simple thing an hour and then I am wiped out and have to go to bed and sleep for about 3 hours; have to go to bed and sleep for about 3 hours; Feeling weaker; Fatigue; This is a spontaneous report from two contactable consumer (patient's partner and patient). A 76-year-old-male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL8982) via an unspecified route of administration on 04Jan2021 (76-year-old at vaccination) at a single dose for COVID-19 immunization. Medical history included sick. Other products were reported as no. The patient also received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL9269) via an unspecified route of administration on 04Feb2021 (77-year-old at vaccination) at a single dose for COVID-19 immunization. Consumer stated, "I hope you can, what's happening is I had my COVID shot on my last one on 04Feb2021 (further clarification unknown) and before that even I was sick ( Intent: medical history) and then now it's been 4 months later. This happen to start when I felt before I had the shot. I was like feeling weaker and weaker, there was no strength and then now I am totally fatigue (the start date of the feeling of weakness and fatigue was stated as "That's going to be hard, it's probably, it was in January. I want to look at this. January, probably, in the beginning of January maybe you can say 5th or something like that"), I can barely walk for maybe for simple thing an hour and then I am wiped out and have to go to bed and sleep for about 3 hours. So, I am looking to you for some help or what can I do." No treatment received. The report was reported as non-serious. The patient was still feeling weak, he was little bit better but he was still very worried about it. The outcome of event feeling weak was resolving, and of other events was unknown. No Follow-up attempts are needed. No further information expected.
76 2021-04-30 weakness temp to 100; weakness; fatigue; nausea; diarrhea; This is a spontaneous report from a contactable ph... Read more
temp to 100; weakness; fatigue; nausea; diarrhea; This is a spontaneous report from a contactable physician, the patient. A 76-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot EN6206, second dose) solution for injection intramuscular in the left arm on 11Mar2021 at 08:20 (at the age of 76-years-old) as a single dose for COVID-19 immunization. Medical history included ongoing blood pressure high from 2010, ongoing high lipid from 1980, and ongoing esophagitis from 1975. Concomitant medications included ongoing atenolol for blood pressure high from 2010, ongoing lisinopril for high blood pressure from 2010, ongoing atorvastatin for high lipids for greater than 10 years, ongoing fenofibrate for high lipid for greater than 10 years, and ongoing lansoprazole (PREVACID) for esophagitis for greater than 10 years. The patient did not receive any other vaccines within four weeks prior to the vaccination. Historical vaccine included BNT162B2 (first dose, lot EL9266) for COVID-19 immunization on 18Feb2021 and experienced headache, nausea, diarrhea, weakness, fatigue, and 99.5 temp (fever). The patient experienced moderate weakness, fatigue, Temp to 100 F, Nausea + diarrhea x2 in Mar2021. Treatment for the event fever included liquid Rx-TYLENOL at 500 mg twice. The outcome of the events weakness, fatigue, Temp to 100, nausea, and diarrhea was unknown. Follow-up attempts are completed. No further information is expected.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of event Fever 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.
76 2021-05-07 weakness Complete loss of strength in arms and legs. Was unable to get off of the floor for 4 hours.
76 2021-05-10 flushing severe allergic reactions; Skin is starting to blister, like a poison ivy breakout, where the rash i... Read more
severe allergic reactions; Skin is starting to blister, like a poison ivy breakout, where the rash is located.; Elevated heart beat, feels flushed; Elevated heart beat, feels flushed; Itching; Broke out in a rash; This is a spontaneous report from a contactable consumer (patient). A 76-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) dose 1 via an unspecified route of administration in left arm on 20Apr2021 10:00 (Lot Number: EW0171) as single dose for covid-19 immunisation. Medical history included ongoing diabetic reported as 10 years ago. No other products. No investigation assessment. No prior vaccinations within 4 weeks. No history of all previous immunization with the Pfizer vaccine considered as suspect. No additional vaccines administered on same date of the Pfizer suspect. On 20Apr2021 after 10 am, patient experienced broke out in a rash, it improved when he took his medication, that he was given in the hospital, but then the rash came back as the medications wears off. About a half hour after the vaccine on 20Apr2021 10:30, patient had itching, when he took the medicine it helped the itching, but as the medicine wears off, the itching came back, with a vengeance. He went to the emergency room, yesterday for treatment. He was released and made contact with his family physician. He was taking Famotidine 20 mg by mouth once a day, and Benadryl every 25 mg, 2 pills, by mouth every 4 hours. He had some relief with these medications, but then started to feel the events as he got closer to taking his next dose. An hour or so after the initial shot on 20Apr2021 11:00 and then at the hospital, patient had elevated heartbeat, felt flushed. He seemed ok, but he wasn't sure, what his heart rate was, as he felt flushed once in a while. This morning on 21Apr2021, skin was starting to blister, like a poison ivy breakout, where the rash was located, it was about the same as when he took the medicine it helped, but as the medicine wears off, it came back. He had severe allergic reactions. Events required a visit to emergency room and physician office. The outcome of events was unknown. No follow-up attempts are needed. No further information is expected.
76 2021-05-10 numbness This is a spontaneous report from a contactable consumer or other non hcp. A 76-years-old male patie... Read more
This is a spontaneous report from a contactable consumer or other non hcp. A 76-years-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection, Lot number: unknown; Expiration Date: unknown) via an unspecified route of administration on 19Mar2021 as single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. on 19Mar2021, the patient experienced left kneecap went numb/started to come back, but just a little bit around the edge of the kneecap (hypoesthesia); on an unspecified date, the patient experienced knee pain/started getting pain, nothing severe/having pain even in bed when he repositioned/pain in the knee which made it to where it hurt to walk/walking I had pain and its making me limp this morning, knee pain/started getting pain, nothing severe/having pain even in bed when he repositioned/pain in the knee which made it to where it hurt to walk/walking I had pain and its making me limp this morning (gait disturbance), back pain, starting in the lower back and it kept getting worse, up my back, pain the size of a dime, like where your kidney is, lasting about 30 seconds, then it would wrap around to my appendix, bothered me all day (back pain), soreness to their arm where the injection was given. The clinical outcome of the events was unknown. No follow-up attempts are needed; information about lot/batch number cannot be obtained.
76 2021-05-12 weakness Acute pancreatitis; No appetite/he was starving himself to death; he lost all use of his extremities... Read more
Acute pancreatitis; No appetite/he was starving himself to death; he lost all use of his extremities; Still not eating and is so weak/No energy/he still has no strength; Whole balance everything was off/His balance is horrible; he took 2 bites of food and vomited; Dizziness; Still not eating and is so weak; Affected his memory; This is a spontaneous report from a contactable consumer (patient wife). A 76-year-old male patient received second dose of BNT162B2 (mRNA PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EL9262; 76-year age at the time of vaccination), via an unspecified route of administration on 09Feb2021 as single dose for COVID-19 immunization. Medical history included allergy, blood pressure, kidney patient (on dialysis three times a week, so he was a kidney patient). Concomitant medication(s) included Insulin aspart (NOVOLOG) (He takes Insulin with each meal he takes 6 units of NovoLog with his Demeter 6 units), Amlodipine besilate (5 mg tablet) taken for Blood pressure as 5 mg (one tablet on Saturday and Sunday, Tuesday and Thursday), Atorvastatin (40 mg tablet), 40 mg daily, Acetylsalicylic acid (BABY ASPIRIN) daily, Cetirizine (5 mg tablets) for Allergy at 5 mg daily, Ascorbic acid, biotin, folic acid, mecobalamin, nicotinic acid, pantothenic acid, pyridoxine hydrochloride, riboflavin, thiamine (DIALYVITE) daily (1 pill daily), Docusate (DOCUSATE capsule) by oral 1 DF, 2x/day (One capsule by mouth twice a day), Fish oil (100 mg capsule) 100 mg, 2x/day orally, insulin glargine 1x/day (At bed time he takes 8 units of his Insulin glargine), Vitamin B complex (SUPER B COMPLEX [VITAMIN B COMPLEX]) and vitamin D3 daily; patient was taking other medications for kidney. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: EL3302; 76 Year age at time vaccination) on 21Jan2021 for COVID-19 immunization and experienced lost his appetite right away, extremely volatile vomiting, lost control of all of his extremities, this has all affected his memory, acute pancreatitis, barely moving, balance was horrible/his whole balance everything was off; had no strength. It was reported patient received his 1st Pfizer vaccine shot on 21Jan2021. He "lost his appetite right away and wasn't eating." Then on 29Jan2021 he took 2 bites of a meal, and "had extremely volatile vomiting and lost control of all of his extremities. My daughter had to help me get him up from the floor." the next day "he was able stand up and use the restroom by himself. This has all affected his memory, he cannot do his medications alone anymore and he cannot take care of himself." 09Feb2021 he received the 2nd vaccine dose. "Again that night he took 2 bites of food and vomited. The next day, he still had no appetite, he took shower and then went to bed with dizziness (10Feb2021) and no energy." stated she took him to the (hospital name) on 12Feb2021 and he was admitted to the (hospital name) with "acute pancreatitis (Feb2021) and was released on the 17Feb2021. They should have kept him longer, because he is still not eating and is so weak (Feb2021), I am worried." Further stated, " He had his first shot of the Pfizer on 21Jan2021 and then he violently threw up on the 29Jan2021 and from that's when on he had no appetite, I couldn't get him to eat anything. And then he had his second shot on the 09Feb2021. On Thursday, the 11Feb2021 he violently threw up again after taking two bites of food. And then on the 12Feb2021 I took him over to the (hospital name) because after when he vomited; he lost all use of his extremities (Feb2021). My daughter and I were having to pick him up of the floor, the Friday night 24 hours it was just horrible. Saturday morning he had gotten use of his extremities back but I mean barely moving and still very, his whole balance everything was off (Feb2021). Now when I took him into the hospital they diagnosed him with acute pancreatitis, but he still, he was in the hospital from Friday the 12Feb2021 and they released him on the 17Feb2021. And he still has no strength (Feb2021). His balance is horrible. It was affecting, whatever it is affecting his memory. the medical records when he went in the hospital and everything if they would like. They have no idea why he came down with acute pancreatitis and he never had any pain with it. They said we are amazed that he was not in severe pain, never any pain. I want to find out if they feel that it had anything to do with the vaccine and if it did if there's anything we can do to improve because he is terribly, terribly getting worse." also stated, "He started experiencing the problems right with in that time period of him getting both shots." Also reported, Affected his memory in Feb2021. Reporter stated, "Because I didn't know, he was starving himself to death (in Feb2021) he couldn't hold anything down. He wouldn't eat and when I went (incomplete sentence)" The seriousness was reported as hospitalization for the events Acute pancreatitis; Appetite lost; Muscle disorder; Asthenia. The outcome of the events was unknown.; Sender's Comments: Linked Report(s) : PFIZER INC-2021191555 Same reporter/patient/product, Different dose/AE
76 2021-05-12 pain in extremity sore arm other than injection site; light headedness; mild diarrhea; This is a spontaneous report fr... Read more
sore arm other than injection site; light headedness; mild diarrhea; This is a spontaneous report from a contactable consumer, the patient. A 76-year-old male patient received first dose of bnt162b2(BNT162B2; formulation: solution for injection; Lot number el9264) via an intramuscular route of administration in left arm on 27Jan2021 at 03:00 PM (Age at vaccination: 76) as single dose for COVID-19 immunization at workplace clinic. The patient medical history and concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient had no Allergies to medications, food, or other products and the patient received other medications within 2 weeks of vaccination, but unspecified. 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 at 09:00 PM (the date of the vaccination), the patient experienced sore arm other than injection site, light headedness, mild diarrhea. The patient did not received treatment for the adverse event. The outcome of the events was recovered. Follow-up attempts are completed. No further information is expected.
76 2021-05-17 pain in extremity shoulder pain; My husband had a sore arm; This is a spontaneous report from a contactable Consumer. ... Read more
shoulder pain; My husband had a sore arm; This is a spontaneous report from a contactable Consumer. This Consumer reported that a 76-year-old male patient received bnt162b2 (BNT162B2, Formulation: Solution for injection), dose 1 via an unspecified route of administration on 25Jan2021 as 1 ST DOSE, UNKNOWN for Covid-19 immunization. The patient's medical history and concomitant medications were not reported. She stated that her husband experienced only shoulder pain. She stated my husband had a sore arm, he (Husband) was fine, he was good with it he just had a sore. The outcome of the events was unknown.
76 2021-05-17 tenderness, breast pain, hot flush, numbness developed a thrombosis on the left arm; varicose veins on the arm; whole arm is swollen; veins are s... Read more
developed a thrombosis on the left arm; varicose veins on the arm; whole arm is swollen; veins are swollen; burning pain in left lung, and it goes up to the breast and lymph nodes/ discomfort on left side Lung; burning pain in left lung, and it goes up to the breast and lymph nodes, it is sensitive there; burning pain in left lung, and it goes up to the breast and lymph nodes, it is sensitive there; has tenderness near the wrist and elbow, clarifying the inside of the elbow; felt numbness in the left arm; hot flashes; This is a spontaneous report from a contactable consumer (patient) and physician. A 76-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), second dose via an unspecified route of administration, administered in left arm on 10Mar2021 (Batch/Lot number was not reported) as single dose for covid-19 immunisation. Medical history included heart conditions, he has had 2 heart attacks in the past, the first one was 21 years ago, and the second was 2 years ago. Concomitant medications included all his regular medications, nothing new; (also reported as No other products). Patient previously received BNT162B2 first dose on 13Feb2021 administered in left arm for COVID-19 immunization. Patient developed varicose veins a month after he received both his shots for Pfizer's COVID vaccine. Caller stated veins are swollen. It's coming down some, but patient need to know what medications could take or not take. On the left arm right inside of his elbow, he started getting some pattern of varicose veins. It was tender to some degree and people told him to massage it and put a warm pad on it. Seems like the veins were going to pop out. Patient stated he received his vaccine at a hospital. On 03May2021, reported patient was calling in regards to a covid vaccine. He developed a thrombosis on the left arm, it was varicose veins on the arm and the whole arm is swollen, it was still swollen but it was coming down. He had been using a heat pad. Initially after 2 weeks from when he got the shot he wasn't concerned, he went to the doctor and they gave him Cat scan, Ultra sound, and blood test and did not find a blood clot. He added that he had discomfort on left side Lung, but he had discomfort several years ago, an MRI in the past that showed he has a spot in the lungs, but they didn't think it was progressing. With this thing in the past 3-5 weeks he has burning pain in left lung, and it went up to the breast and lymph nodes, it is sensitive there, he has no idea what it is. Caller was asked to clarify since he stated that he had a thrombosis but all tests show no blood clot. Caller stated that he thought Thrombosis meant when the veins are popping out and gives impression of varicose veins. He had tenderness near the wrist and elbow, clarifying the inside of the elbow. If looking at the arm from the elbow up little, it looked like worms coming out, it was veins or arteries showing. The varicose veins appearance was more pronounced close to surface initially but is now minimizing. First dose date on 13Feb2021. He was not concerned after the first dose, he was fine, he thought it was a good product and it still is. Second dose date on 10Mar2021. After the second dose he felt numbness in the left arm and hot flashes, he looked down and saw the varicose veins. He did go see the primary care doctor. He also saw his heart doctor but that was an already scheduled appointment, he did not schedule it because of this situation. the heart doctor said to put a warm pad on the arm and lift the arm up over the head every so often. Caller did not have his covid vaccine card, caller stated that he has miss placed it. He found some paper but it only has his ID number and "LHDSER" on it. He received the vaccine in the left arm both times. All symptoms occurred on the left side. He recieved the vaccine in a hospital. Patient asked to refer to his primary care doctor as he has all the results for the tests. Investigation included CAT scan normal; Ultrasound normal; Blood test normal and MRI abnormal which showed spots in the lungs on unspecified date. The event outcome for all events was unknown. Information for batch/ lot number has been requested.
76 2021-05-23 cold sweat Chills for two days after the first vaccine. rash on right foot and right arm after the second vacc... Read more
Chills for two days after the first vaccine. rash on right foot and right arm after the second vaccine which lasted several days and then dried up. At that point I had cold sweats and chills which started today about 10 AM. I texted Dr. who advised me that the rash should disappear in a few days. She was correct and a couple of days later texted that she had no concerns about the cold sweat and chills.
76 2021-05-23 slurring 03/18/2021 FIRST COVID19 VACCINE 04/08/2021 SECOND COVID19 VACCINE 04/09/2021 FELT DIZZY AND FAINTED... Read more
03/18/2021 FIRST COVID19 VACCINE 04/08/2021 SECOND COVID19 VACCINE 04/09/2021 FELT DIZZY AND FAINTED BREIFLY IN THE MORNING 05/03/2021 AT NIGHT, SLUGISH SPEACH, DIZZY, HIGH BLOOD PRESSURE 05/04/2021 WENT TO EMERGENCY ROOM AND HOSPITAIZED (STROKE)
76 2021-05-24 weakness, unresponsive to stimuli 3/5, admitted 3 days after covid vaccine and died. Patient presented to ED feeling very weak and had... Read more
3/5, admitted 3 days after covid vaccine and died. Patient presented to ED feeling very weak and had fallen and could not get up. He was brought to the emergency room, and a trauma evaluation was negative. He was found to have a severe junctional bradycardia with a heart rate in the 20s and systolic blood pressures in the 60s. In addition, he was found to have a creatinine now of greater than 5 when his previously had been in the low 1s. Patient admitted with junctional bradycardia, acute renal failure, hypotension, cardiogenic shock, and acute hypoxemic respiratory failure with high O2 needs. PMH significant for CAD, pulmonary HTN, aortic stenosis, obstructive lung disease, and chronic hypoxia. This patient has been made DNR/DNI over the weekend which is quite appropriate. Patient was found to be unresponsive with fixed/dilated pupils, absent heart and breath sounds, no respiratory effort, absent pulses, and no response to painful stimuli. Patient was pronounced deceased on 03/10/2021 at 0405.
76 2021-05-25 weakness weakness, dizziness upon waking
76 2021-05-25 tremor jaw bone like what hooks onto his head gets achy; it gets achy and is weird; terrible muscle pain an... Read more
jaw bone like what hooks onto his head gets achy; it gets achy and is weird; terrible muscle pain and joint pain; little shaky when getting out of the chair; terrible muscle pain and joint pain; his hands joint do not work right; This is a spontaneous report received from a contactable consumer or other non hcp (patient himself). A 76-years-old male patient received bnt162b2 (BNT162B2, Formulation: Solution for injection, Lot Number: EP7534, Expiration date: Unknown), via an unspecified route of administration in Arm Left on 18Mar2021 10:30 as 2ND DOSE, SINGLE for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. There were no prior vaccinations within 4 weeks and no adverse events prior vaccination. There was no family history relevant to adverse events. The patient previously received first dose was received in his left shoulder as an injection on 25Feb2021 10:30 and the lot number is EN6200. On 19Mar2021, the patient experienced terrible muscle pain and joint pain, little shaky when getting out of the chair, on unspecified date in Apr2021, experienced jawbone like what hooks onto his head gets achy, it gets achy and is weird and on unspecified date in 2021, experienced his hands joint do not work right.. It was stated that he was calling to report what has happened to him from the second shot. The patient stated he got the shot on 18Mar2021 and when he woke up in the next morning he had terrible muscle pain and joint pain so he decided to call his doctor. The patient stated he could not get a hold of his doctor but the information that was given to the caller was provided from the nursing staff. It was stated that before he got the COVID shot he was working out with weights in the fitness center and doing really good and now he was fighting a battle. The patient stated also his jawbone like what hooks onto his head gets achy. The patient stated that mostly the joint pain was in his shoulders. It was stated he was sitting down on his chair and he used to be able to get up real easy but he now he was a little shaky when getting out of the chair now. The patient stated also his hands joint do not work right but he bought some stuff to rub on them which seems to help a little bit, but he has never had any of this before. It was stated he was working out, handling barbells, and for an old guy people would be surprised what he was lifting and he had no problems and stated for example if he goes to eat a breakfast meal with the egg, sausage, and biscuit he can barely open his mouth enough to eat it. The patient stated this started probably at the end of April. It was stated this is no 24 hours a day but he had it this morning and it gets achy and was weird. It was stated that eventually he will go back to the dentist since the dentist has a machine to take a picture of his jaw since he has not gone yet because of COVID but once he gets all this squared away he will go to dentist so they can take that picture. It was stated he was able to squat down towards the floor and go way down all the way down and pop right up and stated he knows he could not do that in the last couple of weeks anyway but he has not tried it since he has had trouble getting out of chair. It was clarified that this started as an introduction the day after getting the second shot on 19Mar2021 and it was still going on. It was stated he was not sure if it is getting worse or not since he has not followed it like a documentary. It was stated the doctor told him to take Tylenol and he has never had anything like this happen to him. It was stated what the doctor relayed to him was to go get a Tylenol rapid release and he takes two pills which is 1,000mg and he takes this 3 times a day and has a schedule knowing it was not recommended to take more than the 3,000 since the doctor was not wanting him to go over 4,000mg because effect the kidneys or liver. It was stated but he had not talked face to face with his doctor and he needs to get an appointment with his doctor but there is a wait and probably won't be able to see him for about a month. The outcome of the events terrible muscle pain and joint pain, jawbone like what hooks onto his head gets achy were not recovered and rest of the events was unknown. No follow-up attempts are needed. No further information is expected.
76 2021-06-08 tingling Chest pain (comes and goes), shortness of breadth, tingling in hands,
76 2021-06-09 pain in extremity nausea; Headache; Fatigue; different feeling than what he normally feels; His arm was sore; This is ... Read more
nausea; Headache; Fatigue; different feeling than what he normally feels; His arm was sore; This is a spontaneous report from a contactable consumer. A 76-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration, administered in right arm on 23Feb2021 14:02 (at the age of 76-year-old) (Batch/Lot Number: EN6202; Expiration Date: 30Jun2021) as 2ND DOSE, SINGLE DOSE for covid-19 immunisation. Medical history included diabetes from 1996. The patient's concomitant medications were not reported. Historical vaccine includes bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number: EN9264) administered in the right arm on 02Feb2021 (at the age of 76-year-old) as 1ST DOSE, SINGLE DOSE for covid-19 immunization where patient also experienced his arm was sore. On 24Feb2021, the patient experienced nausea, headache, fatigue, different feeling than what he normally feels, and his arm was sore. The onset time for the events headache and nausea was at 09:00. The patient was admitted to the hospital due to the events nausea, headache, fatigue, and different feeling than what he normally feels. The events did not require emergency room and physician office visit. There was no treatment received for all events. On an unspecified date, the patient recovered from all events. Follow-up attempts are needed. Further information has been requested.
76 2021-06-14 weakness Dizziness, weakness and fatigue. Had an Echocardiogram and stress test and all was good.
76 2021-06-16 pain in extremity left arm to be a bit sore; tiny little headache; This is a spontaneous report from a contactable con... Read more
left arm to be a bit sore; tiny little headache; This is a spontaneous report from a contactable consumer (patient). A 76-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EN6206), on 16Mar2021 at 13:00, after lunch (at the age of 76-years-old) at 2nd dose, single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient was in good health for age 76, as reported. The patient played semi pro sports. The patient received the first dose of BNT162b2 (lot number: EN6200) on 23Feb2021, at the age of 76-years-old, for COVID-19 immunisation. The patient experienced his left arm to be a bit sore and just one tiny little headache in Mar2021. He had no fever or other possible side effects. Patient asked if drinking alcohol had any effect a few hours later the vaccine. He clarified he was not drunk; only for a couple of glasses of wine/beers. The patient clarified that he had a couple of glasses of wine with dinner and had no reaction. He was speaking about having a couple of glasses of wine with dinner and the pharmacist told him that he was pretty sure that would be fine to do. Patient stated he had a lady friend coming over the night of the report and she was getting her 2nd Pfizer vaccine on that day and he was convinced that a glass of wine would not hurt. The patient asked when after the shot you would have the highest level of protection and how long after the 2nd booster of BNT162b2 he would be best protected and if it would be in another week or 2 weeks before full protection occurred. The outcome of the events was unknown. No follow-up attempts are possible. No further information is expected.
76 2021-06-18 flushing Multiple episodes of tachycardia (60+ since 2/28/2021) with accompanying symptoms of flushing labore... Read more
Multiple episodes of tachycardia (60+ since 2/28/2021) with accompanying symptoms of flushing labored breathing and triggering of bowels.
76 2021-06-30 pain in extremity Pain in the left arm between the elbow and the shoulder; This is a spontaneous report from a contact... Read more
Pain in the left arm between the elbow and the shoulder; This is a spontaneous report from a contactable consumer (patient). A 76-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number, NDC number and Expiry Date were not provided), via an unspecified route of administration, administered in Left arm on an unspecified date in Jan2021 at 10:30 or 11:00 (at the age of 76-years-old) as dose 1, single dose for covid-19 immunisation. Medical history included, patient was tested for covid months ago, prior to receiving the pfizer covid 19 shots and tested negative at that time. Patient's medical history including any illness at time of vaccination were none. Family medical history relevant to adverse events were none. Relevant tests were none. There were no concomitant medications. The patient previously took flu shot over the years and experienced the same sensation (pain) in his arm, only worse occurred. The patient is unable to provide NDC/lot/expiration for the flu shot. There was no antipyretic use around the date(s) of vaccination. The patient stated that he was for the most part a healthy person. 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 not reported. Are there predisposing factors? Unknown/no/ yes (e.g. Immunosuppression, contact with other infected persons) if yes, please specify: not that the patient knows of. Prior vaccinations (within 4 weeks) if applicable, list any other vaccinations within four weeks prior to the first administration date of the suspect vaccines were none. Additional vaccines administered on same date of the pfizer suspect if applicable, list all vaccines administered on same date with the pfizer vaccine considered as suspect were none. There was no investigation assessment. On an unspecified date in Jan2021, the patient experienced pain in his left arm between the elbow and the shoulder, began about two hours after he received both the first and second dose pfizer covid 19 shot. The caller states the pain in the left arm between the elbow and shoulder has gone away. The caller states the pain in the arm went away completely after both doses of the pfizer covid 19 shots. Adverse events required a visit to to urgent care. He stated there were no emergency room visits. The patient underwent lab tests and procedures which included covid (sars-cov-2 test): negative on an unspecified date. Is there a Product Complaint: Yes, description of complaint was the caller received both doses of the Pfizer Covid 19 Vaccine and tested positive for Covid. Product strength and count size dispensed: N/A. Additional lot numbers: The caller states his wife has this information with her and the caller has no clue, the caller states Pfizer should be able to look this information up. The caller states his wife is not available for the next 4 or five hours. The caller is unable to provide this information for the first or second dose received of the Pfizer Covid 19 shots. The outcome of event was recovered on an unspecified date in 2021. Information about lot/batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021733594 similar report from same reporter
76 2021-07-01 weakness Patient received entire vial of undiluted vaccine. Patient being monitored for adverse effects whil... Read more
Patient received entire vial of undiluted vaccine. Patient being monitored for adverse effects while inpatient. Patient received vaccine while admitted for other medical conditions. Currently experiencing weakness and generalized pain.
76 2021-07-01 pain in extremity diagnosed with pneumonia; pain in the left arm between the elbow and the shoulder; pain in the left ... Read more
diagnosed with pneumonia; pain in the left arm between the elbow and the shoulder; pain in the left arm between the elbow and the shoulder; positive for COVID-19; Drug ineffective; This is a spontaneous report from a contactable consumer or other non health professional (patient). A 76-years-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number and Expiration date was unknown), via an unspecified route of administration, in Left Arm on Jan2021 around 10:30 or 11:00, (at the age of 76-years-old) as a DOSE 2, SINGLE for COVID-19 immunization. The patient previously took first dose of BNT162B2 (Solution for injection) via an unspecified route of administration in left arm on Jan2021 around 10:30 or 11:00 (at the age of 76-years-old) as a DOSE 1, SINGLE for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The caller is on doxycycline and a couple of other things. The patient has had the flu shot over the years. On an unspecified date, the patient experienced diagnosed with pneumonia; on 18Jun2021 positive for covid-19, drug ineffective; and on an unspecified date pain in the left arm between the elbow and the shoulder. The caller stated there were no Emergency room visits. No Prior Vaccinations (within 4 weeks) If applicable, list any other vaccinations within four weeks prior to the first administration date of the suspect vaccines. The pain in the caller's left arm between the elbow and the shoulder began about two hours after the caller received both the first and second dose Pfizer Covid 19 shot. The patient stated that the pain in the left arm between the elbow and shoulder has gone away. On 18Jun2021, the patient underwent lab tests and procedures which included sars-cov-2 test: positive. The caller clarifies he was tested for Covid on 13Jun2021 and received the positive test result today, 18Jun2021. The outcome of event pneumonia was recovering, and outcome for pain in the left arm between the elbow and the shoulder was recovered and outcome for other events was unknown. Follow-up attempts are needed. Information on Lot/Batch number can be requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021733999 similar report from same reporter
76 2021-07-05 inability to speak Wife stated that Husband passed after receiving dose of Pfizer vaccine, he developed a Guillain-Barr... Read more
Wife stated that Husband passed after receiving dose of Pfizer vaccine, he developed a Guillain-Barre Syndrome after receiving vaccine. Wife stated that he lost ability to walk, ability to speak was severely impacted, had difficulty eating and drinking bc his throat muscles were effected from the syndrome. Then, he couldn't sit up in bed. Then, after was diagnosed that's when his kidneys started to fail and then his heart stopped. DOD: 04/06/2021
76 2021-07-17 tingling Chest pain; Tingling Pins and Needles All Over his body/pins and needles all over his skin; This is ... Read more
Chest pain; Tingling Pins and Needles All Over his body/pins and needles all over his skin; This is a spontaneous report from contactable consumer via Medical Information Team. A 76-year-old male patient (Husband) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number: Not provided), via an unspecified route of administration on 17Feb2021 09:00 (at the age of 76-year-old) in left arm as single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On 18Feb2021, the patient experienced tingling pins and needles all over his body, pins and needles all over his skin. On an unspecified date, the patient experienced chest pain. Reporter stated that this morning it was only on his left arm where he got his vaccine. February 2021. She explained her husband had "pins and needles all over his skin", and in the morning it was limited to his left arm, where he received the vaccine. She added she experienced "chest pain" the Friday following the injection, which lasted for 4 days. She had a phone consultation with her cardiologist who said it was "fine and muscle pain". She mentioned their second dose was scheduled on 10Mar2021 and asked if they should receive it. She also reported 3 females died post vaccination with the Pfizer-BioNTech COVID-19 vaccine. She explained: one died after the vaccine; the second, in her sixties, died of a heart after the vaccine; and the third, in her fifties, died after experiencing chest pain for 2 weeks post vaccination. She explained she had no additional details on these adverse events. Her husband had pins and needles all over his skin the day after, and it was just in left arm where he had the COVAX. She said he tried to ask the HCP about it, but the HCP would not answer them and told them to call. She had chest pain 4 days after receiving the COVAX and her cardiologist told her it was just muscle pain. She did not have it. Patient was not visited to Emergency Room and physician Office. No vaccine was administered Prior Vaccinations (within 4 weeks). No treatment was given for the events. Outcome of the event chest pain was recovered on an unspecified date, and tingling pins and needles all over his body and pins and needles all over his skin was recovering. Lot/batch number is not available despite the follow up attempts made. Follow-up attempts are completed. No further information is expected.
76 2021-07-19 weakness kept going back and wanting to go to sleep; Fever; weak; chills were real bad, it made him shake; pu... Read more
kept going back and wanting to go to sleep; Fever; weak; chills were real bad, it made him shake; pulse has been high ever since the shot; has the thing you put on finger to read oxygen, it was 92 one time; arm sore; This is a spontaneous report from a contactable consumer(patient). A 76-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection), via an unspecified route of administration, administered in Deltoid Left on 11Feb2021 (at12:00) (Batch/Lot Number: EN9581) as Dose Number Unknown, 0.3ML Single for Covid-19 immunization. Medical history included Gastroesophageal reflux disease, Blood cholesterol; Only takes acid reflux and cholesterol medicine and Covid-19 From an unknown date and unknown if ongoing. The patients' concomitant medications were not reported. The patient experienced Arm sore on 11Feb2021, Fever on 12Feb2021 at 05:48, Chills were real bad, it made him shake, Pulse has been high ever since the shot and Has the thing you put on finger to read oxygen, it was 92 one time, weak on 12Feb2021, Kept going back and wanting to go to sleep on an unspecified date. The patient underwent lab tests and procedures which included body temperature: 101 on 12Feb2021, Body temperature: 101.6 on 12Feb2021, Body temperature: 100.3 on 12Feb2021, Heart rate: high on 12Feb2021, Oxygen saturation: 96-98 on 12Feb2021, Oxygen saturation: was like 92 one time on 12Feb2021. There was no Assessment. A query was raised to confirm Patient's last name and then the response was received After listening to the recording. The outcome of event for Arm, Chills were real bad, it made him shake, Pulse has been high ever since the shot and Has the thing you put on finger to read oxygen, it was 92 one time, and Kept going back and wanting to go to sleep sore was unknown. The outcome for event Fever and weak was resolving. Follow-up attempts are completed. No further information is expected.
76 2021-07-19 pain in extremity sleepy; soreness around the arm; This is a spontaneous report from a contactable consumer (patient h... Read more
sleepy; soreness around the arm; This is a spontaneous report from a contactable consumer (patient himself) via Medical Information Team. A 77-year-old male patient received BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- ER6955, Expiration Date- Jun2021) via an unspecified route of administration in left arm on 05Apr2021 as dose 1, single and received BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- EW0171) via an unspecified route of administration in left arm on 03May2021 as dose 2, single (at the age of 76-years-old) for COVID-19 immunization. Patient medical history included ongoing seasonal allergies, never had an actual diagnosis. He thought there was something wrong with his lungs and said that he was wheezing and the doctor prescribed him something that he did not want to take. Picked up leaves and his throat constricted on him and he said that he diagnosed himself. The concomitant medications were not reported. On an unspecified date in 2021, patient stated he has had both doses of the Pfizer COVID-19 vaccine and reported that the vaccine made him sleepy. He stated he would sleep for 3 to 4 hours after the vaccine. He reported soreness around the arm. He stated he felt great after the nap. He stated he took the Pfizer covid 19 vaccine and feels more at ease now. He stated that his eyes were bad prior to the vaccine and it had no effect on his eyes. He does not like taking medication, but every once in a while would take Benadryl for his allergies. It might have been that he just laid down after the vaccine. He said that he is a old man and can sleep all of the time. The outcome of the events was unknown. Follow up are attempts needed. Further information is expected.
76 2021-07-22 facial paralysis Right side of face became paralized,
76 2021-07-24 burning sensation within a week of the second shot the patient began to have problems with both legs, such as burning ... Read more
within a week of the second shot the patient began to have problems with both legs, such as burning in both legs, continued weakness, and when he walks his feet want to go in one direction and he wants to go in another. It is now July 25, 2021 and his legs are no better.
77 2021-01-15 pain in extremity Red and black spots on inside upper left arm. Soreness and a little pain.
77 2021-01-23 tremor Flu like symptoms, chills, shakiness, stuffy sinuses and moderate fatigue. Occurred 24 hours after ... Read more
Flu like symptoms, chills, shakiness, stuffy sinuses and moderate fatigue. Occurred 24 hours after injection and, with the exception of fatigue, have abated for the most part on day two following injection. I received my shot at hospital. It was the Pfizer formula. Injection site upper left shoulder.
77 2021-01-24 pain in extremity sore arm/soreness in the arm; a little swelling, slight swelling/there was a little swelling where i... Read more
sore arm/soreness in the arm; a little swelling, slight swelling/there was a little swelling where it was injected; This is a spontaneous report from a contactable consumer (patient). This reporter reported similar events for two patients. This is 1st of 2 reports. A 77-year-old male patient received first dose of bnt162b2 (PFIZER- BIONTECH COVID-19 VACCINE) at left arm, via an unspecified route of administration on 11Jan2021 12:00 at single dose for covid-19 immunisation. Medical history included ongoing diabetes mellitus. Family Medical History was None. The patient previously had pneumonia shot that he had a pretty bad reaction to one time. It was hard to explain, he had sloughing to the skin on the left arm. Under the left arm was hanging down about 3-4 inches. There was some fluid of some sort. He went to the clinic and they gave him something and it went away and he was told not to get another one. It was about 8-9 years ago. The patient's concomitant medications were not reported. The patient experienced sore arm and a little swelling, slight swelling on 11Jan2021. The patient noticed the soreness in the arm about 2-3 hours after getting the shot, but it was getting better, but there was a little swelling where it was injected. There was slight swelling, but not much. The outcome of event "sore arm/soreness in the arm" was unknown; of event "a little swelling, slight swelling/there was a little swelling where it was injected" was not recovered. Lot/batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021026404 same reporter/product, different patient.
77 2021-01-25 involuntary muscle movements No reaction originally; but 10 days after receiving the PFIZER-BioNTech COVID 19 Vaccine EUA I had s... Read more
No reaction originally; but 10 days after receiving the PFIZER-BioNTech COVID 19 Vaccine EUA I had severe pain in my left (vaccine site) upper arm muscle and shoulder joint; and was unable to lift my arm up away from my left hip. I have been experiencing these severe symptoms since the 10th day after receiving the COVID Vaccine (now the 12th dasys after the vaccine)
77 2021-01-26 brain damage Patient received unknown covid vaccine 1/20/21, sometime before or after became Covid PCR+. 3 days l... Read more
Patient received unknown covid vaccine 1/20/21, sometime before or after became Covid PCR+. 3 days later developed encephalopathy, was quite agitated, walking around hospital naked. He had LP which ruled out infection and CT imaging to rule out CVA. Improved after 24 hrs with supportive care, pt returned to mental status baseline
77 2021-01-30 weakness Day of injection (01/28/2021) plus 3 hours Approx 12 noon. 4 bouts of Diarrhea lasting several hours... Read more
Day of injection (01/28/2021) plus 3 hours Approx 12 noon. 4 bouts of Diarrhea lasting several hours. Two days post injection (01/30/2021) 11:A.M. 2 bouts of Diarrhea over two hour period. Two days post injection (01/30/2021) 10:00 P.M. Broke out in a full body sweat, weakness with heart rate 120 bpm. Cooled off by using cool wet towels and rested for two hours. Heart rate down to 75bpm. Heart felt like skipping beats for another hour. Now Sunday morning (01/31/2021) and feel normal
77 2021-02-01 feeling hot intense itching/ itching on his hips and on his back; gets red whenever he scratches it; after the i... Read more
intense itching/ itching on his hips and on his back; gets red whenever he scratches it; after the injection his arm got a little sore; Feels like it is hot; This is a spontaneous report from a contactable consumer (patient). A 77-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL3246, expiry: 30Apr2021) intramuscularly into the left arm on 06Jan2021 at a single dose for covid-19 immunisation. Medical history included nerve damage, brain damage, disability from 1997, anxiety, major severe depression, occupational exposure to heavy metal uranium, chronic obstructive pulmonary disease (COPD), early stage emphysema and diabetes. Concomitant medication includes unspecified medications for brain damage, anxiety and major severe depression. It was reported that after the injection, his arm got a little sore on 06Jan2021. On 13Jan2021, patient experienced intense itching; further reported as itching on his hips and on his back which gets red whenever he scratches it. It was also reported that the more he would scratch it, the more intense the itching would get. On an unspecified date in Jan2021, the patient also feels like it is hot. The patient applied EUCERIN cream and CORTISONE 10 for the events "intense itching/ itching on his hips and on his back" and "gets red whenever he scratches it". The patient was scheduled for his second dose on 27Jan2021. Outcome of event "intense itching/ itching on his hips and on his back" was not recovered while for the events "after the injection, his arm got a little sore", "gets red whenever he scratches it" and "feels like it is hot" was unknown.
77 2021-02-03 weakness, feeling cold he doesn't have any energy, he is real low on energy; real sick; tired; freezing to death; Chills; D... Read more
he doesn't have any energy, he is real low on energy; real sick; tired; freezing to death; Chills; Diarrhea; This is a spontaneous report from a contactable consumer (patient) via a Pfizer-sponsored program. A 77-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in left arm on 14Jan2021at single dose for COVID-19 immunization. Medical history includes hearing aids user from unknown date. There were no concomitant medications. On 17Jan2021 Sunday, the patient was freezing to death, had chills and diarrhea and still has them right now. The patient was fully aware that second dose is on 04Feb2021, and wants to know more information, is this going to continue, etc. The patient stated he was real sick, but while being sick, he read the papers, and it actually told him, this was supposed to happen. He was supposed to have chills and fever and all that, and by golly his body has done a good job of that. The real thing is, he is fine with taking it again, but after such a reaction, he wants to know if it is safe to take it again. The patient stated he lost one of his hearing aids, he needs to have another one sent, he had a terrible day yesterday. His symptoms came on in the middle of night, got in clothes stayed in bed. He has no primary care doctor, he has one here but doesn't know if he wants to mess with him. For events freezing to death and chills outcome was the he feels good, he was not chilling or doing anything anymore, but one thing that is bothering him, he doesn't have any energy, he was real low on energy. The freezing to death and chills started leaving yesterday morning, and went away over the day, he is just kind of down with it, just tired. He doesn't know why. The diarrhea didn't hang around a long time. The outcome of the events freezing to death, chills and diarrhea was recovered on unspecified date. The outcome of the remaining events was unknown. Information on the Lot/Batch number has been requested.
77 2021-02-04 pain in extremity Tired; Arm hurt a bit; This is a spontaneous report from a contactable consumer (patient's wife). A ... Read more
Tired; Arm hurt a bit; This is a spontaneous report from a contactable consumer (patient's wife). A 77-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number and Expiration Date were not reported), via an unspecified route of administration in left arm, on 18Jan2021 at 14:30, at a single dose, for COVID-19 immunization; and ibuprofen (ADVIL; Strength: 200 mg, Lot Number: DC5474, Expiration Date: May2022), via an unspecified route of administration, on 18Jan2021, at 400 mg, single, as premedication. The patient's medical history and concomitant medications were not reported. The patient's wife was told by a nurse to give ibuprofen before the patient's first shot. So, the patient's wife told the patient to take ibuprofen before the COVID-19 vaccine shot and he took two 200 mg ibuprofen before the vaccine. The patient's wife feels guilty because she doesn't know if the patient is protected or not. The patient's wife gave the patient two ibuprofen before the COVID-19 shot. On 18Jan2021, the patient felt a bit tired and his arm hurt a bit, but he was fine the next morning (19Jan2021). He only felt a little tired that day and the next day, he felt great. It was further reported that the patient's wife gets allergy shots from a nurse, and the nurse told her to take ibuprofen before the COVID-19 vaccine shot. The patient never takes ibuprofen and the patient's wife can't believe she told him to take it. She had a friend who said ibuprofen could minimize the effectiveness of the shot. So, she was asking if the patient should have another shot since he took ibuprofen before his vaccine. It was a very bad advice because the patient's wife just learnt she shouldn't have. The patient's wife wanted him to have a little reaction as she thinks the vaccine is not going to be effective; asked if the patient should take an additional shot. The patient is scheduled for the second dose of the COVID-19 vaccine on 08Feb2021. The action taken in response to the events for BNT162B2 was not applicable; and for ibuprofen was post-therapy. The patient recovered from the events on 19Jan2021. Information about lot number and expiration date for the suspect product will be requested in follow-up attempts.
77 2021-02-05 weakness fever 102-chills- unable to walk-disorientated-loss of appetite-dizzy- we had to take him to his Dr ... Read more
fever 102-chills- unable to walk-disorientated-loss of appetite-dizzy- we had to take him to his Dr in a wheelchair on Monday ,February the 1st. Doctor put him on covid meds and he is still to this date (Feb. 6th) still weak . we had a covid test done and it was negative.
77 2021-02-06 pain in extremity Very Sore upper left arm with deep bruises covering significant part of upper left arm below injecti... Read more
Very Sore upper left arm with deep bruises covering significant part of upper left arm below injection site.
77 2021-02-07 involuntary muscle movements 2 days after the shot I woke up and I had a hard time moving my mouth and my bottom lip was complete... Read more
2 days after the shot I woke up and I had a hard time moving my mouth and my bottom lip was completely swollen. Its still puffy and very very red.
77 2021-02-07 facial paralysis, bell's palsy Patient began experiencing left facial droop on 1/31/2021. Diagnosed with bell's palsy on 2/1/2021 a... Read more
Patient began experiencing left facial droop on 1/31/2021. Diagnosed with bell's palsy on 2/1/2021 and started on antiviral, PPI, and steroids.
77 2021-02-07 pain in extremity Left arm (arm that received injection) was slightly painful when used to left or push push a snow sh... Read more
Left arm (arm that received injection) was slightly painful when used to left or push push a snow shovel for two (2) days. 3 day was fine. On 3rd day, Sat. 2/6/2021, felt a bit tired and listless most of the day. Next day felt 100%
77 2021-02-08 pain in extremity Events: Soar arm, chills, slight fever, aching muscles and joints Treatment: Tylenol Outcome: Resolv... Read more
Events: Soar arm, chills, slight fever, aching muscles and joints Treatment: Tylenol Outcome: Resolved in two days
77 2021-02-09 feeling cold cold, chills, headache, tired
77 2021-02-10 weakness This patient received his 2nd dose of Pfizer vaccine yesterday. Today, he had focal weakness and di... Read more
This patient received his 2nd dose of Pfizer vaccine yesterday. Today, he had focal weakness and difficulty walking and was transferred for suspected stroke.
77 2021-02-16 tremor ER to bring down temperature and blood pressure; ER to bring down temperature and blood pressure; St... Read more
ER to bring down temperature and blood pressure; ER to bring down temperature and blood pressure; Stomach cramps; nausea; sever body shakes( uncontrollable); This is a spontaneous report from a contactable consumer (patient). A 77-year-old male patient received bnt162b2 (BNT162B2 reported as PFIZER COVID-19 VACCINE; unknown lot number and expiration date), via an unspecified route of administration left arm on 30Jan2021 08:00 at a single dose for covid-19 immunization. Medical history included A-fib. The patient was not diagnosed with COVID-19 prior to vaccination. Concomitant medication included apixaban (ELIQUIS), metoprolol, rosuvastatin, furosemide sodium (LASIX) and spironolactone. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously took aspirin [acetylsalicylic acid] but had allergies. On 31Jan2021 02:00 AM, the patient experienced stomach cramps, nausea and severe body shakes (uncontrollable). They had to call 911 and the patient had to be taken to hospital. The adverse events stomach cramps, nausea and severe body shakes (uncontrollable) resulted in doctor or other healthcare professional office/clinic visit and emergency room (ER)/department or urgent care. The patient received treatment for the adverse events and the patient received treatment in the ER to bring down temperature and blood pressure. The reporter considered the events as non-serious. The patient has been tested for COVID-19 since the vaccination, nasal swab (sars-cov-2 test) with the result of negative on 31Jan2021. The outcome of the events stomach cramps, nausea and severe body shakes (uncontrollable) were recovering while the outcome of the other events was unknown. The following information on the batch/lot number has been requested.
77 2021-02-17 tremor, pain in extremity Hypothermia/A temperature of 93.7 orally/temperature was 92.7/went down to 93.2 degrees; Chills; The... Read more
Hypothermia/A temperature of 93.7 orally/temperature was 92.7/went down to 93.2 degrees; Chills; The arm he received the injection in was tender however progressed to mild to moderately painful/arm was suddenly painful; Shaking; Injection site tenderness; This is a spontaneous report from a contactable physician (patient). A 77-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot: EL9262, expiry: unknown), via an unspecified route of administration in the left arm on 26Jan2021 15:30 at a single dose for protection from the virus at the Physician Office. Medical history included type 2 diabetes mellitus from 2011 and ongoing. The patient also thought he had a Covid respiratory infection in Feb2020. He had a prolonged moderate to severe respiratory infection. He thought at first that he had the flu, but he had a flu shot. He thinks he had Covid. He had antibody studies in May2020 (last spring) that were negative. The patient has no concomitant medications. The patient previously had influenza vaccine (flu shot). The patient reported hypothermia after getting the first dose of the Pfizer Covid 19 vaccine. On the same day of vaccination (26Jan2021), he had injection site tenderness. The next day, (27Jan2021), his arm was suddenly painful; he began to have chills 29 hours after receiving the vaccine (27Jan2021) and was shaking. He also had a temperature of 93.7 orally, confirmed with two different digital thermometers. He took his temperature with a new electronic thermometer that he purchased at a pharmacy. His temperature was 92.7 on 27Jan2021. He repeated it with another electronic thermometer. The first evening (27Jan2021), his temperature went to 96.5 to 98 degrees. Then it went down to 93.2 degrees. He covered up with blankets and his temperature increased and the chills stopped. He stated that this was hypothermia. He had low temperatures the following day (28Jan2021) as well, his temperature was 93-94 degrees. His temperature was 93.7 degrees. Other times he checked his temperature and it was 96.5 degrees. When his temperature was low the first time, it only lasted for about three hours. The second time it happened he went to bed and covered up. It lasted for an hour or two. He noticed it again two days ago. The patient also stated the arm he received the injection in was tender however progressed to mild to moderately painful when he experienced the chills and low temperatures. The arm tenderness after getting the vaccine was very mild. He noticed it when he rolled over on his arm. He took some Tylenol for it. His son is an internist. He said the hypothermia was medically significant. His son also said hypothermia is equivalent to a fever in the elderly. The patient wanted to know if there have been any reports of hypothermia after the administration of the vaccine. He has concerns about this occurring after the second dose. He is scheduled to receive the second dose on 15Feb2021 or 16Feb2021. The outcome of the event hypothermia was recovered on 30Jan2021 and pain in arm recovered on 27Jan2021. The outcome of the other events was unknown. The events hypothermia, arm pain and injections site tenderness were assessed as related to BNT16B2.; Sender's Comments: The Company cannot completely exclude the possible causality between the reported hypothermia and the administration of the COVID-19 vaccine, BNT162B2, based on the reasonable temporal association and lacking alternative explanations. 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 RA, IEC, as appropriate.
77 2021-02-22 unresponsive to stimuli 1/27/21 Emergency room: HPI Patient is a 77 y.o. male who presents after a syncopal episode with cya... Read more
1/27/21 Emergency room: HPI Patient is a 77 y.o. male who presents after a syncopal episode with cyanosis and shortness of breath. Patient came from rehab where they stated he was sitting on his bed, his oxygen saturation dropped down to 76% on 4L and he became cyanotic. By the time EMS arrived, patient was back to 95% on 4 L. On arrival to the ER, he is 98-100% on 4L. He has a history of COPD and has a chronic cough due to this.Currently, he has no pain, no shortness of breath, no weakness, no cyanosis. He is afebrile and sitting comfortably in bed. 2/10/21 emergency room HPI Patient is a 77 y.o. male who presents with in full cardiac arrest. Patient is resident of local nursing home. According to nursing home staff, a tech was in his room talking with him as patient was laying in bed. Tech began walking out of patient's room and turned around to tell him one last thing when the tech noticed patient had gone unresponsive. Patient had no spontaneous respirations or pulse, subsequently CPR was started immediately. 911 was called. This occurred around 5:30 a.m.. Upon EMS arrival on scene, they found a male unresponsive with CPR being performed. There was no spontaneous respirations or circulation. Thus, ET tube was placed and life support guidelines initiated. Patient was found to be in PEA, and according to EMS, patient was given a total of 6, 1 mg epinephrine IV push and 1, 1 Amp sodium bicarb. Patient was worked on at the scene for approximately 40 min before being transferred to ER. Upon arrival to ER trauma room 1 patient is still in full arrest. ET tube in place with good ventilation. Patient remains in PEA. Chest compressions and life support guidelines initiated. In reviewing patient's chart and nursing home notes, patient is a full code. Patient has a significant cardiac history including known coronary artery disease with 4 vessel CABG. Patient also has history of 3rd degree heart block and pacemaker placement. Patient has history of ischemic cardiomyopathy but last echo performed in 2020 shows ejection fraction of 45%.
77 2021-02-23 pain in extremity 11/24/2021 Began with indigestion, chest discomfort and slight arm pain. then on 11/26/2021 symptoms... Read more
11/24/2021 Began with indigestion, chest discomfort and slight arm pain. then on 11/26/2021 symptoms worsened. Admitted to medical center for cath and stint placement.
77 2021-02-24 numbness Numbness on left side of face. Still persisting since vaccination - currently about 8 1/2 hours
77 2021-02-25 pain in extremity Arm is very sore; This is a spontaneous report from a contactable consumer. A 77-year-old male patie... Read more
Arm is very sore; This is a spontaneous report from a contactable consumer. A 77-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL9261), via an unspecified route of administration in left arm on 27Jan2021 10:00 at a single dose for COVID-19 immunisation. The patient's medical history was not reported. Prior to vaccination, the patient has not been diagnosed with COVID-19. Concomitant medications included metformin. The patient experienced arm is very sore on 27Jan2021. The event was reported as non-serious. Since the vaccination, the patient has not been tested for COVID-19. No treatment was received for the adverse event. The outcome of the event was unknown. Information on the lot/batch number has been requested.
77 2021-02-28 flushing, weakness Sudden development of rash all over body, flushed face, tired, weak, headache, temperature 97.8, blo... Read more
Sudden development of rash all over body, flushed face, tired, weak, headache, temperature 97.8, blood pressure 108 over65, pulse 75. Sat down, took prednisone 20 mg and benedryl. Symptoms lasted for a couple of hours. Rash took several hours to reduce. Continued prednisone overnight. Next morning seemed very improved. IT TRULY SEEMED LIKE AN ANAPHALXIS REACTION. Waiting for Health Dept. nurse manager to call back. As noted, this Anaphalixis occurred 72 hours after the vaccination.
77 2021-03-03 burning sensation had severe acid reflux; trouble breathing for about 15 minutes; was wheezing and sounded like an ast... Read more
had severe acid reflux; trouble breathing for about 15 minutes; was wheezing and sounded like an asthma attack.; Felt like something was stuck in his throat; He feels tired now; vomited lying down; Right now his throat is burning; This is a spontaneous report from a contactable consumer (patient). A 77-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number/expiration date unknown), via an unspecified route of administration on 01Feb2021 at a single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. On an unspecified date in Feb2021, the patient woke up and had severe acid reflux, trouble breathing for about 15 minutes, couldn't catch his breath, was wheezing and sounded like an asthma attack. He felt like something was stuck in his throat. It cleared in 10 seconds and he could breathe and swallow fine. He took a Benadryl as treatment and drank water. He also felt tired. The patient further reported that he had the covid vaccine shot. He did not know if he was having a reaction, but he was taking a nap, and he guessed he regurgitated. He had a difficult time catching his breath, it was like it was stuck in the throat. He vomited lying down. He felt the stomach acid come up into mouth after he was able to breath better. But before he was not breathing at all. This never happened before. He was lying flat, he guessed he threw up. He had a large lunch, maybe too large. It was like he was getting something caught in in throat. The patient also reported that his throat was burning and mentioned that he slept on a triangular pillow. The outcome of the events was unknown. No follow-up attempts are possible. No further information is expected. Information about lot/batch number cannot be obtained.
77 2021-03-03 tremor, seizure like phenomena About 24 hours after the injection, I had extreme fatigue and difficulty getting out of bed. along w... Read more
About 24 hours after the injection, I had extreme fatigue and difficulty getting out of bed. along with body aches in both arms and a seizure like blank stare and couldn't move my arms and legs for a short time. Briefly I had shakes in both arms but no fever, chills, or headache. By the next morning the injection arm (left) was achy with no other prominent symptoms.
77 2021-03-04 weakness Patient presented to ED with weakness, black stool and was found to have erosive gastritis with PUD.... Read more
Patient presented to ED with weakness, black stool and was found to have erosive gastritis with PUD. Multiple polyps on colonoscopy. Per , hospitalizations are to be reported irrespective of attribution to the vaccine. This hospitalization does not appear to be related to the vaccine.
77 2021-03-04 weakness Weakness, nausea, headache, chills.
77 2021-03-07 cold sweat, feeling hot During post vaccination observation period complaint of dizzy, warm, clammy and hypertensive BP 180/... Read more
During post vaccination observation period complaint of dizzy, warm, clammy and hypertensive BP 180/96. While being observed complaint of chest pain, transferred to ED. EKG and lab work within normal limits, Observed an additional hour with symptom relief and discharged to home.
77 2021-03-07 tenderness Following Dose 1, Right Arm became sore at injection site for 4 days, at which time Right armpit be... Read more
Following Dose 1, Right Arm became sore at injection site for 4 days, at which time Right armpit became very tender touch and was swollen about size of silver dollar, approx. 1/2 inch thick. Soreness at injection site subsided over the next 17 days, but tenderness in armpit only diminished slightly. Following Dose 2, Right Arm was once again sore at injection site for about 4 days, but tenderness to the right armpit became more pronounced, with swelling increasing to the size of a hockey puck. Size of swelling was easily visible to the eye. Armpit became more tender to the touch, and has diminished only slightly in size,, as of this reporting. Mass remains soft to the feel, but easily defined in size and location. I have taken OTC pain killers to help with the discomfort. Will continue to monitor its progress, unless notified otherwise. Do not anticipate seeing my physician at this point. Have consulted the Web, and have noted that this is a lesser side effect of this vaccine, if swelling remains localized to the injection site. Thought I should report this side effect only because of the size of the swelling that occured.
77 2021-03-09 pain in extremity Sore arm remainder of day of injection, discomfort (soreness) at night
77 2021-03-09 tingling, weakness 1st vaccination Friday. I was fine on Friday. Saturday woke with sore throat, neck, mucus, sore musc... Read more
1st vaccination Friday. I was fine on Friday. Saturday woke with sore throat, neck, mucus, sore muscles and weak. By mid-afternoon had to go to bed and slept for hours. Got up at 9PM and went back to bed at 11PM. Sunday was better, but this AM (Monday) awakened with itchy skin, pins and needles on hands and feet (gone now) and total exhaustion. Had difficulty breathing (better now), can barely lift arms and had to miss work and went back to bed. I am reporting this because I am scheduled for a 2nd shot on the 26th and not certain it's a good idea.
77 2021-03-09 tremor Patient awoke at 01:30 am on 1/31/21 with abdominal cramps, nausea, diarrhea x 3 stools, and chills ... Read more
Patient awoke at 01:30 am on 1/31/21 with abdominal cramps, nausea, diarrhea x 3 stools, and chills with rigors. 01/31/2021 03:22 presented to ED for assessment with complaints of abdominal pain and shaking; 01/31/2021 06:29 patient discharged from ED - symptoms resolved; ED Tx consisted of Acetaminophen 1gm IV x 1 dose; chest x- ray (neg); CBC (WBC 12.9); CMP (AST 77, ALT 94); Respiratory Panel 2.1 IVD (BIOFIRE) - Negative; EKG - A-fib rate 108;
77 2021-03-12 weakness Entire core hurt. Loss of appetite. Fatigue. Joint ache. Mild headache. Second day less severe. Th... Read more
Entire core hurt. Loss of appetite. Fatigue. Joint ache. Mild headache. Second day less severe. Third day weakness and fatigue.
77 2021-03-14 tremor low temperature (96.5); Chills; slight tremors; soreness at injection site; This is a spontaneous re... Read more
low temperature (96.5); Chills; slight tremors; soreness at injection site; This is a spontaneous report from a non-contactable consumer (patient). A 77-years-old male patient received 2nd dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EL3247), via an unspecified route of administration on 10Feb2021 08:15 at age of 77-years-old at arm left at single dose for COVID-19 immunisation. Medical history included bladder cancer, high blood pressure and no known allergies. Concomitant medication included allopurinol, amlodipine, valsartan, indapamide, atorvastatin (LIPITOR), pregabalin (LYRICA), metformin hydrochloride (MEDFORMIN), metoprolol succinate (TOPROL) and vitamin supplements. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The historical vaccine included the 1st dose of BNT162B2 on 18Jan2021 at age of 77-years-old for COVID-19 immunisation. The patient experienced chills, low temperature (96.5) and slight tremors, soreness at injection site on 10Feb2021 06:00 (as reported). No treatment was received for the adverse events. The events outcome was recovered on an unspecified date in Feb2021. No COVID prior vaccination, since the vaccination the patient hadn't been tested for COVID-19.
77 2021-03-15 migraine Almost immediately felt swelling at the injection site, which I felt as being normal. Next day when... Read more
Almost immediately felt swelling at the injection site, which I felt as being normal. Next day when I woke up felt a slight headache , abnormal vision issues that included sparkles, blurred vision and a general tiredness. Did not feel refreshed as I normally do when I wake up in the morning. As the day went on sparkles and vision issues remained and headache got worse. Went to bed earlier than normal and next day when woke up the symptoms got worse, I felt like I had a migraine. Vision issues persisted. Laid down around 11AM and took a nap and when I woke up I noticed a blotch in my left eye reminiscent of the shape of a fish (looked like a shark) and it had different colors. Bright yellow and black almost kind of an iridescent green and orange. The shape was still just the colors were different. I panicked and called the optometrist and explained what happened. They wanted to see me right away. I was able to be seen in the afternoon. They looked at it, did two tests and came with the diagnosis of a branch retinal artery occlusion. I visited my neuro- ophthalmologist on 01/28 and he confirmed the diagnosis had previously given. He then ordered fedrate and a couple of other tests. They also did a visual acuity in the left eye (20/30) and color vision (8/8 normal) and color plates and intraocular pressure (16 OS)
77 2021-03-15 pain in extremity Awakening on Saturday, March 13, I saw blood on my pillow and a pee spot on the bed (my first time ... Read more
Awakening on Saturday, March 13, I saw blood on my pillow and a pee spot on the bed (my first time for either). I could barely get out of bed (an awkward rollover did it). My tongue was numb (still is) and raw from the presumed chewing on it. Walking was slow and painful as all muscles hurt. If I sneezed or coughed, my back would hurt. Those last problems are still true. I periodically cough up phlegm and lacking a good place to spit it out, I just swallow it. I have for the first time in my life been using a walker for stability. Right arm is almost useless due to pain.
77 2021-03-16 cold sweat chief complaint of lightheadedness and an upset stomach onset this morning. Patient states that yest... Read more
chief complaint of lightheadedness and an upset stomach onset this morning. Patient states that yesterday he had his second Pfizer COVID shot. Afterward he felt fine but this morning woke up with an upset stomach, lightheadedness and felt clammy. He describes the upset stomach as feeling hungry. The lightheadedness is described as, "my stomach felt off, which made me feel sick and off". His wife called EMS for the patient to be evaluated as he has a cardiac history. At this time he has no lightheadedness but his stomach is still upset, like "I need to eat". Received pepcid and NS 1000 mL
77 2021-03-17 pain in extremity Progressive Left arm pain/shoulder soreness that began 5 days prior to hospital presentation. Seen i... Read more
Progressive Left arm pain/shoulder soreness that began 5 days prior to hospital presentation. Seen in ambulatory clinic 7 days prior to presentation, given ibuprofen and percocet without relief. New swelling and erythema brought pt to hospital. Around time of vaccination, the pt was using triamcinolone for left forearm rash (described as small, more-spotty and resolved quickly). MRI revealed an abscess (10 x 6.8 x 1 cm) deep to the deltoid muscle and along the lateral aspect of the left proximal humerus. He also has another abscess within the posterior deltoid muscle (3.1 x 2.1 x 2.8 cm). There is surrounding myositis, fasciitis and cellulitis.
77 2021-03-17 tremor dehydrated and then he stayed in the hospital for some time; said patient has Covid; severe reaction... Read more
dehydrated and then he stayed in the hospital for some time; said patient has Covid; severe reaction to the vaccine/severe allergic reaction to the vaccine; high fever/get real hot/running a 103.1; sweating; UTI; could not breathe and he was struggling to breathe; Moaning; diarrhea; chills; shaking all over; severe headache; started throwing up; he was not feeling well; This is a spontaneous report from a contactable consumer (patient's wife). A 77-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EN6202 and expiry date: unknown), via an unspecified route of administration on 26Feb2021 16:00 at a single dose for covid-19 immunization. Medical history included asthma and stage 4 kidney disease. The patient's concomitant medications were not reported. On 27Feb2021 (Saturday), patient was not feeling well and on 28Feb2021, he had diarrhea, chills, shaking all over, severe headache and started throwing up. Reporter stated patient had all the symptoms of the reactions and then "you go again to the serious, more dangerous symptoms, he has all of them". Throwing up, fever, chills, diarrhea and then he get real hot and then he started sweating and it was another day on 01Mar2021. On Monday (01Mar2021), reporter called to take patient to the hospital with high fever. The ambulance put him on IV and oxygen right away. They gave him fluids and were monitoring everything because he was dehydrated and then he stayed in the hospital for some time. He had x-rays, they monitored his blood pressure and heart rate, and the doctor was concerned about his heart rate and blood pressure. Doctor decided to check his urine and he did and he had a UTI on 01Mar2021, and so he gave him antibiotics for that (treatment unspecified). Patient seemed to be better after having the fluids and everything so they let him come home. During the night on 01Mar2021, he had another attack and it was the same thing that he had before. The shaking and the chills the fever and throwing up and the doctor said that it was a reaction from having the vaccination and reporter just wanted to report that he did and reported actually thought he was going to die. Reporter tried to call again the ambulance since she thought that he was not going to make it. The doctor put on the report and he did not put on there that he was in there because of suspected of (incomplete sentence) and then told the reporter himself that he had a reaction from the vaccine. The report stated that patient was in for a UT, but the reporter stated that, once does not call an ambulance for a UTI and she (reporter), have UTI's all the time. After the reporter got the patient home, he was even much worse. Patient could not breathe and he was struggling to breathe on 01Mar2021. He was shivering, shaking, having diarrhea, throwing up, soaking wet, and she had to change his clothes twice, and his fever was 103.1 F around 2:00 or 3:00 in the morning of 02Mar2021. The pharmacist gave medicine for vomiting. Reporter called the hospital and the nurses were busy and they could not take it so 24 hour nurse called. She was finally able to get him comfortable enough that she didn't have to call again. She thought she was going lose him. She said she felt twice he was going to die, when she called. At the hospital they told him he was having a severe reaction to the vaccine but also had a UTI and they gave him antibiotics. Patient contacted her nephew who is a medic in the military and RN and he said patient has Covid and thinks reporter has Covid too because the virus was in the vaccine. The nephew explained that patient just could not fight it off and said the vaccine acts like that. It made sense because it is inhibit in it then your body will learn to fight it off, like if you come in contact with it and that makes sense but the woman never explained. The nephew further stated to reported that patient's immune system or whatever was not able to fight it off. So, he said he has to have Covid and when patient heard that after all they had fought to stay away from it and then what were they supposed to do. Patient got the vaccine and ended up with it and that is what reporter have found out and it was very disturbing. Patient was running a 103.1 earlier on the night of 02Mar2021. He was moaning a little bit on Mar2021. Reporter thought patient had severe allergic reaction to the vaccine because he had all the symptoms and stated there was no doubt in her mind (referring to it being an allergic reaction) as it was too soon after the vaccine. Outcome of the event of dehydration was recovering, while for the remaining events was unknown. Reporter was asking if patient should take the second shot.
77 2021-03-18 weakness Blood Clots in both legs Extreme weakness
77 2021-03-21 weakness ISOLATION-INFECTIOUS DISEASE WEAKNESS - GENERALIZED SHORTNESS OF BREATH Covid-19
77 2021-03-25 inability to speak, speech disorder, weakness Evening of injection: confusion, weakness, Night developed more weakness and incontinence, Next day:... Read more
Evening of injection: confusion, weakness, Night developed more weakness and incontinence, Next day: severe weakness, unable to ambulate, follow directions, mumbling, sleepy, incontinent. Taken to ER - CT of head, EKG, Chest Xray, Labs, UA. Radiologist diagnosis start of Right lower lobe pneumonia. Given IV antibiotic and admitted to hospital. Admission MD thinks no pneumonia with profound weakness. Improved next day and discharged. Same evening as discharge had expressive aphasia. Next day speech normal again and weakness gone. Admitting physician said had another dementia patient with same symptoms and cleared in a couple of days.
77 2021-03-25 facial paralysis, unresponsive to stimuli, difficulty speaking Patient received a vaccine at museum sight on 03/23/2021 at 0130 pm according to fiancé. Around 1:... Read more
Patient received a vaccine at museum sight on 03/23/2021 at 0130 pm according to fiancé. Around 1:30 the next day, his fiance tried to call him and she stated that his voice was garbled, she found him face down with his chin on the table, covered with his own feces and urine. EMS notes that upon their arrival the pt had a right sided facial droop along with some contracture to his left side. Pt was originally awake and confused as he gradually became unresponsive and is only responsive to pain of sternal rub. He has no history of stroke. Pt's BP was noted to be 88/50's en route.
77 2021-03-30 weakness 72 hrs. after dose #1 had a severe anaphalaxis reaction.; red rash; pressure dropped to 102/65/75 pu... Read more
72 hrs. after dose #1 had a severe anaphalaxis reaction.; red rash; pressure dropped to 102/65/75 pulse; Tired; light-headed; weak; This is a spontaneous report from a contactable consumer (patient) and another consumer (receptionist). A 77-years-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Left on 25Feb2021 15:00 (Lot Number: EM9810) as SINGLE DOSE for covid-19 immunisation. Medical history was not reported. The patient did not have COVID prior vaccination. Concomitant medication(s) included simvastatin, losartan, finasteride and tamsulosin. The patient previously took codeine and experienced allergies. On 28Feb2021 15:00, 72 hrs. after dose #1, the patient had a severe anaphalaxis reaction. His whole body turned into a red rash, temp was 97.8, pressure dropped to 102/65/75 pulse. Tired, light-headed, weak. Immediately took Prednisone (20 mg)and benedryl. Was going to call 911, but symptoms subsided slowly. The patient did not test COVID post vaccination. The outcome was recovered.
77 2021-03-30 pain in extremity, tenderness Pain shoots up his leg; hard for him to walk; tenderness in the back of his calf and thigh/the back ... Read more
Pain shoots up his leg; hard for him to walk; tenderness in the back of his calf and thigh/the back of his left leg above the knee and back of his calf feels a little weird, tender; Pain in the bottom of his heel; This is a spontaneous report from a contactable consumer or other non health professional (patient). A 77-years-old male patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL3246), via an intramuscular route of administration in the left arm on 28Jan2021 at 9:30 (at the age of 77-years-old) as a single dose for COVID-19 vaccination. Medical history included low iron from unspecified date to ongoing (diagnosed about two years ago). Concomitant medication included iron infusion taking for about 2 years, they cannot seem to straighten it out, states it is uncurable. He had too many red blood cells due to bone marrow, he got on iron infusions, and if his red blood cells gets to high, then they will perform phlebotomy to have them taken out. This was his second year receiving the infusions. He goes in once a week and they test him and sometimes he was able to get the infusion and sometimes he had to wait till the next week. Stated they took a pint of blood out of him about a week and a half ago. He goes every Thursday and his red blood cell count was 15.7. The weight of the patient was 205-206. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No additional vaccines administered on same date of the Pfizer suspect. On 28Jan2021, the patient had no problem with his arm, not really too many problems at all, except after he got home, the back of his left leg above the knee and back of his calf feels a little weird, tender. Stated he had a crazy feeling on the bottom of his heel, it was killing him, he can barely walk, he did not have this prior to getting the vaccine. He was worried about getting the second dose. Advised to contact hcp. Him and his wife have their second shot scheduled for 28Feb2021. He was told that it can be given up to 4 days ahead or anytime after. He read that Pfizer recommends 21 days between doses The feeling in his heel has stayed the same. States he slept ok. He does had a bad back. When he woke up and tried to put the weight on his left leg he can walk a couple of steps and his heel was killing him. Pain shooted up his leg. It was hard for him to walk. The back of his knee and calf are not really that bad, but he can feel it, he can barely walk. Caller asked have there been any reports of this and how long does it take for the pain to disappear. Caller stated the clinic where they received the vaccine told them the second dose can be scheduled 4 days before 21 days or a week or so after 21 days. Caller also asked if that was going to cause a problem if the second dose is scheduled 28 days after dose 1? they responded saying that "The Pfizer-BioNTech COVID-19 Vaccine vaccination series was 2 doses given 3 weeks apart. This was how Pfizer-BioNTech studied the vaccine. Provided disclaimers that Pfizer was unable to speak outside of the EUA fact sheet and Pfizer was independent of a company guidelines and recommendations. He hoped the heel pain was going to go away and it was something from the vaccine, not something else. The outcome of the event was not recovered.
77 2021-03-30 cold extremities left leg was cold/left foot was 79-82 degrees Celsius; blood clots in his left leg/he had three/firs... Read more
left leg was cold/left foot was 79-82 degrees Celsius; blood clots in his left leg/he had three/first one on 02Mar, second one 13Mar and the third one yesterday; he had the Pfizer vaccine on 15Feb and 26Feb; he had the Pfizer vaccine on 15Feb and 26Feb; This is a spontaneous report from a contactable consumer (patient). A 77-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), second dose via an unspecified route of administration on 26Feb2021 (Batch/Lot Number: EN6203) as single dose for covid-19 immunisation; tafamidis (VYNDAMAX), route of administration, start and stop date, batch/lot number and dose were not reported for an unspecified indication. The patient took the first dose of PFIZER-BIONTECH COVID-19 VACCINE on 15Feb2021 at age of 77 years old for covid-19 immunisation. The patient medical history and concomitant medications were not reported. A patient taking Vyndamax medication who stated that he had experienced blood clot in his left leg. Clarified that he had the Pfizer vaccine on 15Feb2021 and 26Feb2021. Clarified that on 02Mar2021 that he had blood clots in his left leg. Stated that he had three. Stated that he had the first one on 02Mar2021, second one 13Mar2021 and the third one yesterday (15Mar2021). Stated that he was told left leg was cold. Stated that he took his temperature with a thermometer and his left foot was 79-82 degrees Celsius. Stated that the right foot is 95-96 degrees Celsius. Stated that he filled it out for the Covid vaccination. Stated that he reported Vyndalink when it asked what other medications that he took. The action taken in response to the events for tafamidis was unknown. The outcome of events was unknown.
77 2021-04-06 weakness Received first vaccine 11 FEB 2021: Initially had no issues. On 01 Mar 2021, felt myalgias and fatig... Read more
Received first vaccine 11 FEB 2021: Initially had no issues. On 01 Mar 2021, felt myalgias and fatigue with temperature up to 99.2F and patient insists his basal core temp is 97.5F. Received his second vaccine on 04 Mar 2021 with temp < 100F therefore staff encouraged him that he had no contraindication. Same day, noted aches, pains, N/V, decreased appetite, loss of taste. Subsequently noted increased temperature up to 100.4F (single true fever) on 09 Mar 2021. Developed cough on 13 Mar 2021. His remaining symptoms are fatigue, loss of taste, decreased energy. The patient also noticed acute onset Rt chest wall pain after an episode of coughing ? states that it feels like a similar episode previously with known prior Dx of rib fracture. Not worse with exertion or relieved by rest. Not associated with meals. Worse with contact and position changes. He is taking ASA-325, 2 tabs each morning for pain, then 2 x 200mg Motrin tablets at night.
77 2021-04-06 pain in extremity Extreme pain around hip, lower left front torso first night; subsequently, very sore left leg front ... Read more
Extreme pain around hip, lower left front torso first night; subsequently, very sore left leg front of thigh ever since and unable to sleep.
77 2021-04-06 pain in extremity Pain/pain in the right arm/most severe pain patient had ever had; patient would say 30 times worse t... Read more
Pain/pain in the right arm/most severe pain patient had ever had; patient would say 30 times worse than any fly shot for example; Pain into shoulder area, deltoid muscle nearly totally paralyzed; pain down arm to elbow; This is a spontaneous report from a contactable Physician (patient). A 77-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL9263; expiration date: unknown), via an unspecified route of administration on right arm on 21Jan2021 at 14:30 (02:30 PM) at the age of 77 years old at a single dose for COVID-19 immunisation. Medical history included S/P CABG in 2015, S/P ruptured appdx in 2007. He was asymptomatic, major operations (laparotomy and open-heart surgery) and a retired surgeon. He was still solo skydiving from 14,000 feet with no problems. Allergies were none. Concomitant medications included losartan, metoprolol, vit D (ergocalciferol), aspirin (acetylsalicylic acid) and lipitor (atorvaostatin). It was reported that no problems at all until approximately 10 hours post injection. The most severe pain patient had ever had; patient would say 30 times worse than any fly shot for example. Pain into shoulder area, deltoid muscle nearly totally paralyzed, pain down arm to elbow. Got one hour of sleep that night. Amazingly, at about 11 a.m. the next morning while still in severe pain (R arm) all symptoms immediately disappeared. Like a switch was thrown. Two major operations in patient life (laparotomy and open heart surgery) and patient also a retired surgeon. Patient was not exaggerating the degree of this pain in the right arm. Have felt great ever since and would get Shot # 2 tomorrow. The events onset date reported as 21Jan2021 11:30 PM. Patient had not received any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, patient had not been tested for COVID-19. No treatment received for the events. The patient recovered from all the events on an unspecified date in 2021.; Sender's Comments: Based on temporal association and known vaccine safety profile, the reported events are assessed as related to BNT162B2 vaccine. 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 2021-04-07 weakness weakness; diarrhea; Dizziness; Really Bad Tiredness; Swollen lymph nodes; This is a spontaneous repo... Read more
weakness; diarrhea; Dizziness; Really Bad Tiredness; Swollen lymph nodes; This is a spontaneous report from a contactable consumer (patient's wife). A 77-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration at 77-year-old on 11Mar2021 12:00 (lot number: EN6199) at single dose for COVID-19 immunization. Vaccine was received in pharmacy, not at military facility. The patient medical history was reported as none. Family medical history relevant to the events was none. The patient's concomitant medications were not reported. No history of all previous immunization with the BNT162B2 considered as suspect. No additional vaccines were administered on same date of BNT162B2. No other products. No prior vaccinations within 4 weeks. No events following prior vaccinations. The patient experienced diarrhea (hospitalization) on 18Mar2021, weakness (hospitalization) on 22Mar2021, swollen lymph nodes on 18Mar2021, really bad tiredness on 19Mar2021, dizziness on 26Mar2021. Dizziness occurred when he stood up. The patient was hospitalized for diarrhea and weakness from 22Mar2021 to 24Mar2021. The patient was getting weak and they got worried and went to the ER (Emergency Room); he was admitted on 22Mar2021, observed on 23Mar2021 and came out on 24Mar2021. He was "Out of It" and on that Monday he was feeling so tired and weak and he had problems all last year and they were alarmed so they went to be checked out and the patient was released without finding anything. The events resulted in emergency room visit on 22Mar2021. No visit to physician office. Therapeutic measures were taken as a result of events included loperamide hydrochloride (IMODIUM). The outcome of events diarrhea, weakness, swollen lymph nodes, really bad tiredness was recovering, outcome of event dizziness was recovered on 26Mar2021. No medications, medical conditions, or tests relevant to this report. Consumer mentioned that the patient has an appointment to get the second dose of the BNT162B2 on 01Apr2021 and wanted to know if there were reports about getting the second dose will make the side effects stronger.
77 2021-04-09 weakness Hospitalized on 30Jan2021 for COVID pneumonia; Cannot support standing and walking and vocal cords n... Read more
Hospitalized on 30Jan2021 for COVID pneumonia; Cannot support standing and walking and vocal cords not fully closed yet; Cannot support standing and walking and vocal cords not fully closed yet; Cannot support standing and walking and vocal cords not fully closed yet; Weakness; confusion; This is a spontaneous report from a contactable consumer (patient himself). A 77-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EL8982), via an unspecified route of administration in right arm on 18Jan2021 at 14:00 (at the age of 77-year-old) as a single dose for COVID-19 immunization. The patient's medical history included AFib, high blood pressure. Concomitant medications included apixaban (ELIQUIS), hydrazaline hydrochloride (APRESOLINE), losartan potassium (COZAAR) and metoprolol; All received within 2 weeks of vaccination. The patient previously took lisinopril and experienced known allergies: Lisinopril. Allergies to medications, food, or other products: Lisinopril. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient diagnosed with COVID-19 was unknown. Since the vaccination, the patient been tested for COVID-19 was unknown. The patient did not receive other vaccine in four weeks. Hospitalized on 30Jan2021 for COVID pneumonia which occurred on 24Jan2021 at 08:00 AM and put on ventilator on 05Feb2021. 18 days on ventilator, ICU and released to hospital. On 17Mar2021 admitted to hospital for speech, occupational, and physical therapy. Cannot support standing and walking and vocal cords not fully closed yet on 24Jan2021 at 08:00 AM. Weakness and some confusion on 24Jan2021 at 08:00 AM. The adverse events resulted in emergency room/department or urgent care. The patient was hospitalized for 55 days. The events were considered as serious (hospitalization and disability or permanent damage) by the consumer. The patient was treated with medications and ventilator for the adverse events. The outcome of the events was not recovered. Information on the lot/batch number has been requested.
77 2021-04-12 difficulty speaking, tenderness, feeling hot, weakness in hot and sweaty; thought a truck hit him and he must've over done it. He said that as the day went... Read more
in hot and sweaty; thought a truck hit him and he must've over done it. He said that as the day went one he felt worse.; headaches; he felt so bad; He has not moved around much at all; watery eyes; sneezing; abdominal pain; gas; tender if you touched directly at the injection site; in hot and sweaty; weight loss; Mucousy Mouth; Hoarse voice; low oxygen; weird dreams; can't sleep; blood pressure down; no appetite; breathing is shallow; muscle aches; imbalanced; Weakness; Fever; minimal injection site pain; This is a spontaneous report from a contactable pharmacist (patient). A 77-year-old male patient received second dose of bnt162b2 (BNT162B2, Solution for injection, Lot number: EL9209, Expiration date was not reported), via an unspecified route of administration on 06Mar2021 17:15 as single dose for covid-19 immunisation. Medical history included ongoing high cholesterol. Concomitant medication included levothyroxine, tablet via oral from unknown date 2018 at 100 uCi, once a day for chemical thyroid condition, atorvastatin calcium (LIPITOR, tablet) via oral 10 mg once a day for blood cholesterol increased. Historical vaccine included first dose of BNT162B2 on 13Feb2021 for covid-19 immunisation. The patient experienced mucousy mouth, hoarse voice, weight loss on 27Mar2021, low oxygen, weird dreams, can't sleep, blood pressure down, no appetite, breathing is shallow, muscle aches, imbalanced, Weakness, Fever 26Mar2021, patient hot and sweaty, in hot and sweaty, thought a truck hit him and he must've over done it. He said that as the day went one, he felt worse, headaches, he felt so bad, He has not moved around much at all, watery eyes, sneezing, abdominal pain, gas and tender if you touched directly at the injection site on an unspecified date, minimal injection site pain on 14Feb2021. As per the reporter seriousness criteria reported as medically significant. The patient underwent lab tests and procedures which included blood pressure measurement: 128/68 on 26Mar2021 and 132/76 on 28Mar2021, temperature: 100.8 on an unspecified date and 98.3 on 26Mar2021 and 98.3 on 28Mar2021, Pulse oximetry: 89 % on 26Mar2021, 95-96 % and 96 % on 29Mar2021. The outcome of the event mucousy mouth, hoarse voice, weird dreams, can't sleep, weight loss, no appetite, breathing is shallow, muscle aches, imbalanced, Weakness, fever was not recovered, minimal injection site pain was recovered on 15Feb2021, blood pressure down recovering and unknown for other events.
77 2021-04-12 mild one side paralysis Unknown if pt had s/s at time of vaccination on 1/29/2021 and 2/19/2021. From 3/1/2021-3/6/2021, pt... Read more
Unknown if pt had s/s at time of vaccination on 1/29/2021 and 2/19/2021. From 3/1/2021-3/6/2021, pt hospitalized w/ covid, resp insufficiency, acute on chronic diastolic HF, dyspnea, ele. D-dimer, acute pulm edema and acute on chronic renal insufficiency. Dcd to home. Six hrs later, readmitted w/ worsening multifocal airspace opacities, enlarged cardiac silhouette, sob, cough. No PE on CXR. Recd O2, cefepime, remdesivir, vanco, Lasix, heparin, rivaroxaban, dexamethasone, tocilizumab. On 3/8/2021, pt had onset R weakness, CT w/ distal R MZ occlusion, Intubated for decline. Not TPA candidate. Per neuro, CVA r/t either a fib hx or hypercoagulability r/t covid. Pt died.
77 2021-04-12 speech disorder Patient went to physical therapy on that day. Then when he came home I could barely get him out of ... Read more
Patient went to physical therapy on that day. Then when he came home I could barely get him out of the car. patient could barely walk and talking made little sense. He could not stand on his own. He was taken to emergency room by rescue squad. I thought he was having a stroke.
77 2021-04-17 weakness vertigo is debilitating. Caller wanted to know if there have been reports of vertigo; he could not d... Read more
vertigo is debilitating. Caller wanted to know if there have been reports of vertigo; he could not drive. Caller stated he was ok when laying on the couch but when he got up he could not walk without falling down; vertigo is debilitating. Caller wanted to know if there have been reports of vertigo/Vertigo; staggering and unable to walk on his own without someone helping him; complain of being dizzy/slight dizziness/dizziness; This is a spontaneous report from a contactable consumer (wife) on behalf of a 77 years-old male patient. A 77-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number and Expiry Date: unknown), via an unspecified route of administration on arm Left on 3Mar2021 at single dose for COVID-19 immunization. The patient medical history included ongoing Peritoneal dialysis from 2018, ongoing Heart bypass from Jan2019. The patient concomitant medications were not reported. The patient did not receive any other vaccine within 4 weeks prior to the COVID vaccine. On 17mar2021 or 18Mar2021, the patient complained of being dizzy. By 20Mar2021 he was staggering and unable to walk on his own without someone helping him and ongoing vertigo from 20Mar 2021 and reported as vertigo worsened. By 21Mar2021 he could not drive. The patient was ok when laying on the couch but when he got up he could not walk without falling down. The patient had extreme vertigo that started about 2 weeks after the vaccine and is debilitating. The patient is just under 6 feet, he shrunk a little. The events dizziness resulted in hospitalization from an unspecified date. The event vertigo resulted in ER visit and hospitalized from 22Mar2021 to 28Mar2021. The lab test included CT scan and MRI, results: negative; He also had lab tests, but nothing showed a reason why he has the vertigo. No further details provided about lab work. The 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
77 2021-04-21 weakness Death Narrative: Patient was not previously COVID-19 positive and did not have any predisposing fac... Read more
Death Narrative: Patient was not previously COVID-19 positive and did not have any predisposing factors(PMH, allergies, etc.) for experiencing an adverse drug event. The ADR did not occur at the time of the administration of the vaccine nor was there an ADR that occurred between the observation period and the date of death. Patient was 76 and presented to the ER on 2/20/21 with altered mental status, weakness, and persistent diarrhea after just being discharged previous week for bacteremia. Hospital progression included a GI bleed requiring blood transfusions, esophageal varices, and unrecoverable mental status. Care was transitioned to hospice where he passed on 2/28/21. Comorbidities include cirrhosis, CKD, DM, pancytopenia, frequent paracentesis for ascites.
77 2021-04-26 night sweats Fever; nightsweats; This is a spontaneous report from a non-contactable consumer (patient). A 77-yea... Read more
Fever; nightsweats; This is a spontaneous report from a non-contactable consumer (patient). A 77-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 04Mar2021 (Batch/Lot number was not reported) as single dose for COVID-19 immunisation. Medical history included chronic obstructive pulmonary disease (COPD), gout, and lung cancer (remission). Patient has no COVID-19 prior to vaccination. Patient has no known allergies. The patient's concomitant medications were not reported. The patient experienced fever and nightsweats on 01Apr2021. The patient was hospitalized for fever and nightsweats for 3 days. The outcome of the events was recovered. Information about lot/batch number has been requested.
77 2021-04-27 tremor, weakness Patient came to hospital on April 23, 2021 with shortness of breath and a productive cough, very wea... Read more
Patient came to hospital on April 23, 2021 with shortness of breath and a productive cough, very weak and debilitated. Patient was diagnosed with pneumonia and required 2 liters of oxygen. Patient also has mild tremors and family states that this is new. Patient received the first dose of the COVID vaccine 10 days prior to admission on April 13, 2021.
77 2021-04-28 weakness no energy and sleepy all the time
77 2021-05-03 pain in extremity Reports achey on Wednesday after the shot, by midnight reports severe pain in the neck, down into ch... Read more
Reports achey on Wednesday after the shot, by midnight reports severe pain in the neck, down into chest, down arm and down scapula. Sought treatment Thursday morning around 8:30am at ER in. Patient was admitted. Discharged Tuesday 5-4. Hospital tried pain medications and muscle relaxants (chewable baby aspirin, morphine, benadryl (after reaction to morhphine) norco, dilaudid, toradol, valium, oxycodone and flexeril. Sent home with diclofenac gel, and hydrocodone/apap.
77 2021-05-04 weakness, difficulty speaking No energy; no appetite; hot & cold; body aches; Very hoarse; coughing; This is a spontaneous report ... Read more
No energy; no appetite; hot & cold; body aches; Very hoarse; coughing; This is a spontaneous report from a contactable consumer. A 77-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number: unknown), via an unspecified route of administration in left arm on 14Jan2021 at 12:45 as single dose for COVID-19 immunization. Medical history was not reported. Patient had no known allergies. Concomitant medications included ezetimibe, tamsulosin, amlodipine, sumatriptan, finasteride and tadalafil. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 16Jan2021 at 01:00 PM, patient experienced no energy, no appetite, hot & cold, body aches. very hoarse, coughing-No fever. On 25Jan2021, the patient was tested negative for COVID-19 via nasal swab. No treatment was received for the adverse events. Adverse events resulted in doctor or other healthcare professional office/clinic visit. The outcome of the events was not recovered. Information on the lot/batch number has been requested.
77 2021-05-04 weakness Pneumonia due to COVID-19 virus Sepsis Shortness of Breath ? Weakness - Generalized ? Dizziness
77 2021-05-09 face paralysis I63.81 - Other cerebral infarction due to occlusion or stenosis of small artery R29.810 - Facial wea... Read more
I63.81 - Other cerebral infarction due to occlusion or stenosis of small artery R29.810 - Facial weakness I63.81 - Left sided lacunar stroke
77 2021-05-10 pain in extremity he started having pain in his right arm, from elbow to shoulder. He still has it on and off; This is... Read more
he started having pain in his right arm, from elbow to shoulder. He still has it on and off; This is a spontaneous report from a contactable consumer reporting for himself. A 77-years-old male patient received the first dose of BNT162B2 Pfizer-BioNTech COVID-19 mRNA Vaccine via an unspecified route of administration, administered in left arm on 15Apr2021 (Batch/Lot number was not reported) as single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On 16Apr2021, he started having pain in his arm, from elbow to shoulder. He still has it on and off. When it goes away it's only for a little bit. He received the shot in his left arm and the pain is in his right arm. The event had not resolved yet at the time of the report. No follow-up attempts are needed; information about lot/batch number cannot be obtained.
77 2021-05-12 pain in extremity shingles; so he thought it was just a pulled muscle; Back pain; soreness in the arm; This is a spont... Read more
shingles; so he thought it was just a pulled muscle; Back pain; soreness in the arm; This is a spontaneous report from a contactable other health professional via the Pfizer-sponsored program. A 77-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration (at the age of 77-years-old), administered in Arm Left on 26Jan2021 13:30 (Lot Number: EL9263) as 1st dose, single for COVID-19 immunization. Medical history included penicillin allergy. It's been 25-30 years ago and he can't take it. He gets swollen and hives and sick. There were no concomitant medications. The patient previously received a shingles shot about 5-6 years ago and flu shot Nov2020. The patient experienced soreness in the arm on 26Jan2021, back pain on 30Jan2021, so he thought it was just a pulled muscle on Feb2021, shingles on 15Feb2021. The patient received the first COVID shot on 26Jan2021 and didn't really have a reaction, but soreness in the arm a couple of days. He then started having back pain and he is a very active person so he didn't think anything of it. Spouse told him that he needs to see the doctor because she thought he had shingles. They do not know if it's associated to the COVID shot or not. They need to also cancel his appointment for tomorrow because the doctor does not want him to get his second COVID shot since he is on medication for the shingles. Mentions again, his arm was a little sore, but then 4 days after that he had back pain. He is an exceptionally active person, and excavation construction worker and still works and so he thought it was just a pulled muscle. Then a few days later, pain was awful and area was sensitive to touch and it looked a little swollen and he had nothing else. A couple days later he kept saying it bothered him and it was all the way around to his side. It was fine at first it started with a little rash and so he went to the doctor today and diagnosed with shingles. Therapeutic measures were taken as a result of shingles which included valacyclovir (Was given Valacyclovir 1 gram tablet to take three times daily to help the shingles). Adverse events required a visit to Physician Office. The outcome of the event "soreness in the arm" was recovered on 28Jan2021, for Back pain and shingles was not recovered, for "so he thought it was just a pulled muscle" was unknown. No other vaccines given the same day or 4 weeks prior. No problem with vaccines in past. Follow-up attempts are completed. No further information is expected.; Sender's Comments: Based on the information currently available, a possible contributory role of the suspect vaccine BNT162B2 or comirnarty in triggering the onset of Herpes zoster,sorenessin the arm,backpain,pulled muscle cannot be excluded.But also consider.medical history of allergic drug history and other relevant medical history.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.
77 2021-05-13 pain in extremity, flushing flushed; elbow hip pain covid; elbow hip pain covid; appearing toes red swollen painful; appearing t... Read more
flushed; elbow hip pain covid; elbow hip pain covid; appearing toes red swollen painful; appearing toes red swollen painful; appearing toes red swollen painful; elbow hip pain covid; This is a spontaneous report from a contactable other hcp (patient). A 77-years-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection, Lot Number: el3247), via an unspecified route of administration in arm left on 19Jan2021 at 08:30 AM as single dose for COVID-19 immunisation. Medical history included htn (hypertension). Patient had allergy from Indocin. Concomitant medication included (other medications the patient received within 2 weeks of vaccination) lisinopril (LISINOPRIL). The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. On 19Jan2021 at 08:30, the patient experienced flushed, elbow hip pain covid appearing toes red swollen painful still on day 8. The events were considered as non-serious. Patient reported no for seriousness criteria-results in death, seriousness criteria-life threatening, seriousness criteria-caused/prolonged hospitalization, seriousness criteria-disabling/incapacitating and seriousness criteria-congenital anomaly/birth defect. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. Treatment was received for the adverse event (home care). The outcome of the events was reported as not recovered. Follow-up attempts are completed. No further information is expected.
77 2021-05-13 tingling, muscle spasms red blotches on his back and looked in mirror and saw it all on his legs and thighs and it was comin... Read more
red blotches on his back and looked in mirror and saw it all on his legs and thighs and it was coming through skin.; feel something under skin; looked like red rash broke out on his thighs and seemed like the shingles; looked like red rash broke out on his thighs and seemed like the shingles; muscle spasms on the left side of his back; Stiffness and it was hard to straighten up, and it was catching in his left hip and lower part of his back and it was pretty severe; Stiffness and it was hard to straighten up, and it was catching in his left hip and lower part of his back and it was pretty severe; 2nd dose, 3 mg single; This is a spontaneous report from a contactable consumer (who is also the patient). A 77-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN6200), via an unspecified route of administration, administered in the left arm, on 01Mar2021 (also reported as 02Mar2021) a little before 10:00 close to an hour after arriving at 09:00, as 2nd dose, 3 mg single, for COVID-19 immunisation. The patient medical history was not reported. There were no concomitant medications. Historical vaccine included the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL9269), administered in the left arm shoulder, at 0.3 mg, for COVID-19 immunization. On 02Mar2021, the patient started having muscle spasms in the lower part of his back. The patient clarified that the muscle spasm was on the left side of his back which was the same side as the vaccination. On the same day, 02Mar2021, the patient experienced stiffness and it was hard to straighten up, it was catching in his left hip and lower part of his back and it was pretty severe. On 05Mar2021, the patient could feel something under his skin that looked like red rash broke out on his thighs and seemed like the shingles or something and he didn't know what that was. He stated that he saw red blotches on his back and looked in mirror and saw it all on his legs and thighs and it was coming through skin. The patient was recovering from muscle spasms, stiffness, and joint stiffness. The outcome of the remaining events was not recovered.
77 2021-05-21 weakness This is a spontaneous report from a contactable consumer (patient). A 77-year-old male patient recei... Read more
This is a spontaneous report from a contactable consumer (patient). A 77-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: EN6200), via an unspecified route of administration, administered in Arm Left on 13Feb2021 11:30 at 77 years old as 2nd dose, single for COVID-19 immunization. Medical history included hypertension from an unknown date. No medications received within 2 weeks of vaccination. No other vaccine received within 4 weeks of vaccination. The patient was not diagnosed with COVID-19 prior to vaccination. The patient received the first dose BNT162B2 on an unspecified date (lot number: EN6200) for COVID-19 immunization on the left arm. On 14Apr2021, it was reported that patient had lost energy to get out of bed. Patient was transported to the emergency room with fevers and altered mental status. The patient was admitted in the hospital for 6 days from 14Apr2021 to 20Apr2021. The reporter considered the events to have caused disability. The patient received an unspecified treatment. Multiple tests were done to the patient on an unspecified date with unknown result. The patient had a COVID-19 test post vaccination via nasal swab on 15Apr2021 with a negative result. The outcome of the events was recovering.
77 2021-05-28 weakness Unexplained chest pain; Breathing difficulties; Weakness; Costochondritis; This is a spontaneous rep... Read more
Unexplained chest pain; Breathing difficulties; Weakness; Costochondritis; This is a spontaneous report from a contactable consumer (patient). A 77-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), on 11Feb2021 12:00 (Lot: EL9267) (at the age of 77-years-old) as 1 st dose, single then on 11Mar2021 11:00 (Lot: EL6204) as 2 nd dose, single; both via an unspecified route of administration in left arm for covid-19 immunisation. The vaccination facility type was reported as other. No other vaccines within 4 weeks prior to the COVID vaccine. Medical history included Parkinson's disease, high BP, high cholesterol and known allergies: penicillin. Concomitant medications included allopurinol; esomeprazole magnesium (NEXIUM); pravastatin and propranolol. The patient previously took sulfamethoxazole, trimethoprim (BACTRIM) and experienced known allergies: Bactrim. The reported events unexplained chest pain, breathing difficulties, weakness and initially diagnosed costochondritis, all in Feb2021. The patient considered the case as serious due to caused/prolonged hospitalization, did not results in death, not life threatening, non-disabling/incapacitating and no congenital anomaly/birth defect. 3 more incidents of increasing intensity led to 3 ER visits and 2 hospitalizations. The events resulted doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care and hospitalization for 5 days. Treatment for the events included IV antibiotic, furosemide (LASIX), prednisone. Prior to vaccination, patient was not diagnosed with COVID-19and since vaccination, patient was tested for COVID-19 with nasal swab on 29Apr2021 with result of negative. The outcome of the events was recovering.
77 2021-06-01 unresponsive to stimuli Cardiac arrest at home, EMS performed CPR. Return of spontaneous circulation in the field after 2 ro... Read more
Cardiac arrest at home, EMS performed CPR. Return of spontaneous circulation in the field after 2 rounds of epinephrine, In ED unresponsive, placed on a ventilator, required high doses epi to maintain perfusing blood pressure. Has acute kidney injury with hyperkalemia, shock liver and severe metabolic acidosis with arterial pH 7.04. CT of the head showed early findings of anoxic brain injury. Admitted to ICU and treated with aggressively with vasopressors, bicarbonate drip, heparin drip and empiric broad spectrum antibiotics. Very poor medical and neurologic prognosis, discussed with family and patient was transitioned to comfort care and passed away on 03/21/21 at 1626
77 2021-06-03 myelitis transverse Transverse Mylitus
77 2021-06-08 seizure Was living happily and independently in a retirement community. After the second dose because losing... Read more
Was living happily and independently in a retirement community. After the second dose because losing his memory, focus, depression, followed by 2 strokes, brain bleed, blood clots, seizures, and a Dx of Parkinson's and Parkinson's dementia. He saw doctors monthly and never had any signs of any of these things.
77 2021-06-14 numbness and pain in extremities, numbness, tingling I started having numbness in my feet and tingling in my legs, especially my left leg. I went to the ... Read more
I started having numbness in my feet and tingling in my legs, especially my left leg. I went to the ER and they admitted me. I was in the hospital for 3 days. They ran a bunch of tests and they referred me to a specialist. I was diagnosed with some type of a neuropathy. He advised me not to get the second shot.
77 2021-06-15 unresponsive to stimuli, brain damage 77 yo male presented to the ED given unresponsiveness at SNF via EMS, found to be hypoglycemic- intu... Read more
77 yo male presented to the ED given unresponsiveness at SNF via EMS, found to be hypoglycemic- intubated/sedated on admission - he was recently admitted, and had prolonged hospital stay (4/30 - 5/10) after orthopedic intervention / ORIF 4/30 Rt hip Fracture- s/p. - Acute hypoxic and hypercarbic respiratory failure, on mechanical ventilation - Bibasilar infiltrates, Lt > Rt, will small bilateral pleural effusions, HCAP - COVID PNA - Small bilateral pleural effusions - Encephalopathy - A-Fib - HFrEF, EF 45%, Mild MR - Acute on CKD - UTI
77 2021-06-16 burning sensation, night sweats 2 weeks after second shot pt. experienced: feet burning, hand burning, night sweats, chest pain, can... Read more
2 weeks after second shot pt. experienced: feet burning, hand burning, night sweats, chest pain, can't do flight of stairs without being out of breath, sore joints, fatigue
77 2021-06-21 numbness, pain in extremity around 05/30/2021 started experiencing numbness and pain on left arm, along with chest pain. patient... Read more
around 05/30/2021 started experiencing numbness and pain on left arm, along with chest pain. patient was hospitalized at local medical center for 1 week.
77 2021-06-22 pain in extremity spiking of his blood pressure; sore arm; legs swollen; pain on one leg; on and off nausea; not feeli... Read more
spiking of his blood pressure; sore arm; legs swollen; pain on one leg; on and off nausea; not feeling right; This is a spontaneous report from a contactable consumer (patient). A 77-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 2 via an unspecified route of administration on 24Feb2021 (Lot number was not reported) at the age of 77 years, as a single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Historical vaccine included BNT162B2, dose 1 on unspecified date for COVID-19 immunization. On an unspecified date the patient experienced spiking of his blood pressure, sore arm, legs swollen, pain on one leg, on and off nausea, not feeling right. The patient had lab tests and procedures which included blood pressure measurement: 190/80. The clinical outcome of the events was unknown. The clinical course was reported as follows: 77-year-old caller reported receiving his second dose of the Pfizer-BioNTech COVID-19 vaccine 24Feb2021 and experienced a "sore arm" after. He explained that a week after vaccination, on the Monday, he " woke up with his legs swollen and pain on one leg". He stated he also experienced spiking of his blood pressure (BP), however on Monday 03Mar2021 he went to the ER since his BP rose over 190/80. He explained at the ER, he guessed they got him more call, and he received a prescription of "water pills" to take for "a couple weeks". He added then, there were moments when he "didn't feel right". He specified he would be "good" in the morning then he "just didn't feel right" in the afternoon. He reported about a month later, 13Apr2021 he had a "second incident with the spiking" of his BP, which led him to the ER. He explained his cardiologist then changed his amlodipine prescription to "5mg in the morning and 5mg at night". He explained he would take 1 pill of Amlodipine 10mg in the morning before vaccination. He added he would take 5mg of amlodipine for a year before being increased to that 10mg a day. He explained before vaccination, he "never experienced such spiking with his BP and considers himself healthy for his age. DSU agent reported his BP is generally around 120/70 and he routinely use the treadmill. He mentioned he now seems ok, has not have a "violent" BP spike, but has "not felt 100%" yet. He added some days he is "fine" and others he has "on and off nausea" or he "feels his legs are swollen in the evening". The main reason for his call is to see if Pfizer have any experience with people who have covid, the long haulers, with the effects for quite a while, that are 3 months in. He was wondering whether or not any long hauler folks that have had on and off side effects attributed it to the vaccine. Information about Lot Batch number has been requested.
77 2021-06-23 paralysis medical hx for atrial fibrillation, chf, hx of cardiac arrest, CAD, hypertension, prostate cancer, h... Read more
medical hx for atrial fibrillation, chf, hx of cardiac arrest, CAD, hypertension, prostate cancer, hypothyroidism, presents to ER after an episode of inability to move for over one hour, unable to move extremeties but was able to talk. reported that had a cough on friday but no sob or hypoxia and did not report fever or chills to hospital, although did report those to investigator. Discharged on 6/3/2021. symptoms of fever, chills, runny nose/congestion, sore throat and cough began on 5/25, none of these symptoms present upon hospitalization on 6/1/21.
77 2021-06-24 muscle spasms Fever; Dizziness; gland under arm was painful; muscle cramping in legs; This is a spontaneous report... Read more
Fever; Dizziness; gland under arm was painful; muscle cramping in legs; This is a spontaneous report from a contactable consumer (Patient reported for himself). A 77-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration, administered in left arm on 02Feb2021 at 09:00 (at the age of 77-year-old), as First dose, single for Age/COVID-19 immunisation in clinic; warfarin, via oral route of administration from an unspecified date since 15-20 years ago (Batch/Lot number was not reported) and ongoing, at 7.5 mg, daily, (7.5mg by mouth daily) for Blood thinner (anticoagulant therapy). Medical history included cardiac disorder(bad heart) ,back disorder(bad back that is full of metal) from an unknown date and unknown if ongoing. No investigation assessment. There were no concomitant medications. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not receive any other vaccines on same date of the Pfizer vaccine received. No history of all previous immunization with the Pfizer vaccine considered as suspect. Vaccine did not administer at military facility. The patient forgot and did not tell vaccine administrator that he was on a blood thinner prior to getting the vaccine and received the COVID-19 vaccine on Tuesday at clinic. He did not read the papers at first. Later he saw on the papers something that he did not tell them. "What does he need to do." On 03Feb2021, the patient had a fever of 100 degrees,It was down to 98.9 degrees ,He was dizzy. The gland under his arm was painful. He had muscle cramping in his legs. Adverse event did not require a visit to emergency room/physician office. The patient underwent lab tests and procedures which included on 03Feb2021, body temperature: 100 degrees and body temperature: 98.9 degrees. No relevant tests were performed. Therapeutic measure the patient took "Tylenol" as a result of fever, dizziness, gland under arm was painful, muscle cramping in legs and it helped. No product complaint was reported. The outcome of the event gland under arm was painful was resolved on 03Feb2021, outcome of the event fever was resolved on 04Feb2021 and outcome of the events dizziness and muscle cramping in legs was resolving. Information on the lot/batch number has been requested. Follow-up attempts have been completed and no further information is expected.
77 2021-06-24 pain in extremity I was fine just had some discomfort in my arm and I took some Tylenol and I was fine. My husband als... Read more
I was fine just had some discomfort in my arm and I took some Tylenol and I was fine. My husband also had the same reaction/just a little soreness in his arm; This is a spontaneous report from a contactable consumer. This consumer reported for a male patient (Reporter's husband). This is second case out of the two cases. A 77-years-old male patient received bnt162b2 (BNT162B2, Batch/Lot Number: EN5318), via an unspecified route of administration on 02Feb2021 as unknown, single dose for COVID-19 immunisation. Medical history included myocardial infarction : Mild heart attack , blood pressure abnormal from an unknown date. The patient's concomitant medications were not reported. On 02Feb2021, the patient experienced discomfort in the arm, had a little soreness in the arm. Additional Information was reported by the reporter that patient had Mild heart attack last Sep but now he is fit as fiddle and also reported that her husband, I don't know if it's same. Yes his is same, it says lot number, product name, EN5318. Reporter also stated that "Well because we are old. Outcome of the event was recovered on an unspecified date. Follow up (04Feb2021): This is a follow up spontaneous report from a contactable consumer. This consumer reported for a 77-year-old patient (Reporter's husband) that included patient's weight, height, medical history, product batch no, product start date, event with outcome. Follow-up attempts are completed. No further information is expected.
77 2021-07-01 weakness Night of first injection my dad said he missed his bed and fell on the floor and laid in the floor ... Read more
Night of first injection my dad said he missed his bed and fell on the floor and laid in the floor and couldn?t move for an hour. The day after second injection he almost passed out and we went to the ER. He was sent back home. Now he has been diagnosed with Parkinson?s disease. He has low Vitamin D. He is anemic and his iron is so low he is receiving 2 iron infusions. He has blood that has showed up in his stool and is having a colonoscopy on July 15th. He stays very dizzy and weak. He also has problems now with his eyesight.
77 2021-07-02 weakness Visit summaries/notes attached on below visits 3/25/2021 ER with chest pain, worse with deep breath... Read more
Visit summaries/notes attached on below visits 3/25/2021 ER with chest pain, worse with deep breath; diagnosis costochondritis 4/14/2021 ER with chest pain, painful breathing, wheezing, weakness, fever (101.3 rectal). 4 pound weight gain overnight. Differential diagnoses costochondritis, pleurisy, pneumonia, COVID-19; admitted to hospital.Discharged 4/16. 4/25/2021 admitted to hospital; chest pain, shortness of breath, weakness, bloat, inflammation markers high, mild pericardial effusion, near syncope.
77 2021-07-02 involuntary muscle movements Passed out for 5 minutes or so, erratic arm movement during arm episode. Went to emergency room.
77 2021-07-02 hot flush Tachycardia; elevated pulse; High Blood Pressure; Hot flash; This is a spontaneous report from a con... Read more
Tachycardia; elevated pulse; High Blood Pressure; Hot flash; This is a spontaneous report from a contactable physician (patient). A 77-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: EL9262), via an unspecified route of administration, administered in right arm on 25Jan2021 13:45 (at the age of 77-years-old) as a single dose for COVID-19 immunization. The patient's medical history included diabetes mellitus, asthma and hypertension. The patient's concomitant medications were not reported. The patient did not have any allergies. The patient had no other vaccine within four weeks and had other medications received within 2 weeks of vaccination (not reported details of medications). 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 25Jan2021 14:30, the patient experienced hot flash in the face within 45 minutes of the shot. On 26Jan2021 02:45, the patient had tachycardia and high blood pressure which started at approximately 13 hours after the shot. High Blood pressure remained for about the next six days, but the elevated pulse has continued. The adverse event resulted patient to doctor or other healthcare professional office/clinic visit. The patient received treatment - increase in blood pressure medication. Outcome of the event elevated pulse was not recovered and the outcome for other events was recovered with sequel. Follow-up attempts are completed. No further information was expected.
77 2021-07-17 muscle spasms slight headache; muscle cramps; lymph node pain under arm; This is a spontaneous report from a conta... Read more
slight headache; muscle cramps; lymph node pain under arm; This is a spontaneous report from a contactable consumer, the patient. A 77-year-old male patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6200) via an unspecified route of administration in the right arm on 24Feb2021 at 13:30(at the age of 77-years-old) as a single dose for COVID-19 immunisation. Medical history included diabetes, heart attack and bypass surgery. The patient had a history of allergy to ciprofloxacin (CIPRO). Concomitant medications included atorvastatin (MANUFACTURER UNKNOWN), glimepiride (MANUFACTURER UNKNOWN), montelukast sodium (VICTOR) and metoprolol succinate (METOPROLOL) all for unknown indication. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EL9264) via an unspecified route of administration in the right arm on 05Feb2021 at 14:00(at the age of 77-years-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 24Feb2021, the patient experienced slight headache for a month which was still continuing, muscle cramps for 2 days and had lymph node pain under arm when lying on side with arm under body which started two weeks after shot and continued for several weeks. The patient did not receive any treatment for the reported events. The adverse events did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the event muscle cramps was resolved on 20210226. The clinical outcome of the events slight headache and lymph node pain under arm were not resolved at the time of this report. No follow-up attempts are needed. No further information is expected.
77 2021-07-19 trigeminal neuralgia My trigeminal neuralgia became more intense with pain to right side of face; My trigeminal neuralgia... Read more
My trigeminal neuralgia became more intense with pain to right side of face; My trigeminal neuralgia became more intense with pain to right side of face; pain was too intense; This is a spontaneous report from a contactable consumer (patient). A 77-years-old male patient 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 in left arm on 08Jun2021 11:30 (age at vaccination was 77-year-old) for covid-19 immunization. The patient had no known allergies. Medical history included heart diabetes, DVT (deep vein thrombosis), PAD (peripheral arterial occlusive disease), trigeminal neuralgia. Patient previously received dose 1 (Lot number and Expiry date was not reported) via an unspecified route administration in left arm on 18May 11.30 AM as single dose for covid-19 immunization. Facility where the most recent COVID-19 vaccine was administered in Pharmacy or Drug Store. Concomitant medications received within 2 weeks of vaccination was atorvastatin (ATORVASTATIN), cholecalciferol (CHOLECALCIFEROL), gabapentin (GABAPENTIN), glimepiride (GLIMEPIRIDE). 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. On 09Jun2021 patient experienced trigeminal neuralgia became more intense with pain to right side of face, notified Doctor of pain and made 3 trips to ER 2 by ambulance as the pain was too intense. Treatment received for the events was oxycodone, morpheein, Vicodin. Since the vaccination, patient has not been tested for COVID-19. The outcome of the event was not resolved. Information on the lot/batch number has been requested. Additional information is expected.
77 2021-07-27 discomfort The symptoms were ever pain in my chest, great discomfort allowing only one sitting position on the ... Read more
The symptoms were ever pain in my chest, great discomfort allowing only one sitting position on the ground, inability to walk more than about 50 feet without resting. After three attempts to walk, I could no longer continue. I was the beginning of a myocardial infarction. It was four hours before a rescue team could get me to the hospital.
77 2021-07-28 pain in extremity Painful lower left torso and waist and too sore to sleep; Sore left leg; This is a spontaneous repor... Read more
Painful lower left torso and waist and too sore to sleep; Sore left leg; This is a spontaneous report from a contactable consumer, the patient. A 77-year-old male patient received unknown dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: EP6955) via an unspecified route of administration in the left arm on 24Mar2021 at 10:00 (at the age of 77-year-old) as a single dose for COVID-19 immunisation. Medical history was not reported. The patient did not receive any other medications within two weeks of vaccination. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccination. On 24Mar2021, the patient experienced extremely painful lower left torso and waist, then very sore left leg which continued through whole day and at the time of this report and was too sore to sleep. The adverse event resulted in doctor or other healthcare professional office/clinic visit. The patient received treatment for the reported events which included steroid PAK and tylenol. The clinical outcome of the events too sore to sleep, sore left leg, painful lower left torso and waist was not recovered at the time of this report. No follow-up attempts are needed. No further information is expected.
77 2021-07-28 pain in extremity Sore arm; slightly swollen two months after second vaccination; This is a spontaneous report from a ... Read more
Sore arm; slightly swollen two months after second vaccination; This is a spontaneous report from a contactable consumer, the patient. A 77-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 18Feb2021 at 10:30 (at the age of 77-year-old) as a single dose for COVID-19 immunisation. Medical history included asthma, blood pressure high and cholesterol. The past drug included ALEEVE for unknown indication, from an unknown date. The patient received unspecified medication within two weeks prior to the vaccination. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 28Jan2021 at 10:00 (at the age of 77-year-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 23Feb2021 at 1900, the patient experienced sore arm and slightly swollen arm. The patient was concerned with length of time, since it continued to the present -May1. The events resulted in doctor or other healthcare professional office/clinic visit. On 01May2021, the patient underwent COVID test (nasal swab) and the result was negative. The clinical outcome of the event sore arm and swollen arm was not resolved at the time of this report. No follow-up attempts are needed; information about lot/batch number cannot be obtained.
78 2021-01-03 weakness Very dizzy and very weak, tired. Walks with walker, difficult moving around.
78 2021-01-07 facial paralysis Went to ER left side of face sagging. They did MRI it showed he had stroke. happened before 4pm that... Read more
Went to ER left side of face sagging. They did MRI it showed he had stroke. happened before 4pm that same day as vaccine. Happened between 2-4 pm; Went to ER left side of face sagging. They did MRI it showed he had stroke. happened before 4pm that same day as vaccine. Happened between 2-4 pm; This is a spontaneous report from a contactable consumer (patient). A 78-year-old male patient receive BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number: EK5730), on 31Dec2020 11:00 AM via unknown route of administration at single dose for COVID-19 immunization. Medical history included high blood pressure, but went up and down and had to readjust. His BP was high and not sure how long it was that way. Concomitant medications included unspecified blood pressure medications. There were no known allergies. Patient went to ER left side of face sagging. They did MRI it showed he had stroke. It Happened before 4pm that same day as vaccine on 31Dec2020 02:00 PM. And it Happened between 2-4 pm. Patient received treatment. Patient had ER test blood, cat scan, MRI. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient did not have been tested for COVID-19. The outcome of the events was recovering. This case was assessed non-serious by reporter. And the events did not result in death, Life threatening, Caused/prolonged hospitalization, Disabling/Incapacitating, Congenital anomaly/birth defect.
78 2021-01-11 muscle spasms Tested positive for COVID-19; CT showed increased infiltrates 10-15%; Dehydration/Dehydrated; Chills... Read more
Tested positive for COVID-19; CT showed increased infiltrates 10-15%; Dehydration/Dehydrated; Chills; Tested positive for COVID-19; Hypotensive; Achy; Severe achy cramps/Severe cramps all over body; This is a spontaneous report from a contactable nephrologist (patient himself). This 78-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number EK5730), via an unknown route, on 17Dec2020 at single dose for COVID-19 immunisation. Age at vaccination was 78-year-old. The patient was diabetic and hypertensive. Additional medical history included hyperlipidaemia. No relevant concomitant medications were provided. On 18Dec2020, the patient developed severe achy cramps/severe cramps all over body. On 19Dec2020, the patient developed achy. On 20Dec2020, the patient was dehydrated and hypotensive, he had also chills. On unknown date, blood pressure was down to 76/50. His symptoms for COVID were severe achy cramps, hypotension, and dehydration. On 20Dec2020, COVID-19 test was positive. On 21Dec2020, the patient was given monoclonal antibodies. A computerized tomogram (CT) of the lungs was performed on 21Dec2020 and it was ok. A week later (Dec2020), he had a repeat CT which showed increased infiltrates of 10 to 15%. He then started on dexamethasone, apixaban (ELIQUIS) and the rest of the things. He had a repeat CT on 05Jan2021 which showed resolution of the infiltrates; most of the lesions went gone. CT results had improved significantly. The patient underwent a second COVID test a week ago which was still positive. He had a third COVID on 06Jan2021, but results were not available yet. The patient queried if he can proceed with second dose planned on 07Jan2021 or if he should wait. The clinical outcome was recovered for the event 'severe achy cramps/severe cramps all over body' on 19Dec2020, for 'dehydration/dehydrated' on 20Dec2020, for 'chills' on unknown date in Dec2020, for 'achy' on 30Dec2020, for 'hypotensive' on 20Dec2020; the outcome of the event 'CT showed increased infiltrates 10-15%' was recovering; the outcome for 'Tested positive for COVID-19' was unknown. The reporter considered the events 'achy' and 'severe achy cramps/severe cramps all over body' serious because causing disability; the events 'tested positive for COVID-19', 'dehydration/dehydrated', 'chills' and 'hypotensive' were considered medically significant. The reporter considered the events 'Tested positive for COVID-19', 'CT showed increased infiltrates 10-15%' and 'dehydrated/dehydration' unrelated to BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE).; Sender's Comments: A possible contributory effect of suspect BNT162B2 on reported events cannot be excluded. Case will be reassessed when new information is received. 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 2021-01-12 unresponsive to stimuli little bit of a reaction light headed after 5 minutes. vitals were low, so observed for 30 minutes... Read more
little bit of a reaction light headed after 5 minutes. vitals were low, so observed for 30 minutes after being light headed. Patient was found unresponsive and pronounced dead later that day.
78 2021-01-17 involuntary muscle movements, tremor I had no reaction for approximately 4 hours after my vaccination. Then I got the shakes and all the ... Read more
I had no reaction for approximately 4 hours after my vaccination. Then I got the shakes and all the muscles in my body seemed to be vibrating. I could still walk but found a comfortable chair. The shakes would rise and fall in amplitude causing my hands and legs to oscillate then recede after about 30 seconds. This lasted for about 20-25 minutes and simply went away and has not recurred. I have had no other symptoms. As chills were a listed side effect, I assumed at first that it was chills or some variant but I was not cold. It was the chills without an apparent temperature effect although I did not measure my temperature.
78 2021-01-19 tremor On 1/18/21, received the vaccine at 1007. At 1035 while working with PT, he became very fatigued an... Read more
On 1/18/21, received the vaccine at 1007. At 1035 while working with PT, he became very fatigued and short of breath. Pulse ox was 96%. At 1105, he began shaking uncontrollably and projectile vomiting. BP 100/62, P-100, temp 96.0. 1230: temp 99.0 and still shaking. 1315: temp 100.1, shaking less. 1500: temp 102.0 no other symptoms. 1600: Temp 101.3 no other symptoms. 2000: Temp 99.3 no other symptoms. Temp continued to normalize through the night. Doing well and back to baseline on 1/19/21.
78 2021-01-23 tension headache Getting light headed with a tightness across the scalp
78 2021-01-24 tenderness hypoxemia, urinary retention Narrative: Transferred from facility to ED with 1 day of fevers, hypote... Read more
hypoxemia, urinary retention Narrative: Transferred from facility to ED with 1 day of fevers, hypotension, and c/f new oxygen requirement and admitted to acute care ward on 1/14/21. Tachycardia resolved w/ fluids. Patient was ruled out for PE and infectious workup negative. Fevers, hypoxia resolved overnight. Medicine Team felt symptoms were side effects from COVID vaccine (2nd dose received 1/13). He was treated for possible cellulitis at L shin wound (warm and tender to touch with mild erythema, without fluctuation) with 14-day cephalexin course, however cellulitis not deemed severe and unlikely contributing. Regarding urinary retention, the Discharge Summary stated, "Urinary retention seemed new in the last day. Pt on condom cath during admission, urinating well." Discharged 1/15/21 and returned to facility.
78 2021-01-26 weakness, tenderness perfuse sweating; mild tenderness of arm; Muscle pain; Chills; Weakness; This is a spontaneous repor... Read more
perfuse sweating; mild tenderness of arm; Muscle pain; Chills; Weakness; This is a spontaneous report from a contactable physician (patient). A 78-year-old male patient received the 2nd dose of bnt162b2 (BNT162B2) intramuscular at single dose at left deltoid on 11Jan2021 around 13:00 for covid-19 immunisation, administered at hospital. Medical history was none, he was basically healthy. There were no concomitant medications. No prior vaccinations (within 4 weeks), but the patient received the 1st dose of bnt162b2 (BNT162B2) at single dose exactly 3 weeks before 1st dose on 21Dec2020 for covid-19 immunisation. No additional vaccines administered on same date of bnt162b2. The patient began to have muscle pain, chills, and weakness about 8 hours or so after the 2nd vaccine on 11Jan2021. He states these symptoms have maybe gotten a little better, but have been continuing on for 2-3 days now. He is also experiencing perfuse sweating during 13Jan2021night. Right now, he was not experiencing this. Maybe a little bit, but not much. The caller experienced mild tenderness of arm on 12Jan2021: he explained when you press his arm, it hurts a little bit. No events required a visit to Emergency Room or Physician Office. The outcome of muscle pain was and perfuse sweating was unknown, of chills, weakness was recovering, of mild tenderness of arm was not recovered. The patient was his own primary doctor. The reporter considered all events as medically significant and he believed these symptoms are related to receiving the vaccine because he stated he was okay before that. No further information expected. Information about lot/batch number has been requested.; Sender's Comments: There is a reasonable possibility that the event muscle pain was related to BNT162b2 based on known drug safety profile. Based on the temporal relationship, the association between the other events with BNT162b2 can not be completely excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
78 2021-01-27 weakness Fever and weakness/fatigue
78 2021-01-27 weakness Resident displayed tachycardia, diaphoresis, severe weakness - transfer to hospital from skilled fac... Read more
Resident displayed tachycardia, diaphoresis, severe weakness - transfer to hospital from skilled facility
78 2021-01-30 cold sweat Headache, cold sweat, sleepiness, muscle aches, joint aches. 7 day duration
78 2021-01-31 night sweats Fever (101.8), chills, night sweat, all over achy feeling for two days. Did not go to a clinic.
78 2021-01-31 tingling, weakness Weakness, pain, and tingling in right leg; complete collapse of leg twice
78 2021-02-03 numbness, pain in extremity I started having pain in my left shoulder across my back and down my arm into my left hand. It is ge... Read more
I started having pain in my left shoulder across my back and down my arm into my left hand. It is getting progressively getting worse. both shoulders are so painful and I cannot grip anything in my left hand. My fingers on my left hand are going numb. I've been alternating taking tylenol and ibuprofen but they are not helping at all.
78 2021-02-05 cold sweat After receiving injection, waited 30 mins before leaving hospital, when walking to car experienced s... Read more
After receiving injection, waited 30 mins before leaving hospital, when walking to car experienced shortness of breath like I'd run a mile. Breathing so heavily, when I got to car, had to wait 5 mins before I caught my breath. Stopped for errand & had same experience. No other symptoms until next night at 012:15 on 01/24/21 when i woke with shortness of breath, clammy, nausea, heart skipping beats, BP 178/106. Went to ER. Had EKG, check xray,troponin levels checked 6 hrs apart. All were negative. Released. Since that time, I continue to have: chills, no temp, shortness of breath, fatigue, mild headache, sore throat, runny nose, occasional nausea. Went for Covid test 02/04/21 Results were negative. Just began feeling more normal today--2 weeks after innoculation.
78 2021-02-05 night sweats Patient presented with night sweats and shortness of breath the day after receiving the second dos... Read more
Patient presented with night sweats and shortness of breath the day after receiving the second dose of the COVID vaccine. Initially presented to his PCP and received levaquin for presumed PNA, but subsequently presented to the ED with persistent SOB and fatigue. Admitted to the ICU on AIRVO for high O2 requirements. Chest CT showing dense ground-glass opacities with interlobular septal thickening and mild crazy paving pattern. Currently admitted and undergoing workup.
78 2021-02-06 impaired body coordination, tremor Feeling sick, muscle soreness, chills, trembling and loss of muscular control, fever, headache, naus... Read more
Feeling sick, muscle soreness, chills, trembling and loss of muscular control, fever, headache, nausea, hyperglycemia, uncontrollable diarrhea, polyuria, insomnia. Event lasted 32 hours. Slept 16 hours of that time, interrupted 11 times due to polyuria and diarrhea. Lost 5 lbs. Have not felt this sick in at least 20 years - not for any bout of influenza, But it only lasted a day. Took no medication including ibuprofen or acetaminophen. Completely recovered
78 2021-02-09 weakness chills; body aches; fever of 102.9; extreme weakness; dizzy; This is a spontaneous report from a con... Read more
chills; body aches; fever of 102.9; extreme weakness; dizzy; This is a spontaneous report from a contactable consumer reported for himself. This 78-year-old male patient received the 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration at right arm on 22Jan2021 12:00 PM at single dose for covid-19 immunisation. Medical history included Seizures, low white cell count, enlarged prostate and COVID-19. Prior to vaccination, the patient was diagnosed with COVID-19. The patient had no allergies to medications, food, or other products. Concomitant medications included any other medications the patient received within 2 weeks of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 24Jan2021 08:00 AM (reported as 18 hours after injection), the patient experienced chills, body aches, fever of 102.9, extreme weakness, dizzy. At 4 am on 25Jan2021 the fever broke and now he was ok. No treatment received for the adverse event. Outcome of the events chills, body aches, extreme weakness and dizzy was recovered on an unspecified date, of the event fever of 102.9 was recovered on 25Jan2021. Since the vaccination, the patient had not been tested for COVID-19. Seriousness criteria was reported as non-serious. Information on the lot/batch number has been requested.
78 2021-02-09 tremor chills; shakes; Temps ranging from 98.3-102.9 thru the day and into bedtime.; Sweat profusely during... Read more
chills; shakes; Temps ranging from 98.3-102.9 thru the day and into bedtime.; Sweat profusely during the night waking often; Sweat profusely during the night waking often; Had difficulty breathing somewhat; This is a spontaneous report from a contactable consumer (patient). A 78-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EL1284), via an unspecified route of administration (left arm), on 18Jan2021 09:30, at single dose, for covid-19 immunization. The patient has no medical history and has no known allergies. Concomitant medications included rosuvastatin, and metoprolol succinate. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EH9899), vaccine location left arm, on 28Dec2020 08:30 AM, for covid-19 immunization at a hospital at 78-years-old. Four days after the second injection, on 22Jan2021 10:00 mid-morning, the patient started with severe chills and shakes, temps ranging from 98.3-102.9 thru the day and into bedtime, sweat profusely during the night waking often, and had difficulty breathing somewhat. By mid-day the next day, the patient was without any more symptoms. The patient did not receive any treatment for these events. The patient recovered from the events on 23Jan2021. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not have COVID prior vaccination and have not been COVID tested post vaccination.
78 2021-02-10 pain in extremity His left foot was swollen up really bad, red and tender and he could not walk on it; His left foot w... Read more
His left foot was swollen up really bad, red and tender and he could not walk on it; His left foot was swollen up really bad, red and tender and he could not walk on it; His left foot was swollen up really bad, red and tender and he could not walk on it; His left foot was swollen up really bad, red and tender and he could not walk on it; This is a spontaneous report from a contactable consumer (patient's wife). A 78-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number EL9261 with Expiration Date 31May2021), via intramuscular, on 22Jan2021 (at 09:00) at a single dose on the left arm for COVID-19 immunisation. Relevant medical history included ongoing restless legs syndrome and ongoing acid reflux. Relevant concomitant medications included omeprazole ongoing from an unknown date for acid reflux and gabapentin ongoing from an unknown date for restless legs syndrome. Her husband had the injection on Friday 22Jan2021. The next morning his left foot was swollen up really bad, red and tender and he could not walk on it. He has had problems like that before and he had it checked and was told it is not gout. It did not go away and she called the nurse on Sunday morning, and the nurse did not think it was a reaction and told her that a lot of times it is swelling in the lymph nodes. He was advised to go and see a podiatrist on Monday. He saw the podiatrist yesterday morning and the podiatrist gave him a one injection that contained Lidocaine, dexamethasone, and depomederol. After injection, the swelling right down and his foot was ok. The patient went to go get the Moderna injection and she asked those giving the injection if it was ok for her husband to get that injection from the podiatrist. She was told that people are not supposed to take paracetamol (TYLENOL) or ibuprofen. She was told that they did not think it was a good idea for her husband to get that injection from the podiatrist and it may have wiped out the benefit of the Pfizer COVID VACCINE. His foot was 95% recovered, he could walk on it and the swelling was down. The patient was recovering from the events.
78 2021-02-10 tingling, numbness, weakness Tingling and numbness within one hour. That subsided after another 30 minutes but then I lost cont... Read more
Tingling and numbness within one hour. That subsided after another 30 minutes but then I lost control of thumb and pointer finger. That loss of control/strength has continued until today(2/11/2021). I tend to drop things from my left hand.
78 2021-02-10 seizure The next two days following the vaccination, the patient was lethargic and not getting out of bed. H... Read more
The next two days following the vaccination, the patient was lethargic and not getting out of bed. His caregiver had to make him eat and bathe. On the third day his care giver had woken him up and found that he had wet himself (this has never happened before). He had altered mental status and was not able to recognize any of his family members. He was taken to the emergency room on 2/6/2021 where he had a seizure and found to have a subarachnoid hemorrhage. He is still hospitalized.
78 2021-02-13 speech disorder We feel as if the vaccine completely counteracted with his Parkinson's medication. Patient was hallu... Read more
We feel as if the vaccine completely counteracted with his Parkinson's medication. Patient was hallucinating for 2 days, completely unaware of surroundings, making non sensical words, mumbling, showing Parkinson side affects such as hand wringing, not able to balance, walk, completely different than his normal self. Side affects wore off in about 36 hours.
78 2021-02-14 numbness and pain in extremities Injection site developed numbness and tingling of left arm that began 45-60 minutes after reciving t... Read more
Injection site developed numbness and tingling of left arm that began 45-60 minutes after reciving the vaccine on 2/8/2021. Resolved within an hour or so, then no strength between thumb and index finger. Symptoms resolved that night. On 2/10/2021 patient had difficulty picking up things and had less strength than usual. Patient stated he felt clumsy.
78 2021-02-16 tremor, feeling cold At around 9am, my husband started shaking and reported he was very cold. The shaking was spontaneous... Read more
At around 9am, my husband started shaking and reported he was very cold. The shaking was spontaneous and I covered him with electric blanket and within 30 minutes the shaking stopped and he was no longer cold
78 2021-02-17 weakness First 24 hours dizziness, chills, weakness Day 3 vomiting, lasting 20 hours.
78 2021-02-18 weakness myalgia/arthralgia, significant weakness followed by reactivation of rapid ventricular rate w/ his c... Read more
myalgia/arthralgia, significant weakness followed by reactivation of rapid ventricular rate w/ his chronic Atrial Fib leading to angina and hospitalization w/i 2 days of vaccine. symptoms have not yet recovered, resulting in SNF placement
78 2021-02-18 flushing Flushed, nauseous, serious headache and extremely tired within first hour after receiving the injec... Read more
Flushed, nauseous, serious headache and extremely tired within first hour after receiving the injection. took 2 Ibuprofen and laid down. Ate supper with the family, headache still really bad. Stepped outside for a few minutes and my heart began to race wildly. Called hospital after I couldn't get it to calm down with breathing technique after trying for 40 minutes. Too many bpm for me to count myself.
78 2021-02-20 inability to speak Developed expressive aphasia TIA 15 hours post vaccination, requiring 48 hour hospitalization
78 2021-02-20 weakness Pt had 2nd dose on 2/18. Had fall on 2/19 from weakness resulting in rhabdomyolysis.
78 2021-02-22 weakness Patient received his first dose of vaccine on 2/10 at 11:30am. (His 2nd is scheduled for 3/3) He sta... Read more
Patient received his first dose of vaccine on 2/10 at 11:30am. (His 2nd is scheduled for 3/3) He started with sx ~13 hrs later - He started drifting out of consciousness, then had labored breathing through night rendering him unable to sleep. After getting up in the morning, his breathing was better but he felt lightheaded/weak through the day. By the next morning (Friday 2/12), he was so bad next morning that wife called 911 - He reports that he was there and then not there and was losing track of train of thought. He was taken to ER via EMS, where his HR was initially 15 - He was admitted to hospital - initially a temporary pacer was placed, then a permanent one on Monday, 2/22. He has had other episodes like this in past 13 mos. PCP referred him to neurologist and EENT. Neurology work-up, including MRI and 72 hr EEG were unremarkable, although he learned retrospectively that there was a time during EEG where HR was only 35. EENT found no auditory or other issues . *MD in ER told him that if issues were not neuro in nature, they were probably cardiac.
78 2021-02-23 night sweats My dad (78 year old male) received the second Pfizer Covid19 vaccine shot on Wednesday, Jan 27 that ... Read more
My dad (78 year old male) received the second Pfizer Covid19 vaccine shot on Wednesday, Jan 27 that night he started experiencing trouble breathing, Fatigue, chills, night sweats, etc. He was admitted to the hospital on Wed, Feb 3. CT scan showed he has an infection and inflammation of the lungs. Today is day 6 of hospitalization, and he has not improved despite many antibiotics, steroids, IVIG and oxygen. He is also in year two of remission from Multiple Myeloma so he is immunocompromised.
78 2021-02-23 pain in extremity sore arm; This is a spontaneous report from a contactable consumer. This consumer reported similar e... Read more
sore arm; This is a spontaneous report from a contactable consumer. This consumer reported similar events for different patient. This is the first of two reports. A 78-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) on his left arm, via an unspecified route of administration on 19Jan2021 at a single dose for covid-19 immunization. Medical history included egg allergy, bladder cancer and surgery. There were no concomitant medications. It was reported that the patient had a sore arm after getting the shot. The outcome of the event was recovered on an unspecified date in Jan2021. Information about lot/batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021106756 same drug, same event and different patient
78 2021-02-28 weakness Appox. 16 hours after injection I started shivering and cold sweats. was weak. and just out of it. W... Read more
Appox. 16 hours after injection I started shivering and cold sweats. was weak. and just out of it. Went to bed and by mid afternoon shivers were gone as well as sweating. Slept all day and into the evening, by 10pm or so all seemed back to normal. Mid afternoon I sat up on the edge of the bed to go to the bathroom and passed out falling on my left knee (bad one) and hit my forehead on the bathroom door scraping and bruising same above left eye brow. Walking with pain in left knee but getting better daily.
78 2021-02-28 facial paralysis, speech disorder Bell's Palsy caused the side of my face to swell up and droop on one side; Eyes have been bothering ... Read more
Bell's Palsy caused the side of my face to swell up and droop on one side; Eyes have been bothering him and he is blinking; Can't talk very good because his lips are swelled up/hard to talk; This is a spontaneous report from a contactable consumer reporting for himself. A 78-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) (lot number EM9809/expiration date: not provided), via intramuscular route of administration, on 04-FEB-2021 at 14:30 (at the age of 78 years old) 0.3mL as a single dose in the right arm for COVID-19 IMMUNIZATION. Relevant medical history included patient was diabetic since an unknown date and has psoriatic arthritis. Concomitant medication included infliximab (REMICADE) infusion every 8 weeks for psoriatic arthritis and cetirizine hydrochloride (EQUATE ALLERGY RELIEF). The patient had infliximab infusion the morning of 04Feb2021, prior to receiving the vaccination and was told that infliximab would not be a problem with receiving the vaccination on the same day. On 07Feb2021, the patient went to the emergency room due to Bell's palsy, which was described as swelling of lips, nose, mouth, and side of face and stated that he can't talk very good because his lips are swelled up/hard to talk and his eyes have been bothering him and he is blinking. The patient stated, "I went to the emergency room at a hospital and what they said is totally unrelated to the COVID shot I got. In the meantime, few days after I had the shot, I had somehow got Bell's palsy caused the side of my face to swell up and droop on one side. I just wanted to get back to you so you knew that was not some reaction to the COVID shot, it was something else." Treatment for the event Bell's palsy included took Allergy Relief Equate 25mg ultra tablet and another allergy pill and it did not help swelling of lips, nose, mouth, and side of face. Relevant tests included blood work on an unspecified date in 2021 "two weeks ago" that was all good. The outcome of the events Bell's palsy, eyes have been bothering him and he is blinking and hard to talk was unknown.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of event Bell's palsy cannot be totally excluded. The case will be reassessed if additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
78 2021-02-28 feeling hot Felt as though truck kept turning over, but it was all in his head; Felt as though truck kept turnin... Read more
Felt as though truck kept turning over, but it was all in his head; Felt as though truck kept turning over, but it was all in his head; Was hot and everything; This is a spontaneous report from a contactable consumer (patient). A 78-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: PK12ER/EL9261; Expiration date was not reported) on 26Jan2021 (11:30) at a single dose on the right arm, with route of administration unspecified, for COVID-19 immunization/to not get COVID at the public health department. The patient had no relevant medical history and concomitant medications. The patient had no history of problems with vaccines in the past. On 27Jan2021, the patient had felt as though a truck kept turning over, but it was all in his head; and was "hot and everything". The outcome of the events, 'felt as though a truck kept turning over, but it was all in his head' and '"hot and everything"', was recovering.
78 2021-02-28 pain in extremity 11 Hours later ambulance called Taken to hospital C/O of left shoulder arm chest pain ,significant ... Read more
11 Hours later ambulance called Taken to hospital C/O of left shoulder arm chest pain ,significant dizziness, unable to stand without falling over
78 2021-02-28 tremor First day: lethargy all day. Second day, 2-28 starting c 10PM got the shivers and shakes,, had trou... Read more
First day: lethargy all day. Second day, 2-28 starting c 10PM got the shivers and shakes,, had trouble standing. Lasted c one and a half hours. I lay down, it finally stopped
78 2021-03-01 weakness 2nd SHOT Thur Feb. 18, 2021 2:30pm Fri. Feb 19 6:00 p.m Chills! Sun. Fe... Read more
2nd SHOT Thur Feb. 18, 2021 2:30pm Fri. Feb 19 6:00 p.m Chills! Sun. Feb 21 lost taste Fri Feb 26 extreme weakness in legs Otho has had side effects THAT OTHERS HAVE NOT REPORTED. Otho received the first Pfizer shot on January 28, 2021 and only suffered a small ache in his arm. Otho received the second shot of Phizer on February 1 8, 2021 adminsted at the same location. Day 1 arm a little uncomftable Day 2 6:00 pm extreme chills Day 3 chills gone, tired, weak Day 4 LOST SENSE OF TASTE Day 9 Legs so weak, could not walk without a walker Day 13 TODAY Still very weak and still connot taste. Otho is a male age 78 yrs. Usually very active. He does suffer from Carcinod Caner of many years. We did visit with our doctor. He prescribed to take two Ibuprifen morning and night to help with inflammation. And if Legs weakness increases to get back to him.
78 2021-03-01 bell's palsy Bells Palsy, right side of face - decreasing somewhat
78 2021-03-01 burning sensation, pain in extremity SWOLLEN LYMPH NODES UNDERARM PAINFUL BURNING NEEDLE-LIKE SENSATIONS IN LEGS AND ARMS
78 2021-03-01 pain in extremity The patient woke up with severe pain in his leg, a flare of a previous nerve pain issue he was havin... Read more
The patient woke up with severe pain in his leg, a flare of a previous nerve pain issue he was having. He had taken percocet to help with the pain and went to bed. His wife called and she was informed to have him take ibuprofen 400-600 mg every 6 hours to help suppress an inflammatory response that could be increasing the pain he is experiencing.
78 2021-03-01 cold extremities shivering/having in and out chills; slight fever; fever, headache, dry heaves, fatigue, and crazy dr... Read more
shivering/having in and out chills; slight fever; fever, headache, dry heaves, fatigue, and crazy dreams; Adding strange dreams/crazy dreams/ so vivid and frightening that he was afraid to go to sleep over fear that he would never wake up; hands were cold; headache fades in and out; Dry heaves; This is a spontaneous report from a contactable consumer, the patient. A 78-years-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot Number: EM5318, via an unspecified route of administration in the right arm on 08Feb2021 at 11:45 (at the age of 78-years-old) as a SINGLE DOSE for Covid-19 Vaccination. Historical vaccine includes BNT162B2 Dose 1, Lot Number 'He thinks its EL3302'. The patient had no known medical history or allergies. Concomitant medication included metoprolol tartrate (METOPROLOL TARTRATE), lisinopril (LISINOPRIL), atorvastatin (LIPITOR [ATORVASTATIN]). No other vaccines were given within 4 weeks. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination the patient had not been tested for COVID-19. Late on Wednesday 10Feb2021 The patient experienced his hands were cold, he went to bed and he was shivering, he had to put on clothes and 3 quilts and in the meantime he was having in and out chills and slight fever, fatigue and crazy dreams/so vivid and frightening that he was afraid to go to sleep over fear that he would never wake up/three types all repeating four or more times and on Feb2021 experienced headache fades in and out and dry heaves. The patient underwent lab tests and procedures which included pyrexia: little high (using the strips on his forehead) on an unspecified date. As a result of the event abnormal dreams patient did visit a professional office/clinic visit. No treatment was given for the event. The clinical outcome of the event shivering/having in and out chills, slight fever, dry heaves, fatigue, headache and hands were cold were unknown while abnormal dreams was recovered Feb2021.
78 2021-03-01 seizure Patient's wife reported that he broke both of his shoulders four days after his first vaccine. He ha... Read more
Patient's wife reported that he broke both of his shoulders four days after his first vaccine. He had a seizure and fell off the bed breaking his shoulders. No hx of seizures, TBI or stroke. His wife stated they were told by the PCP he could get the second dose of the vaccine. None of these records are accessible by the vaccinating site. No known ED visit or hospitalization related to the event.
78 2021-03-02 unresponsive to stimuli During administration of vaccine, pt. turned head away from vaccinator and did not answer any questi... Read more
During administration of vaccine, pt. turned head away from vaccinator and did not answer any questions would not respond to his name. A rapid response was called and pt. transported via ambulance to ER. Pt. had a history of seizures. "Not controlled with medications" per pt. Pt. discharged stable.
78 2021-03-04 weakness body weakness, nausea, diariah throwing-up.
78 2021-03-04 numbness, slurring Monday morning I found my father lying on couch trying to tell me he couldn?t walk. His speech was s... Read more
Monday morning I found my father lying on couch trying to tell me he couldn?t walk. His speech was slurred he fell and was unable to walk good his body was pulling to one side. His left arm was numb . I called ambulance he was taken to hospital diagnosed with a stroke. Now in rehab
78 2021-03-04 muscle spasms About just after one this morning my whole body began to convulse violently. I am sure it lasted... Read more
About just after one this morning my whole body began to convulse violently. I am sure it lasted for more than a minute or two. I woke up feeling very tired. I woke up feeling that I ma have had a heart attack.
78 2021-03-04 pain in extremity Pain in left/arm Shoulder , back , leg . Lasting one(1) day .
78 2021-03-05 weakness lethargic, like a big fog hit me, loss of energy, loss of balance heavy red ichy rash developed over... Read more
lethargic, like a big fog hit me, loss of energy, loss of balance heavy red ichy rash developed over arms, chest, waist, REALLY ITCHY Prescriptions taken: Levocetirizin E5 mg --1 tablet daily; Hydroxyzine HCL 25mg --two tablets at bedtime, 1 tab every 8 hours as needed
78 2021-03-07 weakness possible infection around hvalve; hemoglobin dropping rapidly; All over body aches; extreme all over... Read more
possible infection around hvalve; hemoglobin dropping rapidly; All over body aches; extreme all over weakness; Blood sugar over 400; This is a spontaneous report from a contactable consumer. A 78-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot number EL9261), via an unspecified route of administration on 02Feb2021 at 16:30 (at the age of 78-years-old) as a single dose in the right arm for COVID-19 vaccination. Medical history included esophagectomy on an unspecified date. The patient previously took morphine (UNKNOWN MANUFACTURER) and adhesive tape (UNKNOWN MANUFACTURER and experienced allergy. The patient's historical vaccinations included the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot number EL1284) on 05Jan2021 at 16:30. Concomitant medications included amlodipine (MANUFACTURER UNKNOWN), atorvastatin (MANUFACTURER UNKNOWN), clonidine (MANUFACTURER UNKNOWN), cyanocobalamin (VITAMIN B-12 MANUFACTURER UNKNOWN), clopidogrel (MANUFACTURER UNKNOWN), cyclobenzaprine (MANUFACTURER UNKNOWN), empagliflozin (JARDIANCE), magnesium oxide (MANUFACTURER UNKNOWN), metformin (MANUFACTURER UNKNOWN), methocarbamol (MANUFACTURER UNKNOWN), pantoprazole (MANUFACTURER UNKNOWN), "orevastatin" (MANUFACTURER UNKNOWN), terazosin (MANUFACTURER UNKNOWN), venlafaxine (MANUFACTURER UNKNOWN), hydrochlorothiazide (MANUFACTURER UNKNOWN), co-q10 (MANUFACTURER UNKNOWN), fish oil (MANUFACTURER UNKNOWN), iron (MANUFACTURER UNKNOWN), melatonin (MANUFACTURER UNKNOWN) multivitamin (MANUFACTURER UNKNOWN), turmeric curcumin (MANUFACTURER UNKNOWN), vitamin d-3, b-12-E (MANUFACTURER UNKNOWN), meloxicam (MANUFACTURER UNKNOWN), dicyclomine (MANUFACTURER UNKNOWN) all from unknown indications from unknown dates and unknown if ongoing. On 16Feb2021 at 09:00, the patient experienced all over body aches, extreme all over weakness, blood sugar over 400 and hemoglobin dropping rapidly. The patient was taken to the Emergency Room and was hospitalized. The patient received treatment for the events which included an infusion of iron for dropping hemoglobin and infusion antibiotic for possible infection around "hvalve." Lab data included a nasal swab SARS-COV 2 test on 16Feb2021 which was negative. The clinical outcomes of the events hemoglobin dropping rapidly, generalized aching, extreme weakness, blood sugar increased and possible infection were unknown. It was also reported that since the vaccination, the patient had been tested for COVID-19 (on 16Feb2021) and it was negative.
78 2021-03-07 seizure Pfizer-BioNTech COVID- 19 Vaccine EUA: Vaccine recipient?s wife reported that she notice he was sl... Read more
Pfizer-BioNTech COVID- 19 Vaccine EUA: Vaccine recipient?s wife reported that she notice he was slurring his speech and had some confusion prior to getting vaccinated. They contemplated seeking medical care but wanted to get the vaccinated first. After receiving the vaccine, the vaccine recipient was reported to have fell back in his chair and began seizing. EMS responded and treated the patient. They have no history of seizures. They were transported to emergency department at e Regional Medical Center. The patient was admitted to the intensive care unit for further work up and currently present.
78 2021-03-07 tremor Chills, shakes, aching joints - overnight
78 2021-03-08 weakness Exacerbation of myasthenia gravis that had been stable for 10 years. Increasing weakness and respira... Read more
Exacerbation of myasthenia gravis that had been stable for 10 years. Increasing weakness and respiratory difficulties within 72 hours of vaccination. Required intubation and mechanical ventilation which continues
78 2021-03-08 pain in extremity Flu-like symptoms beginning 12 hours after the 2nd dose. Joint aches, mild headache, low-grade fever... Read more
Flu-like symptoms beginning 12 hours after the 2nd dose. Joint aches, mild headache, low-grade fever lasting ~24 hours. Symptoms abated after 24 hours and gone by 48 hours after the administration of the 2nd dose or 36 hours after I became symptomatic. NO symptoms other than a slightly sore arm after the 1st dose.
78 2021-03-10 weakness Pfizer-BioNTech COVID-19 Vaccine EUA: patient presents to clinic reporting body aches, heaches, and ... Read more
Pfizer-BioNTech COVID-19 Vaccine EUA: patient presents to clinic reporting body aches, heaches, and chills since receiving vaccination five days prior. No shortness of breath, chest pain, vomiting, or diarrhea. Patient was not in distress or ill-appearing: normal breath sounds (no wheezing, rhonchi, or rales). Five days after clinic visit (ten days after vaccination) patient's wife and daughter reported patient had poor appetite and feeling worse since clinic visit: weakness, pain all over, decreased oral intake, and cough with phlegm. Advised to go to the emergency room immediately. Patient's daughter reported the next day patient admitted to another facility and COVID-19 test was positive.
78 2021-03-10 numbness and pain in extremities Severe hypoglycemia with blurred vision and neuropathy in legs roughly couple hours after receiving ... Read more
Severe hypoglycemia with blurred vision and neuropathy in legs roughly couple hours after receiving vaccine
78 2021-03-14 weakness Collapsed in house; Chills; Total Weakness; Memory problems; Racing heart beat; This is a spontaneou... Read more
Collapsed in house; Chills; Total Weakness; Memory problems; Racing heart beat; This is a spontaneous report from a contactable consumer. A 78-year-old male consumer reported that he received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number unknown), into the left arm on 23Feb2021 at 01:00 PM at single dose for COVID-19 immunization. The patient had Covid prior vaccination. No other medical history. Concomitant drugs were unknown. On 23Feb2021 at 04:00 PM the patient experienced chills, total weakness, memory problems, collapsed in house and racing heart beat. The patient was hospitalized, he was in hospital 4th day now. Cannot get out of bed or walk. the patient was treated with Physical Therapy. The outcome of the events was not recovered. Information on the lot/batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021223394 similar report from same reporter
78 2021-03-14 feeling cold Chilling, cold... nausea, diarrhea
78 2021-03-15 tremor fell, hit head, confusion, memory loss, balance disorder, tremors and shaking, vomiting, headache, h... Read more
fell, hit head, confusion, memory loss, balance disorder, tremors and shaking, vomiting, headache, high blood pressure, TIA, CVA, aneurysm
78 2021-03-16 nerve pain, pain in extremity Arm pain described as sharp/nerve related worst around day 4 after vaccination. somewhat improved a... Read more
Arm pain described as sharp/nerve related worst around day 4 after vaccination. somewhat improved after 3 weeks. Reduced range of motion. Reported to pcp, pcp thinks vaccine was placed improperly
78 2021-03-19 weakness Patient is a 78-year-old male with history of COPD, paroxysmal atrial fibrillation, ischemic cardiom... Read more
Patient is a 78-year-old male with history of COPD, paroxysmal atrial fibrillation, ischemic cardiomyopathy, type 2 diabetes mellitus, status post mitral valve replacement with metallic valve on Coumadin, stage II: CAD status post LAR. Presented to Hospital campus on account of severe shortness of breath in a patient with significant weakness. Patient has had significant shortness of breath progressively worsening. Patient was just discharged from this facility on 03/17/2021. The patient was admitted on 03/05/201 on account of shortness of breath. During the admission, patient had a multiloculated right-sided pleural effusion requiring video-assisted thoracoscopy and evacuation of hemothorax. Associated with chest wall mass. Subsequent biopsy revealed evidence of small cell carcinoma. The patient was seen by oncology during that admission with a Mediport put in place. With plans to follow-up with oncology outpatient for continued management and to hopefully initiate chemotherapy. There was also concern for acute congestive heart failure and required diuresis. Echocardiogram was showing EF of 40% at the time. Now, patient is presented to the emergency room on account of significant weakness in the patient well developed worsening shortness of breath over the last couple of days. Patient was still short of breath and weak he could not even get up the toilet seat. When EMS saw the patient he was satting 80% on room air and required 6 L via nasal cannula. Did not complain of any chest pain or cough with this finding. Neither did he complain of any fever. In the emergency room, patient was tachypneic and slightly tachycardic. Lab work shows lactic acid of 2.3 glucose of 302 and creatinine of 1.90. The patient's BNP was 1170 with GFR of 34. Patient INR was 4.5. Chest x-ray shows Trace right pleural effusion. No pneumothorax. With concern for pneumonia patient was given azithromycin and Unasyn. Also with concern for possible CHF patient was given Bumex.
78 2021-03-20 weakness, cold sweat Shortness of breath/out of breath; Breathing very heavily as if I had been running; Nausea; My body ... Read more
Shortness of breath/out of breath; Breathing very heavily as if I had been running; Nausea; My body was clammy all over; Blood pressure was 178/106; Tightness in my chest; Kept taking deep breaths, with an overall feeling of weakness; Feel unwell with cold like symptoms, including chills; Feel unwell with cold like symptoms, including chills; feel unwell with cold like symptoms, including chills; This is a spontaneous report from a contactable consumer or other non hcp. A 78-years-old male 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 22Jan2021 (Batch/Lot Number: EL3302) at single dose for covid-19 immunisation. Medical history included Heart stent placed in 2016, high blood pressure, enlarged prostate. Concomitant medication included rivaroxaban (XARELTO); metoprolol; losartan; aspirin [acetylsalicylic acid]. The patient previously took finasteride, dutasteride and experienced Known allergies. It was reported that on 24Jan2021 00:15/12:15 AM patient had shortness of breath within 30 minutes of receiving the injection, and was breathing very heavily as if I had been running. By the time I got to the car, I was totally out of breath. Any slight exertion over the next week would bring this on. The day after the injection on the morning of 24Jan2021 I awakened with nausea, my body was clammy all over, Blood pressure was 178/106, tightness in my chest, and kept taking deep breaths, with an overall feeling of weakness. Went to the ER ,and was checked out and released after all tests were neg. for a heart problem. I continued to feel unwell with cold like symptoms, including chills. Adverse event treatment was emergency room protocol for a suspected heart attack, Patient did not had covid prior vaccination, Patient did not tested covid post vaccination. Outcome of the all events was recovering.
78 2021-03-21 weakness H & P states m, 2 weeks after second vaccine, developed myalgias, arthralgias, swelling and generali... Read more
H & P states m, 2 weeks after second vaccine, developed myalgias, arthralgias, swelling and generalized weakness, seen in clinic and started on oral corticosteriods, 9/19 to ER and admitted , given IV,,,,,,,, fluids, steriods. co of increased joint pain, and swelling of upper extremities
78 2021-03-24 weakness, electric shock sensation He received his vaccine, and immediately he could taste it in his mouth. About 5-6 days later his n... Read more
He received his vaccine, and immediately he could taste it in his mouth. About 5-6 days later his normal routine was to work outside and noticed that he had lost his energy issue, and had this issue in the past when his pacemaker was out of wack. As the month went on it got worse and worse. In March he was out cleaning up the yard and as he worked it got worse and worse. He would have to work for 5 and sit down for a minute. He has hyperventilation syndrome and diagnosed back in 1980 and has been under control, this is one thing that always happens, which seems to be an ongoing problem that he's having. His settings on his pacemaker seem to be OK. He was sitting on his couch and watching a race on 3/8/21 and got a shock coming up from the bottom part of his head, through his chest and out through his right eye, this was less than 2 seconds. This was an event, but not a hard "mule" kick event. He wasn't doing anything to get the shock. The defibrillator is connected to the bottom part of his heart. He has a logic system and had an episode of 190-200 BPM which was at the top part of his heart. He had all of his equipment checked out yesterday, but they could not give him an answer why he got a shock. He now has to set up an appointment with his cardiologist to see tomorrow. He has had the pacemaker for 6-7 years now and the device goes into the device clinic and he gets reports regarding this information. They device people said there was no registration that he had any event.
78 2021-03-25 bell's palsy, facial paralysis Pt presented to ED on 3/9 with R eye pain and blurred vision, plus R-sided facial dropping which st... Read more
Pt presented to ED on 3/9 with R eye pain and blurred vision, plus R-sided facial dropping which started that morning. Physical exam positive for facial asymmetry. Per ED provider note: "Pt now with clear R-sided 7th nerve palsy compared to arrival when lower portion was more pronounced.... Labs largely unremarkable.... Overall, exam at this point most consistent with Bell's palsy. Will start on prednisone, acyclovir, eye patch, and artificial tears."
78 2021-03-25 pain in extremity 20 hours after Pfizer immunization C/O left hand pain with dime size hard lump located on palm of ha... Read more
20 hours after Pfizer immunization C/O left hand pain with dime size hard lump located on palm of hand.
78 2021-03-27 pain in extremity 3 days after second Pfizer shot right foot swelled up with pain. Two days later pain shot up right l... Read more
3 days after second Pfizer shot right foot swelled up with pain. Two days later pain shot up right leg and to hip. Intense pain for about 5 days similar to when I had back surgery about 27 years ago. Since then leg and hip pain subsided but my right foot still feels swollen and painful at night and in the morning. Gets better temporarily walking on it during day but feel like there is a stiff pad below the skin on my foot . Had a similar reaction with second pneumonia shot in October where I got spasms in lower back and then right leg started to collapse but only lasted then for about 5 minutes with no long term effects/
78 2021-03-29 weakness myalgias, chills, weakness, nausea. He cannot vomit secondary to history of Nissen fundoplication. ... Read more
myalgias, chills, weakness, nausea. He cannot vomit secondary to history of Nissen fundoplication. In the middle of the night on 3/28 he got up to go to the bathroom and was too weak to get off the toilet - to the point where he had to lower himself to the ground, so EMS was notified and reportedly found him with a fever of 104 Fahrenheit. Hospitalization x2 days. Discharge home.
78 2021-03-30 weakness fast heartbeat; dizziness; weakness; slow thinking; very tired; This is a spontaneous report from a ... Read more
fast heartbeat; dizziness; weakness; slow thinking; very tired; This is a spontaneous report from a contactable consumer, the patient. A 78-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL9265), via an unspecified route of administration in the left arm on 08Feb2021 (at the age of 78-year-old) as single dose for COVID-19 immunization. Medical history included cardiac pacemaker insertion because of chronotropic incompetence. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Concomitant medications included vitamins and zolpidem tartrate (AMBIEN), both were taken for an unspecified indication, start and stop date were not reported. The patient previously took the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL3249) via an unspecified route of administration in the left arm on 18Jan2021 14:00 as a single dose for COVID-19 immunization and experienced sweating, chills and tired. On an unspecified date in Feb2021 after receiving the second dose, the patient experienced fast heartbeat, dizziness, weakness, very tired and slow thinking. No treatment was received for the adverse events. The clinical outcome of the fast heartbeat, dizziness, weakness, very tired and slow thinking was unknown.
78 2021-03-30 paralysis I couldn't move for about 4 hours, I was slight paralyzed laying on the floor; IV (intravenous) by n... Read more
I couldn't move for about 4 hours, I was slight paralyzed laying on the floor; IV (intravenous) by needle; This is a spontaneous report from a contactable consumer (patient). A 78-year-old male patient received bnt162b2 (BNT162B2), dose 2 intravenous (at the age of 78-years-old), administered in Deltoid Left (reported as left shoulder) on 15Mar2021 (Batch/Lot number was not reported) as single dose for COVID-19 immunization. Medical history included none. The patient's concomitant medications were not reported. The patient previously received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration (at the age of 78-years-old), administered on 22Feb2021 (Batch/Lot number was not reported) as single dose for COVID-19 immunization. The patient stated, "I received my second Pfizer shot (captured as Unspecified medication) on Monday (15Mar2021) and on Monday night (15Mar2021) I woke up on the floor and I couldn't move for about 4 hours, now finally got back into the bed by 5 o'clock in the morning and I was slight paralyzed laying on the floor and I felt it. You may did know about this because it is probably related to the vaccine. They have improved drastically (events), after yesterday I tried to get some sleep because I laid on the floor for 4 hours, but today I feel alright." The route of administration was "IV (intravenous) by needle." No treatment received for the events. The outcome of the events "I couldn't move for about 4 hours, I was slight paralyzed laying on the floor" was recovered on an unspecified date. The event Paralyzed was considered as serious (medically significant). Information about Batch/Lot number has been requested.
78 2021-03-30 unresponsive to stimuli CAT scan showing lymphoma all over in his body; The doctors are going back-and-forth between diagnos... Read more
CAT scan showing lymphoma all over in his body; The doctors are going back-and-forth between diagnosing him with lymphoma and leukemia; doctors are going back-and-forth between diagnosing him with lymphoma and leukemia and a bad infection; now he's basically unresponsive; This is a spontaneous report from a contactable consumer reported for patient (father). A 78-years-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 11Mar2021 at single dose for COVID-19 immunisation. The patient medical history was not reported. There was no known allergies. Concomitant medications included blood pressure meds and pain meds. He previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 12Feb2021 (at age of 77 years old) in the left arm for COVID-19 immunisation and got big lumps on his neck and began to feel ill. Four or five days after the first dose the patient got big lumps on his neck and began to feel ill he went to the doctor and they weren't too worried about it, he went back and got his second one in within three days (Mar2021) he was hospitalized after a CAT scan showing lymphoma all over in his body now he's basically unresponsive. The doctors are going back-and-forth between diagnosing him with lymphoma and leukemia and a bad infection and can't figure out what is wrong with him he was perfectly fine before the vaccine. AE resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care, hospitalization, life threatening illness (immediate risk of death from the event). The patient hospitalized for 5 days, no treatment received. COVID test received via nasal swab post vaccination (Mar2021): unknown result. Events outcome was unknown. Information on the lot/batch number has been requested.
78 2021-04-01 tingling Tingling left finger tips
78 2021-04-06 weakness Collapse of lung; Diarrhea; very weak; lost his appetite; This is a spontaneous report from a contac... Read more
Collapse of lung; Diarrhea; very weak; lost his appetite; This is a spontaneous report from a contactable consumer. A 78-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 2 intramuscular, administered on right arm on 03Mar2021 (Batch/Lot Number: EL9261) at single dose (at the age of 78 years old) for COVID-19 immunisation. The patient medical history included had vascular problems in his legs, and his legs were very clogged. The doctors couldn't do anything and tried to do a catheterization. Thyroid was not okay, and now his doctor increased his thyroid medication. The reporter blamed the hospital for doing something wrong when her husband was there the last time. She said the hospital made a mistake and gave her husband the wrong medication. She said the first time her husband was at the hospital, the hospital didn't give her husband his thyroid medicine. She said the second time, the hospital gave her husband the wrong dose of medication. Concomitant medications were not reported. The patient previously took BNT162B2 (lot number: EN9581) dose 1 on 10Feb2021 for COVID-19 immunisation. The patient previously took flu vaccines in Sep2020. On Mar2021, the reporter's husband was okay at first. She said now her husband had diarrhea and pooped in his clothes. She said her husband was very weak and lost his appetite. She clarified her husband's symptoms started probably 2 weeks ago, and her husband was worse, and like a different person now. She said her husband used to eat at the table, and now he just sits in his chair, and after 5:00PM he wants to go to bed. She said she was not sure if her husband's symptoms were related to the COVID-19 Vaccine. She said her husband was supposed to have heart bypass surgery on Monday (22Mar2021), and his surgeon called on Saturday night (20Mar2021) and called off her husband's surgery. She said the surgeon said her husband had a collapsed lung. She said her husband had a chest x-ray in late Feb2021 and his lungs were clear. She said everything that happened to her husband, happened after he had his second dose of the COVID-19 Vaccine. She said she was not sure if her husband's collapsed lung (19Mar2021) was related to his second COVID-19 Vaccine. She said before getting the COVID-19 Vaccine, her husband did not have a problem with his lungs. She said her husband's surgeon can't figure out why her husband's lung collapsed. She said she can't prove his collapsed lung was a side effect of the COVID-19 Vaccine, but her husband never had sick lungs in his life. She said she knows her husband doesn't have the COVID-19 Virus because he had to be tested on Saturday (20Mar2021) for the COVID-19 Virus before he could have his surgery on Monday (22Mar2021). She said her husband's COVID-19 Virus test was negative Saturday, but he has all these problems. The patient's wife was afraid to give her husband Pepto Bismol, so she didn't give her husband anything. She said her husband has an appointment on Thursday (25Mar2021) with his primary care doctor to talk about his symptoms. The outcome of collapsed lung was unknown and other events were not recovered.
78 2021-04-06 weakness Dizziness, imbalance, sleepiness, weakness unable to get up from a chair, fatigue, diarrhea
78 2021-04-08 speech disorder Confusion, drooling, unable to walk, muttering, swelling of hands & legs
78 2021-04-09 numbness eye blurriness; gate affected; auto immune system deterioration; practitioner shook bottle and Injec... Read more
eye blurriness; gate affected; auto immune system deterioration; practitioner shook bottle and Injected discolored (brown) vaccine right arm (# 2 injection March 22, 2021 - 2pm); practitioner shook bottle and Injected discolored (brown) vaccine right arm (# 2 injection March 22, 2021 - 2pm); practitioner shook bottle and Injected discolored (brown) vaccine right arm (# 2 injection March 22, 2021 - 2pm); heart/organ issues; heart/organ issues; brain fog; joint and muscle stiffness/joint stiffness; joint and muscle stiffness; blood; limb numbness/toe numbness; neurological deficit; soreness injection site; mild right temporal headache; This is a spontaneous report from a contactable consumer (patient). A 78-year-old male patient received second dose of bnt162b2 (BNT162B2, formulation: solution for injection)Batch/Lot # EP7534, via an unspecified route of administration in the right arm on 22Mar2021 14:00 (at the age of 78-years-old) as SINGLE DOSE for COVID-19 immunization. Medical history included heart dysfunction, heart surgery, kidney function abnormal and neural dysfunction. Concomitant medication included silodosin (RAPAFLO) at 8 mg daily. The patient previously took bnt162b2 (administration date=03/03/2021, administration time=02:15 PM, vaccine location=Left arm, dose number=1). On 23Mar2021 05:45, the patient experienced auto immune system deterioration, practitioner shook bottle and injected discolored (brown) vaccine right arm (# 2 injection march 22, 2021 - 2pm), heart/organ issues (cardiac disorder), brain fog, joint and muscle stiffness/joint stiffness, joint and muscle stiffness, limb numbness/toe numbness, neurological deficit, soreness injection site, mild right temporal headache. On 24Mar2021, the patient experienced eye blurriness, gate affected. Practitioner shook bottle and Injected discolored (brown) vaccine right arm (# 2 injection 22Mar2021 - 2pm). The patient was concerned about current and future adverse effects as it relates to auto immune system deterioration, heart/organ issues, brain fog, joint and muscle stiffness, blood, limb numbness, neurological deficit and whether such existing health issues have been exacerbated by vaccine injection : currently soreness injection site, mild right temporal headache, toe numbness, joint stiffness, 24Mar early morning eye blurriness, gate affected. The patient did not receive any treatment for the events. The outcome of the events was unknown. Follow-up (25Mar2021) and (31Mar2021): This is a follow-up spontaneous report from a contactable consumer. New information included: Lot/Batch number of the second dose, medical history updates.
78 2021-04-13 trigeminal neuralgia, facial pain about a week after shot developed severe facial pain, felt to have trigeminal neuralgia got temporal... Read more
about a week after shot developed severe facial pain, felt to have trigeminal neuralgia got temporal artery biopsy negative develop FUO hospitalized 4/8 to present
78 2021-04-14 inability to speak He began showing dementia like behaviors within 24 hours of receiving 2nd Pfizer vaccine. To be clea... Read more
He began showing dementia like behaviors within 24 hours of receiving 2nd Pfizer vaccine. To be clear, not referring to forgetfullness, referring to full on, can't remember names children or grandchildren, up to and including 'word salad' related symptoms. On a 04/07/2021 follow up he was given 'SLUMS' test and scored 24 of 30, yet struggled to recall appropriate words in the appropriate context. Ex. degrees for years of age, check for the word 'injection', coinciding with circular coversations, where the same topic is repeated numerous times in a conversation, without recollection...
78 2021-04-15 pain in extremity Received his vaccine, he had soreness in the arm, but nothing else. On 3/3/21 he went to hospital ... Read more
Received his vaccine, he had soreness in the arm, but nothing else. On 3/3/21 he went to hospital ER with diagnosis of kidney stones, had a morphine injection, Flomax and a prescription for Oxycontin and Flomax. At that time he was experiencing also in his right eye swelling and it was reddish, and there was an itching around the eye, and there was a couple blotches on top of his head and his cheek, but did not mention it as he was there for kidney stones. On 3/9/2021 he saw a Urologist, Dr. and that morning he passed a kidney stone. The urologist took an x-ray and did not see any more. The eye then became an issue on 3/9/21 and he made an appointment to see the eye Dr., Dr. at Eye institute on 3/11/21 @ 9:00 AM. The doctor diagnosed shingles on the face and right eye, and she put him on 2 medications (Durezol ophthalmic drops). He is still on that medication still 4/16/21. The other medication that they prescribed for him was Valacyclovir which he took 3 times a day, they reduced it from 1000 mg to 500 mg twice a day. The swelling of the eye itself has gone down a little bit. He is still seeing the eye doctor, and has a FU on 5/5/21 as it is getting better but still has symptoms. He did get a single dose Shingrix shot a couple of years ago.
78 2021-04-17 facial paralysis, bell's palsy Pt is GCS 15 and A&Ox4. Skin is P/W/D to pt ethnicity. Neuro intact and PERRLA. Respirations are reg... Read more
Pt is GCS 15 and A&Ox4. Skin is P/W/D to pt ethnicity. Neuro intact and PERRLA. Respirations are regular/equal and non-labored. pt states he's had left sided facial droop for 2 days and a sore throat for 5 days. pt denies any other symptoms at this time. pt appears to have bells palsy. Dr. was contacted and she ruled out a stroke. Symptoms started 1 week after the completion of vaccine.
78 2021-04-24 pain in extremity pain in left arm (Vax site) migrated down to elbow & forearm; pain in left arm (Vax site) migrated d... Read more
pain in left arm (Vax site) migrated down to elbow & forearm; pain in left arm (Vax site) migrated down to elbow & forearm; pain in left arm (Vax site) migrated down to elbow & forearm; This is a spontaneous report from a contactable physician. A 78-years-old male patient received bnt162b2 (BNT162B2), dose 1 intramuscular, administered in Arm Left on 26Mar2021 14:00 (Batch/Lot Number: EN6198) as SINGLE DOSE for covid-19 immunisation. Medical history included osteoarthritis. Prior to vaccination, the patient was not diagnosed with COVID-19. No known allergies. Concomitant medication included levothyroxine sodium (SYNTHROID) and finasteride (PROSCAR). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced pain in left arm (Vax site) migrated down to elbow & forearm on 27Mar2021 with outcome of recovered. The patient received treatment: ibuprofen. The event was reported as non-serious. Since the vaccination, the patient has not been tested for COVID-19. No follow-up attempts are needed. No further information is expected.
78 2021-04-25 facial paralysis from office visit 4-19-21: Chief Complaint Patient presents with ? Facial Droop started yesterda... Read more
from office visit 4-19-21: Chief Complaint Patient presents with ? Facial Droop started yesterday. ? Neck Pain right side. Yesterday noticed a facial droop without any arm weakness or change in gait. No headaches. Using some artificial tears but eye is getting more red and matting of eyelashes. Having more right rhinorrhea, but that's been a chronic issues. Feels like hearing is off in his right ear. More neck soreness on the right.
78 2021-04-26 weakness Systemic: Body Aches Generalized-Medium, Systemic: Exhaustion / Lethargy-Medium, Systemic: Headache-... Read more
Systemic: Body Aches Generalized-Medium, Systemic: Exhaustion / Lethargy-Medium, Systemic: Headache-Medium, Systemic: Joint Pain-Medium, Systemic: Weakness-Medium, Additional Details: S/P PROSTATE CANCER, TAKES LUPON INJECTION EVERY 6 MONTHS AND IS NOT SURE IF THIS DATA HAS SOMETHING TO DO WITH HIS PROLONGED SYMPTOMS, NEXT DOSE OF LUPON DUE IN A COUPLE OF WEEKS FROM TODAY.
78 2021-04-27 sciatica, pain in extremity severe pain in back and right side thigh, knee and leg; severe pain in back and right side thigh, kn... Read more
severe pain in back and right side thigh, knee and leg; severe pain in back and right side thigh, knee and leg; severe pain in back and right side thigh, knee and leg; rheumatism; sciatica; This is a spontaneous report from a contactable consumer (patient). A 78-years-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EK5730), via an unspecified route of administration, administered in arm left on 05Jan2021 03:30 as SINGLE DOSE for covid-19 immunization. Medical history included hypertension. Concomitant medications included sotalol (SOTALOL), Olmesartan (OLMESARTAN), Amlodipine (AMLODIPINE), tamsulosin (TAMSULOSIN). On 06Jan2021 at 09:00 the patient experienced severe pain in back and right-side thigh, knee and leg, rheumatism, sciatica. Pain started within one day of shot and has not stopped. I have never experienced this before now. The outcome of event was not recovered.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021107296 same reporter/ drug/ AE, different patient
78 2021-04-28 weakness weakness, dizziness, NSTEMI heparin given
78 2021-05-01 numbness Bilateral leg weakness, bilateral hand numbness
78 2021-05-03 weakness Patient admitted to Hospital on 4/16/2021 with 2 weeks of generalized weakness, chills, poor oral in... Read more
Patient admitted to Hospital on 4/16/2021 with 2 weeks of generalized weakness, chills, poor oral intake and nonproductive cough. Chest x-ray shows consolidation. Patient tested for covid-19 which returned positive on 4/18/21. Patient remained hospitalized and started on steroids and vitamin c/e after covid testing returned positive. Patient respiratory status worsened requiring high flow nasal cannula and BiPAP as needed. Patient did not want to be intubated and decided to go to comfort care. Patient passed away on 5/3/21 in the hospital.
78 2021-05-03 tingling 12 days after 2nd shot, he developed gait ataxia, hand paresthesiae, upward gaze palsy and areflexia
78 2021-05-04 numbness, impaired body coordination, tingling, tremor Progressive lower extremity weakness with markedly diminished reflex: Per the history it appears tha... Read more
Progressive lower extremity weakness with markedly diminished reflex: Per the history it appears that patient has had a progressive course of this problem over the last 1 week. His symptomatology is mostly consistent with gait ataxia with some lower extremity weakness. He mentions that his weakness of the lower extremities became more and more pronounced towards the end of the week when he would start trembling in his legs whenever standing for some time. Although he had some numbness and tingling few days ago but that does not seem to be the predominant symptoms. There was no preceding symptoms of any viremia prior to this. Although he has Covid in January, however he did not have cough expectorations upper respiratory infection or any diarrhea in the last 1 month. He has not been exposed to any new pets or any new medications. His clinical exam suggest a lower extremity weakness more proximal than distal although there appears to be some sensory sparing. He has diminished reflexes all over including absent reflexes in his lower extremities and many of the upper extremities. His imaging study did not show any specific etiology for the cause of his problem. He does not have any spinal etiology and his exam does not show any upper motor type of involvement. His spinal fluid shows a high protein with no cells consistent with cytoalbuminogenic dissociation. So he definitely fits with the diagnosis of acute immune mediated demyelinating polyneuropathy or Guillain-Barré syndrome. On IVIG therapy. Overall appears to be some improved however not still able to walk.
78 2021-05-04 unresponsive to stimuli Patient had second dose of Pfizer vaccine in morning. That afternoon began complaining of abdominal ... Read more
Patient had second dose of Pfizer vaccine in morning. That afternoon began complaining of abdominal pain with subsequent vomiting (x2) and possible diarrhea. Patient could not sleep that evening . Awoke next morning with continued abdominal pain throughout the day and ultimately was found unresponsive in bed. Transported to hospital where he was pronounced dead. Subsequently autopsy was performed which revealed significant pre-existing hypertensive and atherosclerotic cardiovascular disease with evidence of acute myocardial infarction. There is no clear evidence that this is related to the vaccination, however it is being reported due to potential public health interest and temporal proximity to vaccination.
78 2021-05-05 weakness, pain in extremity Arm was sore. I started taking Advil the evening of 5-4-21. The next morning, I woke up with chills ... Read more
Arm was sore. I started taking Advil the evening of 5-4-21. The next morning, I woke up with chills and weakness. I was unable to lift arm to shoulder without discomfort. I took more Advil. I had a 101.5 fever. I actually felt worse than I did when I had COVID back on 12-10-20. I spent the next 4 hours in bed. I got up at 11:00 am and went to the couch to lie down for most of the day. I started feeling slightly better around 5:00 pm. I had dinner and laid around. I went to bed at 10:00 pm. Everything lasted a period of 23 hours. I'm feeling back normal today.
78 2021-05-05 muscle spasms muscle weakness and cramping and overall fatigue and chest pains still continuing after a month and ... Read more
muscle weakness and cramping and overall fatigue and chest pains still continuing after a month and a half
78 2021-05-06 numbness, tingling A little over a week ago I was admitted to a local hospital having been diagnosed with Guillain?Barr... Read more
A little over a week ago I was admitted to a local hospital having been diagnosed with Guillain?Barré syndrome, a debilitating condition where the body?s auto immune system attacks the nervous system resulting in peripheral numbness in one?s hands, feet and legs. This condition was diagnosed by a neurologist. Following his diagnosis, I spent 8 days in the Hospital and was treated for 5 days with a daily dose of 400ml of immune globulin (IVIG) to rebuild the damage to my nervous system. On April 10, I began to feel the onset of Guillain Barré syndrome as the bottoms of my feet suddenly began to tingle and feel numb. The next day I tripped while returning our waste management garbage cans to our garage. Fell face forward onto the driveway and was bruised pretty bad. The next day my BP zoomed to 224/160. 911 was called and I was taken to our local hospital fearing and thinking that I was having a heart attack. I spent 4 days in the hospital being checked for a possible heart attack and all the while my Guillain Barré syndrome was progressing undiagnosed. I was discharged and instructed to see a neurologist for the tingling and numbness in my hands, legs and feet. Within 15 minutes of the neurologist consult, a few days following my discharge, I was told I had Guillain Barré syndrome and get to a hospital. I left his office and went straight to the emergency room and I spent the next 8 days there and was discharged Tuesday, 4 May 2021. Several hospital neurologists treating me believed the vaccination triggered the syndrome as do I. It's not being widely reported even though there have been several Facebook postings of people saying the same thing as me.
78 2021-05-06 speech disorder, weakness dizzy, weakness, blurry vision, abnormal speech; non-STEMI
78 2021-05-10 tenderness, speech disorder, weakness On March 2, he woke up feeling bad and had a fever of 102.7. He took tylenol and liquids all day and... Read more
On March 2, he woke up feeling bad and had a fever of 102.7. He took tylenol and liquids all day and the fever came down to around 100. The next morning he woke up complaining of excruciating pain in his left arm (site of the injection). He couldn't stand to have anything touch it, couldn't move it and couldn't sleep because of the pain. The next morning he woke up very weak, wasn't able to speak clearly, wasn't making sense. He had a telemedicine appointment scheduled that morning for another matter. The doctor took one look at him and said we should have him evaluated asap. I took him to the emergency room at Hospital. They did some tests and said he was septic and immediately put him into the ICU. He was started on IV antibiotics while the blood cultures were growing out. It was determined that the bacteria was Strep G but they were unable to identify the source. He was put on a ventilator and an echo cardiogram was done. It was believed that the source of the infection was his pacemaker and I was told the pacemaker would have to be removed. They couldn't do it at that hospital. He was transferred to another hospital. The doctors at that hospital determined the pacemaker was not the source. It was believed by some doctors that the source of infection was the injection site. The infection was cleared from his body and the ventilator was removed after 2 weeks. He lived another 2 weeks but never was able to recover. Until the day he was put on paliative care, he expressed pain in the arm where he had received the vaccination. He died at 5:30 a.m. on April 1, 2021.
78 2021-05-12 weakness 3/3/2021 Chief Complaint Patient presents with ? Covid-19 Screening diarrhea, weakness, fatigue... Read more
3/3/2021 Chief Complaint Patient presents with ? Covid-19 Screening diarrhea, weakness, fatigue. wife is positive. Clinical Support 3/5/2021 COVID-19 virus infection Dx Medication Infusion Reason for Visit Encounter Date: 3/5/2021 ? ? Signed Arrived to the ambulatory infusion site alone via car. Reports intermittent diarrhea, dry nonproductive cough, fatigue.
78 2021-05-12 mild one side paralysis, facial paralysis, slurring Pontine stroke causing dysarthria, right facial droop, right arm weakness, and unsteady gait.
78 2021-05-16 pain in extremity, seizure first shoulder and arm pain later in day post vaccine, subsequent neck pain on the left and eventual... Read more
first shoulder and arm pain later in day post vaccine, subsequent neck pain on the left and eventually right neck pain. Admitted with neck pain. MRI cervical 4/18 with: Zones of anterior epidural thickening and enhancement causing ventral flattening of the thecal sac without cord compression or superimposed epidural fluid collection from the C4-5 through the C6-7 disc space levels. Additional zone of edema and enhancement within the prevertebral soft tissues along the anterior margin of the left longus coli musculature from the C2-C5 levels again without superimposed fluid collection. Given history of fever and neck pain is findings could be consistent with epidural cellulitis as well as prevertebral cellulitis. No evidence for superimposed abscess. Recommend correlation to CRP level in white blood cell count with differential. No evidence for displaced fluid or disc space enhancement to suggest concomitant discitis.
78 2021-05-19 pain in extremity difficulty breathing; pneumonia; human immunodeficiency virus; pain in arm, neck and back; pain in a... Read more
difficulty breathing; pneumonia; human immunodeficiency virus; pain in arm, neck and back; pain in arm, neck and back; pain in arm, neck and back; FACILITATED COLLECT This is a solicited report based on the information received by Pfizer from AbbVie Inc. (MFR Control No. # 21K-163-3841481-00). A non-contactable consumer (patient) reported for himself that a 78-year-old male patient received bnt162b2 (Pfizer, Batch/Lot number was not reported), intramuscular on 12Mar2021 as single dose for covid-19 immunization; adalimumab (HUMIRA, Batch/Lot number was not reported, Solution for injection in pre-filled pen), subcutaneous from an unspecified date to an unspecified date, at unknown dose for moderate to severe chronic plaque psoriasis, psoriatic arthritis. The patient's medical history and concomitant medications were not reported. The patient experienced difficulty breathing on an unspecified date, pneumonia in Mar2021, pain in arm, neck and back in Mar2021, human immunodeficiency virus on an unspecified date. The events difficulty breathing and pneumonia were reported as serious per hospitalization, event human immunodeficiency virus was serious per medically significant. The patient took covid-19 vaccine and afterwards had pain in arm, neck and back and could not breathe. He went to emergency room and was hospitalized due to difficulty breathing and was diagnosed with pneumonia. He did not know if this was due to vaccine and would not be taking second vaccine shot per his primary physician. He also had human immunodeficiency virus. It was unknown if patient was enrolled in a COVID-19 vaccine trial. On 12Mar2021, patient received first dose COVID-19 vaccine manufactured by Pfizer. The action taken in response to the events for adalimumab was unknown. The outcome of events for difficulty breathing was unknown, for other events was resolving. The reporter's causality for the event(s) of Pneumonia, Pain in arm, Human Immunodeficiency virus, Pain in Back and Pain in neck with adalimumab was no reasonable possibility. Causality for all events with COVID-19 vaccine was not reported. The reporter's assessment of the causal relationship of all 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. Information on batch/lot number has been requested.; Sender's Comments: Based on known disease pathophysiology, the reported event of Human Immunodeficiency virus , pneumonia and dyspnea is assessed as not related to suspected product bnt162b2 vaccine and the events pneumonia and dyspnea are more likely due to underlying medical condition of chronic plaque psoriasis. However the reported events of Pain in extremities ,Pain in Back and Pain in neck is assessed as related due to close temporal association with the suspect product. However, more information is required on date of HIV infection deducted to properly assess the case. The case will be reevaluated should additional information become available. The impact of this report on the benefit-risk profile of the Pfizer product and on the conduct of the study 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 2021-05-23 numbness, tingling Stroke, Hemmoragic Numbness, tingling on left side Went to emergency room at the Hospital Forwarde... Read more
Stroke, Hemmoragic Numbness, tingling on left side Went to emergency room at the Hospital Forwarded by ambulance to different Hospital Placed in Nuerology Intensive Care Unit (ICU) at hospital Released from ICU to Nuerology ward Released from Nuerology ward to Rehab Unit Released from Rehab to home for outpatient rehab
78 2021-05-24 weakness Light headedness/ Dizzy; Equilibrium was way off/ he was wobbly; Nauseous; Mild case of vertigo; he ... Read more
Light headedness/ Dizzy; Equilibrium was way off/ he was wobbly; Nauseous; Mild case of vertigo; he ached; felt terrible/ yucky feeling; Stayed down all the day/ he was wobbly; This is a spontaneous report from a contactable consumer (patient). A 78-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left on 13Jan2021 17:20 (Batch/Lot Number: EL3249) as single dose for COVID-19 immunisation. Medical history included tinnitus, Blood pressure, Gout, Cholesterol, Acid Reflux. Concomitant medication(s) included lisinopril (LISINOPRIL) taken for blood pressure abnormal from an unspecified start date and ongoing; aspirin [acetylsalicylic acid] (ASPIRIN) taken for an unspecified indication from an unspecified start date and ongoing; atorvastatin (ATORVASTATIN) taken for blood cholesterol abnormal from an unspecified start date and ongoing; allopurinol (ALLOPURINOL) taken for gout from an unspecified start date and ongoing; omeprazole (OMEPRAZOLE) taken for gastrooesophageal reflux disease from an unspecified start date and ongoing. No prior vaccinations within 4 weeks. No history of previous immunizations with the Pfizer vaccine considered as suspect, this was the first dose. No additional vaccine administered on same date of the Pfizer suspect. On 13Jan2021, the patient received the vaccine. He clarified the reaction as, on Saturday 23Jan2021 all of a sudden it was quick he got real light headed, dizzy, he felt like his equilibrium was way off. He felt like he had a mild case of vertigo. He was wobbly, he ached, and felt terrible. It was a yucky feeling. He also felt nauseous, and it went away soon as he ate. He had never had a feeling like that before. He stayed down all day. He noticed all these events that occurred on Saturday 23Jan2021 started late morning around 10-11 in the morning. By the afternoon he was on his back for the rest of the day. It knocked him for a loop. Sunday 24Jan2021 he woke up and felt a little better. He still had some of the symptoms, but they were milder and kept getting milder through out the day. By Sunday afternoon they were almost gone and by Monday 25Jan2021 he felt normal and great. Tuesday 26Jan2021 these same feelings hit him again, but not the same way and was not as bad. Then 27Jan2021, they were gone and he felt fine. He went to the doctor's office yesterday (27Jan2021). The doctor thought he was having an inner ear problem. He has a history of tinnitus and the doctor thought this was causing the light vertigo symptoms. He was light headed, wobbly. He was prescribed Meclizine-25mg one tablet by mouth three time a day. Now, today, 28Jan2021, he woke up this morning and he had the same feelings again. He was wobbly. He had the same feelings that he experienced on Saturday 23Jan2021. However, they were milder. He felt like it is a little vertigo. He did not feel stable. He had never had anything like this happen before. The patient stated he is pretty healthy for his age. he is very active. He usually plays golf, but has not recently. The patient believes he is having a reaction from vaccine, he is not sure, but he is having some of the symptoms. The doctor provided him with medication, but he has not started it yet. He does not know if he should. Caller is thinking these events are related to the shot. He is due to get his second shot on 03Feb2021. Outcome of the events was not recovered.
78 2021-05-30 pain in extremity An extremely sore area on right arm. Unable to lift above should height. Has persisted since inocula... Read more
An extremely sore area on right arm. Unable to lift above should height. Has persisted since inoculation on 2/25/2021
78 2021-05-31 weakness Muscles hurt and was weak; Muscles hurt and was weak; got excited; tongue became swollen; fell down;... Read more
Muscles hurt and was weak; Muscles hurt and was weak; got excited; tongue became swollen; fell down; felt so weak that he could not lift himself to get up; This is a spontaneous report from a contactable consumer or other non-hcp (Patient). A 78-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection; Batch/Lot Number: Unknown, Expiration date: Unknown) via an unspecified route of administration on 25Jan2021 as a single dose for COVID-19 immunization. Medical history included COVID-19 from Jul2020 to an unknown date; he also mentioned that he had COVID-19 back in July but has already recovered. The patient's concomitant medications were not reported. On an unspecified date in Jan 2021, the following day, he woke up and his tongue was swollen. He got excited and called doctor and he went in. He went to get dressed and as he went in, he fell down. Then he is trying to get up and cannot get up. He layed there for 1/2 hour. He could not get up. He was trying and trying. His wife had to call neighbors to help him get up. He did not want to go to the hospital and wait for 2-3 hours. He took some Benadryl and a couple of Aspirin and fell asleep. The following day when he woke up, his mouth was not swollen and he was able to get up and around. His muscles hurt and he felt like a weakling. The clinical outcome of tongue became swollen, fell down, felt so weak that he could not lift himself to get up was resolved and the outcome of other events was unknown. He is scheduled to get second dose on 24Feb2021. He would like to know if he should get it or not. He was an EMT in Fire Department before he retired. That day when it happened, he really felt old. No further details provided. The seriousness of the events was reported as non-serious. Follow-up (16Apr2021): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
78 2021-05-31 cold sweat loss of appetite; fatigue/completely drained/ragged tired; he got sick the next day/has been sick; w... Read more
loss of appetite; fatigue/completely drained/ragged tired; he got sick the next day/has been sick; whenever he tried to do something, he will break out in a cold sweat; This is a spontaneous report from a contactable consumer other non-health professional (patient) via medical information team. A 78-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for Injection, lot number: Unknown, Expiration date: Unknown), via unspecified route of administration on left arm on 28Jan2021 (age at vaccination 78-year-old) at 1st dose, single for covid immunization. The patient had no medical history. There were no other products. On 28Jan2021 patient took 1st dose of the PFIZER-BIONTECH COVID-19 VACCINE and on 29Jan2021 (day after) the patient experienced loss of appetite, fatigue, and completely drained. Reportedly on 29Jan2021 patient had been sick. The patient experienced ragged tired, totally drained, and whenever he tried to do something, he will break out in a cold sweat. Patient stated that he got a COVID shot on 28Jan2021 (last Thursday), and he had been sick ever since. Patient stated that the sickness does not seem to be going away, it was about the same, it did not seem to be getting any better. Patient was wondering how long this is supposed to last, and if there was something he could do. Patient wanted to know how long he will be experiencing these symptoms. The case was assessed as non-serious as per reporter. No investigation assessment was done. Reporter confirmed that he had no other vaccines on the same day as his COVID vaccine. Reporter did not have his COVID Vaccination card with him at the time to provide Lot number. The outcome of the event was not recovered for sick and unknown for all other events. This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
78 2021-06-01 pain in extremity That evening he called me and told me his groin area was hurting and I went over to his house. He s... Read more
That evening he called me and told me his groin area was hurting and I went over to his house. He said he was having a hard time standing up. His groin and down his leg. He never had complained about it before. I took him to ER Hospital and they checked him out and verbally talked to him. The doctor told him to take Tylenol and told him to go home. He had that pain for about two hours.
78 2021-06-02 weakness Dizziness; loss of balance resulting in falling; Chills; fatigue; sleepiness; diarrhea; Loss of stre... Read more
Dizziness; loss of balance resulting in falling; Chills; fatigue; sleepiness; diarrhea; Loss of strength; loss of appetite; This is a spontaneous report from a contactable consumer, the patient. A 78-years-old male patient received a first dose of BNT162B2 (PFIZER BIONTECH COVID-19 mRNA VACCINE) (Lot number = unknown) via an unspecified route of administration in the left arm on 05Feb2021 at 01:00pm (at the age of 78-years-old) as a single dose for COVID-19 immunisation. Medical history included glaucoma, shingles (15 years ago) and anemia. The patient was allergic to codeine. Concomitant medications included vitamin b12, c, d3, iron and Tylenol (MANUFACTURER UNKNOWN). The patient was not diagnosed with COVID-19 prior to vaccination. The patient did not receive any other vaccine within 4 weeks prior to covid vaccination. On 05Mar2021 at 1:00 PM, the patient experienced dizziness, loss of balance resulting in falling, chills, fatigue, sleepiness, diarrhoea, loss of strength and loss of appetite. On 06Mar2021, the patient underwent COVID-19 virus test (nasal swab type) and the result reported as negative. Adverse events resulted in emergency room/department or urgent care. Clinical outcome of the events dizziness, loss of balance resulting in falling, chills, fatigue, sleepiness, diarrhoea, loss of strength and loss of appetite was reported as not recovered. Information about lot number cannot be obtained and no further information is expected.
78 2021-06-03 numbness unsteady on feet, almost "tipsy", as if returning to land after being on boat, Have been experienci... Read more
unsteady on feet, almost "tipsy", as if returning to land after being on boat, Have been experiencing for 4-5 days; unsteady on feet, almost "tipsy", as if returning to land after being on boat, Have been experiencing for 4-5 days; unsteady on feet, almost "tipsy", as if returning to land after being on boat, Have been experiencing for 4-5 days; This is a spontaneous report from a contactable consumer. This 78-year-old male consumer (Patient) reported for himself that he received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EL 9264 and Expiry date: Unknown), dose 2 via an unspecified route of administration, administered in Arm Left on 08Feb2021 10:15 (Batch/Lot Number: EL 9264) as 2ND DOSE, SINGLE for covid-19 immunization. Medical history included, chronic kidney disease, coronary artery disease, hypothyroidism, hypertension from an unknown date and unknown if ongoing. No known allergies were reported. Historical vaccine included first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EL3247), dose number; 1 on 18Jan2021 at 09:30 am at left arm for covid-19 immunization. Facility type vaccine was reported as other. The patient did not receive any other vaccines within 4 weeks. Concomitant medications (Other medications in two weeks) included allopurinol taken for an unspecified indication, start and stop date were not reported; levothyroxine sodium (SYNTHROID), eicosatetraenoic acid ethyl ester (VASCEPA), rivaroxaban (XARELTO), rosuvastatin calcium (CRESTOR) taken for an unspecified indication, start and stop date were not reported. On 02Mar2021 the patient experienced unsteady on feet, almost "tipsy", as if returning to land after being on boat, have been experiencing for 4-5 days. 2 others, not related, with same approx schedules, experiencing same feelings. No treatment was given for the AE. If covid prior vaccination: No, If covid tested post vaccination: No. The outcome of events was not recovered. No follow up attempts are possible. No further information is expected.
78 2021-06-06 seizure He was living independently in a retirement home. They administered the vaccine. Since the jab he ha... Read more
He was living independently in a retirement home. They administered the vaccine. Since the jab he has been diagnosed with Parkinson's, Parkinson's dementia, Suffered two strokes and we were recently told he now suffers from seizures and will require medication for the rest of his life AND 24 hr. Care.
78 2021-06-07 unresponsive to stimuli During rounds at 10pm, CNA observed resident unresponsive. Nurse was immediately called, who in turn... Read more
During rounds at 10pm, CNA observed resident unresponsive. Nurse was immediately called, who in turn call the code. Nursing staff responded and started CPR. A total of 16 rounds of compressions and shocked x 2, prior to Paramedics taking over 10 minutes later. They continued CPR for another 10 minutes before resident was pronounced dead.
78 2021-06-08 seizure major seizure within minutes of receiving shot; This is a spontaneous report from a contactable cons... Read more
major seizure within minutes of receiving shot; This is a spontaneous report from a contactable consumer. A 78-year-old male patient received the second single dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 05Mar2021 at 14:00 (at the age of 78 years), in left arm, for COVID-19 immunization. The first dose of BNT162B2 was given on 12Feb2021 at 12:00 PM in left arm (at the age of 78 years). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Medical history was not reported. The patient did not have COVID prior vaccination and was not tested for COVID post vaccination. Concomitant medications included unspecified statin drug and blood pressure medicine. On 05Mar2021 the patient experienced major seizure within minutes of receiving shot. The event required Emergency room/department or urgent care and ended up on ventilator in ICU. Treatment received included lorazepam (ATIVAN), intubation, ventilator, CT scan, MRI, EEG. The event was reported as serious as required hospitalization for 6 days and was life-threatening. Event outcome was unknown. Information on the lot/batch number has been requested.
78 2021-06-09 weakness The patient is a 78-year-old male who presents to the hospital with weakness and fever 1 day follow... Read more
The patient is a 78-year-old male who presents to the hospital with weakness and fever 1 day following his second COVID-19 vaccine. Noted o have a transient thrombocytopenia. Presented with severe weakness and unable to get up. He was able to provide some history. His wife provided additional history. He received second dose of mRNA vaccine on 6/5. Developed weakness afterwards and brought to the hospital for further evaluation. Admitted with dehydration low-grade temperatures. Tmax 100.4. Denies bleeding.
78 2021-06-09 pain in extremity Blood clots in left leg from groin area to knee area. Swollen and painful left leg. Prescribed Eliqu... Read more
Blood clots in left leg from groin area to knee area. Swollen and painful left leg. Prescribed Eliquis blood thinner. Currently in treatment phase with symptoms basically the same.
78 2021-06-18 pain in extremity This is a spontaneous report from a contactable consumer (patient). A 78-years-old male patient rece... Read more
This is a spontaneous report from a contactable consumer (patient). A 78-years-old male patient received BNT162B2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm Left on 23Feb2021 15:00 (Batch/Lot Number: EN6203) age at vaccination of 78-years-old, as single dose and dose 2 via an unspecified route of administration, administered in Arm Left on 16Mar2021 15:00 (Batch/Lot Number: ER2613) as 2ND DOSE, SINGLE DOSE for COVID-19 immunization. Medical history included hypersensitivity from an unknown date and unknown if ongoing (Erythromycin and iodine contrast fluid). Concomitant medications included lisinopril (LISINOPRIL) taken for an unspecified indication, start and stop date were not reported; pravastatin (PRAVASTATIN) taken for an unspecified indication, start and stop date were not reported. After 5 weeks from vaccination the patient still experienced pain in upper arm, severe pain in left shoulder with limited use of arm/inability to freely move arm. Physician Office Visit was required and MD prescribed lidocaine patch (that not help) and now patient was taking Prednisone pack. May require orthopedic intervention. The patient was not recovered from the events.
78 2021-06-23 tingling, numbness experiencing numbness/tingling starting in chin and extending up through the next
78 2021-06-24 pain in extremity hardly a sore arm; This is a spontaneous report from a contactable consumer (patient himself). A 78-... Read more
hardly a sore arm; This is a spontaneous report from a contactable consumer (patient himself). A 78-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection) via an unspecified route of administration on 02Feb2021 (Lot Number: EN5318, Expiration Date: 31May2021) as unknown, single for COVID-19 immunisation. Medical history was none and there were no concomitant medications. On an unspecified date of Feb2021, the patient experienced hardly a sore arm. The patient thought it was a good idea to get the vaccine. He did not have anything except hardly a sore arm. The patient underwent lab tests and procedures which included sars-cov-2 test: positive, for it hadn't been 90 days since he had COVID that he got the vaccine on an unspecified date of Dec2020. The outcome of the event was unknown. Follow-up attempts are completed. No further information is expected.
78 2021-07-08 weakness Patient is a 78-year-old white male who was vaccinated with Pfizer Covid 19 vaccines on 3/5 and 3/26... Read more
Patient is a 78-year-old white male who was vaccinated with Pfizer Covid 19 vaccines on 3/5 and 3/26/21 with a known history of chronic respiratory failure and COPD secondary to a work related injury that occurred in the 1980s followed by a compensation/pulmonary physician as well as obesity and diastolic chf, hx atrial fib, who presented to the emergency room on 6/26/21 with a chief complaint of shortness of breath with copious amounts of thick yellowish secretions. Patient was recently admitted and discharged at hospital on 6/11 for pneumonia and a pleural effusion. It was determined during that admission that he had malignant cells in the fluid consistent with adenocarcinoma and chose to not work this up any further and foregone any treatment. He returned back to the hospital with continued shortness of breath, weakness and poor p.o. intake despite using the nebulizer at home. There was no fever no hemoptysis chest pain or pleuritic pain. Imaging again reveals significant airspace disease involving the right lower lobe diffusely and partially involving the right middle lobe on CAT scan with a small right pleural effusion seen. He had a CT of the abdomen and pelvis which was negative for any malignant spread. Patient was also seen by oncology who discussed further work-up, prognosis with the patient and felt that overall he was too ill to pursue any further work-up or treatment at this time and recommended hospice/palliative care. He was discharged home on hospice care with a terminal prognosis on 7/1/21
78 2021-07-17 burning sensation Skin started itching everywhere; Skin started feeling sunburned everywhere; Some little raised bumps... Read more
Skin started itching everywhere; Skin started feeling sunburned everywhere; Some little raised bumps on his stomach like a little area of that itched/On his stomach he had the little welts that started to itch; This is a spontaneous report from a contactable consumer or other non hcp. A 78-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection), dose 2 via an unspecified route of administration, administered in Arm Left on 17Feb2021 11:00 (at the age of 78 years old) (Batch/Lot Number: EN6201; Expiration Date: Jun2021) as single dose for COVID-19 immunisation. Medical history included allergies. The patient's concomitant medications were not reported. Previously the patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection), dose 1 via an unspecified route of administration, administered in Arm Left on 21Jan2021 (Batch/Lot Number: EL3249; Expiration Date: Jun2021) as single dose for COVID-19 immunisation and experienced itching all over his body. States he took Benadryl regularly for the side effects but after 4-5 hours of taking the Benadryl, his symptoms returned. After a few days the itchiness resolved. States he went to allergist and received a prescription for prednisone, epipen and Benadryl with instructions for use by allergist. He was instructed to take Benadryl prior to the 2nd shot of the vaccine. He was instructed to take Benadryl if reaction post vaccine shot was mild and instructed to use epipen and call if he had a bad reaction. Also instructed to take Prednisone if Benadryl was not working. Received his second vaccine shot yesterday and, in the afternoon, developed a sun burning sensation on his skin in addition to itchiness and a welt on his stomach. The patient took Benadryl and within 30 mins symptoms resolved. He had had to take Benadryl regularly (every 4-5 hours) as his symptoms returned about 4 hours after a dose of Benadryl. States he has not needed the epipen or prednisone and would like to know if Benadryl deactivates effectiveness of vaccine. The patient wanted Pfizer to conduct clinical trials/have information on how antihistamines may interfere with the vaccine and asked if there is a blood test he can take after a period after the second vaccine dose to determine effectiveness of the vaccine. Concerned about his reaction as wondering if he should avoid the vaccine if a booster is indicated down the road and especially if his reaction is consider serious reactions and asked about the half-life. This consumer called to ask if Benadryl he has taken would affect the efficacy of the Pfizer COVID-19 Vaccine that he has been administered. He has allergies so he took a Benadryl approximately 2 hours before being administered the vaccine around 11:00. After second dose was administered, he felt ok, he waited on site for about 30 minutes for monitoring like you are supposed to. About 2 hours after vaccine was administered his skin started feeling sunburned everywhere and skin started itching everywhere. In response to events he took another Benadryl. About 30 minutes after taking Benadryl the events went away. About 4-5 hours later the events came back the same way as when they started. He had some little raised bumps on his stomach like a little area of that that itched. His body itched all over but it felt horrible sunburned. He took another Benadryl and in about 30 minutes the events kind of cleared up, it was good. About 4 hours after that the Benadryl wore off, the events came back so he took another Benadryl. Today the events are ongoing but a lot milder than it was on 17Feb2021. It seemed like every 4-5 hours the events would come back but milder today. His question is since he had to take Benadryl or he would have been itching all over the place; and he did not want to go to emergency room which he probably would have had to if he had not taken the Benadryl; and he would like an answer, not a maybe; since he had to take Benadryl and taken Benadryl again today and got the Pfizer COVID-19 Vaccine shot yesterday, is the Benadryl counteracting the efficacy of the Pfizer COVID-19 Vaccine. He has had no other vaccines or immunizations other than the first dose of Pfizer COVID-19 Vaccine. He took Benadryl pill 2 hours before he went for the second dose of Pfizer COVID-19 Vaccine; had the second dose of Pfizer COVID-19 Vaccine shot, nothing happened until he would say maybe around 13:00; because he waited 30 minutes after the shot; got in the car and came home. Around 13:00 he started getting the itchiness but this time his skin felt like it was sunburned everywhere. He was not out in the sun, it is snowing there, there are clouds, no sun; skin all over felt like it was sunburned. On his stomach he had the little welts that started to itch; He took Benadryl. He did not want to use the Epi-Pen because the allergist said he had to call # if he used the Epi-Pen and he did not want to do that. Benadryl cleared it up; did not make it go away; about 4 hours later events started back; so he took Benadryl again; and about 4 hours later events came right back; it did that all night. Today, right now, he took a Benadryl let's say about 4-5 hours ago and events are not coming back like that. If events do not come back, he probably won't take another Benadryl. Events are a lot milder now, seems like they are going away. The Benadryl works. His concern is because he did hear on TV from one of those TV doctors on one of those daily regular daily talk shows that his idea was, and caller reported it is unknown how accurate the information is; but the doctor said avoid taking medications like Aspirin, Tylenol or antihistamines, all that stuff when you get your shot because it could affect the efficacy of the shot. Caller is not sure he is right; because his allergist just said take the Benadryl in case of anaphylactic shock which he did not have. Would like to know if this a waste of all this stuff he did because what they did now was he interfered with the action of the vaccine. No other vaccines were administered on same date with the Pfizer vaccine considered as suspect. The adverse events required visit to Physician office and not required to visit Emergency room and was not hospitalized. Therapeutic measures were taken as a result of the events. The outcome of the events was recovering. No follow up attempts are possible. No further information is expected.
78 2021-07-17 numbness, pain in extremity Parsonage-turner syndrome; pain along inner arm; numbness on his left side of this hand; numbness on... Read more
Parsonage-turner syndrome; pain along inner arm; numbness on his left side of this hand; numbness on thumb and index finger; His wrist dropped in his left hand.; This is a spontaneous report from a contactable physician. A 78-years-old male patient received bnt162b2 (BNT162B2, solution for injection), dose 2 via an unspecified route of administration, administered in Deltoid Left on 12Feb2021 18:30 (78-years-old at the age of vaccination), (Batch/Lot Number: EL9267) as DOSE 2, SINGLE for covid-19 immunisation. Medical history included diabetes mellitus, Coronary artery disease, High blood pressure, prostate cancer, a little arthritis from an unknown date and unknown if ongoing. Concomitant medication included metformin taken for diabetes mellitus from an unspecified start date and ongoing; metformin hydrochloride, sitagliptin (JANUMET [METFORMIN HYDROCHLORIDE;SITAGLIPTIN]) taken for diabetes mellitus from an unspecified start date and ongoing; amlodipine taken for hypertension from an unspecified start date and ongoing; atorvastatin taken for coronary artery disease from an unspecified start date and ongoing; metoprolol taken for hypertension from an unspecified start date and ongoing; acetylsalicylic acid (ASPIRIN 81) taken for coronary artery disease from an unspecified start date and ongoing. Patient reported that received both doses of the Pfizer covid vaccine. Diagnosed with possible Parsonage-Turner syndrome: Had the test done last week and the report received today mentioned this. His doctor mentioned the high likelihood that it may have a connection to the vaccination. The test was 10 days ago. Has had the symptoms since about 03Feb2021. Had the last dose, the second dose, 12Feb2021. He developed pain in the arm, not at the injection site, but along the inner arm. The next day he developed numbness in the left side of the hand, in the middle and ring finger. A couple of days later he developed the same thing on the thumb and index finger. A few days later, he woke up in the night and had wrist drop in the left hand. He recovered most strength of muscles and was able to lift the fingers. Within the next few days, he recovered his strength in his muscles. The numbness continued to be there but slowly showing some improvement. He still had little patches of it. Had the test done last week, it was a nerve conduction EMG. Was initially shocked that this was all of a sudden happening. He knew it was not life threatening. Of course, we know these days doctors are not like they used to be. It took a long time to get an Appointment. Got an appointment more than a week later with the neurologist. A week later, they got the tests. The patient underwent lab tests and procedures which included electromyogram: possible parsonage-turner syndrome on 25May2021 possible Parsonage-Turner Syndrome. The clinical outcome of the events numbness on thumb and index finger, numbness on his left side of this hand was recovering, remaining all were unknown. No follow-up attempts are possible. No further information is expected. Follow-Up (05Jul2021): Follow-up attempts are completed. No further information is expected.
78 2021-07-17 pain in extremity sore arm; slight headache; flu like feelings; right shoulder became extremely sore for several days ... Read more
sore arm; slight headache; flu like feelings; right shoulder became extremely sore for several days (unable to use right arm).; This is a spontaneous report from a contactable consumer, the patient. A 78-year-old male patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: ER8732) via an unspecified route of administration in the left arm on 26Mar2021 (at the age of 78-years-old), as a single dose for COVID-19 immunisation. Medical history included dislocated shoulder. The patient was allergic to sulfa and sun screen. Concomitant medications included benazepril (MANUFACTURER UNKNOWN), finasteride (MANUFACTURER UNKNOWN), simvastatin (MANUFACTURER UNKNOWN) and metoprolol (MANUFACTURER UNKNOWN); all from an unknown date for unknown indication. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6198) via an unspecified route of administration in the left arm on 05Mar2021 at 17:30 (at the age of 78-years-old), as a single dose for COVID-19 immunisation. The patient previously received lidocaine (MANUFACTURER UNKNOWN) and epinephrine (MANUFACTURER UNKNOWN); and experienced drug allergy. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-1. Since the vaccination, the patient had not been tested for COVID-19. On 27Mar2021, the patient experienced sore arm, slight headache and flu like feelings for several days. In addition, the right shoulder became extremely sore for several days (unable to use right arm). It was reported that the right shoulder dislocated 3 times beginning in 1965 through 1996 and the shoulder was almost completely normal after 5 days. 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 sore arm, slight headache, flu like feelings and right shoulder became extremely sore for several days (unable to use right arm) was resolving at the time of this report. No follow-up attempts are needed. No further information is expected.
78 2021-07-21 weakness, pain in extremity, muscle spasms Received covid shots. Within in a few hours developed severe all body muscle cramping, pain and naus... Read more
Received covid shots. Within in a few hours developed severe all body muscle cramping, pain and nausea. Extreme symptoms of gout w/pain and cramping in feet / ankles. Did not eat for 4 days - fatigue, low energy. these symptoms lasted for 4 days. After the second shot on 6-3-21 - Became weak and ill the next day and was taken home from work with extreme pain in right foot and knees. Extensive all over body painful muscle cramping, weakness. Fatigue. To this day has not been able to carry on his normal walking routine. Had consulted with physician.
78 2021-07-22 discomfort experiencing in his left arm where the bump is a sensation of being red/ redness, heat and itching a... Read more
experiencing in his left arm where the bump is a sensation of being red/ redness, heat and itching are in the location of the injection; redness, heat and itching are in the location of the injection/ feels hot; intermittent itchiness/ redness, heat and itching are in the location of the injection; it was just sort of like rash; it's a delayed allergic reaction; I have only minor discomfort; Pfizer Covid-19 vaccine that was given at an angle and a bump occurred; This is a spontaneous report from a contactable consumer (patient). A 78-years-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/Lot Number: EL0261; NDC number, UPC number and expiry date: unknown) via an unspecified route of administration in left arm on 05Feb2021 (age at the time of vaccination was 78-year-old) as a single dose for COVID-19 immunization. The patient's medical history included high blood pressure and epilepsy both from an unknown date and unknown if ongoing. The patient had low level of sodium in his system because of phenobarbital. The patient's wife had metaplastic breast cancer and passed away 12 years ago. The patient's concomitant medications included phenobarbital; phenytoin (DILANTIN [PHENYTOIN]); riboflavin (VITAMIN B 2); cyanocobalamin (VITAMIN B 12 [CYANOCOBALAMIN]); vitamin D3; vitamin C [ascorbic acid]; tocopherol (VITAMIN E [TOCOPHEROL]); colecalciferol (VITAMIN D [COLECALCIFEROL]); calcium; ascorbic acid, ergocalciferol, folic acid, nicotinamide, panthenol, retinol, riboflavin, thiamine hydrochloride (MULTIVITAMINS [ASCORBIC ACID;ERGOCALCIFEROL;FOLIC ACID;NICOTINAMIDE;PANTHENOL;RETINOL;RIBOFLAVIN;THIAMINE HYDROCHLORIDE]) all taken for an unspecified indication, start and stop date were not reported. Previously, the patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EK4176; NDC number and expiry date: not reported) on 15Jan2021 for COVID-19 immunization and experienced dizziness, headache and chest discomfort. The patient received second dose and reported that the injection was given at an angle and then there was bulb (bump) on his arm for 4 months. In Jul2021, the patient had feeling of sensation in his arm, feeling of the thing red, felt hot and had inter massive itchiness. The patient reported that the redness, heat and itching were in the location of the injection (area was in the upper portion of his left arm, almost by his shoulder). At first, the patient didn't really give it much attention because it was just sort of like rash and then it started becoming little bit attended and becoming little bit like heat there, the patient had no fever at all during the whole period. He had only minor discomfort and itching. The patient asked if anyone had experienced the sides effects which the patient felt at the injection site (feeling hot and intermittent itchiness). The events were reported as non-serious. The patient found an article on news entitled rare COVID arm phenomenon, a harmless immune response to vaccination, and the patient said that the article was talking about COVID arm, about where in 1st trial 344 people had the COVID arm but in the 2nd trial 64 people had COVID arm but this was the late body reaction that initially occur 10 to 14 days after the injection. The patient got 4 rounds of house treatment. The patient had been to safety and medical information. The patient had an article that he found online that covers all the symptoms that he had, that indicates that it was a delayed allergic reaction and that was the minor incidence and its extremely rare even on the global level. The patient reported that it occurred within the company Moderna, the other vaccine company like Pfizer that produced the 1st 2 vaccine. It was kind of same technology that they use, and the indication was that it will go away if an individual basically takes an aspirin or some anti-inflammatory for a few days. The patient was concerned about it because the way the owner of report said that the initial allergic reaction occurs with people within 10 to 14 days, the patient was 4 months after the effect and had symptoms. The patient explained the way he received injection. The patient reported that they may have given him the vaccine at an angle which created a small pocket through the medicine to stay into regional muscle and later it was released into his system and the patient experienced side effect, that was the minor side effect by description and he had an article that he can refer and even had a quotation medical journal of medicine, what they called a COVID arm phenomenon. The patient gave the reference of the website to other two ladies, where the rare phenomenon called the Covid arm was listed in detail. The patient further stated left upper right arm almost at the shoulder level. The patient did not receive any treatment medication. Investigations was not reported. The outcome of all the events was unknown.
78 2021-07-25 pain in extremity This patient received a full, diluted multi-dose vial of the Pfizer COVID-19 vaccine instead of the ... Read more
This patient received a full, diluted multi-dose vial of the Pfizer COVID-19 vaccine instead of the single dose of .3mL. The patient was notified on Friday July 23, two days after receiving shot and reported a sore arm, but did not feel it was anything beyond what was expected.
78 2021-07-27 weakness Low energy/weakness; loss appetite; This is a spontaneous report from a contactable consumer (patien... Read more
Low energy/weakness; loss appetite; This is a spontaneous report from a contactable consumer (patient). A 78-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on 26Feb2021 15:30 (Batch/Lot Number: EN6202) as DOSE 1, SINGLE for covid-19 immunisation. The patient's medical history was not reported. There were other concomitant medications in two weeks. The patient experienced low energy/weakness, loss appetite on 05Mar2021. The events resulted in emergency room visit, and were serious per hospitalization and disability. The patient was hospitalized for low energy/weakness and loss appetite for 12 days. The patient underwent lab tests and procedures which included Nasal Swab (covid test): unknown results on an unspecified date. Therapeutic measures were taken as a result of the events with Plasma exchange. The outcome of the events was resolving. Follow-up attempts are completed. No further information is expected.
78 2021-07-27 numbness, sensory loss Caller received his second dose of the Pfizer COVID vaccine and is experiencing numbness in his legs... Read more
Caller received his second dose of the Pfizer COVID vaccine and is experiencing numbness in his legs / numbness in his feet / numbness in his knees; when he pinches his skin in his left leg and some parts of his body, he doesn't feel the pinch; This is a spontaneous report from a contactable consumer (patient). A 78-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection Batch/Lot number: EW0196, Expiration Date was not reported), via an unspecified route of administration 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 historical vaccine included first dose of BNT162B2 (Lot number: EW0196) received on an unspecified date (at the age of 78-years-old) for COVID-19 immunization. Patient states that, the person at the pharmacy told him to mention that he was calling in regards to the Pfizer BioNTech COVID vaccine EUA although his card after both doses has EW0196. Patient received his second dose of the Pfizer COVID vaccine and is experiencing numbness in his legs, feet, and knees. Patient states when pinching his left leg and other parts of his body he doesn't feel the pinch. Patient would like to know if this is a common side effect, if there have been any other reports of this side effect, if this side effect will go away in a couple weeks on its own without having to go get medication for it. No information in PI regarding numbness in legs, feet, and knees being reported as a side effect, when pinching the left leg and other parts of the body not feeling the pinch. Patient confirms he received the Pfizer Covid 19 Vaccine. Additonal information is expected.
79 2021-01-04 flushing BILATERAL WHEEZES SHIVERING FLUCTUATING OXYGEN SATURATION SKIN FLUSH
79 2021-01-04 seizure Episode of vomiting, change in mental status, hypoxia and seizure activity.
79 2021-01-13 discomfort Patient stated "I feel some pressure like I need to burp." Patient was taken back to medic area whe... Read more
Patient stated "I feel some pressure like I need to burp." Patient was taken back to medic area where vital signs and EKG were done. Manual v/s 138/98, O2 98%, HR 70, EKG results normal. Patient burped and stated, "I feel better now." EMT released patient to go home.
79 2021-01-17 tremor Daughter call in for VAERS report to file for father whom committed suicide 1/16/2021 in the AM afte... Read more
Daughter call in for VAERS report to file for father whom committed suicide 1/16/2021 in the AM after reportable ae of COVID 19 vaccine administered 1/14/2021. Patient sought care twice at ER; first visit by ambulance around 5PM and Friday 1/15/2021 Medical Center: Emergency Room. 1st Discharge summary diagnosis: adverse reaction to COVID shot; 2nd Discharge summary diagnosis: adverse reaction to COVID shot, fever, Panic Disorder-- ER. Medical Center Discharge summary diagnosis: Adverse reaction to the vaccine, acute anxiety. Reportable patient symptoms at, 1st visit : fever, shaking stomach cramps, breathing issues. Medical Center -- No fever, confusion and dementia type, patient would not stay in patient bed; patient would get up and sit down again repeatedly, agitated and anxious. Attempted to urinated hospital bed. Patient committed suicide in home.
79 2021-01-19 pain in extremity FINGERS ON LEFT HAND HARD TO BEND (A LOT OF PAIN WHEN BENDING)
79 2021-01-20 weakness Chills, loss of taste and smell, weakness, shallow breathing Narrative: Patient referred to facilit... Read more
Chills, loss of taste and smell, weakness, shallow breathing Narrative: Patient referred to facility ER for COVID- 19 testing and evaluation of symptoms
79 2021-01-22 pain in extremity Started with severe myalgias, back pain, leg pain and fever T 104 He was taken to Urgent Care with C... Read more
Started with severe myalgias, back pain, leg pain and fever T 104 He was taken to Urgent Care with Covid neg, Influenza A/B neg. UA and CXR negative Symptoms lasted 72 hours He has never had fever before and he is 79 years old.
79 2021-01-26 feeling cold Chills and Fever
79 2021-01-29 pain in extremity Headaches/sore arm/tired
79 2021-02-04 weakness Fever to 103.4, malaise,weakness; treatment tylenol supportive care, O2 to 3L
79 2021-02-04 numbness Area of facial numbness about 2 inches in diameter on left mandibular distribution. No motor loss. P... Read more
Area of facial numbness about 2 inches in diameter on left mandibular distribution. No motor loss. Persistent to present, unchanged.
79 2021-02-04 seizure Seizure Activity: Nursing assessment: 1/28/2021 17:55 Staff asked writer to check on resident, stat... Read more
Seizure Activity: Nursing assessment: 1/28/2021 17:55 Staff asked writer to check on resident, stating that there was something wrong with him. Resident found sitting up in wheelchair. Resident noted to be nonverbal, making small jerking movements with upper extremities and head articulated to the left. As writer attempted to assess pupils, resident squeezed eyes shut and grimaced. Resident did squeeze with both hands, equal strength. VS: 94, 16, 138/86, 97% on RA. Resident put into bed with assist of two staff and hoyer lift. MD notified: 1/28/2021 18:10 Return phone call received from Physician. Advised to continue to monitor and OK to send to ED if resident representative wants further evaluation done. Nursing assessment: 1/28/2021 18:35 Resident found to be alert and smiling at this time. Resident speech is garbled per baseline. VS: 111, 20, 129/77, 100% on RA. Resident able to follow commands. ROM equal with strength at baseline. No incontinence noted. Resident noted to be fatigued. Start of episode of seizure-like activity not witnessed. The time between first found by staff to noted resolution was approximately 40 minutes. No further seizure episodes noted. No previous hx of seizure activity.
79 2021-02-06 weakness On Saturday around 12:00 pt began experiencing left sided body weakness and vertigo.
79 2021-02-07 weakness Fever, chills, malaise, weakness and myalgias. Self treated with Tylenol and rest
79 2021-02-09 flushing At just after 5 o'clock, pt received his 1st dose of the COVID-19 vaccine and about 10 minutes later... Read more
At just after 5 o'clock, pt received his 1st dose of the COVID-19 vaccine and about 10 minutes later he began to feel flushed in his face. This was associated with some chest tightness as well. He was referred to the emergency department. He had no difficulty breathing and did not feel like his throat is closing. He had no rash anywhere else on his body but does feel like his face is redder than usual. His symptoms have not been associated with shortness of breath and has no abdominal pain. Upon presentation to emergency department, the patient was hypertensive to the 220s but his vital signs were otherwise within normal limits. Physical exam was fairly unremarkable with exception of some mild redness of the bilateral cheeks. He had no rash there is no evidence of airway compromise or wheezing. Low concern for acute anaphylactoid reaction. Patient was given diphenhydramine. Symptoms resolved and patient was discharged home.
79 2021-02-11 pain in extremity chills, fever, lost of appetite, very sleepy, sore arm beginning one week after injection
79 2021-02-12 mild one side paralysis, speech disorder 2 days after vaccine - left sided weakness in arm and leg, speech/swallowing impairment. ER then 3 d... Read more
2 days after vaccine - left sided weakness in arm and leg, speech/swallowing impairment. ER then 3 days in hospital- home with walker, assistance and home health.
79 2021-02-17 weakness (02/15/2021): vaccine (02/16/2021) : severe body aches and weakness, increased congestion and mucous... Read more
(02/15/2021): vaccine (02/16/2021) : severe body aches and weakness, increased congestion and mucous production. (02/16-17/2021) : death possibly during the night
79 2021-02-20 nerve pain Severe nerve pain in right lower, then right hip, then to right knee
79 2021-02-20 tenderness On February 18 or 19, noticed a 5 mm. purpuric skin lesion on right hand, not painful. On about Feb... Read more
On February 18 or 19, noticed a 5 mm. purpuric skin lesion on right hand, not painful. On about February 19, perhaps in the evening, noted varied perhaps 5 mm discolorations on ankles that in retrospect were probably resolved mild purpuric lesions. On the same evening, noted very mild tenderness in the calf (soleus muscle) regions bilaterally feeling like mild muscle fatigue. On February 21 at about 6 AM, before showering, noted bright cherry red lesions on/under skin of both ankles and more severely on the posterior calf of both lower legs above the calf tenderness. The skin was flat and not tender. Calf tenderness was slightly worse (though still mild). Lesions turned purpuric, fading in hours.
79 2021-02-21 weakness Patient states since he got the first dose of Pfizer vaccine on 2/3 and the second on 2/17. He has ... Read more
Patient states since he got the first dose of Pfizer vaccine on 2/3 and the second on 2/17. He has gained almost 20 pounds since taking the first shot. Patient states he has gained right around 20 pounds since getting the first shot of the Pfizer vaccine. States he had some shortness of breath right after receiving the first dose of vaccine, but that has cleared. Felt achy and stiff and sore after the second injection. Follow up with patient on 2/20/21 F/U with caller - He was advised at ER that he had excessive fluid retention; no other issues were identified. He was advised to increase his furosemide dose from 20mg twice daily to 40mg twice daily for 5 days. He continues to feel tired and weak, with slight shortness of breath. Confirmed with caller that his 2 vaccinations were separated by only 14 days.
79 2021-02-23 inability to speak Patient reported as being altered, GCS 6 with noted aphasia around 1415.
79 2021-02-23 discomfort, weakness on 1/23, rt became winded and confused, weak and began to require more assistance with ADL's, 1/24/2... Read more
on 1/23, rt became winded and confused, weak and began to require more assistance with ADL's, 1/24/21 acting bizzare, anxious, uncomfortable, increasingly more confused, restless, 1/27 blood noted in urine, SOB and abdominal breathing, was sent to ER - returned with dx of SOB and UTI. 1/29/21 confused and trouble voiding, very restless, 1/30/21 confused and restless, 1/31/21, confused and anxious, 02/02/21, very low heart rate, lethargic, admitted to hospital with cystitis and bradycardia, 2/4/21 returned to facility, 2/11/21 received second dose of Pfazer_ BioNTech vaccine, 2/17/21 very lethargic, bradycardia, 2/21/21 large amount of rectal bleeding, sent to hospital and admitted - remains in the hospital at this time
79 2021-02-23 numbness "Pfizer-BioNTech COVID-19 Vaccine EUA" Exagerrated numness on the left side of my face from e... Read more
"Pfizer-BioNTech COVID-19 Vaccine EUA" Exagerrated numness on the left side of my face from ear to mouth
79 2021-02-23 pain in extremity whole elbow 3 to 4 inches either way was swollen a lot and very painful/it went down his arm and int... Read more
whole elbow 3 to 4 inches either way was swollen a lot and very painful/it went down his arm and into his right hand; whole elbow 3 to 4 inches either way was swollen a lot and very painful/it went down his arm and into his right hand; whole elbow 3 to 4 inches either way was swollen a lot and very painful/it went down his arm and into his right hand; having trouble bending his right elbow; This is a spontaneous report from two contactable consumers via the Pfizer-sponsored program. A 79-year-old male patient received his first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EL3249, expiration date 31May2021) on his left arm, intramuscular on 21Jan2021 10:30 at a single dose for covid-19 immunization. Medical history included ongoing congestive heart failure, ongoing type two diabetes, ongoing hypertension, transient ischemic attack, gout, depression and anxiety. Concomitant medication included allopurinol for Gout, ongoing spironolactone for Hypertension, buspirone hydrochloride anxiety and depression, ongoing finasteride, ongoing glipizide for type two diabetes, ongoing valsartan for Hypertension, ongoing apixaban for transient ischemic attack, ongoing doxazosin mesylate for Hypertension, ongoing loperamide, ongoing vitamin d3, ongoing pravastatin sodium, ongoing furosemide for Congestive heart failure and ongoing carvedilol for Hypertension. On Friday afternoon or evening, the patient was having trouble bending his right elbow. When he got up in the morning, his whole elbow 3 to 4 inches either way was swollen a lot and very painful. During the course of the day, it went down his arm and into his right hand. At its height it looked like a surgical glove that gets blown up for kids. It was very painful. Treatment: declines any Outcome: His elbow is still slightly swollen, not much pain at all He puts his glasses on to read the card. The outcome of the events was unknown.
79 2021-02-25 sensory loss 1st dose vaccine 2/23/21; EMS called after pt fell at home 2/25/21; taken to ED and admitted to hosp... Read more
1st dose vaccine 2/23/21; EMS called after pt fell at home 2/25/21; taken to ED and admitted to hospital DX: 1. Right-sided nontraumatic intracerebral hemorrhage, unspecified cerebral location (CMS/HCC) I61.9 431 2. Long term (current) use of anticoagulants Z79.01 V58.61 3. Sensory neglect (left sided) R41.4 781.8 currently still admitted to hospital at the time of this report
79 2021-02-28 weakness Fever; Chills; extreme weakness; so weak he couldn't stand up out of a chair; extreme weakness; so w... Read more
Fever; Chills; extreme weakness; so weak he couldn't stand up out of a chair; extreme weakness; so weak he couldn't stand up out of a chair; felt really bad; This is a spontaneous report from a contactable consumer (patient himself). A 79-year-old male patient received BNT162B2 (Pfizer-BIONTECH COVID-19 Vaccine; EL3247), via an unspecified route of administration in the left arm near the shoulder on 16Jan2021 at about 2-3:00 PM as a single dose for COVID-19 immunization (also reported as to protect himself; hopefully). The patient's medical history was not reported. There were no concomitant medications. The patient did not receive any other vaccines on the same day as BNT162B2 or even four weeks prior and had no problems with vaccines in the past. The patient experienced fever, chills, extreme weakness; so weak he couldn't stand up out of a chair, and felt really bad on 26Jan2021. He had a fever a little over 100 degrees, extreme weakness. He was so week he couldn't stand up out of a chair. He also had chills and just felt really bad. The patient thinks he was over it, he hoped. The events did not require any visit to the Emergency Room or Physician's office. Outcome of the events was recovering.
79 2021-02-28 impaired body coordination, tenderness Initially mild pain and tenderness Left arm shoulder muscle. On third day after second vaccination, ... Read more
Initially mild pain and tenderness Left arm shoulder muscle. On third day after second vaccination, should symptoms gone but I started to develop diffuse myalgias. By 4th day, began having problems with my memory. I could not figure out some instructions on a computer program. I had some trouble recognizing a common object in my hand. Then mild ataxia. Excessive sleepiness in 2-3 hour intervals. On 8th day, developed abdominal pain similar to diverticulitis. And became very constipated. I had forgotten to take the Parnate and missed two doses. I had forgotten to take Metamucil and Miralax. these led to the constipation and abdominal pain. On advice of psychopharmacologist, I resumed Parnate and started to feel better. I resumed laxatives and good effect. Abdominal symptoms abated in two additional days. I had gone to ER but seen only informally by my medical friends. After 3 hour, and getting better, I left. Blood tests were normal. No exam. Since 02/27/2021, I have felt perfectly normal. Recovered.
79 2021-03-02 weakness feeling lousy; chills; low grade fever 101.9; everything hurt, muscles, head; everything hurt, muscl... Read more
feeling lousy; chills; low grade fever 101.9; everything hurt, muscles, head; everything hurt, muscles, head; everything hurt, muscles, head; real tired; weak; a lot of the same symptoms from the COVID virus, he can relate to COVID because he had had the COVID and for 2 weeks he was like that; This is a spontaneous report from a non-contactable consumer. This consumer reported similar events for two patients. This is the first of two reports, reporting for self. This 79-year-old male patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number unknown) via unspecified route of administration on 29Jan2021 at 9 AM at single dose for COVID-19 immunisation. The patient's medical history included COVID virus in Aug2020. The patient's concomitant medications were not reported. The patient received the first dose of vaccine on 29Jan2021 at 9 AM and got a reaction around 9 PM. The patient stated a lot of the same symptoms from the COVID virus came back after the vaccine. The first thing was chills, patient took a couple of paracetamol (TYLENOL), and they went away after about a half hour. The patient had a low grade fever 101.9 at 29Jan2021 night to 30Jan2021, and took paracetamol then as well. The patient reported the biggest thing was everything hurt including muscles and head. Patient felt weak, more or less tired with no energy following the vaccination. The symptoms were from 29Jan2021 night until probably 31Jan2021 morning noon, then he started to feel little bit better. The patient hardly miss work, but missed work on 30Jan2021. The patient stated feeling pretty good and pretty much back to normal on 01Feb2021, it did not affect breathing or cough, just fever and feeling lousy. The patient commented that he can relate to COVID because he had had the COVID and for 2 weeks he was like that. He also had the breathing problem with the virus in Aug2020, and he think he had every symptom but did not lose taste or smell. The patient asked if he should take his second dose of vaccine. The outcome of event chills was resolved on 29Jan2021. The outcome of event fever was resolved on 30Jan2021. The outcome of other events was resolving. No follow-up attempts are possible; information about lot/batch number cannot be obtained. ; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021148753 same reporter/drug/events, different patients
79 2021-03-02 bell's palsy right sided facial palsy, consistent with Bell's palsy, grade 3 treatment with prednisone and valacy... Read more
right sided facial palsy, consistent with Bell's palsy, grade 3 treatment with prednisone and valacyclovir for 7 days with improvement to grade 2 by 1 week
79 2021-03-02 discomfort a little bit of itching; kind of hives; uncomfortable at times, at his feet, and ankles; he has rash... Read more
a little bit of itching; kind of hives; uncomfortable at times, at his feet, and ankles; he has rashes; terrible skin; This is a spontaneous report from a contactable consumer (reporting for himself). A 79-year-old male patient received his first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3248, expiration date: unknown), via an unspecified route of administration from 09Jan2021 to 09Jan2021 at single dose for COVID-19 immunization. The patient's medical history Ablation surgery. The patient's concomitant medications were not reported. On an unspecified date, the patient had a little bit of itching, kind of hives, he did not break out, he was uncomfortable at times, at his feet, and ankles. The patient has rashes, and terrible skin. The outcome of the events was unknown.
79 2021-03-02 pain in extremity slight fatigue the next day; some left arm soreness; This is a spontaneous report from a contactable... Read more
slight fatigue the next day; some left arm soreness; This is a spontaneous report from a contactable consumer (reported for himself). A 79-years-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection, lot EL 9261, expiry date not reported), via an unspecified route of administration on 21Jan2021 at a single dose in the left arm for COVID-19 immunization. Medical history included high blood pressure, a-fib, small stroke 5 years ago and some weakness from that (stroke). Prior to vaccination, the patient was not diagnosed with COVID-19. The patient had no allergies to medications, food, or other products. Concomitant medications included atenolol, amlodipine, warfarin, and lisinopril. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The most recent COVID-19 vaccine was administered in the hospital. On 26Jan2021, patient experienced slight fatigue the next day (as reported) and some left arm soreness. No treatments received in response to the events reported. The events were reported as not serious (did not result in death, not life-threatening, did not cause/prolonged hospitalization, not disabling/incapacitating and not a congenital anomaly/birth defect). Since the vaccination, the patient had not been tested for COVID-19. The outcome of the events fatigue and left arm soreness was recovered in Jan2021.
79 2021-03-08 burning sensation, pain in extremity 23 Hours after the injection, a mild muscular pain started on the mid left arm , within minutes i... Read more
23 Hours after the injection, a mild muscular pain started on the mid left arm , within minutes it became evident on the entire left arm and it extended across from to right shoulder arm. The pain included a burning sensation, being extremely intense (using the standard pain scale I was way over 10) At first it appear to be a heart attack. I never had any cardiac issues. The pain lasted approximately 30 minutes. Second event started on Sunday, 7 at 10 : AM same location, and intensity.
79 2021-03-08 tingling Right Hand swollen and fingers tingle. Unable to hold fork for the past 4 days. Plenty of pain. 1st ... Read more
Right Hand swollen and fingers tingle. Unable to hold fork for the past 4 days. Plenty of pain. 1st shot 3 weeks ago attacked my upper leg muscles - front and back- and shoulders - both sides. Even though rules say not to get 2nd shot if an allergic reaction is still viable, I didn't know this was an allergy reaction. Thusly, I got the 2nd shot. Sorta wish I hadn't. My original e-report # is 327694
79 2021-03-09 pain in extremity Pain developed in right arm at injection site. Pain very slowly diminished for 10 days. First day te... Read more
Pain developed in right arm at injection site. Pain very slowly diminished for 10 days. First day temperature of 101.3F. Very debilitating, making it difficult to dress and to sleep. Hand to take anti anxiety drugs to help sleep for 8 days. I had COVID -19 and was hospitalized from Nov.16 to Dec. 4 2020. Then 2 weeks in bed before able to walk downstairs. Not a pleasant experience!
79 2021-03-14 weakness increased heart rate/slight increase in his blood pressure and heart rate post vaccination/a 97 hear... Read more
increased heart rate/slight increase in his blood pressure and heart rate post vaccination/a 97 heart rate; feel very weak; blood pressure is steady now but pulse is always elevated/slight increase in his blood pressure and heart rate post vaccination/It was 139 over 78 with a 61 heart rate/Next morning at 10 am my blood pressure was 139 over 95; tired; I think I had a reaction to it; This is a spontaneous report from a contactable consumer (patient). A 79-(unit: unknown)-old male patient received first dose of BNT162B2 (Pfizer COVID-19 vaccine, PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EN5318, NDC number, UPC number and Expiry Date: unknown), via an unspecified route of administration on 28Jan2021 13:00 at single dose for covid-19 immunisation at the vaccination facility. COVID Vaccine was a Pfizer product. COVID Vaccine manufacturer was unspecified. Reason for no lot number of COVID Vaccine stated by consumer as he don't know. He stated "I had little card Pfizer EN5318 (further not clarified). There is another number here, I think it D-6152061100." Medical history included a heart disease (A-Fib) (Intent: History) for which the patient takes Eliquis, losartan ,metoprolol and pravastatin and a heart condition. Concomitant medication included apixaban (ELIQUIS), losartan, metoprolol, pravastatin; all for A-Fib. Caller (patient) stated "I receive my first dose of Pfizer COVID-19 vaccine on 28Jan2021. I felt really tired (in Jan2021) for a week after receiving the vaccine. I have a heart disease (A-Fib) for which I take Eliquis, losartan, metoprolol and pravastatin." He noticed a slight increase in his blood pressure and heart rate post vaccination. He had the tendency to monitor his blood pressure and heart rate on regular basis but had been monitoring closely post vaccination. His normal vital signs were around Blood pressure:120/70 to 80 and Heart Rate: 50 -60. However he noticed his BP was high as 139/95 (in 2021) and heart rate 95-103 (in 2021) which is not his normal. His blood pressure is steady now but pulse is always elevated. On 11Feb2021 patient stated "Started to feel very weak. My blood pressure had gone up; Blood pressure was 139 over 95. Heart rate almost doubled: 97 heart rate. Patient stated, "I took the COVID first shot and my age is 79. I took the first shot of the COVID Vaccine on 28Jan2021, around 1 pm in the afternoon at the vaccination facility (a 2 year college, they were doing it outside of the college). I think I had a reaction to it (in 2021). Normally my blood pressure is 110 to 125 on top and I don't know 65 up to 80 on the bottom and my heart is normally between 50 to 65. That's my normal heart rate. I am pretty healthy and I do a lot exercise and lot of power walking, so my heart rate is 'not so' low. That afternoon (28Jan2021) I walk, my power walk training miles. I started to feel very weak and at night I took my blood pressure it wasn't too bad. It was 139 over 78 with a 61 heart rate and then next morning I woke up and my blood pressure had gone up to medically and heart rate almost doubled. Next morning (29Jan2021) at 10 am my blood pressure was 139 over 95 and a 97 heart rate. It kind of continued, I have been writing this all down and monitoring it and blood pressure has come down to some degree but my heart rate continue to be elevated but my blood pressure like this morning, I do in January because I have heart condition and I have Afib (Intent: History). I took the Pfizer vaccine." I am scheduled to get the second dose on the 18th and I am concern about the elevation of my heart rate and elevation of my blood pressure." Outcome of event 'tired' was recovered in 2021; 'Blood pressure raised' was unknown; 'Heart rate increased' was not recovered; 'feel very weak' was unknown; 'I think I had a reaction to it' was unknown. No follow-up attempts are possible, information about batch number cannot be obtained.
79 2021-03-14 numbness, pain in extremity When he raises his left arm where the vaccine was given, he feels a twinge of pain/lifts his arm ove... Read more
When he raises his left arm where the vaccine was given, he feels a twinge of pain/lifts his arm over his head he feels the twinge of pain; When he raises his left arm where the vaccine was given he feels a twinge of pain where that was, and a kind of numbness; when he exercises it and swings his left arm, then he feels a bit tightness; This is a spontaneous report received from a contactable consumer (patient). A 79-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3248, expiry date: unknown), via an unspecified route of administration in the left arm, on 19Jan2021, at single dose, to prevent COVID, at a hospital. Medical history included lung cancer (19-year lung cancer survivor), mild heart attack in 2011, aortic valve replacement in 2013 and a heart issue. Concomitant medications were not reported. Historical vaccine included influenza vaccine received on 06Nov2020 for immunization. The patient reported that on he had the first vaccine shot on 19Jan2021 (10 days ago) and on 20Jan2021, when he raised his left arm where the vaccine was given, he felt a twinge of pain where that was, and a kind of numbness, it was nothing that restricts him in any way, but when he exercised in the morning and lifted his arm over his head he felt the twinge of pain, which was something he never experienced with the flu vaccine or any other vaccines. He wondered if it had something to do with this vaccine. He has not treated it, it has not bothered him much. He stated he feels it when he exercises it and swings his left arm, then he feels a bit tightness or a twinge of pain. He says it does not restrict him or cause him to cry out or anything. The patient also reported that he is scheduled for the second dose on 09Feb2021 and stated that he needs to get a dental procedure done on 04Feb2021 and needs to take amoxicillin for it due to past heart issue. The patient wanted to know if it is okay to take amoxicillin and was wondering if this medication will interfere with the second dose. He also asked if he should cancel the dental procedure. The patient mentioned that he had his annual wellness visit on an unspecified date and they did a lipid profile (unknown results) but it was not relevant in his opinion. The outcome of the events was unknown.
79 2021-03-16 weakness Chills, headache, fever, joint pain, muscle pain, zero energy, lack of appetite.
79 2021-03-18 grand mal seizure Patient experienced a witnessed tonic clonic seizure on 3/12 /21 at 5:30am. Seizure lasted for 3 ... Read more
Patient experienced a witnessed tonic clonic seizure on 3/12 /21 at 5:30am. Seizure lasted for 3 minutes. He was post-ictal for approximately 15-20 minutes afterwards. No prior history of seizure. He was taken for further evaluation.
79 2021-03-22 bell's palsy Bell's Palsy, treated on 2/21/2021 with Prednisone and Valacyclovir for 7 days, will take several mo... Read more
Bell's Palsy, treated on 2/21/2021 with Prednisone and Valacyclovir for 7 days, will take several months to see if improvement in facial nerves/muscles.
79 2021-03-23 sensory loss MUSCLE TIGHTNESS AND LOSS OF SENSATION IN LEFT ARM FOR LAST 3 WEEKS. SAME ARE AS VACCINATION WAS DON... Read more
MUSCLE TIGHTNESS AND LOSS OF SENSATION IN LEFT ARM FOR LAST 3 WEEKS. SAME ARE AS VACCINATION WAS DONE.
79 2021-03-27 weakness diagnosed as having AFIB.; light headed; I had some aches; I was completely down in bed with no ener... Read more
diagnosed as having AFIB.; light headed; I had some aches; I was completely down in bed with no energy/physically weak; This is a spontaneous report from a contactable consumer (patient). A 79-year-old male patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number: EN6202), via an unspecified route of administration administered in left arm on 23Feb2021 00:15 as SINGLE DOSE for COVID-19 immunisation. The patient had no COVID prior vaccination and was not tested for COVID post vaccination. Medical history included hypertension. The patient had no known allergies. Concomitant medications included atenolol, oxybutynin, and tamsulosin. Historical vaccine includes first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) on an unspecified date (at the age of 79-year-old) for COVID-19 immunisation. The patient stated that in the past her pulse rate was in the low 60's. The patient lost energy gradually from 23Feb2021 until 26Feb2021 and 27Feb2021. The patient was completely down in bed with no energy. The patient had some aches on 25Feb2021 at 07:00 AM, but the pulse rate went up to 80 to 100. The patient went to the Cardiologist he believes on 08Mar2021 and was diagnosed as having atrial fibrillation (AFIB) on 08Mar2021. The patient was being treated for AFIB now and have been light headed and physically weak since 25Feb2021 at 07:00 AM. Therapeutic measures were taken as a result of diagnosed as having afib. The patient had not yet recovered from the events.
79 2021-03-29 numbness, tingling Right arm numbness/tingling. Evaluated by EMS-Cleared
79 2021-03-30 weakness, pain in extremity Loss of energy; Loss of energy; Headache; very tired; arm sore; This is a spontaneous report from a ... Read more
Loss of energy; Loss of energy; Headache; very tired; arm sore; This is a spontaneous report from a contactable consumer (patient). A 79-years-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection) via an unspecified route of administration, administered in Arm Left on 03Feb2021 at 12:05 (Batch/Lot number was not reported) as single dose for covid-19 immunisation. The patient's concomitant medications were not reported. The patient previously administered first of BNT162B2 on13Jan2021 for covid-19 immunisation and experienced Headache, loss of taste, very tired, arm sore. The patient experienced headache, very tired, arm sore, loss of energy on 03Feb2021 and patient again experienced loss of energy on 04Feb2021. The patient did not received any treatment for the events. The outcome of the events arm sore was reported as unknown and other events was reported as Recovered. Information of Lot/ Batch number have been requested.
79 2021-03-30 weakness COUGH, WEAKNESS, INSOMNIA, ACUTE ON CHRONIC CKD, ACUTE ON CHRONIC CHF, EMESIS, DEATH Narrative: 1/1... Read more
COUGH, WEAKNESS, INSOMNIA, ACUTE ON CHRONIC CKD, ACUTE ON CHRONIC CHF, EMESIS, DEATH Narrative: 1/12/21-PT REPORTED FEELING TIRED, UNABLE TO SLEEP AND EXPERIENCING DYSPNEA ON EXERTION THAT HE FEELS MAY BE RELATED TO RECENT COVID VACCINE 1/17/21-patient admitted to hospital due to 'severe abdominal pain;' received 1 unit PRBC due to symptomatic anemia and weakness (Hgb 8.4->7.1); dx: acute on chronic CHF exacerbation and difficulty breathing, acute kidney injury-CKD Stage IV; HPI includes chief complaint "weakness/sob since last night, cough x 2 weeks since covid vaccine;" HPI includes "pt states that for 2 weeks he has had SOB, cough, chills, body aches, and weakness, symptoms not improved over the last few days, more weak as of late" 1/28/21-transferred to facility 2/12/21-transferred back to hospital due to SOB, abnormal labs, pleural effusion 2/16/21-episode of coffee ground emesis 2/19/21-EGD showed ulcerative esophagitis and gastritis 2/24/21-transferred to SNF 3/9/21-admitted to hospital d/t multiple episodes of vomiting 3/10/21-pt passed away at hospital Possibility that acute inflammatory process triggered by vaccine resulted in patient's eventual death, but difficult to ascertain due to patient's various comorbidities. Patient never tested positive for COVID. Did not experience immediate ADR following 1st dose of vaccine. Did not received 2nd dose due to illness. Hospitalized multiple times following 1st vaccine dose.
79 2021-03-30 night sweats, feeling hot Cellulitis and red hot swelling upper arm and lower arm; Cellulitis and red hot swelling upper arm a... Read more
Cellulitis and red hot swelling upper arm and lower arm; Cellulitis and red hot swelling upper arm and lower arm; Cellulitis and red hot swelling upper arm and lower arm; Cellulitis and red hot swelling upper arm and lower arm; night sweats; under left armpit tenderness; enlarged swollen lymph nodes; This is a spontaneous report from a contactable consumer (patient). A 79-years-old male patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EM6201), via an unspecified route of administration at arm left on 05Mar2021 02:00 pm at SINGLE DOSE for covid-19 immunisation. Medical history included heart bypass. The patient's concomitant medications were not reported. The patient previously took the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL9265) at the age of 79-years-old, via an unspecified route of administration at arm left on 12Feb2021 02:00 pm at SINGLE DOSE for covid-19 immunisation. The patient experienced cellulitis and red hot swelling upper arm and lower arm, also night sweats, under left armpit tenderness and enlarged swollen lymph nodes, all on 12Mar2021 10:00 pm. Treatment with prescription of Bactrim DS 2x daily 160 mg & Tylenol. Events outcome was recovering. No covid prior vaccination. No covid tested post vaccination.
79 2021-03-30 pain in extremity sore arm; injection site pain; extreme fatigue/Exhaustion; a little headache; chills; muscle pains w... Read more
sore arm; injection site pain; extreme fatigue/Exhaustion; a little headache; chills; muscle pains which makes them a little achy overall; sleepy; feel like they have Covid all over again; feel achy; feel lousy; This is a spontaneous report from a contactable consumer. A 79-year-old male patient received 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EL3248) via intramuscular in left arm on 28Jan2021 at single dose for COVID-19 vaccination. The patient medical history included Covid. Concomitant medications were not reported. On 29Jan2021 the patient was experiencing a sore arm, injection site pain, extreme fatigue, a little headache, chills, and muscle pains which makes them a little achy overall. It was reported that she and her husband both received the vaccine yesterday and stated that they feel like they have Covid all over again on 29Jan2021. She stated that they had Covid already and stated that they have chills and are achy 29Jan2021. Caller said that they are also having that Covid exhaustion. Their arms were quite sore too from the shot, but they did not expect to feel lousy on 29Jan2021. They have been sleepy all afternoon and stated that they sat down and just passed out, caller clarified that they went to sleep on 29Jan2021. Yesterday they were ok. The outcome of the events sore arm, injection site pain, a little headache was unknown, extreme fatigue/exhaustion, muscle pains which makes them a little achy overall, sleepy, feel like they have Covid all over again, feel achy, feel lousy was recovering, chills was resolved on 29Jan2021. No follow-up attempts are possible. No further information is expected.
79 2021-04-01 seizure Seizure 2 days after shot. No history of seizures at all. Hospitalized for a week so far and still i... Read more
Seizure 2 days after shot. No history of seizures at all. Hospitalized for a week so far and still in there.; This is a spontaneous report from a contactable consumer (patient). A 79-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; unknown lot number and expiration), via an unspecified route of administration in right arm on 11Mar2021 at 13:00 as a single dose for COVID-19 immunisation. Medical history included chronic obstructive pulmonary disease (COPD), diabetes, and COVID-19 (if COVID prior vaccination: Yes). No known allergies. Concomitant medications included metformin; insulin lispro (HUMALOG); metoprolol; amlodipine; atorvastatin; vitamin D; and pioglitazone. The patient also received first dose of BNT162B2 on 18Feb2021 at 01:00 pm (at the age of 79 years old) for COVID-19 immunisation. On 13Mar2021 at 12:00am, the patient experienced seizure 2 days after shot. No history of seizures at all. Hospitalized for a week so far and still in there. Patient did not receive other vaccine in four weeks. The patient underwent lab tests and procedures which included COVID test: negative on 13Mar2021. The event resulted in emergency room/department or urgent care visit. The patient received treatment for the event. The patient had not yet recovered from the event. The event was assessed as serious (hospitalization). Information on the lot/batch number has been requested.
79 2021-04-04 discomfort, unresponsive to stimuli, pain in extremity Wife reported that no side effects from vaccine noted until 3/16/2021 when patient had arm and back ... Read more
Wife reported that no side effects from vaccine noted until 3/16/2021 when patient had arm and back pain and wanted to go back to bed and she noted he was extremely sweaty at that time. He was lifted back to bed and was reportioned several times because he could not get comfortable. She went to get him a drink from the kitchen and heard a guttural sound and rushed back to find him unresponsive and blue in color. She called "911" and patient was dead upon arrival (and a DNR) so the Medical examiner arrived and pronounced him dead. She states sx started at about 4pm and he was pronounced dead at about 5pm. Medical examiner determined a heart attack cause of death. The family not sure that the vaccination had anything to do with death but wanted it to be reported.
79 2021-04-06 weakness I need to talk with someone re: effects getting shots Before getting the shots I was walking 3-5 mi... Read more
I need to talk with someone re: effects getting shots Before getting the shots I was walking 3-5 miles a day, going to the gym 5-7 times a week, playing tennis 5 nights a week and getting up before 7 am Now, I don't want together out of bed. every joint in my body aches, I have no energy, my hands are swollen and i have no stamina when I tr to go to the gym or play tennis I hurt so bas the I do not want to play I have gone from being active and strong to being totally depressed because of the constant pain that I am in
79 2021-04-06 pain in extremity red blotches and sores on fingers and toes; very painful and has lasted more than a month
79 2021-04-09 feeling cold, tremor suddenly began shaking horribly from head to feet/shaking of his hands; freezing; My walking is not ... Read more
suddenly began shaking horribly from head to feet/shaking of his hands; freezing; My walking is not as good as before; This is spontaneous report received from a contactable consumer (patient). A 79-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN6202), via an unspecified route of administration on 01Mar2021 at 12:45 (at the age of 79 years) at a single dose in the left arm for COVID-19 immunization. Medical history included stem cell transplant; then soon after GBS from an unknown date and was diagnosed with COVID-19 from an unknown date. No allergies to medications, food, or other products. Concomitant medications included levothyroxine; rosuvastatin; telmisartan; and metformin. The patient previously took the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL9269) on 08Feb2021 at 12:45 pm in the left arm for COVID-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 01Mar2021 at 21:30, patient was getting ready for bed but suddenly began shaking horribly from head to feet and was freezing. His wife put him in bed with six blankets but he was still freezing. His wife brought him to the ER. Upon arrival at the ER, it was noted that the shaking was gone but the shaking of his hands remain that he could not put a spoon of sugar in his coffee cup without spilling it and stated that his walking is not as good as before. The patient was hospitalized due to the events for 2 days. The events were considered serious for disability. Therapeutic measures were taken as a result of the events (needles were placed on both legs as reported) and MRI was performed. Since the vaccination, the patient has not been tested for COVID-19. The outcome of the events was recovered with sequel on an unspecified date.
79 2021-04-15 weakness weakness, near syncope , hypotension
79 2021-04-17 pain in extremity Extreme Fatigue, sore feet, legs , hips, lower back, mid back, upper back neck into skull ........kn... Read more
Extreme Fatigue, sore feet, legs , hips, lower back, mid back, upper back neck into skull ........knees , shoulders , hands , fingers , wrists....Have not been seen by Dr...his office told me there was nothing they could do ......situation has not improved and doing normal things hurt like hell ...getting up and sitting down painful, getting in and out of car hurts .......I need and use a cane to walk.......how long does this side effect go on?????
79 2021-04-24 feeling hot, feeling cold, hot flush, tremor wheezing in the morning; shortness of breathe in-between all the other symptoms; bronchitis; hot fla... Read more
wheezing in the morning; shortness of breathe in-between all the other symptoms; bronchitis; hot flashes/warm flush; lack of appetite; trouble walking; uneasiness in the stomach; feeling of warmth; achiness; feeling so bad; nausea; Fatigue; he got extremely cold; not feeling well/feel lousy/sick; My fever is 97.7 degrees fahrenheit but about 2, 3 or 4 o'clock my fever ticks up a little; chills/Shivering; shaking uncontrollably; This is a spontaneous report from a contactable consumer (patient) via Medical information team. A 79-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration, dose 2, administered in Arm Right on 11Mar2021 (Batch/Lot Number: EN6204) as SINGLE DOSE for COVID-19 immunization. Medical history included prostate cancer from an unknown date and unknown if ongoing and major radial prostatectomy from 04Feb2021 to an unknown date. The patient previously received first dose of BNT162B2 (lot number: EN9581) on 17Feb2021 for COVID-19 immunisation and experienced chills, low grade fever and fatigue. There were no concomitant medications. The patient got the second dose of BNT162B2. The patient was fine, had no problems until 15Mar20201 (4 days afterwards), the patient stated, "I started getting chills, shaking uncontrollably , nausea, fatigue, a little bit of everything. I wouldn't be calling you but this has not subsided. It's been 3 weeks now and I'm not feeling well. It ebbs and tides. I've been taking a diary. I went to the ER last Monday because I was wheezing in the morning and had shortness of breathe in between all the other symptoms. They did all kind of blood tests, covid test which was negative, chest x-ray showed bronchitis. Blood work and ultrasound of my bladder with unknown results. They sent me home with a inhaler, steroid and an antibiotic and every day since then it seems like at night 9, or 10 o'clock I start feeling better and sleep through the night. My fever is 97.7 degrees fahrenheit but about 2, 3 or 4 o'clock my fever ticks up a little and I start to feel lousy, my stomach feels. I feel like I have hot flashes; a feeling of warmth with achiness and lack of appetite. So I take my Tylenol 7 or 8 o'clock at night my temperature is 97.7F. I haven't had 1 good day since. I've been to my doctor, ER, I've talked with the CDC. What information do you have for people who have had long term symptoms/side effects? What am I supposed to do? Someone from Pfizer needs to give me advice. If not I'll go to the news network. I don't feel well. It's directly related. No one has given me relief or help. It's impacting my life. I've been sick every day. Is there someone above you who can tell me what to do? I took their (Pfizer's) vaccine that was recommended. It was your vaccine. Not mine. Someone has to have an answer for me. Unless you want to go and have lawsuit and the news. Just think about it, if you had to go through the symptoms of having the flu everyday. Please relay this to someone. If I don't heard back within a week, then I'm going ballistic. It's not going to be pretty. Someone has to get back to me to help. I want someone to tell me that I'm not crazy, I'm not the only experiencing this. There has to be an answer. I took your vaccine. You are responsible. I want to know. I can't be the only one in the whole world who is feeling like this. I've been to the ER and the doctors. I've had every side effects but theirs go away in a few days, but mine hasn't. I need advice, that I'm not nuts, something that will help me get better. I want to feel better. It's effecting my family my life. Doesn't it seem odd? I can't be the only one? Someone has to know something. They (drug companies) like to hide the facts. I am sick because I took BNT162B2 vaccine. I need someone to get back to me." After the second dose of BNT162B2, the patient has been experiencing an achy feeling, heat throughout the body, shivering, shaking, trouble walking, and some fever. He reports taking Tylenol, and that helps, but he is still having symptoms that come and go and it has been 3 weeks since the second injection of the Pfizer covid-19 vaccine. He reports going to the ER for treatment after the second injection, and a COVID-19 test was negative and they did not find anything else other than the Pfizer COVID-19 vaccine that would be causing his symptoms. The events hasn't gone away, it's now about 3.5 weeks and he hasn't had a good day since then he has been experiencing chills and fever. It goes away for a couple hours, it goes away till around 9 or 10PM at night, then he is good at night, then in the afternoons around 2PM or so the fever kind of comes back and instead of chills he is getting warm flush, when taking his temperature he notices it ticks up. He is taking Tylenol every 6 hours. He would like to know if this is normal and have others reports this? The First time he experienced the chills and fatigue it was on 18Feb2021. Then the second time the chills, fever, fatigue, and nausea started on 15Mar2021. The events were described, "Fever: It is not as steady, when it ticks up, it is never going past 100F, it's been like 98 and 99, that's when he starts to feeling so bad. He provides todays temperatures, this morning 97.5F he usually runs low, then about 10AM 97.7, then at 11AM 98F, then an hour ago it was 98.8F and he can feel the difference. Nausea: It occurs when the temperature ticks up, it's not really nausea but its uneasiness in the stomach, not necessarily nausea but he feels no appetite. It has the Same pattern as the fever. Fatigue: Yesterday morning he got a blood test and he did not have a fever he was normal 97F, but he could barely take 10 steps, the fatigue varies, it does not coincide with the fever. Looking back over the 3 weeks, the fatigue is better now. On 21Mar2021 he went to the ER because he was feeling so bad, there was a little bit of wheezing and shortness of breath, they did lab work and a chest X-ray, they sent him home with an antibiotic and a steroid inhaler. The chest X-ray showed Bronchitis. Blood work results are Unknown. He clarifies that the ER sent him home the same day after 9 hours, he was not admitted to the hospital. When queried if he had a physician office visits he states that he had 2 "Tele-med" appointments with the Primary Care doctor. He has no Allergies. The outcome of the event fever and nausea was not recovered while the outcome of the event fatigue was recovering; and the outcome of the rest of the events was unknown.
79 2021-04-27 weakness Aches Chills Fever From 9pm, Friday, April 23rd until 9pm Sunday, April 25th --- Weakness followed
79 2021-04-28 pain in extremity Patient presented to a doctor's appointment with complaints of blood in stool as well as a sore arm ... Read more
Patient presented to a doctor's appointment with complaints of blood in stool as well as a sore arm ever since his COVID vaccination.
79 2021-05-03 weakness Covid positive 4/19/2021, off balance, weak/tired, trouble hearing, cannot taste, cough, runny nose,... Read more
Covid positive 4/19/2021, off balance, weak/tired, trouble hearing, cannot taste, cough, runny nose, reports not short of breath but breathing heavy, fever comes and goes,
79 2021-05-04 bell's palsy Bells Palsy, started 5/4/21. 1st dose of pfizer vaccine given on 4/14/21. Had been due for second do... Read more
Bells Palsy, started 5/4/21. 1st dose of pfizer vaccine given on 4/14/21. Had been due for second dose on 5/5/21 but will be delayed by a couple of weeks or will switch to J&J.
79 2021-05-09 face paralysis Cerebrovascular accident. Facial weakness.
79 2021-05-10 weakness Initially had chills, myalgia, and weakness. Symptoms worsened with fever and ongoing headache that... Read more
Initially had chills, myalgia, and weakness. Symptoms worsened with fever and ongoing headache that lasted for 2 weeks. Developed visual disturbances. Was admitted twice and ultimately diagnosed with giant cell arteritis
79 2021-05-10 numbness swelling and it felt numb, the numb feeling starting on left side of cheek and wound up settling in ... Read more
swelling and it felt numb, the numb feeling starting on left side of cheek and wound up settling in upper lip; swollen gland he noticed on the left side; the swelling in the mouth on the 11Feb2021 on his lip lasted about 2 days,his upper lip irritated on inside for a day or 2,; swelling that occurred in his mouth/1st occurrence of swelling was like golf ball size, it was visible; This is a spontaneous report from a contactable consumer (patient). A 79-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EL3248), dose 1 via an unspecified route of administration, administered in Arm Left on 27Jan2021 11:00 (at 79-years age) as single dose for covid-19 immunisation. Medical history included diabetes and hypertension (he was diabetic and was on blood pressure medication, but both his hypertension was under control, and his diabetes, sure his A1C is higher than it should be but was under control with oral medication), root canal infection (though this was contributed to the root canal which he had on 29Jan2021, the root canal was on the lower left of the mouth, tooth number 20). Patient provided relevant Family medical History of Hypertension. Concomitant Medications: He was just taking his general medications, like his maintenance medication, nothing out of the normal. He had no other vaccines on the same day as the covid vaccine or in the 4 weeks prior. He had no positive covid or antibody test prior to the first dose (he had never had a test).On 08Feb2021, the patient had the 1st occurrence of swelling was like golf ball size, it was visible, but it went away after 3-4 hours and he didn't have to take anything. Then on the 11Feb2021, the patient woke up at 4:30AM, experienced the swelling and it felt numb, the numb feeling starting on left side of cheek and wound up settling in upper lip, it gave him a distorted appearance, it was severe. The swelling in the mouth, that wound up settling in upper lip which was the 2nd occurrence in a 3-day period. The first occurrence was swelling, not as severe, in the lower inside of the mouth in the lower right inside of the gum, the swelling appearance from the outside, though this was contributed to the root canal (had on 29Jan2021). The swelling in the mouth from 08Feb2021 subsided for him in 3-4 hours. He called endodontist, and told her about the second swelling, she said to come in and look at it, that was on 11Feb2021, she took X-rays and result was normal, she said it was not connected to the root canal and told him to contact his Primary and go from there, he agreed with her because he did not feel any type of sensitivity. On 11Feb2021, patient then called the Primary Care doctor, told how he developed the swelling, and the primary care said that he would rather see an ENT specialist and he got an appointment with the ENT that same day 11Feb2021 at 15:00 in the afternoon. The patient went to see him, the ENT checked his mouth out, checked his nose and throat, he did not know what it was stemming from, and said he will put him on an antibiotic. On 11Feb2021, the ENT said that the patient did had a swollen gland he noticed on the left side. The swelling in the mouth on the 11Feb2021 on his lip lasted about 2 days, his upper lip irritated on inside for a day or 2, but it lasted till about the 13Feb2021. On 11Feb2021 (5 days ago), the patient was put on an antibiotic for swelling that occurred in his mouth which was Clindamycin HCL 300mg, 3 pills a day with his last 2 pills of antibiotics falls same day (18Feb2021) as his second vaccine dose was scheduled on Thursday (18Feb2021; appeared to be scheduled outside of the 21-day recommendation). Patient felt like he was sort of on edge for another occurrence possibly happening. Being on the antibiotic, maybe this was some type of infection. The ENT told honestly that he didn't know why this happened, but if it happened again, he might have a CT scan for the suspect salivary gland, maybe it was clogged or there was an infection in the gland. He asked if he should take the pills or reschedule the vaccine dose and if it was ok to receive the second shot while on this antibiotic (his prescribing doctor couldn't give an answer). On 18Feb2021, the patient was due to have booster. Patient would have 2 pills left on the 18Feb2021, after that he was finished. Therapeutic measures of antibiotic were taken as a result of swelling that occurred in his mouth (mouth swelling). He did not have to go to the emergency room for the mouth swelling but he has visited the physician's office. The outcome for swelling in the mouth and lips was recovered on 13Feb2021 (Duration 5 Day); outcome for swollen gland was unknown. Follow up (16Feb2021): This is a follow up spontaneous report from a contactable consumer. This consumer reported patient information, new event information.
79 2021-05-14 weakness Dizziness; weakness; fever; tinnitus; chills; acid reflux; vomit; difficulty breathing; enhanced sme... Read more
Dizziness; weakness; fever; tinnitus; chills; acid reflux; vomit; difficulty breathing; enhanced smells and taste; enhanced smells and taste; via unspecified route of administration in left leg; This is a spontaneous report received from a non-contactable consumer (patient). A 79-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EN6198), via unspecified route of administration in left leg on 25Feb2021 08:15 AM (at the age of 79-year-old) at 1st dose, single for COVID-19 immunization. The patient's medical history was not reported. Prior to vaccination the patient was not diagnosed with COVID-19. The patient was taking unspecified concomitant medications, it was reported that patient received any other medications within two weeks of vaccination. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On 26Feb2021 the patient experienced dizziness, weakness, fever, tinnitus, chills, acid reflux, enhanced smells and taste, vomit, difficulty breathing. The events were reported as serious with hospitalization and life-threatening criteria. The patient was hospitalized on 14Mar2021 and duration of hospitalization was reported as 5 days (19Mar2021). The adverse events resulted in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. It was reported that since the vaccination, the patient had been tested for COVID-19 with test type nasal swab (negative) and test type other with test name antibodies test to SARS-COVID 19 (negative). The outcome of the events was unknown. No follow-up attempts are possible. No further information is expected.
79 2021-05-18 weakness Patient with new onset of severe dizziness after his first COVID19 vaccine. Pt began having dizzines... Read more
Patient with new onset of severe dizziness after his first COVID19 vaccine. Pt began having dizziness and then felt nauseated, weak, and diaphoretic. Patient left ED.
79 2021-05-18 bell's palsy, facial paralysis Diagnnosis: Bell's Palsy, right ear ache, right peripheral facial palsy, and corneal injury. March... Read more
Diagnnosis: Bell's Palsy, right ear ache, right peripheral facial palsy, and corneal injury. March 29 to April first. Treatment by Opthomologist: eye drops every hour and eye lubricant before bed.
79 2021-05-18 pain in extremity Sore arm; This is a spontaneous report from a contactable consumer. This consumer reported for a 79-... Read more
Sore arm; This is a spontaneous report from a contactable consumer. This consumer reported for a 79-year-old male patient (husband). A 79-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EL1283), via an unspecified route of administration, administered in deltoid right on 26Jan2021 15:00 as unknown, single for covid-19 immunisation. Relevant medical history and concurrent conditions: diabetes type 2, Hypertension, Stroke(Other Conditions: he has completely recovered), incipient Parkinson's disease(Other Conditions: this was minor and he has very little to no symptoms, Congestive heart failure was ongoing. 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): The only vaccine they get was the flu shot and has had to have things like typhoid, the shots needed for international travel. He has had a never had a reaction to a vaccine that she knows about and they had been married over 50 years. No additional vaccines administered on same date of the Pfizer Suspect. No Emergency Room and Physician Office visited. Prior Vaccinations (within 4 weeks) was none. AEs following prior vaccinations was none. Patient's Medical History (including any illness at time of vaccination) was no. Family Medical History Relevant to AEs was no Relevant Tests was no. Time the Vaccination Was Given was 3pm. Anatomical Location of Administration of Pfizer vaccine considered as suspect: right deltoid. On26Jan2021, the patient experienced, sore arm. No other Products. Investigation Assessment was no. Additional Context: Caller, reporting COVID vaccine and who has a question. She explains her and her husband got the vaccine on Tuesday 26Jan2021. Her husband was fine except for the sore arm, but she didn't feel so well. Her normal temperature is 96-97.0 but she was running at 99.5 low grade fever and didn't feel well. She had chills and didn't sleep well. Last night she had a slight headache, chills, and didn't sleep well but today is much better. She has had no other symptom but was taking Tylenol. When speaking with her sister, she was told by her that she read Tylenol could affect the efficacy of the vaccine. She wants to know does it affect the efficacy, also her husband and her had a martini to celebrate getting the vaccine. Is that ok. Prescribing Healthcare: no address, phone or email are known. The night of the 26Jan2021 she had chills that left her she was hot then cold. On 27Jan2021, later in the evening, she had a slight headache and then it went away later on that evening. Treatment: She could not get through the day without the Tylenol. Today, she is a little tired, but her fever was 98.1 when she last took her temperature. She is much better today. The only way to describe yesterday is that she felt really yucky. She was healthy. On 28Jan2021, the outcome of event was recovered Follow-up (07May2021): Follow-up attempts completed. No further information expected.
79 2021-05-27 inability to speak embolic stroke; blood clot; His major issue was speech and wasn't able to formulate any words; left ... Read more
embolic stroke; blood clot; His major issue was speech and wasn't able to formulate any words; left sided weakness on his leg; This is a spontaneous report from a contactable nurse (patient's daughter). A 79-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 30Mar2021 11:00 (Batch/Lot number was not reported) as 2nd dose, single dose (at the age of 79-years-old) for COVID-19 immunisation. Medical history included transient ischaemic attack (TIA) from 2019 to an unknown date, mild hypertension, idiopathic neuropathy: in the left leg, started in the beginning of the year from 2019, melanoma removed in the 1970s, enlarged prostate, neuropathy, cholesterol and fluid retention. Ongoing concomitant medications included tamsulosin taken for enlarged prostate; gabapentin taken for neuropathy; candesartan taken for hypertension; pravastatin taken for cholesterol; acetylsalicylic acid (BABY ASPIRIN); and furosemide (LASIX [FUROSEMIDE]) taken for fluid retention. The patient has been taking all of his meds for quite some time, over 5 years. The patient did not have prior vaccinations within 4 weeks. The patient received the first dose of BNT162B2 on 09Mar2021 10:30 for COVID-19 immunization. The patient completed the Pfizer COVID vaccine series, the second shot was on 30Mar2021. On 09Apr2021, the patient had an embolic stroke. The patient's daughter stated that the patient has a history of TIA in 2019 and was concerned. She does not know if it was related. She added it might be that if people have previous risk, there may be some precautions, like to take a full dose of aspirin before, a week before. She sent an e-mail last 05May2021 and hasn't gotten a response back. The patient went to the ER due to embolic stroke and was in the hospital Friday (09Apr2021) through Wednesday. The patient went to the stroke rehab center for 3 weeks. The daughter clarified that the patient was in the hospital until 14 or 15Apr2021 before being transferred (also reported as 5 or 6 days and in rehab for three weeks). Then was discharged last 06May2021. The patient's condition seemed to be getting better. His major issue was speech and wasn't able to formulate any words. He was able to speak now. His rehab would be a lot of neurological rehab and speech therapy. The patient previously had left sided weakness on his leg from some random thing that happened. It didn't seem to get worse. It really affected his speech and cognition. The patient's daughter thought that the embolic stroke was related to the Pfizer Covid vaccine and added that thought was in some way but cannot say in what way. She thought that it exacerbated some type of blood clotting. She stated that he never had blood clotting issues before and was the type of person that would take a baby aspirin and get a nose bleed, he was the opposite of a clotter. An MRI in the hospital showed blood clot and stroke. He had blood work but does not know what it showed and presumed he was fine (unknown results). He has never really had any kind of blood work issues and does not know why he was on cholesterol medication. The patient required emergency room visit for embolic stroke. The outcome of the events was unknown. Information on the lot/batch number has been requested.; Sender's Comments: Considering a plausible temporal relationship and known product safety profile, a possible contributory role of suspect product BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) to the reported "embolic stroke" cannot be excluded. Previous medical history and Old age is a risk factor for the onset of stroke. 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.
79 2021-05-28 pain in extremity right wrist was "quite sore and painful"/left wrist then "started swelling and being painful"; carpa... Read more
right wrist was "quite sore and painful"/left wrist then "started swelling and being painful"; carpal tunnel; feeling anxious; feels "warm" outside of his left wrist/ felt like a fire underneath his kneecap/ was hotter than a firecracker; arm was so sore he couldn't pick it up straight in the air; trouble walking; right shoulder was swollen; left knee is swollen real bad; right shoulder was pretty sore and is getting worst all the time; left knee was "sore"; right wrist twice as thick as [his] left one/left wrist then "started swelling and being painful"; This is a spontaneous report from a contactable consumer, the patient. This 80-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: UNKNOWN) via unspecified route in Apr2021 (at the age of 79-years-old) as a single dose for the corona virus, to get rid of it/ it's supposed to be sure he didn't get it. Patient had no medical history. There was no relevant family medical history. There were no additional vaccines administered on same date of the COVID-vaccine. Patient had no adverse events following prior vaccinations. He remembers his first polio shot he got that back in the early 50's and his second shot was a cube of sugar, called the salt vaccine. Stated he's been getting vaccines for a long time and he never had any trouble with any of them. The patient previously received the initial dose of the BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) in 2021 (March or April) in the left arm which was deemed invalid by the vaccination provider due to temperature related issues (i.e wasn't cold enough). He explained he received a letter informing him of this incident and recommending a replacement dose (which he thinks was on 06Apr2021). About 2 to 3 weeks before he got his first COVID shot, he got a flu shot in his left arm, about 4 or 5 inches above where he got his COVID shot. The patient's concomitant medications were not specified. He reported that the second vaccine (BNT162b2) caused him problems. On 06May2021, he woke up with his right wrist twice as thick as his left one, it was swollen real bad. The right wrist was quite sore and painful. He didn't know if he was getting carpal tunnel or what it was, so he went to the ER about it and they gave him three different kinds of pills, two of which included tramadol 50mg one every day and ibuprofen 400 mg. The ER couldn't determine the cause for his reaction. About 3-4 days after taking the prescribed medication, his reaction subsided quite a bit and was not nearly as hurtful, but his left wrist then started swelling and being painful/sore. Therefore, he continued to take his medication and it improved. It was like that for a couple/ three days, and it calmed down. He thought he was okay 2-3 days ago, but this morning (14May2021), his right shoulder was swollen and pretty sore and was getting worse; he was in so much pain, so sore he could hardly even move his arm, he couldn't pick it up straight in the air, couldn't get his elbow up past his ear. The patient also reported that when he got off his bed, his left knee was sore and it felt like a fire underneath his kneecap and he was having trouble walking. The left knee was swollen real bad and was hotter than a firecracker. Thus, he went back to taking his pill again. The knee pain started the morning of 14May2021 about the same time it seemed and has worsened, and he took a 400mg ibuprofen and the other pill he's taking, "100 mg doxycycline or something". Patient hadn't been doing much since, he was feeling kind of laid up, he had thought it was all done with yesterday (13May2021). He stated he's been hearing things about allergic reactions to this COVID shot, was sure that a lot of people are having complaints of allergic reactions, and was sure he's not the only one who has had a problem like this. He asked if there was anything he can take to block it because he is sure when this calms down after a week or whatever, it will be his in his right knee or left shoulder or wrists or ankles and he's 100% it's about that COVID shot. He stated he's never had arthritis before. He stated that he has never had any problems like this before. He is supposed to go see his doctor in a week or two. He tried to call the doctor to make an appointment, but he figured he would wait a couple days, but he is hurting bad today (14May2021), and he hasn't been to anybody yet except for the ER. The patient stated it looks like the vaccine is methodically causing this spread into his body. He also reported that it feels warm outside of his left wrist, towards the edge of it and all the way to the joint of the little finger and he thinks the swelling will start again. He expressed feeling anxious about his reactions. He asked if there were any kinds of pills he could take to block the effects of the vaccine from working in his body. He stated it seems like it's going from one area to the next and it seems like it's going through his joints and he doesn't like that. His left wrist still got a little bit of soreness in the back near the joint, but doesn't appear to be swollen. Regarding the right wrist, he has recovered completely, it feels better; doesn't feel any soreness in any place and doesn't look swollen. The clinical outcome of right wrist twice as thick/left wrist started swelling recovered on unspecified date; left wrist painful/sore not recovered; right shoulder is so sore not recovered; left knee was sore not recovered; anxious was unknown; feels "warm" outside of his left wrist/ felt like a fire underneath his kneecap was unknown; left knee is swollen not recovered; arm was so sore unknown; carpal tunnel unknown; trouble walking unknown; right shoulder was swollen was not recovered. The lot number for the vaccine, BNT162b2 , was not provided and will be requested during follow up.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021551521 same patient/reporter/drug with different AE/time gap.
79 2021-06-01 concussion dizziness/When I stand up I can't move right away. I have to wait until the dizziness goes away/dizz... Read more
dizziness/When I stand up I can't move right away. I have to wait until the dizziness goes away/dizzy feeling like he a concussion; dizziness/When I stand up I can't move right away. I have to wait until the dizziness goes away/dizzy feeling like he a concussion; dizziness/When I stand up I can't move right away. I have to wait until the dizziness goes away/dizzy feeling like he a concussion; This is a spontaneous report from a contactable consumer (patient) via medical information team. A male patient of 79-year-old received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration (Batch/Lot number was not reported) on 31Jan2021 (reported as yesterday morning (Sunday)) as 2ND DOSE, SINGLE DOSE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. On 31Jan2021 (reported as starting last night), the patient experienced dizziness/when he stands up, can't move right away. He has to wait until the dizziness goes away/dizzy feeling like he a concussion. This morning he was having the dizzy feeling like he a concussion. He wants to know, if this could be a side effect. He sat and waited for 15 minutes after with no reaction. The outcome of all the events was unknown. There was no product quality complaint (PQC) present. Information on the lot/batch number has been requested. This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
79 2021-06-03 pain in extremity Two weeks and one day after receiving second dose of COVID19 vaccine, patient experienced extreme sh... Read more
Two weeks and one day after receiving second dose of COVID19 vaccine, patient experienced extreme sharp pain in injection arm (left arm: injection site, shoulder and elbow) as well as muscle in opposite leg and hip that prevented him from walking. Pain has minimized since then (report is one week after incident) but patient still feels some minor pain, and says he will report to his primary care provider if symptoms persist for one week. Patient took aspirin for pain, which helped.
79 2021-06-09 seizure Patient presented to the ED with dehydration, elevated lactic acid and seizure, and was subsequentl... Read more
Patient presented to the ED with dehydration, elevated lactic acid and seizure, and was subsequently hospitalized for elevated troponin and seizure. This is within 6 weeks of receiving second covid vaccination.
79 2021-06-14 muscle spasms Pt had 1st Pfizer Covid 19 vaccine on 3/5/21 and 2nd Pfizer Covid 19 vaccine on 4/2/21. He started ... Read more
Pt had 1st Pfizer Covid 19 vaccine on 3/5/21 and 2nd Pfizer Covid 19 vaccine on 4/2/21. He started to have mild muscle pain just before the 2nd vaccine and continued. Few days after the 2nd vaccine, his muscle pain got worse. He went to a pain clinic from 4/5/21 to 4/9/21. He stopped going there because his muscle pain got worse and he could not walk or move. On 4/16, he made an appointment to see Dr. (orthopedic) and Dr. could not see anything wrong with the X-ray. Dr. said he had a similar case with other patients and pain shots will not fix it. Pt saw PCP (his main doctor) on 6/7/21 and told him he still has muscle pain with muscle spasm and he cannot move or walk. PCP told him to exercise. Pt is still in serious muscle pain and he is homebound from 4/9/21 to now. He cannot walk or move. His symptoms have not improved at all. We do not know what to do because his muscle pain won?t go away for about 4 months now.
79 2021-06-16 pain in extremity a shooting pain started up into his knee and it just aches all the time; It is irritated where he ca... Read more
a shooting pain started up into his knee and it just aches all the time; It is irritated where he cannot wear a shoe now/He cannot get up and out of chair/ He cannot do anything; Everything was normal except for that same mass in his foot; he has a soft tumor on both feet/ the tumor is sticking out; his foot started hurting/his right foot is having pain/ the pain is starting to get worse; now I can't walk; This is a spontaneous report from a contactable consumer (patient reported himself). A 79-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for Injection, Lot Number: EN6201), via an unspecified route of administration, administered in arm left on 16Feb2021 09:00 (at the age of 79-year-old) at a 2nd dose, single dose for COVID-19 immunization. The patient medical history included foot tumor. The patient's concomitant medications were not reported. Patient did not receive any other vaccines within 4 weeks prior vaccinations. The patient previously took historical vaccine of first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for Injection, Lot Number: EL9265) via an unspecified route of administration, administered in arm left on 29Jan2021 09:00 as single dose for COVID-19 immunization. The patient reported he has a soft tumor on both feet/ the tumor is sticking out, his foot started hurting/his right foot is having pain/ the pain is starting to get worse, now I can't walk, it is irritated where he cannot wear a shoe now/he cannot get up and out of chair/ he cannot do anything, everything was normal except for that same mass in his foot on an unspecified date in 2021, a shooting pain started up into his knee and it just aches all the time on 26Apr2021. AE resulted to visit physician office. Patient is a consumer, asking what do I do or what can I take to make this pain go away. Patient reported that he received both doses of the Pfizer covid vaccine, his first dose in January and his second dose February 1. Patient reported that around the same time that he got his shots his foot started hurting and now I can't walk. Patient reported that he has a soft tumor on both feet but his right foot is having pain, the tumor is sticking out and the pain is starting to get worse. Patient reported that nothing works to take the pain away. Patient reported that he saw his doctor a while back but reports that back then the pain wasn't as bad, they did x-rays and nothing was wrong. Patient reported that now the pain is terrible. Soon after having the COVID vaccine shot in Jan 2021, patient started having foot problems on his right foot. Patient did have a preexisting soft tumor in that foot. It is irritated where he cannot wear a shoe now. Patient can't stand or walk on it. It is constantly aching. A couple of days ago, a shooting pain started up into his knee and it just aches all the time. Patient was wondering if this is one of the side effects. Patient wants to find out if it is caused by the vaccine. Patient had a x-ray three weeks ago, and there was nothing wrong with his foot. Patient had no break, no spurs, or anything. Everything was normal except for that same mass in his foot. Patient thinks the vaccine affected the mass. Patient can't walk on his foot it just aches. Patient foot became irritated in Jan 2021. It was irritating. It has worsened. The shooting pain up to his knee started 26 Apr 2021. Patient just drove to the hospital today to get information and the pain shot up a little bit today. Even when patient is sitting in a chair he has aching and shooting pains in his foot. Patient went to the store in pain. Patient cannot do anything, cannot get up and out of chair, can't turn around with his foot on the floor. The patient underwent lab tests and procedures which included x-ray was normal -he had a x-ray three weeks ago, and there was nothing wrong with his foot. He had no break, no spurs, or anything. Everything was normal except for that same mass in his foot. Outcome of the event a shooting pain started up into his knee and it just aches all the time was not recovered, and rest of the events was unknown. No follow-up attempts are needed. No further information is expected.
79 2021-06-21 burning sensation Clients wife called to report adverse event. Wife reported client having episodes of lungs feeling l... Read more
Clients wife called to report adverse event. Wife reported client having episodes of lungs feeling like they are burning, experiencing shortness of air when walking thirty to forty feet, and elevated blood pressure at times of episode. Wife reported she has called primary care provider to let doctor know. Doctor referred client to see his lung doctor as soon as possible. Wife reports they are in another state working on their farm and is having trouble getting client to cooperate to go to doctor. Clients wife reported primary care provider recommended going to ER as soon as client experiences any of those symptoms again. Educated wife the importance of listening to providers recommendations. Clients wife reported client using his own CPAP machine when episode occurs and it does bring some relief to symptoms.
79 2021-06-23 tremor, feeling cold, weakness Loss of breath, unable to stand, loss of memory, oxygen level became low, dizzy, weakness, blood pre... Read more
Loss of breath, unable to stand, loss of memory, oxygen level became low, dizzy, weakness, blood pressure declined, diarrhea, vomiting, injection sight swollen, disoriented, shakes, was freezing, uncontrollable bowls, unknown substance coming from mouth, loss of strength in arm
79 2021-06-24 weakness generalize weakness- emergency room visit
79 2021-06-24 feeling cold depressed; he was freezing and was shivering; he was freezing and was shivering; blood pressure was ... Read more
depressed; he was freezing and was shivering; he was freezing and was shivering; blood pressure was a little high; pulse was high; Nauseated; slept a lot; feeling tired; chills; high fever; muscle aches; This is a spontaneous report from a contactable consumer or other non hcp (Patient wife). A 79-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Solution for injection, Lot Number: EN5318), intramuscularly, administered in Arm Left on 03Feb2021 08:00 as 1st dose, single for covid-19 vaccination (79 years old when vaccinated). Medical history included ongoing High blood pressure, additional Information for Other Conditions: Diagnosed years ago, ongoing CAC score high from 2018, ongoing urinary tract disorder from 2007- She said that he takes urinary medication, nephrolithiasis and also felt like it was like when he had a kidney stone. She said that he does not have a kidney stone. She said that he was really sick and hospitalized with the kidney stone. The patient's concomitant medications were not reported. Patient did not receive any other prior Vaccinations within 4 weeks Shingles vaccine, 2nd dose, No manufacturer or lot number at the time of the call, Intramuscular injection, Left arm 1 previous dose, given 2.5 weeks prior to the Covid vaccine at the beginning of Jan2021.It was reported that, Consumer called on behalf of her husband, who had his 1st dose of the Pfizer Covid vaccine last Wednesday morning (03Feb2021). He then started experiencing symptoms yesterday (on 04Feb2021) and last night he started feeling tired, had chills, high fever and muscle aches which was worried. She said that everything was ok until yesterday other than being tired, he had no reaction and no real soreness in his arm. Yesterday he was really tired and slept a lot and at about 20:30 he yelled out he was freezing and was shivering felt like it was like when he had a kidney stone, that he does not have a kidney stone. She said that his fever spiked really high, and he was treated with Tylenol and it came down. His highest temperature was 102. When he first got up this morning(05Feb2021), his temperature was normal, but within the next hour it went to 101.9 at 10:00, then to over 101, and then it came back down to 100. It maintained during the night, he had some muscle aches now, he was a little bit nauseated, but that has gone away also, and the Nausea did not last very long. The blood pressure was a little high and his pulse little high, but the blood pressure is better. His next appointment for his 2nd dose of the Covid-19 Vaccine is 24Feb2021. She said that he takes high blood pressure medication. urinary medication, and cholesterol medication. He had been a little depressed because of Covid and he is taking antidepressant medication, but it should be temporary. Therapeutic measures were taken Tylenol as a result of high fever, blood pressure was a little high, depressed. The outcome of the events Fatigue, chills and Nausea, feeling cold were resolved; for Fever, Muscle ache, pulse was high, Myalgia, Hypertension, Depression mood were not recovered, blood pressure was a little high was recovering was unknown. Follow-up (14May2021): Follow-up attempts completed. No further information expected.
79 2021-06-28 pain in extremity On 03/27/2021 I had the second dose and 3 weeks later I started to have a swollen hand and painful w... Read more
On 03/27/2021 I had the second dose and 3 weeks later I started to have a swollen hand and painful wrist and hand and I was unable to pick up things. I decided to go to the doctor and he gave me injections in the wrist and they did some x-rays. The second time I visited the doctor they diagnosed me with Rheumatoid arthritis in the hand and wrist in the same arm I had the injection. And they put me on prednisone.
79 2021-07-05 difficulty speaking AFib; His voice is hoarse today.; This is a spontaneous report from a contactable consumer (patient)... Read more
AFib; His voice is hoarse today.; This is a spontaneous report from a contactable consumer (patient). A 79-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in arm left on 13Feb2021 19:00 (Batch/Lot Number: EN6201) as dose 2, single for covid-19 immunisation. Patient age at vaccination was 79 years old. Medical history included ongoing COPD (chronic obstructive pulmonary disease), ongoing emphysema, ongoing high blood pressure (he couldn't say, it has to have been a good 15 years he has had it), ongoing high cholesterol (he had it for over 10 years), ongoing Low red blood cell count (depending on his blood count, they give him either a Vitamin B shot or Procrit), ongoing idiopathic pulmonary fibrosis. Both of his parents had type 2 diabetes, and he had type 2 diabetes. Historical vaccine included 1st dose of BNT162B2 (Lot no: EL9263) on 25Jan2021 at 19:00 in left arm for COVID-19 Immunization and flu shot back on October for immunization. Concomitant medications included prednisone (It was for his lungs (unspecific). It was prescribed by his lung doctor. It affected the immune system. He took 10mg. He was taking 5mg then they changed it to 10mg about a month ago. He had taken it for maybe 1 and a half to 2 years); epoetin alfa (PROCRIT) taken for red blood cell count decreased, he only took it as needed when his count was below 10. He had not taken it in 6 months; losartan taken for high blood pressure, from May2021 and ongoing (It was new, he started it about a month ago); amlodipine taken for high blood pressure from May2021 and ongoing (He had been taking it for about a month); atorvastatin taken for blood cholesterol increased from an unspecified start date and ongoing (He had taken it for a couple years); nintedanib esilate (OFEV) taken for idiopathic pulmonary fibrosis from an unspecified start date and ongoing (He had been on it for about a year). The patient experienced AFib on an unspecified date with outcome of recovered. His voice was hoarse today (21Jun2021) with outcome of unknown. He stated he spent 4 days in the hospital and got his rhythm back to normal after 2 days. They put him on apixaban (ELIQUIS), which was a blood thinner. The AFib has resolved, he had no problem with it anymore. The patient underwent lab tests which included COVID-19 antibody test: negative on both 09Jun2021 and 16Jun2021. His HCP told him it was due to prednisone that lowers his immune system.
79 2021-07-14 difficulty speaking Hoarse voice, uncontrolled deep sneezes, dizziness
79 2021-07-17 pain in extremity Chronic Orthostatic Hypotension; Chronic Pain in the Arm that got the shot still; Dizziness; Cannot... Read more
Chronic Orthostatic Hypotension; Chronic Pain in the Arm that got the shot still; Dizziness; Cannot walk without support and fall to my knees to prevent falling; This is a spontaneous report from a contactable consumer (patient). A 79-years-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration, administered in Arm Right on 20Mar2021 12:00 (at the age of 79-years-old) (Batch/Lot number was not reported) as single dose for COVID-19 immunisation. Medical history included seizure. The patient had no known allergies. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medication(s) included midodrine; levetiracetam; doxazosin; finasteride, all taken for an unspecified indication, start and stop date were not reported. 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), via an unspecified route of administration, administered in Arm Right in Feb2021 at 12.00 (at the age of 79-years-old) (Batch/Lot number was not reported) for COVID-19 immunisation. Since 15Apr2021, 12:00 PM, the patient experienced chronic orthostatic hypotension, chronic pain in the arm that got the shot still, dizziness, cannot walk without support and fall to my knees to prevent falling. AE resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Hosp, Disability or permanent damage. The patient was hospitalized for 10 days. The patient received treatment for AE, adjusted medications. Since the vaccination, the patient had not been tested for COVID-19. Outcome of the events was not recovered. Information on lot/batch number has been requested.
79 2021-07-23 seizure, tremor 1 significant episode of asymptomatic Supraventricular tachycardia; transient ischemic attack; seizu... Read more
1 significant episode of asymptomatic Supraventricular tachycardia; transient ischemic attack; seizure-like shaking; shaking episode arms going up and down; extremely tired; This is a spontaneous report from a contactable physician (patient himself). A 79-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration in Feb2021 (Batch/Lot number was not reported) at the age of 79-year-old male as single dose for covid-19 immunisation. Medical history included ongoing diabetes type two from 30 years, ongoing hypertension from 15 or 20 years ago, depression from 20 years ago, hyperlipidemia from 15 to 20 years, orthostatic hypertension (had it off and on for years; but it got bad in the last couple of months), pain and radiculopathy. Concomitant medication included metformin (1000 mg) taken for diabetes from an unspecified start date and ongoing (taking for years); glipizide (4 mg) taken for diabetes from an unspecified start date and ongoing (taking for years); lisinopril (10 mg) taken for hypertension from Mar2021 and ongoing; duloxetine (60 mg) taken for depression and pain from an unspecified start date and ongoing (taking for years); gabapentin (NEURONTIN) taken for radiculopathy, start and stop date were not reported. The patient previously took flu shot for immunization and took dose 1 of bnt162b2 in Jan2021 for Covid-19 immunization at the age of 79-year-old. Physician was calling regarding the Pfizer BioNTech COVID 19 vaccine. He had a very strange experience; added he was a physician and in reasonable good health. He had mild side effects, not much; the one side effect he did have was one week after the second shot he and his wife both felt extremely tired the whole day from Feb 2021. Physician mentioned that 4-6 weeks after getting the 2nd dose, he had a 3-5 minute episode of seizure-like shaking, shaking episode arms going up and down on 21Mar2021 and that he was just blankly staring and non-responsive. He had no other symptoms to suggest a seizure; no biting; no urination. This episode lasted three to five minutes. During the episode his wife said he was just staring ahead and he was non responsive to his wife who was only six inches away speaking to him. Then he started to vaguely he heard his wife's voice in the distance and then he woke up and then he was fine. Later that day he was hospitalized, they did a work up and discharged him about 4 days later. While in the hospital he thought he had a Blood work, CAT Scan; MRI; holter monitor; EEG but they were all normal. He had no other complications and the effect completely went away. Adds he was completely recovered when it went away. At discharge they put him baby aspirin, 81mg enteric coated aspirin once daily, and gave him a tentative diagnosis of transient ischemic attack (TIA). This further resulted to being hospitalized for 3 days but his physicians were not able to see anything significant on his MRI, 72 hours EEGs and telemetry tests (everything was normal). However, during his out-patient visit, his physician mentioned that he had 1 significant episode of asymptomatic Supraventricular tachycardia that may be causing the seizure (inconclusive). They further specified to him that it was not much of a tonic clonic seizure. He also verified that he only had 1 episode of the mentioned event, no other side effects experience and been feeling fine since then. After discharge he had a work up on the outside including a 72 hour EEG; 72 hour holter with the only thing that was abnormal that one run of 3 beat supraventricular tachycardia that was asymptomatic. His doctor put him on Metoprolol 12 mg once daily at night by mouth to help prevent arrhythmias as well as control his blood pressure. He had previously taken lisinopril. He added the only thing he knew that he never had anything like this before in his life. Patient mentions he was at a good weight now as he lost 40 pounds last year for his daughter's wedding. He added sometime in the last 6 to 8 months he had severe left side radiculopathy and was taking small dose of gabapentin. He did not remember if it happened before or after the vaccine but he went to see a pain specialist. The medication worked and he tapered it down and discontinued it. It may have been before the vaccine, he is unsure. But the medication worked like a miracle as he had intractable pain down his leg. All events resulted in emergency room. In line with this, he would like to know in relevance to the news of Pfizer releasing a possible booster dose, if there are any reports of anything that may be related to seizure and/or Transient ischemic attack (TIA) of cardiac origin or a like. Extremely tired was reported as non-serious, other events was serious and caused hospital from 21Mar2021 to 24Mar2021. Outcome shaking episode arms going up and down was recovered on 21Mar2021, of extremely tired was recovered in 2021, of other events was unknown.; Sender's Comments: There is no reasonable possibility that the events supraventricular tachycardia, seizure, tremor, and transient ischemic attack happening 4-6 weeks after vaccination were related to BNT162b2. It is more likely to be complications of pre-existing conditions of hypertension, hyperlipidemia, and diabetes. Advanced age may have been contributory as well. 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.
79 2021-07-28 weakness 79 Male received both doses of Pfizer. Developed symptoms - SOA, decreased activity, generalized we... Read more
79 Male received both doses of Pfizer. Developed symptoms - SOA, decreased activity, generalized weakness, decreased P. O. intake. Tested PCR positive 4/26/2021 & serology 4/29/2021. Hospitalized 4/27/2021. Diagnosis at time of death: Hypoxic ARF requiring MV, COVID-19 PNA, rule out superimposed bacterial PNA, renal failure, oliguric, metabolic acidosis. CWP/COPD exacerbation, CAD, DM present on admission
80 2021-01-07 bell's palsy Development of Bells Palsy approximately 48 hours after initial (dose 1) vaccination with Pfizer vac... Read more
Development of Bells Palsy approximately 48 hours after initial (dose 1) vaccination with Pfizer vaccine.
80 2021-01-07 numbness, bell's palsy I received a call from the pharmacist at the clinic at 10:30 am on 1/8/2021, to let me know that a s... Read more
I received a call from the pharmacist at the clinic at 10:30 am on 1/8/2021, to let me know that a staff member at the facility we were at on Tuesday 1/5/2021 developed Bell's Palsy on 1/7/2021. Half of his face went numb and they feared the patient had a stroke. They rushed the patient to urgent care where it was determined it was Bell's Palsy and NOT a stroke. The patient is back home and recovering well.
80 2021-01-10 pain in extremity Feeling unwell, chills, achy legs, nausea
80 2021-01-11 pain in extremity only a sore arm but enough to interfere with sleeping
80 2021-01-13 tremor shaking, altered consciousness Narrative: One day after pt received his first covid vaccine, pt exp... Read more
shaking, altered consciousness Narrative: One day after pt received his first covid vaccine, pt experienced upper extremity shaking leading to ED visit and subsequent hospitalization with concern for seizure. Examination and labs were not consistent with seizure. He had features of lewy body disease and parkinsonism. Labs were significant for leukocytosis, but pt had no other signs/symptoms of infection or findings to indicate a source of infection. Pt referred to Neurology.
80 2021-01-17 pain in extremity Tiredness, loss of appetite, coughing, nausea, Arm ache, excessive thirst, some sweating. NO high te... Read more
Tiredness, loss of appetite, coughing, nausea, Arm ache, excessive thirst, some sweating. NO high temperature.
80 2021-01-19 weakness Hypoxia; Shortness of breath; Viral pneumonia; COVID-19; Weakness. COVID+ 1/7; Pt had Telephone enco... Read more
Hypoxia; Shortness of breath; Viral pneumonia; COVID-19; Weakness. COVID+ 1/7; Pt had Telephone encounter 1/1 reporting mild symptoms (fever, cough). Possibly infected prior to vaccination; still admitted
80 2021-01-20 tingling, difficulty speaking, numbness, muscle twitching, involuntary muscle movements, slurring Patient reports intermittent left land paresthesias lasting about 10 minutes with a glove distributi... Read more
Patient reports intermittent left land paresthesias lasting about 10 minutes with a glove distribution just in the hand initially on 1/16/21. On 1/18/21, patient had symptoms lasting about 4 hours and could not pick up objects. By the time he came to the ER for this, symptoms had resolved. On Tues, 1/19, patient went skeet shooting and experienced an episode of numbness involving the entire left arm from shoulder to fingertips, involuntary hand movements, and left cheek twitching. These symptoms lasted about 10 minutes. Patient also reported dysarthria, slurred speech, strange sensation on left side of face, and facial asymmetry. His wife reports his voice was a whisper and patient's left arm was dangling at his side. Reports voice feeling weak along with these symptoms.
80 2021-01-20 unresponsive to stimuli Patient's wife called this morning stating that her husband has passed away last night. After receiv... Read more
Patient's wife called this morning stating that her husband has passed away last night. After receiving first dose of Pfizer COVID-19 vaccine at around 0830, patient remained in the Immunizations Department for the 15-minute monitoring period. Per wife, patient's only complaint was pain at the injection site. At 1300, wife states that patient complaint of dizziness which "dissipated after a few minutes" followed by a headache which "dissipated after a few minutes" as well. Then patient complained of nausea, no vomiting and "couldn't relax." Per wife, from around 1400/1500, patient stayed on his recliner while still having a conversation with her--"he didn't get up to eat." Last conversation they had was around 2000/2100. Per wife, at around 2100/2200, patient was quiet and when she checked on him, "he wasn't responding anymore." Wife then called 911, "but they couldn't revive him."
80 2021-01-24 cold extremities 1:32 Shivering and fatigue, chills; BP: 132/35, O2: 97%, HR: 70, Temp: 98.4, Med team alerted; Non-v... Read more
1:32 Shivering and fatigue, chills; BP: 132/35, O2: 97%, HR: 70, Temp: 98.4, Med team alerted; Non-verbal at baseline, hands cold, wearing gloves; (Given warm compress for hands) 1:43: Back to baseline per family, BP: 131/54, MAP: 67, continued observation 1:50: Observation ended, left with 2 family members
80 2021-01-31 weakness he is shrinking; chills; tired; cant walk; it hit me like I had the virus; it hit me like I had the ... Read more
he is shrinking; chills; tired; cant walk; it hit me like I had the virus; it hit me like I had the virus; My eyes are hurting; no matter which way I turned it was hurting, knees, everything was hurting really bad/aches and pain; dizzy/dizziness; weak; muscle pain; joint pain/back knees elbow joint pain; fever; headaches; This is a spontaneous report from a contactable consumer (patient). An 80-year-old male patient received first dose of bnt162b2 (Pfizer BioNtech Covid 19 vaccine, lot number EL1283) , via an unspecified route of administration on 17Jan2021 01:15 at single dose for covid-19 immunisation. Medical history included open heart surgery 11 years ago, covid-19 from Jul2020 to an unknown date. The patient's concomitant medications were not reported. The patient received bnt162b2 yesterday, with no problems. However today (18Jan2021), in 15 minutes after waking up at 11, he had the chills really bad, that went away, then he went to sleep again and woke up and he had all the symptoms on the paperwork, he had dizziness, headache, he's hardly ever had a headache ever. He had aches and pain. Caller states that he was just asking right now about another company, and their vaccine in started with an M, and her daughter is at a girls home, because she has a epileptic type thing, and this particular shot, that started with M, the nurse called over, and the problems that he is having he explained to the nurse is like when he had the virus previously about in Jul2020, when he had the virus he was in hospital for a week, because he had to get rid of the virus, and they got him out of that. Now he took this shot yesterday and the next day is when he got all these symptoms, he's tired, cant walk, muscle pain, had chills not any more, pain in the knees, everywhere really, he couldn't get any position to go back to sleep, his back knees elbow joint pain. Since he had these things, the nurse at the girls home, told his wife if having these problems he can take 300 mg of Zinc, 1000mg of Vitamin C, and 2000IU or Vitamin D, the same thing, that amount, he asks will it over come the symptoms. Another person felt good after getting those, it helped him he does state however that is what the person took when he actually had the Covid 19 Virus. Caller states that he received paperwork after the vaccine from the (State), it has a bunch of blocks asking if he has this or that symptom. His First dose was 17Jan2021 at 1:15, then on 07Feb2021 if this Second Dose. All the side effects started Today 18Jan2021. His doctor said he's in good health. He did have open heart surgery 11 years ago. The patient reported he is 5 feet 8 and a half inches, he is shrinking. He stated, "I was good until this morning, it hit me like I had the virus. The product they gave me at the (State) was the Pfizer-biontech vaccine. I had all the symptoms except vomiting/throwing up. I got all the other symptoms. no matter which way I turned it was hurting, knees, everything was hurting really bad. I was dizzy and weak so I don't want to walk around too much. I had muscle pain, joint pain, fever, headaches, chills, never went away. I hurt everywhere. I am really weak. My eyes are hurting. My daughter is in a girls home (paralysis problem). They had the vaccine from the another company and they have heard so many negative stuff so they decided they did not want to, when my wife told her I was having these problems. I had the virus 4 months, the nurse told me to take 300mg of zinc, 1000mg vitamin C and 2000mg vitamin D (the person took that when he had the disease). Should I take this stuff? Is there any information on that? what's in this? protein? my wife got the disease. They said she had enough antibodies. How long is the immunity? When does it start?" The outcome of the event chills was resolved, of other events was unknown.
80 2021-02-01 bell's palsy, facial paralysis Noticed facial drooping on the left side starting on Friday night and symptoms increasing. Went to u... Read more
Noticed facial drooping on the left side starting on Friday night and symptoms increasing. Went to urgent care on Monday morning. facial drooping increased over the weekend also lift eye was irritated from lack of moister and did not close or blink without extra effort. wore a patch and lubricated over the weekend. Diagnosed as Bellys Palsy at Lander urgent care medical clinic. Prescribed course of prednisone. Also Erythromycin op mgigm oin akor for the left eye and wear a patch until eye will blink and close normally.
80 2021-02-04 weakness weakness, dizziness, loss of appetite, shortness of breath
80 2021-02-04 pain in extremity Arm was sore this morning and red; Arm was sore this morning and red; his left side of his face was ... Read more
Arm was sore this morning and red; Arm was sore this morning and red; his left side of his face was swollen into his left side of his neck; his left side of his face was swollen into his left side of his neck; Headache; This is a spontaneous report from a contactable consumer. A 80-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EL3248) on right arm, via an unspecified route of administration on 21Jan2021 10:15 at single dose for covid-19 immunisation. Medical history included chronic obstructive pulmonary disease (COPD) (home oxygen), heart disease, high blood pressure and diabetes. The patient's concomitant medications were not reported. The patient got the shot (vaccine) yesterday (21Jan2021) at 10:15 at the veteran administration. He got a headache right after that, just a slight headache. His arm was sore this morning (21Jan2021) and red and his left side of his face was swollen into his left side of his neck. The patient didn't receive any treatment for the problem and didn't visit any Physician Office/ Emergency Room. The outcome of events was unknown.
80 2021-02-06 weakness Weakness, hypernatremia
80 2021-02-07 inability to speak On the 3rd day after vaccination, the patient developed mild malaise. As the day progressed, there w... Read more
On the 3rd day after vaccination, the patient developed mild malaise. As the day progressed, there was increasing difficulty moving and talking. That night the patient began hallucinating,. Later at night the patient awoke and couldn't move at all. By the morning, things were better and patient could get out of bed and eat. Ity sounds like a dopamine reaction which the aptient has previosuly expeicned, however, there was no irregularity in L-dopa dosing.
80 2021-02-10 facial paralysis Bell's Palsy right side of face; This is a spontaneous report from a contactable physician and consu... Read more
Bell's Palsy right side of face; This is a spontaneous report from a contactable physician and consumer. An 80-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: unknown) via intramuscular first dose on 12Jan2021 14.00 at a single dose for COVID-19 immunisation. The patient medical history included DM (diabetes mellitus), hypertension, CAD (Coronary artery disease) and Atrial Fib (Atrial fibrillation). The patient concomitant medication was not reported. The patient visited physician office and it was reported that patient experienced bell's palsy right side of face on 27Jan2021 06.00. The patient did not receive therapeutic measures for the event. The patient did not have COVID prior vaccination and not tested COVID post vaccination. The patient had not received any vaccine in four weeks (as reported). The outcome of the event was not recovered. Information on the lot/batch number has been requested.; Sender's Comments: A possible contributory effect of suspect BNt162B2 on reported event 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.
80 2021-02-10 tremor, involuntary muscle movements At 1200 it was noted resident had a small emisis. Resident responded minimally to this writer verbal... Read more
At 1200 it was noted resident had a small emisis. Resident responded minimally to this writer verbally and does track writer with his eyes. Respirations are noted to be labored. Respirations 32. Mouth cleaned, no obstruction noted. Oxygen applied via nonbreather at 5L. Temp 91.3, pulse weak and thready, BP 98/50 on R)arm, Pulse 90. Resident is very weak, pale diaphoretic. Resident shaking and jerking. Initially unable to obtain pulse ox. Emergency services contacted. At 1212PM BS 135 BP to R)arm 108/68, Sats 99% on 5L nonrebreather, respirations are even and unlabored 18. Resident is noted to open eyes and communicate. Dr.is notified and okays sending resident to ER. Wife notified of pt condition by staff she will meet at ER. EMS arrives and transports resident to ER 1223 and RN gives report to the ER.
80 2021-02-10 tremor Shaking chills Elevated temp Marked aching Sore shoulder
80 2021-02-15 pain in extremity Later in evening I had intense muscle pain in legs and chills. It progressed later in that day to a... Read more
Later in evening I had intense muscle pain in legs and chills. It progressed later in that day to a piercing headache and 100 degree fever. Ibuprofin helped to lessen the pain. The following day the pain was greatly improved but I was very lethargic and tired.
80 2021-02-16 unresponsive to stimuli Patient received 2nd dose of the COVID-19 Pfizer vaccine, was observed in office x 15+ minutes, and ... Read more
Patient received 2nd dose of the COVID-19 Pfizer vaccine, was observed in office x 15+ minutes, and released home. Pt and his son exited the building and when they got to the car, the pt shouted out "oh no!" and collapsed to the ground. The patient was unconscious experiencing agonal respirations, and unresponsive to painful stimuli. There is an Emergency Room at the same location. Their staff came out and helped to transfer the pt to the ED for further evaluation. It was found that the patient had a known Anterior communicating artery aneurysm (7/28/2017) that seemed to have ruptured. The patient was stabilized and transported to our local hospital and upon arrival, he was effectively comatose with a GCS 3. CT Head notated an extensive subarachnoid and intraventricular hemorrhage most probably related to a bleeding anterior communicating artery aneurysm. Neuro-Interventional Radiologist dictation reads "Hunt Hess 5 Fisher grade 4 extensive subarachnoid hemorrhage with intraventricular hemorrhage and early hydrocephalus secondary to rupture of a known anterior communicating artery aneurysm. Initial ICP after EVD placement noted to be in the 120s now 68 treatment complicated by aneurysm rerupture after admission and increased volume of blood although large volume of hemorrhage was seen on initial scan and no change in the patient's clinical exam on her scale was noted due to this rerupture. Patient's exam and prognosis are poor giving extensor posturing lack of extraocular movements to doll's maneuver and weak pupillary reflex as well as cough and gag. Follows no commands or instructions at this time with no spontaneous movement on ventilator set at 12 overbreathing at 14-16 at this time without any sedation." The family opted to discontinue any further treatment to include surgical intervention given the findings. The patient was given comfort care with son and daughter at the bedside. The patient was extubated and expired at 1545h on 2/13/2021.
80 2021-02-17 weakness, unresponsive to stimuli Systemic: Confusion-Medium, Systemic: Fainting / Unresponsive-Medium, Additional Details: Patient fo... Read more
Systemic: Confusion-Medium, Systemic: Fainting / Unresponsive-Medium, Additional Details: Patient found unresponsive sitting in recliner and breathing. Vitals normal. After 5min sternum rub patient became conscious and stated he could hear being spoken to but could not respond. Felt weak rest of the day. Although this occurred several days later there were 3 patients at same facility experiencing similar issues on same day
80 2021-02-17 cold sweat Pt experienced chest pain while waiting in line for vaccine. 5 out of 10 chest pain persisted post v... Read more
Pt experienced chest pain while waiting in line for vaccine. 5 out of 10 chest pain persisted post vaccination. Reported feeling nervous, anxious, cold sweats. Pt with hx of HTN, on cardizem. Denied hx of afib. Denied other past medical hx. Pt with elevated BP 160s with labile pulse, ranging from 30-80s. O2sat 99%. Pt escorted to ED.
80 2021-02-18 sensory loss Dizzy, loss of sensation in arms and across chest shoulders
80 2021-02-20 unresponsive to stimuli Systemic: Fainting / Unresponsive-Medium
80 2021-02-21 inability to speak Fever (up to 102 F); headache; mental confusion; lack of responsive speech or delay in responding t... Read more
Fever (up to 102 F); headache; mental confusion; lack of responsive speech or delay in responding to questions. Symptoms began around 11:30 a.m. on Feb. 21. Administered one Tylenol at 2:30 p.m. on Feb. 21. By 6 p.m. on Feb. 21, the fever and headache abated. But confusion and lack of speech continues to Feb. 22 (10:30 a.m.) as I prepare this report.
80 2021-02-21 weakness 1st dose vaccine 1/30/21; 2nd dose vaccine 2/20/21; new onset weakness 2/21/21; fell at home and see... Read more
1st dose vaccine 1/30/21; 2nd dose vaccine 2/20/21; new onset weakness 2/21/21; fell at home and seen in ED and admitted to hospital 2/22/21 Dx on admission: 1. Hypoxia 2. Elevated troponin 3. Elevated brain natriuretic peptide (BNP) level 4. Generalized weakness 5. Closed head injury, initial encounter
80 2021-02-22 weakness Immediately he had a headache associated with dizziness and the headache persisted. He was known to... Read more
Immediately he had a headache associated with dizziness and the headache persisted. He was known to be unstable on his feet with muscle weakness. Other complaints include shortness of breath, confusion, decreased appetite. O2 saturation dropped from 90% to 80% on room air. He complained of low back pain and weakness and heart rate of 115.
80 2021-02-24 discomfort sudden extreme pain in right shoulder radiating in arm pit and to clavicle area. Unable to extend or... Read more
sudden extreme pain in right shoulder radiating in arm pit and to clavicle area. Unable to extend or lift right arm and no strength to lift object. Felt swelling in nymph node area under arm and in neck. Totally immobile arm on day 8; improvement and dissipation on day 9. Today, day 10 no after effects; back to normal. Treated the pain and discomfort with Tylenol extra strength.
80 2021-02-24 pain in extremity 2-22-21 JOINTS ON RT SIDE PAINFUL - NECK, SHOULDER, ELBOW, WRIST, HIP AND KNEE. HAS BEEN TAKING TYLE... Read more
2-22-21 JOINTS ON RT SIDE PAINFUL - NECK, SHOULDER, ELBOW, WRIST, HIP AND KNEE. HAS BEEN TAKING TYLENOL AND USING ICE PACKS WITH TEMPORARY RELIEF - ADVISED TO CALL PCP FOR EVALUATION 2/23/21. 2-24-21 8:30AM TC - PT STATES HE FEELS BETTER TODAY. PCP GAVE HIM A STEROID SHOT AND RX FOR PREDNISONE.
80 2021-02-24 unresponsive to stimuli Resident found unresponsive in his room. CPR performed and patient expired.
80 2021-02-25 pain in extremity Underarm swelling and mile pain in arm shot was given
80 2021-02-26 weakness Per Patients Wife - Same day - Flu like symptoms, Nausea, Headache. Restless that night. Next day... Read more
Per Patients Wife - Same day - Flu like symptoms, Nausea, Headache. Restless that night. Next day - Weak, shortness of breath. Wife called squad to get him out of his wheelchair but patient refused hospital as it gets him agitated. Patient passed away around 11 AM the day after vaccination.
80 2021-02-28 weakness Patient is an 80 year old male who has a history of multiple medical problems, including body mass i... Read more
Patient is an 80 year old male who has a history of multiple medical problems, including body mass index of 30, hypertension, dyslipidemia, giant-cell arteritis on a slow prednisone taper (currently 2 mg daily), past pulmonary embolism on warfarin, sleep apnea, history of diverticulitis (treated in August 2020), past abdominal surgeries (including umbilical hernia repair ×2 and open recurrent incarcerated epigastric hernia repair with mesh in October 2020), chronic anemia, and type-2 diabetes. The patient had received the first dose of the COVID-19 (SARS-CoV-2) vaccine on January 31, 2021 and the second dose on February 21. He presented to his primary care provider?s office on February 22, 2021 with complaints of 10 days of progressive weakness and muscle soreness. The weakness had reportedly involved the bilateral thighs and arms and was associated with muscle aches. Blood pressure measured 90/40 mmHg and examination was notable for symmetrical proximal weakness in the upper and lower extremities. The peripheral blood leukocyte count measured 3.5 x10e3/µL, hemoglobin 8.3 grams per deciliter and platelets 147 x10e3/µL. A peripheral blood smear was consistent with neutropenia and normocytic anemia with 9% circulating blasts. Total CK measured 1424 U/L. The patient was referred to hematology/oncology and rheumatology and had appointment scheduled for both on February 26. With the above background, he presented to emergency room on February 24 with altered mental status and continued weakness. He was taken to the hospital by emergency medical services. A temperature of 103 degrees Fahrenheit was recorded when emergency medical personnel had arrived. The peripheral blood leukocyte count was 1.4 x10e3/µL for an ANC of 0.8 x10e3/µL. Hemoglobin was 8.1 g/dL and platelets 111 x10e3/µL. A few schistocytes and teardrop cells were noted. The serum creatinine was 1.47 mg/dL. AST was 174, ALT 91 and alkaline phosphatase 93 U/L. The lactic acid level of the venous blood was 2.1 mmol per liter. A repeat total CK was 4631 U/L. Sedimentation rate measured 34 mm/h and CRP 52.3 mg/L. Urinalysis showed 0-2 wbc?s/hpf, 0-2 rbc?s/hpf, 3+ blood, negative nitrites, negative leukocyte esterase. A haptoglobin level of the blood was within normal limits. The lactic acid level of the venous blood was 2.0 mmol/L. LDH measured 838 U/L. A ferritin level was 3464 nanograms/mL. A test for COVID-19 (SARS-CoV-2) was negative. A chest radiograph showed minimal streaky right basilar atelectasis, trace left effusion and a mildly enlarged cardiac silhouette. A head CT showed no acute abnormality. An abdominopelvic CT without contrast was limited by motion artifact. No acute intra-abdominal or pelvic finding was noted. Nonspecific soft tissue stranding was seen in the right inguinal region. There was no soft tissue gas or drainable fluid collection. Cultures of specimens of the blood were obtained. The patient was started on empiric cefepime, vancomycin and doxycycline and admitted for further care. A peripheral blood smear for intracellular parasites was negative. The admission blood cultures came back positive for E. coli. With the blood culture results, the vancomycin and doxycycline were discontinued. The E. coli isolate has since been determined to be pansusceptible. A MRSA PCR of the nares was negative. He was found on exam to have swelling, cellulitis and exquisite pain of the right groin area on February 25. Surgical consultation was pursued. They did not feel that he had necrotizing fasciitis. The CT scan of the abdomen and pelvis was repeated with contrast, revealing increased extensive subcutaneous edema of the right groin region with extension into the thigh musculature and mild extension into the right inferior pelvis. There was no associated soft tissue gas or drainable abscess. A bone marrow biopsy was performed February 25. Results showed acute undifferentiated leukemia with 60-70% infiltration of the bone marrow with blasts. The blasts were negative for lineage markers. He was faintly CD33 positive. He is felt to likely have acute myeloid leukemia. Cytogenetics are pending.
80 2021-03-04 weakness weakness, fall Narrative: Pt with history of CAD (s/p PCI mid and prox RCA in 2006, on ASA/Plavix; ... Read more
weakness, fall Narrative: Pt with history of CAD (s/p PCI mid and prox RCA in 2006, on ASA/Plavix; CABG, AVR), afib, GERD, HTN, HLD, hypothyroidism, BPH, diverticulosis, aortic stenosis, small fiber neuropathy (since 2010), lumbar stenosis at S1. Also, pt presented to outside ED on 12/26/20 for increasing falls and weakness over one week and was admitted to outside hospital 12/26/20 for generalized weakness, dehydration, hyponatremia all secondary to covid 10 infection. Hospital course included sepsis due to covid 19, elevated liver enzymes, acute kidney injury. Pt discharged 12/29/2021. After first COVID vaccine 2/12/2021, patient experienced fever x 1 day, weakness, and fall. Presented to outside ED 2/13/21 abd was admitted for critical illness myopathy 2/2 recent COVID infection +/-COVID vaccination. Pt was discharged 2/18/2021.
80 2021-03-05 weakness Intense fatigue and weakness; breathing hard when sleep at night.
80 2021-03-07 bell's palsy bells palsy
80 2021-03-10 weakness Weakness and shortness of breath
80 2021-03-10 pain in extremity 'Severe stiff neck from 2/4 to3/10, with shoulder muscle aches, vague headache, and slight "fuzzy" ... Read more
'Severe stiff neck from 2/4 to3/10, with shoulder muscle aches, vague headache, and slight "fuzzy" feeling and fatigue. By 3/1, I also had thigh and buttock ache with effort and left TMJ pain. On 3/2, I saw Dr. My sed rate was 24. She made a diagnosis of probable PMR and prescribed prednisone. After I single dose, my symptoms almost magically abated and I was almost normal. On 3/11, the only residual symptom with soreness with with extreme neck rotation. On clinical grounds, this confirms the diagnosis of PMR. I assume treatment will continue for several weeks.
80 2021-03-22 pain in extremity 79 yo woman received Pfizer Covid vaccine #1 on 2/23/21. She has been experiencing diffuse body pain... Read more
79 yo woman received Pfizer Covid vaccine #1 on 2/23/21. She has been experiencing diffuse body pain-especially her hands. Patient had a ground level fall requiring sutures for a head lac on 1/25/21. The diffuse body aches and pains seem to pre-date the vaccine. Certainly, vaccine related reactions such as myalgias can be expected from the vaccine and may have exacerbated her symptoms. MD recommended, based on the above, for patient to receive the 2nd dose of Pfizer vaccine. However, patient can be reassured that she can safely get the second covid vaccine to finish her immunization. She may take pain medication as needed after the vaccine is given to relieve pain.
80 2021-03-23 bell's palsy Pt presented to the ED with right-sided facial drooping and was diagnosed with Ball's Palsy. Pt was ... Read more
Pt presented to the ED with right-sided facial drooping and was diagnosed with Ball's Palsy. Pt was prescribed prednisone in the ED. Evaluated today at our office and was prescribed valtrex. Currently experiencing right eye dryness and irritation.
80 2021-03-24 muscle spasms, pain in extremity Muscle ache; Spasms/buttock spasms/ muscle cramps; Injection site hurt; walking difficulty; walking ... Read more
Muscle ache; Spasms/buttock spasms/ muscle cramps; Injection site hurt; walking difficulty; walking painful; both legs are hurting; This is a spontaneous report from a contactable consumer, the patient. An 80-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot number EL3242), via an unspecified route of administration in the left arm on 06Feb2021 (at the age of 80 years-old) as a single dose for COVID-19 immunization. Ongoing relevant medical history included myopathy, neuropathy, neurological issues, and chronic pain. Additional medical history included the patient also had spinal cord surgery several years ago and sensation issues for a lot of years. The patient's concomitant medications were not reported. On an unknown date the patient experienced muscle ache, muscle spasms, injection site hurt bit, walking difficulty and walking painful. On 10Feb2021 the patient experienced both legs are hurting. The patient reported that they had the first vaccine on the 06Feb2021 and the injection site hurt a little bit and a couple of days went by and then the patient had the muscle aches and all of a sudden it was severe with muscle cramps and spasms from the buttocks down the leg on the left side. The patient stated that now both legs are hurting a lot from about 10Feb2021. The patient stated that he could barely walk and it was very painful to walk. The patient stated he was using a walker, cane, and holding onto objects when walking. The patient said it is a little better, but the patient still has to take baby steps and the patient is currently having a buttock spasms. The patient stated they have the second appointment 27Feb2021 and the patient is leery of taking the second dose as the patient has not been able to function for the last 2.5 weeks and is not sure about getting the second dose. The clinical outcome of the muscle ache, injection site hurt, walking difficulty, walking painful and both legs are hurting was unknown. The outcome of the event muscle spasms/buttock spasms/ muscle cramps was not recovered.
80 2021-03-26 tremor Shaking Uncontrollably, Sweats, Dry mouth, sore all over, injection site was swollen, memory loss, c... Read more
Shaking Uncontrollably, Sweats, Dry mouth, sore all over, injection site was swollen, memory loss, confusion
80 2021-03-27 speech disorder During the evening of March 26, 2021 at home I could not pronounce words to describe something on TV... Read more
During the evening of March 26, 2021 at home I could not pronounce words to describe something on TV. This condition lasted only a few minuted.
80 2021-03-30 pain in extremity Received 1st Pfizer dose 3/2/2021, on 3/4 pm he started not feeling well. On 3/5 he slept through... Read more
Received 1st Pfizer dose 3/2/2021, on 3/4 pm he started not feeling well. On 3/5 he slept through the day and was not feeling well. He reported his legs and back were hurting, and he had difficulty walking due to problems with his balance. He got up at 9pm and fell in the bathroom. He was dizzy. His wife assisted him back to bed. He was not able to sit, he would fall over. On 3/6 his balance was still off. His wife assisted him to the car and took him to the Hospital. They treated him for dehydration and discharged him. On 3/7 he developed a rash over his body, "big red spots". 3/8 his wife called the physician , who saw him the following day, on 3/9. He was advised not to take the 2nd Pfizer vaccine. The rash lasted 5-6 days. At the time of this report, his symptoms have resolved. His wife reports she completed a VAERS. His report number is 346254
80 2021-03-31 pain in extremity Woke up the day after the vaccine was administered (2nd Dose) and legs were weak ("muscles felt like... Read more
Woke up the day after the vaccine was administered (2nd Dose) and legs were weak ("muscles felt like jelly"). The next day I developed aches in lower extremities. The third day, I went to the emergency room and was given a muscle relaxer. This has not relieved the pain. The pain has now moved into my ankle joints and it is very painful to walk. I visited my doctor on the seventh day and was given a pain killer, Meloxicam (15mg), and this is relieving some of the pain when I walk.
80 2021-04-11 weakness COMPLETE WEAKNESS, FULL BODY ACHES, CHILLS. PATIENT UNABLE TO GET OUT OF BED.
80 2021-04-11 weakness Patient, of 80-year-old male, with significant past medical history of hypertension, paroxysmal atri... Read more
Patient, of 80-year-old male, with significant past medical history of hypertension, paroxysmal atrial fibrillation, hyperlipidemia, coronary artery disease s/p stent, and BPH. Patient comes from urgent care after being found hypoxic. He refers that for the last 3 weeks felt weak, with loss of appetite and poor oral intake. He went to a to the urgent care to get it evaluated and he could get some IV fluid because he felt dehydrated. Patient refers that in the past when he gets severely dehydrated had episodes loss of conscious and this time he wanted to avoid that. He states that on February 4th got tested positive for COVID-19 because his fiancee tested positive the previous day. He quarantined and was asymptomatic. On February 27nd got first dose of COVID-19 vaccine. But since he tested positive feels that has no energy. Besides this patient denies fever chills shortness of breath, chest pain, abdominal pain, diarrhea nausea, vomiting, headache, lightheadedness, loss of sense of smell or taste.
80 2021-04-14 weakness Fever for 3 days, Shortness of breath and Weakness increasingly, Dizziness, became very pale, and s... Read more
Fever for 3 days, Shortness of breath and Weakness increasingly, Dizziness, became very pale, and so on... Visited PCP on March 24, 2021 . Blood work showed 4.8 Hemoglobin. Was hospitalized on March 25, 2021. Diagnosis - Autoimmune Hemolytic Anemia due to IgG.
80 2021-04-16 weakness, pain in extremity My Husband and I received the same day a strong pain in our left arms. The next day my husband compl... Read more
My Husband and I received the same day a strong pain in our left arms. The next day my husband complained about pain in his entire body and weakness, and I had the same. In the evening he collapsed falling out of his wheelchair. He tried for an hour to sit down back in his wheelchair with my help, but he couldn't. He agreed that I call 911. Two nurses took him to Emergency Room at Hospital and didn't allow me to go with him. In the morning on Saturday, he was transferred to Room at Hospital and the next day to the Intensive Care Room, where he sadly passed away on Tuesday April 13 at 4:22 am.
80 2021-04-16 pain in extremity At some time after the vaccines were given I started having muscle aches and pains throughout my bod... Read more
At some time after the vaccines were given I started having muscle aches and pains throughout my body. Thighs, calves, butt, hips, biceps, forearms, and inside area between bicep and lower arm (opposite side of elbow) which would keep me awake at night due to the pain. That pain was only at night, the other pains were during the day and most times would last the whole day, but other times would lessen as the day went on. I still cannot sleep on my left side, due to hip and arm pain, but the very painful left arm pain persists as described above even when sleeping on my right side. I still have these pains as of the date of this writing, April 17, 2021.
80 2021-04-20 numbness, tingling Patient has left arm numbness after his 2nd pfizer covid vaccine. He states that exercise helps. It ... Read more
Patient has left arm numbness after his 2nd pfizer covid vaccine. He states that exercise helps. It is not a pins/needles feeling, but more of a whole arm numbness, Patient reports that it happens every other day. Pt states it did not happen between his first and second dose; it started only after his second dose.
80 2021-04-21 weakness, brain damage Presented to ER via private vehicle with complaints of general malaise, weakness, "not feeling good"... Read more
Presented to ER via private vehicle with complaints of general malaise, weakness, "not feeling good" beginning the morning before (04/16/2021), complaints not more specific. Associated symptoms included encephalopathy, lethargy, anorexia, progressively unsteady gait. Wife denied nausea, vomiting, diarrhea, fever, bloody stools, difficulty/painful urination. Diagnosed with thrombotic thrombocytopenic purpura with an initial hemoglobin of 4.8g/dL, hematocrit 14.2%, platelet count 6000uL, PT 12.2sec, INR 1.2, BUN 75mg/dL, creatinine 2.4 mg/dL, total bilirubin 3.3 mg/dL, direct bilirubin 0.60mg/dL, troponin 3.81ng/mL, and ADAMTS13 activity <2.0. He received 2 units PRBC, 2 units platelets, and plasmapheresis was initiated. As of today, he has had 5 consecutive days of plasmapheresis. Repeat laboratory evaluation this morning hemoglobin 8.8, hematocrit 28.4, platelet count 97000, BUN 35, creatinine 1.5, total bilirubin 1.3. Now awake, alert, and oriented. Eating and ambulating with physical therapy
80 2021-04-26 unresponsive to stimuli Systemic: Confusion-Medium, Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unrespo... Read more
Systemic: Confusion-Medium, Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Mild, Systemic: Nausea-Mild
80 2021-04-28 unresponsive to stimuli Patient is a 80 y.o. male with significant PMHx of CAD, HTN, HLD, CKD who is admitted to ICU as a tr... Read more
Patient is a 80 y.o. male with significant PMHx of CAD, HTN, HLD, CKD who is admitted to ICU as a transfer from hospital for acute liver failure and cardiac arrest. Pt presented to hospital on 04/28 w/ complaints of nausea and vomiting. He stated that he had recently gotten his COVID vaccine. Pt was found to be in acute liver failure in the ED w/ AST and ALT > 1000. Lactate > 15.0. BMP showed AKI on CKD and BG >500. Pt did have cardiac arrest while undergoing CT Scan and ROSC was achieved after CPR x 20 mins. Pt was hence transferred to the ICU for higher level management and admitted for cardiac arrest and acute liver failure. Upon arrival, Pt was intubated and sedated. He was non-responsive to verbal and physical stimuli. Pt was acidotic. ABG: 6.99 / 28 / 165 / 7. 1 amp of HCO3 was given upon arrival. Pt was started on insulin gtt for DKA and was started on Levophed for low BP. Pt underwent cardiac arrest shortly after arrival to the ICU. CPR was performed for > 20 mins without ROSC. Family arrived at bedside and decision was made to stop CPR at 0205 on 04/29/2021.
80 2021-05-03 weakness Vomiting and weakness for four days.
80 2021-05-03 pain in extremity Pain in my right arm and shoulder, pain in my right wrist, paiin my my thighs and hanstring, pain in... Read more
Pain in my right arm and shoulder, pain in my right wrist, paiin my my thighs and hanstring, pain in my kness
80 2021-05-08 weakness Reaction was more intense, but of shorter duration than the reaction to the first shot on 4/15/2021 ... Read more
Reaction was more intense, but of shorter duration than the reaction to the first shot on 4/15/2021 (lot # ER8729) I experienced weakness, dizziness and remained in bed until 5 PM on Saturday 5/8/2021, the day after the shot. This time, there was no pain, swelling, or redness at the shot location on my right arm. I experienced a loss of appetite, slight headache and some groin aches through most of the day on Saturday. I'm feeling much better today, Sunday 5/9/2021. Side effects from the first shot lasted a full two days
80 2021-05-12 pain in extremity, weakness Patient was in his usual state of health and independent with his ADLs until 2-3 days after his 2nd ... Read more
Patient was in his usual state of health and independent with his ADLs until 2-3 days after his 2nd COVID vaccination on Feb 26th when he began to have bilateral knee and LE pain. He then was having difficulty walking for a couple of weeks. The leg pain was not constant, but he did fatigue easily with walking. On 3/11 he had his lower dentures placed and that evening/early morning of 3/12 he apparently fell. Patient does not remember anything about the fall - he cannot recall when he fell, how he fell, or any of his symptoms leading up to the fall. Patient remembers being on the floor and attempting to get up but was too weak. He has rug burns on his forearms from attempting to get up. He was hospitalized on 3/13 for dehydration, traumatic rhabdomyolysis, and w/u following fall. Despite very stable labs prior to 1st dose of vaccination on 2/5/21, following vaccination he has had significant and substained leukocytosis as well as transfusion dependent anemia that has not resolved at the time of the reporting (5/13/21). He remains at a skilled nursing facility due to debility.
80 2021-05-17 numbness, slurring Two right MCA ischemic strokes occurring 3-5 days after each dose of Pfizer vaccine. Both episodes h... Read more
Two right MCA ischemic strokes occurring 3-5 days after each dose of Pfizer vaccine. Both episodes he presented with by waking up with acute left arm weakness, numbness and dysarthria. Both episodes happened a few days after COVID vaccine (Covid #2 was administered 4/27). Previous Right MCA stroke from 4/11 was fully worked up. The etiology of this stroke was cryptogenic. TSH from 4/11 was 2.57 and T4 was 0.69. Hgb A1c on 4/11 was noted to be 5.6%. LDL on 4/11 was noted to be 73. MRI brain 4/11/2021 showed multifocal small acute infarcts in the right cerebral cortical/subcortical and periventricular matter infarcts, favored to be embolic. CTA head and neck from 4/11 showed no evidence of large vessel occlusion. Ultrasound of bilateral lower extremities on 4/12 was negative for DVT. ECHO on 4/12 was positive for PFO with an WF > 55%, mild LVH and no thrombus. He also has an atrial septal aneurysm. Cardiac MRI was negative for thrombus. He was discharged on 4/14 with 30 day Holter monitor to evaluate for AFIB.
80 2021-05-19 weakness dizziness; weakness; fatigue; loss of appetite; shortness of breath; This is a spontaneous report fr... Read more
dizziness; weakness; fatigue; loss of appetite; shortness of breath; This is a spontaneous report from a contactable Nurse. An 80-year-old male patient received first dose of bnt162b2 (BNT162B2, Solution for injection, Lot number: EL1284, Expiration date was not reported), via intramuscular, administered in left arm on 14Jan2021 15:00 as first dose single for covid-19 immunisation. Medical history included chronic obstructive pulmonary disease (COPD), atrial fibrillation (A-Fib), coronary artery disease (CAD), hypercholesterolemia, GERD, benign prostatic hyperplasia (BPH) and peripheral vascular disorder (PVD). The patient concomitant medication was not reported. Patient did not receive any other vaccine in four weeks. Patient received other medications in two weeks. Patient did not have covid prior vaccination. Patient did not test covid post vaccination. Resident within 15 minutes of vaccination complained of dizziness, he then subsequently had other symptoms of weakness, fatigue, no fever, loss of appetite, shortness of breath on 14Jan2021 03:15 AM. Patient received treatment of prednisone. The patient underwent lab tests and procedures which included nasal swab test: negative on 03Feb2021. The outcome of the events was recovering. Information on the lot/batch number has been requested.
80 2021-05-21 pain in extremity, speech disorder Arm soreness after each dose was given/ Severe pain in legs; was 187 pounds and now down to 170; fel... Read more
Arm soreness after each dose was given/ Severe pain in legs; was 187 pounds and now down to 170; fell and busted his spleen; fell and busted his spleen; started peeing; developed blisters in his mouth and on his tongue; developed blisters in his mouth and on his tongue; Vaccination facility staff made a mistake resulted that the patient received the third dose of Covid-19 vaccine; mouth was also full of saliva, started slobbering and couldn't stop; Pain in shoulder/ Severe pain in joints; Severe diarrhea; having problems with words; had some problems with his balance; couldn't hardly walk because of his balance; Has no taste of food; Mouth Burning; break out with bumps around mouth; Scrotum blood blisters; This is a spontaneous report from a contactable consumer (patient). An 80-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 3 via an unspecified route of administration, administered in left arm on 17Apr2021 (Batch/Lot Number: EW0171) as 3rd dose, single for covid-19 immunisation. Ongoing medical history included diagnosed with vertigo 5 years ago but had vertigo long before that, diagnosed with COPD, emphysema, asthma 12 years ago, Congestive heart failure after having a heart attack in Nov2018, stomach problem (had gastric bypass back in the 80's), had Pacemaker in 2020. Patient does take medications, but is unable to provide details. Patient received flu shot in Nov2020. No Prior Vaccinations within 4 weeks. Patient had first dose on 02Feb2021, second dose on 05Mar2021, and Vaccination facility staff made a mistake resulted that the patient received the third dose of Covid-19 vaccine on 17Apr2021. He had gone to Vaccination facility to get a B12 shot and the staff messed up and gave him the Covid-19 vaccine. He states he had arm soreness after each dose was given. On the night of 17Apr2021 after the third dose, pain in his shoulder began, the pain lasted about 3 days and had intensified a little more from the previous dose of the Covid-19 vaccine. When he woke up on 21Apr2021, his mouth was also full of saliva, he started slobbering and couldn't stop. On 22Apr2021 or 23Apr2021, he began experiencing severe diarrhea he began and having problems with words, he knew what he wants to say but it just doesn't come out. About 23Apr2021 or 24Apr2021, he began experiencing problems with his balance. He had vertigo for a long time and has always had some problems with his balance, couldn't hardly walk because of his balance, but the problems with his balance have intensified to where he needs someone to help him stand up now. On 24Apr2021 when he first gets up in the morning, he developed blisters in his mouth and on his tongue. On 27Apr2021 he began having problems with control, and started peeing all over himself, he didn't take his water pill on 27Apr2021 because he was going out and he still peed all over himself, he has been wearing adult diapers so that he doesn't mess himself again. On 04May2021 night, he fell and busted his spleen. And on an unspecified date in Apr2021, has no taste of food, Mouth Burning and break out with bumps around mouth. Scrotum blood blisters. Severe pain in legs and joints. He was 187 pounds and now down to 170. Patient received fourth injection on 21Apr2021 in left arm, but he is unsure if he received a B12 shot or something else. Attempts were made to clarify if the patient received 3 or 4 doses of the Covid-19 vaccine. Patient had blood tests, an EKG, and X-rays with unknown results, his heart looked good. The outcome of events was unknown.
80 2021-05-24 pain in extremity, feeling cold his neck was stiff; it was very, very cold; a lot of pressure on his eyes; pain in arm the injection... Read more
his neck was stiff; it was very, very cold; a lot of pressure on his eyes; pain in arm the injection was given in; I got a lot of headaches and I still have them./unbelievable headaches; More back pain than usual; My blood pressure went up a little bit but not much; This is a spontaneous report from a contactable consumer (patient). Follow-up information received on 17Feb2021 was processed together with initial information. A 80-years-old male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EM9809, Expiration date: UNKNOWN), via an intramuscular route on 08Feb2021 (at the age of 80-years-old) as single dose in the left arm for covid-19 immunization. The patient medical history included and back pain. The patient concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 08Feb2021, the patient experienced blood pressure went up, More back pain than usual and on unspecified date experienced Stiff neck, Headache, pain in arm the injection was given in, pressure on his eyes, cold. The clinical course of the event was as follows: blood pressure went up a little bit but not much. It was reported that blood pressure was up which he was told by the nurse was normal. It was just a little bit high. The nurse at the facility said it was not that concerning and that it was fine. The facility let him stay a half an hour and then he was able to driven home. He hadn't wanted to stayed long because it was very, very cold. He had a lot of back pain. He does have back pain all the time, but not that much. It was more back pain than usual. The pain in his back increased/doubled, and the pain is still high. He clarifies he has had problems with his backed and have had backed pain normally, but after the shot it was liked a lot of pain in his backed and his neck was stiff very, very stiff hasn't knew if it's from vaccine or what. Patient stated that before the vaccine, he was okay and was able to worked in his house and outside. He believes the stiff neck began after 2 or 3 days of receiving the vaccine and it have had worsened. Patient stated that pain in his armed where he received the shot went away completely. He clarifies further the pain in his armed went away the second day. He got a lot of headaches and he still had them. The headaches began right away, and the headaches still c continued. He mentions the headache got a little better last night. He was really worried about it and hadn't knew what to did. It was reported that he told his son everything and his son said to not went to hospital because there was a lot of people that had been in contact with covid and it's going to have been worse. He states his son told him to drink a lot of water and saw if he got better. He did that and he did got a little better but not that much. Patient mentions that he had a lot of pressure on his eyes. The patient did not went to emergency room because he was told it was normal to had headaches but they went away and his should went away in 2-3 days. His armed where he received the vaccine was also okay the next day. The patient did not visit to physician office. Patient mentions that he took blood pressure medication, and everything was under controlled and he took 10mg of a cholesterol medication. Patient declined to include these medications for the report, stating he gave all of this information at the facility he received the vaccine at. He had to filled the paperwork out. He confirms he hasn't had any NDC, lot number or expiry date for these medications at this time. It was reported that patient had a blood tests done about 3 weeks before he received the vaccine and the doctor said everything was okay at the time. The outcome of the events headache was recovering, backed pain and neck was stiff was not recovered and other events was unknown.
80 2021-05-27 weakness Patient received second COVID 19 vaccine 5/15/21. Patient presented to the ED on 5/17/21 with cheif ... Read more
Patient received second COVID 19 vaccine 5/15/21. Patient presented to the ED on 5/17/21 with cheif complaint of increased shortness of breath and weakness. On 5/16/21, he did not sleep well and felt sweaty with chills. He took ibuprofen and Tylenol. He states he feels like he has no power when he walks. No chest pain. No fevers. He also notes slight diarrhea. Patient denies any Covid contacts. There are no other modifying factors or associated symptoms
80 2021-05-28 weakness Headache; I was weak; This is a spontaneous report from a contactable consumer (patient). A 80-year-... Read more
Headache; I was weak; This is a spontaneous report from a contactable consumer (patient). A 80-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: EN6203, Expiry Date/ UPC/ NDC number: Unknown), via an unspecified route of administration on 01Mar2021 as 2nd dose, single for covid-19 immunisation. Patient's age at vaccination was 80 years. Medical history included thyroid from an unknown date and unknown if ongoing. Concomitant medication included levothyroxine sodium (SYNTHROID) taken for an unspecified indication, start and stop date were not reported. Historical Vaccine included first dose of BNT162B2 on 08Feb2021 for COVID-19 immunisation. The patient experienced headache and i was weak on 02Mar2021. Additional Context received as, the patient stated, "I got the vaccine, I got the first shot last month and I got the second shot on 01Mar (clarified as 01Mar2021), and I feel nothing on the 02Mar2021, I was okay. Then on 02Mar (not clarified), all of a sudden, I get a headache, not so bad but still a headache and today, in the afternoon, I was weak. I thought I had a fever but I have no fever, I just have a headache but now it is going away. Today, when I wake up, it was fading away and I got it in vaccination facility. When probed to clarify if consumer want to know that headache wais related to the Covid vaccine, consumer stated, as yes. For treatment in response to events, the patient stated, that was yesterday, today, I feel little better. No, I did not take anything. Outcome of the events was recovering. No follow-up attempts are possible. No further information was expected.
80 2021-05-28 pain in extremity, weakness Had inflammation on face red as a beet; Malaise; had arm hurt, Left arm; Headache; Weakness; Dizzine... Read more
Had inflammation on face red as a beet; Malaise; had arm hurt, Left arm; Headache; Weakness; Dizziness; This is a spontaneous report from a contactable consumer (patient). An 80-year-old male patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm Left on 28Apr2021 07:30am, at the hospital, (at the age of 80-years-old) as single dose for Covid-19 immunisation. Medical history included eczema from an unknown date and unknown if ongoing, drug hypersensitivity to penicillin (about 21 years old, Inflammation and redness, system gets flush), sulfonamide derivatives. The patient previously took aspirin (e.c.), keflex, sulfur, cellcept and experienced hypersensitivity to all. Concomitant medication included dupilumab (DUPIXENT) taken for eczema, start and stop date were not reported. The patient had inflammation on face, red as a beet, (dermatitis) (non-serious) on an unspecified date with outcome of unknown , malaise (non-serious) on an unspecified date with outcome of unknown, had arm hurt, left arm (pain in extremity) (non-serious) on an unspecified date with outcome of unknown , headache (non-serious) on an unspecified date with outcome of unknown , weakness (non-serious) on an unspecified date with outcome of unknown , dizziness (non-serious) on an unspecified date with outcome of unknown. The clinical course was as follows, at about 4pm the patient went outside, he "felt flushed, but didn't look in the mirror a friend told me to put sunblock on. I looked at my face and saw my face beet red. I just laid down, my arm felt bad, like a Charlie horse, like someone smacked me in the arm." Caller states his symptoms are, "basically inflammation through the body, then headache, weakness, dizziness, malaise, one good thing, no fever or nausea. Some uneasiness, vacillation, physical weakness. The patient don't drink alcohol, drink water and took Tylenol after the vaccine. No follow-up attempts are needed; information about lot/batch number cannot be obtained.
80 2021-05-28 tremor slight headache; Tiredness; Joint pain; Chills; hands were shaking; Fever; Diarrhea; This is a spont... Read more
slight headache; Tiredness; Joint pain; Chills; hands were shaking; Fever; Diarrhea; This is a spontaneous report from a contactable consumer (patient). A 80-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number: EL9262), via an unspecified route of administration on 28Jan2021 at 15:00 as unknown, single for COVID-19 immunization. Medical history and concomitant medications were not reported. Patient said he was calling about the Pfizer shot that he got yesterday (28Jan2021) at about 3pm. He stated he experienced some of the stuff they have on the list. He got the shot around 3PM and around 7PM that evening he started having chills, his hands were shaking really bad so he covered himself up really good and once he got some warmth to his body and about an hour later the chills calmed down and he started getting a fever his temp, the highest it got was 101.3 and it did come down after all night. He had a cold rag on his head the whole night. He had some joint pain, headache and tiredness, the headache was not severe. He had some diarrhea he does not know if that is associated with that or not. He did have some food, he ate that so he doesn't know if that is the cause of the diarrhea but it would not have caused all the other symptoms. He didn't have any redness where they gave the shot at all everything was fine on that end but he figured he better call to report it since he seen these are on the list. It was reported that slight headache was pretty mild now and it was not severe, he could just feel it in there but it is pretty much gone right now. Diarrhea went through the night and in the morning. He went 3 different times but now he thinks he is cleared out and needs to get some food back in him. His card says Pfizer COVID 19 vaccine. He does not see an NDC number or expiration date. He saw healthcare clinic site. Patent received vaccine because wants to be protected like all the other seniors. He went through night and that was pretty bad but he was starting to feel better now. He was tired it drained him he still feels pretty out of it but he is starting to feel better. He asked is there any concern about any of this stuff. He said everything was starting to quiet down now he doesn't think that would be necessary unless he had a relapse and he does not think that would happen at this point. The outcome of the event chills was recovered, slight headache was recovering and outcome of the other events was unknown. Follow-up attempts are completed. No further information is expected.
80 2021-06-01 inability to speak Within one week of vaccine dad lost interest in everything, developed incontinence, became extraordi... Read more
Within one week of vaccine dad lost interest in everything, developed incontinence, became extraordinarily sleepy, stopped gregarious talking and only responded to questions asked, became extremely confused, eventually losing his ability to walk, talk, and swallow. All occurring in short order. ER twice, hospitalized twice, rehabilitation twice. As yet, no formal diagnosis despite three hospitals seeing my father and testing him extensively.
80 2021-06-03 facial paralysis R29.810 - Facial droop I63.9 - Cerebrovascular accident (CVA), unspecified mechanism (CMS/HCC) J18.9... Read more
R29.810 - Facial droop I63.9 - Cerebrovascular accident (CVA), unspecified mechanism (CMS/HCC) J18.9 - Pneumonia, unspecified organism
80 2021-06-08 pain in extremity Approximately one month after second dose of Pfizer injection patient began to have shoulder joint p... Read more
Approximately one month after second dose of Pfizer injection patient began to have shoulder joint pain, progressing to hand and then opposite shoulder. Has persisted greater than 3 months. New onset/diagnosis rheumatoid arthritis, connective tissue disorder. Patient states he has had similar pain and swelling in joints in the past that resolves quickly, however states this pain and swelling is severe and persistent now three months
80 2021-06-12 unresponsive to stimuli Pt had a spontaneous brain hemorrhage, leading to his death. Pt was found by his wife at approximat... Read more
Pt had a spontaneous brain hemorrhage, leading to his death. Pt was found by his wife at approximately 0800, slumped over in the corner of the room, pt was brought into the ER unresponsive. Pt died 4 hours later.
80 2021-06-14 tingling, pain in extremity Extreme tiredness, aching legs, pains across whole of chest, swollen left foot, shortness of breath ... Read more
Extreme tiredness, aching legs, pains across whole of chest, swollen left foot, shortness of breath , "pins and needles" in bothe hands at the same time as each other, loss of balance when walking, stomach pains only in the evening after eating a Small amount of food as I have put on weight recently even though I am eating the same amount ( less recently as above) as normal for the last 70 years.
80 2021-06-21 weakness 81-year-old male with a history of stage IV renal disease, breast carcinoma status post mastectomy l... Read more
81-year-old male with a history of stage IV renal disease, breast carcinoma status post mastectomy last year, hypertension, diabetes, hyperlipidemia presents to the ED via EMS complaining of general weakness and tiredness. Patient also had 2 episodes of vomiting prior to arrival to the ED (one time this morning, and one time on the EMS ride). He denies any abdominal pain, he denies any fever, he denies any chest pain, denies diarrhea or urinary symptoms. Of note, pt is 3 days post op from left upper extremity AV graft placement. Denies any pain or excessive bleeding at the site, but site is noted to be bruised appearing. He had lung infiltrates. He has been on doxycycline. He was also found to be positive for Covid 19. He was seen by multiple consultant including nephrologist, cardiologist, infectious disease specialist., Diabetes management, vascular surgery, Pulmonology. Due to his comorbidities, he was given bamlanivimab 700, etesevimab 1400 mg monoclonal antibody infusion on 4/29/2021.
80 2021-06-26 numbness Arrhythmia, shortness of breath and numbness in legs
80 2021-06-29 pain in extremity is in a lot pain going down the right side in to his crotch and legs and screams out in pain. Pain i... Read more
is in a lot pain going down the right side in to his crotch and legs and screams out in pain. Pain is getting worse; he has lost some weight; He is having trouble with his memory; is in a lot pain going down the right side in to his crotch and legs and screams out in pain. Pain is getting worse/He has pain down his right side into his crotch and down his leg; This is a spontaneous report from a contactable consumer (wife). An 80-year-old male patient received his first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: solution for injection, batch/lot number: 2L3247) intramuscularly into the right arm on 20Jan2021 15:00 (at the age of 80-year-old) as single dose for COVID-19 immunisation. The patient's medical history included diabetic, COPD, prostrate cancer. He has a hard time breathing and was on oxygen. Concomitant medications were not reported. The patient received his second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: solution for injection, batch/lot number: EN5318) intramuscularly into the right arm on 17Feb2021 10:30 AM as single dose for COVID-19 immunisation. On an unspecified date, the reporter stated that her husband had the first dose of the Pfizer covid 19 vaccine on 20Jan2021 and was in a lot pain going down the right side into his crotch and legs and screams out in pain. Pain was getting worse and wanted to know if this was a side effect of the vaccine. He was not getting the second dose of the Pfizer covid 19 vaccine because of the adverse event he experienced with the first dose. He was on oxygen and had to carry an oxygen tank. He was due to get the second shot on Wednesday. She wanted to check and make sure. It may be a muscle thing. It seems to be getting worse and worse. He can hardly get up. He cannot hardly sleep in the bed. He does not want to get the next shot and his left side be in pain. Then he would not be able to do anything. He had lost some weight around 230 pounds. He has the first stages of Alzheimer's and clarified that has not been diagnosed yet with Alzheimer's. He had a test a couple years ago and it was normal. He was having trouble with his memory. He got the flu shot on 01Sep2020. He takes two cases full of medication. He was diabetic. He took shots in his stomach. It was changed over. No further details provided. Pain on right side started two days later. She does not know, but was assuming it was the muscle, going to be a little sore. It had progressively worsened. He could hardly move to go to the bathroom. He had prostate cancer a few years ago and has to wear underpants. He cannot bend over to put on his underpants or socks. He screams in pain. He does not do well with pain. No prior vaccinations within 4 weeks. Relevant tests included X-Ray on 26Feb2021 with unknown results. Outcome was unknown for all the events. Follow-up attempts are completed. No further information was expected.
80 2021-07-02 cold extremities coughing; Pulmonary embolism/ respiratory impairment; Sinus infection; Was cold and so cold to the t... Read more
coughing; Pulmonary embolism/ respiratory impairment; Sinus infection; Was cold and so cold to the touch/ couldn't get warm; tired; Didn't feel good; just wanted to stay down and didn't want to get up/ just couldn't wake up; eat very little and he didn't like to eat; color was off, looked grey; Pressure in lower stomach; Lost weight; This is a spontaneous report from a contactable consumer (patient's wife). An 80-year-old male patient of unspecified age and gender received the first/second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, batch/lot number and expiration date unknown) via intramuscular at left arm on 02Feb2021 10:00 (80-year-old at time of vaccination), at single dose, for COVID-19 immunisation. The patient's medical history included Stents from 2005 (a stent placed in 2005; a heart attack in 2017 and additional 5 stents were placed in 2017; a stent placed in his neck in Nov2019); Heart attack from 2017; Reaction to contrast dye from 2005 (has a reaction to the dye that they use for stents; had a stent placed in 2005 and had a reaction to the dye then; a mild heart attack in 2017 and did stents; once again had a reaction to the contrast dye); Sensitivity to bug bites (When the patient got big bites, you would think someone had beat him he had so many knots; the last few years the patient's reaction to bug bites got much worse); High blood pressure. Additional information for other conditions: The patient was very highly allergic or has a reaction to the dye that they use for stents. The patient had some heart stents and he had bad reactions to the contrast used. The patient was allergic to different things. The patient couldn't take codeine. When the patient got big bites, you would think someone had beat him he had so many knots. Reaction to contrast dye: the patient's physicians then wanted to do imaging with contrast dye on the patient's neck. Physician put the patient on a cocktail for 24-48 hours before the stent was placed and the patient still had a reaction. The patient was given a cocktail of Benadryl and 2 other medications that she cannot remember. The patient's reaction to the dye was not as bad as the first 2 but he still had one. The patient had the stent placed in his neck in Nov2019. The patient still had a reaction to the contrast dye, a mild reaction, even with the cocktail. The reaction was enough the patient was told to continue taking the medication afterward. The patient always carried a nitro bottle in his pocked but he never took any of them. They asked how the nitro tablets were and they were powder. They were blessed as far as the patient's heart. Concomitant medications included cetirizine taken for allergy problems; amlodipine taken for high blood pressure for years; acetylsalicylic acid (ASPIRIN) (for the arteries, just to keep the blood thin, the patient began taking aspirin after experiencing side effects from Effient). The patient previously received codeine and experienced sensitivity (Couldn't take codeine, goes way back, 40-50 years). The patient previously received prasugrel hydrochloride (EFFIENT) from 2017 and experienced shortness of breath (The patient was put on Effient after his stent placement in 2017. Doctor took the patient off of Effient and instructed him to just take aspirin because the patient was showing side effects of shortness of breath and different things. Doctor informed the patient that he would rather the patient just take Aspirin than have the side effects from Effient). The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, batch/lot number and expiration date unknown) at left arm on 12Jan2021 (80-year-old at time of vaccination) for COVID-19 immunisation and experienced "so excited" (the patient was so excited after the first shot of the COVID-19 vaccine). The patient previously received tetanus vaccine toxoid (TETANUS) shot for immunisation (20 years ago at least) and experienced "Couldn't move arm, arm swelled and turned red and was messed up for a while". Prior vaccinations within 4 weeks was none. Patient's wife reported that she and her husband (the patient) took the COVID-19 vaccines on 12Jan2021 and 02Feb2021. After his second dose, the patient kept telling her that he didn't feel good and that he was tired (from 03Feb2021). The patient just did not feel good. The patient was cold and so cold to the touch (from 03Feb2021). On 03Feb2021, he was dragging. The patient just wanted to stay down and didn't want to get up. She asked the patient if this was going to keep him in the room all day. The patient replied that he just couldn't wake up. The patient was tired and cold and couldn't get warm. The patient lost 30 pounds (in Feb2021) after he got the second dose of the COVID-19 vaccine. The patient walked around holding his pants up. The patient would eat very little and he didn't like to eat. When he was weighed at the doctor on Friday 02Apr2021, he weighed 136 pounds fully clothed. The patient normally weighed 150-160 pounds. The patient had lost a lot of weight. The patient's color was off, stating that one of her friends said the patient looked grey. The patient experienced pressure in lower stomach (in Feb2021). The patient told her that in his lower stomach, he described it as pressure, and the patient thought he was just kind of sore from coughing from the sinus infection. The patient couldn't stand clothes to touch him and would cut holes in his underwear elastic so that it wouldn't press into him. The patient went to the doctor twice from the time he took the second shot of the COVID-19 vaccine to his death (on 04Apr2021). The patient went to the clinic. The clinic thought the patient had a sinus infection (from 27Mar2021) and gave him a shot that would make him feel good. The patient got a shot on 27Mar2021. She wasn't sure what the shot was and she didn't get a print out. They treated the sinus infection with amoxicillin-clavulanate (875mg-125mg, manufacturer is Teun). The amoxicillin hadn't worked well and the patient went back to the clinic a second time on Friday, 02Apr2021. When the patient went to the doctor on 02Apr2021, they were unable to get a register on the finger pulse-ox monitor. The patient's physician did an X-ray (on 02Apr2021) and the X-ray was perfectly fine (normal). Nothing showed up on the X-ray at all. The patient passed away easter Sunday morning (04Apr2021). The cause of death listed on the patient's death certificate is due to consequence or problem of pulmonary embolism (from 04Apr2021), respiratory impairment. The patient did not receive an autopsy. The family didn't feel the need and the staff didn't even ask if the family wanted an autopsy. "When you live to be 80 years old, you're blessed." HCP: The patient's heart doctor did not see the patient on 04Apr2021 before he died. The last time the patient saw the doctor was Dec2020. The wife reported that she is not complaining, the patient made the decision to take the shot, she is just concerned that the patient had something that could help someone else. The wife stated she was not trying to complain at all, she took the COVID-19 vaccine right beside him and had no consequences. She didn't even have a sore arm. The family is just concerned that there is an ingredient in the COVID-19 vaccine or something that could trigger that in them. Yesterday, 23Jun2021, they were showing a lady on TV that was so sick (unable to provide details). "The patient" (unknown to which patient this is referring) got the shot and ended up in the hospital with side effects. The wife reported that's why she wanted to let Pfizer know about her husband. She was just reporting the patient's symptoms and was not wanting to hurt anyone's feelings in the world. She is not blaming the COVID-19 vaccine for the patient's death, and stated that it could have been his heart or more anything. She just felt like she needed to let pfizer know some of the side effects the patient was having that didn't start until after the second COVID-19 shot. The wife unable to provide the NDC number, lot number, or expiry date of the patient's COVID-19 vaccines. She does not have the information but her son does have that if Pfizer wanted to call and talk to him. The adverse events did not require a visit to emergency room; the adverse events requiref a visit to physician office (The patient went to the clinic 27Mar2021 and went back 02Apr2021 for Sinus infection). Therapeutic measures were taken as a result of the event sinus infection and included a shot and amoxicillin-clavulanate. The outcome of the event pulmonary embolism/ respiratory impairment was fatal; outcome of other events was unknown. The patient died on 04Apr2021. No autopsy was done. The cause of death was pulmonary embolism/ respiratory impairment. Information on the lot/batch number has been requested.; Reported Cause(s) of Death: Pulmonary embolism/ respiratory impairment
80 2021-07-02 tremor Headache; Fever; Chills; Shakes; Body aches; Muscle aches; Fatigue; Shortness of breath; This is a s... Read more
Headache; Fever; Chills; Shakes; Body aches; Muscle aches; Fatigue; Shortness of breath; This is a spontaneous report from a contactable consumer, the patient. An 80-years-old male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: ED7534) via an unknown route of administration in the left arm on 19Mar2021 at 17:15 (at the age of 80-years old) as single dose for COVID-19 immunisation. Medical history included chronic obstructive pulmonary disease (COPD), emphysema, angina, diabetes, hypertension and COVID-19 prior to vaccination. The patient had no allergies to medications, food, or other products. Concomitant medications included potassium (MANUFACTURER UNKNOWN) and amlodipine (MANUFACTURER UNKNOWN). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was diagnosed with COVID-19. Since vaccination, the patient had not been tested for COVID-19. On 20Mar2021 at 09:00, the patient experienced headache, fever, chills, shakes, body aches, muscle arches, fatigue and shortness of breath. Any therapeutic measures were not taken as a result of 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 body aches, chills, fatigue, fever, headache, muscle aches, shakes and shortness of breath was not recovered at the time of reporting. No follow-up attempts are needed. No further information is expected.
80 2021-07-08 coordination abnormal No adverse event after the vaccination in March. Case went for his Dialysis (at a separated private ... Read more
No adverse event after the vaccination in March. Case went for his Dialysis (at a separated private setting for their covid patients) on 6/29/2021. Was supposed to have dialysis tx on 6/26 but that one got cancelled due to his sxs and subsequent test. After dialysis session on 6/29, case was disoriented (more than usual after tx), hard to direct/assist in transfer, decreased coordination at home, diarrhea. Family tried to care for him but by next day 6/30 (Wed) realized it was more serious, and via ambulance went to the hospital and admitted on 6/30/2021 through 7/7/2021. Was in ICU but not ventilated. DIscharged to an extended care facility on 7/8/2021.
80 2021-07-17 tingling Sour tongue; sour taste in my mouth 24 hours a day; Diarrhea like symptoms; Tiredness; Occasional ti... Read more
Sour tongue; sour taste in my mouth 24 hours a day; Diarrhea like symptoms; Tiredness; Occasional tingling in my fingertips; Mouth irritation; This is a spontaneous report form a contactable consumer. This 80-year-old male patient reported for himself stating that he received his second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number: EN6205) via an unspecified route of administration into the left arm on 11Mar2021 14:00 (at the age of 80-year-old) as single dose for COVID-19 immunisation. The patient medical history was not reported. Have a surgery but have seem to get a clean health, thinks that all was good. He has no other health problems really, nothing other the old age, no problems. Concomitant medication included vitamin d [vitamin d nos] (VITAMIN D [VITAMIN D NOS]) taken for an unspecified indication, start and stop dates were not reported, takes one of them every day. The patient previously received his first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number: EL9266) via an unspecified route of administration into the left arm on 18Feb2021 16:00 (at the age of 80-year-old) as single dose for COVID-19 immunisation. On 11Mar2021, the patient experienced mouth irritation. On an unspecified date, he experienced sour tongue; sour taste in his mouth 24 hours a day, diarrhoea like symptoms, tiredness and occasional tingling in his fingertips. The patient underwent lab tests which showed magnetic resonance imaging on 10Jun2021 and positron emission tomogram on 15Jun2021, both as negative, they could not find any cancer, correct. He spoke to several doctors since his changes of taste were occurring and had constant mouth irritation, sour tongue since, third week from his first COVID shot. Did not know how to describe it but it was a sour taste in his mouth 24 hours a day and it seems to he does not know what else to say about it expect talked to doctor several times and couples of other specialists that he has been seeing and they think it possible that it could be linked to the COVID shot since it was the sourness that he feels in his mouth was one of the symptoms of COVID. He had a couple of other side effects but few weeks ago they went away, for about a month from that day he was going to call loose bowels, not terrible but diarrhoea like symptoms and they lasted probably 3 weeks. Had tiredness that he experienced and was not experiencing now. Seemed to be quite good about that and occasional tingling in his fingertips but that seems to be helped, it was almost gone but once in a while. Those all sort occurred at same time but the sour taste in his mouth and tongue was constant or just do not go away. No other medical conditions. Treatment for event included that he went to doctor several times and he just suggested nothing to do about it.no prior vaccination. He was thrilled that he was able to get through there that day. Outcome was not resolved for event sour tongue; sour taste in my mouth 24 hours a day and was unknown for rest of the events.
81 2021-01-14 flushing flushing Narrative: RRT @ 1200
81 2021-01-15 tremor Severe shaking chills and tremors starting 12 hours after injection, and lasting 90 min. No fever
81 2021-01-17 migraine worst migraine headache of my life. Have had occasional migraine auras but not headaches
81 2021-01-18 pain in extremity tired and fatigue, soreness in arm on first day, diarrhea,sore knee, magnified any type of pain he i... Read more
tired and fatigue, soreness in arm on first day, diarrhea,sore knee, magnified any type of pain he initially had:shoulder pain as well
81 2021-01-19 slurring Slurred speech started morning of 1/8 and patient went to ED after dialysis appointment. Admitted fo... Read more
Slurred speech started morning of 1/8 and patient went to ED after dialysis appointment. Admitted for TIA (transient ischemic attack). Discharged home on 1/10 with follow up appts with Neurology.
81 2021-01-24 weakness The patient began experiencing trouble breathing and weakness a few hours after administration of th... Read more
The patient began experiencing trouble breathing and weakness a few hours after administration of the vaccine. He was recovering from a kidney infection, so it is unknown what the cause of the symptoms originated from. It was determined to involve EMS, and they came and picked him up at the Long Term Care facility and took him to the hospital.
81 2021-01-26 unresponsive to stimuli (Report per patients wife ) Patient took his usual nap around 12pm. She found him lying in the bed u... Read more
(Report per patients wife ) Patient took his usual nap around 12pm. She found him lying in the bed unresponsvie at 2pm. EMS was not called. Patient's wife called the Funeral home.
81 2021-01-27 difficulty speaking Patient had full body hives starting on 1/25/2021 (mainly on arms) Hoarseness in throat and congest... Read more
Patient had full body hives starting on 1/25/2021 (mainly on arms) Hoarseness in throat and congestion Child treated with Benadryl Advised treatment from PCP was/is as of 1/28/2021 Zyrtec 10 mg AM + pepcid 20 mg AM Zyrtec 10 mg PM + pepcid 20 mg PM Limit benadryl but if give it then only at night and replace it for the zyrtec
81 2021-01-27 pain in extremity sore arm
81 2021-02-01 inability to speak, unresponsive to stimuli the doctor was concerned that it might be a mini stroke; couldn't think of what he wanted to say; Th... Read more
the doctor was concerned that it might be a mini stroke; couldn't think of what he wanted to say; This is a spontaneous report from a contactable consumer reporting for the father. An 81-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 14Jan2021 08:45 at single dose in right arm because of his age group /mass senior vaccination order. Medical history included blood pressure abnormal from an unknown date and unknown if ongoing. Concomitant medications included blood pressure medicine since recent years. The patient previously had a flu shot (INFLUENZA VACCINE) but had that in early Nov2020. He kept saying it was the shot, but that he was fine. There were no additional vaccines administered on same date of the Pfizer Suspect. The patient got vaccinated with the Pfizer COVID vaccine on 14Jan2021. He was feeling great with no problems. He sat and waited 15 minutes, and felt fine. When they were driving home after breakfast, her mother said she was talking asking him a question, and he wouldn't respond. Her father could hear her mother asking the question, but he said he could not think of what he wanted to say. He told her he couldn't think of what he was thinking on 14Jan2021. It probably started 1 hour to 1 hour 15 minutes after vaccination, and lasted 15-20 minutes. He kept trying to think of stuff. He kept repeating this for a little bit. His wife thought he was just trying to think of something, but couldn't remember. He was 81. He was very healthy and in shape. He still rides his bike every day. He walks in the morning to play golf too. When they got home and woke up from the nap, and he felt fine. He did say it was the weirdest thing, and that it had to have come from the shot. Since then, he has felt perfectly fine. He had nothing more going on that would indicate any side effect. Her concern was that it sounded like possibly a mini stroke. Upon checking with an HCP (Healthcare professional), the doctor was concerned that it might be a mini stroke and scheduled him for a CAT (Computerised axial tomography) scan. He kept saying it had to be the shot because he has been fine ever since. He had no issues with soreness at site or anything. He didn't have a prescribing doctor. He was driving when it happened. He didn't have a slur or anything. His second appointment is on the 04Feb2021. The event did not require a visit to Emergency Room, but required a visit to Physician Office in the morning of 18Jan2021. The outcome of the event couldn't think of what he wanted to say was recovered, and of the other event was unknown. Information on lot/batch number has been requested.
81 2021-02-04 feeling hot not feeling well/feeling unwell; aches all over his body/Aches all over with muscles pains; muscle p... Read more
not feeling well/feeling unwell; aches all over his body/Aches all over with muscles pains; muscle pains; headache; joint pain; chills; Injection site pain on left arm; body slightly warm/felt slightly warm; This is a spontaneous report from a contactable consumer (Patient's wife). A 81 years old male patient received first dose BNT162B2 (Pfizer BioNTech Covid 19 vaccine, lot number EL3247 or EL3427), via an unspecified route of administration at Arm Left on 21Jan2021 09:33 at the 81 years old at single dose for COVID-19 immunization. The medical history was none. The family medical history was none. The concomitant medications included warfarin from Mar2012 for Atrial fibrillation( AFib) and standard medications . The patient was not feeling well. All occurred on 21Jan2021 18:00, the patient developed symptoms, such as aches all over his body, aches all over with muscles pains with muscle pains, headache, joint pain, chills, injection site pain on left arm, body slightly warm, felt slightly warm, feeling unwell. He had chills all night and could not get warm. The reporter had not taken the patient's temperature yet. The patient takes regular medications. The patient was on warfarin and standard medications. The reporter stated the vaccine cards were mixed up because they did not write their names on them and the vaccine lot numbers looks like they were mixed up. Someone probably made a mistake because one says EL3247 and the other says EL3427, so she is not sure which it is. The handwriting is different on the cards. There was no Additional Vaccines Administered on Same Date of the Pfizer Suspect. There was not Emergency Room Visit or physician's office required Prior Vaccinations (within 4 weeks). The outcome of the event was not recovered.
81 2021-02-09 weakness Rigors, weakness, and diarrhea
81 2021-02-10 weakness lost about 10 lbs; short of breath; chills; tested positive for Covid 19; tested positive for Covid ... Read more
lost about 10 lbs; short of breath; chills; tested positive for Covid 19; tested positive for Covid 19; feel weak/doesn't feel good; sinuses were terrible and he still has it today. Like when he got up and got to the sink to blow his nose it was like a hard bloody scab that came out, blood tinge.; temperature went to 99.1/Temperature increased; he had the aching, pain, his muscles; headache; This is a spontaneous report from a Pfizer-sponsored program from a contactable consumer (patient). An 81-years-old male patient received first dose of bnt162b2 (Pfizer Covid-19 Vaccine), via an unspecified route of administration in Left Arm on 14Jan2021 at SINGLE DOSE for Covid-19 immunization. The patient's medical history was none. The patient's concomitant medications were not reported. The patient had never had any sickness. On 14Jan2021 he got his first dose and before the vaccine his temperature was normal. When he got the shot, before leaving his temperature went to 99.1, they told him don't be surprised if it goes to 100. He was supposed to go back for his second dose on 04Feb2021. When he got home that same day he began to feel weak, he has been in bed for 2 weeks now. He tested positive for Covid 19 on 22Jan2021. He described the test was a Long stick in the right nostril down to the throat. It was positive, he took the test on 22Jan2021 and on 25Jan2021 is when they called him with results. He just did not feel good. He was wondering if he should take the second shot on 04Feb2021. He had researched on Google and it said not to take it, if you've had the flu. On 14Jan2021 was when he experienced the increase in temperature and weakness on the same day. He did not get real bad, but felt those symptoms for a few days and got worse. He went out in Public the next day with no problem. He did go to grocery store and did wear a mask. He had lost about 10 lbs Weight. Temperature Increased: He had a fever last night (27Jan2021). He was over the worst and he would live now (28Jan2021). He was hoping to get 24 hours without a fever, but yesterday (27Jan2021) it was a low 99 point something and he had chills. Weakness: Right now (28Jan2021) he was strong but when getting through breakfast and this conversation he would be short of breath and weak. The weakness was the biggest problems. On the 14Jan2021 it was not bad, he didn't think nothing of it but he didn't feel good, he had the aching, pain, his muscles, headache, his sinuses were terrible and he still has it today. Like when he got up and got to the sink to blow his nose it was like a hard bloody scab that came out, blood tinge. The outcome of event tested positive, "sinuses were terrible", short of breath, Muscle ache, headache, lost about 10 lbs and chills was unknown, of event weakness was not recovered, temperature increased was recovered with sequel on 27Jan2021. Information about lot/batch number has been requested.
81 2021-02-10 depressed level of consciousness Resident found on floor beside chair, unable to rouse. Blood Sugar upon paramedics arrival to facili... Read more
Resident found on floor beside chair, unable to rouse. Blood Sugar upon paramedics arrival to facility of 66, blood sugar reported by hospital upon emergency department arrival of 18. Emergency Department discovered Urinary Tract Infection present, resident admitted to hospital and discharged from hospital to rehabilitation skilled nursing facility.
81 2021-02-10 unresponsive to stimuli non responsive to verbal stimuli, unable to hold trunk upright, eyes not focused; non responsive to ... Read more
non responsive to verbal stimuli, unable to hold trunk upright, eyes not focused; non responsive to verbal stimuli, unable to hold trunk upright, eyes not focused; This is a spontaneous report from a contactable other health professional. An 81-years-old male patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number EL3249), intramuscular in left arm on 22Jan2021 10:00 at single dose for covid-19 immunisation. Medical history included Parkinson's disease, post polio syndrome, Alzheimer's disease, atrial fibrillation, benign prostatic hyperplasia, right knee replacement, sleep apnoea, restless legs syndrome, covid-19 prior to vaccination. Concomitant medication included carbidopa monohydrate, levodopa (CARB/LEVO), cephalexin (unknown manufacturer), cetirizine (unknown manufacturer), citalopram (unknown manufacturer), donepezil (unknown manufacturer), etodolac (unknown manufacturer), finasteride (unknown manufacturer), furosemide (unknown manufacturer), metoprolol (unknown manufacturer), omeprazole (unknown manufacturer), oxybutynin (unknown manufacturer), senna alexandrina leaf (unknown manufacturer), tamsulosin (unknown manufacturer). The patient experienced had vaccine on friday and on sunday had neurological symptoms, non responsive to verbal stimuli, unable to hold trunk upright, eyes not focused on 24Jan2021 14:00 with outcome of recovered in Jan2021. The patient was sent to ER and CVA/TIA were ruled out. Has no history of seizure disorder. Returned and had 1 more episode later in the day. Vitals were all within his normal limits. ER physician felt was possible reaction to vaccine. The patient was not treated due to the events. The patient had not been tested for COVID-19 since the vaccination.; Sender's Comments: A causal association between BNT162B2 and the reported events cannot be excluded based on a compatible temporal relation. 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.
81 2021-02-13 night sweats High fever at night (up to 103.9) persisting from January 30 until present, night sweats, chills. L... Read more
High fever at night (up to 103.9) persisting from January 30 until present, night sweats, chills. Lower fever during the day (100- 101.4)
81 2021-02-13 pain in extremity Fever 100.5, High Blood Sugar sudden Drop to Low, Fatigue, Feet Stabbing Pain
81 2021-02-14 pain in extremity Arm Ache but very minor. Not any more painful than a regular flu shot.
81 2021-02-14 unresponsive to stimuli, inability to speak Presented to ED with altered mental status. He became fatigued and lethargic with a brief period of ... Read more
Presented to ED with altered mental status. He became fatigued and lethargic with a brief period of unresponsiveness. Could not speak and had a gaze to his left. Could not carry on conversation or answer questions appropriately. Stroke team activated and CT completed. CT negative for bleed. Neurology ordered Alteplase to be administered. Patient then transferred for further evaluation and treatment. Patient had left MCA occlusion with TICI IIb achieved. Admitted to neurology stroke service in ICU following procedure. Started on aspirin with plavix. Rehab referral.
81 2021-02-18 tenderness Hurt at touch for 1 day.
81 2021-02-19 tremor, flushing Received first COVID vaccine today and started having throat tightening, SOB, flushing, and tremors ... Read more
Received first COVID vaccine today and started having throat tightening, SOB, flushing, and tremors in his hands. Had a syncopal episode and chest pressure. Went to ER on 2/20/21
81 2021-02-21 weakness Patient is a 81 y.o. gentleman with a history of smoldering multiple myeloma, urinary retention for ... Read more
Patient is a 81 y.o. gentleman with a history of smoldering multiple myeloma, urinary retention for which he self catheterizes twice daily, as well as recently diagnosed atrial fibrillation that presents complaining of increasing weakness and falls. Patient fell 2/18 pm trying to get out of bed and he took about 20 minutes to get himself to a position where he could pull himself back up. Again 2/19 he was trying to get up and his legs were too weak to carry him and he fell to the ground. He needed assistance to get up and family asked him to come to emergency room for evaluation. He has been feeling poorly for about a month, with poor appetite and has lost about 15 pounds. He is not nauseated or short of breath and has no cough. He was apparently treated for UTI about 4 to 6 weeks ago after a visit to urgent care. He has since been to a different urgent care and was diagnosed with atrial fibrillation which was new in onset and was referred to a cardiologist who is planning to do a stress test in a few weeks. I believe he is on Eliquis now. In ER he was found to have significant pyuria and bacteriuria and was given a dose of Rocephin. Renal function shows worsening from levels in December although it is pretty stable over the past month from looking through other labs.
81 2021-02-23 flushing Elevated heart rate, flushing of the face and ears, vomiting, trouble breathing, pulmonary edema
81 2021-02-24 tremor The patient developed sudden onset nausea, diaphoresis and hypotension and shaking. Symptoms improve... Read more
The patient developed sudden onset nausea, diaphoresis and hypotension and shaking. Symptoms improved with IV fluids and rest. She was hospitalized 2 days.
81 2021-02-25 weakness Client c/o generalized weakness, stated that symptom began immediately after receiving vaccine. Cli... Read more
Client c/o generalized weakness, stated that symptom began immediately after receiving vaccine. Client was seen by EMS and assessment rendered. Vitals are BP 177/87, HR 66, O2 97. Client express that symptoms decrease and cleared to go home by EMS.
81 2021-02-25 weakness 1st dose vaccine 2/21/21; developed weakness and went to ED via EMS on 2/26/21 and admitted to Hospi... Read more
1st dose vaccine 2/21/21; developed weakness and went to ED via EMS on 2/26/21 and admitted to Hospital from ED DX: Acute respiratory failure with hypoxia ; Pleural effusion, left; Community acquired pneumonia of right lung, unspecified part of lung currently admitted to hospital during time of this report.
81 2021-03-01 weakness patient reported feeling dizzy and weak, admitted to local hospital. Continued to be weak and dizzy ... Read more
patient reported feeling dizzy and weak, admitted to local hospital. Continued to be weak and dizzy for several weeks Narrative: Patient reported not eating breakfast the day of his first vaccine, 02/7/21. He stated he waited the full observation time and upon leaving was told if he had any symptoms/side effects to call 911 or go to the ED. On his way home he pulled over because he was very dizzy and felt like passing out. Stated almost called but instead proceeded to drive to the ED. There he was admitted for cardiac workup. He states he continued to be weak and dizzy for several weeks, just now feeling better in the past week. He is currently wearing a holter at home. He reports never having any other reaction to any other drug or vaccine. States "that was a powerful shot"
81 2021-03-01 weakness injection site swelling; heart rate increased (95 bpm); jumping heart rhythm; Weakness; coughing whi... Read more
injection site swelling; heart rate increased (95 bpm); jumping heart rhythm; Weakness; coughing while trying to take a full breath; sore right arm; This is a spontaneous report from a contactable consumer reporting for himself. An 81-year-old male patient received the 1st dose of bnt162b2 (BNT162B2, Manufacturer Pfizer-BioNTech, lot# EN6201), via an unspecified route of administration in the right arm, on 11Feb2021 at 11:45, at single dose, for COVID-19 immunisation. Medical history included ulcer haemorrhage, ongoing arthritis, blood pressure abnormal, coagulopathy, surgery (for his chronic arthritis in the neck and shoulder), cardiac disorder (with heart aneurysm and a murmur). Concomitant medications included indapamide (unknown manufacturer) for blood pressure abnormal, acetylsalicylic acid (ECOTRIN 81 MG) for anticoagulant therapy, potassium (unknown manufacturer), candesartan (unknown manufacturer) for blood pressure abnormal, clorazepate dipotassium (TRANXENE) for muscle relaxant therapy for his chronic arthritis in the neck and shoulder. The patient experienced jumping heart rhythm on 15Feb2021 with outcome of not recovered, weakness on 15Feb2021 with outcome of recovered, coughing while trying to take a full breath on 15Feb2021 with outcome of recovered, sore right arm on 11Feb2021 with outcome of recovering, injection site swelling on an unspecified date with outcome of unknown, heart rate increased (95 bpm) on 15Feb2021 with outcome of unknown. The patient underwent lab tests and procedures which included heart rate: 95 bpm on 15Feb2021, prostatic specific antigen (PSA): unknown result on 03Feb2021. Therapeutic measures were taken as a result of sore right arm and included treatment with Tylenol.
81 2021-03-07 tingling Tongue felt "thick", cheeks tingled, and he developed chest pain.
81 2021-03-10 weakness 81 y.o. male with a past medical history of anemia, DVT, gout, hyperlipidemia, hypertension, present... Read more
81 y.o. male with a past medical history of anemia, DVT, gout, hyperlipidemia, hypertension, presents to the ER with change in mental status. Patient was otherwise in his usually state of health. He got his 2nd COVID-19 vaccine on 3/5. His wife noticed on Sunday, he started acting strangely, more confused. He was given his remote, and forgotten how to use it. He came to the hospital; has progressively gotten weaker, unable to walk, swallow, severe dysphagia, pupil unreactive, patient staring at ceiling. CT head; normal; CXR is normal. Platelets: 91,000.
81 2021-03-13 bell's palsy patient reported me to his primary care provider he got his covid 19 vaccine Pfizer through departme... Read more
patient reported me to his primary care provider he got his covid 19 vaccine Pfizer through department of health, he was diagnosed of Bells palsy thereafter and treated
81 2021-03-14 weakness he tested COVID-19 positive; he tested COVID-19 positive; fever and chills; fever of 100.5; takes al... Read more
he tested COVID-19 positive; he tested COVID-19 positive; fever and chills; fever of 100.5; takes all his energy to walk around or eat or do anything; injection site turned red and sore; injection site turned red and sore; The initial safety information received was reporting only non-serious adverse drug reactions, Upon receipt of follow-up information on 15Feb2021, this case now contains serious adverse reaction. Information processed together. This is a spontaneous report from a Pfizer-sponsored program received from a contactable consumer (patient). An 81-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: EL2347), intramuscularly, in the left arm, on 29Jan2021 at 11:00 at single dose for COVID-19 immunisation. Medical history included esophageal cancer from 2020, had major surgery from an unknown date about 4 months ago, and a third of his esophagus was taken out from an unknown date. There were no concomitant medications. No history if immunizations were provided. No other vaccines within 4 weeks prior to vaccination. The patient had the first dose on 29Jan2021 at 11:00 at a site sponsored by the health department, on 12Feb2021, it was reported that patient tested COVID-19 positive. On 31Jan2021, the patient reported that he had chills and a fever of 100.5, a couple times his fever spike up and goes away. He does not want to do anything since it takes all his energy to walk around or eat or do anything. On 29Jan2021, after the injection, the patient reported injection site turned red and got sore. He is asking how long the symptoms last. The events did not require physician's office or emergency room visit. No treatment was given. The outcome of the events injection site turned red and sore was recovered while for the rest of the events was unknown. The patient was asking if he should get the second dose.
81 2021-03-14 speech disorder 4 intermittent episodes of blurred vision/unclear speech/unsteady gait/slight confusion lasting 30-4... Read more
4 intermittent episodes of blurred vision/unclear speech/unsteady gait/slight confusion lasting 30-45mins in past 9 days.
81 2021-03-16 pain in extremity Deceased Narrative: Patient was a 79 yo male with a hx of HTN, ETOH and tobacco use, PVD, HLD with n... Read more
Deceased Narrative: Patient was a 79 yo male with a hx of HTN, ETOH and tobacco use, PVD, HLD with no contact with health care since 2014. Patient presented to facility on 9/30 with worsening bilateral leg pain and SOB. During that hospitalization he dx with severe decompensated HF (EF 20-25%) and cardiomyopathy. Cardiac cath with severe CAD, however unable to perform interventions. Upon goals of care discussion, patient no longer wished to go to facility or aggressive medical management. Patient was transitioned to hospice for comfort care.
81 2021-03-19 weakness Day 1-Confusion and weakness Day2-Increase in weakness, inability to swallow, confusion, fatigue Day... Read more
Day 1-Confusion and weakness Day2-Increase in weakness, inability to swallow, confusion, fatigue Day 3-Weakness, confusion, incontinence, hospitalized for hypoxia, pneumonia Day 20- Deceased
81 2021-03-31 weakness Fever, fatigue, headache, weakness, muscle pain, chills, feeling unwell, behavioral changes.
81 2021-03-31 weakness Patient waited the 15 minutes in front of the pharmacy and then started shopping in the store and pa... Read more
Patient waited the 15 minutes in front of the pharmacy and then started shopping in the store and passed out on one aisle in the store. I was called to look at patient and they had already placed him in a chair and he was alert but weak and was able to answer questions coherently. His son that was with him call EMS to come. I called the son later in the day to see how everything was going and the son said that EMS told him all vitals were normal and he did not go with them. He then told me that his dad and him were having dinner at the time I called and that he felt fine. He also said his dad did not have breakfast that morning which could have contributed to it since he had T2DM.
81 2021-04-07 pain in extremity Site: Pain at Injection Site-Mild, Systemic: Severe pain in right arm (non vaccine arm) with sever j... Read more
Site: Pain at Injection Site-Mild, Systemic: Severe pain in right arm (non vaccine arm) with sever joint pain also-Severe, Systemic: Joint Pain-Severe, Additional Details: Severe pain in opposite arm with severe joint pain
81 2021-04-09 unresponsive to stimuli Pt here for covid vaccine. Received Pfizer at 800am. Was in observation area and RN noticed that pt ... Read more
Pt here for covid vaccine. Received Pfizer at 800am. Was in observation area and RN noticed that pt was experiencing SOB at approx 811am . Upon questioning Pt stated this was his normal breathing and needed to use inhaler. Pt stated he has been experiencing this SOB for several weeks. Used inhaler was stared was feeling better. RN went to get grandson from parking lot, he stated that pt was SOB this AM when he picked him up. Pt was being questioned by RN when he became diaphoretic and less responsive. 911 called at 819am. VS attempted difficult to get BP via dianamap. Pulse was present. 4L O2 placed on pt . Pox per dianamap was in the 60's. Paramedics arrived at approx 823 am and left at approx 826am . Pt opened eyes and responded to name on way out to ambulance.
81 2021-04-14 weakness death Weakness Fever Sepsis
81 2021-04-15 weakness Positive COVID-19 result by PCR, weakness, fatigue, altered mental status.
81 2021-04-15 tenderness muscle tenderness; stiffness in his upper shoulder and the neck; stiff neck and shoulder; local ligh... Read more
muscle tenderness; stiffness in his upper shoulder and the neck; stiff neck and shoulder; local light pain; This is a spontaneous report from a contactable physician (patient). A 81-years-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, lot number: EL9261, expiration date: unknown), via an unspecified route of administration in the left arm on 21Jan2021at 12:50 as a SINGLE DOSE for COVID-19 immunization. Medical history included back pain and arthritis. Concomitant medications include propafenone taking for more 5 year still ongoing for indication atrial fibrillation and dutasteride taking for a year and half still ongoing for indication prostate. No history of all previous immunization with Pfizer vaccine and no prior vaccination in four weeks. On 21Jan2021, received first dose of the vaccine about 2 and a half weeks ago. He stated, it went fine but the day after, on 22jan2021 had some muscle tenderness (local light pain) and stiff neck and shoulder developed that was pretty mild but it was still going. It's about 2 and a half weeks now. In the morning it was maybe a tad more stiff mostly on left arm, it improved some when walking around and with exercising so he doesn't have to take medication. He stated, when you don't move it doesn't hurt, it's when you move the neck muscle that it was sore but not much at all. At his age you have back pain and a little arthritis. It was strange that it started the day of or day after. He stated he did report just a bit of local pain but only when you touch the area and a very mild muscle pain, but it has continued and he doesn't know if it was related. He asked if this was related to the vaccine and how long this typically lasts. Mentioned he has had this pain before but he feels that he has avoided exercise or yoga or anything that would cause it now. he does have arthritis in his back. He was scheduled to receive the second dose of the vaccine on 11Feb2021. He didn't receive any treatment for the events. The clinical outcome of the events was still unsure if he had this before vaccine or not and its persisting.The outcome of all events were not recovered.
81 2021-04-17 flushing The patient has been tired since the vaccine was given. The patient slept for 3 hours after vaccinat... Read more
The patient has been tired since the vaccine was given. The patient slept for 3 hours after vaccination and was nevertheless tired. His forehead looked hot.
81 2021-04-23 night sweats, weakness, pain in extremity, cold extremities difficulty breathing; He hasn't been able to walk the last couple of days and has had to use his whe...