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Vaccine VAERS ID Adverse Event Description
Pfizer 905345-1 Patient received Pfizer COVID 19 vaccine last Thursday 12/17. Admitted today (12/21) with bleeding and low platelet count - working up for ITP, TTP. Given recency of vaccination and no known contributory allergy or medical history, physician thought potentially associated with vaccination.
Pfizer 906910-1 HPI: 56 y.o. male with no pmhx c/o generalized bruising for 2 days, noticed small blood tinged spots generalized. Gradual onset, severe on severity, no alleviating or aggravating factors. Patient denies fevers, chills, N/V/D, abdominal pain. In ER: Platelet <1. Platelet transfusion in ER. Admitted for Thrombocytopenia/ITP
Pfizer 908869-1 12/18/2020: COVID19 vaccine received. 12/19/2020: Patient noticed petechiae/bruising on arms, legs and face. Worsened over next 48 hours. 12/21/2020: Patient had blood drawn (CMP, PT/INR, CBC) at lab. 12/22/2020: Labs resulted; CMP and PT/INR WNL (exceptions: SCr 1.24, TBil 1.7); CBC with platelet count of 1,000 resulting in patient admission to Hospital. At admission he received 80 mg of prednisone, 40 g of IV Ig and a unit of platelets. 12/23/2020: Continued hospitalization. Patient’s platelets improved to 20,000 and he received another 35g of IV Ig. 12/24/2020: Patient discharged with platelets of 38,000.
Pfizer 910316-1 TTP; This is a spontaneous report from a non-contactable pharmacist. A 22-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), intramuscular on 17Dec2020 as a single dose for COVID-19 immunization. The patient did not have any known relevant medical history. The patient had no 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. It was unknown if the patient received any other vaccines within four weeks prior to the vaccination. On 21Dec2020, the patient experienced thrombotic thrombocytopenic purpura (TTP); which was serious for hospitalization. The clinical course was as follows: The patient went to the emergency room/urgent care and was admitted in the early morning of 21Dec2020 due to TTP. Work-up was ongoing with no known results. On 21Dec2020, the patient also had a COVID-19 test which was negative. The patient was treated with unspecified corticosteroids and platelets. The clinical outcome of the TTP was unknown. The reporter assessed that it was unknown if the TTP was related to the vaccination. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.; Sender’s Comments: Current limited information does not allow a full medically meaningful assessment, especially lack of medical history, concomitant medications, concurrent illness and diagnostic workups such as coagulation test, Combs test, bacterial/virologic/immunological biomarkers to identify the etiology. 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.
Pfizer 912314-1 drop in platelets; This is a spontaneous report from a Pfizer-sponsored program. A contactable pharmacist reported that a patient of unspecified age and gender started to receive bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot/batch number not reported), via an unspecified route of administration on an unspecified date at a single dose for covid-19 immunization. The patient’s medical history and concomitant medications were not reported. Pharmacist on the line calling about COVID 19 Vaccine. He was doing some administrative work and noticed they have patient who received the COVID 19 vaccine and has since experienced a drop in platelets. He wanted to know if we have any information about any other reports of this occurring. The COVID 19 vaccine was given and then noticed patient had a drop in platelets. The reporter stated he does not know when the patient experienced the drop in platelets. He was provided with this question yesterday, so it’s possible the drop occurred yesterday, but he does not know. It was unknown to the caller if the drop in platelets is still ongoing or has resolved. The outcome of the event was unknown. Information on the lot/batch number has been requested.
Pfizer 920719-1 starting to feel lethargic and weak. Had menses with increased blessed. Called physician to have blood work done to see if I was experiencing anemia. Blood work complete on 12/31/2020. On 1/3/2021, I woke up with blood blisters all over the inside of my mouth and petechia on my trunk and bilateral upper and lower extremities. I called my primary physician to report the symptoms. He suggested to go to the ER if my symptoms worsened. Later that evening I started with a nose bleed and did go to the ER. Upon arrival to the ER, my platelet count was 9. I was admitted to the hospital and diagnosed with ITP.
Pfizer 930153-1 ITP Plt 2
Pfizer 935452-1 1/6/21 8pm started with Nasuea, vomiting, diarrhea and fever. 1/7/21 started having intermittent chest pain in the morning. Then in the evening it became constant. Went to ER that evening due to chest pain. EKG showed t wave abnormality. 1st Trop was negative went from 0.08 to 2.3 Had 2 Echo’s done and they were normal. Platelets were 85. Was discharged without chest pain. Troponin on discharge was 0.67 and platelets 61. Was admitted due to Chest pain and troponin. Attending provider diagnosed as myocarditis and thrombocytopenia R/T vaccine.
Pfizer 944270-1 He collapsed with left sided hemiparesis; Stroke; Rt basal ganglia hemorrhage w/ edema and mass effect.; Rt basal ganglia hemorrhage w/ edema and mass effect.; Low platelets, 114; His bp as high as 200s/100; Hand weakness; Myalgia; Fever; Severe fatigue; This is a spontaneous report from a contactable physician. A 58-year-old male patient received first dose of bnt162b2 (Pfizer BioNTech COVID vaccine), intramuscularly on 16Dec2020 at a single dose for COVID-19 immunization. Medical history included hypertension with reported med noncompliance in the last few months due to stress. Concomitant medication included hypertension medications in two weeks. The patient was presumed neg covid status prior to vaccine. He worked as a Pulm/critical care physician. He reported fever, myalgia, fatigue on 16Dec2020. Next day (17Dec2020), he took off from work due to his symptoms. The following day (18Dec2020), he came to work. He c/o ongoing severe fatigue & hand weakness in am. Staff noted him to be evaluating his hands during clinic. At 12:15, he collapsed with left sided hemiparesis. The reporter had suspicion for stroke. He was transported to the Emergency Room (ER), head CT showed Rt basal ganglia hemorrhage w/ edema and mass effect. Labs notable for Low platelets, 114 (unknown baseline) on 18Dec2020, normal coags on an unspecified date. BP recorded as 179/101, but it was noted in trauma room his bp as high as 200s/100. He had a history of hypertension with reported med noncompliance in the last few months due to stress. Patient was transferred for further care. Full course was unknown but had rebleed there with low plts. Adverse event (he collapsed with left sided hemiparesis) resulted in hospitalization (22 days), life threatening illness (immediate risk of death from the event), disability/incapacitating or permanent damage. Treatment was received for adverse events. Results of tests and procedures for investigation of the patient: on 18Dec2020, Nasal Swab test: negative. The outcome of events was not recovered. Unknown if 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 was not tested for COVID-19. Information on the lot/batch number has been requested.; Sender’s Comments: Collapsed with left sided hemiparesis/suspicion for stroke are as consequences of basal ganglia hemorrhage with edema, which is caused by worsening of hypertension. Low platelet also contributes to brain hemorrhage. All these serious events are unrelated to the vaccine use. 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.
Pfizer 958845-1 thrombocytopenia; This is a spontaneous report from a contactable other health professional (patient). A 59-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in arm left on 04Jan2021 13:30 at single dose for COVID-19 immunization. Medical history was none. The patient’s concomitant medications were not reported. The patient did not have COVID tested post vaccination and did not have COVID prior vaccination. The patient experienced thrombocytopenia on an unspecified date with outcome of unknown. It was reported he had thrombocytopenia but did not experience any side effects. Information about lot/batch number has been requested.; Sender’s Comments: A possible contributory effect of suspect BNT162B2 on reported thrombocytopenia 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.
Pfizer 968354-1 Acute Gastrointestinal Bleeding per rectum with massive bloody diarrhea, transfer to Emergency room by EMS with IV placement and fluid resuscitation, vital signs unstable, emergency assessment and massive transfusion over next 4 hours of 4 units of PRBC and 2 units platelets, dual 16 gauge IV’s, intrarterial line. ER Summary available and can be scanned and sent. Low HgB, Low platelets in 60 k range and multiple consultants and diagnositcs
Pfizer 969839-1 Onset of hemmoragic oral bullae after eating very hot cheese toast 1-20-2021 Widely scattered petechiae lower and upper extremeties 1-21-2021 Extensive petechaie lower extremities and a few on trunk face 1-22-2021 CBC in ER showed severe thrombocytomenia with platelets less than 2000 1-22-2021 Admitteed and treated with Decadron 40 mg IV, and IVIG infusions once daily Jan. 23rd and 24th 2021 Hepatiitis pannel negative EBV negative, COVID Nasopharengeal negative, splenic U/S upper limit of normal but unchanged on comparison with old imaging. With treatment platlets increased to 65,000, Discharged from hospital. IVIG discontinued Oral decadron 40mg will continue for 2 days with CBC hematology f/u in 36 hours
Pfizer 970161-1 Three weeks after taking the Pfizer vaccine (COVID Vaccine) he developed ITP. He was bleeding from his head, his brain; Three weeks after taking the Pfizer vaccine (COVID Vaccine) he developed ITP. He was bleeding from his head, his brain; This is a spontaneous report from a contactable physician. A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date at single dose for covid-19 immunization. The patient’s medical history and concomitant medications were not reported. Three weeks after taking the pfizer vaccine (covid vaccine) he developed ITP (Idiopathic thrombocytopenic purpura), he was bleeding from his head, his brain on an unspecified date in Dec2020 and he died. The patient was healthy, he never had ITP in the past. The patient died on an unspecified date. It was not reported if an autopsy was performed. Information on the lot/batch number has been requested.; Sender’s Comments: Based on temporal association, a possible contributory role of suspect BNT162B2 cannot be completely excluded for events idiopathic thrombocytopenic purpura and hemorrhage brain. However information is limited and does not allow a full medical assessment. 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.; Reported Cause(s) of Death: Three weeks after taking the Pfizer vaccine (COVID Vaccine) he developed ITP. He was bleeding from his head, his brain; Three weeks after taking the Pfizer vaccine (COVID Vaccine) he developed ITP. He was bleeding from his head, his brain
Pfizer 971562-1 died; acute immune thrombocytopenia; This is a spontaneous report from two contactable consumers. A patient of unspecified age and gender received BNT162B2(lot number and expiration date not provided) via an unspecified route of administration on unspecified date at single dose for COVID-19 immunization. The patient’s medical history and concomitant medications were not reported. The patient died after receiving the covid vaccine on an unknown date. The patient developed acute immune thrombocytopenia on an unknown date. It was unknown if autopsy was performed. The cause of death was unknown. The outcome of the event ““died”” was fatal and of the event “” acute immune thrombocytopenia”” was unknown. The reporter wondered if a platelets blood problem may lead to death and if who have a blood platelets condition like essential thrombocytosis should not risk taking the vaccine. Information on the lot/batch number has been requested.; Reported Cause(s) of Death: Died””
Pfizer 976971-1 thrombocytopenia; Stroke; bleed in the brain; This is a spontaneous report from a contactable physician (patient’s sibling). A 39-year-old female patient received first dose of BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine, lot number: EJ1685), via an unspecified route of administration in the left arm deltoid on 18Dec2020 at a single dose for COVID-19 immunization. The patient’s medical history was not reported. There were no concomitant medications. The reporter is calling about the COVID Vaccine. She is calling on behalf of her sister (patient). The patient had her first dose on 18Dec2020, then she had thrombocytopenia (reported to be life threatening) causing her to bleed in the brain which led to a stroke (reported to be disabling). The reporter stated that she is a doctor herself, as well as her sister who experienced the stroke is a doctor also. The thrombocytopenia was diagnosed on 30Dec2020, which is the same day she had the stroke on 30Dec2020. They did the Tensilon Test when she was admitted to the emergency room on 30Dec2020. When admitted her platelets were Low, it was 36, that is dangerously low. They did a CT scan and found a large massive amount of blood clot. When queried if this is an infarct or hemorrhage, the reporter stated that this was an internal bleed for the stroke. She’s in the hospital and had brain surgery. The thrombocytopenia at the moment was gone now. They gave her 6 units of blood and 4-5 units of platelets. The thrombocytopenia ended about 7 days after the diagnosis. Her sister is still in the hospital at this moment but in the Neuro Rehab unit. She is now confused after the stroke. Her sister has had no positive tests for Covid prior to the vaccine and no Antibody Test prior to the vaccine. Her sister has had no issues with vaccines in the past. Her sister had no vaccines on the same as the covid vaccine. At the end of the call, the reporter stated that because this was an injury caused by the vaccine, she is looking for compensation. The outcome of the event thrombocytopenia was recovered with sequel on 06Jan2021; for the event stroke was recovered with sequel on 30Dec2020; while for bleed in the brain was unknown.; Sender’s Comments: Based on the information available, a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported events thrombocytopenia, bleed in the brain and stroke. Additional information regarding relevant medical history, underlying conditions and concomitant medications will aid in comprehensive assessment of the case. 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.
Moderna 932915-1 Severe thrombocytopenia (plts 3k/uL), oral mucosal bleeding, bruising
Moderna 933935-1 Sever thrombocytopenia (platelet count 2,000) 8 days following Moderna COVID vaccine. Clinically suspicious for ITP.
Moderna 934990-1 26-year-old lady came in after she noticed she had bruises on her left hand after a CPR procedure at hospital. Patient was apparently in well health, she had received COVID-19 mRNA vaccine on January 7 at 3 PM, she has taken 2 pills with ibuprofen and tylenol for pain in right deltoid following vaccination. She was doing the CPR at 1:00 this afternoon, and she noticed that her left dorsum had some bruises. She took day off and went home and noticed that she also had bruises in both medial thighs, above the knee and some bruises in scalp. Patient presented to the Emergency Room 1/9/2021 ~6PM and platelet count was found to be 2x10^3/uL. Patient required transfusion of 7 units of platelets, steroids, and IVIG.
Moderna 937579-1 On 12/31/2020, at approximately 00:15, pt developed a fever of 102.9 F and tachycardia with rate of 120. He was treated with acetaminophen. Later in the morning, he complained of nausea, generalized muscle aches, intermittent increase in confusion. At approximately 14:00, he had a fall out of bed and at that time noted to be short of breath, tachypneic. He was taken via ambulance to Emergency Department. From there he was transferred to Hospital for admission with acute respiratory distress, suspected sepsis with lactic acid 7.4 and Bilateral Pulmonary Emboli. He was started on heparin and broad spectrum antibiotics and transitioned to ELIQUIS on 1/3/2021. Infectious etiology of sepsis was unclear. He continued broad spectrum antibiotics with clinical improvement. Abdominal CT scan was obtained due to intermittent nausea, vomiting, abdominal pain, loose stools. His heart rhythm flipped to Atrial Fibrillation with RVR on 1/2 and his rate improved with titration of metoprolol. He was also treated with prednisone for suspected underlying undiagnosed COPD. It is noted in his hospital summary that PEs presumed provoked in the setting of his recent COVID 19 infection. He was discharged from the hospital on 1/8/2021 and readmitted to the Veterans Home. He has been stable.
Moderna 950980-1 On January 14, 2021, I noticed generalized petechiae all over my body. I went to seek medical care and was found to have platelet count of 2. I was hospitalized for idiopathic thrombocytopenic purapura. I was given platelets which increased my platelets to 4. Next day, given IVIG dose. Also receiving 4 doses of decadron. Day after IVIG, platelets to 20. I am still in the hospital getting treatment today.
Moderna 953404-1 Severe rash. Platelets drop to almost needing transfusion
Moderna 958885-1 The patient was seen in my office on 1/19/21 with complaint of heavy vaginal bleeding. A CBC was obtained which revealed an H/H of 12.2/36.1 and a platelet count of 1 (not 1K, but 1 platelet!) and this was confirmed on smear review. She was immediately sent to the Hospital ED and repeat CBC confirmed the critically low platelet count. She is currently hospitalized and she has received platelet transfusions but her platelet count is still critically low. She is also receiving steroids and immunoglobulin and is under the care of MD (Heme/Onc)
Moderna 961499-1 Severe thrombocytopenia platelet count of 1.
Moderna 962980-1 admitted to shady grove hospital for ITP(immune mediated thrombocytopenia) plts were 1 on admission have not responded to typical ITP therapies, platelets still 4 today after 4 days in hospital workup shows ITP no other risk factors or history of itp or autoimmunity
Moderna 972719-1 Received second COVID vaccine Moderna on Wednesday evening at 6pm. Later that night, I was a little light-headed and achey, but went to bed. On thursday, my legs and arms were extremely achy. I took Tylenol and Motrin in the morning. It seemed to help some, but continued to feel very achy in my legs. I left work early (I am a pediatrician) on Thursday and went home and just sat and rested. I felt terrible, but had talked to other colleagues who felt very bad that first day after the shot. Friday morning, I woke up still achy but feeling better overall. I took motrin and Tylenol again on Friday morning. I worked the whole day seeing patients. Was tired, but got thru the workday. At around 6pm, I noticed petechiae rash on my lower legs. The rash started spreading thru the night- up my legs and to my arms. I went to ER. They did order CBC, CMP. Platelets were undetectable- 1 platelet was seen under microscope. CMP was normal. I was told to go to bigger hospital. I went, My platelets read as 4. I was admitted for two nights. Two doses of IVIG were given and I was put on Decadron 40mg PO daily for 4 days. I had tylenol, benadryl, zofran before the IVIG and after. I will see Hematology next week for follow up. Platelets yesterday at discharge were 60. Will be checked frequently for the next few months. ITP= diagnosis. COVID shot was trigger.
Moderna 973796-1 Thrombocytopenia Narrative: thrombocytopenia requiring hospitalization, meds and platelet infusion
# of Cases 27