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From the 10/15/2021 release of VAERS data:

Found 121 cases where Age is 12-or-more-and-under-20 and Vaccine targets COVID-19 (COVID19) and Symptom is Aortic thrombosis or Arterial thrombosis or Arterial thrombosis limb or Arteriovenous fistula thrombosis or Arteriovenous graft thrombosis or Atrial thrombosis or Axillary vein thrombosis or Basilar artery thrombosis or Brachiocephalic vein thrombosis or Brain stem thrombosis or Cardiac ventricular thrombosis or Carotid artery thrombosis or Catheter site thrombosis or Cavernous sinus thrombosis or Cerebellar artery thrombosis or Cerebral artery thrombosis or Cerebral thrombosis or Cerebral venous sinus thrombosis or Cerebral venous thrombosis or Coronary artery thrombosis or Deep vein thrombosis or Foetal placental thrombosis or Graft thrombosis or Hepatic artery thrombosis or Hepatic vascular thrombosis or Hepatic vein thrombosis or Iliac artery thrombosis or Injection site thrombosis or Intracranial venous sinus thrombosis or Intrapericardial thrombosis or Jugular vein thrombosis or Mesenteric artery thrombosis or Mesenteric vein thrombosis or Ophthalmic artery thrombosis or Ophthalmic vein thrombosis or Ovarian vein thrombosis or Paraneoplastic thrombosis or Pelvic venous thrombosis or Penile vein thrombosis or Peripheral artery thrombosis or Portal vein thrombosis or Portosplenomesenteric venous thrombosis or Postoperative thrombosis or Postpartum thrombosis or Postpartum venous thrombosis or Precerebral artery thrombosis or Prosthetic cardiac valve thrombosis or Pulmonary artery thrombosis or Pulmonary thrombosis or Pulmonary venous thrombosis or Renal artery thrombosis or Renal vascular thrombosis or Renal vein thrombosis or Retinal artery thrombosis or Retinal vascular thrombosis or Retinal vein thrombosis or Shunt thrombosis or Spinal artery thrombosis or Splenic artery thrombosis or Splenic thrombosis or Splenic vein thrombosis or Subclavian artery thrombosis or Subclavian vein thrombosis or Superior sagittal sinus thrombosis or Thrombosis or Thrombosis corpora cavernosa or Thrombosis in device or Thrombosis mesenteric vessel or Thrombosis prophylaxis or Transverse sinus thrombosis or Truncus coeliacus thrombosis or Tumour thrombosis or Umbilical cord thrombosis or Vaccination site thrombosis or Vascular access site thrombosis or Vascular graft thrombosis or Vascular stent thrombosis or Vena cava thrombosis or Venous thrombosis or Venous thrombosis in pregnancy or Venous thrombosis limb or Vertebral artery thrombosis or Visceral venous thrombosis and Vaccination Date from '2020-12-01' to '2021-09-30'

Table

   
AgeEvent OutcomeCountPercent
12-17 YearsPermanent Disability75.79%
Office Visit119.09%
Emergency Doctor/Room1512.4%
Hospitalized2722.31%
Recovered108.26%
Life Threatening108.26%
Not Serious32.48%
total8368.6%
17-44 YearsDeath21.65%
Permanent Disability86.61%
Office Visit2218.18%
Emergency Doctor/Room2722.31%
Hospitalized3528.93%
Recovered2016.53%
Birth Defect10.83%
Life Threatening2016.53%
Not Serious1310.74%
total148122.31%
TOTAL† 231† 190.91%
† Because some cases have multiple vaccinations and symptoms, a single case can account for multiple entries in this table. This is the reason why the Total Count is greater than 121 (the number of cases found), and the Total Percentage is greater than 100.



Case Details

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VAERS ID: 919376 (history)  
Form: Version 2.0  
Age: 19.0  
Sex: Female  
Location: Montana  
Vaccinated:2020-12-30
Onset:2021-01-02
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-01-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 LA / IM

Administered by: Private       Purchased by: ?
Symptoms: Limb discomfort, Limb mass, Pain of skin, Skin warm, Thrombosis, Ultrasound scan abnormal
SMQs:, Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Malignancy related therapeutic and diagnostic procedures (narrow), Thrombophlebitis (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Dasetta 1/35, Bile salts OTC, Proair Inhaler PRN
Current Illness: N/a
Preexisting Conditions: Asthma
Allergies: Penicillin
Diagnostic Lab Data: 1/4/2021 confirmed with ultrasound of lower extremity.
CDC Split Type:

Write-up: Patient received Moderna vaccine, Wednesday 12/30. On Saturday 1/3/2021 patient felt pressure/tightness in lower extremity. When patient touched area, a noticeable ball was felt under the skin, tender to the touch and warm. Patient went into urgent care on Monday 1/4/2021 with a confirmed dx of a superficial blood clot. Unknown etiology of whether this is from current birth control or the COVID19 Moderna vaccine.


VAERS ID: 955565 (history)  
Form: Version 2.0  
Age: 19.0  
Sex: Female  
Location: Ohio  
Vaccinated:2021-01-07
Onset:2021-01-14
   Days after vaccination:7
Submitted: 0000-00-00
Entered: 2021-01-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 011L20A / 1 LA / IM

Administered by: Other       Purchased by: ?
Symptoms: Abdominal distension, Activated protein C resistance test positive, Coagulation test, Computerised tomogram abdomen, Constipation, Deep vein thrombosis, Electrocardiogram, Erythema, Faecaloma, Flank pain, Laboratory test, May-Thurner syndrome, Oedema peripheral, Pain in extremity, Prothrombin level increased, Thrombectomy, Urinary retention, Vascular test, Venogram, Venous stent insertion
SMQs:, Cardiac failure (broad), Anaphylactic reaction (broad), Acute pancreatitis (broad), Angioedema (broad), Anticholinergic syndrome (broad), Retroperitoneal fibrosis (broad), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Embolic and thrombotic events, venous (narrow), Thrombophlebitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? Yes
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, 3 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: Benztropine Mesylate 1 mg. by mouth twice daily clozapine 50 mg. by mouth daily at 0700 and 1600, 100 mg. daily by mouth at 8 p.m. (200 mg. total daily) Junel 1-20, one tablet by mouth once daily Ativan 0.5 mg. by mouth three times daily
Current Illness: Patient was actively being treated for Bipolar disorder with most recent episode depression, Anxiety disorder, ADHD, Oppositional Defiant disorder, Autism Spectrum Disorder, Fetal Alcohol Syndrome, Intermittent Explosive Disorder, a history of Pseudo-seizures, and insomnia. She has Alopecia Areata, and allergic rhinitis, and constipation. She has a history of left eye strabismus and uses glasses. She has not been acutely ill prior to vaccination.
Preexisting Conditions: See above, history also of right radial neck fracture in 2019 with ORIF repair. Living at Center for behavioral management and stabilization
Allergies: Ideopathic reaction to clonidine and benadryl - Awake for days after use Risperdal causes Aggression No true allergies
Diagnostic Lab Data: Vascular studies venogram with radiology review and interpretation CT of Abd. and Pelvis Left Hip and Pelvis EKG Labs - including coagulation studies Stint insertion into Left Iliac vein
CDC Split Type:

Write-up: One week after the shot (1-14-2021) Patient (19 y.o.)reported side pain and appeared constipated, Laxatives given along with Tylenol, on further assessment Patient was noted to have left leg redness and abdominal fullness. Dr. was updated and we had orders for close monitoring, the next day when she got up, her leg appeared better, and she had passed a small BM, but by lunch she had developed significant pain and edema in her left leg, and the color of her leg was reddened again. She was sent to the emergency room with her symptoms. She was admitted back to our facility yesterday, her diagnoses included Acute provoked left external illiac, femoral, popliteal, and peroneal DVT. Elevated Factor II levels, Elevated APC resistant, May-Thurner Syndrome, history of developmental disabilities, fecal impaction and urinary retention - suspected related to her fecal impaction. Vascular surgery was consulted, and pt. was started on a heparin drip, and mechanical thrombectomy was needed for both legs due to multiple clots. She was started on Eliquis and Plavix, and thigh high compression stockings were ordered, ace wraps being used until these are supplied. Her Fecal impaction was addressed also and the urinary retention resolved.


VAERS ID: 1162619 (history)  
Form: Version 2.0  
Age: 18.0  
Sex: Female  
Location: Nevada  
Vaccinated:2021-03-16
Onset:2021-04-01
   Days after vaccination:16
Submitted: 0000-00-00
Entered: 2021-04-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / 1 - / IM

Administered by: Private       Purchased by: ?
Symptoms: Angiogram cerebral, Magnetic resonance imaging head, Superior sagittal sinus thrombosis
SMQs:, Embolic and thrombotic events, venous (narrow), Central nervous system vascular disorders, not specified as haemorrhagic or ischaemic (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: CT angiogram head, MRI brain
CDC Split Type:

Write-up: Superior sagittal sinus thrombosis diagnosed on 4/1/2021. Symptoms started early on April 1, 2021


VAERS ID: 1169265 (history)  
Form: Version 2.0  
Age: 18.0  
Sex: Female  
Location: Texas  
Vaccinated:2021-02-11
Onset:2021-03-22
   Days after vaccination:39
Submitted: 0000-00-00
Entered: 2021-04-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EM9809 / 2 UN / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: Anti factor Xa assay normal, Coagulation factor VIII level increased, Deep vein thrombosis, Fibrin D dimer, Limb discomfort, Pain in extremity, Skin tightness, Thrombosis, Ultrasound Doppler abnormal
SMQs:, Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Embolic and thrombotic events, venous (narrow), Thrombophlebitis (broad), Cardiomyopathy (broad), Tendinopathies and ligament disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Depo-Provera (started 11/30/20), cholecalciferol, Briviact, diazepam, Diastat PRN, Epidiolex, felbamate, folic acid, Keppra, melatonin, norethindrone, pregabalin, Vitamin B6
Current Illness:
Preexisting Conditions: Cerebral venous sinus thrombosis - onset 7/10/20 after extensive neurosurgery (Resolved on Lovenox x3 months), Vitamin D deficiency Speech delay Cerebral venous sinus thrombosis - Onset: 07/10/2020 Left hemiparesis Generalized convulsive epilepsy Severe myoclonic epilepsy in infancy Menstrual epilepsy Epilepsy Deep venous thrombosis of lower extremity - Onset: 03/23/2021, Left Genetic mutation Constipation Cyst of ovary Oligomenorrhea Sleep disorder Abnormal gait Hemi-neglect Urinary incontinence Gastrostomy present Severe myoclonic epilepsy in infancy, refractory
Allergies: Fosphenytoin, Ketamine (seizure), Benadryl (phlebitis)
Diagnostic Lab Data: 3/24/21 - Anti-Xa=0.53 D-dimer = 3421 Factor VIII assay $g150 3/29/21 Anti Xa = 0.49 Sedated ultrasound - Extensive thrombus is noted extending from external iliac vein to distal femoral vein. Some non-occlusive thrombus also noted in the proximal greater saphenous vein. There appears to be decreased thrombus noted in the popliteal vein with near recanalization as well as in the posterior tibial vein.
CDC Split Type:

Write-up: Acute DVT in left LE. Patient presented to ED on 3/22/21. She had 2 day h/o leg discomfort and leg was taught and painful on the day she went to the ED. Study was limited due to pt lack of cooperation. Lovenox started.


VAERS ID: 1200320 (history)  
Form: Version 2.0  
Age: 18.0  
Sex: Female  
Location: D.C.  
Vaccinated:2021-03-13
Onset:2021-03-20
   Days after vaccination:7
Submitted: 0000-00-00
Entered: 2021-04-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / 1 LA / SYR

Administered by: Private       Purchased by: ?
Symptoms: Influenza like illness, Muscle spasms, Thrombosis
SMQs:, Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Dystonia (broad), Thrombophlebitis (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Albuterol Sulfate, Tretinoin Cream 0.0025%, Xulane birth control patch
Current Illness: None
Preexisting Conditions: Asthma.
Allergies: None
Diagnostic Lab Data:
CDC Split Type:

Write-up: Flu-like symptoms. Muscle cramping in the left leg. Continuos period with heavy blood clotting.


VAERS ID: 1206380 (history)  
Form: Version 2.0  
Age: 19.0  
Sex: Female  
Location: Texas  
Vaccinated:2021-04-08
Onset:2021-04-10
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-04-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / 1 RA / SYR

Administered by: Private       Purchased by: ?
Symptoms: Chest X-ray, Computerised tomogram thorax, Dyspnoea, Headache, Magnetic resonance imaging, Thrombosis
SMQs:, Anaphylactic reaction (broad), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Thrombophlebitis (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Estarylla
Current Illness: N/A
Preexisting Conditions: N/A
Allergies: N/A
Diagnostic Lab Data: 4/13/2021: -Chest x-ray -Chest CT -MRI
CDC Split Type:

Write-up: On 4/8/2021 I developed a headache after receiving the Johnson and Johnson vaccine. I took the next few days easy, and laid in bed for the majority of the weekend. On 4/10/2021 I left my residence to get dinner and noticed I was short of breath just walking from the building to my car. The shortness of breath worsened over the next few days. On 4/13/2021 I called a clinic and told them I had been short of breath and they directed me to the ER. I arrived to the ER around 2:30 in the afternoon. They ordered a chest x-ray and ran a test to determine if I could have a blood clot. The test came back with results indicating I could have a blood clot, so they did a chest CT and an MRI. The chest CT showed a blood clot in my left pulmonary artery. They prescribed a blood thinner, told me to stop taking oral birth control, and discharged me.


VAERS ID: 1206421 (history)  
Form: Version 2.0  
Age: 17.0  
Sex: Male  
Location: California  
Vaccinated:2021-03-11
Onset:2021-03-14
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-04-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EN6204 / 1 RA / SYR

Administered by: Other       Purchased by: ?
Symptoms: Blood test abnormal, Deep vein thrombosis, Nodule, Pain in extremity, SARS-CoV-2 test negative, Thrombosis, Ultrasound scan abnormal
SMQs:, Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Embolic and thrombotic events, venous (narrow), Malignancy related therapeutic and diagnostic procedures (narrow), Thrombophlebitis (broad), Tendinopathies and ligament disorders (broad), COVID-19 (broad)

Life Threatening? Yes
Birth Defect? Yes
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, 5 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: melatonin,
Current Illness: none
Preexisting Conditions: none
Allergies: none
Diagnostic Lab Data: Ultrasound on 3/18 showed DVT in right calf, and blood panels were also done, covid test was negative. Blood work showed he was positive for heterozygous positivity for Factor11 (prothrombin) gene mutation
CDC Split Type:

Write-up: Blood clot in right calf. Noticed pain and knot in calf on Sunday 3/14/2021. It worsened over the next few days. Went to Urgent care on 3/18 and they sent us straight to ER for Ultrasound. In hospital they found it was a clot identified as deep vein thrombosis, and started a treatment of blood thinner and pain medication.


VAERS ID: 1208555 (history)  
Form: Version 2.0  
Age: 18.0  
Sex: Female  
Location: Unknown  
Vaccinated:2021-04-09
Onset:2021-04-12
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-04-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / 1 AR / IM

Administered by: Private       Purchased by: ?
Symptoms: Epistaxis, Thrombosis
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Thrombophlebitis (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: She did have blt turbinate reduction 3 weeks prior to vaccine, but drainage had been clear for $g1 week prior to vaccine. Day after vaccine she had large blood clots from nares
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: multiple large blood clots from her nares on Monday 4/12


VAERS ID: 1220371 (history)  
Form: Version 2.0  
Age: 19.0  
Sex: Male  
Location: California  
Vaccinated:2021-03-11
Onset:2021-03-15
   Days after vaccination:4
Submitted: 0000-00-00
Entered: 2021-04-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 LA / -

Administered by: Senior Living       Purchased by: ?
Symptoms: Axillary pain, Chest X-ray normal, Chest pain, Computerised tomogram thorax, Electrocardiogram normal, Heart rate irregular, Peripheral artery thrombosis, Ultrasound scan
SMQs:, Embolic and thrombotic events, arterial (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad), Cardiac arrhythmia terms, nonspecific (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: none
Current Illness: none
Preexisting Conditions: none
Allergies: none
Diagnostic Lab Data: CT chest 3/30- Negative Ultrasound 4/14/21- Thrombosis left brachial vein
CDC Split Type:

Write-up: Pain left axilla developed evening of vaccine given date, next day developed pain over left side chest with fluctuating heart rate. Per patient he went to ERD on 3/15 where he had a chest xray and ekg with normal results, advised to take pain meds and follow up with PCP. On 3/16/21 pt seen via call advised to take anti inflamatories and labs ordered. Follow up OV on 3/22/21 CT chest ordered, prescribed pain med and anti inflammatories. 3/29 follow up visit- symptoms unresolved, 4/5 sympt unresolved, 4/15 4wks post injection sympt continue order Ultra sound left extremity


VAERS ID: 1224262 (history)  
Form: Version 2.0  
Age: 19.0  
Sex: Female  
Location: California  
Vaccinated:2021-03-28
Onset:2021-03-30
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-04-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ER8734 / 1 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Bone pain, Mass, Pain, Thrombosis
SMQs:, Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Thrombophlebitis (broad), Osteonecrosis (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: USPFIZER INC2021349630

Write-up: strange pain on her left collar bone; going to see someone just in case it''s a blood clot; lump on her collar bone, left collar bone; does hurt a little bit; This is a spontaneous report from a contactable consumer or other non hcp (patient herself). A 19-years-old female patient received bnt162b2 (BNT162B2, Formulation: Solution for injection), dose 1 intramuscularly administered in Arm Left (like the shoulder area) on 28Mar2021 09:00 (Lot Number: ER8734 and Expiry date: unknown) as single dose for covid-19 immunisation. The patient medical history was not reported. There were no concomitant medications. No additional Vaccines administered on same date of the Pfizer suspect. On 30Mar2021, the patient experienced going to see someone just in case it''s a blood clot, lump on her collar bone, left collar bone, does hurt a little bit and on unspecified date strange pain on her left collar bone. 19-year-old female got the first Pfizer Covid vaccine at 9 am on Sunday, March 28 and this morning, she woke up with a strange pain on her left collar bone and there was a lump there, states when she woke up, she noticed a pain, checked in the mirror, she saw on the left side she saw a bump and checked on the right side and didn''t see anything and that''s when she got worried. Caller states she was just calling to report it, she''s worried that it''s a blood clot or something else. Why was the patient taking Pfizer BioNTech COVID Vaccine (Verbatim): she wanted to be vaccinated to protect herself and her community. Caller states she would not like to provide her last name at this time. However, provided her last name initial. She also reports she would not like to provide her address, height, or weight right now. She states she used to volunteer at a hospital. She does not see expiration or NDC number on card she received when she got her vaccine. Caller states she does know that one of her family members has the Factor 5. She is not sure if she has it but would like to be tested for it. The outcome of the event going to see someone just in case it''s a blood clot was recovered, lump on her collar bone, left collar bone and does hurt a little bit was not recovered and strange pain on her left collar bone was unknown. Information on batch/Lot number has been requested.


VAERS ID: 1231186 (history)  
Form: Version 2.0  
Age: 18.0  
Sex: Male  
Location: Tennessee  
Vaccinated:2021-04-05
Onset:2021-04-16
   Days after vaccination:11
Submitted: 0000-00-00
Entered: 2021-04-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EP7533 / 1 - / -

Administered by: Private       Purchased by: ?
Symptoms: Pain, Pain in extremity, Thrombosis, Ultrasound scan abnormal
SMQs:, Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Malignancy related therapeutic and diagnostic procedures (narrow), Thrombophlebitis (broad), Tendinopathies and ligament disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Bupropion 150 mg/day Adhansia 45 mg/day Men''s multivitamin
Current Illness: None
Preexisting Conditions: None
Allergies: Sulfa drugs
Diagnostic Lab Data: Ultrasound of left leg
CDC Split Type:

Write-up: Approximately 11 days after receiving my first dose, I began feeling dull pain in my left calf. By Saturday, 4/17, the pain was severe enough to warrant a trip to the emergency room. After receiving an ultrasound of my leg, two blood clots were found in my left calf. One fully occluded a vein and another partially occluded a different vein.


VAERS ID: 1234443 (history)  
Form: Version 2.0  
Age: 16.0  
Sex: Female  
Location: Colorado  
Vaccinated:2021-03-31
Onset:2021-03-31
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-04-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ER8734 / 1 RA / IM
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0161 / 2 RA / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: Blood thromboplastin, Epistaxis, Full blood count normal, Thrombosis
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Thrombophlebitis (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Methotrexate
Current Illness:
Preexisting Conditions: JIA and Sjogrens
Allergies:
Diagnostic Lab Data: After dose #1 CBC (normal) and Urinalysis (abnormal- clarity and elevated pH) after dose #2 CBC (normal) PTT and PT. Pediatrician consulting a hematologist
CDC Split Type:

Write-up: After the first dose, mild dizziness and nausea followed by massive inflammation in joints and face, severe fatigue and loss of hearing in right ear. Hearing returned in 3 days, general malaise until a week before 2nd shot when she started having severe bloody noses and EXTREMELY heavy period. After the second dose, 45 minute nose bleed soaked through two wash cloths, so many blood clots it clogged the sink.


VAERS ID: 1251532 (history)  
Form: Version 2.0  
Age: 19.0  
Sex: Female  
Location: Connecticut  
Vaccinated:2021-04-10
Onset:2021-04-11
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-04-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 205A21A / 1 RA / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: Adverse reaction, Pain in extremity, Thrombosis
SMQs:, Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Thrombophlebitis (broad), Tendinopathies and ligament disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Anovera 0.013-0.15 mg / 24 hr ring
Current Illness:
Preexisting Conditions: asthma and anemia
Allergies: no known allergies
Diagnostic Lab Data:
CDC Split Type:

Write-up: Patient stated she needed to go to hospital for adverse reaction of pain in leg. After asking MD to check her leg, they discovered a blood clot per patient. She is now doing well per her.


VAERS ID: 1273276 (history)  
Form: Version 2.0  
Age: 19.0  
Sex: Female  
Location: Illinois  
Vaccinated:2021-04-12
Onset:2021-04-24
   Days after vaccination:12
Submitted: 0000-00-00
Entered: 2021-04-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 206A21A / 1 LA / IM

Administered by: Private       Purchased by: ?
Symptoms: Cerebral venous thrombosis, Venogram abnormal
SMQs:, Ischaemic central nervous system vascular conditions (narrow), Embolic and thrombotic events, venous (narrow), Thrombophlebitis (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: levothyroxine 50 mcg tablet (taken for Hashimoto thyroiditis) naproxen 250 mg tablet (taken PRN)
Current Illness:
Preexisting Conditions: Hashimoto thyroiditis
Allergies: no allergies on file
Diagnostic Lab Data: 4/29-MRV Brain without contrast
CDC Split Type:

Write-up: 19 y.o. female with h/o Hashmoto''s thyroiditis now admitted 4/29/2021 with cerebral venous thrombosis. She received J&J COVID vaccine on 4/12.


VAERS ID: 1286564 (history)  
Form: Version 2.0  
Age: 19.0  
Sex: Female  
Location: Maryland  
Vaccinated:2021-03-26
Onset:2021-04-02
   Days after vaccination:7
Submitted: 0000-00-00
Entered: 2021-05-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ER8732 / 1 LA / IM
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0158 / 2 RA / IM

Administered by: Other       Purchased by: ?
Symptoms: Deep vein thrombosis, Hypoaesthesia, Pain in extremity
SMQs:, Peripheral neuropathy (broad), Embolic and thrombotic events, venous (narrow), Thrombophlebitis (broad), Guillain-Barre syndrome (broad), Tendinopathies and ligament disorders (broad), Sexual dysfunction (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, 1 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: none
Current Illness: none, no travel
Preexisting Conditions: none
Allergies: none
Diagnostic Lab Data: L upper extremity ultrasound revealed L DVT in brachial vein and superficial basilic vein. Hematology was consulted and she was started on Xarelto 15mg to be increased to 20mg. She has OP follow up with hematologist
CDC Split Type:

Write-up: She developed pain a week after date of injection, this seemed to get better but then returned again about 2 weeks later. Her L arm pain got progressively worse. She then received the 2nd dose of pfeizer vaccine on 4/19/2021 this time she got it in her R arm because of the pain in her L arm. Her L arm pain got worse to the point she was not able to feel her entire L arm. So she decided to go the ER


VAERS ID: 1288388 (history)  
Form: Version 2.0  
Age: 18.0  
Sex: Male  
Location: Tennessee  
Vaccinated:2021-04-05
Onset:2021-04-13
   Days after vaccination:8
Submitted: 0000-00-00
Entered: 2021-05-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 RA / OT

Administered by: Private       Purchased by: ?
Symptoms: Thrombosis
SMQs:, Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Thrombophlebitis (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: AVANZA
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: ADD
Allergies:
Diagnostic Lab Data:
CDC Split Type: USPFIZER INC2021437727

Write-up: Developed two blood clots in my left calf; This is a spontaneous report from a contactable consumer, the patient. An 18-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot unknown, first dose) solution for injection intramuscular in the right arm on 05Apr2021 at 10:00 (at the age of 18-years-old) as a single dose for COVID-19 vaccination. Medical history included ADD (attention deficit hyperactivity disorder). Concomitant medication included mirtazapine (AVANZA). The patient had no known allergies. The patient did not receive any other vaccine within 4 weeks prior to the vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient developed two blood clots in my left calf on 13Apr2021 at 14:00 which resulted in emergency room/department or urgent care visit. Treatment for the event blood clots included rivaroxaban (XARELTO). The outcome of the event blood clots was recovering. The patient was not tested for Covid post vaccination. Information on the lot/batch number has been requested.


VAERS ID: 1290426 (history)  
Form: Version 2.0  
Age: 17.0  
Sex: Male  
Location: Utah  
Vaccinated:2021-04-21
Onset:2021-04-21
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-05-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 RA / IM

Administered by: Private       Purchased by: ?
Symptoms: Activated partial thromboplastin time, Angiogram cerebral abnormal, Anticoagulant therapy, Arteriogram carotid abnormal, Blood fibrinogen, Body temperature increased, C-reactive protein normal, Computerised tomogram abnormal, Computerised tomogram head abnormal, Computerised tomogram neck, Deep vein thrombosis, Epstein-Barr virus antibody, Full blood count, Gene mutation identification test, Headache, Influenza A virus test, Influenza virus test, Intensive care, International normalised ratio normal, Localised oedema, Lymphadenitis bacterial, Malaise, Metabolic function test, Neck pain, Prothrombin time normal, SARS-CoV-2 test negative, Scan with contrast, Thrombophlebitis, Transverse sinus thrombosis
SMQs:, Angioedema (broad), Neuroleptic malignant syndrome (broad), Embolic and thrombotic events, arterial (narrow), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Embolic and thrombotic events, venous (narrow), Thrombophlebitis (narrow), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Central nervous system vascular disorders, not specified as haemorrhagic or ischaemic (narrow), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (broad), Hypersensitivity (broad), Arthritis (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: Lexapro, Gabapentin
Current Illness: Previously healthy
Preexisting Conditions: Previously healthy
Allergies: NKDA
Diagnostic Lab Data: CT Head and Neck - 4/26: Significant diffuse right-sided deep spatial neck edema. Right-sided adenopathy is present and there is a right level 2 1.8 cm suppurative lymph node or abscess. CTA Head and Neck - 5/4: 1. Deep venous thrombosis involving the left internal jugular vein from the skull base to approximately the level of the hyoid bone. Of note CT of the brain performed the same day shows extension of this thrombus into the transverse sinus. 2. Suppurative lymphadenopathy in the right side of the neck. This was present on the previous study and has decreased slightly in size. 3. No evidence of embolic disease in the visualized portions of the lungs on today?s study. CBC, BMP, PTT, PT, INR, CRP, covid-19, RSV and influenza A+B PCR, EBV Ab, Fibrinogen, Factor V liden, Prothrombin 20210 G/A mutation Neurology Consult Hematology Consult Admitted to ICU
CDC Split Type:

Write-up: 17-year-old male who presents with 8 days of headache. He received his first dose of the Pfizer vaccine on 4/21. He felt like he had the flu after getting the vaccine and developed right-sided neck pain and a temperature to 100. The patient did endorse being elbowed in the neck playing basketball during this time as well, as he played in a basketball tournament in right after this. He got his Covid vaccine in his right deltoid. He saw his pediatrician on 4/26 and a CT scan of his neck with IV contrast was done and this showed significant diffuse right-sided deep spatial neck edema and right-sided adenopathy. The pediatrician discussed the findings with ENT who recommended augmentin and a medrol dosepak. The patient developed a headache several days after this and went to urgent care for evaluation. There was concern that the augmentin and steroids had caused the headache, so the steroids were stopped and he was switched to keflex on 4/30. He was given phenergan and toradol at Urgent Care and discharged home. His mom notes that several days ago he had fevers of 101-104. He has not had a fever for several days now. His headache continued and he felt unwell at basketball practice so he returned to urgent care on 5/4. A CT scan of his head was done which showed right sigmoid and transverse sinus thrombosis as well as thrombophlebitis of the right IJ. He was sent to ED for further management at that time. In the ED, the patient was hemodynamically stable and well-appearing. The CTs were overread by our radiologists here. The patient had some labs done at the outside urgent care but PT/PTT/INR and a CRP were drawn here, which were unremarkable. A Covid PCR is negative. Neurosurgery, neurology, and hematology were consulted. Neurology recommended heparin and a hypercoagulable workup and hematology agreed with this plan. The patient was admitted to the ICU for neuro checks and monitoring during initiation of heparin.


VAERS ID: 1310737 (history)  
Form: Version 2.0  
Age: 18.0  
Sex: Female  
Location: Ohio  
Vaccinated:2021-04-07
Onset:2021-05-03
   Days after vaccination:26
Submitted: 0000-00-00
Entered: 2021-05-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 201A21A / UNK - / -

Administered by: Private       Purchased by: ?
Symptoms: Deep vein thrombosis, Pain in extremity, Peripheral swelling, Thrombophlebitis superficial
SMQs:, Cardiac failure (broad), Angioedema (broad), Embolic and thrombotic events, venous (narrow), Thrombophlebitis (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Tendinopathies and ligament disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 5 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: ? polyethylene glycol 3350 17 gram/dose oral powder (Miralax) ? famotidine 40 mg tablet (Pepcid) ? lansoprazole 30 mg capsule,delayed release (Prevacid) ? linaCLOtide 145 mcg capsule (Linzess) ? azelastine 137 mcg (0.1 %) nasal spra
Current Illness: G tube site cellulitis
Preexisting Conditions: AV canal s/p repair, gastric fisula at G tube site s/p repair, obesity, asthma, nocturnal enuresis, IBS, premature baby- had multiple central lines placed as an infant
Allergies: environmental
Diagnostic Lab Data: US doppler on 5/3/21
CDC Split Type:

Write-up: Deep venous thrombosis involving the common femoral vein and central portions of both superficial and deep femoral veins. Thrombus is also present within the saphenous vein. symptoms- leg swelling and pain since 5/2/21


VAERS ID: 1320793 (history)  
Form: Version 2.0  
Age: 17.0  
Sex: Male  
Location: Utah  
Vaccinated:2021-04-16
Onset:2021-04-27
   Days after vaccination:11
Submitted: 0000-00-00
Entered: 2021-05-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 LA / SYR
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 LA / SYR

Administered by: Public       Purchased by: ?
Symptoms: Appendicitis, Laboratory test, Pulmonary thrombosis, Thrombosis
SMQs:, Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Embolic and thrombotic events, venous (narrow), Thrombophlebitis (broad)

Life Threatening? Yes
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, 6 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: Bupropion, sertraline, clonidine
Current Illness: Depression
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Dozens and dozens of labs/tests were run after admitted to hospital for both cases. (We?re still currently in the hospital for appendix)
CDC Split Type:

Write-up: After 1st shot; Patient developed multiple blood clots (lungs and legs) about 10-11 days afterwards. All tests for cause of clots were inconclusive. Patient received his second dose and with in 48 hours was hospitalized for appendicitis. If it was a reaction after just one shot, I would normally think it was a coincidence. With him have severe reactions after both shots, it seems very suspicious!


VAERS ID: 1323977 (history)  
Form: Version 2.0  
Age: 16.0  
Sex: Female  
Location: Ohio  
Vaccinated:2021-05-17
Onset:2021-05-17
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-05-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0158 / 2 UN / IM

Administered by: Private       Purchased by: ?
Symptoms: Anticoagulant therapy, Chest pain, Computerised tomogram thorax abnormal, Deep vein thrombosis, Intensive care, Pulmonary embolism, Ultrasound Doppler abnormal
SMQs:, Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Embolic and thrombotic events, venous (narrow), Thrombophlebitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad)

Life Threatening? Yes
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, 3 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: norgestimate-ethinyl estradiol, ferrous sulfate
Current Illness: none
Preexisting Conditions: iron deficiency anemia, prolonged uterine bleeding
Allergies: none known
Diagnostic Lab Data: ultrasound of R leg with DVT Chest CT with bilateral pulmonary emboli
CDC Split Type:

Write-up: Presented with acute onset chest pain, found to have right lower extremity DVT and bilateral PEs. Required short stay in ICU for close monitoring given clot burden in her lungs. Required heparin infusion and then transitioned to lovenox for home-going therapy.


VAERS ID: 1337043 (history)  
Form: Version 2.0  
Age: 18.0  
Sex: Male  
Location: Unknown  
Vaccinated:2021-05-08
Onset:2021-05-12
   Days after vaccination:4
Submitted: 0000-00-00
Entered: 2021-05-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / UNK - / -

Administered by: Public       Purchased by: ?
Symptoms: Cerebral thrombosis, Intensive care, Magnetic resonance imaging head abnormal, Seizure
SMQs:, Systemic lupus erythematosus (broad), Ischaemic central nervous system vascular conditions (narrow), Convulsions (narrow), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Generalised convulsive seizures following immunisation (narrow), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 3 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Patient received dose 1 of Moderna vaccine on 5/8/2021 and had witnessed seizure 5/12/2021- (first time ever). He was admitted to ICU on 5/12/2021 and discharged 5/15/2021. He states he had one seizure while in the ICU and another seizure 5/16/2021- at home after discharge. He has since been placed on anti-seizure medications and is scheduled for follow up with neurology on 6/2/2021. Patient''s mother states ICU doctors told her they found a blood clot in the brain picked up by MRI.


VAERS ID: 1347325 (history)  
Form: Version 2.0  
Age: 17.0  
Sex: Male  
Location: D.C.  
Vaccinated:2021-05-07
Onset:2021-05-23
   Days after vaccination:16
Submitted: 0000-00-00
Entered: 2021-05-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 UN / IM

Administered by: Private       Purchased by: ?
Symptoms: Activated partial thromboplastin time abnormal, Anticoagulant therapy, Back pain, Catheter directed thrombolysis, Coagulation test abnormal, Deep vein thrombosis, Groin pain, Pain in extremity, Peripheral swelling, Protein S decreased, Renal vein thrombosis, Vena cava thrombosis
SMQs:, Cardiac failure (broad), Liver-related coagulation and bleeding disturbances (narrow), Angioedema (broad), Haemorrhage laboratory terms (broad), Retroperitoneal fibrosis (broad), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Embolic and thrombotic events, venous (narrow), Thrombophlebitis (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Osteonecrosis (broad), Renovascular disorders (narrow), Tendinopathies and ligament disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 2 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: none
Current Illness: none
Preexisting Conditions: none
Allergies:
Diagnostic Lab Data: Protein S is low. aPTT abnormal with abnormal mixing study suggesting possible lupus anticoagulant. Further tests pending.
CDC Split Type:

Write-up: Patient presented with one week of back, right leg and right groin pain. Right lower extremity swelling and was diagnosed with deep vein thrombosis from right popliteal vein into IVC involving a renal vein. He is on anticoagulation currently and going for catheter-directed thrombolysis today. Patient has been in hospital two days and hospitalization is ongoing at the time of this report.


VAERS ID: 1357945 (history)  
Form: Version 2.0  
Age: 19.0  
Sex: Female  
Location: Texas  
Vaccinated:2021-04-18
Onset:2021-05-05
   Days after vaccination:17
Submitted: 0000-00-00
Entered: 2021-05-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 046821A / 2 UN / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: Back pain, Cardio-respiratory arrest, Deep vein thrombosis, Dyspnoea, Lung assist device therapy, Movement disorder, Pain in extremity, Pulmonary embolism
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (narrow), Arrhythmia related investigations, signs and symptoms (broad), Retroperitoneal fibrosis (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Embolic and thrombotic events, venous (narrow), Akathisia (broad), Dyskinesia (broad), Dystonia (broad), Parkinson-like events (broad), Thrombophlebitis (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Respiratory failure (broad), Tendinopathies and ligament disorders (broad)

Life Threatening? Yes
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 14 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: Lo loestrin Fe oral
Current Illness: none
Preexisting Conditions: none
Allergies: none
Diagnostic Lab Data:
CDC Split Type:

Write-up: extensive deep vein thrombosis with embolization and massive pulmonary embolism ; patient presented with shortness of breath and severe bilateral leg and back pain unable to move with extensive thrombosis noted. patient had cardiopulmonary arrest was on ecmo now decannulated and extubated , awake, alert oriented in recovery phase


VAERS ID: 1358106 (history)  
Form: Version 2.0  
Age: 17.0  
Sex: Female  
Location: Massachusetts  
Vaccinated:2021-05-18
Onset:2021-05-22
   Days after vaccination:4
Submitted: 0000-00-00
Entered: 2021-05-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0185 / 1 LA / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: Paget-Schroetter syndrome, Peripheral swelling, Skin discolouration, Subclavian vein occlusion, Subclavian vein thrombosis, Thrombolysis, Ultrasound Doppler abnormal, Venogram abnormal
SMQs:, Cardiac failure (broad), Angioedema (broad), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Embolic and thrombotic events, venous (narrow), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, 2 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: strattera, lexapro
Current Illness: none
Preexisting Conditions: She has a known prothrombin gene mutation (G20210A) that was previously identified because of a family history of thrombosis.
Allergies: azithromycin, prednisone
Diagnostic Lab Data: see above.
CDC Split Type:

Write-up: Vaccine 5/18. On 5/22 4 days after vaccine, she developed right arm swelling and skin discoloration. On 5/23 she went to the ED. Ultrasound revealed acute, occlusive thrombosis of right subclavian vein. She was admitted to the hospital, started on enoxaparin, achieved therapeutic levels. On 5/25 she underwent thrombolysis and venogram and was confirmed to have findings consistent with Paget-Schroetter syndrome. She was discharged home on 5/25 in good condition. Note: she also has known prothrombin gene mutation G20210A that confers an increased risk of thrombosis. She does have repetitive use of the right arm (lacrosse player).


VAERS ID: 1365073 (history)  
Form: Version 2.0  
Age: 19.0  
Sex: Female  
Location: Massachusetts  
Vaccinated:2021-05-20
Onset:2021-05-28
   Days after vaccination:8
Submitted: 0000-00-00
Entered: 2021-06-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 LA / IM

Administered by: Private       Purchased by: ?
Symptoms: Deep vein thrombosis, Ultrasound Doppler
SMQs:, Embolic and thrombotic events, venous (narrow), Thrombophlebitis (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: heterozygosity for factor V Leiden
Allergies:
Diagnostic Lab Data: doppler ultrasound LUE on 5/28
CDC Split Type:

Write-up: deep venous thrombosis of left axillary vein in same arm as vaccine was administered


VAERS ID: 1365379 (history)  
Form: Version 2.0  
Age: 19.0  
Sex: Female  
Location: Hawaii  
Vaccinated:2021-01-26
Onset:2021-01-29
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-06-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Military       Purchased by: ?
Symptoms: Abdominal pain, Anticoagulant therapy, Back pain, Deep vein thrombosis, Laboratory test, Pain in extremity, Peripheral swelling, Pulmonary embolism, Thrombectomy
SMQs:, Cardiac failure (broad), Acute pancreatitis (broad), Angioedema (broad), Retroperitoneal fibrosis (broad), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Embolic and thrombotic events, venous (narrow), Thrombophlebitis (broad), Extravasation events (injections, infusions and implants) (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Haemodynamic oedema, effusions and fluid overload (narrow), Tendinopathies and ligament disorders (broad)

Life Threatening? Yes
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, 5 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: Birth Control
Current Illness: none
Preexisting Conditions: none
Allergies: no
Diagnostic Lab Data: more than 30+
CDC Split Type:

Write-up: 1st day of pain: Extreme Pain in Lower Extremities (Right Leg, Right abdomen, right lower back) Swelling of Right Leg 3rd day: Admitted into the hospital after visiting the ER Acute DVT in R Leg, multiple Pulmonary Embolisms 3rd-5th day in hospital: 2 Surgical Procedures to remove blood clot, on Blood thinners for a year to life


VAERS ID: 1367764 (history)  
Form: Version 2.0  
Age: 12.0  
Sex: Male  
Location: West Virginia  
Vaccinated:2021-05-21
Onset:2021-05-25
   Days after vaccination:4
Submitted: 0000-00-00
Entered: 2021-06-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0171 / 1 LA / SYR

Administered by: School       Purchased by: ?
Symptoms: Induration, Nodule, Tenderness, Thrombosis, Ultrasound scan
SMQs:, Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Thrombophlebitis (broad), Extravasation events (injections, infusions and implants) (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: ??Prozac, Amphetamine Salts er,Abilify,Trileptal
Current Illness: No
Preexisting Conditions: No
Allergies: No
Diagnostic Lab Data: Ultrasound of left arm?
CDC Split Type:

Write-up: He got a superficial blood clot in left arm ?He''s got the shot May 21 and I noticed he had two hard knots on left arm and there was probably about a half inch between them and as hard as a rock on that following Monday may 24,2021 , he said it was sore some more when you touched it we was told to keep an ion it make sure it didn''t get any worse, turn red, swell, feel hot to the touch, and then to put a warm compresses on it ??


VAERS ID: 1376919 (history)  
Form: Version 2.0  
Age: 17.0  
Sex: Male  
Location: Arizona  
Vaccinated:2021-04-24
Onset:2021-05-08
   Days after vaccination:14
Submitted: 0000-00-00
Entered: 2021-06-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0150 / 1 LA / SYR
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ER8729 / 2 LA / SYR

Administered by: Pharmacy       Purchased by: ?
Symptoms: Anticoagulant therapy, Computerised tomogram, Deep vein thrombosis, Hypoaesthesia, Laboratory test, Nasopharyngitis, Paraesthesia, Peripheral artery thrombosis, Surgery, Ultrasound scan
SMQs:, Peripheral neuropathy (broad), Embolic and thrombotic events, arterial (narrow), Embolic and thrombotic events, venous (narrow), Thrombophlebitis (broad), Guillain-Barre syndrome (broad), Sexual dysfunction (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, 8 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: Vitamin D Primidone for tremors
Current Illness: None
Preexisting Conditions: Tremors and allergies
Allergies: Allergy to melon, olives, orange blossom, and some environmental allergies
Diagnostic Lab Data: Multiple tests run including CT and ultra sounds from 5/25/21 through 5/29/21. Hospital has records.
CDC Split Type:

Write-up: First shot received on 4/3/21, and second received on 4/24/21. Symptoms of cold, tingling, and numb left toes and left foot noticed about 2 weeks after 2nd Pfizer dose. Went to ER and blood clots were found in arteries in left knee and ankle, and clots in the vein in left calf. Four procedures performed by Intervention Radiology (IR) at Hospital on 5/25/21, and was treated with Heparin and TPA. Released from hospital with clot remaining in left calf vein and is taking Eliquis. Continuing treatment with hematologist post release from hospital.


VAERS ID: 1377017 (history)  
Form: Version 2.0  
Age: 18.0  
Sex: Female  
Location: New York  
Vaccinated:2021-04-20
Onset:2021-05-16
   Days after vaccination:26
Submitted: 0000-00-00
Entered: 2021-06-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / UNK UN / -

Administered by: Private       Purchased by: ?
Symptoms: Acute respiratory distress syndrome, Confirmed e-cigarette or vaping product use associated lung injury, Deep vein thrombosis, Dyspnoea, Endotracheal intubation, Gastrointestinal disorder, Pyrexia, Systemic inflammatory response syndrome
SMQs:, Anaphylactic reaction (broad), Angioedema (broad), Interstitial lung disease (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Embolic and thrombotic events, venous (narrow), Thrombophlebitis (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Cardiomyopathy (broad), Eosinophilic pneumonia (narrow), Tumour lysis syndrome (broad), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Sepsis (broad), Opportunistic infections (broad), Immune-mediated/autoimmune disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: Lexapro, Atarax
Current Illness:
Preexisting Conditions: Concern for substance use, depression
Allergies: None
Diagnostic Lab Data:
CDC Split Type:

Write-up: The patient developed progressively worsening dyspnea, GI symptoms and fevers starting 5/16/2021, 3.5 weeks after receiving second Moderna vaccine. She was admitted 5/22/2021 with ARDS requiring intubation, found to have severe systemic inflammation with acute DVT of right right subclavian, axillary, brachial, and upper arm radial veins, chronic DVT of left subclavian, and possible thrombus tricuspid valve. Remains intubated with ongoing evidence of systemic inflammation. Working diagnosis EVALI.


VAERS ID: 1381062 (history)  
Form: Version 2.0  
Age: 19.0  
Sex: Female  
Location: Pennsylvania  
Vaccinated:2021-05-14
Onset:2021-05-01
Submitted: 0000-00-00
Entered: 2021-06-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0182 / 1 LA / -

Administered by: Pharmacy       Purchased by: ?
Symptoms: Contusion, Fatigue, Malaise, Nausea, Pain, Pyrexia, Thrombosis
SMQs:, Acute pancreatitis (broad), Haemorrhage terms (excl laboratory terms) (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Thrombophlebitis (broad), Accidents and injuries (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: USPFIZER INC2021581727

Write-up: blood clots; she did get really sick / she was displaying a lot of symptoms; fever; whole body was aching; fatigue; nauseated; bruises on the legs / now she''s getting more / she would say they have worsened; This is a spontaneous report received from a contactable consumer (patient''s mother). A 19-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EW0182), via an unspecified route of administration in arm left on 14May2021 at single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. Patient previously received flu shot and experienced nausea. The patient experienced blood clots on an unspecified date, bruises on the legs, she was getting more, she would say they have worsened in May2021, fever on 15May2021, whole body was aching on 15May2021, fatigue on 15May2021, nauseated on 15May2021, and she did get really sick, she was displaying a lot of symptoms on an unspecified date. Patient started having bruises on the legs and thought that it might be related to blood clots. She mentioned that she also experienced the common side effects but she was not concerned of that as people she knew also had those symptoms but was more concerned about the bruising. On patient''s legs, she had a bunch of bruises. Reporter was just really nervous about her daughter''s bruises. When patient was working, she was not noticing, but today patient noticed her legs and said reporter it was a lot of them. Patient did get really sick with her first shot, she had a fever, she couldn''t go to work the next day. Reporter was not sure if the patient should get the second dose on 04Jun2021. Patient''s whole body was aching, she was nauseated, she was displaying a lot of symptoms. Reporter checked online and they said it was a normal thing. Patient came down and showed reporter the bruises. Patient wasn''t really paying attention to them. Patient had one or two bruises when she noticed and at the time of the report she was getting more. They had worsened. Patient took ibuprofen (ADVIL) for fever and she felt better. Outcome of events blood clots and she did get really sick, she was displaying a lot of symptoms was unknown, of event bruises on the legs, she was getting more, she would say they have worsened was not resolved, and of other events was resolved.


VAERS ID: 1382163 (history)  
Form: Version 2.0  
Age: 19.0  
Sex: Female  
Location: Tennessee  
Vaccinated:2021-05-01
Onset:2021-05-26
   Days after vaccination:25
Submitted: 0000-00-00
Entered: 2021-06-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW153 / 1 - / IM

Administered by: Private       Purchased by: ?
Symptoms: Angiogram cerebral abnormal, Cerebral venous sinus thrombosis, Computerised tomogram head abnormal, Headache, Migraine, Nausea, Subdural haematoma, Syncope, Vomiting
SMQs:, Torsade de pointes/QT prolongation (broad), Acute pancreatitis (broad), Haemorrhage terms (excl laboratory terms) (narrow), Arrhythmia related investigations, signs and symptoms (broad), Haemorrhagic central nervous system vascular conditions (narrow), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Embolic and thrombotic events, venous (narrow), Accidents and injuries (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Central nervous system vascular disorders, not specified as haemorrhagic or ischaemic (narrow), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (broad), Hypotonic-hyporesponsive episode (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 8 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: diclofenac sodium 50 mg oral delayed release tablet birth control (unknown specifics) prochlorperazine 10 mg oral tablet
Current Illness:
Preexisting Conditions:
Allergies: none
Diagnostic Lab Data: see above
CDC Split Type:

Write-up: 2nd COVID19 Pfizer vaccine 5/1/21 lot # EW0167. both vaccines received at pharmacy. 5/24/21 awoke at 0400 with headache and nausea and vomiting. Headache worsened throughout the day and went to ED where she had syncopal episode and was treated for migraine headache with migraine cocktail and sent home. Symptoms continued and progressed the next day and she went to Hospital ED in where a CTH revealed SDH near her sinuses. She was transferred to Medical Center in for higher level of care. On arrival she had a CTH/CTA which revealed and extensive central venous sinus thrombosis.


VAERS ID: 1384595 (history)  
Form: Version 2.0  
Age: 17.0  
Sex: Female  
Location: Florida  
Vaccinated:2021-05-03
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-06-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 RA / -
UNK: VACCINE NOT SPECIFIED (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / -

Administered by: Pharmacy       Purchased by: ?
Symptoms: Dizziness, Fatigue, Muscle spasms, Thrombosis
SMQs:, Anticholinergic syndrome (broad), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Dystonia (broad), Thrombophlebitis (broad), Vestibular disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: USPFIZER INC2021593296

Write-up: received the first dose of the Pfizer COVID-19 vaccine and also recently started taking Depo-Provera. After receiving the first dose of the Pfizer COVID-19 vaccine her daughter developed a blood clot; tired and frail; feels lost and light headed; cramping pain; This is a spontaneous report from a contactable consumer (Patient''s mother). A 17-year-old female patient received first dose of BNT162B2 (BNT162B2) via an unspecified route of administration, administered in Arm Right on 03May2021 15:00 (Batch/Lot number was not reported) as 1ST DOSE SINGLE for covid-19 immunization and medroxyprogesterone acetate (DEPO-PROVERA), route of administration, start and stop date, batch/lot number and dose were not reported for contraception. The patient''s medical history and concomitant medications were not reported. The patient experienced received the first dose of the pfizer covid-19 vaccine and also recently started taking depo-provera. after receiving the first dose of the pfizer covid-19 vaccine her daughter developed a blood clot, tired and frail, feels lost and light headed and had cramping pain all on unspecified dates. It was reported that after receiving the first dose of the Pfizer COVID-19 vaccine her daughter developed a blood clot. Her daughter, who is currently on Depo Provera got her first dose of the Covid 19 vaccine. The daughter has been experiencing blood clotting and would like to further document this experience. Is also seeking medical advice to inform her daughter. Her daughter Has been on Depo Provera for 4 to 5 months. Since she had the Covid vaccine, she has been having bad blood clotting and has been having a continuous period. When she got the shot, she has been getting blood clots straight for three weeks. Patient is Tired and frail: She is a waitress, so all of this has made it hard. It started right when she got the shot and has pretty much stayed the same. She will feel like she is lost when she wakes up and is light headed from the loss of blood. It occurs when she is doing activities, like working. Patient took some Midol one day for cramping pain but it barely did anything. The action taken for medroxyprogesterone acetate was unknown. Outcome of tired and frail was not recovered. Outcome of all the other events was unknown. Information on Lot/Batch number was not available. Additional information has been requested.


VAERS ID: 1385500 (history)  
Form: Version 2.0  
Age: 15.0  
Sex: Female  
Location: Pennsylvania  
Vaccinated:2021-06-04
Onset:2021-06-06
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-06-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 LA / IM

Administered by: Public       Purchased by: ?
Symptoms: Heavy menstrual bleeding, Menstruation irregular, Thrombosis
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Thrombophlebitis (broad), Fertility disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Fluoxetine, 20 mg daily
Current Illness: No
Preexisting Conditions: Born with one kidney
Allergies: Spring time pollen allergies
Diagnostic Lab Data: None. We have communicated with our pediatrician, who encouraged us to report the occurence.
CDC Split Type:

Write-up: Very heavy period began, 2 weeks ahead of schedule. Much heavier bleeding began after about 12 hours and has continued for 3 days. This level of bleeding is not typical. Many blood clots have also been passed.


VAERS ID: 1386054 (history)  
Form: Version 2.0  
Age: 18.0  
Sex: Female  
Location: Ohio  
Vaccinated:2021-05-14
Onset:2021-06-06
   Days after vaccination:23
Submitted: 0000-00-00
Entered: 2021-06-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 2 RA / -

Administered by: Public       Purchased by: ?
Symptoms: Autopsy, Death, Thrombosis
SMQs:, Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Thrombophlebitis (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-06
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: VANAFLAXINE BUSPIRONE ABILIFY SPRINTEC
Current Illness: CHLAMYDIA
Preexisting Conditions: NA
Allergies: NA
Diagnostic Lab Data: AUTOPSY 6/8/21
CDC Split Type:

Write-up: DEATH FROM BLOOD CLOT


VAERS ID: 1392656 (history)  
Form: Version 2.0  
Age: 17.0  
Sex: Female  
Location: Ohio  
Vaccinated:2021-06-07
Onset:2021-06-08
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-06-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0153 / 2 LA / IM

Administered by: Private       Purchased by: ?
Symptoms: Anticoagulant therapy, Deep vein thrombosis, Iliac vein occlusion, Pelvic venous thrombosis, Peripheral vein occlusion, Thrombolysis, Vascular operation, Venogram abnormal
SMQs:, Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Embolic and thrombotic events, venous (narrow), Thrombophlebitis (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 5 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: Xulane 150-35 mcg/ 24 hour patch ( birth control), Lexapro, Midodrine, Mag-Ox, Corlanor
Current Illness: None
Preexisting Conditions: repaired gastroschisis, left thoracic outlet syndrome surgery, POTS (postural orthostatic tachycardia syndrome), and tension headaches
Allergies: Morphine
Diagnostic Lab Data: MRV pelvis on 6/9: Complete occluding thrombosis beginning in the right groin of the right venous system, the common femoral vein is occluded as are the right internal and external iliac veins and numerous smaller unnamed pelvic veins. Thrombus extends into and occludes the right common iliac although a left to the level of the expected anastomosis with the left system to form the IVC. There is no evidence of thrombus in the IVC. On the left side, clot is seen occluding several left-sided unnamed pelvic veins, thrombosis extends into the left internal iliac vein which is occluded, thrombus extends into the left common iliac which contains nonoccluding thrombus leading up to just proximal to the formation of the IVC. The left external iliac and the common femoral vein on the left side are patent.
CDC Split Type:

Write-up: Patient with significant right leg DVT requiring thrombolysis by vascular surgery. She will need to continue on anticoaggulants outpatient.


VAERS ID: 1392757 (history)  
Form: Version 2.0  
Age: 16.0  
Sex: Female  
Location: Unknown  
Vaccinated:2021-05-28
Onset:2021-06-01
   Days after vaccination:4
Submitted: 0000-00-00
Entered: 2021-06-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Private       Purchased by: ?
Symptoms: Anticoagulant therapy, Chest pain, Coagulation test normal, Deep vein thrombosis, Electrocardiogram abnormal, Fibrin D dimer increased, Haemoptysis, Imaging procedure abnormal, Pain in extremity, Peripheral swelling, Pleuritic pain, Pulmonary embolism, SARS-CoV-2 antibody test, Sinus tachycardia
SMQs:, Cardiac failure (broad), Angioedema (broad), Haemorrhage terms (excl laboratory terms) (narrow), Haemorrhage laboratory terms (broad), Arrhythmia related investigations, signs and symptoms (broad), Supraventricular tachyarrhythmias (narrow), Embolic and thrombotic events, venous (narrow), Malignancy related therapeutic and diagnostic procedures (narrow), Thrombophlebitis (broad), Extravasation events (injections, infusions and implants) (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad), Tendinopathies and ligament disorders (broad), Infective pneumonia (broad), Dehydration (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: Was taking tylenol q4 for 3-4 days prior to today for pain Also took 1-2 doses of naproxen at home OCP use for a month prior to today
Current Illness: none
Preexisting Conditions: none
Allergies: none
Diagnostic Lab Data: D Dimer 4000 Normal coags COVID IGG 184 AU/ml EKG sinus tachy
CDC Split Type:

Write-up: Patient vaccinated on 5/28. She reported having pleuritic chest pain and hemoptysis 3 days after that lasted about a week. Then after she developed right leg pain and swelling x 3 days. Seen at our ER 6/11- studies show DVT of the common femoral vein and other veins of the right lower extremity. Also had b/l pulmonary emboli. Started on lovenox treatment and pending thrombectomy by vascular surgeons in 2 days. (In addition she also had admitted to OCP use for a month prior to this event; no reported FH of clotting disorders)


VAERS ID: 1408002 (history)  
Form: Version 2.0  
Age: 16.0  
Sex: Male  
Location: Utah  
Vaccinated:2021-05-24
Onset:2021-06-02
   Days after vaccination:9
Submitted: 0000-00-00
Entered: 2021-06-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0178 / 2 LA / SYR

Administered by: Pharmacy       Purchased by: ?
Symptoms: Anticoagulant therapy, Deep vein thrombosis, Pain in extremity, Ultrasound Doppler abnormal
SMQs:, Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Embolic and thrombotic events, venous (narrow), Thrombophlebitis (broad), Cardiomyopathy (broad), Tendinopathies and ligament disorders (broad)

Life Threatening? Yes
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Daily multi-vitamin
Current Illness: None
Preexisting Conditions: None
Allergies: No known
Diagnostic Lab Data: 06/07/2021: Ultrasound performed in the ER. Diagnosis was Deep Vein Thrombosis (DVT) of distal vein of right lower extremity.
CDC Split Type:

Write-up: Pain in the back of patient''s right calf started after a flight on 6/2/2021. We ended up in the ER on 6/7/2021. There he was diagnosed per ultrasound with DVT or having a blood clot in a vein in his right calf. He was prescribed Eliquis and counseled to follow up with his physician at home. Patient met with our family physician on 6/9/2021, the day we arrived home to follow-up. After receiving the medical records Dr. advised us to file this report. We understand that blood clots can happen on flights, but Dr. felt that this event was such an anomally for patient that it merited further reporting. Patient is a completely healthy 16 year old male who is an extremely active athlete who participates in basketball, track, cross-country and other physical activities daily. For him to develop a blood clot after a 4 hour flight is an exceptional, unexpected event. Dr. long term plan is to keep patient on Eliquis for 6 months, then take him off of the medicine and then run more blood tests after 2 weeks to fully investigate the incident.


VAERS ID: 1408197 (history)  
Form: Version 2.0  
Age: 18.0  
Sex: Female  
Location: Virginia  
Vaccinated:2021-04-21
Onset:2021-04-21
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-06-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 RA / IM

Administered by: Other       Purchased by: ?
Symptoms: Gait disturbance, Pain in extremity, Thrombosis, Ultrasound scan
SMQs:, Peripheral neuropathy (broad), Anticholinergic syndrome (broad), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Parkinson-like events (broad), Thrombophlebitis (broad), Guillain-Barre syndrome (broad), Tendinopathies and ligament disorders (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Xulane (Birth Control Patch)
Current Illness: N/A
Preexisting Conditions: N/A
Allergies: No
Diagnostic Lab Data: Ultrasound on my knee done on 4/24 - Found DVT in my left knee ; Xarelto started Office Visit 5/5 - Hematologist told me not to go back on any birth control with Estrogen in it; He also ordered a lot of tests to test for clotting disorders; my blood was taken this day Virtual Visit 5/12 - Me and my doctor went over my labs; he told me that my labs showed that I do not have a clotting disorder; Dr. also that he wanted me to stay on the Xarelto for 6 months because he doesn''t know where the blood clot came from
CDC Split Type:

Write-up: I started experiencing pain in my calf on 4/21 that same night of the vaccination. There was a tight feeling in my knee and every time I took a step with my right leg there was pain that radiated down my calf. It almost felt like a muscle pain so I ignored it for a few days. By 4/24 the pain had gotten so bad that I didn''t want to walk anywhere and cried when I walked. My mom came and picked me up and took me to the urgent care center. They asked me a few questions and told me that I needed to go to the ER to get checked for a blood clot. I went to hospital on 4/24, and an ultrasound of my knee was done. The doctor diagnosed me with a blood clot and told me to stop taking the Xulane which was my birth control at the time. They told me to follow up with my OBGYN and a hematologist. (I had been on my birth control for about 6 months and I have never had any issues with blood clots and they do not run in my family. The NP is who told me to report my blood clot to the CDC because she is a little suspicious that the shot is where it come from.)


VAERS ID: 1413393 (history)  
Form: Version 2.0  
Age: 14.0  
Sex: Female  
Location: Ohio  
Vaccinated:2021-05-21
Onset:2021-05-22
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-06-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0168 / 1 LA / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: Thrombosis, Vaginal haemorrhage
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Thrombophlebitis (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Patient started birth control on 05/22/2021, no other medications reported
Current Illness: None reported
Preexisting Conditions: None reported
Allergies: Neosporin and Bactroban
Diagnostic Lab Data: None reported - her physician wanted to wait and see
CDC Split Type:

Write-up: The next day after vaccination the patient started having vaginal bleeding that lasted for 30 days. She was even bleeding out clots of blood


VAERS ID: 1427461 (history)  
Form: Version 2.0  
Age: 14.0  
Sex: Female  
Location: Ohio  
Vaccinated:2021-05-22
Onset:2021-06-20
   Days after vaccination:29
Submitted: 0000-00-00
Entered: 2021-06-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Unknown       Purchased by: ?
Symptoms: Cerebral venous thrombosis
SMQs:, Ischaemic central nervous system vascular conditions (narrow), Embolic and thrombotic events, venous (narrow), Thrombophlebitis (broad)

Life Threatening? Yes
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: Oral contraceptive
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Intracranial venous thrombosis


VAERS ID: 1429410 (history)  
Form: Version 2.0  
Age: 18.0  
Sex: Female  
Location: Georgia  
Vaccinated:2021-04-18
Onset:2021-04-23
   Days after vaccination:5
Submitted: 0000-00-00
Entered: 2021-06-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0158 / 2 RA / -

Administered by: Unknown       Purchased by: ?
Symptoms: Acute kidney injury, Nephrotic syndrome, Peripheral swelling, Thrombosis, Urinary retention, Weight increased
SMQs:, Rhabdomyolysis/myopathy (broad), Acute renal failure (narrow), Cardiac failure (broad), Angioedema (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Anticholinergic syndrome (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (broad), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (broad), Toxic-septic shock conditions (broad), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Thrombophlebitis (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Chronic kidney disease (broad), Tumour lysis syndrome (broad), Proteinuria (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Dehydration (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: LEVOCETIRIZINE
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: USPFIZER INC2021691761

Write-up: A doctors office visit on 4/28. Discussed the symptoms (minimal change disease-like symptoms, possible nephrotic syndrome, possible acute kidney injury, possible blood clots).; A doctors office visit on 4/28. Discussed the symptoms (minimal change disease-like symptoms, possible nephrotic syndrome, possible acute kidney injury, possible blood clots).; A doctor''s office visit on 4/28. Discussed the symptoms (minimal change disease-like symptoms, possible nephrotic syndrome, possible acute kidney injury, possible blood clots).; no facilitated urination; Severe swelling on both legs with sudden body weight increase (over 10 lbs) after about a week of second dose; Severe swelling on both legs with sudden body weight increase (over 10 lbs) after about a week of second dose; This is a spontaneous report form a contactable consumer (patient) reported for herself. A 18-year-old non pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE Solution for injection Batch/Lot Number: EW0158) via an unspecified route of administration in arm right on 18Apr2021 as dose 2, single for covid-19 immunisation. Medical history included none history. Concomitant medications include levocetirizine (LEVOCETIRIZINE Batch/Lot number was not reported) via an unspecified route of administration from an unspecified date, at 5 mg for an unspecified indication. Historical vaccine includes bnt162b2 (Dose 1 lot number=EP7534 vaccine location=Right arm) on 26Mar2021 for COVID-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. On 23Apr2021, the patient experienced a doctors office visit on 28Apr. Discussed the symptoms (minimal change disease-like symptoms, possible nephrotic syndrome, possible acute kidney injury, possible blood clots). Started to take 20mg furosemide for 7 days from 28Apr and 20mg prednisone for 10 days and 20mg furosemide on 04May. Even after finishing medication, there were no changes in symptoms. Continued leg swelling and no facilitated urination. There was severe swelling on both legs with sudden body weight increase (over 10 lbs) after about a week of second dose. After finishing both, the swelling in legs subsided and weight returned to normal. About 10 days later, moderate swelling in legs returned and body weight increased by about 5 lbs. The patient visited nephrologist visit on 02Jun and was prescribed 20mg prednisone, 3 tablets every other am for 20 days. Currently, patient have been taking the medicine since 03Jun. As of now 12Jun2021, the leg swelling partially decreased and the body weight decreased by 1-1.5 lbs. The clinical outcome of all the events was not resolved.


VAERS ID: 1430179 (history)  
Form: Version 2.0  
Age: 16.0  
Sex: Female  
Location: Texas  
Vaccinated:2021-05-30
Onset:2021-06-12
   Days after vaccination:13
Submitted: 0000-00-00
Entered: 2021-06-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0187 / 2 UN / UN

Administered by: Private       Purchased by: ?
Symptoms: Anticoagulant therapy, Cerebral thrombosis
SMQs:, Ischaemic central nervous system vascular conditions (narrow), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow)

Life Threatening? Yes
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 5 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: contraceptive
Current Illness: N/A
Preexisting Conditions: N/A
Allergies: N/A
Diagnostic Lab Data: Blood clots on the brain Tuesday June 15th 2021
CDC Split Type:

Write-up: Blood clots on brain. Needed to be hospitalized for 5 days on blood thinners. Will Continues to self administer blood thinners for 3 more months


VAERS ID: 1430330 (history)  
Form: Version 2.0  
Age: 16.0  
Sex: Male  
Location: Oregon  
Vaccinated:2021-05-25
Onset:2021-06-23
   Days after vaccination:29
Submitted: 0000-00-00
Entered: 2021-06-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Pharmacy       Purchased by: ?
Symptoms: Basilar artery thrombosis, Computerised tomogram, Magnetic resonance imaging, SARS-CoV-2 antibody test positive, Status epilepticus
SMQs:, Systemic lupus erythematosus (broad), Ischaemic central nervous system vascular conditions (narrow), Convulsions (narrow), Embolic and thrombotic events, arterial (narrow), Generalised convulsive seizures following immunisation (narrow), Hypoglycaemia (broad), Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 4 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: sertraline 100mg daily, sumatriptan prn migraine
Current Illness: NA
Preexisting Conditions: depression
Allergies: PCN
Diagnostic Lab Data: 6/23 current admission multiple MRIs and CTs 6/25 SARS IgG +
CDC Split Type:

Write-up: admitted 6/23 in status epilepticus. Found to have a basilar artery thrombus


VAERS ID: 1430451 (history)  
Form: Version 2.0  
Age: 19.0  
Sex: Female  
Location: Washington  
Vaccinated:2021-05-11
Onset:2021-06-15
   Days after vaccination:35
Submitted: 0000-00-00
Entered: 2021-06-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 AR / SYR

Administered by: Pharmacy       Purchased by: ?
Symptoms: Heavy menstrual bleeding, Muscle spasms, Thrombosis
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Dystonia (broad), Thrombophlebitis (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Allergy medication Iron supplement
Current Illness: none
Preexisting Conditions: none
Allergies: none
Diagnostic Lab Data:
CDC Split Type:

Write-up: Extremely heavy period, blood clotting, and intense cramps throughout the month


VAERS ID: 1430529 (history)  
Form: Version 2.0  
Age: 18.0  
Sex: Male  
Location: Virginia  
Vaccinated:2021-05-18
Onset:2021-06-03
   Days after vaccination:16
Submitted: 0000-00-00
Entered: 2021-06-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH BR6716 / 1 RA / IM
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0186 / 2 RA / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: Deep vein thrombosis, Pain, Peripheral swelling, Thrombosis, Ultrasound scan abnormal
SMQs:, Cardiac failure (broad), Angioedema (broad), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Embolic and thrombotic events, venous (narrow), Malignancy related therapeutic and diagnostic procedures (narrow), Thrombophlebitis (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies: tree nuts, cefazolin
Diagnostic Lab Data: Ultrasound done in ED and patient diagnosed with DVT.
CDC Split Type:

Write-up: Blood Clot/DVT Pain and swelling in lower extremity following left elbow reconstruction with contralateral gracilis autograft.


VAERS ID: 1431554 (history)  
Form: Version 2.0  
Age: 19.0  
Sex: Female  
Location: Michigan  
Vaccinated:2021-01-23
Onset:2021-02-04
   Days after vaccination:12
Submitted: 0000-00-00
Entered: 2021-06-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EL0140 / 1 LA / SYR
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EL3248 / 2 LA / SYR

Administered by: Private       Purchased by: ?
Symptoms: Anticoagulant therapy, Antiphospholipid syndrome, Cardiac dysfunction, Chest pain, Dyspnoea, Pulmonary thrombosis, Stress cardiomyopathy, Thrombectomy
SMQs:, Cardiac failure (broad), Anaphylactic reaction (broad), Embolic and thrombotic events, arterial (narrow), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Embolic and thrombotic events, venous (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (narrow), Other ischaemic heart disease (narrow), Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (broad), Immune-mediated/autoimmune disorders (narrow)

Life Threatening? Yes
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, 3 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: Lexapro Birth control (Viorelle)
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Patient experienced shortness of breath and chest pain resulting in a visit to the ER (02/07/2021) where doctors found multiple blood clots in lungs as well as decreased heart function due to stress on cardiac system. Patient was hospitalized for 3 days and had to have an INR procedure to remove the blood clots (Patient is now on blood thinner and diagnosed with Antiphospholipid Syndrome after event.)


VAERS ID: 1440900 (history)  
Form: Version 2.0  
Age: 16.0  
Sex: Female  
Location: New Jersey  
Vaccinated:2021-06-01
Onset:2021-06-26
   Days after vaccination:25
Submitted: 0000-00-00
Entered: 2021-07-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 LA / IM

Administered by: Private       Purchased by: ?
Symptoms: Computerised tomogram thorax, Limb discomfort, Pain in extremity, Thrombosis, Ultrasound Doppler abnormal
SMQs:, Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Thrombophlebitis (broad), Cardiomyopathy (broad), Tendinopathies and ligament disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Phenteramine
Current Illness: None
Preexisting Conditions: Obesity
Allergies: Rash to Amoxicillan
Diagnostic Lab Data: 6/29 upper extremity doppler 6/29 Chest CT
CDC Split Type:

Write-up: L distal internal jugular venous thrombus found on 6/29 after pt had three days of squeezing sensation on upper arm followed by acute pain on day of presentation to ED. In ED upper extremity Doppler demonstrated clot. Pt transferred to our hospital where she started on anticoagulation therapy for treatment.


VAERS ID: 1460045 (history)  
Form: Version 2.0  
Age: 16.0  
Sex: Female  
Location: Louisiana  
Vaccinated:2021-06-14
Onset:2021-06-21
   Days after vaccination:7
Submitted: 0000-00-00
Entered: 2021-07-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EP7533 / 2 AR / IM

Administered by: Private       Purchased by: ?
Symptoms: Dysmenorrhoea, Menstruation delayed, Thrombosis
SMQs:, Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Thrombophlebitis (broad), Fertility disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Mydayis; Wellbutrin
Current Illness: No
Preexisting Conditions: No
Allergies: Augmentin, sulfa
Diagnostic Lab Data: No
CDC Split Type: vsafe

Write-up: She started her menstrual 10 days late with heavy clots and cramps which is abnormal. When she went to her 16 yr old well visit on 7/17 we informed her PCP of the concerns.


VAERS ID: 1461717 (history)  
Form: Version 2.0  
Age: 15.0  
Sex: Female  
Location: Michigan  
Vaccinated:2021-06-24
Onset:2021-06-25
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-07-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0150 / 2 RA / SYR

Administered by: School       Purchased by: ?
Symptoms: Asthenia, Blood test, Haemoglobin decreased, Heavy menstrual bleeding, Menstrual disorder, Pallor, Syncope, Thrombosis, Vomiting
SMQs:, Torsade de pointes/QT prolongation (broad), Acute pancreatitis (broad), Haematopoietic erythropenia (broad), Haemorrhage terms (excl laboratory terms) (narrow), Haemorrhage laboratory terms (broad), Arrhythmia related investigations, signs and symptoms (broad), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Thrombophlebitis (broad), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: n/a
Current Illness: n/a
Preexisting Conditions: n/a
Allergies: n/a
Diagnostic Lab Data: Blood work (Hemoglobin) taken on June 28 (10.3), June 29 (9?), July 3 (7.3), July 7 (8).
CDC Split Type:

Write-up: Abnormal menstrual cycle started on June 25, the day after dose 2; she already had a period June 10-16. This involved increasingly heavy bleeding, with large blood clots. My daughter became very pale, weak on the morning of Mon, June 28, she fainted, then vomited. Made dr appt and got bloodwork. Started her on iron supplements. Dr said the hemoglobin was at 10.6, but had us get blood checked 3 more times, lowest hemoglobin was at 7.3.


VAERS ID: 1463786 (history)  
Form: Version 2.0  
Age: 15.0  
Sex: Female  
Location: Michigan  
Vaccinated:2021-06-22
Onset:2021-07-11
   Days after vaccination:19
Submitted: 0000-00-00
Entered: 2021-07-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0217 / 1 - / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: Angiogram cerebral, Arteriogram carotid, Cerebral venous sinus thrombosis, Computerised tomogram head, Haemorrhage intracranial, Seizure
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Systemic lupus erythematosus (broad), Haemorrhagic central nervous system vascular conditions (narrow), Convulsions (narrow), Embolic and thrombotic events, venous (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Central nervous system vascular disorders, not specified as haemorrhagic or ischaemic (narrow), Generalised convulsive seizures following immunisation (narrow), Hypoglycaemia (broad)

Life Threatening? Yes
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, 1 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: Sprintec
Current Illness: NONE
Preexisting Conditions: PCOS
Allergies:
Diagnostic Lab Data: CT HEAD, CTA HEAD/NECK
CDC Split Type:

Write-up: Venous Sinus Thrombosis, Intracranial Hemorrhage, Seizure


VAERS ID: 1464846 (history)  
Form: Version 2.0  
Age: 17.0  
Sex: Female  
Location: Arizona  
Vaccinated:2021-04-14
Onset:2021-05-01
   Days after vaccination:17
Submitted: 0000-00-00
Entered: 2021-07-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ER2613 / 2 - / IM

Administered by: Other       Purchased by: ?
Symptoms: Anticoagulant therapy, Chest pain, Cough, Deep vein thrombosis, Haemoptysis, Intensive care, Pain in extremity, Peripheral swelling, Positron emission tomogram abnormal, Pulmonary embolism, Skin discolouration, Thrombosis
SMQs:, Cardiac failure (broad), Anaphylactic reaction (broad), Angioedema (broad), Haemorrhage terms (excl laboratory terms) (narrow), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Embolic and thrombotic events, venous (narrow), Thrombophlebitis (broad), Extravasation events (injections, infusions and implants) (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Tendinopathies and ligament disorders (broad), Infective pneumonia (broad)

Life Threatening? Yes
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, 5 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: None
Current Illness: None
Preexisting Conditions: None
Allergies: NKMA
Diagnostic Lab Data: See above Can contact mother for more information.
CDC Split Type:

Write-up: First vaccine 3/24/21 Second vaccine 4/14/21 In early may, mom can''t remember date, patient c/o left leg and foot pain. Went to podiatrist - no diagnosis made - was told to monitor. Mid to late May developed dry cough. Not seen for this. On June 10 taken to ED lower left leg extremely painful and swollen and mom reported discoloration to back of leg. Diagnosed with DVT and put on blood thinner Xeralto and discharged. A week later went to hematologist who said to continue Xeralto and monitor. A week after seeing Dr. and two weeks after initial ED visit, on a Wednesday, patient started to cough up blood. Went back to Dr. and patient was taken off of Xeralto. PE scan ordered. The next day patient developed chest pain and went to ED. PE scan done and diagnosed with two PE''s on right lung. Was informed had six blood clots in lower left leg. Admitted to ICU. Was an inpatient for 5 days then discharged. Now patient is taking Lovenox injections twice daily.


VAERS ID: 1487514 (history)  
Form: Version 2.0  
Age: 19.0  
Sex: Female  
Location: South Carolina  
Vaccinated:2021-05-21
Onset:2021-07-06
   Days after vaccination:46
Submitted: 0000-00-00
Entered: 2021-07-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / 1 LA / SYR

Administered by: Pharmacy       Purchased by: ?
Symptoms: Thrombosis, Ultrasound Doppler abnormal
SMQs:, Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Thrombophlebitis (broad), Cardiomyopathy (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Sprintec birth control pills
Current Illness: None
Preexisting Conditions: None
Allergies: NKA
Diagnostic Lab Data: Ultrasound was given to locate clot
CDC Split Type:

Write-up: Blood clot in left leg


VAERS ID: 1498693 (history)  
Form: Version 2.0  
Age: 17.0  
Sex: Female  
Location: Washington  
Vaccinated:2021-07-06
Onset:2021-07-23
   Days after vaccination:17
Submitted: 0000-00-00
Entered: 2021-07-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Unknown       Purchased by: ?
Symptoms: Chest X-ray, Computerised tomogram, Dyspnoea, Electrocardiogram, Fibrin D dimer, Pulmonary thrombosis
SMQs:, Anaphylactic reaction (broad), Embolic and thrombotic events, venous (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Birth control pills, paxil
Current Illness: none
Preexisting Conditions:
Allergies: none
Diagnostic Lab Data: Blood work ( D-Dimer) Chest xray, CT scan EKG
CDC Split Type:

Write-up: Blood clots near / in lungs, shortness of breath


VAERS ID: 1500622 (history)  
Form: Version 2.0  
Age: 16.0  
Sex: Male  
Location: Nevada  
Vaccinated:2021-05-20
Onset:2021-07-06
   Days after vaccination:47
Submitted: 0000-00-00
Entered: 2021-07-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0186 / 2 LA / -

Administered by: Unknown       Purchased by: ?
Symptoms: Cerebral haemorrhage, Cerebral thrombosis, Cerebrovascular accident, SARS-CoV-2 test
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Ischaemic central nervous system vascular conditions (narrow), Haemorrhagic central nervous system vascular conditions (narrow), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: TYLENOL
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: ADHD
Allergies:
Diagnostic Lab Data: Test Date: 20210706; Test Name: Nasal Swab for COVID-19; Test Result: Negative
CDC Split Type: USPFIZER INC2021868587

Write-up: Clot and bleed in brain causing stroke; Clot and bleed in brain causing stroke; Clot and bleed in brain causing stroke; This is a spontaneous report from a contactable consumer (patient''s parent). A 16-year-old male patient received BNT162B2 (Lot Number: EW0186), dose 2 via an unspecified route of administration, administered in arm left on 20May2021 11:30 as single dose for covid-19 immunisation. Medical history included attention deficit hyperactivity disorder (ADHD). No known allergies. Concomitant medication included paracetamol (TYLENOL). The patient previously received first dose of BNT162B2 (lot number: ER8735) in left arm on 29Apr2021 17:15 for covid-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced clot and bleed in brain causing stroke on 06Jul2021 17:00. The events were reported as serious due to hospitalization. Events resulted in: doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care, hospitalization. Treatment received for the adverse events: Current hospitalization in PICU, rehabilitation, and pending further follow up actions. Prior to vaccination, was the patient diagnosed with COVID-19. The patient underwent lab tests and procedures which included nasal swab for Covid-19: negative on 06Jul2021. The outcome of events was recovering.


VAERS ID: 1505464 (history)  
Form: Version 2.0  
Age: 17.0  
Sex: Male  
Location: Massachusetts  
Vaccinated:2021-04-24
Onset:2021-04-27
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-07-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / IM

Administered by: Private       Purchased by: ?
Symptoms: Deep vein thrombosis, Ultrasound scan
SMQs:, Embolic and thrombotic events, venous (narrow), Thrombophlebitis (broad)

Life Threatening? Yes
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 4 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: None
Current Illness: Infectious mononucleosis diagnosed on 4/4/2021
Preexisting Conditions: None
Allergies: None
Diagnostic Lab Data: Sonogram on 4/27/2021
CDC Split Type:

Write-up: Right leg deep vein thrombosis


VAERS ID: 1510444 (history)  
Form: Version 2.0  
Age: 16.0  
Sex: Male  
Location: Arizona  
Vaccinated:2021-07-27
Onset:2021-07-27
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FA7484 / 2 LA / SYR

Administered by: Private       Purchased by: ?
Symptoms: Blood test normal, Chromaturia, Fear, Haematuria, Thrombosis, Urine analysis
SMQs:, Rhabdomyolysis/myopathy (broad), Haemorrhage terms (excl laboratory terms) (narrow), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Thrombophlebitis (broad), Tubulointerstitial diseases (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness: Nazel stuffiness approx. two weeks ago
Preexisting Conditions: No
Allergies: No
Diagnostic Lab Data: The medical team that was assisting my son, tested his urine and found Microscopic Hematuria-at that point his urine sample was back to normal color by the naked eye. They also decided to do a blood test and the results came back normal.
CDC Split Type:

Write-up: After my son received his 2nd Dose of the Pfizer on the scheduled date at approx.10:45 am, we went home and were just relaxing and at approx 1:54 pm. My son in a panic yelled for me to come into the bathroom and he showed me his urine and it was bright red with clots (Gross Hematuria). I know the time because as soon as I saw it I took a picture (of which I still have on my phone). I proceeded to access how he was feeling and after he said he felt okay just scared-no pain or anything, I called his Pediatrician whose office instructed me to take him to the ER and that is what I did. He was not rough housing, there was no trauma and again no pain. This has never happened before.


VAERS ID: 1513430 (history)  
Form: Version 2.0  
Age: 15.0  
Sex: Female  
Location: Montana  
Vaccinated:2021-06-23
Onset:2021-07-18
   Days after vaccination:25
Submitted: 0000-00-00
Entered: 2021-07-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0169 / 2 RA / IM

Administered by: Private       Purchased by: ?
Symptoms: Activated partial thromboplastin time prolonged, Anticoagulant therapy, Axillary vein thrombosis, Basophil count, Blood creatinine normal, Blood electrolytes normal, Blood fibrinogen decreased, Blood glucose normal, Blood lactic acid normal, Blood magnesium normal, Blood urea nitrogen/creatinine ratio, Blood urea normal, Brachiocephalic vein thrombosis, Discomfort, Erythema, Full blood count normal, Haematocrit normal, Haemoglobin normal, Immature granulocyte count, International normalised ratio normal, Limb discomfort, Liver function test normal, Lymphocyte count, Metabolic function test abnormal, Monocyte count, Neutrophil count, Peripheral swelling, Platelet count normal, Pregnancy test urine negative, Prothrombin time normal, Thrombolysis, Ultrasound Doppler abnormal, Venogram abnormal, White blood cell count normal
SMQs:, Cardiac failure (broad), Liver-related coagulation and bleeding disturbances (narrow), Anaphylactic reaction (broad), Angioedema (broad), Haemorrhage laboratory terms (broad), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Embolic and thrombotic events, venous (narrow), Thrombophlebitis (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad), Hypersensitivity (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, 2 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: none
Current Illness: none
Preexisting Conditions: scoliosis
Allergies: none
Diagnostic Lab Data: Ultrasound. Venogram. PTT 7/22/21 @ 0429-7/23/21 @ 4149: 115.5, 96.3, 39, 48.8, 47.6, 50.6, 43.5, 41.9 Fibrinogen 7/22/21 @ 1757-7/23/21 @ 1351: 282, 217, 147, 150, 154, 153 7/21/21 CBC: Normal. WBC 7.95, Hgb 13.2, Hematocrit 38.4, Plts 197 ANC 5.33, ALC 1.83, AMC 0.42, AEC 0.33, Absolute basophils 0.03, Imm Grans 0.01 K/mcL 7/21/21 PTT: Normal at 32.3 seconds 7/21/21 PT/INR: Normal at 14.1 and 1.16 7/21/21 CMP: Normal other than mildly increased BUN/Creatinine ratio of 25 (BUN 16, Crt 0.65). Liver enzymes normal. Electrolytes and glucose normal. 7/21/21 Mg: normal at 2.0 7/21/21 Lactate: Normal at 1.1 7/22/21 UPT: Negative
CDC Split Type:

Write-up: Presented with right arm redness and swelling. Ultrasound evaluation reveal DVT. Underwent heparinization and thrombolysis. Underwent post thrombolysis venogram. Patient is a 15 year old previously healthy female with unprovoked thrombosis located in right upper extremity, per the Admission Note specifically at the right distal subclavian through axillary vein as well as a DVT in the basilic and proximal brachial vein. Associated symptom was sensation of pressure on right arm "like blood pressure" cuff. Duration as of admission of these symptoms and presumably underlying clot was three days with onset of these symptoms was Sunday 7/18/2021. Timing was cyclical with discomfort in the arm worse in the morning than in the evening. Context of this thrombosis was healthy female who does not smoke, does not use hormonal contraception, is not active in sports where upper body workouts are emphasized, and was not injured.


VAERS ID: 1520184 (history)  
Form: Version 2.0  
Age: 16.0  
Sex: Male  
Location: Oregon  
Vaccinated:2021-06-21
Onset:2021-06-23
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-08-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / IM

Administered by: Private       Purchased by: ?
Symptoms: Basilar artery thrombosis, Intensive care, Ischaemic stroke, Mental status changes, Nausea
SMQs:, Acute pancreatitis (broad), Ischaemic central nervous system vascular conditions (narrow), Dementia (broad), Embolic and thrombotic events, arterial (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: 100 mg sertraline daily sumatriptan abortive agent no herbal or dietary supplements
Current Illness: None
Preexisting Conditions: Dx of depression currently under control taking sertraline Dx of migraine takes sumatriptan abortive agent
Allergies: none
Diagnostic Lab Data: Admission to Pediatric ICU
CDC Split Type:

Write-up: Pt presented with nausea and altered mental status, imaging confirmed a R pons ischemic stroke, later found to be due to basilar artery thrombosis


VAERS ID: 1534766 (history)  
Form: Version 2.0  
Age: 16.0  
Sex: Female  
Location: Wisconsin  
Vaccinated:2021-04-28
Onset:2021-07-26
   Days after vaccination:89
Submitted: 0000-00-00
Entered: 2021-08-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 LA / IM

Administered by: Private       Purchased by: ?
Symptoms: Dysmenorrhoea, Heavy menstrual bleeding, Menstrual disorder, Thrombosis
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Thrombophlebitis (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations: at 9 y.o. chicken pox vacc: pneumonia and cellulitis
Other Medications: Meningitis vacc on 6/4/2021 hycosamine
Current Illness: IBS
Preexisting Conditions: IBS
Allergies: gluten sensitive
Diagnostic Lab Data: n/a
CDC Split Type: ?

Write-up: 7/26/2021 had insanely heavy menstrual cycle that was soaking pads within an hour (normal is ~4-5 hours). She had cramps that she has never experienced before 7/26 eve and 7/27 daytime. There were large blood clots present ($g$g quarter size) 7/26-7/28. Normally only small clots. First heavy point of 1 hour soaks were 6am-11am on 7/26. Then was medium changing 3-5 hours until 7pm. Then became insanely heavy again until 10pm with pad change out at 2 hours. 7/27 normal medium flow but every hour change outs that night. Other days back to a normal routine of medium and light


VAERS ID: 1535431 (history)  
Form: Version 2.0  
Age: 17.0  
Sex: Female  
Location: New Jersey  
Vaccinated:2021-05-14
Onset:2021-07-23
   Days after vaccination:70
Submitted: 0000-00-00
Entered: 2021-08-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0170 / 1 AR / IM
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0182 / 2 AR / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: Anticoagulant therapy, Antiphospholipid antibodies negative, Antithrombin III, Aphasia, Apraxia, Beta-2 glycoprotein antibody negative, Blood homocysteine increased, Blood iron normal, Bradycardia, Cardiolipin antibody, Cerebral haemorrhage, Cerebral mass effect, Cerebral venous thrombosis, Coagulation factor VIII level increased, Computerised tomogram head, Decompressive craniectomy, Drain placement, Echocardiogram, Echocardiogram normal, Generalised tonic-clonic seizure, Haematocrit normal, Haemoglobin normal, Headache, Hemiparesis, Human chorionic gonadotropin negative, Iron binding capacity total decreased, Laboratory test normal, Lipoprotein (a) normal, Magnetic resonance imaging head abnormal, Mean cell volume normal, Protein C, Protein S, SARS-CoV-2 antibody test negative, Thrombotic cerebral infarction, Tongue paralysis, Transferrin saturation decreased, Ultrasound Doppler, Ultrasound scan normal
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Systemic lupus erythematosus (broad), Arrhythmia related investigations, signs and symptoms (broad), Ischaemic central nervous system vascular conditions (narrow), Haemorrhagic central nervous system vascular conditions (narrow), Dementia (broad), Convulsions (narrow), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Embolic and thrombotic events, venous (narrow), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Thrombophlebitis (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (narrow), Generalised convulsive seizures following immunisation (narrow), Hypoglycaemia (broad), COVID-19 (broad)

Life Threatening? Yes
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, 19 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: None
Current Illness: None
Preexisting Conditions: None
Allergies: None
Diagnostic Lab Data: Of note, pt mother hx 1 episode of DVT/PE w/ first pregnancy and 1 miscarriage (unknown GA) after 2nd pregnancy. Pt not on OCPs 07/23: MRI/CT: L vein of Labbe occlusion w/ L temporal lobe infarct w/ inferior parietal lobe infarct w/ minor hemorrhage w/ midline shift 07/23: Hcg: Neg 07/24: LE duplex - normal 07/26: Factor V mutation absent, Factor VIII 173%, Protein C 29%, Protein S 83%, Absent Prothrombin gene mutation, Lupus anticoagulant negative, ATIII 51% -- $g 87% (07/29), B2 glycoprotein IgG/IgM <9.4 07/26: COVID nucleocapsid neg, COVID spike antibody 2126 07/27: TTE w/ bubble - normal study no PFO 07/27: lipoprotein A <6, cardiolipin IgG 6, cardiolipin IgM 24.5, homocysteine 3.0, negative heparin associated antibody 07/28: Hb 9.7, MCV 72.3, Hct 31.8, Fe 14, TIBC 223, % sat 6
CDC Split Type:

Write-up: Pt admitted on 07/23 w/ hx of headache for 5 days and GTC on day of admission, found to have L vein of Labbe thrombosis complicated by L temporal lobe infarct extending into the left inferior parietal lobe w/ minor hemorrhage in infarct. Pt started on heparin gtt but still developed midline shift and bradycardia, so was send for decompressive L. hemicrani w/ subglaeal hemovac placement on 07/24. After sx, patient had persistent R hemiparesis w/ R tongue deviation and profound expressive aphasia w/ some evidence of apraxia. Pt then managed w/ lovenox for AC, keppra for seizure ppx as well as PT/OT/ST for improving strength and language. Pt expected discharge to acute rehab on 08/11.


VAERS ID: 1549292 (history)  
Form: Version 2.0  
Age: 19.0  
Sex: Female  
Location: Texas  
Vaccinated:2021-06-30
Onset:2021-07-17
   Days after vaccination:17
Submitted: 0000-00-00
Entered: 2021-08-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 RA / SYR

Administered by: Pharmacy       Purchased by: ?
Symptoms: Peripheral swelling, Thrombosis
SMQs:, Cardiac failure (broad), Angioedema (broad), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Thrombophlebitis (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow)

Life Threatening? Yes
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, 4 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: Epidiolex , Alprazolam,Trazodone
Current Illness: Epilepsy. Anxiety
Preexisting Conditions: Trisonometry 18
Allergies: none
Diagnostic Lab Data: Blood Clot
CDC Split Type:

Write-up: Swelling Right Leg


VAERS ID: 1549546 (history)  
Form: Version 2.0  
Age: 19.0  
Sex: Female  
Location: Florida  
Vaccinated:2021-03-13
Onset:2021-03-14
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-08-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EN6206 / 1 LA / IM
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ER8734 / 2 LA / IM

Administered by: Other       Purchased by: ?
Symptoms: Arthralgia, Fatigue, Feeling abnormal, Heavy menstrual bleeding, Joint stiffness, Skin exfoliation, Thrombosis, Vaccine positive rechallenge, Vaginal discharge
SMQs:, Severe cutaneous adverse reactions (broad), Haemorrhage terms (excl laboratory terms) (narrow), Dementia (broad), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Thrombophlebitis (broad), Hypersensitivity (broad), Arthritis (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Q-var (asthma) Fexofenadine (allergies) Vit D Zinc Fish OIl Daily Vitamin
Current Illness: None
Preexisting Conditions: Asthma Anaphylactic to Peanuts
Allergies: Peanuts (anapjhylactic) Wheat (not anaphylactic) Dairy (not anaphylactic)
Diagnostic Lab Data: None
CDC Split Type:

Write-up: *Menstrual Cycle: Abnormal cycles. The second dose coincided with the start of menstrual bleeding, cycles are normally 5-7 days. This one lasted 13, with clotting and watery, brown discharge for four days at the end. Next cycle was also mild clotting. Has resolved. *Fatigue: started day after dose 1, lasted for 3 days; started again day after dose 2 and lasted for 2+ months. Especially noticed after moderate exercise. Not normal fatigue, it was like she had been out in the sun too long and was exhausted. It took the rest of the day+ to resolved with each instance. *Hollow-head: 5 days post dose 1; worse after dose 2, lasted about 1 week. Not your normal light-headedness. It felt like it was made of stone and filled with helium. Lots of ''empty space'' but hard and heavy. *Joint pain and stiffness: started day after dose 1, lasted 4-5 days; started day after dose 2 and has not resolved as of today (8.12.2021) *Peeling feet: both heels of feet and bottoms of toes peeled June 20th-June23rd, completely. I (mom) wouldn''t have thought about this being a side effect, except I belong to a adverse event vaccine group myself and see this reported frequently by people who have had worse reactions.


VAERS ID: 1578185 (history)  
Form: Version 2.0  
Age: 17.0  
Sex: Female  
Location: New York  
Vaccinated:2021-06-09
Onset:2021-06-10
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0175 / 1 LA / SYR
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EN0217 / 2 LA / SYR

Administered by: Other       Purchased by: ?
Symptoms: Diarrhoea, Dysmenorrhoea, Influenza, Insomnia, Thrombosis
SMQs:, Pseudomembranous colitis (broad), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Thrombophlebitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Noninfectious diarrhoea (narrow), Infective pneumonia (broad), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Patient took first Vaccine on 5/19/2021. The day after she was experiencing flu symptoms. When the patient cycles started it was extremely painful. She was in bed for three days due to the pain. The Second vaccine was given on 6/09/2021. Patient had flu symptoms again. When her cycle started she had blood clots, and loose stool. Patient was very active, now all she wants to do is stay on bed. When patient is on her cycle she can not sleep from the pain.


VAERS ID: 1623532 (history)  
Form: Version 2.0  
Age: 16.0  
Sex: Male  
Location: Michigan  
Vaccinated:2021-05-12
Onset:2021-06-29
   Days after vaccination:48
Submitted: 0000-00-00
Entered: 2021-08-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 AR / IM

Administered by: Public       Purchased by: ?
Symptoms: Condition aggravated, Epistaxis, Influenza like illness, Injection site pain, Malaise, Pyrexia, Thrombosis
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Thrombophlebitis (broad), Extravasation events (injections, infusions and implants) (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations: Childhood vaccines caused some adverse reactions such as fever, malaise, diarrhea
Other Medications: None
Current Illness: None
Preexisting Conditions:
Allergies: Unaware of any. Previous reactions to vaccinations, some food sensitivities.
Diagnostic Lab Data:
CDC Split Type:

Write-up: Within hours, feeling of malaise and sore at injection site. Developed a fever and was in a flu-like state for the next 4 days. This resolved. Although there is a history of mild nosebleeds due to dry weather, my child began having regular and hard to control nosebleeds after receiving the second dose. He is passing clots up to six inches in length and going through dozens of tissues to soak up the blood and clots. Bleeds are lasting roughly 15 minutes


VAERS ID: 1623852 (history)  
Form: Version 2.0  
Age: 14.0  
Sex: Male  
Location: Wisconsin  
Vaccinated:2021-06-14
Onset:2021-07-09
   Days after vaccination:25
Submitted: 0000-00-00
Entered: 2021-08-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / UNK UN / SYR

Administered by: Unknown       Purchased by: ?
Symptoms: Cerebral venous sinus thrombosis, Magnetic resonance imaging head abnormal, Venogram abnormal
SMQs:, Embolic and thrombotic events, venous (narrow), Central nervous system vascular disorders, not specified as haemorrhagic or ischaemic (narrow)

Life Threatening? Yes
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 2 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: focalin during school year (unsure if was on during the time)
Current Illness: none
Preexisting Conditions: ADD In hospital ultimately found - Factor V Leiden heterozygote - variant 1691G$gA (c.1601G$gA)
Allergies: none
Diagnostic Lab Data: MRI brain/MRV with extensive clot burden
CDC Split Type:

Write-up: extensive cerebral sinus venous thrombosis


VAERS ID: 1633335 (history)  
Form: Version 2.0  
Age: 19.0  
Sex: Female  
Location: Florida  
Vaccinated:2021-06-01
Onset:2021-08-09
   Days after vaccination:69
Submitted: 0000-00-00
Entered: 2021-08-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 204A21A / 1 LA / SYR

Administered by: Pharmacy       Purchased by: ?
Symptoms: Angiogram, Angiogram abnormal, Arthralgia, Atelectasis, Deep vein thrombosis, Dyspnoea, Echocardiogram abnormal, Intracardiac thrombus, Pain in extremity, Pulmonary embolism, Pulmonary pain, Thrombosis
SMQs:, Anaphylactic reaction (broad), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Embolic and thrombotic events, venous (narrow), Thrombophlebitis (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Arthritis (broad), Tendinopathies and ligament disorders (broad), Infective pneumonia (broad)

Life Threatening? Yes
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 4 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: Nuva ring birth control
Current Illness:
Preexisting Conditions: Irritable bowel syndrome, polycystic ovarian syndrome, asthma, fibromyalgia
Allergies: Dairy products
Diagnostic Lab Data: CTA on 8/20/21: multiple blood clots in left lung moderate to sever clot bourden. Echocardiogram on 8/21/21: small clot in heart. CTA on 8/23/21: clot bourden has lessened, showed fluid under left lung and bilateral lower lobe consolidation, likely atelectasis
CDC Split Type:

Write-up: Multiple DVTs is left arm axillary and basilic veins, multi clot pulmonary embolism in left lung and heart. Symptoms started as DVT pain in left fore arm early to mid 07/2021, shortness of breath started on 8/9/2021 and continued and worsened with left lung pain and right shoulder pain continuing and worsening, hospitalized on 8/20/2021 after CT showed multiple blood clots in the left lung with severe pain, hospitalized until 8/24/2021 still having symptoms of DVT after leaving hospital.


VAERS ID: 1641021 (history)  
Form: Version 2.0  
Age: 16.0  
Sex: Female  
Location: Texas  
Vaccinated:2021-06-01
Onset:2021-06-01
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Private       Purchased by: ?
Symptoms: Cerebral venous sinus thrombosis, Dehydration, Magnetic resonance imaging head abnormal, Venogram abnormal
SMQs:, Hyperglycaemia/new onset diabetes mellitus (broad), Embolic and thrombotic events, venous (narrow), Central nervous system vascular disorders, not specified as haemorrhagic or ischaemic (narrow), Dehydration (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: OCP, spironolactone, and doxyxycline at home.
Current Illness: Acne and hx ovarian cyst
Preexisting Conditions: none
Allergies: NKDA
Diagnostic Lab Data: 6/16/21 MRI/MRV- Venous sinus thrombosis
CDC Split Type:

Write-up: New onset sinus venous thrombosis 15 days after 2nd dose of COVID19 vaccine. Patient did had other predisposing factors that include use of OCP, sinus issues since she is a swimmer, and dehydration at admission.


VAERS ID: 1682808 (history)  
Form: Version 2.0  
Age: 17.0  
Sex: Male  
Location: Unknown  
Vaccinated:2021-07-12
Onset:2021-07-18
   Days after vaccination:6
Submitted: 0000-00-00
Entered: 2021-09-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 1 UN / IM

Administered by: Unknown       Purchased by: ?
Symptoms: Chest pain, Pulmonary embolism, Vena cava thrombosis
SMQs:, Embolic and thrombotic events, venous (narrow), Thrombophlebitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad)

Life Threatening? Yes
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, 3 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: -History of left iliofemoral deep venous thrombosis and pulmonary embolism in setting of May-Thurner anatomy & recent surgery in February 2020. Iliac stent placed in March 2020. -Depression and anxiety
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Patient developed chest pain approximately 6 days after receiving first dose of Pfizer vaccine. He presented to the ER on 7/23/21 (11 days after vaccine) and was found to have a pulmonary embolism and deep venous thrombosis in his inferior vena cava (IVC).


VAERS ID: 1685612 (history)  
Form: Version 2.0  
Age: 19.0  
Sex: Female  
Location: Tennessee  
Vaccinated:2021-03-06
Onset:2021-06-26
   Days after vaccination:112
Submitted: 0000-00-00
Entered: 2021-09-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 1805029 / 1 LA / SYR

Administered by: Pharmacy       Purchased by: ?
Symptoms: Dizziness, Headache, Nausea, Peripheral swelling, Pulmonary thrombosis, Pyrexia
SMQs:, Cardiac failure (broad), Acute pancreatitis (broad), Angioedema (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Embolic and thrombotic events, venous (narrow), Extravasation events (injections, infusions and implants) (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Haemodynamic oedema, effusions and fluid overload (narrow), Vestibular disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, 3 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: surtuleen , loryna, hydroxoline
Current Illness:
Preexisting Conditions:
Allergies: seasonal allergies and melons
Diagnostic Lab Data: blood clot on lung
CDC Split Type: vsafe

Write-up: swelling in left arm, headache, extreme dizziness, nausea, fever


VAERS ID: 1693704 (history)  
Form: Version 2.0  
Age: 19.0  
Sex: Female  
Location: California  
Vaccinated:2021-05-08
Onset:2021-05-23
   Days after vaccination:15
Submitted: 0000-00-00
Entered: 2021-09-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Unknown       Purchased by: ?
Symptoms: Autopsy, Death, Pulmonary thrombosis, Toxicity to various agents
SMQs:, Anticholinergic syndrome (broad), Embolic and thrombotic events, venous (narrow), Drug abuse and dependence (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-05-23
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: none
Current Illness: none
Preexisting Conditions: depression, anxiety
Allergies: none
Diagnostic Lab Data:
CDC Split Type:

Write-up: The decedent was found deceased at home on 05/23/2021. The decedent''s cause of death is acute fentanyl toxicity. The pathologist found blood clots in her lungs during autopsy, and she was concerned the blood clots may be related to the vaccine she received on 05/08/2021.


VAERS ID: 1718354 (history)  
Form: Version 2.0  
Age: 15.0  
Sex: Male  
Location: Illinois  
Vaccinated:2021-08-11
Onset:2021-08-31
   Days after vaccination:20
Submitted: 0000-00-00
Entered: 2021-09-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FC3180 / 2 LA / -

Administered by: Pharmacy       Purchased by: ?
Symptoms: Blood test, Bradyphrenia, Cerebrovascular accident, Computerised tomogram, Fatigue, Feeling abnormal, Headache, Investigation, Meningitis, Pain, Thrombosis, Urine analysis
SMQs:, Ischaemic central nervous system vascular conditions (narrow), Haemorrhagic central nervous system vascular conditions (narrow), Dementia (broad), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Parkinson-like events (broad), Thrombophlebitis (broad), Psychosis and psychotic disorders (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: ADHD (Verbatim: ADHD diagnosed at the end of sixth grade and he is sophomore in high school, so about 3.5 years ago)
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: Blood works; Result Unstructured Data: Test Result:Unknown Result; Test Name: stroke; Result Unstructured Data: Test Result:negative; Test Name: CAT scan; Result Unstructured Data: Test Result:negative; Test Name: Mono; Result Unstructured Data: Test Result:negative; Test Name: meningitis; Result Unstructured Data: Test Result:negative; Test Name: Blood clots; Result Unstructured Data: Test Result:negative; Test Name: urinalysis; Result Unstructured Data: Test Result:negative; Comments: He also had urinalysis to check for diabetes.
CDC Split Type: USPFIZER INC202101211850

Write-up: When he bent over at the waist he had sharp pain across his forehead.; severe brain fog; inability to think clearly; Exhaustion; headache; This is a spontaneous report from a contactable consumer (mother) reported for male patient (son) that: A 15-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 2 via an unspecified route of administration, administered in Arm Left on 11Aug2021 (Batch/Lot Number: FC3180; Expiration Date: Oct2021) as DOSE 2, SINGLE for covid-19 immunization. The patient past Medical history included attention deficit hyperactivity disorder from 2018 and ongoing (ADHD), diagnosed at the end of sixth grade and he is sophomore in high school, so about 3.5 years ago. The Historical Vaccine include Comirnaty (1st dose) on 23Jul2021(lot number: EW0179/expiry date: Aug2021) for covid-19 immunization. The patient''s concomitant medications were not reported. The Family Medical History Relevant to AE(s): caller suffers from migraines, but she is not sure if it is relevant. Migraines are more sudden and don''t last days on end. His maternal grandfather had Meniere''s Disease and died of a heart attack at age 45. The patient did not receive any other vaccine within 4 weeks prior to covid-19 vaccination. She is not sure if that is relevant. She is calling to report a possible side effect the first day when he went to the school nurse for the sharp headache. When he bent over at the waist, he had sharp pain across his forehead. Severe brain fog, inability to think clearly, and Exhaustion: around Labor Day weekend about on 05Sep2021. when he told her that it was getting worse, and he wanted to see a doctor. He went to the doctor on 07Sep2021. Went to ER on 08Sep2021 and again to ER on 12Sep2021. He was not admitted to the hospital and was only treated in the emergency room and they were unable to find anything wrong. The patient underwent lab tests and procedures which included Investigations: Tested for Mono, Meningitis, blood clots, and stroke. He has had CAT scan and urinalysis to check for diabetes. All have been negative. The event outcome was unknown.


VAERS ID: 1719060 (history)  
Form: Version 2.0  
Age: 14.0  
Sex: Male  
Location: North Carolina  
Vaccinated:2021-09-20
Onset:2021-09-21
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-09-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 LA / IM

Administered by: Unknown       Purchased by: ?
Symptoms: Atrioventricular block complete, Blood test, Cerebral thrombosis, Cerebrovascular accident, Computerised tomogram, Drooling, Magnetic resonance imaging, Mental status changes, Speech disorder, Thrombectomy
SMQs:, Conduction defects (narrow), Ischaemic central nervous system vascular conditions (narrow), Haemorrhagic central nervous system vascular conditions (narrow), Dementia (broad), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Dyskinesia (broad), Dystonia (broad), Parkinson-like events (broad), Psychosis and psychotic disorders (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Cardiomyopathy (broad), Hypokalaemia (broad)

Life Threatening? Yes
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: NONE
Current Illness: none
Preexisting Conditions: none
Allergies: none
Diagnostic Lab Data: CT, MRI, blood work
CDC Split Type:

Write-up: Student was drooling, and had an altered state. Speech was mumbled, student was able to smile and it was equal. Student''s heart rate was in the 50s, Sp02 98-99% , EMS/911 was called, student transported to hospital after monitor showed 3rd degree heartblock. EMS took student to hospital where a code stroke was called. student had a CT and an MRI, student then was taken to surgery to remove clot from brain.


VAERS ID: 1737016 (history)  
Form: Version 2.0  
Age: 13.0  
Sex: Female  
Location: Colorado  
Vaccinated:2021-08-20
Onset:2021-08-25
   Days after vaccination:5
Submitted: 0000-00-00
Entered: 2021-09-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FC3180 / 1 LA / IM

Administered by: Unknown       Purchased by: ?
Symptoms: Angiogram peripheral abnormal, Anticoagulant therapy, Antiphospholipid antibodies negative, Asthenia, Atrial thrombosis, Beta-2 glycoprotein antibody negative, Blood electrolytes normal, Blood fibrinogen, Blood homocysteine, Cardiolipin antibody negative, Catheterisation cardiac, Echocardiogram abnormal, Full blood count, Haematocrit normal, Haemoglobin normal, Heart valve replacement, Hypoaesthesia, International normalised ratio increased, Mitral valve incompetence, Mitral valve stenosis, Myxoma, Pain in extremity, Peripheral artery occlusion, Peripheral artery thrombosis, Platelet count normal, Prothrombin time prolonged, Pulse absent, Right ventricular enlargement, SARS-CoV-2 RNA undetectable, Thrombectomy, Thromboembolectomy, Ultrasound Doppler abnormal, White blood cell count increased
SMQs:, Cardiac failure (broad), Liver-related coagulation and bleeding disturbances (narrow), Peripheral neuropathy (broad), Haemorrhage laboratory terms (broad), Neuroleptic malignant syndrome (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Embolic and thrombotic events, arterial (narrow), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Pulmonary hypertension (narrow), Guillain-Barre syndrome (broad), Cardiomyopathy (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), COVID-19 (broad), Sexual dysfunction (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 7 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: None
Current Illness: None reported
Preexisting Conditions: asthma
Allergies: None reported
Diagnostic Lab Data: Labs: SARS-CoV-2: RNA: negative Electrolytes: within normal ranges Initial PT/INR on arrival from outside facility: 16.5 seconds/1.4 CBC: hemoglobin: 11.7 gm/dL, hematocrit: 34.5%, WBC: 14.2 10*9/L, platelets: 393 10*9/L Fibrinogen: 316 mg/dL Lupus anticoagulant, Beta-glycoprotein antibodies, Anti-Cardiolipin antibodies: within normal ranges Homocysteine: 4.1 umol/L Imaging: CTA: occlusive thrombus in left distal common femoral artery into proximal profunda; occlusive thrombus in right distal popliteal artery; non occlusive thrmbus extending into tibial peroneal trunk ECHO: echogenic structure in left atrium (myxoma), enlarged right ventricle, mitral valve stenosis and regurgitation
CDC Split Type:

Write-up: Pfizer-BioNTech COVID-19 Vaccine EUA: patient presented to another hospital with sudden onset left leg pain, numbness, and weakness during athletic activity. No Doppler pedal pulse detected and transferred to this facility. Found to have occlusions on left CFA, right profunda, and right popliteal as well as a left atrial mass (myxoma), left atrial thrombus, and mitral insufficiency. Admitted, anticoagulated, and underwent balloon embolectomies, mechanical valve replacement, right heart catheterizations, and thrombectomies. Discharged to home stable on anticoagulation with cardiology follow-up in place.


VAERS ID: 1742387 (history)  
Form: Version 2.0  
Age: 19.0  
Sex: Female  
Location: Wisconsin  
Vaccinated:2021-08-24
Onset:2021-09-08
   Days after vaccination:15
Submitted: 0000-00-00
Entered: 2021-09-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FC3183 / 1 RA / IM

Administered by: Private       Purchased by: ?
Symptoms: Anticoagulant therapy, Back pain, Laboratory test abnormal, Pain in extremity, Stent placement, Thrombectomy, Thrombosis
SMQs:, Retroperitoneal fibrosis (broad), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Thrombophlebitis (broad), Tendinopathies and ligament disorders (broad)

Life Threatening? Yes
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 10 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: birth control
Current Illness: none
Preexisting Conditions: none
Allergies: none
Diagnostic Lab Data: Transfer of three hospitals to meet patient needs. Labs - thrombectomy - stents placement - lifetime medication
CDC Split Type:

Write-up: Paint to back and leg - Showered blood clots - result hospitalization with continuous heparin drip - daily thrombectomy- stents placed - on Xarelto for lifetime


VAERS ID: 1749892 (history)  
Form: Version 2.0  
Age: 17.0  
Sex: Female  
Location: Massachusetts  
Vaccinated:2021-05-20
Onset:2021-06-11
   Days after vaccination:22
Submitted: 0000-00-00
Entered: 2021-09-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0177 / 2 LA / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: Computerised tomogram, Deep vein thrombosis, Pulmonary embolism, Ultrasound Doppler, Ultrasound scan
SMQs:, Embolic and thrombotic events, venous (narrow), Thrombophlebitis (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 2 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: Apri, Lamictal, Fluoxetine, Quetiapine
Current Illness: None
Preexisting Conditions: Depression , anxiety and obesity
Allergies: Amoxicillin
Diagnostic Lab Data: doppler sonogram and CT scan
CDC Split Type:

Write-up: deep vein thrombosis and pulmonary embolism


VAERS ID: 1772573 (history)  
Form: Version 2.0  
Age: 13.0  
Sex: Male  
Location: Iowa  
Vaccinated:2021-09-04
Onset:2021-09-16
   Days after vaccination:12
Submitted: 0000-00-00
Entered: 2021-10-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0170 / 1 RA / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: Fibrin D dimer, Thrombosis, Ultrasound scan abnormal
SMQs:, Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Malignancy related therapeutic and diagnostic procedures (narrow), Thrombophlebitis (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: aripiprazole 5mg, hydroxyzine 50mg, citalopram 40mg, alprazolam 0.5 mg
Current Illness:
Preexisting Conditions:
Allergies: penicillins
Diagnostic Lab Data: d-dimer 0.75, ultrasound showed clot
CDC Split Type:

Write-up: Developed clot in lower leg (shin), 60 mg Lovenox at ER, 81 mg aspirin daily, cephalexin 500 mg three times a day for 10 days, smz/tmp 800mg/160mg twice daily for 3 days


VAERS ID: 1152868 (history)  
Form: Version 2.0  
Age: 16.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-02-17
Onset:2021-02-24
   Days after vaccination:7
Submitted: 0000-00-00
Entered: 2021-03-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 2 LA / -

Administered by: Other       Purchased by: ?
Symptoms: Arterial thrombosis
SMQs:, Embolic and thrombotic events, arterial (narrow)

Life Threatening? Yes
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Smoker
Allergies:
Diagnostic Lab Data:
CDC Split Type: ILPFIZER INC2021329787

Write-up: Thrombosis with blockage of several arteries in the left hand; This is a spontaneous report from a contactable consumer. A 16-year-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date: unknown), via an unspecified route of administration, administered in left arm on 17Feb2021 as single dose for COVID-19 immunization. The patient''s was smoker. The patient''s concomitant medications were not reported. The patient previously took first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) on 21Jan2021 for COVID-19 immunization. On 24Feb2021, the patient experienced thrombosis with blockage of several arteries in the left hand. The adverse event required hospitalization and surgical treatment. There is no background diseases. Other reasons which may have caused the thrombosis were denied. The patient also received Clexane as treatment. The outcome of the events was recovering. The patient was not diagnosed with COVID-19 prior to vaccination. The patient has not been tested for COVID-19 since the vaccination. The event resulted in visit in office or physician clinic or other health care provider, visit in emergency room or emergency center, hospitalization, life threatening condition (immediate damage to death as a results from the adverse event), disability or permanent damage. Information on the lot/batch number has been requested.


VAERS ID: 1211706 (history)  
Form: Version 2.0  
Age: 16.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-03-06
Onset:2021-04-06
   Days after vaccination:31
Submitted: 0000-00-00
Entered: 2021-04-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ER1741PF / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Cerebral infarction, Cerebral venous sinus thrombosis, Cerebrovascular accident, Computerised tomogram abnormal, Full blood count, Headache, Nausea, SARS-CoV-2 test, Vomiting
SMQs:, Acute pancreatitis (broad), Ischaemic central nervous system vascular conditions (narrow), Haemorrhagic central nervous system vascular conditions (narrow), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Embolic and thrombotic events, venous (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Central nervous system vascular disorders, not specified as haemorrhagic or ischaemic (narrow), COVID-19 (broad)

Life Threatening? Yes
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: INSULIN ASPART; INSULIN DETEMIR
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Asthma (no current treatment); Headache; Hydrocephalus; Stroke; Type 1 diabetes mellitus
Allergies:
Diagnostic Lab Data: Test Name: CT venogram; Result Unstructured Data: Test Result:venogram cerebral showed "Conclusion; Comments: Extensive left sided venous sinus thrombosis and left internal jugular thrombosis with secondary venous haemorrhage within the left parietal lobe.; Test Date: 20210406; Test Name: FBC; Result Unstructured Data: Test Result:No results provided; Test Date: 20210406; Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:Inconclusive test
CDC Split Type: GBPFIZER INC2021387063

Write-up: headache; vomiting; haemorrhagic venous infarct; nausea; Thrombosis of venous sinuses; stroke; This is a spontaneous report from a contactable pharmacist received from the Regulatory Agency (RA). The regulatory authority report number is GB-MHRA-WEBCOVID-202104071535023370. Safety Report Unique Identifier GB-MHRA-ADR 25096240. A 16-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration on 06Mar2021 (Batch/Lot Number: ER1741PF) as single dose for covid-19 immunisation. Medical history included asthma childhood but no treatment at this time, hyrocephalus, headache, cerebrovascular accident, type 1 diabetes mellitus All from an unknown date and unknown if ongoing. Concomitant medication(s) included insulin aspart (INSULIN ASPART) and insulin detemir (INSULIN DETEMIR) taken for an unspecified indication, start and stop date were not reported. The patient experienced stroke (cerebrovascular accident), headache (headache), vomiting (vomiting) haemorrhagic venous infarct (cerebral infarction), nausea (nausea) on an unspecified date with outcome of recovering, and thrombosis of venous sinuses (cerebral venous sinus thrombosis) on 06Apr2021 with outcome of not recovered. All events reported with seriousness criteria of hospitalization, medically significant, and life threatening. The patient was hospitalized from 06Apr2021 to an unknown date. The patient underwent lab tests and procedures which included computerised tomogram abnormal: venogram cerebral showed "conclusion", explained as extensive left sided venous sinus thrombosis and left internal jugular thrombosis with secondary venous haemorrhage within the left parietal lobe, full blood count: no results provided on 06Apr2021, sars-cov-2 test: inconclusive test on 06Apr2021. Therapeutic measures were taken as a result of stroke (cerebrovascular accident), haemorrhagic venous infarct (cerebral infarction) , thrombosis of venous sinuses (cerebral venous sinus thrombosis) reported as patient was stable at present and ongoing discussion with haematology consultant with a view to switch to a direct acting oral anticoagulant from dalteparin that was started overnight. Patient has not had symptoms associated with COVID-19, and was not enrolled in clinical trial. The clinical course was reported as follows: Patient indicated to have T1DM (Type I diabetes Melitis) Looks like childhood asthma but no current treatmentAdmitted 06/04/21 with reported 4week of headache. L sided. Deteriorated and had vomiting and nausea. Had COVID vaccine 06/03/21 several days prior to symptom onset. Past medical history of T1DM. CT venogram cerebral showed "Conclusion: Extensive left sided venous sinus thrombosis and left internal jugular thrombosis with secondary venous haemorrhage within the left parietal lobe. Urgent discussion with stroke team advised. Consultant opinion: Agreed. Venous sinus thrombosis distal superior sagittal sinus and filling left transverse and sigmoid sinuses and in the visualise rostral left IJV with haemorrhagic venous infarct left parietal lobe. No significant mass effect. No hydrocephalus." Patient stable at present and ongoing discussion with haematology consultant with a view to switch to a direct acting oral anticoagulant from dalteparin that was started overnight. Patient has not tested positive for COVID-19 since having the vaccine Reaction Does your report relate to possible blood clots or low platelet counts? If yes, we will ask you additional questions at the end of this report: "No" Suspect Reactions Please provide details of any relevant investigations or tests conducted: "CT venogram cerebral, various antibody tests, FBC, etc". Patient has not tested positive for COVID-19 since having the vaccine. Follow-up attempts are completed. No further information is expected


VAERS ID: 1226616 (history)  
Form: Version 2.0  
Age: 17.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-09
Onset:2021-04-09
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-04-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EM4965 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Anaphylactic reaction, Chest pain, Hot flush, Platelet count, Platelet count decreased, Thrombosis, Vomiting, Wheezing
SMQs:, Anaphylactic reaction (narrow), Acute pancreatitis (broad), Angioedema (broad), Asthma/bronchospasm (broad), Haematopoietic thrombocytopenia (narrow), Systemic lupus erythematosus (broad), Anaphylactic/anaphylactoid shock conditions (narrow), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Thrombophlebitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? Yes
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Autism; Food allergy (allergic to nuts and dairy)
Allergies:
Diagnostic Lab Data: Test Name: platelet count; Result Unstructured Data: Test Result:low
CDC Split Type: GBPFIZER INC2021393672

Write-up: possible blood clots or low platelet counts; possible blood clots or low platelet counts; wheezy; hot flushes; vomiting; chest pain; Anaphylaxis; Regulatory Agency (RA). The regulatory authority report number is GB-MHRA-WEBCOVID-202104091248264720. Safety Report Unique Identifier GB-MHRA-ADR 25112154. A 17-years-old male patient received first dose bnt162b2 (BNT162B2), via an unspecified route of administration on 09Apr2021 (Batch/Lot Number: EM4965) as single dose for Covid-19 immunisation. Medical history included allergic to nuts and dairy, autism. Patient has not had symptoms associated with COVID-19. Not had a COVID-19 test. Patient is not enrolled in clinical trial. The patient''s concomitant medications were not reported. The patient experienced wheezy, hot flushes, vomiting, chest pain on 09Apr2021 with outcome of unknown, anaphylaxis on 09Apr2021 with outcome of recovering, possible blood clots or low platelet counts on an unspecified date with outcome unknown. Patient was treated by the medical emergency team and transferred to A&E. The events were assessed as serious and life threatening. The clinical course was reported as follows: Within minutes of having the Pfizer vaccine, patient began having hot flushes and complaining of chest pain. He sounded wheezy and began vomiting. Patient has not tested positive for COVID-19 since having the vaccine Reaction. Does your report relate to possible blood clots or low platelet counts? If yes, we will ask you additional questions at the end of this report: "Yes". Suspect Reactions. Please provide details of any relevant investigations or tests conducted: "Pt was treated by the medical emergency team and transfered to A&E". Thromboembolic event / Thombocytopenia additional questions. Was the platelet count <150 A--109/L?: "Unknown" Was the D-dimer $g4000?: "Unknown". Were anti-PF4 antibodies identified?: "Unknown" Is there any additional medical history, not already provided, that relates to previous venous or arterial thromboses?: "No". Please specify the details of the thromboembolic event: "N/A" Follow-up attempts are completed. No further information is expected.


VAERS ID: 1297204 (history)  
Form: Version 2.0  
Age: 18.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-04-21
Onset:2021-05-02
   Days after vaccination:11
Submitted: 0000-00-00
Entered: 2021-05-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EX3510 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Deep vein thrombosis
SMQs:, Embolic and thrombotic events, venous (narrow), Thrombophlebitis (broad)

Life Threatening? Yes
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC2021502557

Write-up: developed a thrombosis after the first dose of the vaccine (2-level thrombosis involving the popliteal vein); This is a spontaneous report from a contactable physician based on information received by Pfizer from BioNTech [manufacturer reference number: 49809 and 50355], license party for COMIRNATY. An 18-year-old female patient received BNT162B2 (COMIRNATY) on 21Apr2021, dose 1, as single dose for Covid-19 immunisation at the age of 18-year-old. Lot Number was EX3510. Medical history and concomitant medications were unknown. Patient was not pregnant at the time of report. It was reported that the patient had swellings on left lower leg and pain on left calf on stepping since 02May2021; 2 level thrombosis involving popliteal vein potentially (life threatening); the patient was treated for the event. The outcome of the event was unknown.; Sender''s Comments: Based on the information provided by the reporter, it appears unlikely that subject vaccine contributed to the event of deep vein thrombosis. The reported event likely represent intercurrent medical conditions. There is limited information provided in this report. This case will be reassessed upon receipt of follow-up information. Based on the information provided in the case, this individual report would not seem to modify the risk-benefit profile of the subject product.


VAERS ID: 1377597 (history)  
Form: Version 2.0  
Age: 18.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-04-21
Onset:2021-05-02
   Days after vaccination:11
Submitted: 0000-00-00
Entered: 2021-06-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EX3510 / UNK LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Body mass index, Deep vein thrombosis, Orthopaedic examination, Ultrasound scan
SMQs:, Embolic and thrombotic events, venous (narrow), Thrombophlebitis (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Contraception (has been using a gin ring); Non-smoker
Allergies:
Diagnostic Lab Data: Test Name: BMI; Result Unstructured Data: Test Result:19.8; Test Date: 20210426; Test Name: orthopaedic examination; Result Unstructured Data: Test Result:V.a.static complaints; Test Date: 20210413; Test Name: sonography; Result Unstructured Data: Test Result:there was no thrombosis; Comments: there was no thrombosis: examination by ultrasound because of swelling and pain on the left side of the thigh, on the inner side, after a long walk; Test Date: 20210504; Test Name: sonography; Result Unstructured Data: Test Result:a 2-level thrombosis of the left lower leg; Comments: a 2-level thrombosis of the left lower leg with inclusion of the popliteal vein was diagnosed by sonography
CDC Split Type: DEPFIZER INC2021590227

Write-up: Thrombosis of the lower leg on the left side ,2 level thrombosis; This is as spontaneous report from a non contactable physician downloaded from the Regulatory Authority -WEB. The regulatory authority report number is DE-PEI-202100056559. An 18-year-old female patient received bnt162b2 (COMIRNATY) intramuscular administered in left deltoid on 21Apr2021 (Lot Number: EX3510) as 0.3 mL single for COVID-19 immunisation. Medical history included non-smoker and had been using a gin ring for contraception since September 2020. The patient''s concomitant medications were not reported. Sonography was performed on 13Apr2021 and showed there was no thrombosis: examination by ultrasound because of swelling and pain on the left side of the thigh, on the inner side, after a long walk. The patient experienced thrombosis of the lower leg on the left side, 2 level thrombosis (deep venous thrombosis distal) on 02May2021. Event was reported as serious (medically significant). Sonography was performed on 04May2021 and a 2-level thrombosis of the left lower leg with inclusion of the popliteal vein was diagnosed by sonography. The differential diagnoses "peripheral artery disease" and "orthopaedic examination showed V.a.static complaints" were excluded. The patient received outpatient treatment for events. The outcome of event was not recovered. Reporter''s comment: Thrombosis is a potentially life-threatening condition if untreated. She has a BMI of 19.8.So far, thrombophilia is not known or has not been investigated. Relatedness of drug to reaction/event was D. Unclassifiable per Regulatory Authority. No follow-up attempts possible. No further information expected.; Reporter''s Comments: Thrombosis is a potentially life-threatening condition if untreated. She has a BMI of 19.8.So far, thrombophilia is not known or has not been investigated.


VAERS ID: 1379838 (history)  
Form: Version 2.0  
Age: 17.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-17
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-06-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH NOT KNOWN / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Angiogram, Arthralgia, Central nervous system vasculitis, Colonoscopy, Diarrhoea haemorrhagic, Eosinophil count, Eosinophilia, Eosinophilic colitis, Gastrointestinal motility disorder, Headache, Hemiplegia, Hypoaesthesia, Hypokinesia, Leukocytosis, Magnetic resonance imaging, Nervous system disorder, Photophobia, Platelet count decreased, Positron emission tomogram, SARS-CoV-2 test, Venous thrombosis, White blood cell count
SMQs:, Haematopoietic thrombocytopenia (narrow), Peripheral neuropathy (broad), Haemorrhage terms (excl laboratory terms) (narrow), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Pseudomembranous colitis (broad), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Embolic and thrombotic events, venous (narrow), Parkinson-like events (broad), Gastrointestinal obstruction (narrow), Gastrointestinal haemorrhage (narrow), Guillain-Barre syndrome (broad), Noninfectious meningitis (narrow), Gastrointestinal nonspecific dysfunction (broad), Ischaemic colitis (broad), Glaucoma (broad), Corneal disorders (broad), Eosinophilic pneumonia (broad), Retinal disorders (broad), Central nervous system vascular disorders, not specified as haemorrhagic or ischaemic (narrow), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (narrow), Vasculitis (narrow), Hypotonic-hyporesponsive episode (broad), Hypersensitivity (broad), Arthritis (broad), Noninfectious diarrhoea (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Immune-mediated/autoimmune disorders (narrow), COVID-19 (broad), Sexual dysfunction (broad)

Life Threatening? Yes
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: CO-TRIMOXAZOLE; CYCLOPHOSPHAMIDE; DALTEPARIN; HYDROXYCARBAMIDE; IVERMECTIN; METHYLPREDNISOLONE; OMEPRAZOLE; PREDNISOLONE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Bloody diarrhoea; Colonoscopy (showed active inflammation in the terminal ileum in keeping with suspected crohns disease.); Colonoscopy; Eosinophilic colitis; Hemiplegia; Joint pain
Allergies:
Diagnostic Lab Data: Test Name: Cerebral angiogram; Result Unstructured Data: Test Result:normal; Test Name: colonoscopy; Result Unstructured Data: Test Result:suspected eosinophilic colitis; Test Name: eosinophils; Result Unstructured Data: Test Result:56; Test Name: MRI head; Result Unstructured Data: Test Result:some areas of restricted diffusion on the right; Comments: MRI head showed some areas of restricted diffusion on the right and subacute lesion on the left; Test Name: platelets; Result Unstructured Data: Test Result:1210; Comments: up to 1210; Test Name: PET; Result Unstructured Data: Test Result:showed some bowel enhancement; Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:Negative; Comments: No - Negative COVID-19 test; Test Name: White Cell Count; Result Unstructured Data: Test Result:100; Comments: up to 100
CDC Split Type: GBPFIZER INC2021620181

Write-up: bloody diarrhoea; eosinophilic colitis; Hypereosinophilia; neurological deterioration; cerebral vasculitis; joint pain; leucocytosis; right thalamocaudate vein thrombosis; hemiplegia; some bowel enhancement; severe headache; photophobia; clumsy and numb left hand; clumsy and numb left hand; This is a spontaneous report from a contactable physician from the Regulatory Agency (RA). The regulatory authority report number is GB-MHRA-WEBCOVID-202105272059089750-4F1CM and Sender''s (Case) Safety Report Unique Identifier is GB-MHRA-ADR 25375956. A 17-year-old male patient received bnt162b2 (COMIRNATY), dose 1 via an unspecified route of administration on 17Apr2021 (Batch/Lot Number: not known) as single dose at the age of 17-year-old for COVID-19 immunisation. Medical history included arthralgia, eosinophilic colitis, diarrhoea haemorrhagic from Dec2020 to an unknown date, colonoscopy showed active inflammation in the terminal ileum in keeping with suspected Crohns disease, arthralgia, hemiplegia. Patient has not had symptoms associated with COVID-19. Patient was not enrolled in clinical trial. Concomitant medication(s) included co-trimoxazole (CO-TRIMOXAZOLE); cyclophosphamide (CYCLOPHOSPHAMIDE); dalteparin (DALTEPARIN); hydroxycarbamide (HYDROXYCARBAMIDE); ivermectin (IVERMECTIN); methylprednisolone (METHYLPREDNISOLONE); omeprazole (OMEPRAZOLE); prednisolone (PREDNISOLONE), all taken for an unspecified indication, start and stop date were not reported. The patient previously took hydroxyurea. On an unspecified date the patient experienced cerebral vasculitis with outcome of recovered in 2021, joint pain with outcome of recovered on an unknown date, bloody diarrhoea with outcome of recovered on an unknown date, eosinophilic colitis with outcome of recovered in 2021, hypereosinophilia with outcome of not recovered. In 2021, 2 weeks after vaccination, the patient experienced severe headache with photophobia with outcome of recovered in 2021, and subsequently he experienced a clumsy and numb left hand with outcome of unknown, leucocytosis with outcome of recovered in 2021, neurological deterioration with outcome of unknown, hemiplegia with outcome of recovered in 2021, right thalamocaudate vein thrombosis with outcome of unknown, some bowel enhancement with outcome of unknown. All events were serious as per hospitalization, disability, medically significant, life threatening. The course of events was as follows: Severe headache 2 weeks after vaccination with photophobia, which self resolved but subsequently developed a clumsy and numb left hand. Attended hospital where was found to have significant leucocytosis (WCC up to 100, eosinophils of 56, platelets up to 1210). MRI head showed some areas of restricted diffusion on the right and subacute lesion on the left. Treated with steroids initially. Symptoms resolved but then further neurological deterioration with significant left sided hemiplegia. Multiple repeat imaging - further MRI has shown right thalamocaudate vein thrombosis. PET performed which showed some bowel enhancement. Subsequent colonoscopy and biopsies have shown suspected eosinophilic colitis. Cerebral angiogram performed as concern about cerebral vasculitis - this was normal. Treated with hydroxyurea, methylprednisolone and cyclophosphamide. Blood counts and platelets are improving but has ongoing significant hemiplegia. Notably had joint pain and bloody diarrhoea in Dec2020 (related) (as reported). Well aside from joint pain and some bloody diarrhoea in Dec 2020 - colonoscopy showed active inflammation in the terminal ileum in keeping with suspected Crohns disease. The patient underwent lab tests and procedures which included (unspecified date): angiogram: normal, colonoscopy: suspected eosinophilic colitis, eosinophil count: 56, magnetic resonance imaging (MRI): some areas of restricted diffusion on the right and subacute lesion on the left, platelet count decreased: up to 1210, positron emission tomogram: showed some bowel enhancement, Sars-cov-2 test: negative No - Negative COVID-19 test, white blood cell count: up to 100. Patient has not tested positive for COVID-19 since having the vaccine The reporting physician assessed that this report was not related to possible blood clots or low platelet counts. No follow-up attempts possible. No further information expected. Information on batch number cannot be obtained.


VAERS ID: 1396865 (history)  
Form: Version 2.0  
Age: 17.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-02
Onset:2021-04-02
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-06-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3000495 / UNK - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Headache, Paraesthesia, Product administered to patient of inappropriate age, Thrombosis
SMQs:, Peripheral neuropathy (broad), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Thrombophlebitis (broad), Guillain-Barre syndrome (broad), Medication errors (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEMODERNATX, INC.MOD20212

Write-up: Thrombosis; Paraesthesia; Headache; Inappropriate age at vaccine administration; This regulatory authority case was reported by a consumer and describes the occurrence of THROMBOSIS (Thrombosis), PARAESTHESIA (Paraesthesia) and HEADACHE (Headache) in a 17-year-old male patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch no. 3000495) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 02-Apr-2021, the patient received dose of mRNA-1273 (COVID 19 Vaccine Moderna) (unknown route) unknown. On 02-Apr-2021, the patient experienced THROMBOSIS (Thrombosis) (seriousness criteria hospitalization prolonged and medically significant), PARAESTHESIA (Paraesthesia) (seriousness criterion hospitalization prolonged), HEADACHE (Headache) (seriousness criterion hospitalization prolonged) and PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Inappropriate age at vaccine administration). At the time of the report, THROMBOSIS (Thrombosis), PARAESTHESIA (Paraesthesia) and HEADACHE (Headache) had resolved and PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Inappropriate age at vaccine administration) outcome was unknown. The action taken with mRNA-1273 (COVID 19 Vaccine Moderna) (Unknown) was unknown. Concomitant medication use was not provided. No Treatment information was provided. Based on the current available information and temporal association between the use of the product and the thrombosis, headache and paresthesia, a causal relationship cannot be excluded. Event terms, onset dates and outcomes captured per SD Authority reporting. Event added tp reflect that the patient was below age specified in label. Events seriousness per assessment by Authority and per IME list; Sender''s Comments: Based on the current available information and temporal association between the use of the product and the thrombosis, headache and paresthesia, a causal relationship cannot be excluded. Event terms, onset dates and outcomes captured per SD Authority reporting. Event added tp reflect that the patient was below age specified in label. Events seriousness per assessment by Authority and per IME list


VAERS ID: 1427547 (history)  
Form: Version 2.0  
Age: 18.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-28
Onset:2021-05-28
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-06-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Heavy menstrual bleeding, Thrombosis
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Thrombophlebitis (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: CAPFIZER INC2021691606

Write-up: Blood clots the size of peas 5x a day; Heavy vaginal bleeding from May 28-Present (at least 17 days); This is spontaneous report received via COVAES from a contactable consumer (patient, self-reported) regarding pfizer product (PFIZER-BIONTECH COVID-19 VACCINE). A 18-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number and expiry date were not reported), via intramuscularly, in Arm Left, on 28May2021 at 13:15 PM (age at vaccination: 18 year), as a single dose for COVID-19 immunization. The patient was not pregnant at the time of vaccination. The patient''s medical history was not reported. Past drug event included penicillin. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received other medication included birth control within 2 weeks of vaccination. Prior to vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient was not tested for COVID-19. The patient reported that she had heavy vaginal bleeding from 28May2021 at 15:00 to present (at least 17 days). Blood clots the size of peas 5x a day. Changing out a super tampon every 4 hours for the entire length of the period. Unusual, as she has taken birth control throughout this timespan and consistently have taken it for 3 years with no irregular periods. No chance of pregnancy or other health concerns. Outcome of the events was not recovered.


VAERS ID: 1433080 (history)  
Form: Version 2.0  
Age: 18.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-03
Onset:2021-06-08
   Days after vaccination:5
Submitted: 0000-00-00
Entered: 2021-06-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 LA / -

Administered by: Other       Purchased by: ?
Symptoms: Asthenia, Muscle rigidity, Nervous system disorder, Pain, Phlebitis, Thrombosis
SMQs:, Neuroleptic malignant syndrome (broad), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Parkinson-like events (narrow), Thrombophlebitis (broad), Guillain-Barre syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: SYMBICORT
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: CAPFIZER INC2021702904

Write-up: blockage of the muscle; phlebitis in the blood vessels (clot); phlebitis in the blood vessels (clot); pain all over; decrease in strength; spasm of the nerve; This is a spontaneous report from a non-contactable consumer (patient). An 18-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in arm left on 03Jun2021 at 15:15 (Batch/Lot Number: unknown), at the age of 18-years-old, as dose 1, single for Covid-19 immunisation. The patient has no known allergies and no other medical history. 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. Concomitant medication included budesonide, formoterol fumarate (SYMBICORT) taken for an unspecified indication, start and stop date were not reported. The patient experienced phlebitis in the blood vessels (clot), pain all over, decrease in strength, spasm of the nerve on 08Jun2021 at 16:00 with outcome of not recovered, and finally blockage of the muscle on an unspecified date with outcome of not recovered. Treatment for the events was unknown. Since the vaccination, the patient has not been tested for COVID-19.


VAERS ID: 1454926 (history)  
Form: Version 2.0  
Age: 19.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-20
Onset:2021-05-22
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-07-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EX8679 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Product use issue, Venous thrombosis limb
SMQs:, Embolic and thrombotic events, venous (narrow), Medication errors (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC2021758814

Write-up: Product use for unapproved combination; Lower leg vein thrombosis to just above the knee on the left; This is a spontaneous report downloaded from the regulatory authority-WEB DE-PEI-202100105621. A non-contactable physician reported that a 19-years-old female patient received bnt162b2 (COMIRNATY), dose 1 via an unspecified route of administration on 20May2021 (Batch/Lot Number: EX8679), vaccinated at the age of 19 years old, as single dose for covid-19 immunisation; covid-19 vaccine nrvv ad (chadox1 ncov-19) (VAXZEVRIA), via an unspecified route of administration on 15Mar2021 (Batch/Lot Number: ABV5443), at DOSE 1, SINGLE for covid-19 immunisation. The patient medical history was not reported. The patient''s concomitant medications were not reported. 2 days after vaccination with Comirnaty, 2 months after Vaxzevria, on 22May2021 the patient experienced Lower leg vein thrombosis to just above the knee on the left. Outcome of event Leg venous thrombosis was recovering. No follow-up attempts possible. No further information expected.


VAERS ID: 1471102 (history)  
Form: Version 2.0  
Age: 17.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-03-30
Onset:2021-04-13
   Days after vaccination:14
Submitted: 0000-00-00
Entered: 2021-07-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Allen's test, Diagnostic procedure, Echocardiogram, Embolism, Thrombosis
SMQs:, Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Thrombophlebitis (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210413; Test Name: allen test; Result Unstructured Data: Test Result:absent reperfusion; Comments: absent reperfusion via ulnar artery; Test Date: 20210415; Test Name: diagnostic procedure; Result Unstructured Data: Test Result:no evidence of a Thoracic-outlet-Syndrom; Comments: Acral oscillography: functional provocation test, there was no evidence of a Thoracic-outlet-Syndrome on either side; Test Date: 20210416; Test Name: Transesophageal echocardiography; Result Unstructured Data: Test Result:no evidence of a cardiac source of embolism
CDC Split Type: DEPFIZER INC2021804103

Write-up: Acral perfusion disturbance D5 (little finger) left, Differential diagnosis embolism, Differential diagnosis local thrombose; Acral perfusion disturbance D5 (little finger) left, Differential diagnosis embolism, Differential diagnosis local thrombose; This is a spontaneous report from a non-contactable physician downloaded from the WEB, regulatory authority number is DE-PEI-202100038823. A 17-year-old female patient received BNT162B2 (COMIRNATY, solution for injection), intramuscular on 30Mar2021 (Batch/Lot Number: Unknown) (at the age of 17-years-old) as dose 1, single for COVID-19 immunisation. The patient''s medical history and concomitant medications were not reported. On 13Apr2021, patient was presented with acral perfusion disturbance D5 (little finger) left, differential diagnosis embolism, differential diagnosis local thrombose. Allen test result on 13Apr2021: absent reperfusion via ulnar artery. The reporter assessed the events as serious causing hospitalization. Outcome of events was not recovered. Sender''s comments: About 14 days after receiving the first vaccination with Biontech, the patient developed an acral underperfusion of the left little finger (D5). A thrombosis of the arm veins could be excluded. With a highly pathological Allen test, we are most likely to assume an embolism or local thrombosis. A cardiac source of embolism could largely be ruled out. The following differential diagnoses were excluded: Transesophageal echocardiography on 16Apr2021: showed no evidence of a cardiac source of embolism. Acral oscillography, finger on 15Apr2021: In the functional provocation test, there was no evidence of a Thoracic-outlet-Syndrome on either side. No follow-up attempts are possible; information about lot/batch number cannot be obtained.


VAERS ID: 1486476 (history)  
Form: Version 2.0  
Age: 18.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-14
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-07-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3002621 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Dizziness, Illness, Thrombosis
SMQs:, Anticholinergic syndrome (broad), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Thrombophlebitis (broad), Vestibular disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBMODERNATX, INC.MOD20212

Write-up: blood clots; Sickness; Light headed; This regulatory authority case was reported by a pharmacist and describes the occurrence of THROMBOSIS (blood clots) in an 18-year-old male patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 3002621) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 14-Jul-2021, the patient received first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced THROMBOSIS (blood clots) (seriousness criterion medically significant), ILLNESS (Sickness) and DIZZINESS (Light headed). At the time of the report, THROMBOSIS (blood clots) and DIZZINESS (Light headed) outcome was unknown and ILLNESS (Sickness) had resolved. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna CoviD-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Concomitant product use was not reported. Treatment information was not provided.; Sender''s Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.


VAERS ID: 1486493 (history)  
Form: Version 2.0  
Age: 19.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-11
Onset:2021-07-11
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3003608 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Dizziness, Fall, Loss of consciousness, Phobia, Thrombosis, Vomiting
SMQs:, Torsade de pointes/QT prolongation (broad), Acute pancreatitis (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Thrombophlebitis (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Accidents and injuries (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Vestibular disorders (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Phobia
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBMODERNATX, INC.MOD20212

Write-up: Blood clots; Loss of consciousness; Fell; Phobia; Vomiting; Dizziness; This regulatory authority case was reported by a pharmacist and describes the occurrence of THROMBOSIS (Blood clots) and LOSS OF CONSCIOUSNESS (Loss of consciousness) in a 19-year-old male patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 3003608) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Phobia. On 11-Jul-2021, the patient received first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 11-Jul-2021, the patient experienced DIZZINESS (Dizziness). On an unknown date, the patient experienced THROMBOSIS (Blood clots) (seriousness criterion medically significant), LOSS OF CONSCIOUSNESS (Loss of consciousness) (seriousness criterion medically significant), FALL (Fell), PHOBIA (Phobia) and VOMITING (Vomiting). On 11-Jul-2021, DIZZINESS (Dizziness) had resolved. At the time of the report, THROMBOSIS (Blood clots), PHOBIA (Phobia) and VOMITING (Vomiting) had resolved and LOSS OF CONSCIOUSNESS (Loss of consciousness) and FALL (Fell) outcome was unknown. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. For mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. The concomitant medications on use were not provided. After the vaccination, patient was under observation for the post vaccination. He did not mention the he had any difficulties but he fell to the floor. He was conscious and when he was comfortable he sat again. The 999 team was called. In the meantime, he felt alright and we asked him to sit on a chair and he was observed. He felt dizzy once again and he vomited. Once recovered, he was insistent to use the toilet facilities and the Pharmacist held his hand and accompanied him to the toilet. His mother was called and was given further instruction to follow per 999 advise. No treatment information was provided. Company comment:Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender''s Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.


VAERS ID: 1486513 (history)  
Form: Version 2.0  
Age: 18.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-07
Onset:2021-07-07
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3002615 / 1 - / -

Administered by: Unknown       Purchased by: ?
Symptoms: Dizziness, Thrombosis
SMQs:, Anticholinergic syndrome (broad), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Thrombophlebitis (broad), Vestibular disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Fainting; Fear of needles
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBMODERNATX, INC.MOD20212

Write-up: blood clots; Felt faint; This regulatory authority case was reported by an other health care professional and describes the occurrence of THROMBOSIS (blood clots) in an 18-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 3002615) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient''s past medical history included Fear of needles and Fainting. On 07-Jul-2021, the patient received first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 07-Jul-2021, the patient experienced DIZZINESS (Felt faint). On an unknown date, the patient experienced THROMBOSIS (blood clots) (seriousness criterion medically significant). On 07-Jul-2021, DIZZINESS (Felt faint) had resolved. At the time of the report, THROMBOSIS (blood clots) had resolved. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown Route) was unknown. For mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments. After having the vaccine the patient said they felt faint. Was made to lie on the floor with the legs elevated and then made a full recovery. No concomitant medication was reported. No treatment information was provided. No laboratory data was provided Company Comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Further information is not expected.; Sender''s Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Further information is not expected.


VAERS ID: 1488575 (history)  
Form: Version 2.0  
Age: 19.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-15
Onset:2021-07-15
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3002621 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Hypotension, Syncope, Thrombosis
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Thrombophlebitis (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Hypoglycaemia (broad), Dehydration (broad), Hypokalaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Comments: No medical history was reported.
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBMODERNATX, INC.MOD20212

Write-up: Blood clots; Faints; Fainting; This regulatory authority case was reported by an other health care professional and describes the occurrence of THROMBOSIS (Blood clots) and SYNCOPE (Fainting) in a 19-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 3002621) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No medical history was reported. On 15-Jul-2021, the patient received first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 15-Jul-2021, the patient experienced SYNCOPE (Fainting) (seriousness criterion medically significant). On an unknown date, the patient experienced THROMBOSIS (Blood clots) (seriousness criterion medically significant) and HYPOTENSION (Faints). On 15-Jul-2021, SYNCOPE (Fainting) had resolved. At the time of the report, THROMBOSIS (Blood clots) and HYPOTENSION (Faints) outcome was unknown. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. For mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. The patient normally faints after vaccination. Patient was fine when asked to lie down on the floor straight with legs elevated and observed for 15 minutes. Later she was asked to sit on the chair for further 5 minutes, she fainted and lost consciousness. Concomitant medication information was not provided. Treatment information was not provided. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. No further information is expected at this time.; Sender''s Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. No further information is expected at this time.


VAERS ID: 1489038 (history)  
Form: Version 2.0  
Age: 18.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-18
Onset:2021-06-19
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-07-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EY5420 / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Back pain, Blood creatinine increased, Body temperature, C-reactive protein increased, Haematuria, Haemorrhage, Hyperthermia, Hypoaesthesia, Inflammation, Paraesthesia, Pyrexia, Renal haemorrhage, Restlessness, Splenomegaly, Thrombosis, Ultrasound scan, Urine analysis
SMQs:, Rhabdomyolysis/myopathy (broad), Acute renal failure (broad), Peripheral neuropathy (broad), Haemorrhage terms (excl laboratory terms) (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Retroperitoneal fibrosis (broad), Dementia (broad), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Akathisia (broad), Thrombophlebitis (broad), Guillain-Barre syndrome (broad), Noninfectious encephalopathy/delirium (broad), Accidents and injuries (broad), Chronic kidney disease (broad), Tumour lysis syndrome (broad), Tubulointerstitial diseases (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (narrow), Hypoglycaemia (broad), Sexual dysfunction (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: SAIREITO. ORIENT. TUBER;ATRACTYLODES LANCEA RHIZOME;BUPLEURUM FALCATUM
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Chronic nephritis; Hematuria; Nephritis (controlled by taking oral medicine); Splenomegaly
Allergies:
Diagnostic Lab Data: Test Date: 20210618; Test Name: sCr; Result Unstructured Data: Test Result:0.80; Comments: increased; Test Date: 20210618; Test Name: Body temperature; Result Unstructured Data: Test Result:36.5 Centigrade; Comments: Before vaccination; Test Date: 20210618; Test Name: CRP; Result Unstructured Data: Test Result:0.27; Comments: increased a bit; Test Date: 20210618; Test Name: Abdominal echo; Result Unstructured Data: Test Result:brightness of the whole kidney increased; Comments: Found brightness of the whole kidney increased through ultrasound scan. And it was considered as Haemorrhage, Thrombus and Inflammation.; Test Name: Urine analysis; Result Unstructured Data: Test Result:Protein -, Occult blood 1+; Test Date: 20210618; Test Name: Urine analysis; Result Unstructured Data: Test Result:Protein 1+, Occult blood 3+
CDC Split Type: JPPFIZER INC2021846732

Write-up: difficulty in sitting; Numbness of left hand and feet; Suspected Haemorrhage; Suspected Thrombus; Suspected Inflammation; Paraesthesia; Hyperthermia; Frank haematuria; Back pain (same position of the right kidney)/Right back pain; Renal haemorrhage; Splenomegaly; Pyrexia; This is a spontaneous report from a contactable physician received from the Regulatory authority report number is v21118261. The patient was an 18-year and 3-month-old female. Body temperature before vaccination was 36.5 degrees Centigrade on 18Jun2021. The patient had no family history. The patient had history of mild splenomegaly; haematuria syndrome; chronic nephritis, patient had been seeing doctor for nephritis since she was 15-year-old (mild nephritis before, but it had been controlled by taking oral medicine). The patient was commuting hospital for the diseases above and concomitant medication included patient was taking alisma plantago-aquatica var. orient. tuber, atractylodes lancea rhizome, bupleurum falcatum root, cinnamomum cassia bark, glycyrrhiza spp. root, panax ginseng root, pinellia ternata tuber, polyporus umbellatus sclerotium, poria cocos sclerotium, scutellaria baicalensis root, zingiber officinale rhizome, ziziphus jujuba var. inermis fruit (SAIREITO) by oral from 23Jul2019 and ongoing for haematuria syndrome and chronic nephritis. The patient had no adverse event to other vaccines. On 28May2021, the patient previously received the first dose of bnt162b2 (COMIRNATY, Lot number EY0779, Expiration date 31Aug2021) for COVID-19 immunisation. On 18Jun2021 (as reported) (the day of vaccination), the patient received the second dose of bnt162b2 (COMIRNATY, Solution for injection, Lot number EY5420, Expiration date 31Aug2021) via an unspecified route of administration as a single dose for COVID-19 immunisation. On 19Jun2021 at 06:00 (1 day 6 hrs after the vaccination), the patient experienced pyrexia, frank haematuria, back pain (same position of the right kidney), renal haemorrhage, splenomegaly; hyperthermia for two days; paraesthesia. On 25Jun2021 (7 days after the vaccination), the outcome of the events was not recovered. The course of the event was as follows: The patient experienced Pyrexia and Frank haematuria after the vaccination, and Right back pain appeared. Found CRP increased a bit to 0.27 and sCr increased to 0.80 through blood test. Found brightness of the whole kidney increased through Abdominal echo. And Haemorrhage, Thrombus and Inflammation was suspected. Mild Splenomegaly from before was also increasing. After that, low back pain became worse, difficulty in sitting. On 23Jun2021 (5 days after the vaccination), the patient complained numbness of left hand and feet, then went to hospital. The patient''s normal Urine analysis data was Protein -, Occult blood 1+, but this time became worse to Protein 1+, Occult blood 3+ on 18Jun2021. Events resulted in physician office visit. Outcome of events was not recovered. The reporting physician classified the event as serious (Events were likely to cause disability) and assessed that the event was related to bnt162b2. There was no other possible cause of the event such as any other diseases. Reporter comment: The patient was an 18-year-old girl. The patient had been seeing doctor for nephritis since she was 15. Since the night after received the second dose of the vaccination on 16Jun2021 (as reported), the patient experienced Hyperthermia for two days, and Frank haematuria appeared, felt pain on right back (exactly where the kidneys are). The patient came to the outpatient which she visited regularly for the reason above. The patient''s normal Urine analysis data was Protein -, Occult blood 1+, but this time became worse to Protein 1+, Occult blood 3+. Found CRP increased a bit to 0.27 and sCr increased to 0.80 through blood test. Found brightness of the whole kidney increased through ultrasound scan. And it was considered as Inflammation like Haemorrhage or Thrombus. And mild splenomegaly from before was also increasing. After that, low back pain became worse, difficulty in sitting, and on 23Jun2021, the patient complained numbness of left hand and feet, then went to hospital. The patient had mild nephritis before, but it had been controlled by taking oral medicine. There were no other causes except COVID-19 vaccine, it was reported for causal relationship existed.; Reporter''s Comments: Summary of Reporter Comment: patient experienced hyperthermia, Frank haematuria appeared, felt pain on right back. Mild splenomegaly from before was also increasing. Low back pain became worse, difficulty in sitting, and patient complained numbness of left hand and feet.


VAERS ID: 1510434 (history)  
Form: Version 2.0  
Age: 18.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-26
Onset:2021-06-26
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Chest pain, Computerised tomogram thorax, Dizziness, Dyspnoea exertional, Electrocardiogram, Haemorrhage, Palpitations, Pericarditis, SARS-CoV-2 test, Syncope, Tachycardia, Thrombosis, X-ray
SMQs:, Torsade de pointes/QT prolongation (broad), Haemorrhage terms (excl laboratory terms) (narrow), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Thrombophlebitis (broad), Pulmonary hypertension (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad), Vestibular disorders (broad), Hypotonic-hyporesponsive episode (broad), Chronic kidney disease (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Dehydration (broad), Immune-mediated/autoimmune disorders (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: LUCETTE; Ibuprofen
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Contraception; Pregnancy; Suspected COVID-19 (Unsure when symptoms stopped)
Allergies:
Diagnostic Lab Data: Test Date: 20210627; Test Name: CTPA; Result Unstructured Data: Test Result:showed no PE; Test Date: 20210627; Test Name: ECG; Result Unstructured Data: Test Result:showed no PE; Test Date: 20210104; Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:Yes - Positive COVID-19 test; Test Date: 20210627; Test Name: X-ray; Result Unstructured Data: Test Result:Unknown results
CDC Split Type: GBPFIZER INC2021894064

Write-up: bleeding; passed large blood clots; SOB on exertion; palpitations; dizzy; faint; tachycardia; chest pain; Pericarditis; This is a spontaneous report from a contactable consumer received from the Regulatory Agency (RA). The regulatory authority report number is GB-MHRA-WEBCOVID-202107131429017500-0Q4OY. Safety Report Unique Identifier GB-MHRA-ADR 25641432. A 18-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 26Jun2021 10:40 (at the age of 18 years) (Batch/Lot number was not reported) as DOSE 1, SINGLE for covid-19 immunization; and ibuprofen (manufacturer unknown), route of administration, start and stop date, batch/lot number and dose were not reported for an unspecified indication. Medical history included pregnancy, suspected COVID-19 on 04Jan2021 (Unsure when symptoms stopped), and contraception. Patient has not tested positive for COVID-19 since having the vaccine. Patient is not enrolled in clinical trial. Concomitant medication included drospirenone, ethinylestradiol (LUCETTE) taken for contraception from 23May2021 to an unspecified stop date. It was reported that the patient had the vaccine at 10:40 and developed left sided chest pain at 21:30 sharp pain lasting a few seconds intermittent approximately 1 minute apart. Woke from sleep the following day (27Jun2021) at 06.30 and pain was constant in left side of chest worse lying flat and better on sitting forward, worse on inspiration. Had some palpitations off and on. Went to ED, felt dizzy and faint and fainted in X-ray. ECG showed tachycardia and CTPA done and showed no PE. Pain easier with ibuprofen. Noticed SOB on exertion the next day (28Jun2021) walking to friends house. Stopped taking OCP on same day as vaccine (started OCP approximately 8 weeks prior) and started bleeding 30Jun2021 and passed large blood clots (took pictures) not sure if related to the vaccine. It was reported that the patient experienced pericarditis on 26Jun2021. The events were assessed as serious (medically significant). Lab data includes: COVID-19 virus test: Yes - Positive COVID-19 test on 04Jan2021. The outcome of the event pericarditis was recovering, shortness of breath on exertion was unknown, while not recovered for the rest of the events. No follow-up attempts are possible, information about the batch number cannot be obtained.


VAERS ID: 1537687 (history)  
Form: Version 2.0  
Age: 15.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-25
Onset:2021-07-16
   Days after vaccination:21
Submitted: 0000-00-00
Entered: 2021-08-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Feeling cold, Pain in extremity, Peripheral artery thrombosis, Peripheral ischaemia
SMQs:, Embolic and thrombotic events, arterial (narrow), Tendinopathies and ligament disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: ATPFIZER INC202100985067

Write-up: partial thrombosis of the a. radialis left side was diagnosed on 16Jul2021 with ischemia of the fingers I,II and V; partial thrombosis of the a. radialis left side was diagnosed on 16Jul2021 with ischemia of the fingers I,II and V; pain and feeling of cold in the left thumb 7 days after the vaccination; pain and feeling of cold in the left thumb 7 days after the vaccination; This is a spontaneous report from a contactable physician received from medical information team. A 15-years-old female patient received first dose of bnt162b2 (COMIRNATY, Solution for injection, Batch/Lot Number: unknown), via an unspecified route of administration on 25Jun2021 (age at vaccination 15-years-old) as dose 1, single for covid-19 immunization. The patient medical history and concomitant medications were not reported. In 2021, 7 days after receiving first dose, the patient developed pain and a feeling of coldness in her left thumb, after a further 5 days a heat difference right/left could also be objectively determined. A partial thrombosis of the left radial artery with ischemia of fingers I, II and V was diagnosed at the Hospital on 16Jul2021. The clinic has improved under therapy with prostaglandin and Arixta. The investigation of thrombosis (coagulation disorder, vasculitis) was negative. A vaccination side effect was suspected. The patient was discharged on 24Jul2021 and receives thrombosis prophylaxis with Inhixa 60mg s.c. daily for another 14 days. It was reported that the patient mother is a high-risk patient with regards to COVID, the daughter should definitely be fully immunized. The reporter asked how likely thrombosis was to be seen as a side effect of the vaccination and how should one proceed with the second vaccination. The originally planned date was 06Aug21, wanted to know about postponing the date by how much, should stay with Comirnaty or should you change the preparation. Therapeutic measures were taken as a result of events. The outcome for the events was reported as resolving at the time of this report. Follow up information has been requested.; Sender''s Comments: Based on limited available information, a possible contributory role of BNT162B2 vaccine cannot be excluded for the reported event of "Peripheral arterial thrombosis" "Peripheral ischemia" due to temporal relationship and current known drug safety profile. 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


VAERS ID: 1537896 (history)  
Form: Version 2.0  
Age: 19.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-08
Onset:2021-07-17
   Days after vaccination:9
Submitted: 0000-00-00
Entered: 2021-08-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Angiogram, Cerebral venous sinus thrombosis, Fibrin D dimer, Magnetic resonance imaging head
SMQs:, Embolic and thrombotic events, venous (narrow), Central nervous system vascular disorders, not specified as haemorrhagic or ischaemic (narrow)

Life Threatening? Yes
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: venous MR angiography; Result Unstructured Data: Test Result:Sinus vein thrombosis; Comments: supported by; Test Name: D-dimers; Result Unstructured Data: Test Result:increased; Comments: in the laboratory; Test Name: MRI head; Result Unstructured Data: Test Result:Sinus vein thrombosis; Comments: supported by
CDC Split Type: DEPFIZER INC202100987755

Write-up: Thrombosis of venous sinuses; This is a spontaneous report from a non contactable consumer or other non health professional downloaded from the regulatory authority-WEB DE-PEI-202100148316. A 19-years-old female patient received BNT162b2 (COMIRNATY, solution for injection, Lot Number: Unknown), via an intramuscular route on 08Jul2021 (at the age of 19-years) as dose number unknown, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On 17Jul2021, the patient experienced thrombosis of venous sinuses. The patient underwent lab tests and procedures which included MRI head, venous MR angiography shows sinus vein thrombosis supported by, increased D-dimers in the laboratory. The outcome of event was not recovered. Sender Comment: Sinus vein thrombosis supported by MRI head, venous MR angiography, increased D-dimers in the laboratory. A cerebral mass, bleeding and cerebral infarction were excluded. Batch/lot number: [UNK] (UNKNOWN) Relatedness of drug to reaction(s)/event(s) Cerebral venous sinus thrombosis assessed by Agency as B. Indeterminate. No follow-up attempts possible. No further information expected. Batch/Lot numbers can not be obtained.


VAERS ID: 1571329 (history)  
Form: Version 2.0  
Age: 18.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-31
Onset:2021-07-31
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3003651 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Abdominal distension, Blood pressure measurement, Heart rate, Presyncope, Thrombosis
SMQs:, Acute pancreatitis (broad), Anticholinergic syndrome (broad), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Thrombophlebitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hypotonic-hyporesponsive episode (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Fear of needles (The patient had a needle phobia and had fainted in the past when receiving an injection.)
Preexisting Conditions: Medical History/Concurrent Conditions: Fainting
Allergies:
Diagnostic Lab Data: Test Date: 20210731; Test Name: Blood pressure; Result Unstructured Data: 83/52; Test Date: 20210731; Test Name: Blood pressure; Result Unstructured Data: 117/88; Test Date: 20210731; Test Name: Pulse; Result Unstructured Data: 43; Test Date: 20210731; Test Name: Pulse; Result Unstructured Data: 50
CDC Split Type: GBMODERNATX, INC.MOD20212

Write-up: blood clots; gradually sat up over 10mins; Near syncope; This regulatory authority case was reported by an other health care professional and describes the occurrence of THROMBOSIS (blood clots) in an 18-year-old male patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 3003651) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient''s past medical history included Fainting. Concurrent medical conditions included Fear of needles (The patient had a needle phobia and had fainted in the past when receiving an injection.). On 31-Jul-2021, the patient received first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 31-Jul-2021, the patient experienced PRESYNCOPE (Near syncope). On an unknown date, the patient experienced THROMBOSIS (blood clots) (seriousness criterion medically significant) and ABDOMINAL DISTENSION (gradually sat up over 10mins). On 31-Jul-2021, PRESYNCOPE (Near syncope) had resolved. At the time of the report, THROMBOSIS (blood clots) and ABDOMINAL DISTENSION (gradually sat up over 10mins) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 31-Jul-2021, Blood pressure measurement: 83/52 (Low) 83/52 and 117/88 (normal) 117/88. On 31-Jul-2021, Heart rate: 43 (Low) 43 and 50 (Low) 50. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. For mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No concomitant medications were reported. It was reported that patient felt unwell immediately post vaccine, assisted to a couch to lay down. As a treatment patient was given a drink and reassurance and patient gradually sat up over 10mins. Based on the current available information and temporal association between the use of the product and the start date of the event ''Presyncope'', a causal relationship cannot be excluded. Very limited information regarding the event ''Thrombosis'' has been provided at this time. No further information is expected at this time. Of note, the patient''s history of needle phobia and fainting in the past when receiving an injection are confounding factors that may play possible contributory roles.; Sender''s Comments: Based on the current available information and temporal association between the use of the product and the start date of the event ''Presyncope'', a causal relationship cannot be excluded. Very limited information regarding the event ''Thrombosis'' has been provided at this time. No further information is expected at this time. Of note, the patient''s history of needle phobia and fainting in the past when receiving an injection are confounding factors that may play possible contributory roles.


VAERS ID: 1575985 (history)  
Form: Version 2.0  
Age: 19.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-08-01
Onset:2021-08-01
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3003651 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Headache, Thrombosis
SMQs:, Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Thrombophlebitis (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBMODERNATX, INC.MOD20212

Write-up: Blood clots; Headache; This regulatory authority case was reported by an other health care professional and describes the occurrence of THROMBOSIS (Blood clots) in a 19-year-old male patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 3003651) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 01-Aug-2021, the patient received first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 01-Aug-2021, the patient experienced HEADACHE (Headache). On an unknown date, the patient experienced THROMBOSIS (Blood clots) (seriousness criterion medically significant). On 01-Aug-2021, HEADACHE (Headache) had resolved. At the time of the report, THROMBOSIS (Blood clots) had resolved. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. For mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No concomitant medications were given by the reporter. No Treatment information were provided by the reporter. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Very limited information regarding these events has been provided at this time. No further information is expected at this time; Sender''s Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Very limited information regarding these events has been provided at this time. No further information is expected at this time


VAERS ID: 1577760 (history)  
Form: Version 2.0  
Age: 19.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-03
Onset:2021-06-18
   Days after vaccination:15
Submitted: 0000-00-00
Entered: 2021-08-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Venous thrombosis
SMQs:, Embolic and thrombotic events, venous (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: CHMODERNATX, INC.MOD20212

Write-up: This regulatory authority case was reported by a physician and describes the occurrence of VENOUS THROMBOSIS in a 19-year-old male patient who received mRNA-1273 (COVID-19 Vaccine Moderna) for COVID-19 vaccination. No Medical History information was reported. On 03-Jun-2021, the patient received first dose of mRNA-1273 (COVID-19 Vaccine Moderna) (Intramuscular) 1 dosage form. On 18-Jun-2021, after starting mRNA-1273 (COVID-19 Vaccine Moderna), the patient experienced VENOUS THROMBOSIS (seriousness criterion medically significant). At the time of the report, VENOUS THROMBOSIS had not resolved. For mRNA-1273 (COVID-19 Vaccine Moderna) (Intramuscular), the reporter considered VENOUS THROMBOSIS to be possibly related. Concomitant medications was not reported . Treatment history was not reported. Company comment: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. Sender''s Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded


VAERS ID: 1583402 (history)  
Form: Version 2.0  
Age: 16.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-12
Onset:2021-07-01
   Days after vaccination:50
Submitted: 0000-00-00
Entered: 2021-08-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EX8680 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Cardiac ventricular thrombosis, Myocarditis
SMQs:, Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Cardiomyopathy (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Immune-mediated/autoimmune disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEPFIZER INC202100990148

Write-up: acute myocarditis; Thrombus in left ventricle; This is a spontaneous report from a contactable consumer and physician downloaded from a regulatory authority, regulatory authority number DE-PEI-202100147551. A 16-year-old male patient received bnt162b2 (COMIRNATY), dose 1 via an unspecified route of administration on 12May2021 (Batch/Lot Number: EX8680) as dose 1, single for covid-19 immunisation. The patient''s medical history and concomitant medications were not reported. On 01Jul2021, the patient was diagnosed with acute myocarditis which required hospitalization on unspecified date. The patient also experienced thrombus in left ventricle on unspecified date. The patient received second dose on 23Jul2021 (lot FD7958). The outcome of event acute myocarditis was not recovered while unknown for thrombus in left ventricle. The PEI assessed the causality of the events to the vaccine as unclassifiable.


VAERS ID: 1585089 (history)  
Form: Version 2.0  
Age: 18.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-10
Onset:2021-07-02
   Days after vaccination:22
Submitted: 0000-00-00
Entered: 2021-08-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / 1 - / OT
UNK: VACCINE NOT SPECIFIED (NO BRAND NAME) / UNKNOWN MANUFACTURER UNKNOWN / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Biopsy, Fibrin D dimer, Postoperative thrombosis, Ultrasound Doppler
SMQs:, Embolic and thrombotic events, venous (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: PARACETAMOL
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Malformation venous; Osteochondritis; Thrombosis (Several episodes)
Allergies:
Diagnostic Lab Data: Test Date: 20210729; Test Name: tissue biopsies for quantitative PCR; Result Unstructured Data: Test Result:unknown results; Comments: in search of the genetic determinism of the patient''s venous malformation; Test Date: 20210518; Test Name: D dimer; Result Unstructured Data: Test Result:551 ug/L; Test Date: 2019; Test Name: Doppler ultrasound; Result Unstructured Data: Test Result:venous dilations in lakes starting at the elbow, m; Comments: venous dilations in lakes starting at the elbow, more marked at the ulnar border with numerous venous ectasias of the hand and all of the fingers.
CDC Split Type: FRPFIZER INC202101002597

Write-up: Postoperative thrombosis; This is a spontaneous report from a contactable physician downloaded from a regulatory authority, regulatory authority number FR-AFSSAPS-NY20213284. A 18-years-old female patient received BNT162B2 (COMIRNATY, Solution for injection, Lot number- unknown), intramuscularly on 10Jun2021 as DOSE 1, SINGLE for covid-19 immunization. Patient was also taking enoxaparin sodium (LOVENOX [ENOXAPARIN SODIUM]), subcutaneous from 29Jun2021 (Batch/Lot Number: Unknown) to an unspecified date, at 4000 iU, 1x/day for thrombosis prophylaxis. Medical history included malformation venous from an unknown date, osteochondritis from an unknown date, thrombosis from an unknown date (Several episodes). Concomitant medication(s) included paracetamol (PARACETAMOL) taken for pain from 29Jul2021 to an unspecified stop date. On 02Jul2021, 23 days after beginning Comirnaty and 04days after beginning Lovenex, the patient was diagnosed with thrombosis at biopsy sites (medically significant). No thrombophilia work-up to date. The event was assessed as Non-serious. The patient had lab test on an unknown date in 2019 which included Ultrasound Doppler and results show venous dilations in lakes starting at the elbow, more marked at the ulnar border with numerous venous ectasias of the hand and all of the fingers. On 18May2021, the patient checked for D-dimers and results were 551 ?g / L. On 29Jul2021, the patient was hospitalized with a view to performing tissue biopsies for quantitative PCR, in search of the genetic determinism of the patient''s venous malformation. It was unknown if the patient received specific treatment for the event or not, but compression therapy was implemented and is effective against thrombosis, but patient compliance is poor. The second injection of COMIRNATY is scheduled for 21Jul2021. The outcome of the event was reported as thrombosis being resolved on 15Jul2021. Reporter Comment: Young 18-year-old woman who presented with thrombosis at biopsy sites 3 weeks after her first injection of Pfizer covid vaccine (COMIRNATY) and in the context of preventive anticoagulation by enoxaparin (LOVENOX). No thrombophilia assessment to date. N.B. Accountability without prejudice to the elements of investigation which could be carried out within the framework of legal or amicable compensation procedures. No follow-up attempts are possible. Information on batch/lot number cannot be obtained. No further information expected.; Reporter''s Comments: Young 18-year-old woman who presented with thrombosis at biopsy sites 3 weeks after her first injection of Pfizer covid vaccine (COMIRNATY) and in the context of preventive anticoagulation by enoxaparin (LOVENOX). No thrombophilia assessment to date.


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