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From the 7/23/2021 release of VAERS data:

Found 506,830 cases where Vaccine is COVID19 and Patient Did Not Die



Case Details (Reverse Sorted by Onset Date)

This is page 229 out of 5,069

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VAERS ID: 1453717 (history)  
Form: Version 2.0  
Age: 17.0  
Sex: Female  
Location: Florida  
Vaccinated:2021-06-05
Onset:2021-06-05
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0196 / 2 LA / -

Administered by: Other       Purchased by: ?
Symptoms: Blood test, Computerised tomogram, Electroencephalogram, Tremor, Urine analysis
SMQs:, Neuroleptic malignant syndrome (broad), Parkinson-like events (broad), Noninfectious encephalopathy/delirium (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? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: Blood and Urine Analysis; Result Unstructured Data: Test Result:unknown; Test Name: CT Scan; Result Unstructured Data: Test Result:unknown; Test Name: EEG; Result Unstructured Data: Test Result:unkown; Test Name: Urine Analysis; Result Unstructured Data: Test Result:unknown
CDC Split Type: USPFIZER INC2021690855

Write-up: Violent involuntary twitching / shaking of left arm, then right arm, then Neck and Head; This is a Spontaneous case report a contactable consumer(patient). A 17-years-old non pregnant female patient received second dose of BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EW0196), via an unspecified route of administration on 05Jun2021 at 18:30 into left arm as a single dose for COVID-19 immunization (at the age of 17 years). The patient medical history and concomitant medications were not reported. The historical vaccine includes the patient received first dose of BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EW0172), via an unspecified route of administration on 04May2021 at 19:00 pm into left arm as a single dose for COVID-19 immunization. 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 been tested for COVID-19.On 05Jun2021 at 20:30, patient had Violent involuntary twitching / shaking of left arm, then right arm, then Neck and Head. The patient underwent lab tests and procedures which included blood test, computerised tomogram, electroencephalogram, urine analysis was unknown on an unspecified date. The patient was visited to Emergency room/department or urgent care for the events. The patient had received Benadryl as a treatment for the adverse event. The outcome of the events was recovering.


VAERS ID: 1454223 (history)  
Form: Version 2.0  
Age: 31.0  
Sex: Female  
Location: Colorado  
Vaccinated:2021-06-05
Onset:2021-06-05
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0LS0 / 1 LA / SYR

Administered by: Pharmacy       Purchased by: ?
Symptoms: Amnesia, Blepharospasm, Chest pain, Computerised tomogram normal, Confusional state, Disturbance in attention, Drooling, Eye disorder, Eyelid ptosis, Fatigue, Headache, Injection site pain, Magnetic resonance imaging normal, Mobility decreased, Muscle spasms, Muscle twitching, Nausea, Pain, Pain in extremity, Vomiting
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Dyskinesia (broad), Dystonia (broad), Parkinson-like events (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Extravasation events (injections, infusions and implants) (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Corneal disorders (broad), Retinal disorders (broad), Depression (excl suicide and self injury) (broad), Periorbital and eyelid disorders (narrow), Ocular motility disorders (narrow), 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: generic Zyrtec
Current Illness:
Preexisting Conditions: asthma, fibromyalgia, arthritis spinal degeneration
Allergies: amoxicillin, latex, Bactrim, iodine contrast
Diagnostic Lab Data: MRI, CT both came back normal
CDC Split Type: vsafe

Write-up: Within 5 minutes I had uncontrollable spasms, I can''t control my eyes, extreme fatigue, loss of memory and time. Sharp shooting pains from injection site to all the tips of my fingers across my chest up to my skull. I have a lot generalized pain on my left side. now that a month has gone by it my left side gets worse, a drool, my left eye droops and shakes. My whole face and arm will be paralyzed. I get facial ticks. I have overwhelming fatigue and confusion. I have chest pain. I can''t read at all, and I can''t process what I hear at times. I have nausea and vomiting.


VAERS ID: 1454326 (history)  
Form: Version 2.0  
Age: 50.0  
Sex: Male  
Location: Florida  
Vaccinated:2021-06-04
Onset:2021-06-05
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-07-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 207A21A / 1 LA / SYR

Administered by: Pharmacy       Purchased by: ?
Symptoms: Arthralgia, Feeling of body temperature change, Influenza like illness, Pain, Pain in extremity, Peripheral swelling, Skin discolouration, Thrombosis, Ultrasound scan abnormal
SMQs:, Cardiac failure (broad), Angioedema (broad), Embolic and thrombotic events, vessel type unspecified and mixed arterial and 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), Hypotonic-hyporesponsive episode (broad), Arthritis (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? No
Hospitalized? No
Previous Vaccinations:
Other Medications: NONE
Current Illness: NONE
Preexisting Conditions: NONE
Allergies: NONE
Diagnostic Lab Data: ON JUNE 14TH, 2021 I HAD AN ULTRASOUND DONE ON MY LEFT LEG. THEY LOCATED MULTIPLIE BLOOD CLOTS.
CDC Split Type:

Write-up: I WOKE UP SATURDAY MORNING WITH FLU LIKE SYMPTOMS (FREEZING ONE MOMENT THEN BURNING UP THE NEXT). THAT WENT ON UNTIL MONDAY AFTERNOON. SATURDAY MORNING I ALSO NOTICED MY LEFT LEG WAS SWOLLEN AND HAD A BLUEISH/REDDISH COLOR AND WAS THROBBING. FROM TIME TO TIME i WOULD EXPERIENCE A SHARP PAIN BEHIND MY KNEE AND THIGH. AFTER A WEEK THE SYMPTOMS DID NOT GO AWAY SO I WENT TO THE DOCTOR. HE ORDERED AN ULTRASOUND ON MY LEG. THAT SAME DAY I HAD THE ULTRASOUND WHERE THEY FOUND MULTIPLE BLOOD CLOTS IN MY LEFT LEG. DOCTOR IMMEDIATELY PUT ME ON ELIQUIS. THE DOSE FOR THE FIRST 2 WEEKS WAS 10MG TWICE A DAY (10 MG MORNING AROUND 8AM AND 10 MG AROUND 8 PM). AFTER 14 DAYS HE REDUCED MY DOSE TO 5 MG AM AND 5 MG PM.


VAERS ID: 1454374 (history)  
Form: Version 2.0  
Age: 32.0  
Sex: Female  
Location: Georgia  
Vaccinated:2021-06-05
Onset:2021-06-05
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0179 / 1 LA / SYR

Administered by: Pharmacy       Purchased by: ?
Symptoms: Oedema peripheral
SMQs:, Cardiac failure (broad), Angioedema (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? No
Hospitalized? No
Previous Vaccinations:
Other Medications: none
Current Illness: herpes simplex
Preexisting Conditions: depression
Allergies: none
Diagnostic Lab Data: NONE
CDC Split Type:

Write-up: Found a swelling under the left arm pit, no lumps in the breast. denies redness, streaks or warmth to the touch. had vaccine in that arm on 6/5/2021


VAERS ID: 1454837 (history)  
Form: Version 2.0  
Age: 13.0  
Sex: Male  
Location: California  
Vaccinated:2021-06-03
Onset:2021-06-05
   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 - / 2 UN / IM

Administered by: Private       Purchased by: ?
Symptoms: Chest pain, Echocardiogram normal, Electrocardiogram normal
SMQs:, Gastrointestinal nonspecific symptoms and therapeutic procedures (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? No
Hospitalized? No
Previous Vaccinations:
Other Medications: cholecalciferol 50mcg CAPS Oral capsule mupirocin 2% topical ointment
Current Illness: None
Preexisting Conditions: None
Allergies: none known
Diagnostic Lab Data:
CDC Split Type:

Write-up: Chest pain which stared a few days after receiving 2nd dose vaccine and has persisted with activity. EKG was normal without any ST segment changes. Echocardiogram is normal. Will consider exercise stress test in 3 months


VAERS ID: 1454847 (history)  
Form: Version 2.0  
Age: 48.0  
Sex: Female  
Location: Ohio  
Vaccinated:2021-06-05
Onset:2021-06-05
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 LA / SYR

Administered by: Pharmacy       Purchased by: ?
Symptoms: Dizziness, Fatigue, Influenza like illness, Migraine, Pain in extremity, Peripheral swelling, Rash, Urticaria
SMQs:, Cardiac failure (broad), Anaphylactic reaction (broad), Angioedema (narrow), Anticholinergic syndrome (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Vestibular disorders (broad), Hypersensitivity (narrow), 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? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations: Flu
Other Medications: No
Current Illness: No
Preexisting Conditions: Asthma, reflux, migraines, anxiety, depression, allergies
Allergies: Flu vaccaine, cortizon, tylenol, cipro
Diagnostic Lab Data: No
CDC Split Type: vsafe

Write-up: Right after the shot. I got light headed and dizzy. My arm was sore. I was fatigue. My arm had swell and I had broken out in hives and rash. I had migraine. Flu symptoms


VAERS ID: 1455094 (history)  
Form: Version 2.0  
Age: 34.0  
Sex: Female  
Location: California  
Vaccinated:2021-06-05
Onset:2021-06-05
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 LA / SYR

Administered by: Public       Purchased by: ?
Symptoms: Erythema, Headache, Illness, Nausea, Oropharyngeal pain, Pain in extremity, Pyrexia, Taste disorder
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Taste and smell disorders (narrow), Anticholinergic syndrome (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hypersensitivity (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? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Got taste in mouth after I left the place and went Home I got flash of red in neck and face . Headache. Nauseated. Arm hurt a lot next day. Headache wouldn?t go away. Day offer shot I got sick. Fever, sore throat.


VAERS ID: 1457434 (history)  
Form: Version 2.0  
Age: 63.0  
Sex: Female  
Location: Massachusetts  
Vaccinated:2021-05-22
Onset:2021-06-05
   Days after vaccination:14
Submitted: 0000-00-00
Entered: 2021-07-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0122 / 2 LA / SYR

Administered by: Pharmacy       Purchased by: ?
Symptoms: Migraine, Musculoskeletal stiffness
SMQs:, Dystonia (broad), Parkinson-like events (broad), Noninfectious encephalitis (broad), Noninfectious meningitis (broad), Arthritis (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: Tylenol
Current Illness:
Preexisting Conditions: Celiac Disease Heart Murmur Thyroid Problems Chronic Kidney Disease
Allergies: Mushrooms
Diagnostic Lab Data:
CDC Split Type: vsafe

Write-up: I started with a stiff neck and a migraine headache. I received Tylenol for the migraine. I went to the ER for the symptoms (Medical Center). They told me that they could not give me anything for the stiff neck. I was unable to move my neck for several days. I did try an Icey hot for the stiff neck. The stiff neck still bothers me today as well. I am worried about blood clots.


VAERS ID: 1457583 (history)  
Form: Version 2.0  
Age: 55.0  
Sex: Female  
Location: Nebraska  
Vaccinated:2021-06-03
Onset:2021-06-05
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-07-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH RE0168 / 1 LA / IM

Administered by: Public       Purchased by: ?
Symptoms: Axillary mass, Hypoaesthesia, Muscular weakness, Peripheral swelling
SMQs:, Rhabdomyolysis/myopathy (broad), Cardiac failure (broad), Angioedema (broad), Peripheral neuropathy (broad), Guillain-Barre syndrome (broad), Noninfectious encephalopathy/delirium (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? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: NA
Current Illness: NA
Preexisting Conditions: NA
Allergies: NKA
Diagnostic Lab Data: NA
CDC Split Type:

Write-up: Pt. describes swelling in arm with lumps around axilla and mid upper ark States fourth and fifth fingers on left had are numb and weak.


VAERS ID: 1458356 (history)  
Form: Version 2.0  
Age: 68.0  
Sex: Female  
Location: California  
Vaccinated:2021-06-04
Onset:2021-06-05
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-07-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0217 / 1 RA / IM
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0217 / 2 LA / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: Abdominal pain upper, Arthralgia, Chest pain, Chills, Dizziness, Fatigue, Headache, Hypersomnia, Lymphadenopathy, Myalgia, Pyrexia, Rash, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Rhabdomyolysis/myopathy (broad), Anaphylactic reaction (broad), Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Depression (excl suicide and self injury) (broad), Vestibular disorders (broad), Hypotonic-hyporesponsive episode (broad), Hypersensitivity (narrow), Arthritis (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (narrow), 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: Gotta lie down during most inoculations. Always. Induce slowly, and the lest acceptable; otherwise, I''ll probably faint, despite
Other Medications: Aspirin/acetaminophen on occasion.
Current Illness: Cushing''s. In recovery. 18 months since transsphenoidal surgery.
Preexisting Conditions: Cushing''s. In recovery. 18 months since transsphenoidal surgery.
Allergies: Codeine, Zolpidem, Citalopram, Diazepam, Epinephrine
Diagnostic Lab Data: Vitals recovered after 1.5 hours after 2nd vaccine. Heavy/prolonged sleep after both.
CDC Split Type:

Write-up: Fever, fatigue, headache, muscle pain, chills, joint pain, swollen lymph nodes, persistent stomach pain, chest pain, dizzy, faint, spreading rash from upper back, upper arms, neck & face. COVID arm on 1st vaccine for 16 days. 2nd vaccine: No COVID arm, but...all of the above + faint within 1st hour, then again on the following Friday... on the floor.


VAERS ID: 1459830 (history)  
Form: Version 2.0  
Age: 54.0  
Sex: Female  
Location: Utah  
Vaccinated:2021-01-22
Onset:2021-06-05
   Days after vaccination:134
Submitted: 0000-00-00
Entered: 2021-07-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EL0140 / 1 LA / SYR

Administered by: Work       Purchased by: ?
Symptoms: Gait inability, Inflammation, Laboratory test
SMQs:, Anticholinergic syndrome (broad), Dystonia (broad), Guillain-Barre 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? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Wellbutrin, Pantoprazole, Ambien, Singulair, Albuterol, Trazadone, Elmiron, Gabapentin, Estradiol, Citalopram
Current Illness: Depression, Asthma, Chronic Back Pain, Menopause, GERD, Ulcerative Colitis
Preexisting Conditions: Same as above
Allergies: Sulfa, Shellfish, Fish, Walnuts, Percocet
Diagnostic Lab Data: Extensive lab work
CDC Split Type:

Write-up: I had the first vaccine 12/29/20 Pfizer EL0140, second vaccine 1/22/2021 EL3246 The first signs appeared the first part of June, extensice inflammation, unable to walk.


VAERS ID: 1459925 (history)  
Form: Version 2.0  
Age: 43.0  
Sex: Female  
Location: Florida  
Vaccinated:2021-06-05
Onset:2021-06-05
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ELU0185 / 1 RA / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: Dyspnoea, Feeling hot, Rash, Upper-airway cough syndrome
SMQs:, Anaphylactic reaction (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Hypersensitivity (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: Zyrtec, Errin, multivitamin
Current Illness: no
Preexisting Conditions: thyroid nodule, allergies
Allergies: Mushroom allergy, weeds, oak, cat/dog, cockroaches
Diagnostic Lab Data:
CDC Split Type:

Write-up: About 2 hours after vaccination started with rash on the right side of cheek and neck. Then started with hot sensation all over the upper body and difficulty breathing. Worsening of post nasal drainage. She have herself an epi-pen injection. Continued to have difficulty breathing and went to the ER for evaluation.


VAERS ID: 1461477 (history)  
Form: Version 2.0  
Age: 42.0  
Sex: Female  
Location: California  
Vaccinated:2021-05-18
Onset:2021-06-05
   Days after vaccination:18
Submitted: 0000-00-00
Entered: 2021-07-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 008C21A / 2 LA / SYR

Administered by: Private       Purchased by: ?
Symptoms: Heavy menstrual bleeding, Menstrual disorder, Menstruation delayed
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Fertility 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: None
Current Illness: none
Preexisting Conditions: none
Allergies: Penicillian
Diagnostic Lab Data: N/A
CDC Split Type:

Write-up: After receiving the first dose, I missed my period for the first time in 27 years. I started 20 days late and then my period lasted 2 weeks extremely heavy and not normal. I then only went 1 week and have started another heavy period.


VAERS ID: 1461864 (history)  
Form: Version 2.0  
Age: 76.0  
Sex: Female  
Location: Pennsylvania  
Vaccinated:2021-01-25
Onset:2021-06-05
   Days after vaccination:131
Submitted: 0000-00-00
Entered: 2021-07-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EL9262 / 2 RA / IM

Administered by: Private       Purchased by: ?
Symptoms: Anticoagulant therapy, Blood test, Computerised tomogram, Pulmonary embolism, Surgery, X-ray
SMQs:, Embolic and thrombotic events, 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? Yes
Hospitalized? Yes, 5 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: JARDIANCE LEVIMIR OZEMPIC VITAMIN D MEGA RED
Current Illness:
Preexisting Conditions: DIABETES
Allergies:
Diagnostic Lab Data: 6-7-21 CT SCAN XRAY BLOOD TESTS
CDC Split Type:

Write-up: SADDLE PE IN BOTH LUNGS ELIQUIS-HEPARIN-TPA SURGERY TO BUST UP CLOTS


VAERS ID: 1461888 (history)  
Form: Version 2.0  
Age: 52.0  
Sex: Female  
Location: Massachusetts  
Vaccinated:2021-06-02
Onset:2021-06-05
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-07-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 00SC21A / 2 RA / IM

Administered by: Public       Purchased by: ?
Symptoms: Anaemia, Blood iron decreased, Blood test, Heavy menstrual bleeding
SMQs:, Haematopoietic erythropenia (broad), Haemorrhage terms (excl laboratory terms) (narrow)

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: synthroid
Current Illness: none
Preexisting Conditions: none
Allergies: no
Diagnostic Lab Data: My pcp tested my iron levels and they were very low. I have doubled my iron supplementation.
CDC Split Type:

Write-up: I had my period when getting the second shot. Instead of ending in two or three days after the time of the vaccination, my period continued for another two and a half weeks. The blood flow was unusually heavy, clotted, and dark. I became anemic as a result of this excessive blood loss and am still trying to rebuild my energy through iron supplements. (I will never take a Moderna shot again!!!)


VAERS ID: 1462093 (history)  
Form: Version 2.0  
Age: 11.0  
Sex: Female  
Location: Wisconsin  
Vaccinated:2021-06-05
Onset:2021-06-05
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0191 / 2 RA / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: No adverse event, Product administered to patient of inappropriate age
SMQs:, Medication errors (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:

Write-up: Patient''s guardian, provided inaccurate information regarding patients date of birth. The date of birth provided on the consent form, and subsequent identity verification steps, was 08/12/2008. The correct date of birth was actually 08/12/2009 making patient only 11 years old, and an ineligible candidate for the Pfizer covid-19 vaccine. Patient received her first dose 05/15/2021 and the second dose on 06/05/2021. No adverse effects were reported to my knowledge.


VAERS ID: 1462161 (history)  
Form: Version 2.0  
Age: 23.0  
Sex: Female  
Location: New York  
Vaccinated:2021-06-05
Onset:2021-06-05
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 048C21A / 2 LA / SYR

Administered by: Pharmacy       Purchased by: ?
Symptoms: Headache, Injection site swelling, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (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:

Write-up: The injection site was swollen and sore for four days. I had a bad headache and a slight fever for four days. I had frequent headaches for a month after my second shot.


VAERS ID: 1463267 (history)  
Form: Version 2.0  
Age: 15.0  
Sex: Male  
Location: West Virginia  
Vaccinated:2021-06-05
Onset:2021-06-05
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0202 / 1 LA / -

Administered by: Pharmacy       Purchased by: ?
Symptoms: Blindness, Feeling hot, Muscle rigidity, Mydriasis, Nervousness
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Parkinson-like events (narrow), Glaucoma (broad), Optic nerve disorders (broad), Retinal disorders (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:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: USPFIZER INC2021785703

Write-up: Pupils dilated and he couldn''t see.; Pupils dilated and he couldn''t see.; shaky; rigid; and was very hot to touch; This is a spontaneous report from a non-contactable consumer (patient). A 15-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection. Lot Number: EW0202), dose 1 via an unspecified route of administration, administered in Arm Left on 05Jun2021 (at the age of 15-years-old) as dose 1, single for COVID-19 immunization. No medical history was reported. Patient had no known allergy. Other medical history was none. No concomitant medication was reported. Patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. Patient did not receive any other medication within 2 weeks prior to the COVID vaccine. The patient had not been tested for COVID-19 nor before neither since the vaccination. Facility where the most recent COVID-19 vaccine was administered at Pharmacy or Drug Store. The patient experienced pupils dilated and could not see, shaky, rigid, and was very hot to touch on 05Jun2021. This was within a few minutes of receiving the vaccine and lasted about 20-30 minutes. Seriousness criteria was reported as no. As AE treatment, Pharmacist used cold compresses and gave him juice. The outcome of the events were recovered on 2021. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1463769 (history)  
Form: Version 2.0  
Age: 35.0  
Sex: Female  
Location: Texas  
Vaccinated:2021-04-08
Onset:2021-06-05
   Days after vaccination:58
Submitted: 0000-00-00
Entered: 2021-07-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 201A21A / 1 UN / UN

Administered by: Private       Purchased by: ?
Symptoms: Atrial septal defect, COVID-19, Cerebral artery occlusion, Cerebrovascular accident, Chills, Fatigue, Headache, SARS-CoV-2 test positive, Thrombectomy
SMQs:, Ischaemic central nervous system vascular conditions (narrow), Haemorrhagic central nervous system vascular conditions (narrow), Congenital, familial and genetic disorders (narrow), Embolic and thrombotic events, arterial (narrow), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (narrow)

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, 8 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: Xarelto
Current Illness: antiphospholipid syndrome
Preexisting Conditions: antiphospholipid syndrome
Allergies: None reported
Diagnostic Lab Data:
CDC Split Type:

Write-up: 6/5/2021 Positive PCR for COVID-19 and onset of chills, fatigue, headache (had a previous COVID-19 positive PCR 1/14/2021) 6/5/2021 Acute R MCA ischemic stroke 2/2 M1 occlusion s/p thrombectomy (HCC) PFO (patent foramen ovale) 6/12/2021 Discharged to inpatient rehabilitation


VAERS ID: 1464015 (history)  
Form: Version 2.0  
Age: 45.0  
Sex: Female  
Location: Illinois  
Vaccinated:2021-04-20
Onset:2021-06-05
   Days after vaccination:46
Submitted: 0000-00-00
Entered: 2021-07-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 041B21A / 2 LA / SYR

Administered by: Pharmacy       Purchased by: ?
Symptoms: Arthralgia, Swelling
SMQs:, Anaphylactic reaction (broad), Angioedema (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Arthritis (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: multi vitamins, biotin, b-12 & Goli apple cider vinager gummies
Current Illness: Sinus issues
Preexisting Conditions: Sinus issues
Allergies: None
Diagnostic Lab Data:
CDC Split Type:

Write-up: Continual left shoulder joint pain.... after shot normal pain and swelling after shot but still get continual shoulder pain.


VAERS ID: 1464029 (history)  
Form: Version 2.0  
Age: 60.0  
Sex: Male  
Location: California  
Vaccinated:2021-06-05
Onset:2021-06-05
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 021C21A / 2 RA / SYR

Administered by: Unknown       Purchased by: ?
Symptoms: Disturbance in attention, Dizziness, Dyspnoea, Dysstasia, Fatigue, Nausea, Pain, Sleep disorder, Somnolence
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Anticholinergic syndrome (broad), Dementia (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Depression (excl suicide and self injury) (broad), Vestibular 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? No
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness: None
Preexisting Conditions: None
Allergies: None
Diagnostic Lab Data: None
CDC Split Type:

Write-up: Within 20 minutes of receiving the vaccine, I was experiencing extreme shortness of breath, my entire body hurt and I was dizzy to the point that I could not stand up without holding onto something. Since the injection, I have felt nauseous everyday, I cannot concentrate, I become fatigued just standing up. It''s been almost six weeks since the injection & I still do not feel right. I fall asleep whenever I sit down and I''ve fallen asleep while driving.


VAERS ID: 1464084 (history)  
Form: Version 2.0  
Age: 70.0  
Sex: Male  
Location: Missouri  
Vaccinated:2021-03-27
Onset:2021-06-05
   Days after vaccination:70
Submitted: 0000-00-00
Entered: 2021-07-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 8B21A / 2 - / -

Administered by: Private       Purchased by: ?
Symptoms: Blood test, Retinal artery occlusion, Thrombosis, Ultrasound scan
SMQs:, Embolic and thrombotic events, arterial (narrow), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Thrombophlebitis (broad), Retinal disorders (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Carved lol tab 25mg Clonidine hydrochloride tab 0.2mg Chlorthalidone tab 25mg Lisinopril tab 40mg Allopurinol tab 300mg Clopidogrel tab 75mg Rosuvastatin 20 mg Fenofibrate 134mg
Current Illness: None
Preexisting Conditions: Pad
Allergies: None
Diagnostic Lab Data: Many sonagrams and blood flow tests
CDC Split Type:

Write-up: Micro sized blood clots causing strokes in rt eye


VAERS ID: 1464217 (history)  
Form: Version 2.0  
Age: 70.0  
Sex: Male  
Location: Pennsylvania  
Vaccinated:2021-06-03
Onset:2021-06-05
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-07-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 050C21A / 1 RA / SYR

Administered by: Pharmacy       Purchased by: ?
Symptoms: Deafness
SMQs:, Hearing impairment (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: Synthroid 137
Current Illness: None.
Preexisting Conditions: Macular degeneration and retinis pigmentosa. Thyroid condition.
Allergies: None.
Diagnostic Lab Data: None.
CDC Split Type:

Write-up: Hearing loss began several days after vaccine. Approximately 10 days after vaccine hearing loss became severe. Approximately 20 days after vaccine hearing began to restore. It is about 80 % restored now.


VAERS ID: 1464432 (history)  
Form: Version 2.0  
Age: 15.0  
Sex: Male  
Location: West Virginia  
Vaccinated:2021-06-05
Onset:2021-06-05
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0182 / 2 - / IM

Administered by: Private       Purchased by: ?
Symptoms: Brain natriuretic peptide normal, C-reactive protein increased, Cardiac telemetry, Chest X-ray, Chest pain, Chills, Dyspnoea, Echocardiogram normal, Electrocardiogram ST segment elevation, Electrocardiogram repolarisation abnormality, Fatigue, Magnetic resonance imaging heart, Myocardial oedema, Myocarditis, Nausea, Pericarditis, Troponin increased, Vomiting
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Acute pancreatitis (broad), Systemic lupus erythematosus (broad), Myocardial infarction (narrow), Arrhythmia related investigations, signs and symptoms (narrow), Conduction defects (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad), Chronic kidney disease (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? 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: None
Allergies: None
Diagnostic Lab Data: Troponin trend (6/7/2021-6/10/2021): 11, 654 -- $g 12,397 -- $g 13, 376 -- $g 20, 104 -- $g 13, 126 -- $g 7, 835 -- $g 12, 913 -- $g 10, 733 -- $g 8, 710 -- $g 5, 574 CRP (6/9-6/10/21): 23.5--13.8 BNP: 29 EKG 6/7/2021: Normal Sinus rhythm with diffuse ST-elevation CMRI 6/9/2021: Myocardial edema seen which involves the interventricular septum, mid and apical anterior left ventricular wall regions, most likely consistent with myocarditis. Epicardial enhancement on LGE imaging in mid and apical left ventricular free wall and apical interventricular septum consistent with myopericarditis (non-ischemic distribution) ECHO 6/8/2021: Normal LV. NO pericardial effusion.
CDC Split Type:

Write-up: Patient admitted fur to chest pain and dyspnea and found to have myopericarditis after 2nd dose of COVID-19 Pzifer vaccine. Vaccine was administered at pharmacy. First dose received on 5/15/2021, second dose on 6/5/2021. Fatigue and chills started a few hours after second dose and then developed shortness of breath, nausea, emesis and 8/10 midsternal chest pain. Presented to an urgent care facility where CXR and EKG were obtained. EKG showed early repolarizations. Labs were obtained at a local ED and showed elevated troponins, initially 11k and then to 20k and peaked there. BNP was within normal limits. Subsequent EKG showed diffuse ST-segment elevations concerning for acute pericarditis. No prior infections or symptoms like this previously. He was given colchicine at outside facility prior to transfer. At hospital he was continued on ibuprofen and monitored with telemetry and had ECHO and cardiac MRI. Latter was consistent with myopericarditis. ECHO showed normal function. He received PPI while on NSAIDs. His symptoms resolved and he was discharged to home on 6/10/2021 with activity restrictions and plan to follow-up with peds cardiology. Of note, there was an error submitting the initial VAERS report for this patient during the admission, therefore, this delayed report is being submitted.


VAERS ID: 1464480 (history)  
Form: Version 2.0  
Age: 35.0  
Sex: Female  
Location: Texas  
Vaccinated:2021-05-05
Onset:2021-06-05
   Days after vaccination:31
Submitted: 0000-00-00
Entered: 2021-07-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 207A21A / UNK - / SYR

Administered by: Unknown       Purchased by: ?
Symptoms: Amenorrhoea
SMQs:, Fertility 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: N/A
Current Illness: N/A
Preexisting Conditions: Heart murmur
Allergies: Penicillin
Diagnostic Lab Data: N/A
CDC Split Type:

Write-up: Periods have stopped.


VAERS ID: 1465772 (history)  
Form: Version 2.0  
Age: 49.0  
Sex: Female  
Location: Ohio  
Vaccinated:2021-05-18
Onset:2021-06-05
   Days after vaccination:18
Submitted: 0000-00-00
Entered: 2021-07-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0170 / 1 LA / SYR
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0176 / 2 RA / SYR

Administered by: Private       Purchased by: ?
Symptoms: Abdominal discomfort, Chills, Herpes zoster, Pain in extremity, Pyrexia, Rash
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Gastrointestinal perforation, ulcer, haemorrhage, obstruction non-specific findings/procedures (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hypersensitivity (narrow), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Opportunistic infections (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: Hydrolyzed Pam 25 MG as needed, Citalopram HBR 20 MG x1, Divalproex Sod ER 250 MG x2, Zolpidem Tartrate 10 MG x1, Dextroamp-Amphetamin 15 MG x2, Tylenol
Current Illness: None
Preexisting Conditions: Mental health
Allergies: None
Diagnostic Lab Data:
CDC Split Type:

Write-up: About 2 hours after vaccine I had a fever, chills, and upset stomach. Arm was in extreme pain. This lasted 3 days. About maybe 5 days later got a rash on my hip. Didn''t think much of it. The rash came and went in different parts of my body. Went to urgent care on 6/5/21. I was given a steroid cream went home and proceeded to use that on my rash I would use it it would go away and a day or two later it will come back in a different spot. So I ended up doing a phone visit with on 6/9/21. He gave me another steroid cream which did the same thing the first one did. Had a second appointment with same doctor and he prescribed Permethrin. I knew that was the wrong diagnosis but I use the cream anyways but no results of making me better. Nothing was taken away this rash so I went back to Urgent Care on 07/05/2021. I sat with the doctor and we went through everything we could possibly imagine. I have been a creature of habit my entire life I do not eat new foods I do not change anything in my lifestyle I am osidea so I''ve always repeated the same things for over 30 years nothing new introduced to me I got the flu shot yearly so I assumed this would be okay this is the only thing new that has been in my body so the doctor had concluded that I probably had shingles due to the covid vaccine I am taking the antibiotics and still have the extreme rash I''m almost done with antibiotics and if I still have it I''m going to the emergency room and that''s all I have for now


VAERS ID: 1465780 (history)  
Form: Version 2.0  
Age: 59.0  
Sex: Female  
Location: Wisconsin  
Vaccinated:2021-06-05
Onset:2021-06-05
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (UNKNOWN)) / UNKNOWN MANUFACTURER - / 1 LA / SYR

Administered by: Pharmacy       Purchased by: ?
Symptoms: Asthenia, Blister, Cellulitis, Feeling abnormal, Headache, Herpes zoster, Impaired work ability, Induration, Joint swelling, Laboratory test, Neuralgia, Pain, Pain in extremity, Peripheral swelling, Pyrexia, Rash, Skin warm, Skin weeping, Sleep disorder, Somnolence, Swelling
SMQs:, Cardiac failure (broad), Severe cutaneous adverse reactions (broad), Anaphylactic reaction (broad), Angioedema (broad), Peripheral neuropathy (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (narrow), Arthritis (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (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? Yes
Hospitalized? Yes, 2 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: levothyroxine, oxycodone, linsinopril,
Current Illness: none
Preexisting Conditions: neutropenia, arthritis, back and neck pain
Allergies: penicillan
Diagnostic Lab Data: lab work
CDC Split Type:

Write-up: 5 hours after getting vaccine my left ankle developed a rash. I felt achy and slight headache. The next day the rash had spread up and began to swell. I also had a low fever,99.9 degrees. On Monday my leg and foot were swollen and very pain and warm. I got in to see my Dr. He wasn''t sure what it''s cause was. He put me on antibiotics. That night when my boyfriend got home he couldn''t wake me up. I had a fever of 103, so he called an ambulance and I went to the hospital. They found no blood clots. I was admitted for IV antibiotics and pain meds. I was released Wednesday afternoon. I have severe swelling of my leg and foot. I got blisters and oozing spots on the back of my leg. I am still in a lot of pain and have shingles that I believe was brought on by covid shot. I couldn''t work. I have nerve pain that shoots up my leg. I have no energy to do anything. One Dr. said it could be from shot others said it was cellulitis.I still am having major problems with pain and nerve pain. I just don''t feel good. I can''t sleep at night because of pain. I was on antibiotics for 3 weeks. The swelling is down but my ankle where the rash was is still hard and very, very painful.


VAERS ID: 1466689 (history)  
Form: Version 2.0  
Age: 58.0  
Sex: Male  
Location: Maryland  
Vaccinated:2021-04-05
Onset:2021-06-05
   Days after vaccination:61
Submitted: 0000-00-00
Entered: 2021-07-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 048B21A / 2 - / -

Administered by: Unknown       Purchased by: ?
Symptoms: Axillary web syndrome, Blood test, Computerised tomogram, Hypoaesthesia, Pain in extremity, Ultrasound scan
SMQs:, Peripheral neuropathy (broad), Guillain-Barre syndrome (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: Aspirin 80 mg carvedilol 3.25 mg. Clopidogrel 75 mg. Ezetimbe 10 mg. Lisinopril 20 mg.
Current Illness: None
Preexisting Conditions: Heart Disease
Allergies: None
Diagnostic Lab Data: Left arm and shoulder ultrasound left shoulder ct scan blood work two trips to Er one trip to urgent car three visits to Doctors office
CDC Split Type:

Write-up: Axillary cording right and left arm pain left face numbness left and right chest and shoulder pay


VAERS ID: 1466700 (history)  
Form: Version 2.0  
Age: 52.0  
Sex: Female  
Location: Washington  
Vaccinated:2021-03-11
Onset:2021-06-05
   Days after vaccination:86
Submitted: 0000-00-00
Entered: 2021-07-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 1805031 / 1 LA / IM

Administered by: Private       Purchased by: ?
Symptoms: Blood test, Cough, Dry mouth, Dysphagia, Fatigue, Hypoaesthesia, Inflammation, Joint lock, Malaise, Muscular weakness, Nocturia, Pain, Paraesthesia, Thirst, Vitreous floaters, Vomiting
SMQs:, Rhabdomyolysis/myopathy (broad), Anaphylactic reaction (broad), Acute pancreatitis (broad), Peripheral neuropathy (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Anticholinergic syndrome (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Retinal disorders (narrow), 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: Wellbutrin, Amolodipine, Lexapro, Adderral
Current Illness: n/a
Preexisting Conditions: hypertension, sleep apnea, depression, anxiety, ADHD, history of osteodegenerative osteoarthritis, history of joint replacement (R hip, 1995).
Allergies: Diflucan, ACE-inhibitors
Diagnostic Lab Data: Two fasting blood tests at 79
CDC Split Type:

Write-up: Adverse Events Starting in June 2021, patient experienced continuing severe nerve numbness, tingling pain, and weakness in the Right arm, neck, back, and shoulders. Patient is so experiencing finger and joints locking, severe inflammation, muscular weakness. Patient is experiencing floaters in her eyes, frequent nighttime urination, general malaise, fatigue, vomiting, and pain. Insatiable thirst and dry mouth. Also, Patient is experiencing trouble swallowing while eating. Also, a lingering cough.


VAERS ID: 1466708 (history)  
Form: Version 2.0  
Age: 15.0  
Sex: Male  
Location: Colorado  
Vaccinated:2021-06-05
Onset:2021-06-05
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0187 / 2 LA / IM

Administered by: Unknown       Purchased by: ?
Symptoms: Vomiting
SMQs:, Acute pancreatitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (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:

Write-up: PT ADVISED THAT HE VOMITTED FROM HIS LAST COVID19 VACCINE. PT HAD THE SAME REACTION WITH THE 2ND DOSE FROM THE PFIZER COVID 19 VACCINE. PT VOMITED X 2.


VAERS ID: 1466751 (history)  
Form: Version 2.0  
Age: 14.0  
Sex: Female  
Location: North Carolina  
Vaccinated:2021-06-05
Onset:2021-06-05
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH 22277DK / 2 LA / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: Dizziness, Hyperhidrosis
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Vestibular disorders (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: none
Current Illness: none
Preexisting Conditions: none
Allergies: none
Diagnostic Lab Data: none
CDC Split Type:

Write-up: Pt. Dizzy and sweating called emts checked vitals and released.


VAERS ID: 1466908 (history)  
Form: Version 2.0  
Age: 71.0  
Sex: Female  
Location: Montana  
Vaccinated:2021-03-30
Onset:2021-06-05
   Days after vaccination:67
Submitted: 0000-00-00
Entered: 2021-07-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 003B21A / 2 LA / IM

Administered by: Public       Purchased by: ?
Symptoms: Anticoagulant therapy, Aortic occlusion, Computerised tomogram abdomen, Computerised tomogram abnormal, Iliac artery occlusion, Laboratory test, Nausea, Scan with contrast abnormal, Vomiting, Weight decreased
SMQs:, Acute pancreatitis (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Embolic and thrombotic events, arterial (narrow), Malignancy related therapeutic and diagnostic procedures (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow)

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, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: Takes no home medications
Current Illness: unknown
Preexisting Conditions: none
Allergies: No known allergies
Diagnostic Lab Data: CT of abdomen/Pelvis with contrast. Lab studies including chemistries, hematologies, coagulation studies
CDC Split Type:

Write-up: Patient presented to Clinic with nausea and vomiting that had been going on since June 5. 30lb wt loss. Work up in the clinic included a CT scan that showed infrarenal abd aortic occlusion and common and iliac artery occlusion with reconstitution at the level of the external iliac arteries. Patient was started on heparin and shipped to a higher level of care.


VAERS ID: 1467757 (history)  
Form: Version 2.0  
Age: 29.0  
Sex: Male  
Location: Michigan  
Vaccinated:2021-06-03
Onset:2021-06-05
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-07-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 050C21A / 2 LA / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: Bursitis, Limb discomfort, Musculoskeletal discomfort, Pain in extremity
SMQs:, Rhabdomyolysis/myopathy (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? No
Hospitalized? No
Previous Vaccinations:
Other Medications: not known
Current Illness: Not Known
Preexisting Conditions: Not KNown
Allergies: NKDA
Diagnostic Lab Data: Not Known
CDC Split Type:

Write-up: Per patient initially the first couple of days he experienced normal superficial discomfort in the arm and shoulder-but then on June 5th he began to feel the pain deeper in the arm. The pain continued to persist and according to him it was a level 10. He did go to the physician''s office to get examined and per patient, MD stated it was bursitis and it would take time to heal. I did speak with him on 7/12/21 and he mentioned the pain is gradually getting better.


VAERS ID: 1467967 (history)  
Form: Version 2.0  
Age: 12.0  
Sex: Male  
Location: Arizona  
Vaccinated:2021-06-05
Onset:2021-06-05
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0170 / 2 LA / -

Administered by: Unknown       Purchased by: ?
Symptoms: Mass
SMQs:

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: No
Current Illness: No
Preexisting Conditions: No
Allergies: No
Diagnostic Lab Data: We have not done any.
CDC Split Type:

Write-up: A little ball at the level of the left shoulder.


VAERS ID: 1468216 (history)  
Form: Version 2.0  
Age: 39.0  
Sex: Female  
Location: Maryland  
Vaccinated:2021-06-05
Onset:2021-06-05
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 LA / -

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure diastolic increased, Blood pressure increased, Chest pain, Dizziness, Feeling hot, Headache, Impaired work ability, Malaise
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Hypertension (narrow), Cardiomyopathy (broad), Vestibular 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: Chlorpheniramine Maleate 4 mg 1x/day
Current Illness: None
Preexisting Conditions: Heart murmur
Allergies: Allergic to White Hickory tree and dust mites
Diagnostic Lab Data:
CDC Split Type:

Write-up: Approx 2 hrs after being vaccinated on 6/5, I felt somewhat unwell. I checked my VS. My temp, SPO2, HR seemed to be WNL. My BP was somewhat higher than usual 141/96mmHg as I have no history of HTN and was not on any medication except for antihistamine for my allergies. I continued to monitor it throughout the rest of the day and it was gradually going up with the highest reading of 156/105mmHg that night with dizziness whether sitting or lying down. The dizziness/headache and high diastolic continued on for almost 3.5 weeks everyday with warm sensation on chest area around the heart on day 7 and day 8 from being vaccinated which I started taking garlic extract 1000mg on day 7 with the hopes of bring my bp down as I have no medication with me. I could not go back to working out as I was working out 3x/wk from 30 to 60mins prior to being vaccinated with my last workout day on 6/4. I was giving myself a week to let my body recuperate when my BP was not improving I scheduled an appointment with my primary. At week 5 close to 6 week after being vaccinated, I only experience intermittent dizziness when my diastolic is higher than 10, able to tolerate more activities without unreasonable BP elevation with some random chest pain which is not activity or time specific as it happens briefly whether sitting, lying or walking.


VAERS ID: 1470185 (history)  
Form: Version 2.0  
Age: 26.0  
Sex: Male  
Location: Michigan  
Vaccinated:2021-05-18
Onset:2021-06-05
   Days after vaccination:18
Submitted: 0000-00-00
Entered: 2021-07-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 032M20A / 1 - / IM

Administered by: Private       Purchased by: ?
Symptoms: Atrial fibrillation, COVID-19, Chest pain, Pneumonia, SARS-CoV-2 test positive
SMQs:, Supraventricular tachyarrhythmias (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (narrow), Opportunistic infections (broad), COVID-19 (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? Yes, 9 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: None
Current Illness: None known
Preexisting Conditions: None known
Allergies: No known drug allergies
Diagnostic Lab Data: COVID-19 Positive on 6/5/2021.
CDC Split Type:

Write-up: Presented to emergency department on 6/5/2021 with chest pain. He was found to be COVID-19 positive at that time and was treated for pneumonia. During admission, he was found to be in atrial fibrillation and possible myopericarditis. Patient improved clinically and was discharged to home on 6/14/2021.


VAERS ID: 1470208 (history)  
Form: Version 2.0  
Age: 43.0  
Sex: Female  
Location: New Jersey  
Vaccinated:2021-06-05
Onset:2021-06-05
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 041C21A / 2 LA / SYR

Administered by: Private       Purchased by: ?
Symptoms: Asthenia, Blood test, Condition aggravated, Diarrhoea, Malaise, Pyrexia, Vision blurred, Vitreous floaters
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Pseudomembranous colitis (broad), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Glaucoma (broad), Lens disorders (broad), Retinal disorders (narrow), Noninfectious diarrhoea (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (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? No
Hospitalized? No
Previous Vaccinations: hepatitis b vaccine 10 years ago and experienced confusion for a few days.
Other Medications: I take Meclizine, vitamin C and B, Coq 10, multi vitamin, migravent
Current Illness: none
Preexisting Conditions: Barakat syndrome and Menieres
Allergies: I have gluten intolerance and sulfa
Diagnostic Lab Data: On July 10, 2021 I went to see Dr. and he ran blood test which I have not received my results back yet. The day of my blood test I had to take a potassium pill because my potassium was low.
CDC Split Type:

Write-up: On June 5, 2021 I started to feel sick and I have diarrhea and I woke up in the night with a fever for 3 days and after a few days the fever subsided and I continued to feel weaker and weaker. On July 2, 2021 I went to my eye Dr., because I was having floaters and blurred vision. Which actually happened after my first dose and after my second dose it got worse. Dr. stated I should follow up with my regular doctor. I followed up with my PCP Dr., on July 8, 2021 and they told me to walk in the morning on July 9th, 2021, because they did not have any available appointments On July 9, 2021 I went to see Dr. and he ordered me a blood test for July 10, 2019, because I didn''t fast the night before and I have not received my results back yet. However, Dr. pitched me and stated that I was dehydrated. The day of my blood test I had to take a potassium pill because my potassium was low. I am still waiting on the blood test result.


VAERS ID: 1474325 (history)  
Form: Version 2.0  
Age: 38.0  
Sex: Male  
Location: Maine  
Vaccinated:2021-01-01
Onset:2021-06-05
   Days after vaccination:155
Submitted: 0000-00-00
Entered: 2021-07-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EL1284 / 1 LA / IM
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EL3302 / 2 LA / IM

Administered by: Private       Purchased by: ?
Symptoms: Ageusia, Anosmia, COVID-19, Cough, Dyspnoea, Myalgia, Pyrexia, SARS-CoV-2 test positive
SMQs:, Rhabdomyolysis/myopathy (broad), Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Taste and smell disorders (narrow), Anticholinergic syndrome (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (broad), Opportunistic infections (broad), Immune-mediated/autoimmune disorders (broad), COVID-19 (narrow)

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: Advise, Zyrtec, Lisinopril, MVI
Current Illness:
Preexisting Conditions: Asthma, OSA, HTN
Allergies: None
Diagnostic Lab Data: COVID PCR - Positive on June 9
CDC Split Type:

Write-up: On June 4, 2021 I developed fever, myalgias, Shortness of breath and cough. A few days later I lost my sense of smell and taste. I got a COVID PCR test which resulted in a positive result. Thereupon I quarantined for 2 weeks in accordance with the CDC and my employer. I also received banvanivimab. Within 7 days my symptoms were mostly resolved. I did not require hospitalization or other interventions.


VAERS ID: 1475657 (history)  
Form: Version 2.0  
Age: 51.0  
Sex: Male  
Location: California  
Vaccinated:2021-05-13
Onset:2021-06-05
   Days after vaccination:23
Submitted: 0000-00-00
Entered: 2021-07-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA O27C21A / 2 LA / IM

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: None
Current Illness: None
Preexisting Conditions: Obesity
Allergies: Mold
Diagnostic Lab Data: I don''t know.
CDC Split Type:

Write-up: Blood clot on left leg from knee to the groin area. Never had problems before, not 1 person in my family ever had this , not long trips , ground or Arial.


VAERS ID: 1478167 (history)  
Form: Version 2.0  
Age: 53.0  
Sex: Female  
Location: Arizona  
Vaccinated:2021-03-16
Onset:2021-06-05
   Days after vaccination:81
Submitted: 0000-00-00
Entered: 2021-07-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EP7534 / 1 LA / SYR

Administered by: Other       Purchased by: ?
Symptoms: Antinuclear antibody, Autoimmune disorder, Blood test, C-reactive protein, Gait inability, Impaired self-care, Impaired work ability, Loss of personal independence in daily activities, Mobility decreased, Muscular weakness, Pain, Polymyalgia rheumatica, Red blood cell sedimentation rate, Rheumatoid factor
SMQs:, Rhabdomyolysis/myopathy (broad), Peripheral neuropathy (broad), Anticholinergic syndrome (broad), Dementia (broad), Dystonia (broad), Parkinson-like events (broad), Guillain-Barre syndrome (broad), Noninfectious encephalopathy/delirium (broad), Depression (excl suicide and self injury) (broad), Vasculitis (narrow), Tendinopathies and ligament disorders (broad), Immune-mediated/autoimmune disorders (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
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: Rheumatoid Factor 7/10/2021 ANA Screen 7/10/2021 ESR 7/10/2021 CRP 7/10/2021
CDC Split Type:

Write-up: Since receiving the vaccine I have developed a autoimmune disease called Polymyalgia Rheumatica- PMR. I was unable to walk or lift my arms for sever al weeks. I couldn''t get out of bed, comb my hair, brush my teeth, get dressed, etc. This is a nerve/joint disease that comes on suddenly. After going to several doctors and being in excruciating pain PMR was diagnosed through blood work and symptoms. I am currently unable to work and carry on with normal day to day activities due to pain. I am currently on prednisone. I need to now see a rheumatologist for life long treatment. The prednisone is very dangerous to take with multiple side effects, I will on that for a minimum of a year.


VAERS ID: 1479081 (history)  
Form: Version 2.0  
Age: 78.0  
Sex: Female  
Location: Florida  
Vaccinated:2021-04-22
Onset:2021-06-05
   Days after vaccination:44
Submitted: 0000-00-00
Entered: 2021-07-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Pharmacy       Purchased by: ?
Symptoms: Arthralgia, Decreased activity, Myalgia
SMQs:, Rhabdomyolysis/myopathy (broad), Eosinophilic pneumonia (broad), Arthritis (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? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Losartan, multi vitamin, turmeric, cranberry, vitamin D, vitamin C, Glucosamine , low dose aspirin.
Current Illness: None
Preexisting Conditions: None
Allergies: Codine
Diagnostic Lab Data:
CDC Split Type:

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


VAERS ID: 1483021 (history)  
Form: Version 2.0  
Age: 63.0  
Sex: Female  
Location: Illinois  
Vaccinated:2021-06-05
Onset:2021-06-05
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EL3247 / 2 RA / -

Administered by: Private       Purchased by: ?
Symptoms: Cardiac disorder, Dysstasia, Exercise tolerance decreased, Fatigue, Gait disturbance, Groin pain, Headache, Inappropriate schedule of product administration, Muscular weakness, Pain
SMQs:, Rhabdomyolysis/myopathy (broad), Peripheral neuropathy (broad), Anticholinergic syndrome (broad), Parkinson-like events (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Osteonecrosis (broad), Medication errors (narrow), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
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: USPFIZER INC2021798399

Write-up: Severe right groin pain; Difficulty walking; exercise is extremely limited; Quite painful; Weakness in legs and muscles; Very tired; heart seems taxed; Standing become laborious; Headache; Received BNT162B2 of first dose on 15Apr2021 at 15:15 and second dose on 05Jun2021 at 15:15; This is a spontaneous report from a contactable consumer (patient). A 63-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in the right arm on 05Jun2021 at 15:15 (Lot number: EL3247) as single dose for COVID-19 immunization. The patient medical history was not reported. Family medical history included thyroid med use, arthritis, increased blood pressure. Concomitant medications reported as none. None of prior vaccinations. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in the right arm on 15Apr2021 at 15:15 (Lot number: EL9265) as single dose for COVID-19 immunization that patient had a severe ear problem/cannot hear. On 06Jun2021, the patient experienced severe right groin pain - difficulty walking, exercise was extremely limited and quite painful; weakness in legs/muscles; very tired (heart seems taxed). This seemed to come in ''out-of-the-blue'' standing becomes laborious (patient cannot seem to go on a walk anymore); headaches. One day patient would see some improvement but, the next was another story. Patient was taking Tylenol. Overall it was getting better-sort of (xtra with regular strength). Exactly 1 month to the day of 2nd vaccination (Pfizer) that this ghostly ailment came on, the right side of my body. Patient had called her GP & was scheduled for a blood test. Also, patient had scheduled an orthopaedic visit (neighbour recommended) at end of month. Patient was sleeping more, moving slow and trying to figure out how to help herself. Isometric exercise helped sometimes. Events resulted in physician office visit. Treatment received for events including Tylenol xtra strength and reg. strength. Outcome of the event "received BNT162B2 of first dose on 15Apr2021 at 15:15 and second dose on 05Jun2021 at 15:15" was unknown, while of the other events was not recovered. Seriousness criteria was assessed by the reporting consumer as persistent/ significant disability/incapacity. Follow-up attempts are completed. No further information is expected.


VAERS ID: 1483350 (history)  
Form: Version 2.0  
Age: 49.0  
Sex: Male  
Location: Colorado  
Vaccinated:2021-06-05
Onset:2021-06-05
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0175 / 2 LA / OT

Administered by: Private       Purchased by: ?
Symptoms: Bradyphrenia, Dyspnoea, Gastrointestinal disorder, Headache
SMQs:, Anaphylactic reaction (broad), Parkinson-like events (broad), Acute central respiratory depression (broad), Psychosis and psychotic disorders (broad), Pulmonary hypertension (broad), Noninfectious encephalopathy/delirium (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? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: COVID-19
Allergies:
Diagnostic Lab Data:
CDC Split Type: USPFIZER INC2021824113

Write-up: Shortness of breath; Upper and lower GI side effects; Slowed mentation; Daily severe headaches/Massive headache; This is a spontaneous report from a contactable physician. A 49-years-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EW0175), dose 2 intramuscular, administered in Arm Left on 05Jun2021 12:00 (age at the vaccination 49-year-old) as DOSE 2, SINGLE for covid-19 immunisation at Doctor''s office/urgent care. Medical history included prior to vaccination the patient was diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. There were no concomitant medications. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EW0185), via an intramuscular, administered in Arm Left on 15May2021 12:00 PM date as 1st dose, single for COVID-19 immunization. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced shortness of breath on 05Jun2021 12:45, daily severe headaches /massive headache on 05Jun2021 12:45, upper and lower gi side effects on 05Jun2021 12:45, slowed mentation on 05Jun2021 12:45. Every afternoon patient had massive headache which patient had never before, shortness of breath and had digestive problems every night, digestive problem like patient can have days of digestive problems upper GI and Lower GI. Adverse event (AE) required visit to the Physician Office. It was getting worst. Therapeutic measures were taken as a result of daily severe headaches/massive headache. Patient took Motrin for headache. The outcome of the events was not recovered.; Sender''s Comments: Based on temporal association and profile of the product, a contribution from the suspect drug bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), to the event Dyspnea cannot be completely excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.


VAERS ID: 1483419 (history)  
Form: Version 2.0  
Age: 50.0  
Sex: Female  
Location: Georgia  
Vaccinated:2021-03-29
Onset:2021-06-05
   Days after vaccination:68
Submitted: 0000-00-00
Entered: 2021-07-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ER8727 / UNK RA / -

Administered by: Unknown       Purchased by: ?
Symptoms: Pulmonary thrombosis, SARS-CoV-2 test, Thrombosis
SMQs:, Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Embolic and thrombotic events, venous (narrow), Thrombophlebitis (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? Yes, 5 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: PREDNI; ASTELIN [AZELASTINE HYDROCHLORIDE]; ALBUTEROL HFA
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Allergy; Allergy to nuts; Asthma; Seafood allergy
Allergies:
Diagnostic Lab Data: Test Date: 20210605; Test Name: SARS-CoV-2 test; Result Unstructured Data: Test Result:Negative; Comments: Nasal swab
CDC Split Type: USPFIZER INC2021830072

Write-up: Blood clots in right leg that traveled to both lungs; Blood clots in right leg that traveled to both lungs; This is a spontaneous report from a contactable consumer (patient herself). A 50-years-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection, Lot Number: ER8727, Expiry date was not reported) via an unspecified route of administration in arm right on 29Mar2021 (at the age of 50-years-old) as dose number unknown, single and bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection, Lot Number: ER8735, Expiry date was not reported), via an unspecified route of administration in arm right on 29Mar2021 (at the age of 50-years-old) as dose number unknown, single for COVID-19 immunisation. Medical history included asthma, allergies, seafood allergy and nuts allergy. Concomitant medications included predni (PREDNISOLONE ACETATE), azelastine hydrochloride (ASTELIN [AZELASTINE HYDROCHLORIDE]) unknown daily at night and salbutamol (ALBUTEROL HFA) when needed. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has been tested for COVID-19. On 05Jun2021 at 09:00, the reporter stated that the patient experienced blood clots in right leg that travelled to both lungs. Her unprovoked event on 05Jun2021 and hospitalized for five days. The patient started taking blood thinners for the rest of my life. The reporter classified the events as serious and stated the events result in emergency room/department or urgent care, hospitalization for 5 days. The patient underwent lab tests and procedures on 05Jun2021 which included sars-cov-2 test (nasal swab): negative. Therapeutic measures were taken as a result of events with blood thinners. The outcome of the events was resolved with sequelae. Follow up needed, further information was requested.


VAERS ID: 1484081 (history)  
Form: Version 2.0  
Age: 52.0  
Sex: Female  
Location: Washington  
Vaccinated:2021-06-05
Onset:2021-06-05
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0179-H / 1 LA / IM

Administered by: Other       Purchased by: ?
Symptoms: Arthralgia, Hypoaesthesia, Laboratory test normal, Pain in extremity, Pain in jaw, Paraesthesia, Paraesthesia oral, Tinnitus
SMQs:, Peripheral neuropathy (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Guillain-Barre syndrome (broad), Hearing impairment (narrow), Osteonecrosis (broad), Arthritis (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? No
Hospitalized? No
Previous Vaccinations:
Other Medications: 1/2 Grain Thyroid supplement and daily vitamins.
Current Illness: None.
Preexisting Conditions: Suffer from migraines, one to two a month.
Allergies: None.
Diagnostic Lab Data: 7/9/21: all labs are normal; PCP may order brain MRI
CDC Split Type:

Write-up: Face numbness began 25 minutes following injection, and extreme pain in left jaw, neck, shoulder and arm, very loud tinnitus also started same day; approximately one week later, began experiencing numbing and tingling in face around nose, cheeks, lips, and tongue, and both forearms and hands, and both legs below the knees and feet; numbing/tingling feeling and tinnitus ongoing for over six weeks and continues as of this report.


VAERS ID: 1484113 (history)  
Form: Version 2.0  
Age: 28.0  
Sex: Male  
Location: Unknown  
Vaccinated:2021-06-04
Onset:2021-06-05
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-07-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Unknown       Purchased by: ?
Symptoms: Urticaria
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), 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? Yes
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: opexa, easyhealer 400mcdose
Current Illness: allrgic reactions
Preexisting Conditions: none
Allergies: cat-
Diagnostic Lab Data:
CDC Split Type:

Write-up: after the second dose of the vaccine, urticaria started to appear in a very strong way. I was too close to get in shock, I had to visit an emergency clinck. everything started after the second dose and since then it didn''t go well. each day I had more symptoms


VAERS ID: 1484117 (history)  
Form: Version 2.0  
Age: 48.0  
Sex: Female  
Location: Michigan  
Vaccinated:2021-05-19
Onset:2021-06-05
   Days after vaccination:17
Submitted: 0000-00-00
Entered: 2021-07-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 041L20A / 2 LA / -

Administered by: Private       Purchased by: ?
Symptoms: Ear infection, Vaccine positive rechallenge
SMQs:

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: none
Current Illness: none
Preexisting Conditions: none
Allergies: none
Diagnostic Lab Data: June 5, 2021 and June 25, 2021
CDC Split Type:

Write-up: I experienced and right ear infection 2 or 3 weeks after each vaccine


VAERS ID: 1484547 (history)  
Form: Version 2.0  
Age: 42.0  
Sex: Male  
Location: New York  
Vaccinated:2021-05-17
Onset:2021-06-05
   Days after vaccination:19
Submitted: 0000-00-00
Entered: 2021-07-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FZW0172 / 1 LA / SYR
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FZW0182 / 2 LA / SYR

Administered by: Other       Purchased by: ?
Symptoms: Blood test, Chest pain
SMQs:, Gastrointestinal nonspecific symptoms and therapeutic procedures (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? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Pain killer mainly. Advil and Acetaminophen
Current Illness: None
Preexisting Conditions: None
Allergies: None
Diagnostic Lab Data: No yet, the doctor that I was referred to is busy and my appointment is Aug/10. Dr took a blood sample so he might want to do testing - I am not sure.
CDC Split Type:

Write-up: I had a shape left chest pain that lasted for almost 2 weeks starting in the first week of June. The pain started to ease and now I feel it every now and then. I talked to my doctor this morning and he recommended I do the heart echo and report this here.


VAERS ID: 1485974 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Unknown  
Vaccinated:0000-00-00
Onset:2021-06-05
Submitted: 0000-00-00
Entered: 2021-07-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN UNKNOWN / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Peripheral swelling, Rash
SMQs:, Cardiac failure (broad), Anaphylactic reaction (broad), Angioedema (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (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: USJNJFOC20210735427

Write-up: ARM IS SWOLLEN; FACE IS FULL OF RASH; This spontaneous report received from a patient concerned a male of unspecified age. The patient''s height, and weight were not reported. No past medical history or concurrent conditions were reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 21-MAY-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 05-JUN-2021, the subject experienced arm is swollen. On 05-JUN-2021, the subject experienced face is full of rash. Treatment medications (dates unspecified) included: cortisone. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the arm is swollen and face is full of rash was not reported. This report was non-serious.


VAERS ID: 1487029 (history)  
Form: Version 2.0  
Age: 24.0  
Sex: Female  
Location: Tennessee  
Vaccinated:2021-03-06
Onset:2021-06-05
   Days after vaccination:91
Submitted: 0000-00-00
Entered: 2021-07-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 036A21A / 1 LA / SYR
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 008B21A / 2 AR / -

Administered by: Work       Purchased by: ?
Symptoms: Ageusia, COVID-19, Dry throat, Headache, Malaise, Oropharyngeal discomfort, Oropharyngeal pain, Rhinorrhoea, SARS-CoV-2 test positive, Streptococcus test negative
SMQs:, Taste and smell disorders (narrow), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Infective pneumonia (broad), Dehydration (broad), Opportunistic infections (broad), COVID-19 (narrow)

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: Adderall XR 20 mg, Adderall IR 10 mg, Sprintec (Birth Control)
Current Illness: None
Preexisting Conditions: None/ADHD
Allergies: None known
Diagnostic Lab Data: Strep Throat test 6/7/21: Negative 6/8/21 @ 3:55 P.M. Rapid Covid-19 Nasal Test. Positive.
CDC Split Type:

Write-up: 6/5/21: Throat felt weird; it didn''t hurt, but felt like it does when I eat too much candy. Very slimy I guess? 6/6/21: Throat felt the same. No other symptoms at all. 6/7/21: Throat felt the same. Went to the doctor and he said to come back if it got worse so they could test for COVID. 6/8/21: Throat felt the same, but also had a headache and other symptoms that I can''t currently remember. Runny nose. Went to doctor and tested positive for COVID-19. 6/9/21: Throat started feeling very, very dry. It hurt. Lost all taste for just 4 hours. Felt sick overall and had a headache and a runny nose. 6/10/21: I don''t remember how I felt, but my journal says I spent all day on the couch, so probably not very well. 6/11/21: Symptoms started disappearing/I was recovering


VAERS ID: 1487271 (history)  
Form: Version 2.0  
Age: 43.0  
Sex: Male  
Location: Florida  
Vaccinated:2021-05-17
Onset:2021-06-05
   Days after vaccination:19
Submitted: 0000-00-00
Entered: 2021-07-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 1808982 / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Unevaluable event
SMQs:

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: Olmersartan medoxomil 40mg Paro re?ne 20mg Rosuvastatin calcium 20mg Testosterone cyp 1ML Anastrozole .25mg
Current Illness:
Preexisting Conditions: High blood pressure Cholesterol Hypogonadism
Allergies:
Diagnostic Lab Data: None
CDC Split Type:

Write-up: Typed this within first 5 fields.


VAERS ID: 1487363 (history)  
Form: Version 2.0  
Age: 64.0  
Sex: Male  
Location: Florida  
Vaccinated:2021-05-05
Onset:2021-06-05
   Days after vaccination:31
Submitted: 0000-00-00
Entered: 2021-07-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / UNK - / -

Administered by: Pharmacy       Purchased by: ?
Symptoms: Blood test, Chest X-ray, Computerised tomogram, Dyspnoea, Full blood count, Pain, Pulmonary embolism, Scan
SMQs:, Anaphylactic reaction (broad), Embolic and thrombotic events, venous (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (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, 1 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: None
Current Illness: None
Preexisting Conditions: None
Allergies: None
Diagnostic Lab Data: CT Scan, CBC Blood Test, Chest X-Ray, Leg scans
CDC Split Type:

Write-up: Unable to Breath, Excessive pain, Pulmonary Embolism. Resulted in Hospitalization. No prior history of PE''s.


VAERS ID: 1490457 (history)  
Form: Version 2.0  
Age: 48.0  
Sex: Female  
Location: Colorado  
Vaccinated:2021-06-04
Onset:2021-06-05
   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 EW0187 / 2 LA / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: Dyspnoea, Hyperhidrosis, Nasal congestion, Pain, Paraesthesia oral, Pharyngeal swelling, Pulse abnormal, Swelling
SMQs:, Anaphylactic reaction (narrow), Angioedema (narrow), Neuroleptic malignant syndrome (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (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? No
Previous Vaccinations:
Other Medications: vitamin D3, cyclobenzaprine, naproxen
Current Illness: none reported
Preexisting Conditions: vitamin D deficiency, fibroid
Allergies: biotin, latex, penicillin, sulfa
Diagnostic Lab Data:
CDC Split Type:

Write-up: Pfizer-BioNTech COVID-19 Vaccine EUA: patient reported 12 hours after immunization lip tingling, swelling, shortness of breath, body aches, diaphoresis, nasal congestion, and feeling of difficulty breathing. Twelve hours after symptom onset patient presented to urgent care as symptoms were not resolving. Vital signs within normal ranges except pulse 125 beats per minute and temperature 38.0 degrees Celsius. On exam, pharyngeal swelling and posterior oropharyngeal erythema were present. Diphenhydramine, prednisone, acetaminophen were administered with improvement in symptoms and vital signs. Patient monitored, continued to improve, and discharged home stable.


VAERS ID: 1493632 (history)  
Form: Version 2.0  
Age: 39.0  
Sex: Female  
Location: South Carolina  
Vaccinated:2021-06-03
Onset:2021-06-05
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-07-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 2 RA / IM

Administered by: Private       Purchased by: ?
Symptoms: Full blood count normal, Pain
SMQs:

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: Zyrtec, Pepcid, Gabapentin, Prozac, Vistaril
Current Illness: None
Preexisting Conditions: SVT, Anxiety, Obesity
Allergies: Aspirin, Sumatriptan, Vancomycin
Diagnostic Lab Data: Normal CBC on 06/07/21
CDC Split Type:

Write-up: Patient presented with hypersensitivity after administration of COVID vaccine (COVID arm). Her first dose was treated as a cellulitis with antibiotics (10 day course of Keflex). Patient went to urgent care before seeing me in the office and again was treated as a cellulitis with Keflex. Second vaccine reaction was a lot worse than the first. She was also given Norco and tylenol for pain at the urgent care to help with pain. At my visit she was prescribed Prednisone for 7 days and famotidine and zyrtec. She was also given a shot of solumedrol. A couple days later was told to increase her Prednisone dose.


VAERS ID: 1493961 (history)  
Form: Version 2.0  
Age: 13.0  
Sex: Female  
Location: New York  
Vaccinated:2021-06-05
Onset:2021-06-05
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 LA / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: Anxiety, Dizziness, Vision blurred
SMQs:, Anticholinergic syndrome (broad), Glaucoma (broad), Lens disorders (broad), Retinal disorders (broad), Vestibular disorders (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: no
Current Illness:
Preexisting Conditions: anxiety
Allergies: nka
Diagnostic Lab Data:
CDC Split Type:

Write-up: Shortly after vaccination the pt was very anxious and said she felt dizzy. Pt never did past out but was very dizzy and had blurred vision. We laid the pt down and elevated her feet and she was much better. Mom called EMS and the pt was monitored and recovered. I spoke with the mom Sat night and Sun and she was feeling fine. Pt returned on 6/26/21 for second dose and had no reaction.


VAERS ID: 1494157 (history)  
Form: Version 2.0  
Age: 56.0  
Sex: Male  
Location: Wisconsin  
Vaccinated:2021-06-01
Onset:2021-06-05
   Days after vaccination:4
Submitted: 0000-00-00
Entered: 2021-07-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / IM

Administered by: Private       Purchased by: ?
Symptoms: Amnesia, Borrelia test negative, CSF protein increased, CSF white blood cell count increased, Confusional state, Encephalitis, Herpes simplex test negative, Immunology test normal, Lumbar puncture, Magnetic resonance imaging head abnormal, Polymerase chain reaction, Pyrexia, Treponema test negative
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (narrow), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Immune-mediated/autoimmune 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? Yes, 2 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: MRI 7/1/21 Lumbar puncture 7/1 CSF protein elevated, 18 WBC HSV PCR negative VDRL negative Lyme PCR negative autoimmune encephalopathy panel negative
CDC Split Type:

Write-up: Developed what we believe was an encephalitis with confusion, memory loss, fever. MRI with abnormal enhancement of the mesial termporal lobes bilaterally. No other obvious etiology found. Slowly over several weeks improve.


VAERS ID: 1376664 (history)  
Form: Version 2.0  
Age: 36.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-04
Onset:2021-06-05
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-06-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (UNKNOWN)) / UNKNOWN MANUFACTURER - / UNK LA / IM

Administered by: Unknown       Purchased by: ?
Symptoms: Urticaria
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Hypersensitivity (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: Bactrim F, Contumax
Current Illness: Urinary track infection.
Preexisting Conditions: None
Allergies: None
Diagnostic Lab Data:
CDC Split Type:

Write-up: Hives all over the body.


VAERS ID: 1394865 (history)  
Form: Version 2.0  
Age: 21.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-04
Onset:2021-06-05
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-06-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0221-CC09 / 1 LA / SYR

Administered by: Private       Purchased by: ?
Symptoms: Abdominal pain, Chest discomfort, Chills, Decreased appetite, Dizziness, Dyspnoea, Fatigue, Migraine, Nausea, Pyrexia, Vomiting
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Retroperitoneal fibrosis (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), 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? 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: Migraine, fever, chills 24hr after inject. 24hr- current, symptoms include nausea, vomiting, light headed, shortness of breath, dizziness, fatigue, pain in abdomen, loss of appetite, tight chest.


VAERS ID: 1397834 (history)  
Form: Version 2.0  
Age: 35.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-05
Onset:2021-06-05
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-06-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3002332 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Cold sweat, Hyperhidrosis, Malaise, Seizure
SMQs:, Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Convulsions (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? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBMODERNATX, INC.MOD20212

Write-up: clammy; immediately felt unwell; sweaty; Seizure; This regulatory authority case was reported by a pharmacist and describes the occurrence of SEIZURE (Seizure), COLD SWEAT (clammy), MALAISE (immediately felt unwell) and HYPERHIDROSIS (sweaty) in a 35-year-old male patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 3002332) for COVID-19 vaccination. No Medical History information was reported. On 05-Jun-2021, the patient received first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 05-Jun-2021, the patient experienced SEIZURE (Seizure) (seriousness criterion medically significant). On an unknown date, the patient experienced COLD SWEAT (clammy) (seriousness criterion medically significant), MALAISE (immediately felt unwell) (seriousness criterion medically significant) and HYPERHIDROSIS (sweaty) (seriousness criterion medically significant). At the time of the report, SEIZURE (Seizure) was resolving and COLD SWEAT (clammy), MALAISE (immediately felt unwell) and HYPERHIDROSIS (sweaty) 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. Patient immediately felt unwell , LOC 1 minute. tonic Clonic/ vasovagal seizure. Patient felt clammy and sweaty. Patient had not tested positive for COVID-19 since having the vaccine. 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: 1397840 (history)  
Form: Version 2.0  
Age: 35.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-04
Onset:2021-06-05
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-06-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3002332 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: COVID-19, Chest pain, Fatigue, Feeling abnormal, Myalgia, SARS-CoV-2 test
SMQs:, Rhabdomyolysis/myopathy (broad), Dementia (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Tendinopathies and ligament disorders (broad), Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (narrow)

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? No
Previous Vaccinations:
Other Medications: METFORMIN
Current Illness: Polycystic ovaries
Preexisting Conditions: Medical History/Concurrent Conditions: Lactation decreased
Allergies:
Diagnostic Lab Data: Test Date: 20201015; Test Name: COVID-19 virus test; Test Result: Positive ; Result Unstructured Data: Yes-Positive COVID-19 test
CDC Split Type: GBMODERNATX, INC.MOD20212

Write-up: unbearable side effects; Chest pain; COVID-19; Generalised muscle aches; Fatigue; This regulatory authority case was reported by a consumer and describes the occurrence of CHEST PAIN (Chest pain), COVID-19 (COVID-19), MYALGIA (Generalised muscle aches), FATIGUE (Fatigue) and FEELING ABNORMAL (unbearable side effects) in a 35-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 3002332) for COVID-19 vaccination. The patient''s past medical history included Lactation decreased. Concurrent medical conditions included Polycystic ovaries. Concomitant products included METFORMIN from 01-Jul-2013 to an unknown date for Polycystic ovary. On 04-Jun-2021, the patient received first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Jun-2021, the patient experienced CHEST PAIN (Chest pain) (seriousness criterion disability), COVID-19 (COVID-19) (seriousness criterion disability), MYALGIA (Generalised muscle aches) (seriousness criterion disability) and FATIGUE (Fatigue) (seriousness criterion disability). On an unknown date, the patient experienced FEELING ABNORMAL (unbearable side effects) (seriousness criterion disability). At the time of the report, CHEST PAIN (Chest pain), COVID-19 (COVID-19), MYALGIA (Generalised muscle aches) and FATIGUE (Fatigue) had not resolved and FEELING ABNORMAL (unbearable side effects) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 15-Oct-2020, SARS-CoV-2 test: yes - positive covid-19 test (Positive) Yes-Positive COVID-19 test. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Intramuscular) was unknown. No treatment information was 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. It seems that the patient has not developed COVID-19. Company causality for COVID-19 is not applicable.; 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. It seems that the patient has not developed COVID-19. Company causality for COVID-19 is not applicable.


VAERS ID: 1397852 (history)  
Form: Version 2.0  
Age: 32.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-05
Onset:2021-06-05
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-06-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3002332 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Blood glucose, Blood pressure measurement, Blood test, Electrocardiogram, Seizure, Syncope, Vomiting
SMQs:, Torsade de pointes/QT prolongation (broad), Acute pancreatitis (broad), Systemic lupus erythematosus (broad), Arrhythmia related investigations, signs and symptoms (broad), Convulsions (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (narrow), 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? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Fainting; Lactation decreased; Pain; Comments: The patient reported that in the past they have fainted/fitted twice as a pain response but there are no other health issues. The patient has not had symptoms associated with COVID-19 and has not have a COVID-19 test. The patient is not enrolled in a clinical trial, is not pregnant, and is not currently breastfeeding.
Allergies:
Diagnostic Lab Data: Test Date: 20210605; Test Name: Blood sugar; Result Unstructured Data: Normal; Test Date: 20210605; Test Name: Blood pressure; Result Unstructured Data: Blood pressure dropping rapidly; Test Date: 20210605; Test Name: Blood test; Result Unstructured Data: Normal; Test Date: 20210605; Test Name: ECG; Result Unstructured Data: Normal
CDC Split Type: GBMODERNATX, INC.MOD20212

Write-up: Fainting; Seizure; Vomited; This regulatory authority case was reported by a consumer and describes the occurrence of SYNCOPE (Fainting), SEIZURE (Seizure) and VOMITING (Vomited) in a 32-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 3002332) for COVID-19 vaccination. The patient reported that in the past they have fainted/fitted twice as a pain response but there are no other health issues. The patient has not had symptoms associated with COVID-19 and has not have a COVID-19 test. The patient is not enrolled in a clinical trial, is not pregnant, and is not currently breastfeeding. The patient''s past medical history included Lactation decreased, Pain and Fainting. On 05-Jun-2021, the patient received first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 05-Jun-2021, the patient experienced SYNCOPE (Fainting) (seriousness criteria hospitalization and medically significant), SEIZURE (Seizure) (seriousness criteria hospitalization and medically significant) and VOMITING (Vomited) (seriousness criteria hospitalization and medically significant). On 05-Jun-2021, SYNCOPE (Fainting), SEIZURE (Seizure) and VOMITING (Vomited) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 05-Jun-2021, Blood glucose: normal (normal) Normal. On 05-Jun-2021, Blood pressure measurement: abnormal (abnormal) Blood pressure dropping rapidly. On 05-Jun-2021, Blood test: normal (normal) Normal. On 05-Jun-2021, Electrocardiogram: normal (normal) Normal. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. Concomitant product use was not provided by the reporter. Treatment information was not provided. A couple of minutes after the jab the patient fainted and had a fit. For the following 40 minutes to an hour the patient was very light headed, fainted again when she was aided to sit up due to blood pressure dropping rapidly, and was very weak. 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. Blood sugar, blood tests, ECG (electrocardiogram), and blood pressure were all normal a couple of hours post vaccination. Blood pressure was the only test that was abnormal at any stage. The patient has not tested positive for COVID-19 since having the vaccine.; 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: 1397856 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-05
Onset:2021-06-05
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-06-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Myalgia, Pain in extremity, SARS-CoV-2 test
SMQs:, Rhabdomyolysis/myopathy (broad), Eosinophilic pneumonia (broad), Tendinopathies and ligament 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? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: COVID-19
Allergies:
Diagnostic Lab Data: Test Date: 20200321; Test Name: COVID-19 virus test; Test Result: Positive ; Result Unstructured Data: Positive COVID-19 test.
CDC Split Type: GBMODERNATX, INC.MOD20212

Write-up: Painful arm; Muscle pain; This regulatory authority case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Painful arm) and MYALGIA (Muscle pain) in a female patient of an unknown age who received mRNA-1273 (Moderna CoviD-19 Vaccine) for COVID-19 vaccination. The patient''s past medical history included COVID-19 on 21-Mar-2020. On 05-Jun-2021, the patient received first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Jun-2021, the patient experienced PAIN IN EXTREMITY (Painful arm) (seriousness criterion medically significant) and MYALGIA (Muscle pain) (seriousness criterion medically significant). At the time of the report, PAIN IN EXTREMITY (Painful arm) and MYALGIA (Muscle pain) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 21-Mar-2020, SARS-CoV-2 test: positive (Positive) Positive COVID-19 test.. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Intramuscular) was unknown. Concomitant medications were not provided. No treatment information was 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. 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: 1397865 (history)  
Form: Version 2.0  
Age: 36.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-04
Onset:2021-06-05
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-06-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3002332 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Decreased appetite, Influenza, Myalgia, Pyrexia, SARS-CoV-2 test
SMQs:, Rhabdomyolysis/myopathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Eosinophilic pneumonia (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (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: Lactation decreased
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative ; Result Unstructured Data: No - Negative COVID-19 test
CDC Split Type: GBMODERNATX, INC.MOD20212

Write-up: exactly 24 hours after jab i had flu symptoms; fever; Muscle ache; Appetite lost; This regulatory authority case was reported by a consumer and describes the occurrence of INFLUENZA (exactly 24 hours after jab i had flu symptoms), PYREXIA (fever) and MYALGIA (Muscle ache) in a 36-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 3002332) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient''s past medical history included Lactation decreased. On 04-Jun-2021, the patient received first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 05-Jun-2021, the patient experienced INFLUENZA (exactly 24 hours after jab i had flu symptoms), PYREXIA (fever), MYALGIA (Muscle ache) and DECREASED APPETITE (Appetite lost). On 06-Jun-2021, MYALGIA (Muscle ache) and DECREASED APPETITE (Appetite lost) had resolved. At the time of the report, INFLUENZA (exactly 24 hours after jab i had flu symptoms) and PYREXIA (fever) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: negative (Negative) No - Negative COVID-19 test. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. Concomitant product use was not provided. Treatment information was not provided. Patient has not tested positive for COVID-19 since having the vaccine. 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: 1398612 (history)  
Form: Version 2.0  
Age: 31.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-29
Onset:2021-06-05
   Days after vaccination:7
Submitted: 0000-00-00
Entered: 2021-06-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3002332 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Diarrhoea, Injection site erythema, Lymphadenopathy, Pain, Peripheral swelling, SARS-CoV-2 test
SMQs:, Cardiac failure (broad), Angioedema (broad), Pseudomembranous colitis (broad), Extravasation events (injections, infusions and implants) (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Haemodynamic oedema, effusions and fluid overload (narrow), Noninfectious diarrhoea (narrow), 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? No
Previous Vaccinations:
Other Medications: CETIRIZINE; DESOGESTREL; FLUOXETINE; PARACETAMOL
Current Illness: Chronic fatigue syndrome; Myalgic encephalomyelitis
Preexisting Conditions: Medical History/Concurrent Conditions: Lactation decreased; Vaccination adverse reaction
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative ; Result Unstructured Data: No - Negative COVID-19 test
CDC Split Type: GBMODERNATX, INC.MOD20212

Write-up: Day 7 post-moderna vaccine; Swelling arm; Pain; Swollen glands; Injection site redness; This regulatory authority case was reported by a consumer and describes the occurrence of DIARRHOEA (Day 7 post-moderna vaccine), PERIPHERAL SWELLING (Swelling arm), PAIN (Pain), LYMPHADENOPATHY (Swollen glands) and INJECTION SITE ERYTHEMA (Injection site redness) in a 31-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 3002332) for COVID-19 vaccination. The patient''s past medical history included Lactation decreased and Vaccination adverse reaction. Concurrent medical conditions included Myalgic encephalomyelitis and Chronic fatigue syndrome. Concomitant products included CETIRIZINE, DESOGESTREL, FLUOXETINE and PARACETAMOL for an unknown indication. On 29-May-2021, the patient received first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) at an unspecified dose. On 05-Jun-2021, the patient experienced PERIPHERAL SWELLING (Swelling arm) (seriousness criterion medically significant), PAIN (Pain) (seriousness criterion medically significant), LYMPHADENOPATHY (Swollen glands) (seriousness criterion medically significant) and INJECTION SITE ERYTHEMA (Injection site redness) (seriousness criterion medically significant). On an unknown date, the patient experienced DIARRHOEA (Day 7 post-moderna vaccine) (seriousness criterion medically significant). At the time of the report, DIARRHOEA (Day 7 post-moderna vaccine) outcome was unknown and PERIPHERAL SWELLING (Swelling arm), PAIN (Pain), LYMPHADENOPATHY (Swollen glands) and INJECTION SITE ERYTHEMA (Injection site redness) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: (Negative) No - Negative COVID-19 test. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. The action taken with mRNA-1273 in response to the event was not applicable. The patient developed a large, hot tender swelling around the injection site, which has rapidly spread to the whole upper arm. Lymph glands are swollen and tender, and have pins and needles down arm into wrist and fingers. 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: 1400944 (history)  
Form: Version 2.0  
Age: 25.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-05
Onset:2021-06-05
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-06-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Chest pain, Ear pain, Fatigue, Headache, Pain, SARS-CoV-2 test, Vomiting
SMQs:, Acute pancreatitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), COVID-19 (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? No
Previous Vaccinations:
Other Medications: PARACETAMOL
Current Illness: Ear pain
Preexisting Conditions: Medical History/Concurrent Conditions: Lactation decreased
Allergies:
Diagnostic Lab Data: Test Date: 20210304; Test Name: COVID-19 virus test; Test Result: Positive ; Result Unstructured Data: Tested Positive for COVID-19
CDC Split Type: GBMODERNATX, INC.MOD20212

Write-up: Vomiting; Headache; Chest pain; Ear pain; General body pain; extreme fatigue; This regulatory authority case was reported by an other health care professional and describes the occurrence of VOMITING (Vomiting), HEADACHE (Headache), CHEST PAIN (Chest pain), EAR PAIN (Ear pain) and PAIN (General body pain) in a 25-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient''s past medical history included Lactation decreased. Concurrent medical conditions included Ear pain. Concomitant products included PARACETAMOL from 05-Jun-2021 to 06-Jun-2021 for General body pain. On 05-Jun-2021, the patient received first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 05-Jun-2021, the patient experienced VOMITING (Vomiting) (seriousness criterion disability), HEADACHE (Headache) (seriousness criterion disability), CHEST PAIN (Chest pain) (seriousness criterion disability), EAR PAIN (Ear pain) (seriousness criterion disability), PAIN (General body pain) (seriousness criterion disability) and FATIGUE (extreme fatigue). At the time of the report, VOMITING (Vomiting), HEADACHE (Headache) and FATIGUE (extreme fatigue) outcome was unknown and CHEST PAIN (Chest pain), EAR PAIN (Ear pain) and PAIN (General body pain) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 04-Mar-2021, SARS-CoV-2 test: yes - positive covid-19 test (Positive) Tested Positive for COVID-19. 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 about 12 hours post receiving the vaccine developed body aches and a general feeling of being unwell. Post 17 hours the patient had ear pain and pressure, headache, vomiting, chest pain and extreme fatigue. No treatment information was 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. 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: 1404395 (history)  
Form: Version 2.0  
Age: 35.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-04-06
Onset:2021-06-05
   Days after vaccination:60
Submitted: 0000-00-00
Entered: 2021-06-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Myalgia, Peripheral swelling, Pyrexia, SARS-CoV-2 test
SMQs:, Rhabdomyolysis/myopathy (broad), Cardiac failure (broad), Angioedema (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Eosinophilic pneumonia (broad), Tendinopathies and ligament disorders (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? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20201226; Test Name: COVID-19 virus test; Test Result: Positive ; Result Unstructured Data: Yes - Positive COVID-19 test
CDC Split Type: GBMODERNATX, INC.MOD20212

Write-up: Large arm swelling; Fever chills; Muscular pains; This regulatory authority case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (Large arm swelling), PYREXIA (Fever chills) and MYALGIA (Muscular pains) in a 35-year-old male patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 06-Apr-2021, the patient received first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Jun-2021, the patient experienced PERIPHERAL SWELLING (Large arm swelling) (seriousness criterion medically significant), PYREXIA (Fever chills) (seriousness criterion medically significant) and MYALGIA (Muscular pains) (seriousness criterion medically significant). At the time of the report, PERIPHERAL SWELLING (Large arm swelling) and MYALGIA (Muscular pains) had not resolved and PYREXIA (Fever chills) was resolving. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 26-Dec-2020, SARS-CoV-2 test: positive (Positive) Yes - Positive COVID-19 test. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Intramuscular) was unknown. No concomitant medications were reported. Treatment information was not provided. The patient did not have symptoms associated with COVID-19 and did not test positive for COVID-19 since having the vaccine. Limited information regarding the events has been provided at this time and a causal relationship cannot be excluded although their onset a month after receiving the vaccine is unusual for these otherwise relatively common adverse events. Event terms, onset dates and outcomes captured per SD Authority reporting. Events seriousness per overall case assessment by Authority.; Sender''s Comments: Limited information regarding the events has been provided at this time and a causal relationship cannot be excluded although their onset a month after receiving the vaccine is unusual for these otherwise relatively common adverse events. Event terms, onset dates and outcomes captured per SD Authority reporting. Events seriousness per overall case assessment by Authority


VAERS ID: 1404401 (history)  
Form: Version 2.0  
Age: 30.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-05
Onset:2021-06-05
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-06-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3002332 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Chills, Fatigue, Headache, Maternal exposure during breast feeding, Myalgia, Pain in extremity
SMQs:, Rhabdomyolysis/myopathy (broad), Eosinophilic pneumonia (broad), Neonatal exposures via breast milk (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? No
Previous Vaccinations:
Other Medications:
Current Illness: Breast feeding
Preexisting Conditions: Medical History/Concurrent Conditions: Suspected COVID-19 (Unsure when symptoms stopped.)
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBMODERNATX, INC.MOD20212

Write-up: Maternal exposure during breast feeding; Painful arm; Headache; Fatigue; Chills; Muscle ache; This regulatory authority case was reported by a consumer and describes the occurrence of MATERNAL EXPOSURE DURING BREAST FEEDING (Maternal exposure during breast feeding), PAIN IN EXTREMITY (Painful arm), MYALGIA (Muscle ache), HEADACHE (Headache), FATIGUE (Fatigue) and CHILLS (Chills) in a 30-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 3002332) for COVID-19 vaccination. The patient''s past medical history included Suspected COVID-19 (Unsure when symptoms stopped.) on 31-Oct-2020. Concurrent medical conditions included Breast feeding. On 05-Jun-2021, the patient received first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Jun-2021, the patient experienced MYALGIA (Muscle ache) (seriousness criterion medically significant). On an unknown date, the patient experienced MATERNAL EXPOSURE DURING BREAST FEEDING (Maternal exposure during breast feeding) (seriousness criterion medically significant), PAIN IN EXTREMITY (Painful arm) (seriousness criterion medically significant), HEADACHE (Headache) (seriousness criterion medically significant), FATIGUE (Fatigue) (seriousness criterion medically significant) and CHILLS (Chills) (seriousness criterion medically significant). At the time of the report, MATERNAL EXPOSURE DURING BREAST FEEDING (Maternal exposure during breast feeding) outcome was unknown and PAIN IN EXTREMITY (Painful arm), MYALGIA (Muscle ache), HEADACHE (Headache), FATIGUE (Fatigue) and CHILLS (Chills) had not resolved. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Intramuscular) was unknown. No concomitant medications were reported. No treatment information was provided. Patient was not enrolled in clinical trial. Patient did not tested positive for COVID-19 since having the vaccine. 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: 1404412 (history)  
Form: Version 2.0  
Age: 37.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-05
Onset:2021-06-05
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-06-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3002332 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Diarrhoea, Dizziness, Fatigue, Injection site pain, Nausea
SMQs:, Acute pancreatitis (broad), Anticholinergic syndrome (broad), Pseudomembranous colitis (broad), Extravasation events (injections, infusions and implants) (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Vestibular disorders (broad), Noninfectious diarrhoea (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: CODEINE; NAPROXEN; OMEPRAZOL; PREGABALIN
Current Illness: Gastrooesophageal reflux; Nerve pain; Pain
Preexisting Conditions: Medical History/Concurrent Conditions: Lactation decreased; Suspected COVID-19 (Unsure when symptoms stopped)
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBMODERNATX, INC.MOD20212

Write-up: Injection site pain; Diarrhea; Exhaustion; Nausea; Dizziness; This regulatory authority case was reported by a consumer and describes the occurrence of INJECTION SITE PAIN (Injection site pain), DIARRHOEA (Diarrhea), FATIGUE (Exhaustion), NAUSEA (Nausea) and DIZZINESS (Dizziness) in a 37-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 3002332) for COVID-19 vaccination. The patient''s past medical history included Lactation decreased and Suspected COVID-19 (Unsure when symptoms stopped) on 29-Apr-2020. Concurrent medical conditions included Pain, Gastrooesophageal reflux and Nerve pain. Concomitant products included CODEINE and NAPROXEN for Back pain, OMEPRAZOL for Gastrooesophageal reflux, PREGABALIN from April 2020 to an unknown date for Nerve pain. On 05-Jun-2021, the patient received first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 05-Jun-2021, the patient experienced INJECTION SITE PAIN (Injection site pain) (seriousness criterion medically significant), DIARRHOEA (Diarrhea) (seriousness criterion medically significant), FATIGUE (Exhaustion) (seriousness criterion medically significant), NAUSEA (Nausea) (seriousness criterion medically significant) and DIZZINESS (Dizziness) (seriousness criterion medically significant). On 06-Jun-2021, DIARRHOEA (Diarrhea) had resolved. At the time of the report, INJECTION SITE PAIN (Injection site pain) and FATIGUE (Exhaustion) had not resolved and NAUSEA (Nausea) and DIZZINESS (Dizziness) was resolving. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. Patient experienced frequent passing of stools for 24 hours. On an unknown date, the patient tested negative for COVID. No treatment information was 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.; 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: 1404419 (history)  
Form: Version 2.0  
Age: 39.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-29
Onset:2021-06-05
   Days after vaccination:7
Submitted: 0000-00-00
Entered: 2021-06-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 300R332 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Anaphylactic reaction, Hypersensitivity, Vaccination site erythema, Vaccination site rash
SMQs:, Anaphylactic reaction (narrow), Angioedema (broad), Anaphylactic/anaphylactoid shock conditions (narrow), Hypersensitivity (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: Medical History/Concurrent Conditions: Coagulation disorder; Factor X deficiency; Lactation decreased
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBMODERNATX, INC.MOD20212

Write-up: hypersensitive reaction; red patch; Bumpy rash; Hypersensitivity reaction; This regulatory authority case was reported by a consumer and describes the occurrence of HYPERSENSITIVITY (Hypersensitivity reaction) and ANAPHYLACTIC REACTION (hypersensitive reaction) in a 39-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 300r332) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient''s past medical history included Coagulation disorder, Factor X deficiency and Lactation decreased. On 29-May-2021, the patient received first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Jun-2021, the patient experienced HYPERSENSITIVITY (Hypersensitivity reaction) (seriousness criterion medically significant). 05-Jun-2021, the patient experienced VACCINATION SITE ERYTHEMA (red patch) and VACCINATION SITE RASH (Bumpy rash). On an unknown date, the patient experienced ANAPHYLACTIC REACTION (hypersensitive reaction) (seriousness criterion medically significant). At the time of the report, HYPERSENSITIVITY (Hypersensitivity reaction) was resolving and ANAPHYLACTIC REACTION (hypersensitive reaction), VACCINATION SITE ERYTHEMA (red patch) and VACCINATION SITE RASH (Bumpy rash) outcome was unknown. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Intramuscular) was unknown. No concomitant medications and treatment medications provided by the reporter. The patient experienced bumpy rash turned into 20cm x 10 cm hot fluid filled red patch. The patient was not tested positive for COVID-19 since having the vaccine. 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: 1404420 (history)  
Form: Version 2.0  
Age: 30.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-05
Onset:2021-06-05
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-06-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3002332 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Dry throat, Dyspnoea, Limb discomfort, Myocardial infarction, Nausea, Pain in extremity, Pyrexia, Respiration abnormal, SARS-CoV-2 test, Tension headache, Vaccination site warmth
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Myocardial infarction (narrow), Anticholinergic syndrome (broad), Embolic and thrombotic events, arterial (narrow), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Respiratory failure (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (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? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Lactation decreased; Suspected COVID-19
Allergies:
Diagnostic Lab Data: Test Date: 20210428; Test Name: COVID-19 virus test; Test Result: Negative
CDC Split Type: GBMODERNATX, INC.MOD20212

Write-up: four hours after the vaccine; shortness of breath; fever; nausea; Nauseous; Feverish; the arm was very painful, it felt heavy and hot; the arm was very painful, it felt heavy and hot; Tension headaches; Abnormal breathing; Painful arm; Dry throat; This regulatory authority case was reported by a consumer and describes the occurrence of MYOCARDIAL INFARCTION (four hours after the vaccine), DYSPNOEA (shortness of breath), TENSION HEADACHE (Tension headaches), RESPIRATION ABNORMAL (Abnormal breathing), PAIN IN EXTREMITY (Painful arm), DRY THROAT (Dry throat), PYREXIA (fever), NAUSEA (nausea), NAUSEA (Nauseous) and PYREXIA (Feverish) in a 30-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 3002332) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient''s past medical history included Lactation decreased and Suspected COVID-19 on 27-Apr-2021. On 05-Jun-2021, the patient received first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Jun-2021, the patient experienced TENSION HEADACHE (Tension headaches) (seriousness criterion medically significant), RESPIRATION ABNORMAL (Abnormal breathing) (seriousness criterion medically significant), PAIN IN EXTREMITY (Painful arm) (seriousness criterion medically significant), DRY THROAT (Dry throat) (seriousness criterion medically significant), NAUSEA (Nauseous) (seriousness criterion medically significant), PYREXIA (Feverish) (seriousness criterion medically significant), VACCINATION SITE WARMTH (the arm was very painful, it felt heavy and hot) and LIMB DISCOMFORT (the arm was very painful, it felt heavy and hot). On an unknown date, the patient experienced MYOCARDIAL INFARCTION (four hours after the vaccine) (seriousness criterion medically significant), DYSPNOEA (shortness of breath) (seriousness criterion medically significant), PYREXIA (fever) (seriousness criterion medically significant) and NAUSEA (nausea) (seriousness criterion medically significant). The patient was treated with PARACETAMOL at a dose of every 6 hours. On 05-Jun-2021, TENSION HEADACHE (Tension headaches) was resolving, RESPIRATION ABNORMAL (Abnormal breathing), NAUSEA (Nauseous) and PYREXIA (Feverish) had resolved. On 06-Jun-2021, DRY THROAT (Dry throat) had resolved. At the time of the report, MYOCARDIAL INFARCTION (four hours after the vaccine), DYSPNOEA (shortness of breath), PAIN IN EXTREMITY (Painful arm), PYREXIA (fever) and NAUSEA (nausea) was resolving and VACCINATION SITE WARMTH (the arm was very painful, it felt heavy and hot) and LIMB DISCOMFORT (the arm was very painful, it felt heavy and hot) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 28-Apr-2021, SARS-CoV-2 test: Negative. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Intramuscular) was unknown. Patient has not tested positive for COVID-19 since having the vaccine Patient was not enrolled in clinical trial Patient was not pregnant, Patient was not currently breastfeeding 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: 1404421 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-05
Onset:2021-06-05
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-06-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3002332 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Influenza, Pain in extremity, Pruritus
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (broad), Opportunistic infections (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: GBMODERNATX, INC.MOD20212

Write-up: Flu symptoms; Itchy; Painful arm; This regulatory authority case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Painful arm), INFLUENZA (Flu symptoms) and PRURITUS (Itchy) in a male patient of an unknown age who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 3002332) for COVID-19 vaccination. No Medical History information was reported. On 05-Jun-2021, the patient received first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Jun-2021, the patient experienced PAIN IN EXTREMITY (Painful arm) (seriousness criterion medically significant). On 06-Jun-2021, the patient experienced INFLUENZA (Flu symptoms) (seriousness criterion medically significant) and PRURITUS (Itchy) (seriousness criterion medically significant). At the time of the report, PAIN IN EXTREMITY (Painful arm), INFLUENZA (Flu symptoms) and PRURITUS (Itchy) had not resolved. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Intramuscular) was unknown. No concomitant and treatment products reported. 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: 1404452 (history)  
Form: Version 2.0  
Age: 38.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-05
Onset:2021-06-05
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-06-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Chills, Headache, Myalgia, Pyrexia, SARS-CoV-2 test
SMQs:, Rhabdomyolysis/myopathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Eosinophilic pneumonia (broad), Tendinopathies and ligament disorders (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? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Suspected COVID-19 (Unsure when symptoms stopped)
Allergies:
Diagnostic Lab Data: Test Date: 20210105; Test Name: COVID-19 virus test; Test Result: Positive ; Result Unstructured Data: Positive COVID-19
CDC Split Type: GBMODERNATX, INC.MOD20212

Write-up: Fever; Chills; Muscle ache; Headache; This regulatory authority case was reported by a consumer and describes the occurrence of PYREXIA (Fever), CHILLS (Chills), MYALGIA (Muscle ache) and HEADACHE (Headache) in a 38-year-old male patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) for COVID-19 vaccination. The patient''s past medical history included Suspected COVID-19 (Unsure when symptoms stopped) on 05-Jan-2021. On 05-Jun-2021, the patient received first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 05-Jun-2021, the patient experienced PYREXIA (Fever) (seriousness criterion medically significant), CHILLS (Chills) (seriousness criterion medically significant), MYALGIA (Muscle ache) (seriousness criterion medically significant) and HEADACHE (Headache) (seriousness criterion medically significant). At the time of the report, PYREXIA (Fever), CHILLS (Chills), MYALGIA (Muscle ache) and HEADACHE (Headache) was resolving. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 05-Jan-2021, SARS-CoV-2 test: positive (Positive) Positive COVID-19. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. Concomitant medication was not provided by the reporter. Treatment information 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 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. Of note, there is a discrepancy and possible data error in the source document regarding the patient''s gender (male) and history of pregnancy.; 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. Of note, there is a discrepancy and possible data error in the source document regarding the patient''s gender (male) and history of pregnancy.


VAERS ID: 1406235 (history)  
Form: Version 2.0  
Age: 38.0  
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2021-06-05
Submitted: 0000-00-00
Entered: 2021-06-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Dizziness, Loss of consciousness
SMQs:, Torsade de pointes/QT prolongation (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Vestibular disorders (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypoglycaemia (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: ITJNJFOC20210626364

Write-up: 5 MINUTES AFTER THE INOCULATION OF THE JANSSEN VACCINE FAINTED WITH LOSS OF CONSCIOUSNESS; 5 MINUTES AFTER THE INOCULATION OF THE JANSSEN VACCINE SUDDENLY EXPERIENCED A STRONG DIZZINESS; This spontaneous report received from a consumer via a Regulatory Authority [EMEA EVHUMAN NLP, IT-MINISAL02-740170] concerned a 38 year old male. The patient''s weight was 68 kilograms, and height was 170 centimeters. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: XD985 expiry: Unknown) dose was not reported, 1 total, administered on 05-JUN-2021 for prophylactic vaccination. No concomitant medications were reported. On 05-JUN-2021, 5 minutes after the inoculation of the Janssen vaccine the patient suddenly experienced a strong dizziness and fainted with loss of consciousness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered with sequelae from 5 minutes after the inoculation of the Janssen vaccine the patient suddenly experienced a strong dizziness and fainted with loss of consciousness.This report was serious (Life Threatening).; Reporter''s Comments: Allergy to gramineaes and dust; Sender''s Comments: 20210626364- covid-19 vaccine ad26.cov2.s- 5 minutes after the inoculation of the Janssen vaccine the patient suddenly experienced a strong dizziness and fainted with loss of consciousness. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).


VAERS ID: 1408054 (history)  
Form: Version 2.0  
Age: 83.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-29
Onset:2021-06-05
   Days after vaccination:7
Submitted: 0000-00-00
Entered: 2021-06-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 LA / -

Administered by: Other       Purchased by: ?
Symptoms: Bell's palsy, Ear pain, Inappropriate schedule of product administration
SMQs:, Hearing impairment (broad), Medication errors (narrow)

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:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: COPD; Eczema
Allergies:
Diagnostic Lab Data:
CDC Split Type: CAPFIZER INC2021684280

Write-up: patient received first dose on 25Feb2021 and second dose on 29May2021; bell''s palsy preceded by earache; bell''s palsy preceded by earache; This is a spontaneous report received from a contactable consumer (patient). A 83-year-old non-pregnant female received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection; Lot number: unknown) via unspecified route of administration in left arm on 29May2021 at 16:45 (at the age of 83-year-old) as single dose for COVID-19 immunisation. Medical history of the patient included COPD (Chronic obstructive pulmonary disease), eczema. Concomitant medications were not reported. Other medications patient received within 2 weeks of vaccination included blood pressure, cholesterol, anticoagulant, inhaler. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19, since the vaccination, the patient has not been tested for COVID-19. Patient previously received penicillin and iodine on an unspecified date for unspecified indication and experienced allergy. Patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection; Lot number: unknown) via an unspecified route of administration in left arm on 25Feb2021 at 06:15 as single dose for COVID-19 immunisation. On 05Jun2021, at 09:00, seven days after second dose of vaccination, the patient experienced bell''s palsy preceded by earache. Event led to patient visit in emergency room/department or urgent care. Treatment given in response to the event bell''s palsy preceded by earache included antiviral, cortisone and ophthalmological drops. Outcome of the event "bell''s palsy preceded by earache" was recovering and for the event "patient received first dose on 25Feb2021 and second dose on 29May2021" was unknown.


VAERS ID: 1408778 (history)  
Form: Version 2.0  
Age: 35.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-05
Onset:2021-06-05
   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 FA1027 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Abdominal pain, Anaphylactic reaction, Cold sweat, Dizziness, Dyspnoea, Feeling guilty, Hypopnoea, Muscle spasms, Paraesthesia, Paraesthesia oral, Syncope, Tearfulness, Tongue spasm
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (narrow), Acute pancreatitis (broad), Peripheral neuropathy (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Retroperitoneal fibrosis (broad), Anaphylactic/anaphylactoid shock conditions (narrow), Dystonia (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Acute central respiratory depression (narrow), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Depression (excl suicide and self injury) (narrow), Vestibular disorders (broad), Hypotonic-hyporesponsive episode (broad), Hypersensitivity (narrow), Respiratory failure (narrow), Hypoglycaemia (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? No
Previous Vaccinations:
Other Medications: ADRENALINE [EPINEPHRINE]; LORATADINE; OXYGEN
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Hay fever; Comments: Patient has not had symptoms associated with COVID-19 Not had a COVID-19 test Patient is not enrolled in clinical trial
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC2021657446

Write-up: pins and needles/arms cramped up with pins and needles/so did legs and then tongue and then chest and then abdomen; pins and needles/arms cramped up with pins and needles/so did legs and then tongue and then chest and then abdomen; pins and needles/arms cramped up with pins and needles/so did legs and then tongue and then chest and then abdomen; Feeling regretful and tearful; Feeling regretful and tearful; Anaphylactic reaction; gasping; dizzy; shallow breathing; clammy; faint; pins and needles/arms cramped up with pins and needles/so did legs and then tongue and then chest and then abdomen; pins and needles/arms cramped up with pins and needles/so did legs and then tongue and then chest and then abdomen; This is a spontaneous report from a contactable consumer received from the Regulatory Agency. The regulatory authority report number is GB-MHRA-WEBCOVID-202106051421340190-9KO8Q, Safety Report Unique Identifier GB-MHRA-ADR 25425935. A 35-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: FA1027), via an unspecified route of administration on 05Jun2021 (at the age of 35 years old) as 1st dose, single dose for COVID-19 immunization. The patient''s medical history included hay fever from an unknown date and unknown if ongoing. No known drug allergies. Patient has not had symptoms associated with COVID-19 and not had a COVID-19 test. Patient is not enrolled in clinical trial. Concomitant medications included adrenaline [epinephrine] and oxygen, both taken for an unspecified indication; and loratadine taken for hay fever; all start and stop dates were not reported. The patient experienced anaphylactic reaction, gasping, dizzy, shallow breathing, clammy, faint, pins and needles/arms cramped up with pins and needles/so did legs and then tongue and then chest and then abdomen, feeling regretful and tearful on 05Jun2021. It was reported that 5 minutes after the vaccine shot, the patient felt dizzy and faint in waiting room. Needed to lie down. Got on the chair to bay and lay down on bed. Skin clammy. Arms cramped up with pins and needles. So did legs and then tongue and then chest and then abdomen. Shallow breathing, gasping for air. Feeling regretful and tearful. Staff administered oxygen 100 and adrenaline 500mcg IM. Symptoms resolved in around 10 to 15 minutes. Emergency services arrived and assessed. The reporter assessed all events as serious (life-threatening). The outcome of the event anaphylactic reaction was recovered on 05Jun2021 while the outcome of all other events was recovered on an unspecified date in Jun2021. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1408779 (history)  
Form: Version 2.0  
Age: 32.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-29
Onset:2021-06-05
   Days after vaccination:7
Submitted: 0000-00-00
Entered: 2021-06-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3002332 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Rash erythematous
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (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: PARACETAMOL
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Lactation decreased
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBMODERNATX, INC.MOD20212

Write-up: Red rash; This regulatory authority case was reported by a consumer and describes the occurrence of RASH ERYTHEMATOUS (Red rash) in a 32-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 3002332) for COVID-19 vaccination. The patient''s past medical history included Lactation decreased. Concomitant products included PARACETAMOL for Headache. On 29-May-2021, the patient received first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Jun-2021, the patient experienced RASH ERYTHEMATOUS (Red rash) (seriousness criterion medically significant). At the time of the report, RASH ERYTHEMATOUS (Red rash) had not resolved. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Intramuscular) was unknown. 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 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: 1408782 (history)  
Form: Version 2.0  
Age: 28.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-03
Onset:2021-06-05
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-06-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Nervousness, Renal pain
SMQs:, 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? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Lactation decreased
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBMODERNATX, INC.MOD20212

Write-up: Shaky feelings; Pain kidney; This regulatory authority case was reported by a consumer and describes the occurrence of RENAL PAIN (Pain kidney) and NERVOUSNESS (Shaky feelings) in a 28-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) for COVID-19 vaccination. The patient''s past medical history included Lactation decreased. On 03-Jun-2021, the patient received first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 05-Jun-2021, the patient experienced RENAL PAIN (Pain kidney) (seriousness criterion medically significant). On 06-Jun-2021, the patient experienced NERVOUSNESS (Shaky feelings) (seriousness criterion medically significant). At the time of the report, RENAL PAIN (Pain kidney) and NERVOUSNESS (Shaky feelings) was resolving. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. No concomitant medications were reported. No treatment medications 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.; 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: 1408786 (history)  
Form: Version 2.0  
Age: 35.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-05
Onset:2021-06-05
   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 ET8885 / 1 LA / -

Administered by: Other       Purchased by: ?
Symptoms: Facial paralysis, Hypoaesthesia, Paraesthesia, SARS-CoV-2 test
SMQs:, Peripheral neuropathy (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious meningitis (broad), Hearing impairment (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? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Lactation decreased
Allergies:
Diagnostic Lab Data: Test Date: 20210601; Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC2021671388

Write-up: numbness; pins and needles; Facial droop; This is a spontaneous report from a contactable consumer (patient) received from the Regulatory Agency. The regulatory authority report number is GB-MHRA-WEBCOVID-202106071335194240-PAR3D. A 35-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, batch/lot number was ET8885 and expiration date was not reported), dose 1 via an unspecified route of administration, administered in arm left on 05Jun2021 as 1st dose, single dose (age at vaccination was 35 years) for COVID-19 immunisation. Medical history included lactation decreased from an unknown date and unknown if ongoing. Patient had not had symptoms associated with COVID-19. Patient was not enrolled in clinical trial. She was not pregnant and was not currently breastfeeding. The patient''s concomitant medications were not reported. The patient experienced facial droop on 05Jun2021, numbness and pins and needles on an unspecified date. The patient underwent lab tests and procedures which included COVID-19 virus test: no-negative on 01Jun2021. Additional information included: About 45 minutes after the vaccine was administered to her left arm, she started to feel pins and needles in her left hand. She then started to feel the same in her left foot, and then the left side of her face felt numb. It felt as thought the pins and needles were spreading down the left side of her body. The pins and needles in her foot went away in a few hours. The pins and needles in her hand remain but were very slight. The numbness in the left side of her face had stayed and was still the same. It felt as though she had been to the dentist and had a dental injection. Patient had not tested positive for COVID-19 since having the vaccine. The outcome of the event facial droop was not recovered and outcome of the other events was recovering. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1408792 (history)  
Form: Version 2.0  
Age: 34.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-30
Onset:2021-06-05
   Days after vaccination:6
Submitted: 0000-00-00
Entered: 2021-06-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3002332 / 1 LA / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Lymphadenopathy, Pain, Pruritus, Rash, Rash macular, SARS-CoV-2 test, Vaccination site mass
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (narrow), 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? No
Previous Vaccinations:
Other Medications: CIMIZT
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Lactation decreased
Allergies:
Diagnostic Lab Data: Test Date: 20210604; Test Name: COVID-19 virus test; Test Result: Negative ; Result Unstructured Data: No - Negative COVID-19 test
CDC Split Type: GBMODERNATX, INC.MOD20212

Write-up: itch; blotchy; pain; soft bump; rash; Swollen lymph nodes; This regulatory authority case was reported by a consumer and describes the occurrence of PRURITUS (itch), RASH MACULAR (blotchy), PAIN (pain), VACCINATION SITE MASS (soft bump), RASH (rash) and LYMPHADENOPATHY (Swollen lymph nodes) in a 34-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 3002332) for COVID-19 vaccination. The patient''s past medical history included Lactation decreased. Concomitant products included DESOGESTREL, ETHINYLESTRADIOL (CIMIZT) for Oral contraception. On 30-May-2021, the patient received first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 05-Jun-2021, the patient experienced LYMPHADENOPATHY (Swollen lymph nodes) (seriousness criterion medically significant). On an unknown date, the patient experienced PRURITUS (itch) (seriousness criterion medically significant), RASH MACULAR (blotchy) (seriousness criterion medically significant), PAIN (pain) (seriousness criterion medically significant), VACCINATION SITE MASS (soft bump) (seriousness criterion medically significant) and RASH (rash) (seriousness criterion medically significant). At the time of the report, PRURITUS (itch), RASH MACULAR (blotchy), PAIN (pain), VACCINATION SITE MASS (soft bump) and RASH (rash) outcome was unknown and LYMPHADENOPATHY (Swollen lymph nodes) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 04-Jun-2021, SARS-CoV-2 test: no - negative covid-19 test (Negative) No - Negative COVID-19 test. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. No treatment information was 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.; 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: 1408842 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-28
Onset:2021-06-05
   Days after vaccination:8
Submitted: 0000-00-00
Entered: 2021-06-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW3143 / 1 LA / -

Administered by: Other       Purchased by: ?
Symptoms: Bell's palsy
SMQs:, Hearing impairment (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC2021682433

Write-up: Bell''s palsy; This is a spontaneous report from a non-contactable consumer. A 32-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for Injection, Batch/Lot Number: EW3143) via an unspecified route of administration, administered in Arm Left on 28May2021 as first dose, single dose for covid-19 immunization. The patient medical history and concomitant medications were not reported. Prior to the vaccination, the patient was not diagnosed with covid-19. Since the vaccination, the patient had not been tested for covid -19. On 05Jun2021 the patient experienced bell''s palsy. The patient visited the emergency room and physician office. The patient received prednisolone 5 mg, 10 tabs/day for 10 day in response to the events. The patient did not receive any other vaccines within 4 weeks prior to the covid vaccine. The patient had not received other medications within 2 weeks of vaccination. Outcome of the event was not recovered. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1409222 (history)  
Form: Version 2.0  
Age: 90.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-04
Onset:2021-06-05
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-06-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EY5420 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure decreased, Blood pressure measurement, Body temperature, Heart rate, Hypopnoea, Pulse absent, Shock
SMQs:, Anaphylactic reaction (narrow), Neuroleptic malignant syndrome (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Hypovolaemic shock conditions (narrow), Toxic-septic shock conditions (narrow), Anaphylactic/anaphylactoid shock conditions (narrow), Hypoglycaemic and neurogenic shock conditions (narrow), Acute central respiratory depression (narrow), Hypotonic-hyporesponsive episode (broad), Hypersensitivity (narrow), Respiratory failure (narrow), Dehydration (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? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210605; Test Name: Blood pressure; Result Unstructured Data: Test Result:decreased; Test Date: 20210604; Test Name: Body temperature; Result Unstructured Data: Test Result:36.4 Centigrade; Comments: Before vaccination; Test Date: 20210605; Test Name: Pulse; Result Unstructured Data: Test Result:not palpable
CDC Split Type: JPPFIZER INC2021666474

Write-up: This is a report received from the Regulatory Authority. Regulatory authority report number is v21112013. A 90-year-old female patient received bnt162b2 (COMIRNATY), dose 1 via an unspecified route of administration on 04Jun2021 at 12:40 (Batch/Lot Number: EY5420; Expiration Date: 31Aug2021) at 90-years-old as a single dose for COVID-19 immunisation. The patient''s medical history and concomitant medications were not reported. On 05Jun2021 09:40, the patient experienced: shock (blood pressure decreased and hypopnoea) (medically significant, life threatening), pulse was not and palpable (medically significant, life threatening). The clinical course was reported as follows: The patient was a 90-year and 7-month-old female. Body temperature before vaccination was 36.4 degrees Centigrade. There were no points to be considered on the vaccine screening questionnaire (primary diseases, allergies, vaccinations and illnesses within the last one month, medications the patient was taking, past adverse effect history, growth status). No information on family history was provided. On 04Jun2021 at 12:40 (the day of vaccination), the patient received the first dose of BNT162b2 (COMIRNATY, Solution for injection, Lot# EY5420, Expiration date 31Aug2021) via an unspecified route of administration as a single dose for COVID-19 immunization. On 05Jun2021 at 21:40 (1 day after the vaccination), the patient experienced shock (blood pressure decreased and hypopnoea). On 07Jun2021 at 21:40 (3 day after vaccination), the outcome of the event was recovered. The course of the event was as follows: On 05Jun2021 at 21:40, blood pressure decreased (shock status, pulse was not palpable). Although 24 hours passed after the vaccination, the patient developed blood pressure decreased and weakened respiratory function. The patient was being observed while receiving fluid infusion. The symptoms spontaneously improved. The reporting physician classified the event as serious (Life-threatening condition) and assessed the causality between the event and BNT162b2 as unassessable. The reporting physician considered that there was other possible cause of the event such as any other diseases. The patient underwent lab tests and procedures which included blood pressure: decreased on 05Jun2021, body temperature: 36.4 Centigrade on 04Jun2021 (Before vaccination), pulse: not palpable on 05Jun2021. Therapeutic measures were taken as a result of shock (blood pressure decreased and hypopnoea), and pulse was not palpable (pulse absent). The clinical outcome of the events was recovered on 07Jun2021.


VAERS ID: 1409825 (history)  
Form: Version 2.0  
Age: 78.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-02
Onset:2021-06-05
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-06-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FA7812 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Hemiparesis, Hemiplegia, Ischaemic stroke, Speech disorder
SMQs:, Ischaemic central nervous system vascular conditions (narrow), Dementia (broad), Embolic and thrombotic events, arterial (narrow), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Psychosis and psychotic disorders (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (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: BILOCOR; ECOTRIN; METFORMIN; PANTOR
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Bypass surgery (Good recovery); Diabetes; Prostate surgery
Allergies:
Diagnostic Lab Data:
CDC Split Type: ZAPFIZER INC2021687258

Write-up: Difficulty of speech; weakness/paralysis of the right arm and leg.; weakness/paralysis of the right arm and leg.; Admitted to ICU with a stroke (thrombotic); This is a spontaneous report from a contactable consumer. A 78-year-old male patient received the first dose of BNT162B2 via an unspecified route of administration on 02Jun2021 (Batch/ Lot number: FA7812) at 78-year-old as single dose for COVID-19 immunization. Medical history included quadruple bypass from 2018 to an unknown date and good recovery, prostate scrapping from 2019, post surgery diabetes from 2018. Concomitant medications included bisoprolol fumarate (BILOCOR), acetylsalicylic acid (ECOTRIN), metformin and pantoprazole sodium sesquihydrate (PANTOR). On 05Jun2021, the patient experienced difficult of speech, weakness/paralysis of the right of arm and leg, admitted to ICU with a stroke. The patient was hospitalization. The outcome of evens was unknown. No follow-up attempts are possible; no further information is expected.


VAERS ID: 1409841 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-04
Onset:2021-06-05
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-06-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Cerebral infarction, Fall
SMQs:, Ischaemic central nervous system vascular conditions (narrow), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Accidents and injuries (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:
CDC Split Type: JPTAKEDA2021TJP036538

Write-up: Hospitalized for cerebral infarction; Transported to the hospital by ambulance due to fell on next day of received vaccination; This regulatory authority case was reported by a consumer and describes the occurrence of CEREBRAL INFARCTION (Hospitalized for cerebral infarction) and FALL (Transported to the hospital by ambulance due to fell on next day of received vaccination) in a male patient of an unknown age who received mRNA-1273 (COVID 19 Vaccine Moderna) for COVID-19 vaccination. No Medical History information was reported. On 04-Jun-2021, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) 1 dosage form. On 05-Jun-2021, after starting mRNA-1273 (COVID 19 Vaccine Moderna), the patient experienced FALL (Transported to the hospital by ambulance due to fell on next day of received vaccination) (seriousness criterion hospitalization). On 05-Jun-2021 at 10:00 AM, the patient experienced CEREBRAL INFARCTION (Hospitalized for cerebral infarction) (seriousness criteria hospitalization and medically significant). At the time of the report, CEREBRAL INFARCTION (Hospitalized for cerebral infarction) and FALL (Transported to the hospital by ambulance due to fell on next day of received vaccination) had not resolved. The action taken with mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) was unknown. Concomitant medications were not provided. On an unknown date, body temperature before vaccination was unknown. Treatment information was not reported. The events developed after the administration of COVID-19 vaccine mRNA (mRNA 1273) but a possibility such as accidental incident was also considered. 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: 1410594 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-01
Onset:2021-06-05
   Days after vaccination:35
Submitted: 0000-00-00
Entered: 2021-06-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Computerised tomogram, Fibrin D dimer, Pulmonary embolism
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? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: CR Scan; Result Unstructured Data: Test Result:pending result; Comments: pending result; Test Name: D-dimer; Test Result: Negative
CDC Split Type: CAPFIZER INC2021677922

Write-up: pulmonary embolism; This is a spontaneous report received from a contactable nurse. A 20-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), unknown dose two weeks before the reporting time in May2021 as single dose for COVID-19 Immunization. Medical history and concomitant medications were not reported. The patient had pulmonary embolism on the reporting day 05Jun2021. Admitted to hospital. She had had CR (unknown meaning) scan to confirm. Event took place after use of product. The treatment received for the event. This was reported by a nurse at another hospital that works with the patient''s sister. Patient was sent home same day on Eliquis. D-dimer was negative. The outcome of the event was Not recovered. No follow-up attempts are possible. No further information is expected.; Sender''s Comments: Limited information can not support a complete medical assessment. Apossible contributory role of BNT162B2 vaccine can not be excluded for the reported event of pulmonary embolism due to temporal relationship. Case will be re-assessed upon the additional information provided. 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: 1411621 (history)  
Form: Version 2.0  
Age: 34.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-28
Onset:2021-06-05
   Days after vaccination:8
Submitted: 0000-00-00
Entered: 2021-06-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW3143 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Herpes zoster
SMQs:, 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: ACICLOVIR
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Lactation decreased; Comments: Patient has not had symptoms associated with COVID-19 Not had a COVID-19 test Patient is not enrolled in clinical trial Patient is not pregnant,Patient is not currently breastfeeding
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC2021657199

Write-up: Shingles; This is a spontaneous report from a contactable consumer or other non hcp received from the Regulatory Agency. The regulatory authority report number is GB-MHRA-WEBCOVID-202106060022039510-FSVIL. Safety Report Unique Identifier (GB-MHRA-ADR 25426633). A 34-years-old female patient received bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection, Lot number: EW3143; Expiration Date: unknown), dose 1 via an unspecified route of administration on 28May2021 (at the age of 34 years) as 1st dose, single dose for COVID-19 immunization. Medical history included suppressed lactation. Concomitant medication(s) included acyclovir (antiviral medication) taken for an unspecified indication. Patient has not had symptoms associated with COVID-19. Not had a COVID-19 test. Patient was not enrolled in clinical trial. Patient was not pregnant, Patient was not currently breastfeeding. Patient had not tested positive for COVID-19 since having the vaccine. On 05Jun2021, the patient experienced shingles ("Visited GP"). The clinical outcome of the event was not recovered. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1411624 (history)  
Form: Version 2.0  
Age: 18.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-05
Onset:2021-06-05
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-06-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Asthenia, Headache, Pain in extremity, SARS-CoV-2 test
SMQs:, Guillain-Barre syndrome (broad), Tendinopathies and ligament 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? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Lactation decreased
Allergies:
Diagnostic Lab Data: Test Date: 20210605; Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC2021682072

Write-up: Weakness; Pain in arm; Headache; This is a spontaneous from two contactable consumer downloaded from the Regulatory Authority. Regulatory authority report number GB-MHRA-WEBCOVID-202106062059574020-W6J7H with Safety Report Unique Identifier GB-MHRA-ADR 25427821. An 18-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 05Jun2021 (at the age of 18-year-old) at single dose for COVID-19 immunisation. Relevant medical history included suppressed lactation. Patient has not had symptoms associated with COVID-19. Patient is not enrolled in clinical trial. Patient is not pregnant. Patient is not currently breastfeeding. Patient has not tested positive for COVID-19 since having the vaccine. Concomitant medications were not reported. On 05Jun2021 the patient experienced weakness, pain in arm and headache. All the events were serious as medically significant. The patient underwent lab tests and procedures which included SARS-CoV-2 test: negative on 05Jun2021 (No - Negative COVID-19 test). Weakness and pain in arm were not resolved, headache resolved on an unspecified date. No follow-up attempts are possible. Information about lot/batch number cannot be obtained.


VAERS ID: 1411630 (history)  
Form: Version 2.0  
Age: 32.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-05
Onset:2021-06-05
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-06-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3002332 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Chills, Headache, Nausea, Pain in extremity, Presyncope, Pyrexia, SARS-CoV-2 test
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hypotonic-hyporesponsive episode (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (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? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Lactation decreased
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative
CDC Split Type: GBMODERNATX, INC.MOD20212

Write-up: Near fainting; Headache; Fever; Nausea; Shivering; Painful arm; This regulatory authority case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Painful arm), PRESYNCOPE (Near fainting), HEADACHE (Headache), PYREXIA (Fever), NAUSEA (Nausea) and CHILLS (Shivering) in a 32-year-old female patient who received mRNA-1273 (COVID-19 Vaccine Moderna) (batch no. 3002332) for COVID-19 vaccination. The patient''s past medical history included Lactation decreased. On 05-Jun-2021, the patient received first dose of mRNA-1273 (COVID-19 Vaccine Moderna) (unknown route) 1 dosage form. On 05-Jun-2021, the patient experienced PAIN IN EXTREMITY (Painful arm) (seriousness criterion medically significant), HEADACHE (Headache) (seriousness criterion medically significant), PYREXIA (Fever) (seriousness criterion medically significant), NAUSEA (Nausea) (seriousness criterion medically significant) and CHILLS (Shivering) (seriousness criterion medically significant). On 06-Jun-2021, the patient experienced PRESYNCOPE (Near fainting) (seriousness criterion medically significant). On 06-Jun-2021, PRESYNCOPE (Near fainting) had resolved. On 07-Jun-2021, NAUSEA (Nausea) had resolved. At the time of the report, PAIN IN EXTREMITY (Painful arm), HEADACHE (Headache) and PYREXIA (Fever) had not resolved and CHILLS (Shivering) was resolving. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: no - negative covid-19 test Negative. The action taken with mRNA-1273 (COVID-19 Vaccine Moderna) (Unknown) was unknown. The concomitant medications and treatment details were not provided. Patient has not tested positive for COVID-19 since having the vaccine. Patient was not enrolled in clinical trial. Patient was not pregnant. Patient was not currently breastfeeding. 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: 1411632 (history)  
Form: Version 2.0  
Age: 23.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-05
Onset:2021-06-05
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-06-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Fatigue, Hot flush, Influenza like illness, Injection site pain, Nasal congestion, Pain in extremity, SARS-CoV-2 test
SMQs:, Extravasation events (injections, infusions and implants) (broad), Tendinopathies and ligament 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: NORTRIPTYLINE; SERTRALINE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Chronic pain (Have suffered from chronic pain and 10kg weightloss since August 2020); Gallbladder removal (Waiting for my gallbladder removal surgery on the 22nd of June); Lactation decreased; Suspected COVID-19 (Unsure when symptoms stopped); Weight loss (Have suffered from chronic pain and 10kg weightloss since August 2020)
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative ; Result Unstructured Data: Negative COVID-19 test
CDC Split Type: GBMODERNATX, INC.MOD20212

Write-up: painful arm; Hot flushes; Nose congestion; Flu like symptoms; Fatigue; Injection site pain; This regulatory authority case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (painful arm), HOT FLUSH (Hot flushes), NASAL CONGESTION (Nose congestion), INFLUENZA LIKE ILLNESS (Flu like symptoms), INJECTION SITE PAIN (Injection site pain) and FATIGUE (Fatigue) in a 23-year-old female patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) for COVID-19 vaccination. The patient''s past medical history included Lactation decreased, Chronic pain (Have suffered from chronic pain and 10kg weightloss since August 2020) in August 2020, Suspected COVID-19 (Unsure when symptoms stopped) on 01-Mar-2020, Weight loss (Have suffered from chronic pain and 10kg weightloss since August 2020) in August 2020 and Gallbladder removal (Waiting for my gallbladder removal surgery on the 22nd of June). Concomitant products included NORTRIPTYLINE from 11-Jun-2013 to an unknown date for Migraine, SERTRALINE from 07-Feb-2021 to an unknown date for an unknown indication. On 05-Jun-2021, the patient received first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 05-Jun-2021, the patient experienced INJECTION SITE PAIN (Injection site pain) (seriousness criterion medically significant). On 06-Jun-2021, the patient experienced HOT FLUSH (Hot flushes) (seriousness criterion medically significant), NASAL CONGESTION (Nose congestion) (seriousness criterion medically significant), INFLUENZA LIKE ILLNESS (Flu like symptoms) (seriousness criterion medically significant) and FATIGUE (Fatigue) (seriousness criterion medically significant). On an unknown date, the patient experienced PAIN IN EXTREMITY (painful arm) (seriousness criterion medically significant). The patient was treated with PARACETAMOL at an unspecified dose and frequency. On 07-Jun-2021, NASAL CONGESTION (Nose congestion) had resolved. At the time of the report, PAIN IN EXTREMITY (painful arm), HOT FLUSH (Hot flushes), INFLUENZA LIKE ILLNESS (Flu like symptoms), INJECTION SITE PAIN (Injection site pain) and FATIGUE (Fatigue) was resolving. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: no (Negative) Negative COVID-19 test. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. Patient is not enrolled in clinical trial. Patient is not pregnant, Patient is not currently breastfeeding. Patient has not tested positive for COVID-19 since having the vaccine. 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. The current condition "gallbladder removal" seems to be erroneous coding from the verbatim "Waiting for my gallbladder removal surgery on the 22nd of June." Strange sensation in arm up to neck and down to the hand. Next day really painful arm and hot flushes. Fatigue and flu like symptoms. Lack of appetite and severe body aches. The day after that fatigue and hot flushes continues. Spent day in bed and couldn''t concentrate on work. Took paracetamol every 4-6 hours.; 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. The current condition "gallbladder removal" seems to be erroneous coding from the verbatim "Waiting for my gallbladder removal surgery on the 22nd of June."


VAERS ID: 1411633 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-04
Onset:2021-06-05
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-06-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: SARS-CoV-2 test, Vasospasm
SMQs:, 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? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative ; Result Unstructured Data: Negative COVID-19 test
CDC Split Type: GBMODERNATX, INC.MOD20212

Write-up: Spasm of vein; This regulatory authority case was reported by a consumer and describes the occurrence of VASOSPASM (Spasm of vein) in a male patient of an unknown age who received mRNA-1273 (COVID 19 Vaccine Moderna) for COVID-19 vaccination. No Medical History information was reported. On 04-Jun-2021, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (unknown route) 1 dosage form. On 05-Jun-2021, the patient experienced VASOSPASM (Spasm of vein) (seriousness criterion medically significant). At the time of the report, VASOSPASM (Spasm of vein) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: negative (Negative) Negative COVID-19 test. The action taken with mRNA-1273 (COVID 19 Vaccine Moderna) (Unknown) was unknown. Concomitant product use was not provided by the reporter. No treatment information was provided. Patient had not had symptoms associated with COVID-19. Patient was not enrolled in clinical trial and had not tested positive for COVID-19 since having the vaccine. 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: 1411636 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-11
Onset:2021-06-05
   Days after vaccination:25
Submitted: 0000-00-00
Entered: 2021-06-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Herpes zoster, SARS-CoV-2 test
SMQs:, Opportunistic infections (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? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Immunodeficiency (Has an illness or condition, not listed above, which reduces the immune response (e.g. immunodef).)
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Result Unstructured Data: Test Result:No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC2021677398

Write-up: Shingles; This is a spontaneous report from a contactable consumer. This is a report received from the Regulatory Authority. Regulatory authority report number GB-MHRA-WEBCOVID-202106081033357950-RMD9V, Safety Report Unique Identifier GB-MHRA-ADR 25436776. A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Batch/Lot Number: Unknown, Expiration Date: Not reported), via an unspecified route of administration in an unspecified anatomical location on 11May2021 as first dose, single dose for COVID-19 immunisation. Medical history included an illness or condition which reduces the immune response "(e.g. immunodeficiency)" from an unknown date and unknown if ongoing. The patient had not had symptoms associated with COVID-19 and was not enrolled in clinical trial. The patient''s concomitant medications were not reported. Since the vaccination, the patient had not tested positive for COVID-19. The patient experienced shingles on 05Jun2021. The seriousness of shingles was reported as serious (medically significant). The patient underwent lab tests and procedures which included sars-cov-2 test: negative COVID-19 on an unknown date. The patient outcome of shingles was reported as not resolved. No follow-up attempts are possible; information about lot/batch number cannot be obtained.


VAERS ID: 1411643 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-04
Onset:2021-06-05
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-06-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Herpes zoster, SARS-CoV-2 test, Suspected COVID-19
SMQs:, 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? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Lactation decreased
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative ; Comments: No - Negative COVID-19 test
CDC Split Type: GBPFIZER INC2021692874

Write-up: Shingles; Suspected COVID-19; This is a spontaneous report from a contractable consumer. This is a report received from the regulatory authority. The regulatory authority report number is, GB-MHRA-WEBCOVID-202106111811095690-LV9KA. Safety Report Unique Identifier GB-MHRA-ADR 25460882. A 30-year-old (non-pregnant) female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on 04Jun2021 as single dose for COVID-19 immunization. Medical history included suppressed lactation from an unknown date and unknown if ongoing. Patient was not enrolled in clinical trial. Patient was not pregnant and she was not currently breastfeeding. Patient had not tested positive for COVID-19 since having the vaccine. The patient''s concomitant medications were not reported. On 05Jun2021, the patient experienced shingles and suspected covid-19 which was on going. The patient underwent lab tests and procedures which included sars-cov-2 test: negative No - Negative COVID-19 test on an unknown date. The outcome of the events was not recovered. No follow-up attempts are possible. Information about lot/batch number cannot be obtained.


VAERS ID: 1411650 (history)  
Form: Version 2.0  
Age: 39.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-05-15
Onset:2021-06-05
   Days after vaccination:21
Submitted: 0000-00-00
Entered: 2021-06-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ET8885 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Herpes zoster
SMQs:, Opportunistic infections (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: Lactation decreased; Suspected COVID-19
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC2021710127

Write-up: Shingles; This is a spontaneous report from a contactable consumer. This is a report received from the regulatory authority. Regulatory authority report number GB-MHRA-WEBCOVID-202106141430279010-Z0UXU, Safety Report Unique Identifier GB-MHRA-ADR 25470695. A 39-year-old non pregnant and currently not breastfeeding female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection, Lot number ET8885) via an intramuscular route of administration on 15May2021 as 1ST DOSE, SINGLE DOSE (at the age of 39-years-old) for COVID-19 immunization. The patient''s medical history included suppressed lactation from an unknown date and unknown if ongoing and suspected COVID-19 from 14Mar2020 to 02Apr2020. The patient''s concomitant medications were not reported. The patient did not have a COVID-19 test and was not enrolled in clinical trial. On 05Jun2021, patient experienced shingles. The event was assessed as medically significant. Outcome of the event was not recovered. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1411652 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:2021-05-20
Onset:2021-06-05
   Days after vaccination:16
Submitted: 0000-00-00
Entered: 2021-06-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ET8885 / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Bell's palsy, Computerised tomogram, Facial paralysis
SMQs:, Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious meningitis (broad), Hearing impairment (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: PREDNISOLONE
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210606; Test Name: CT scan; Result Unstructured Data: Test Result:Stroke excluded
CDC Split Type: GBPFIZER INC2021709749

Write-up: facial droop; Palsy Bells; This is a spontaneous report from a contactable physician received from theregulatory authority report number is GB-MHRA-WEBCOVID-202106141920422470-S3HZR, Safety Report Unique Identifier GB-MHRA-ADR 25472825. A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/lot number: ET8885, expiry date: not reported) dose 1 via an unspecified route of administration on 20May2021 as single dose for COVID-19 immunization. The patient medical history was not reported. Otherwise fit and well, NKDA. Patient had not any symptoms associated with COVID-19 and not had a COVID-19 test. Patient had not tested positive for COVID-19 since having the vaccine. Unsure if patient was enrolled in clinical trial. Concomitant medication included prednisolone. On 05Jun2021, the patient experienced bell''s palsy and facial droop on an unknown date. On 06Jun2021, the patient underwent lab tests and procedures which included computerised tomogram to exclude stroke. The outcome of the event facial droop was unknown. The outcome of the event bell''s palsy was reported as recovering. Therapeutic measures were taken as a result of facial droop and Bell''s Palsy with prednisolone 60mg. Additional information: 05Jun21 - unilateral facial droop, investigated in hospital, treated with. Patient has not tested positive for COVID-19 since having the vaccine Reaction: It was asked if there report relate to possible blood clots or low platelet counts. If yes, they may ask additional questions at the end of this report: "No" Suspect Reactions: Please provide details of any relevant investigations or tests conducted: "CT Head 06Jun21 to exclude stroke" No follow-up attempts are possible. No further information is expected.


VAERS ID: 1411654 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-05-29
Onset:2021-06-05
   Days after vaccination:7
Submitted: 0000-00-00
Entered: 2021-06-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Herpes zoster
SMQs:, Opportunistic infections (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: FLUCLOXACILLIN
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Infected toe
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBPFIZER INC2021715837

Write-up: Shingles; This is a spontaneous report. The 32-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on 29May2021 as 1st dose, single dose for covid-19 immunisation. The medical history included localised infection from an unknown date and unknown if ongoing. The concomitant medications included flucloxacillin (FLUCLOXACILLIN) taken for localised infection from 02Jun2021 to 07Jun2021. Patient did not have symptoms associated with COVID-19. Patient was not tested for COVID-19. Not had a COVID-19 test. Patient was not enrolled in clinical trial. Was also taking antibiotics for an infected toe. Flucoxycillin. Patient was not tested positive for COVID-19 since having the vaccine. On 05Jun2021 the patient experienced shingles. The outcome of the event was recovering. No follow-up attempts are possible; information about lot/batch number cannot be requested.


VAERS ID: 1411675 (history)  
Form: Version 2.0  
Age: 38.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-05
Onset:2021-06-05
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-06-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH 8885 / 1 LA / -

Administered by: Other       Purchased by: ?
Symptoms: Blood glucose, Blood glucose decreased, Dizziness, Hyperhidrosis, Malaise, Nausea, Syncope, Vision blurred
SMQs:, Torsade de pointes/QT prolongation (broad), Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Glaucoma (broad), Cardiomyopathy (broad), Lens disorders (broad), Retinal disorders (broad), Vestibular disorders (broad), Hypotonic-hyporesponsive episode (broad), Hypoglycaemia (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: Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None
Allergies:
Diagnostic Lab Data: Test Name: Blood sugar; Result Unstructured Data: Test Result:lower
CDC Split Type: GBPFIZER INC2021656367

Write-up: fainted; Vision blurred; sweaty; lower your blood sugar levels; light headed; very unwell; felt queasy; This is a spontaneous report from a contactable consumer (patient). A 38-years-old male patient received BNT162B2 (Pfizer BioNTech COVID vaccine, Lot#8885), dose 1 administered in arm left on 05Jun2021 09:30 at age of 38-year-old as single dose for COVID-19 immunisation. The patient''s concomitant medications and medical history were none. The patient experienced fainted, vision blurred, sweaty and lower your blood sugar levels, all on 05Jun2021 09:45. The outcome was recovering. No treatment received. The lab tests included blood glucose: lower. The clinical course was reported as follows: Minutes after having the vaccine I felt queasy, light headed then completely blacked out / fainted and fell off my chair. After coming round my vision was blurred, I felt clammy / sweaty and very unwell.


VAERS ID: 1411922 (history)  
Form: Version 2.0  
Age: 72.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-04
Onset:2021-06-05
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-06-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FA4597 / 1 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Dizziness, Feeling abnormal, Vomiting
SMQs:, Acute pancreatitis (broad), Anticholinergic syndrome (broad), Dementia (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Vestibular 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:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Hyperlipidaemia; Osteoporosis
Allergies:
Diagnostic Lab Data:
CDC Split Type: JPPFIZER INC2021656033

Write-up: vomiting; Giddiness; floating feeling; This is a spontaneous report from a contactable physician received via COVID-19 Vaccine Adverse Event Reporting System (COVAES). A 72-year-old female patient received bnt162b2 (COMIRNATY, Solution for injection), first dose at the age of 72-year-old (Lot number FA4597, Expiration date 31Aug2021). On 04Jun2021 at 10:00 Intramuscularly in the left arm as single dose for COVID-19 immunisation. The patient was non-pregnant. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient had no known allergies. Other medical history included Hyperlipidaemia, Osteoporosis. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medications were not reported. On 05Jun2021 at 07:00 (21hours after the vaccination), the patient experienced vomiting, Giddiness, floating feeling. The treatment included Fluid replacement, Antiemetic, Meylon Intravenous drip. The reporter stated the events resulted in doctor or other healthcare professional office/clinic visit. Since the vaccination, the patient has not been tested for COVID-19. The outcome of the event was recovered/resolved.; Sender''s Comments: A causal association between BNT162B2 and the reported events cannot be excluded based on temporal relationship. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.


VAERS ID: 1411935 (history)  
Form: Version 2.0  
Age: 90.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-04
Onset:2021-06-05
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-06-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FA4597 / 1 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Conjunctival haemorrhage
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Conjunctival disorders (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: Medical History/Concurrent Conditions: Diabetes mellitus; Obstructive arteriosclerosis of lower extremities
Allergies:
Diagnostic Lab Data:
CDC Split Type: JPPFIZER INC2021656169

Write-up: Subconjunctival haemorrhage; This is a spontaneous report from a contactable physician. The patient was a non-pregnant 90-year-old female. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received Prescription drug within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Whether the patient had allergies to medications, food, or other products was unknown. Other medical history included Diabetes mellitus and Obstructive arteriosclerosis of lower extremities. On 04Jun2021 at 12:15 at (the day of vaccination), the patient received the first single dose of bnt162b2 (COMIRNATY, Solution for injection, Lot number FA4597, Expiration date 31Aug2021), at same age, intramuscular route of administration in the arm left for COVID-19 immunization. On 05Jun2021 at 08:00 (1 day after the vaccination), the patient experienced subconjunctival haemorrhage of the left eye. The reporter classified the event as non-serious. The outcome of the event was unknown without treatment. Since the vaccination, the patient has not been tested for COVID-19. No follow-up attempts are possible. No further information is expected.; Sender''s Comments: Based on the close temporal relationship, the association between the events subconjunctival haemorrhage of the left eye with COMIRNATY use can not be fully excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.


VAERS ID: 1411960 (history)  
Form: Version 2.0  
Age: 51.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-05
Onset:2021-06-05
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-06-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FA2453 / 2 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure increased, Blood pressure measurement, Discomfort, Epigastric discomfort, Hyperhidrosis, Nausea
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Gastrointestinal perforation, ulcer, haemorrhage, obstruction non-specific findings/procedures (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hypertension (narrow), Hypoglycaemia (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: Medical History/Concurrent Conditions: Livedoid vasculitis
Allergies:
Diagnostic Lab Data: Test Date: 20210605; Test Name: blood pressure; Result Unstructured Data: Test Result:increased
CDC Split Type: JPPFIZER INC2021656914

Write-up: Blood pressure increased; Sweaty; Queasy; Epigastric discomfort; discomfort; This is a spontaneous report from a contactable physician received via COVID-19 Adverse Event Self-Reporting Solution. The patient was a non-pregnant 52-year-old female. 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. The patient had the medical history including livedoid vasculitis. On 24Apr2021(the day of vaccination), the patient previously received the first single dose of BNT162B2 (COMIRNATY, Solution for injection, Lot number ER7449, Expiration date 30Jun2021) for COVID-19 immunization. On 05Jun2021 at 02:00 AM (as reported) (the day of vaccination), the patient received the second single dose of BNT162B2 (COMIRNATY, Solution for injection, Lot number FA2453, Expiration date 31Aug2021) intramuscular in the left arm for COVID-19 immunization. Patient age at vaccination was 51 years old. On 05Jun2021 at 02:30 AM (as reported) (25 minutes after the vaccination), the patient experienced blood pressure increased, sweaty, queasy, epigastric discomfort and discomfort. The outcome of the event was recovered with treatment including the treatment of intravenously drip of calcium chloride dihydrate;potassium chloride;sodium chloride;sodium lactate (SOLULACT S500) and followed with observation. The reporter stated the events results in doctor or other healthcare professional office/clinic visit. Since the vaccination, the patient had not been tested for COVID-19.


VAERS ID: 1411962 (history)  
Form: Version 2.0  
Age: 35.0  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-05
Onset:2021-06-05
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-06-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EY5420 / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Anaphylactic reaction, Blood pressure measurement, Body temperature, Dizziness, Headache, Heart rate, Hypoaesthesia oral, Nausea, Neck pain, Respiratory rate
SMQs:, Anaphylactic reaction (narrow), Acute pancreatitis (broad), Anticholinergic syndrome (broad), Anaphylactic/anaphylactoid shock conditions (narrow), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Vestibular disorders (broad), Hypersensitivity (narrow), Arthritis (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: Test Date: 20210605; Test Name: blood pressure; Result Unstructured Data: Test Result:116/70; Test Date: 20210605; Test Name: body temperature; Result Unstructured Data: Test Result:36.7 Centigrade; Comments: before vaccination; Test Date: 20210605; Test Name: P; Result Unstructured Data: Test Result:72; Test Date: 20210605; Test Name: respiratory rate; Result Unstructured Data: Test Result:18
CDC Split Type: JPPFIZER INC2021656918

Write-up: mild Anaphylactic reaction (Digestive symptoms); Numbness lips; Queasy; Giddiness; pain from neck to neck back/neck pain; Occipital pain; This is a spontaneous report from a contactable physician received via Regulatory Authority. This report received from the Regulatory Authority. Regulatory authority report number is v21111926. The patient was a 35 year-old female. Body temperature before vaccination was 36.7 centigrade. There were no points to be considered on the vaccine screening questionnaire (primary diseases, allergies, vaccinations and illnesses within the last one month, medications the patient was taking, past adverse effect history, growth status, etc). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not receive any other medications within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient had no allergies to medications, food, or other products. The patient had no other medical history. On 15May2021 (the day of vaccination), the patient received the first single dose of BNT162B2 (COMIRNATY, Solution for injection, Lot number was unknow, Expiration date was unknow) at the age of 35 year-old, intramuscular for COVID-19 immunization. On 05Jun2021 at 14:30, the patient received the second dose of bnt162b2 (COMIRNATY intramuscular injection, Lot# EY5420 Expiration date: 31Aug2021) at the age of 35 year-old, intramuscular as single dose for COVID-19 immunization. On 05Jun2021 at 14:45 (15mins after vaccination), the patient experienced Anaphylactic reaction (mild). On 05Jun2021 (10 minutes after the vaccination), the patient experienced queasy, giddiness, neck pain, occipital pain, numbness lips. Because blood pressure, pulse rate, and respiratory rate were normal, and no respiratory or skin symptoms were observed. After lying down and observing the progress, the symptoms almost disappeared after 50 minutes, so let the patient return home. The outcome of the event was recovered on 05Jun2021 without treatment. Since the vaccination, the patient has not been tested for COVID-19. The course of the event was as follows: Queasy, dizziness, pain from neck to neck back and Numbness lips developed 10 mins after the second dose of vaccine. Blood pressure 116/70, Heart rate (P)72, respiratory rate 18. No change in vital sign. The patient was observed at bed. No Respiratory system symptom and no skin symptom observed. The patient felt condition disappeared and came back home after about 50mins of observation of vaccination. The reporter classified the events as non-serious. The causality between the event and bnt162b2 was related. There was no other possible cause of the event such as any other diseases. Reporter comment: Since the symptom developed in a short time after vaccination, it was considered as mild Anaphylactic reaction (Digestive symptoms). No follow up attempts are possible. No further information is expected.


VAERS ID: 1413644 (history)  
Form: Version 2.0  
Age: 18.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-04
Onset:2021-06-05
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-06-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 3002332 / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Adverse drug reaction, Dizziness, Dyspnoea, Fatigue, Headache, Nausea, Pyrexia, SARS-CoV-2 test
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Vestibular disorders (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? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Test Result: Negative ; Result Unstructured Data: No - Negative COVID-19 test
CDC Split Type: GBMODERNATX, INC.MOD20212

Write-up: Nausea; High temperature; Head ache; Exhaustion; Breathing difficulties; Dizziness; Drug side effect; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 08-Jun-2021 and was forwarded to Moderna on 08-Jun-2021. This regulatory authority case was reported by a consumer and describes the occurrence of DYSPNOEA (Breathing difficulties), DIZZINESS (Dizziness), ADVERSE DRUG REACTION (Drug side effect), NAUSEA (Nausea), PYREXIA (High temperature), HEADACHE (Head ache) and FATIGUE (Exhaustion) in an 18-year-old male patient who received mRNA-1273 (Moderna CoviD-19 Vaccine) (batch no. 3002332) for COVID-19 vaccination. No Medical History information was reported. On 04-Jun-2021, the patient received first dose of mRNA-1273 (Moderna CoviD-19 Vaccine) (unknown route) 1 dosage form. On 05-Jun-2021, the patient experienced ADVERSE DRUG REACTION (Drug side effect) (seriousness criterion medically significant). On an unknown date, the patient experienced DYSPNOEA (Breathing difficulties) (seriousness criterion medically significant), DIZZINESS (Dizziness) (seriousness criterion medically significant), NAUSEA (Nausea) (seriousness criterion medically significant), PYREXIA (High temperature) (seriousness criterion medically significant), HEADACHE (Head ache) (seriousness criterion medically significant) and FATIGUE (Exhaustion) (seriousness criterion medically significant). At the time of the report, DYSPNOEA (Breathing difficulties), DIZZINESS (Dizziness), NAUSEA (Nausea), PYREXIA (High temperature), HEADACHE (Head ache) and FATIGUE (Exhaustion) outcome was unknown and ADVERSE DRUG REACTION (Drug side effect) was resolving. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: no - negative covid-19 test (Negative) No - Negative COVID-19 test. The action taken with mRNA-1273 (Moderna CoviD-19 Vaccine) (Unknown) was unknown. Concomitant product use was provided by the reporter as Heart burn medications. Treatment information was provided as Antibiotics. Patient has not tested positive for COVID-19 since having the vaccine. 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.


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