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From the 5/7/2021 release of VAERS data:

Found 188,897 cases where Vaccine is COVID19 and Patient Did Not Die



Case Details (Reverse Sorted by Onset Date)

This is page 57 out of 1,889

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VAERS ID: 1242778 (history)  
Form: Version 2.0  
Age: 39.0  
Sex: Female  
Location: Maryland  
Vaccinated:2021-04-12
Onset:2021-04-12
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-04-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 202A21A / 1 LA / SYR

Administered by: Public       Purchased by: ?
Symptoms: Dizziness, Motion sickness, Nausea
SMQs:, Acute pancreatitis (broad), Anticholinergic syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Vestibular disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: loratadine turmeric women''s multi-vitamin calcium/zinc/magnesium supplement cod liver oil
Current Illness: none
Preexisting Conditions: none
Allergies: penicillin
Diagnostic Lab Data: none
CDC Split Type:

Write-up: Began feeling nauseous and light-headed, almost like motion sickness by the evening of vaccination. Still feeling this way ten days later.


VAERS ID: 1243072 (history)  
Form: Version 2.0  
Age: 40.0  
Sex: Female  
Location: D.C.  
Vaccinated:2021-04-11
Onset:2021-04-12
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-04-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / 1 LA / IM

Administered by: Unknown       Purchased by: ?
Symptoms: Headache, Migraine, Platelet count normal
SMQs:

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: Mirena
Current Illness: None
Preexisting Conditions: None
Allergies: None
Diagnostic Lab Data: Platelet test - normal
CDC Split Type:

Write-up: Migraine headaches, lingering headaches


VAERS ID: 1243073 (history)  
Form: Version 2.0  
Age: 78.0  
Sex: Male  
Location: Oregon  
Vaccinated:2021-04-11
Onset:2021-04-12
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-04-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (UNKNOWN)) / UNKNOWN MANUFACTURER - / 1 LA / IM

Administered by: Private       Purchased by: ?
Symptoms: Arthralgia, Neck pain, Sleep disorder
SMQs:, Arthritis (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: Acetaminophen Apixaban Diltiazem Lisinopril Metoprolol Rosuvastatin Vitamin D3 Travoprost ophthalmic drops Furosemide Fish Oil Potassium Tramadol
Current Illness: None
Preexisting Conditions: Afib, HTN, prostate CA, and glaucoma.
Allergies: No known medication or food allergies.
Diagnostic Lab Data:
CDC Split Type:

Write-up: Patient has been having severe neck pain (b/l right below ears) and severe bilateral shoulder pain since 04/12/21 (the day after his Johnson and Johnson COVID vaccine). Patient has been unable to sleep due to the severe pain. Patient was given some PO pain medication from his PCP and has not been able to get any relief.


VAERS ID: 1243086 (history)  
Form: Version 2.0  
Age: 28.0  
Sex: Female  
Location: Colorado  
Vaccinated:2021-04-12
Onset:2021-04-12
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-04-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / 1 LA / SYR

Administered by: Pharmacy       Purchased by: ?
Symptoms: Chills, Cold sweat, Condition aggravated, Fatigue, Headache, Heavy menstrual bleeding, Lethargy, Menstruation irregular, Nasal congestion, Nasopharyngitis, Nausea, Vaginal haemorrhage, Vascular pain
SMQs:, Acute pancreatitis (broad), Haemorrhage terms (excl laboratory terms) (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Fertility disorders (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: 5HTP, iron supplement, vitamin D, B12 complex, Ashawaganda
Current Illness: No
Preexisting Conditions: Varicose Veins
Allergies: No
Diagnostic Lab Data:
CDC Split Type:

Write-up: Severe headache for two days. Extreme chills, nausea, cold sweats, fatigue for three days. On the third day previous symptoms went away and I got an extreme head cold, congestion, tiredness, lethargic. My varicose veins have been midly painful but it might be from laying all day for a week. On day five I started my menstrual cycle two weeks early, it was completely black and clumpy (not normal). It is now day 10 and I still have a slight cold, very tired, and am still on my period.


VAERS ID: 1243276 (history)  
Form: Version 2.0  
Age: 27.0  
Sex: Female  
Location: Minnesota  
Vaccinated:2021-04-10
Onset:2021-04-12
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-04-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 203A21A / 1 RA / SYR

Administered by: Public       Purchased by: ?
Symptoms: Chills, Laboratory test normal, Sexually transmitted disease test, Vaginal ulceration
SMQs:, Severe cutaneous adverse reactions (broad), Hypersensitivity (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Multivitamin, collagen peptides, calcium, vitamin D
Current Illness: None
Preexisting Conditions: None
Allergies: None
Diagnostic Lab Data: Tested for SDIs and saw medical professionals - all tests came back negative. Tested on 4/14 and 4/19.
CDC Split Type:

Write-up: Janssen COVID-19 Vaccine Symptom: vaginal ulcers appeared approximately two days after dosage. Chills one day after vaccine.


VAERS ID: 1243292 (history)  
Form: Version 2.0  
Age: 46.0  
Sex: Female  
Location: Rhode Island  
Vaccinated:2021-04-12
Onset:2021-04-12
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-04-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 206A21A / 1 RA / UN

Administered by: Pharmacy       Purchased by: ?
Symptoms: Arthralgia, Chills, Fatigue, Injection site pain, Muscle spasms, Pain, Pain in extremity, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dystonia (broad), Extravasation events (injections, infusions and implants) (broad), Arthritis (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: hydrochlorothiazide, theralogix, vitamin D, singulair, zyrtec, mulit-vitamin
Current Illness: none
Preexisting Conditions: hypocalciuria caused kidney stones (currently controlled with hydrochlorthiazide, theralogix, and vitamin D)
Allergies: sulfa drugs, sulfa trimeth, shellfish (shrimp, lobster)
Diagnostic Lab Data: none
CDC Split Type:

Write-up: fever (up to 101.8 degrees), body aches, and chills for 24 hours after vaccine fatigue, pain at site of injection, and pain in underarm radiating through to shoulder blade for 6 days after injection muscle spasms in shoulder and chest on side of injection, 9 days after injection called doctors office once to see if I could take pain medication for aches, and they said yes. have not called since


VAERS ID: 1243892 (history)  
Form: Version 2.0  
Age: 41.0  
Sex: Male  
Location: Kentucky  
Vaccinated:2021-04-06
Onset:2021-04-12
   Days after vaccination:6
Submitted: 0000-00-00
Entered: 2021-04-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 1808609 / 1 RA / IM

Administered by: Other       Purchased by: ?
Symptoms: Allergy test, Axillary pain, 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: Lipitor, Lisinopril, Alvesco inhaler, Xopenex, BaclofenRemeron
Current Illness: N/A
Preexisting Conditions: HTN, COPD, Hyperlipidemia
Allergies: PCN, Sulfa, NSAIDS
Diagnostic Lab Data: Wool test
CDC Split Type:

Write-up: 4-12-21 Patient reported to sick call with soreness under right arm. Not relieved by cool compresses or hydrocortisone cr. came to clinic for c/o allergy to possibly wool blanket- Wool test performed 4-22 wool test negative, but several zosters noted. Dx Shingles- started on Acyclovir


VAERS ID: 1243975 (history)  
Form: Version 2.0  
Age: 49.0  
Sex: Male  
Location: Texas  
Vaccinated:2021-04-02
Onset:2021-04-12
   Days after vaccination:10
Submitted: 0000-00-00
Entered: 2021-04-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK LA / SYR

Administered by: Pharmacy       Purchased by: ?
Symptoms: Angiogram pulmonary abnormal, Blood test abnormal, Computerised tomogram thorax abnormal, Echocardiogram, Electrocardiogram, Pulmonary embolism, SARS-CoV-2 test, Ultrasound Doppler
SMQs:, Embolic and thrombotic events, venous (narrow), Pulmonary hypertension (broad), Cardiomyopathy (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, 1 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: Cortef 15mg daily, doxycycline 100mg x2 daily, Omeprazole 20mg daily, Finasteride 1/5mg daily, Allegra allergy, Nasacort at night. The various IV treatments and supplements I take for chronic fatigue have since been reviewed by my Hematolo
Current Illness: Unconfirmed tick bite that looked like Lyme disease (doxycycline started April 7) and mild acid reflux (Omeprazole started in late March)
Preexisting Conditions: Chronic Fatigue Syndrome
Allergies: Valium, erythromycin
Diagnostic Lab Data: See above. Ultrasound of legs, blood tests, right heart "echo" scan, EKGs, COVID-19 test and other tests performed. Do not have a full list. Damage to right lung tissue.
CDC Split Type:

Write-up: Pulmonary embolism symptoms felt April 12, 13. Pulmonary infarction felt night of April 15th forward. Blood test was positive for possible clots done April 16th. CT/CTA chest scan done at hospital (also April 16th) confirmed the above embolism and infarction. Blood thinner via shots, then via tablet (Xarelto) until discharge on April 17th. Continuing on Xarelto.


VAERS ID: 1244339 (history)  
Form: Version 2.0  
Age: 37.0  
Sex: Female  
Location: Washington  
Vaccinated:2021-04-08
Onset:2021-04-12
   Days after vaccination:4
Submitted: 0000-00-00
Entered: 2021-04-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / 1 LA / SYR

Administered by: Other       Purchased by: ?
Symptoms: Pain in extremity, Paraesthesia
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: Estrodial 1mg 1 per day
Current Illness: Anemic
Preexisting Conditions: Lynch Syndrome
Allergies: None
Diagnostic Lab Data:
CDC Split Type:

Write-up: Pins and needles / tingling feelings on both legs, slight pain on both legs.


VAERS ID: 1244780 (history)  
Form: Version 2.0  
Age: 64.0  
Sex: Female  
Location: North Carolina  
Vaccinated:2021-04-12
Onset:2021-04-12
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-04-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

Administered by: Public       Purchased by: ?
Symptoms: Head discomfort, Hypertension, Paranasal sinus discomfort, Swelling, Swelling face, Tinnitus
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Neuroleptic malignant syndrome (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypertension (narrow), Hearing impairment (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: Tetnus
Other Medications: Warfarin Omeprazole
Current Illness: DVT in left leg from March 4,2021 Was treated with Heparin ,one week in Hospital
Preexisting Conditions: History of DVT?s,will be on Warfarin for life,Obesity,CRPS,IVC filter in place
Allergies: Vicodin,Cipro,Codeine,Morphine
Diagnostic Lab Data:
CDC Split Type:

Write-up: One hour after getting the vaccine,my face and neck swelled,but I had no breathing problems. Then 4 days after vaccine I experienced a strange buzzing feeling in my brain,and Tinitus ring in my ears,with sinus pressure. It lasted less than 10 minutes,and stopped. On the fifth day after vaccine,I noticed High Blood Pressure symptoms,and went to ER. On 8th day after vaccine,I I went to hospital for High Blood pressure again,and was put on medication!


VAERS ID: 1244852 (history)  
Form: Version 2.0  
Age: 58.0  
Sex: Female  
Location: Maryland  
Vaccinated:2021-04-12
Onset:2021-04-12
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-04-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK LA / IM

Administered by: Private       Purchased by: ?
Symptoms: Abdominal pain upper, Chills, Fatigue, Headache, Injection site pain, Insomnia, Malaise, Mouth ulceration, Nausea, Oropharyngeal pain, Pyrexia, Vomiting
SMQs:, Severe cutaneous adverse reactions (broad), Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Extravasation events (injections, infusions and implants) (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hypersensitivity (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Metoprolol succinate 50mg, Amlodipine 5mg Vitamin D soft gel 1 (125 mcg)
Current Illness: None
Preexisting Conditions: Benign HBP under control with meds
Allergies: Penicillin injection Raw ripe tomatoes Camoquin
Diagnostic Lab Data: None
CDC Split Type:

Write-up: After vaccination on April 12 had nausea and vomiting, chills and headache, stomachache most of the day. At night had fever, pain at injection site, malaise. Same on day2 but milder and headache. Insomnia Day 3 -7chills at day and night time mild headache, sore throat, insomnia Day 7 nausea, chills and headache, tiredness, sorethroat, insomnia Day 8- 10 chills, mouth sores, tiredness, insomnia On eAch day took antihistamine cetrizine


VAERS ID: 1244954 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: North Carolina  
Vaccinated:0000-00-00
Onset:2021-04-12
Submitted: 0000-00-00
Entered: 2021-04-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN UNKNOWN / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Rash
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:
Current Illness:
Preexisting Conditions: Comments: Unknown
Allergies:
Diagnostic Lab Data:
CDC Split Type: USJNJFOC20210430087

Write-up: RASH/SEVERE RASH ON FACE NECK AND ARMS; This spontaneous report received from a patient concerned a female of unspecified age. The patient''s weight, height, and medical history were not 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 09-APR-2021 for prophylactic vaccination. Batch number was not reported. The company has requested follow-up for batch number. No concomitant medications were reported. On 12-APR-2021, the subject experienced rash/severe rash on face neck and arms. Treatment medications (dates unspecified) included: cortisone, and prednisone. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from rash/severe rash on face neck and arms. This report was non-serious.


VAERS ID: 1244969 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Unknown  
Vaccinated:0000-00-00
Onset:2021-04-12
Submitted: 0000-00-00
Entered: 2021-04-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN UNKNOWN / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Chills, Dyspnoea, Feeling abnormal, Hot flush
SMQs:, Anaphylactic reaction (broad), Dementia (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Comments: Unknown
Allergies:
Diagnostic Lab Data:
CDC Split Type: USJNJFOC20210431211

Write-up: SHORTNESS OF BREATH; BRAIN FOG; HOT FLASHES; CHILLS; This spontaneous report received from a patient concerned a female of unspecified age. The patient''s weight, height, and medical history were not 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 12-APR-2021 for prophylactic vaccination. The batch number was not reported. The company was unable to perform follow up to request batch number/lot number. No concomitant medications were reported. On 12-APR-2021 22:00, the subject experienced hot flashes. On 12-APR-2021 22:00, the subject experienced chills. On 13-APR-2021, the subject experienced brain fog. On 14-APR-2021, the subject experienced shortness of breath. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from brain fog, hot flashes, and chills on 14-APR-2021, and had not recovered from shortness of breath. This report was non-serious.; Sender''s Comments: V0: Medical assessment comments not required as per standard procedure as the case is considered non serious.


VAERS ID: 1245066 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Pennsylvania  
Vaccinated:0000-00-00
Onset:2021-04-12
Submitted: 0000-00-00
Entered: 2021-04-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 206A21A / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Underdose
SMQs:, Medication errors (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Comments: Unknown
Allergies:
Diagnostic Lab Data:
CDC Split Type: USJNJFOC20210431735

Write-up: PARTIAL DOSE; This spontaneous report received from a pharmacist concerned an adult of multiple patients of unspecified sex. The patient''s weight, height, and medical history were not reported. The patients received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 206A21A, expiry: 23-JUN-2021) dose was not reported, administered on 12-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 12-APR-2021, the subject experienced partial dose. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of partial dose was not reported. This report was non-serious.


VAERS ID: 1245121 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Illinois  
Vaccinated:0000-00-00
Onset:2021-04-12
Submitted: 0000-00-00
Entered: 2021-04-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 201A21A / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Medication error, Product storage error
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: Allergic reaction to antibiotics
Preexisting Conditions: Comments: Unknown
Allergies:
Diagnostic Lab Data:
CDC Split Type: USJNJFOC20210436473

Write-up: MEDICATION ERROR; TEMPERATURE EXCURSION EXPOSURE/ NO MORE TEMPERATURE WAS RECORDED FOR ABOUT 3 HOURS AND 20 MINUTES PAST THE LAST RECORDED WITHIN RANGE TEMPERATURE; This spontaneous report received from a pharmacist concerned a 52 year old female. The patient''s height, and weight were not reported. The patient''s concurrent conditions included augmentin allergy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 201A21A, and batch number: 201A21A expiry: 23-JUN-2021) dose was not reported, administered on 12-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 12-APR-2021, the subject experienced temperature excursion exposure/ no more temperature was recorded for about 3 hours and 20 minutes past the last recorded within range temperature. On an unspecified date, the subject experienced medication error. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the temperature excursion exposure/ no more temperature was recorded for about 3 hours and 20 minutes past the last recorded within range temperature and medication error was not reported. This report was non-serious.


VAERS ID: 1245409 (history)  
Form: Version 2.0  
Age: 36.0  
Sex: Female  
Location: Minnesota  
Vaccinated:2021-04-11
Onset:2021-04-12
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-04-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 027B21A / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Abdominal pain upper, Headache, Hyperhidrosis, Loss of consciousness, Pain, Seizure, Vomiting
SMQs:, Torsade de pointes/QT prolongation (broad), Acute pancreatitis (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (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), Hypotonic-hyporesponsive episode (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? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: No adverse event (No medical history provided.)
Allergies:
Diagnostic Lab Data:
CDC Split Type: USMODERNATX, INC.MOD20210

Write-up: seizure; passed out due to extreme vomiting as per doctor in ER; vomiting every 40 minutes; stomachaches; body pain; Sweating; Headache; This case was received via an unknown source no reference has been entered for a health authority or license partner on 15-Apr-2021 and was forwarded to Moderna on 15-Apr-2021. This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of SEIZURE (seizure) and LOSS OF CONSCIOUSNESS (passed out due to extreme vomiting as per doctor in ER) in a 36-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient''s past medical history included No adverse event (No medical history provided.). On 11-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Apr-2021, the patient experienced SEIZURE (seizure) (seriousness criterion medically significant), LOSS OF CONSCIOUSNESS (passed out due to extreme vomiting as per doctor in ER) (seriousness criterion medically significant), HEADACHE (Headache), ABDOMINAL PAIN UPPER (stomachaches), VOMITING (vomiting every 40 minutes), PAIN (body pain) and HYPERHIDROSIS (Sweating). The patient was treated with IBUPROFEN at an unspecified dose and frequency. At the time of the report, SEIZURE (seizure), LOSS OF CONSCIOUSNESS (passed out due to extreme vomiting as per doctor in ER), HEADACHE (Headache), ABDOMINAL PAIN UPPER (stomachaches), VOMITING (vomiting every 40 minutes), PAIN (body pain) and HYPERHIDROSIS (Sweating) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No medical history or concomitant medications provided. Patient used ibuprofen for treatment of headache. 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: 1245426 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Massachusetts  
Vaccinated:2021-04-12
Onset:2021-04-12
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-04-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 039K20A / 1 RA / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Anaphylactic reaction
SMQs:, Anaphylactic reaction (narrow), Anaphylactic/anaphylactoid shock conditions (narrow), Hypersensitivity (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? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: No adverse event (No medical history was reported.)
Allergies:
Diagnostic Lab Data:
CDC Split Type: USMODERNATX, INC.MOD20210

Write-up: Anaphylactic reaction; This spontaneous case was reported by a consumer and describes the occurrence of ANAPHYLACTIC REACTION (Anaphylactic reaction) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20A) for COVID-19 vaccination. The patient''s past medical history included No adverse event (No medical history was reported.). On 12-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Apr-2021, after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced ANAPHYLACTIC REACTION (Anaphylactic reaction) (seriousness criteria medically significant and life threatening). At the time of the report, ANAPHYLACTIC REACTION (Anaphylactic reaction) outcome was unknown. Not Provided The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Concomitant product use was not provided. The patient received treatment with oral Benadryl 50mg (Diphenhydramine). She was given IV push 50mg of benadryl in the ambulance. Then in the hospital, she received Epi-pen (epinephrine) and other medications. Reportedly, the patient had an anaphylactic reaction 10 minutes after the dose was administered and was sent to the emergency room. They observed her there at about 11 AM and discharged her about 5-6 PM. They gave her IV push 50 mg Benadryl and 50 mg oral Benadryl and gave her Epi-pen and other meds in the hospital. Patient does not have a HCP. 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: 1245477 (history)  
Form: Version 2.0  
Age: 84.0  
Sex: Male  
Location: California  
Vaccinated:2021-03-01
Onset:2021-04-12
   Days after vaccination:42
Submitted: 0000-00-00
Entered: 2021-04-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Dyspnoea, Pulmonary fibrosis
SMQs:, Anaphylactic reaction (broad), Interstitial lung disease (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Immune-mediated/autoimmune disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Urothelial carcinoma
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: USMODERNATX, INC.MOD20210

Write-up: Pulmonary Fibrosis; Shortness of breath that required oxygen; This spontaneous case was reported by a pharmacist (subsequently medically confirmed) and describes the occurrence of PULMONARY FIBROSIS (Pulmonary Fibrosis) and DYSPNOEA (Shortness of breath that required oxygen) in an 84-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. Concurrent medical conditions included Urothelial carcinoma. In March 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Apr-2021, the patient experienced DYSPNOEA (Shortness of breath that required oxygen) (seriousness criterion hospitalization). On 16-Apr-2021, the patient experienced PULMONARY FIBROSIS (Pulmonary Fibrosis) (seriousness criterion hospitalization). The patient was hospitalized on 12-Apr-2021 due to DYSPNOEA and PULMONARY FIBROSIS. At the time of the report, PULMONARY FIBROSIS (Pulmonary Fibrosis) and DYSPNOEA (Shortness of breath that required oxygen) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Concomitant medications included were many medications for underlying urothelial cancer. Treatment included for the events was oxygen high flow nasal cannula. 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: 1245507 (history)  
Form: Version 2.0  
Age: 73.0  
Sex: Female  
Location: California  
Vaccinated:2021-04-05
Onset:2021-04-12
   Days after vaccination:7
Submitted: 0000-00-00
Entered: 2021-04-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / UNK - / -

Administered by: Private       Purchased by: ?
Symptoms: Arthralgia, Back pain, Gait disturbance, Pain, Sleep disorder
SMQs:, Peripheral neuropathy (broad), Anticholinergic syndrome (broad), Retroperitoneal fibrosis (broad), Parkinson-like events (broad), Guillain-Barre syndrome (broad), Arthritis (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: Vitamin D, Quercetin, turmeric, kelp, Women''s alive multivitamin,
Current Illness: Sore ankle
Preexisting Conditions: In remission from breast cancer, and kidney cancer, high blood pressure
Allergies: Sulfa, latex, various grasses from hayfever
Diagnostic Lab Data: None have been done but I requested a referral from my doctor to an orthopedist. I have a phone appointment scheduled 5/5/21.
CDC Split Type:

Write-up: I had aches all over 2 days after 2nd vaccination on 4/5/21. Within a week, I had constant pain in my left knee and a little in my right. I''m in constant pain which is not relieved with Tylenol, ice or heat compresses, epsom baths, light exercise, or stretching. At night I have trouble sleeping because my knee is so painful. Several times I''ve almost fallen. My lower back is also bothering me because I can''t walk normally and am putting even pressure on my knees, legs, and back. Prior to the second shot, I was having this kind of ongoing pain. It has severely limited my ability to get around and I often use a cane so I won''t fall.


VAERS ID: 1246241 (history)  
Form: Version 2.0  
Age: 70.0  
Sex: Male  
Location: South Carolina  
Vaccinated:2021-02-24
Onset:2021-04-12
   Days after vaccination:47
Submitted: 0000-00-00
Entered: 2021-04-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 RA / SYR

Administered by: Unknown       Purchased by: ?
Symptoms: Tinnitus
SMQs:, Hearing impairment (narrow)

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. Amlodipine bysylate 5 mg. BP med 2. Atorvastatin 40 mg. Collateral med. 3.Omeprazole 40 mg. Acid reflux. 4. Irbesartan 150 mg. New BP med as of 10/17 take in PM 5. Baby aspirin
Current Illness: None
Preexisting Conditions: None
Allergies: LINISIPRIL
Diagnostic Lab Data:
CDC Split Type:

Write-up: Ringing in ears tennitus after 2nd. Shot


VAERS ID: 1246503 (history)  
Form: Version 2.0  
Age: 17.0  
Sex: Male  
Location: North Carolina  
Vaccinated:2021-04-12
Onset:2021-04-12
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-04-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 1808978 / 1 RA / IM

Administered by: Private       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? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Flovent, Simvastatin, Zyrtec, and Ventolin
Current Illness: Hyperlipidemia
Preexisting Conditions: Asthma
Allergies: None
Diagnostic Lab Data:
CDC Split Type:

Write-up: Patient given vaccine at 17 years and 8 months of age when he should have been 18. No adverse effects noted day of vaccine or following day when staff called to check on him.


VAERS ID: 1246599 (history)  
Form: Version 2.0  
Age: 38.0  
Sex: Female  
Location: Texas  
Vaccinated:2021-04-12
Onset:2021-04-12
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-04-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / 1 RA / SYR

Administered by: Pharmacy       Purchased by: ?
Symptoms: Chills, Cold sweat, Dizziness, Headache, Injection site pain, Pain, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Extravasation events (injections, infusions and implants) (broad), Vestibular disorders (broad), 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? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness: None
Preexisting Conditions: Hypertension
Allergies: Ceclor
Diagnostic Lab Data: None
CDC Split Type:

Write-up: Local pain at injection site laster about 4 days. Severe headache, fever of 102F, nausea, chills, body aches, cold sweats for 36 hours post injection. Still current multiple episodes of dizziness daily. Took tylenol for first 24hrs to reduce fever.


VAERS ID: 1246852 (history)  
Form: Version 2.0  
Age: 26.0  
Sex: Female  
Location: Florida  
Vaccinated:2021-04-11
Onset:2021-04-12
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-04-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 203A21A / 1 LA / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: Heart rate increased, Pain, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Dehydration (broad)

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

Write-up: Fever, Local pain, heart rate increase Bayer ASA


VAERS ID: 1247075 (history)  
Form: Version 2.0  
Age: 57.0  
Sex: Female  
Location: Ohio  
Vaccinated:2021-04-01
Onset:2021-04-12
   Days after vaccination:11
Submitted: 0000-00-00
Entered: 2021-04-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 1808980 / 1 RA / IM

Administered by: Private       Purchased by: ?
Symptoms: Diverticulitis, Scan abdomen abnormal
SMQs:, Retroperitoneal fibrosis (broad), Malignancy related therapeutic and diagnostic procedures (narrow), Gastrointestinal nonspecific inflammation (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: enalapril, celexa, ASA
Current Illness:
Preexisting Conditions: Depression HTN
Allergies: None
Diagnostic Lab Data: CT consistent with acute sigmoid diverticultitis
CDC Split Type:

Write-up: Patient diagnosed via CT scan with acute diverticulitis about 4/14/21


VAERS ID: 1247178 (history)  
Form: Version 2.0  
Age: 46.0  
Sex: Male  
Location: Virginia  
Vaccinated:2021-04-09
Onset:2021-04-12
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-04-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 202A21A / 1 LA / SYR

Administered by: Other       Purchased by: ?
Symptoms: Constipation, Diarrhoea
SMQs:, Pseudomembranous colitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), 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: No
Current Illness: No
Preexisting Conditions: No
Allergies: No
Diagnostic Lab Data:
CDC Split Type:

Write-up: Had been having constipation (2-3 days) and diaheera(1-2) in repeated fashion.


VAERS ID: 1247304 (history)  
Form: Version 2.0  
Age: 47.0  
Sex: Female  
Location: Wisconsin  
Vaccinated:2021-04-12
Onset:2021-04-12
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-04-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 043A21A / 1 LA / IM

Administered by: Private       Purchased by: ?
Symptoms: Condition aggravated, Hypersensitivity, Rash
SMQs:, Anaphylactic reaction (broad), Angioedema (broad), Hypersensitivity (narrow), 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: Influenza - age 44, Tdap (Adacel)-age 36
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies: Bactrim, Bee Sting, Influenza Vaccines, Latex (environmental), Sulfamethoxazole w/trimethoprim, Tdap(Adacel)
Diagnostic Lab Data: Reported to NP that gave the vaccination right away. The NP told her as long as she does not have any shortness of breath within the first 30 min. she was ok. Was reported 3 days later wanted recorded in her file. Was to contact her provider office to determine if appt. is needed. Has been added to her listing of allergies in her medical record. 4/23/2021 rash went away by 5 days after vaccination. Was NOT seen by her personal provider, though condition noted.
CDC Split Type:

Write-up: By 5 minutes after receiving the vaccination rash began on bilateral arms, then moved neck, stomach, back, under arms, and legs.


VAERS ID: 1247356 (history)  
Form: Version 2.0  
Age: 37.0  
Sex: Female  
Location: California  
Vaccinated:2021-04-03
Onset:2021-04-12
   Days after vaccination:9
Submitted: 0000-00-00
Entered: 2021-04-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 1808980 / 1 LA / SYR

Administered by: Other       Purchased by: ?
Symptoms: Hypomenorrhoea, Menstrual disorder
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: Fluoxetine
Current Illness: No
Preexisting Conditions: No
Allergies: Aspirin
Diagnostic Lab Data:
CDC Split Type:

Write-up: My menstrual cycle is typically 5 to 6 days long and extremely heavy. Once I was vaccinated my menstrual cycle shortened the next cycle to 3 to 4 days and extremely light. I also had less cramping and less pain from my menstrual cycle


VAERS ID: 1247420 (history)  
Form: Version 2.0  
Age: 41.0  
Sex: Female  
Location: Wisconsin  
Vaccinated:2021-03-29
Onset:2021-04-12
   Days after vaccination:14
Submitted: 0000-00-00
Entered: 2021-04-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 1808978 / 1 LA / IM

Administered by: Public       Purchased by: ?
Symptoms: Burning sensation, Dizziness, Headache, Pain, Visual impairment
SMQs:, Peripheral neuropathy (broad), Anticholinergic syndrome (broad), Glaucoma (broad), Optic nerve disorders (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: HORMONE REPLACEMENT - ESTROGEN 1ML / DAY, PO, DAILY. VITAMIN D AND VITAMIN B12, PRN.
Current Illness: NO
Preexisting Conditions: BICUSPID AORTIC VALVE, PCOS (TREATED), HYSTERECTOMY, RHEUMATOID ARTHRITIS, ENDOMETRIOSIS (TREATED)
Allergies: LACTOSE SENSITIVE/INTOLERANT.
Diagnostic Lab Data: NO
CDC Split Type: 401

Write-up: PATIENT REPORTS: DIZZINESS 2 WEEKS POST-INJECTION, SEEING STARS ON SIDES OF VISION 2 WEEKS POST-VACCINATION, AND EXPERIECING FEELING OF "SHOOTING PAIN" OR "BURNING PAIN" INSIDE OF HEAD 2 WEEKS POST-INJECTION. NOT TYPICAL SYMPTOMS FOR PATIENT.


VAERS ID: 1247546 (history)  
Form: Version 2.0  
Age: 32.0  
Sex: Female  
Location: West Virginia  
Vaccinated:2021-04-12
Onset:2021-04-12
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-04-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / 1 LA / SYR

Administered by: Pharmacy       Purchased by: ?
Symptoms: Fibrin D dimer normal, Laboratory test, Pain in extremity
SMQs:, Tendinopathies and ligament disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Synthroid
Current Illness: No
Preexisting Conditions: Hypothyroidism and Hashimoto''s Disease
Allergies: No
Diagnostic Lab Data: D-Dimer was normal.
CDC Split Type:

Write-up: I had very severe pain in both legs. This lasted for a few days before I ended up in the emergency room. They only drew labs and determined I did not have a blood clot. I''m taking ibuprofen and a baby aspirin but I do still have pain in both of my legs.


VAERS ID: 1247766 (history)  
Form: Version 2.0  
Age: 21.0  
Sex: Male  
Location: Washington  
Vaccinated:2021-04-12
Onset:2021-04-12
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-04-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 202A21A / 1 RA / SYR

Administered by: Unknown       Purchased by: ?
Symptoms: Asthenia, Body temperature increased, Chills, Headache, Loss of personal independence in daily activities, Muscle twitching, Myalgia
SMQs:, Rhabdomyolysis/myopathy (broad), Neuroleptic malignant syndrome (broad), Dementia (broad), Dyskinesia (broad), Dystonia (broad), Guillain-Barre syndrome (broad), Eosinophilic pneumonia (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? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: fludrocortisone, telmisartan, sotolol hydrochloride, vit D
Current Illness: n/a
Preexisting Conditions: n/a
Allergies: n/a
Diagnostic Lab Data:
CDC Split Type: VSAFE

Write-up: 4/12/21 Vaccination About 10 hours later, I had 102 fever for couple hours, chills, HA, muscle pain, weakness. 4/13 HA pain, muscle pain, muscle weakness, not chills no fever. Lasted 5 days after vaccine. Muscle twitching, weakness, HA. I couldn''t work for 3 days. telemedicine consult that Friday; Tylenol but wait till Monday if the pain was still present. Was feeling better by Monday so I didn''t take.


VAERS ID: 1247907 (history)  
Form: Version 2.0  
Age: 44.0  
Sex: Male  
Location: New Jersey  
Vaccinated:2021-04-12
Onset:2021-04-12
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-04-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK LA / IM

Administered by: Other       Purchased by: ?
Symptoms: Dizziness, Fatigue, Feeling hot, Limb discomfort, Nausea, Pyrexia
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Vestibular disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? 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: Penicillin
Diagnostic Lab Data: I DID NOT GO TO THE DOCTOR BUT INSTEAD STAYED HOME FROM WORK RESTING. I AM EXTREMELY ATLETIC AND IN GOOD HEALTH SO I DECIDED TO STAY HOME.
CDC Split Type:

Write-up: 5 MINUTES AFTER INJECTION WHILE IN THE CAR, I FELT HOT, NAUSEUS THEN FOLLOWED A STRONG SURGE OF DIZZINESS. IT HAPPENED TWICE WITHIN 15 MINUTES. 12 HOURS LATER, I WOKE UP WITH HEAVY LEGS AND SLIGHTLY FEVERISH. MILD FATIGUE PERSISTED THROUGHOUT THE DAY EVENTUALLY GOING AWAY AFTER A DAY OF REST.


VAERS ID: 1247954 (history)  
Form: Version 2.0  
Age: 54.0  
Sex: Female  
Location: Idaho  
Vaccinated:2021-04-12
Onset:2021-04-12
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-04-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: Erythema, Hypersensitivity
SMQs:, Anaphylactic reaction (broad), Angioedema (broad), Hypersensitivity (narrow), 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:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Had a mild allergic reaction, face turned red under the eyes and on the nose and cheeks within about 10 minutes after receiving vaccination. Administered 50mg diphenhydramine orally. Symptoms remained the same for about 20 minutes then started lessening. After about 45 minutes from time of administration of vaccine symptoms were nearly resolved and patient was allowed to go home with instructions to call 911 or the pharmacy if symptoms returned and difficulty breathing occurred. No further response from patient.


VAERS ID: 1247967 (history)  
Form: Version 2.0  
Age: 38.0  
Sex: Male  
Location: Massachusetts  
Vaccinated:2021-04-12
Onset:2021-04-12
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-04-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 203A21A / 1 LA / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: Ear discomfort, Platelet count normal, Tinnitus
SMQs:, Hearing impairment (narrow)

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: Red meat (alpha-gal) allergy
Diagnostic Lab Data: Platelet count (normal)
CDC Split Type:

Write-up: Ringing/pressure in left ear began within 4 hours of vaccine administration and continues almost 2 weeks later. Some varying degrees of intensity but continuous symptoms.


VAERS ID: 1248329 (history)  
Form: Version 2.0  
Age: 34.0  
Sex: Female  
Location: Massachusetts  
Vaccinated:2021-04-10
Onset:2021-04-12
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-04-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 041A21A / N/A LA / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: Chills, Headache, Injection site pain, Injection site pruritus, Menstruation irregular, Myalgia, Nausea, Pyrexia
SMQs:, Rhabdomyolysis/myopathy (broad), Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Extravasation events (injections, infusions and implants) (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Eosinophilic pneumonia (broad), Fertility disorders (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? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Escitalopram - 20 mg once a day; levothyroxine -50 mcg once a day
Current Illness: none
Preexisting Conditions: hypo thyroid; anxiety
Allergies: no
Diagnostic Lab Data: no
CDC Split Type: vsafe

Write-up: April 10 - I only had mild pain at injection site; no impact to activities. At 9:40 PM that evening, I started feeling feverish, pain, itching at the injection site (continued for about 6 days); muscles aches (ongoing) headache, nausea, and uncontrollable chills. And I was not able to do anything the next day and that was the 11th. I l also got my period that day. The 12th, my period became a geyser - I never had a period like that before - I was bleeding a lot for about 5 days (my period didn''t last longer than a normal period though) ; and I still had some muscle aches (they continued through the 12th). So I gave my PCP a call and went in, and she told me to watch it (she didn''t know I had been vaccinated. I''ve had an ongoing headache this week: on Wednesday (the 21st) - for 22 hours non-stop and Thursday (the 22nd I had another one on Thursday - it was about 6 or 7 hours).


VAERS ID: 1248473 (history)  
Form: Version 2.0  
Age: 59.0  
Sex: Female  
Location: New Mexico  
Vaccinated:2021-04-12
Onset:2021-04-12
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-04-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

Administered by: Pharmacy       Purchased by: ?
Symptoms: Chills, Fatigue, Headache, Hyperhidrosis, Nausea, Oropharyngeal pain, Pain, Pain in extremity, Pyrexia, Vertigo
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Vestibular disorders (narrow), Tendinopathies and ligament disorders (broad), 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? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness: Allergy?s a month before.
Preexisting Conditions: None
Allergies: Not aware of any.
Diagnostic Lab Data: None
CDC Split Type:

Write-up: Sore throat,-lasted a week,/sweating, chills, -a few hours, /nausea a few hours/, headache, fever, - on and off for 2 weeks,/ vertigo,, sore arm, fatigue,body ache -2 weeks.


VAERS ID: 1248557 (history)  
Form: Version 2.0  
Age: 61.0  
Sex: Female  
Location: California  
Vaccinated:2021-04-05
Onset:2021-04-12
   Days after vaccination:7
Submitted: 0000-00-00
Entered: 2021-04-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 043A21A / 1 LA / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: Arthralgia, Burning sensation, Disturbance in attention, Headache, Pain in extremity
SMQs:, Peripheral neuropathy (broad), Noninfectious encephalopathy/delirium (broad), Depression (excl suicide and self injury) (broad), Arthritis (broad), Tendinopathies and ligament disorders (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: METROPOLOL, VIT-D, VIT-C, ZINC
Current Illness: FIBROMYALGIA, IRREGULAR HEAT BEAT
Preexisting Conditions: FIBROMYALGIA, IRREGULAR HEAT BEAT
Allergies: NONE
Diagnostic Lab Data:
CDC Split Type:

Write-up: Patient discribed mild headache immediately after. Patient experienced sore arm for about 10 days. Patient started experiencing pain all over a week after the injection. she describes it as a burning sensation though her nervous system and joint pain. Patient also experienced a brain fog a week after her injection. She states that she has trouble putting her thoughts to words. She still feel this reactions on your 17th day.


VAERS ID: 1249204 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: New York  
Vaccinated:0000-00-00
Onset:2021-04-12
Submitted: 0000-00-00
Entered: 2021-04-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN UNKNOWN / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Seizure
SMQs:, 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? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Comments: Unknown
Allergies:
Diagnostic Lab Data:
CDC Split Type: USJNJFOC20210424312

Write-up: SEIZURE; This spontaneous report received from a patient concerned a female of unspecified age. The patient''s weight, height, and medical history were not 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, 1 total administered on 08-APR-2021 to left deltoid for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 12-APR-2021, the patient experienced seizure which lasted for one minute 30 seconds. The patient did not take any medication for her seizure. She never had a seizure before and did not know if there was a correlation with vaccine or not. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from seizure on 12-APR-2021. This report was serious (Other Medically Important Condition).; Sender''s Comments: V0;20210424312-covid-19 vaccine ad26.cov2. s-seizure. This event is considered unassessable. The event 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.


VAERS ID: 1249205 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: New Jersey  
Vaccinated:0000-00-00
Onset:2021-04-12
Submitted: 0000-00-00
Entered: 2021-04-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN UNKNOWN / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Atrial fibrillation
SMQs:, Supraventricular tachyarrhythmias (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: Atrial fibrillation
Preexisting Conditions: Comments: Unknown
Allergies:
Diagnostic Lab Data:
CDC Split Type: USJNJFOC20210424331

Write-up: ATRIAL FIBRILLATION; This spontaneous report received from a patient concerned a female of unspecified age. The patient''s height, and weight were not reported. The patient''s concurrent conditions included atrial fibrillation. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: unknown, and expiry date: unknown) dose was not reported, administered on 08-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 12-APR-2021, four days after the vaccination the patient experienced atrial fibrillation. The patient was confused with the event occurred due to the vaccine or the fact that the patient was concerned about the vaccine and misinformation. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from atrial fibrillation. This report was serious (Other Medically Important Condition). .; Sender''s Comments: V0: 20210424331-JANSSEN COVID-19 VACCINE Ad26.COV2.S- Atrial fibrillation. This event is considered not related. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event than the drug. Specifically: MEDICAL HISTORY, UNDERLYING DISEASE.


VAERS ID: 1249238 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: California  
Vaccinated:0000-00-00
Onset:2021-04-12
Submitted: 0000-00-00
Entered: 2021-04-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN UNKNOWN / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Dizziness, Headache, Heart rate increased, Vision blurred
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Glaucoma (broad), Lens disorders (broad), Retinal disorders (broad), Vestibular disorders (broad), Hypoglycaemia (broad), Dehydration (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Comments: Unknown
Allergies:
Diagnostic Lab Data:
CDC Split Type: USJNJFOC20210427607

Write-up: FAST HEARTBEAT; BLURRED VISION IN LEFT EYE; LIGHTHEADEDNESS; PRESSURE IN THE HEAD, HEADACHE; This spontaneous report received from a consumer concerned a male of unspecified age. The patient''s weight, height, and medical history were not 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 05-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 12-APR-2021, the subject experienced fast heartbeat. On 12-APR-2021, the subject experienced blurred vision in left eye. On 12-APR-2021, the subject experienced lightheadedness. On 12-APR-2021, the subject experienced pressure in the head, headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from fast heartbeat, blurred vision in left eye, and lightheadedness on 12-APR-2021, and was recovering from pressure in the head, headache. This report was non-serious.; Sender''s Comments: V0:Medical assessment comment not required as per standard procedure as case assessed as non serious.


VAERS ID: 1249240 (history)  
Form: Version 2.0  
Age: 40.0  
Sex: Female  
Location: North Carolina  
Vaccinated:0000-00-00
Onset:2021-04-12
Submitted: 0000-00-00
Entered: 2021-04-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN UNKNOWN / UNK - / -

Administered by: Military       Purchased by: ?
Symptoms: Chest discomfort, Headache
SMQs:, Anaphylactic reaction (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: CONTRACEPTIVES
Current Illness: Non-smoker
Preexisting Conditions: Medical History/Concurrent Conditions: Basilar artery thrombosis; Vertebral artery thrombosis; Comments: No illicit use of drugs.
Allergies:
Diagnostic Lab Data:
CDC Split Type: USJNJFOC20210427724

Write-up: CHEST TIGHTNESS; INTERMITTENT HEADACHES; This spontaneous report received from a patient concerned a 40 year old female. The patient''s height, and weight were not reported. The patient''s past medical history included basilar artery thrombosis, and vertebral artery thrombosis, and concurrent conditions included non-smoker, and other pre-existing medical conditions included no illicit use of drugs. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported) dose was not reported, administered on 10-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. Concomitant medications included . On 12-APR-2021, the subject experienced chest tightness. On 12-APR-2021, the subject experienced intermittent headaches. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from intermittent headaches, and chest tightness. This report was non-serious.; Sender''s Comments: V0; MAC Comment is not required for non serious case as per standard protocol.


VAERS ID: 1249252 (history)  
Form: Version 2.0  
Age: 42.0  
Sex: Male  
Location: Washington  
Vaccinated:0000-00-00
Onset:2021-04-12
Submitted: 0000-00-00
Entered: 2021-04-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN UNKNOWN / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure decreased, Blood pressure measurement, Heart rate, Heart rate decreased, Syncope, Tremor
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Parkinson-like events (broad), Noninfectious encephalopathy/delirium (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Hypoglycaemia (broad), Dehydration (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: Abstains from alcohol; Non-smoker; Seasonal allergy
Preexisting Conditions: Comments: The patient did not had drug abuse or illicit drug use. The patient did not had reactions before with any other vaccine.
Allergies:
Diagnostic Lab Data: Test Date: 20210412; Test Name: Blood pressure; Result Unstructured Data: 60/50 mmHg; Test Date: 20210412; Test Name: Heart rate; Result Unstructured Data: 30 Beats Per Minute
CDC Split Type: USJNJFOC20210428755

Write-up: PASSING OUT/FAINTING; LOW HEART RATE (30 BEATS PER MINUTE); DECREASED BLOOD PRESSURE (60/50); SHAKING; This spontaneous report received from a patient concerned a 42 year old white, not Hispanic or Latino male. The patient''s height and weight were not reported. The patient''s concurrent conditions included seasonal allergy, non alcoholic and non smoker. The patient did not had drug abuse or illicit drug use. The patient did not had reactions before with any other vaccine. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of administration not reported, batch number: Unknown) frequency one total, dose was not reported, administered on 12-APR-2021 at left arm for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 12-APR-2021 after vaccination, the patient immediately experienced low heart rate (30 beats per minute), decreased blood pressure (60/50), profuse sweating and shaking and as the result he passed out immediately. The patient reported that he was under care of the medical staff at the facility and both his heart rate and blood pressure were reassessed multiple times within the hour of observation. The patient reported that vaccination provider advised him that his reaction was not related to the Janssen Covid-19 vaccine and that he fainted only because he was afraid of the needle but the patient denied and stated that he was not afraid of the needle. Laboratory data included: Blood pressure (NR: not provided) 60/50 mmHg and heart rate (NR: not provided) 30 beats per minute. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from passing out/fainting on 12-APR-2021, and low heart rate (30 beats per minute), decreased blood pressure (60/50) and shaking on unspecified date APR-2021. This report was serious (Other Medically Important Condition).; Sender''s Comments: V0: 20210428755 -JANSSEN COVID-19 VACCINE Ad26.COV2.S- Passing out/fainted, low heart rate, Decreased blood pressure. 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: 1249263 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Unknown  
Vaccinated:0000-00-00
Onset:2021-04-12
Submitted: 0000-00-00
Entered: 2021-04-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN UNKNOWN / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, Dyspnoea, Headache, Pyrexia
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Comments: Unknown
Allergies:
Diagnostic Lab Data: Test Date: 20210412; Test Name: Body temperature; Result Unstructured Data: 103 F; Test Date: 20210413; Test Name: Body temperature; Result Unstructured Data: 102 F
CDC Split Type: USJNJFOC20210429270

Write-up: SHORTNESS OF BREATH; FEVER; HEADACHE; This spontaneous report received from a patient concerned a female of unspecified age. The patient''s weight, height, and medical history were not 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 12-APR-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On 12-APR-2021, the subject experienced fever. On 12-APR-2021, the subject experienced headache. Laboratory data included: Body temperature (NR: not provided) 103 F. On 13-APR-2021, Laboratory data included: Body temperature (NR: not provided) 102 F. On 14-APR-2021, the subject experienced shortness of breath. Treatment medications (dates unspecified) included: paracetamol, and ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from fever, headache, and shortness of breath. This report was non-serious.; Sender''s Comments: V0: Medical assessment comment not required as per standard procedure as case assessed as non-serious.


VAERS ID: 1249265 (history)  
Form: Version 2.0  
Age: 27.0  
Sex: Female  
Location: Minnesota  
Vaccinated:0000-00-00
Onset:2021-04-12
Submitted: 0000-00-00
Entered: 2021-04-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN UNKNOWN / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Anaemia, Body temperature fluctuation, Haemoglobin, Headache, Myalgia, Oropharyngeal pain, Paraesthesia oral, Platelet count, Pyrexia
SMQs:, Rhabdomyolysis/myopathy (broad), Haematopoietic erythropenia (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Guillain-Barre syndrome (broad), Eosinophilic pneumonia (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Secondary anaemia; Comments: The patient was not pregnant at the time of reporting.
Allergies:
Diagnostic Lab Data: Test Date: 20210412; Test Name: Hemoglobin; Result Unstructured Data: 6.2 (unit not specified); Test Date: 20210413; Test Name: Body temperature fluctuation; Result Unstructured Data: 101.1 F; Test Name: Platelet count; Result Unstructured Data: Normal
CDC Split Type: USJNJFOC20210429348

Write-up: ANEMIA SECONDARY TO MENSTRUATION; TINGLING OF TONGUE; SORE THROAT; MUSCLE ACHES; FEVER; HEADACHE; This spontaneous report received from a physician concerned a 27 year old female. The patient''s height, and weight were not reported. The patient''s past medical history included anemia secondary to menstruation. The patient was not pregnant at the time of reporting. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported) dose was not reported, 1 total, administered on 12-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 12-APR-2021 (same day after vaccination), the patient experienced tingling of tongue, sore throat, muscle ache, fever, headache and was hospitalized. On the same day, the patient experienced anemia secondary to menstruation as her hemoglobin was 6.2 (unit not specified) and was transfused. On 13-APR-2021, the patient had a mild headache at night and labile temperatures (her maximum temperature was 101.1 F in 24 hours prior to this report). On 14-APR-2021, the patient symptoms were improved and she had no thrombocytopenia to date. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from tingling of tongue, headache, muscle aches, sore throat, fever, and anemia secondary to menstruation. This report was serious (Hospitalization Caused / Prolonged).; Sender''s Comments: V0 : 20210429348-covid-19 vaccine ad26.cov2.s- anemia secondary to menstruation. This event is considered not related. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event than the drug. Specifically: MEDICAL HISTORY, UNDERLYING DISEASE 20210429348-JANSSEN COVID-19 VACCINE Ad26.COV2.S-Tingling of tongue, Sore throat. This event(s) are 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). 20210429348-covid-19 vaccine ad26.cov2.s - headache, muscle aches, fever. This event(s) are labeled per and is therefore considered potentially related.


VAERS ID: 1249279 (history)  
Form: Version 2.0  
Age: 48.0  
Sex: Unknown  
Location: North Carolina  
Vaccinated:0000-00-00
Onset:2021-04-12
Submitted: 0000-00-00
Entered: 2021-04-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 203A21A / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Dizziness, Pain, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (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? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Comments: Unknown
Allergies:
Diagnostic Lab Data:
CDC Split Type: USJNJFOC20210431342

Write-up: DIZZINESS; BODY ACHES; FEVER; This spontaneous report received from a patient concerned a 48 year old of unspecified sex. The patient''s weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 203A21A expiry: UNKNOWN) dose was not reported, administered on 12-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 12-APR-2021, the subject experienced dizziness. On 12-APR-2021, the subject experienced body aches. On 12-APR-2021, the subject experienced fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from dizziness, body aches, and fever on APR-2021. This report was non-serious.


VAERS ID: 1249436 (history)  
Form: Version 2.0  
Age: 42.0  
Sex: Male  
Location: Maryland  
Vaccinated:0000-00-00
Onset:2021-04-12
Submitted: 0000-00-00
Entered: 2021-04-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN UNKNOWN / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Ear discomfort, Tinnitus
SMQs:, Hearing impairment (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: Unknown
Allergies:
Diagnostic Lab Data:
CDC Split Type: USJNJFOC20210440043

Write-up: EAR FEELS CLOGGED; RINGING IN EARS; This spontaneous report received from a consumer concerned a 42 year old male. The patient''s weight, height, and medical history were not 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 11-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 12-APR-2021, the subject experienced ear feels clogged. On 12-APR-2021, the subject experienced ringing in ears. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from ear feels clogged, and ringing in ears. This report was non-serious.


VAERS ID: 1249453 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Florida  
Vaccinated:0000-00-00
Onset:2021-04-12
Submitted: 0000-00-00
Entered: 2021-04-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 202A21A / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Headache
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:
Current Illness:
Preexisting Conditions: Comments: Unknown
Allergies:
Diagnostic Lab Data:
CDC Split Type: USJNJFOC20210440584

Write-up: HEADACHE; This spontaneous report received from a consumer concerned a male of unspecified age. The patient''s weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 202A21A expiry: UNKNOWN) dose was not reported, administered on 12-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, treatment medications included: paracetamol. On 12-APR-2021, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from headache. This report was non-serious.


VAERS ID: 1249512 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Texas  
Vaccinated:0000-00-00
Onset:2021-04-12
Submitted: 0000-00-00
Entered: 2021-04-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 201A21A / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Headache, Nausea, Pain
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: Thyroid disorder
Preexisting Conditions: Comments: Unknown
Allergies:
Diagnostic Lab Data:
CDC Split Type: USJNJFOC20210442818

Write-up: BODY ACHES; NAUSEA; HEADACHE; This spontaneous report received from a patient concerned a 60 year old female. The patient''s height, and weight were not reported. The patient''s concurrent conditions included thyroid issues. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 201A21A, and expiry: UNKNOWN) dose was not reported, administered on 12-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 12-APR-2021, the subject experienced headache. On 13-APR-2021, the subject experienced body aches. On 13-APR-2021, the subject experienced nausea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from headache, nausea, and body aches. This report was non-serious.


VAERS ID: 1249516 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: California  
Vaccinated:0000-00-00
Onset:2021-04-12
Submitted: 0000-00-00
Entered: 2021-04-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 18052029 / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Balance disorder, Confusional state, Dizziness, Fatigue, Headache, Panic attack, Polymerase chain reaction
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Vestibular disorders (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Abstains from alcohol; Hypertension; Non-smoker
Preexisting Conditions: Comments: Patient had no known drug allergies.
Allergies:
Diagnostic Lab Data: Test Date: 202102; Test Name: PCR; Result Unstructured Data: Negative
CDC Split Type: USJNJFOC20210442961

Write-up: PANIC ATTACK; DIZZINESS; HEADACHE; VERY FATIGUE; LOSS OF BALANCE; CONFUSION; This spontaneous report received from a consumer concerned a 60 year old male. The patient''s height, and weight were not reported. The patient''s concurrent conditions included hypertension, non alcoholic, and non smoker, and other pre-existing medical conditions included patient had no known drug allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 18052029 expiry: UNKNOWN) dose was not reported, administered on 27-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On FEB-2021, Laboratory data included: PCR (NR: not provided) Negative. On 12-APR-2021, the subject experienced loss of balance. On 12-APR-2021, the subject experienced confusion. On 12-APR-2021, the subject experienced dizziness. On 12-APR-2021, the subject experienced headache. On 12-APR-2021, the subject experienced very fatigue. On 15-APR-2021, the subject experienced panic attack. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from panic attack on 16-APR-2021, and had not recovered from loss of balance, headache, confusion, very fatigue, and dizziness. This report was non-serious.


VAERS ID: 1249541 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Kentucky  
Vaccinated:0000-00-00
Onset:2021-04-12
Submitted: 0000-00-00
Entered: 2021-04-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 206A21A / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Fatigue, Feeling jittery, Headache, Insomnia, Pain, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Drug allergy; Seasonal allergy
Preexisting Conditions: Comments: Unknown
Allergies:
Diagnostic Lab Data:
CDC Split Type: USJNJFOC20210443879

Write-up: SORENESS; JITTERINESS; UNABLE TO SLEEP; FATIGUE; FEVER; HEADACHE; This spontaneous report received from a patient concerned a 71 year old of unspecified sex. The patient''s height, and weight were not reported. The patient''s concurrent conditions included seasonal allergy, and codeine allergy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 206A21A expiry: UNKNOWN) dose was not reported, administered on 12-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 12-APR-2021, the subject experienced soreness. On 12-APR-2021, the subject experienced jitteriness. On 12-APR-2021, the subject experienced unable to sleep. On 12-APR-2021, the subject experienced fatigue. On 12-APR-2021, the subject experienced fever. On 12-APR-2021, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from jitteriness, unable to sleep, and fever on 13-APR-2021, fatigue on 14-APR-2021, and headache on 15-APR-2021, and was recovering from soreness. This report was non-serious.


VAERS ID: 1249567 (history)  
Form: Version 2.0  
Age: 40.0  
Sex: Female  
Location: Florida  
Vaccinated:2021-03-29
Onset:2021-04-12
   Days after vaccination:14
Submitted: 0000-00-00
Entered: 2021-04-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / 1 LA / SYR

Administered by: Other       Purchased by: ?
Symptoms: Arthralgia, Back pain, Heavy menstrual bleeding, Menstruation irregular
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Retroperitoneal fibrosis (broad), Fertility disorders (broad), 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:
Current Illness:
Preexisting Conditions: eczema
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: My first period after the vaccine arrived 6 days early, which is quite abnormal for me. The day before I couldn''t work at my desk due to pain in my low back and hip flexors, which is also abnormal. Then the period was heavier than normal lasted 3 days longer than normal. It looked like there were clots in the blood. I mentioned this experience to a friend, who said several of his female friends also experienced bizarre periods after receiving the JJ vaccine. Was this drug tested on women of reproductive age before being released?


VAERS ID: 1249637 (history)  
Form: Version 2.0  
Age: 56.0  
Sex: Female  
Location: California  
Vaccinated:2021-04-12
Onset:2021-04-12
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-04-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 LA / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Asthenia, Dyspnoea at rest, Fatigue, Feeling abnormal, Head discomfort, Myalgia, Neck pain, Pyrexia
SMQs:, Rhabdomyolysis/myopathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Eosinophilic pneumonia (broad), Arthritis (broad), Respiratory failure (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Arthritis; COPD; Multiple sclerosis spinal cord lesion; Osteoporosis
Allergies:
Diagnostic Lab Data: Test Date: 20210412; Test Name: fever; Result Unstructured Data: 100 F
CDC Split Type: USMODERNATX, INC.MOD20210

Write-up: no energy; pain all over body, feel like train wreck; pain all over body, feel like train wreck / every muscle in their body hurt; temperature 100F; patient is also very tired; shortness of breath; night of vaccination administration patient felt discomfort in neck and head on left side; night of vaccination administration patient felt discomfort in neck and head on left side; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of DYSPNOEA AT REST (shortness of breath) in a 56-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. Concurrent medical conditions included Arthritis, Osteoporosis, Multiple sclerosis spinal cord lesion and COPD. On 12-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Apr-2021, the patient experienced DYSPNOEA AT REST (shortness of breath) (seriousness criterion medically significant), HEAD DISCOMFORT (night of vaccination administration patient felt discomfort in neck and head on left side), NECK PAIN (night of vaccination administration patient felt discomfort in neck and head on left side), MYALGIA (pain all over body, feel like train wreck / every muscle in their body hurt), PYREXIA (temperature 100F) and FATIGUE (patient is also very tired). On an unknown date, the patient experienced ASTHENIA (no energy) and FEELING ABNORMAL (pain all over body, feel like train wreck). At the time of the report, DYSPNOEA AT REST (shortness of breath), HEAD DISCOMFORT (night of vaccination administration patient felt discomfort in neck and head on left side), NECK PAIN (night of vaccination administration patient felt discomfort in neck and head on left side), ASTHENIA (no energy), FEELING ABNORMAL (pain all over body, feel like train wreck), MYALGIA (pain all over body, feel like train wreck / every muscle in their body hurt), PYREXIA (temperature 100F) and FATIGUE (patient is also very tired) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 12-Apr-2021, Pyrexia: 100 (High) 100 F. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. There is no concomitant list provided. Treatment information was not provided. Company Comment Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded.


VAERS ID: 1249671 (history)  
Form: Version 2.0  
Age: 76.0  
Sex: Female  
Location: Tennessee  
Vaccinated:2021-03-25
Onset:2021-04-12
   Days after vaccination:18
Submitted: 0000-00-00
Entered: 2021-04-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 031L20A / 1 RA / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: VICTOZA; TOUJEO
Current Illness: Hypertension
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210412; Test Name: ultrasound; Result Unstructured Data: found a blood clot in her right leg behind the knee
CDC Split Type: USMODERNATX, INC.MOD20210

Write-up: they did ultrasound and found a blood clot in her right leg behind the knee; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of DEEP VEIN THROMBOSIS (they did ultrasound and found a blood clot in her right leg behind the knee) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination. Concurrent medical conditions included Hypertension. Concomitant products included LIRAGLUTIDE (VICTOZA) and INSULIN GLARGINE (TOUJEO) for an unknown indication. On 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 12-Apr-2021, the patient experienced DEEP VEIN THROMBOSIS (they did ultrasound and found a blood clot in her right leg behind the knee) (seriousness criterion medically significant). At the time of the report, DEEP VEIN THROMBOSIS (they did ultrasound and found a blood clot in her right leg behind the knee) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 12-Apr-2021, Ultrasound scan: found a blood clot in her right leg behind the kne (abnormal) found a blood clot in her right leg behind the knee. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Treatment included xarelto 15mg. Concomitant medication included BP medicine. Her right leg started swelling and turned red a week ago(10Apr2021). She went to the doctor on 12Apr2021 and they did ultrasound and found a blood clot in her right leg behind the knee (12Apr2021). She is scheduled to get 2nd dose on 22Apr2021. She never had blood clot before so wanted to report it. Company comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Further information has been requested; Sender''s Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Further information has been requested


VAERS ID: 1249675 (history)  
Form: Version 2.0  
Age: 49.0  
Sex: Female  
Location: Oregon  
Vaccinated:2021-02-26
Onset:2021-04-12
   Days after vaccination:45
Submitted: 0000-00-00
Entered: 2021-04-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Cerebrovascular accident
SMQs:, Ischaemic central nervous system vascular conditions (narrow), Haemorrhagic central nervous system vascular conditions (narrow), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow)

Life Threatening? Yes
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 6 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: No adverse event (No relevant medical history provided)
Allergies:
Diagnostic Lab Data:
CDC Split Type: USMODERNATX, INC.MOD20210

Write-up: stroke; This spontaneous case was reported by a consumer and describes the occurrence of CEREBROVASCULAR ACCIDENT (stroke) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The patient''s past medical history included No adverse event (No relevant medical history provided). On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 12-Apr-2021, the patient experienced CEREBROVASCULAR ACCIDENT (stroke) (seriousness criteria hospitalization and life threatening). The patient was hospitalized from 12-Apr-2021 to 17-Apr-2021 due to CEREBROVASCULAR ACCIDENT. At the time of the report, CEREBROVASCULAR ACCIDENT (stroke) outcome was unknown. Not Provided No medical history and concomitant medications were provided. No treatment information provided. Based on the information provided which includes a temporal association between the use of mRNA-1273 vaccine and onset of the reported events, a causal relationship cannot be excluded; Sender''s Comments: Based on the information provided which includes a temporal association between the use of mRNA-1273 vaccine and onset of the reported events, a causal relationship cannot be excluded


VAERS ID: 1249810 (history)  
Form: Version 2.0  
Age: 61.0  
Sex: Female  
Location: California  
Vaccinated:2021-04-12
Onset:2021-04-12
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-04-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 205A21A / 1 LA / SYR

Administered by: Pharmacy       Purchased by: ?
Symptoms: Dizziness, Nausea, Swelling face
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Angioedema (narrow), Anticholinergic syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Vestibular disorders (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-D, Zinc, Multivitamin, Magnesium L-Threonate, Curcumin, Vitamin C, Sulforaphane, MitoQ (mitoquinol mesylate)
Current Illness: None
Preexisting Conditions: None
Allergies: Penicillin, Chlorhexidine, Benzoates, Metronidazole, Shellfish, Honeydew, Mold, Trees, Grass
Diagnostic Lab Data: None
CDC Split Type:

Write-up: April 12, 2021-Mild face swelling and light dizziness began about one hour after injection and lasted for about 2 hours. I took a Zyrtec-D the morning of the injection so I think that helped keep the swelling under control. April 15, 2021-around 6:00 pm I became very nauseous and dizzy. The nausea subsided by the next morning but the dizziness has continued to this day. Had to stay in bed all day April 17 and 18 due to dizziness.


VAERS ID: 1250896 (history)  
Form: Version 2.0  
Age: 69.0  
Sex: Male  
Location: New Jersey  
Vaccinated:2021-04-06
Onset:2021-04-12
   Days after vaccination:6
Submitted: 0000-00-00
Entered: 2021-04-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 1805031 / 1 LA / IM

Administered by: Other       Purchased by: ?
Symptoms: Abdominal pain, Chest X-ray normal, Chest discomfort, Computerised tomogram head, Dizziness, Dyspnoea, Electrocardiogram normal, Fatigue, Headache, Lip swelling, Nausea, Peripheral swelling, Ultrasound Doppler
SMQs:, Cardiac failure (broad), Anaphylactic reaction (narrow), Acute pancreatitis (broad), Angioedema (narrow), Anticholinergic syndrome (broad), Retroperitoneal fibrosis (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Extravasation events (injections, infusions and implants) (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad), Vestibular disorders (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? Yes
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations: Flu
Other Medications: Atorvastatin, Exetimibe, Omeprazole, Flonase
Current Illness:
Preexisting Conditions: Gastritis, glaucoma, arthritis.
Allergies: Penicillin
Diagnostic Lab Data: Went to ER on 04/15 where they did US Doppler Venous Lower Extremity ; results negative. Also did EKG which was "normal". Headache continued so went back to ER on 04/17 where they did a EKG (normal), Chest X-ray (normal) and a CT Head without contrast (determined no clots). Was given Toradol and Reglan. Those drugs calmed my headache and I started to feel better. Slight headache ret 04/24.
CDC Split Type:

Write-up: Started 1 week after injection. Swelling in lower legs, felt like balloons. Feeling of swelling in lips. Headache started in left temple area of head; after a couple of days went across forehead and on back of head with intensity increasing but not extreme pain. Slight nausea; no vomiting. Some abdominal pain that would come and go. Periods of shortness of breath; tightness feeling in upper chest. Loss of energy and some light headed feeling.


VAERS ID: 1250927 (history)  
Form: Version 2.0  
Age: 44.0  
Sex: Female  
Location: South Dakota  
Vaccinated:2021-04-12
Onset:2021-04-12
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-04-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / N/A LA / SYR

Administered by: Public       Purchased by: ?
Symptoms: Blood test, Cerebrovascular accident, Computerised tomogram, Dysarthria, Ear discomfort, Electrocardiogram, Feeling hot, Gait disturbance, Head discomfort, Hemiparesis, Hypoaesthesia, Magnetic resonance imaging, Neurological symptom, Paraesthesia
SMQs:, Peripheral neuropathy (broad), Anticholinergic syndrome (broad), Ischaemic central nervous system vascular conditions (narrow), Haemorrhagic central nervous system vascular conditions (narrow), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Parkinson-like events (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (narrow), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: n/a
Current Illness: n/a
Preexisting Conditions: n/a
Allergies: mild allergies to chicken eggs and bakers yeast
Diagnostic Lab Data: CT scan; MRI; EKG; bloodwork; cognitive testing for suspected stroke
CDC Split Type:

Write-up: 1 hour after the vaccine I was walking with my sister and began experiencing neurological adverse effects--I was dragging my right lag and slurring my speech. 3 hours after the vaccine my right arm and right leg began tingling, went numb, and became weak. These symptoms persisted and my doctor advised me to go to the ER for brain imaging 24 hours after the vaccine. On day 3 after the vaccine, my symptoms had diminished but not subsided and I began to have new symptoms: extreme heat and pressure starting at my right ear and spreading through my face and head. The heat has subsided but not the pressure, as I am writing this it is day 13. Tests came back normal, but weakness and pressure neurological symptoms persist.


VAERS ID: 1251313 (history)  
Form: Version 2.0  
Age: 59.0  
Sex: Female  
Location: Mississippi  
Vaccinated:2021-03-31
Onset:2021-04-12
   Days after vaccination:12
Submitted: 0000-00-00
Entered: 2021-04-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 1808978 / 1 RA / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: Blood urine present, Computerised tomogram, Impaired work ability, Laboratory test abnormal, Loss of personal independence in daily activities, Magnetic resonance imaging, Platelet count decreased, Thrombocytopenia
SMQs:, Haematopoietic thrombocytopenia (narrow), Haemorrhage terms (excl laboratory terms) (narrow), Haemorrhage laboratory terms (narrow), Systemic lupus erythematosus (broad), Dementia (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? Yes, 2 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: thyroid is underactive
Allergies: surgical tape
Diagnostic Lab Data: lab work, MRI''s, CT scans
CDC Split Type: vsafe

Write-up: On 04-12-2021 at night, I noticed blood in my urine. I saw my PCP on 04-13-2021. On 04-14-2021, I again had blood in my urine. I called my urologist and was seen on 04-14-2021. My blood platelets were extremely low. I was then referred to see a hematologist who sent me to the hospital. I was admitted at Hospital where they performed lab work, MRI''s and CT scans. I stayed two days at the hospital. The hematologist who saw me said I have thrombocytopenia. Other tests were also performed and they checked me for stroke and I did not have a stroke. I am concerned due to my thrombocytopenia, if I get cut, I will bleed a lot and this is interfering with my job and to carry out my daily functions. I am still not recovered and my platelets are low. I still have to follow-up with my PCP and my hematologist has to check my bone marrow as the next step of treatment.


VAERS ID: 1251451 (history)  
Form: Version 2.0  
Age: 46.0  
Sex: Female  
Location: Michigan  
Vaccinated:2021-04-12
Onset:2021-04-12
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-04-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 1808982 / 1 LA / IM

Administered by: Other       Purchased by: ?
Symptoms: Tinnitus
SMQs:, Hearing impairment (narrow)

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: Penicillin
Diagnostic Lab Data: None
CDC Split Type:

Write-up: Injection received around 10:45 AM on 4/12/2021. By 10:00PM that night I noticed the development of Tinnitus. It has been constant and nonstop sense.


VAERS ID: 1251601 (history)  
Form: Version 2.0  
Age: 63.0  
Sex: Female  
Location: Ohio  
Vaccinated:2021-04-10
Onset:2021-04-12
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-04-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

Administered by: Pharmacy       Purchased by: ?
Symptoms: Abdominal pain upper, Arthralgia, Asthenia, Back pain, Blood pressure increased, Decreased appetite, Diplopia, Disorientation, Dizziness, Feeling abnormal, Metabolic function test, Muscle tightness, Pain in extremity, Pelvic pain, Peripheral swelling, Thirst, Urine analysis abnormal
SMQs:, Cardiac failure (broad), Acute pancreatitis (broad), Angioedema (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (narrow), Retroperitoneal fibrosis (broad), Dementia (broad), Dystonia (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Extravasation events (injections, infusions and implants) (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Haemodynamic oedema, effusions and fluid overload (narrow), Hypertension (narrow), Vestibular disorders (broad), Ocular motility disorders (broad), Arthritis (broad), Tendinopathies and ligament disorders (broad), Hypoglycaemia (broad), Dehydration (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: None
Current Illness: fibrosis caused by exposure to injected gadolinium-based contrast dye
Preexisting Conditions: gadolinium deposition disease, tachycardia
Allergies: yes, antibiotics, penicillins, MRI contrast dyes
Diagnostic Lab Data: Saw Dr at urgent Care where a Comprehensive metabolic was done. I hope to attach the results. On April 18th When I was with Dr. I had dizziness and disorientation and again on the April 20th along with a spike in blood pressure.
CDC Split Type:

Write-up: got it April 10th First day fine, second-day urine dark, third-day fog and disoriented sensation in my head and double vision, and periods of weakness in hands (now coming and going), lack of appetite, extreme thirst, no fever, no vomiting, pains in my thighs and stomach, middle back pain, Hips, pelvis, 9th day: calves so painful and tight I could not get out of bed, figures swelled up to the point that I could not put on my finds, 10th day my calves are very painful (like the soreness that is felt after someone punches you) Especially right calf. The batch number is 206a21a if I can read it from my card.


VAERS ID: 1251762 (history)  
Form: Version 2.0  
Age: 56.0  
Sex: Female  
Location: California  
Vaccinated:2021-03-16
Onset:2021-04-12
   Days after vaccination:27
Submitted: 0000-00-00
Entered: 2021-04-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 1805029 / N/A LA / SYR

Administered by: Other       Purchased by: ?
Symptoms: Balance disorder, Cognitive disorder, Computerised tomogram normal, Dizziness, Electrocardiogram normal, Fatigue, Headache, Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling, Magnetic resonance imaging normal, Nausea, SARS-CoV-2 test negative, Speech disorder, Vertigo
SMQs:, Acute pancreatitis (broad), Anticholinergic syndrome (broad), Dementia (broad), Psychosis and psychotic disorders (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Extravasation events (injections, infusions and implants) (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Haemodynamic oedema, effusions and fluid overload (narrow), Vestibular disorders (narrow), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Levothyroxine 5 mcg 2x week Levothyroxine 75 mcg 5x week Liothyronine 5 mcg 1x daily Clindamycin Phosphate & Benzyne Peroxide Gel 1.2%/5% 1x daily morning Tretinoin Cream USP 0.1% 1x daily evening Claritin Ready Tabs 1x daily as needed Niac
Current Illness: none
Preexisting Conditions: Hypothyroid
Allergies: Indocin, Acacia pollen. Occasional itchiness with avocado, pork, shrimp, and lobster.
Diagnostic Lab Data: April 14 - COVID19 negative, requested MRI of brain. EKG normal. April 16 - COVID19 negative, requested MRI of brain. EKG normal. Stroke negative, CT scan, MRI of brain all normal.
CDC Split Type:

Write-up: Date of injection: swelling, redness, soreness and itchy around injection site that continued for a week. April 12 Unexplained symptoms. Woke with throbbing head, light headed, off balance, impaired cognitive functions, impaired speech and random mild nausea that continued through mid-day April 13. Throbbing head and dizziness all dissipated when sitting or lying down. Visited Doctor on April 14 and ruled out stroke, heart attack and tested negative for COVID19. Symptoms lessened but did not disappear and visited hospital where they again ruled out stroke, heart attack and tested negative for COVID19. Performed Catscan and MRI of the brain that all showed normal. Performed inner ear testing that was normal, although they said I appeared to be experiencing some vertigo. April 23 still experiencing mild speech impairment and tire after talking for more than 10 minutes. Cognitive abilities inhibited by ongoing focus issues and search for right words. Balance issues easily impacted vigorous head movement.


VAERS ID: 1252632 (history)  
Form: Version 2.0  
Age: 24.0  
Sex: Female  
Location: Illinois  
Vaccinated:2021-04-06
Onset:2021-04-12
   Days after vaccination:6
Submitted: 0000-00-00
Entered: 2021-04-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / 1 RA / SYR

Administered by: Pharmacy       Purchased by: ?
Symptoms: Burning sensation, Head discomfort, Headache, Muscle spasms, Nasal discomfort, Pain, Pain in extremity, Paraesthesia, Ultrasound scan normal
SMQs:, Peripheral neuropathy (broad), Dystonia (broad), Guillain-Barre syndrome (broad), Tendinopathies and ligament 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? No
Previous Vaccinations:
Other Medications: Junel 1.5/30 Levothyroxine 50 mcg
Current Illness: N/A
Preexisting Conditions: N/A
Allergies: N/A
Diagnostic Lab Data: Ultrasound of leg with no clots reported on 4/15/2021. Physical neurological exam on 4/15/2021 and 4/18/2021. Nothing of concern on either exam. Ultimately prescribed Butabital-Acetaminophen and Gabapentin for the persistent headache.
CDC Split Type:

Write-up: Mild headache and mild leg pain started on 4/12/2021 at around 23:00. Leg pain can best be described as cramping, shooting pain in the back of the calf and thigh, at times radiating through the rest of the leg. Headache was a dull throbbing on right side of the head. Pain increased to moderate in both areas in the following days. Headache and Leg pain persisted through 4/23/2021. The leg pain continued to be sharp/shooting/cramping, but the headache transformed from a dull throbbing on the side of the head to a moderate sharp, burning feeling in the temples. This was also accompanied by a burning feeling in the nasal cavity and a "pins and needles"/heaviness feeling around the ears. Pain was not severe enough to be debilitating but required frequent pain medication to manage. The headache and leg pain appear to have ceased as of 4/24/2021.


VAERS ID: 1253827 (history)  
Form: Version 2.0  
Age: 20.0  
Sex: Female  
Location: New Jersey  
Vaccinated:2021-04-06
Onset:2021-04-12
   Days after vaccination:6
Submitted: 0000-00-00
Entered: 2021-04-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / 1 RA / SYR

Administered by: School       Purchased by: ?
Symptoms: Burning sensation, Paraesthesia, Pruritus
SMQs:, Anaphylactic reaction (broad), Peripheral neuropathy (broad), Guillain-Barre syndrome (broad), Hypersensitivity (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

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

Write-up: About a week after vaccination I started to feel a tingling, burning, almost itching feeling in my thighs and calves. It is not very uncomfortable but very noticeable.


VAERS ID: 1254999 (history)  
Form: Version 2.0  
Age: 52.0  
Sex: Male  
Location: California  
Vaccinated:2021-04-02
Onset:2021-04-12
   Days after vaccination:10
Submitted: 0000-00-00
Entered: 2021-04-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / 1 RA / -

Administered by: Public       Purchased by: ?
Symptoms: Acute kidney injury, Asthenia, Blood glucose increased, Blood pressure increased, Blood test, Cerebrovascular accident, Computerised tomogram head abnormal, Condition aggravated, Dysstasia, Hypoaesthesia, Magnetic resonance imaging head abnormal, Muscular weakness, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Rhabdomyolysis/myopathy (broad), Acute renal failure (narrow), Peripheral neuropathy (broad), Hyperglycaemia/new onset diabetes mellitus (narrow), Neuroleptic malignant syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Ischaemic central nervous system vascular conditions (narrow), Haemorrhagic central nervous system vascular conditions (narrow), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (broad), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (broad), Toxic-septic shock conditions (broad), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypertension (narrow), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Tumour lysis syndrome (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Dehydration (broad)

Life Threatening? Yes
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, 5 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: Enalapril 10 by mouth daily for high blood pressure
Current Illness:
Preexisting Conditions: High blood pressure controlled by Enalapril
Allergies:
Diagnostic Lab Data: CT Scan, MRI, blood work- hospital stay 04/15-21/2021 CT Scan and blood work 04/24/2021
CDC Split Type:

Write-up: We were vaccinated on April 2 in the morning. On April 12, 2021 we came home from work in the morning and he complained of numbness in his left. We thought it was related to the weather getting warm and we work the night shift, so he rested and increased his water intake. He was able to go to work on Monday night and return home and continued to rest on Tuesday. On Tuesday, there was no numbness, but there was weakness in both his legs. On Wednesday, he felt weakness throughout his body, especially in his legs. On Thursday, he collapsed. He did not lose consciences but his legs gave out under him and he was not able to get up up. He was taken to the hospital. He was diagnosed with a stroke, increased sugars (diabetes he has never had before), acute kidney injury, and uncontrolled increased blood pressure. He was hospitalized and discharged April 19, 2021. He was readmitted 04/24/2021 for another stroke.


VAERS ID: 1255569 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Ohio  
Vaccinated:0000-00-00
Onset:2021-04-12
Submitted: 0000-00-00
Entered: 2021-04-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
SMQs:, Lack of efficacy/effect (narrow), 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:
Allergies:
Diagnostic Lab Data: Test Date: 20210412; Test Name: COVID-19 virus test; Test Result: Positive
CDC Split Type: USPFIZER INC2021410140

Write-up: tested positive for Covid-19; COVID-19; This is a spontaneous report from a contactable consumer (patient) via Medical Information Team. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date were not reported), first dose on an unspecified date and second dose on 09Apr2021, both via an unspecified route of administration at single doses for COVID-19 immunization. The patient''s medical history and concomitant medications were not reported. The patient reported that she tested positive for COVID-19 on 12Apr2021 despite receiving second dose of the vaccine. Outcome of the events was unknown. Information on the lot/batch number has been requested.; Sender''s Comments: Linked Report(s) : US-PFIZER INC-2021412463 same patient/drug, different doses/events


VAERS ID: 1256268 (history)  
Form: Version 2.0  
Age: 46.0  
Sex: Male  
Location: Unknown  
Vaccinated:2021-04-06
Onset:2021-04-12
   Days after vaccination:6
Submitted: 0000-00-00
Entered: 2021-04-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / IM

Administered by: Other       Purchased by: ?
Symptoms: Abdominal pain lower, Computerised tomogram abdomen abnormal, Computerised tomogram pelvis abnormal, Pelvic venous thrombosis, Scan with contrast abnormal
SMQs:, Retroperitoneal fibrosis (broad), Embolic and thrombotic events, venous (narrow), Malignancy related therapeutic and diagnostic procedures (narrow), Thrombophlebitis (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? No
Hospitalized? Yes, 3 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: Synthroid, lipitor, spironolactone, protonix, naproxen
Current Illness: none
Preexisting Conditions: Down''s syndrome, hypothyroidism, GERD
Allergies: NKDA
Diagnostic Lab Data: CT abdomen/pelvis with contrast found the thrombosis on 4/23/21
CDC Split Type:

Write-up: Iliac vein thrombosis pt started with right lower quadrant abdominal pain six days after vaccine. Persistent pain since then leading to hospital stay and diagnosis on imaging of right iliac vein thrombosis. no prior history of DVT, no family history of DVT, no inciting event/travel/change in activity level/surgery/illness


VAERS ID: 1256805 (history)  
Form: Version 2.0  
Age: 37.0  
Sex: Female  
Location: California  
Vaccinated:2021-04-12
Onset:2021-04-12
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-04-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / 1 LA / SYR

Administered by: Public       Purchased by: ?
Symptoms: Migraine, Pain in extremity
SMQs:, 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: Iron (otc) Cambia (prn) Ubrelvy (prn) Ujovy (1x monthly) Wellbutrin Xanax (prn) Gabalentin
Current Illness: Anemia Anxiety Depression
Preexisting Conditions: Anemia Anxiety Depression
Allergies: Pencillin
Diagnostic Lab Data:
CDC Split Type:

Write-up: Migraine/headache since date of vaccine Sore arm


VAERS ID: 1257027 (history)  
Form: Version 2.0  
Age: 68.0  
Sex: Female  
Location: Colorado  
Vaccinated:2021-04-11
Onset:2021-04-12
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-04-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 207A21A / 1 RA / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: Adverse reaction, Nausea, Tremor
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Parkinson-like events (broad), Noninfectious encephalopathy/delirium (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), 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: IBUPROFEN 800MG, GABAPENTIN 100MG, TRIMETHOPRIM100MG, ONDANSETRON 8 MG, TRAZODONE 150MG, ATORVASTATIN 40MG , DIAZEPAM 5 MG, PEPTOBISMOL
Current Illness: UNKNOWN
Preexisting Conditions: UNKNOWN
Allergies: SULFA
Diagnostic Lab Data: UNKNOWN
CDC Split Type:

Write-up: ON 4/25/21, PT STOPPED AT PHARMACY COMPLAINING OF ADVERSE REACTIONS SHE WAS HAVING DUE TO THE JOHNSON AND JOHNSON VACCINE SHE GOT. SHE C/O NAUSEA AND HANDS SHAKING. I TOLD HER I WOULD SUBMIT A REPORTAND FOR HER TO SEEK TREATMENT FROM HER PCP. I ASKED THAT SHE CONTACT ME WITH ANY CONCERNS OR SHARE COMMENTS THAT DR SHARES WITH HER.


VAERS ID: 1257314 (history)  
Form: Version 2.0  
Age: 37.0  
Sex: Male  
Location: North Carolina  
Vaccinated:2021-04-06
Onset:2021-04-12
   Days after vaccination:6
Submitted: 0000-00-00
Entered: 2021-04-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 042A21A / 1 RA / SYR

Administered by: Pharmacy       Purchased by: ?
Symptoms: Blood test, Computerised tomogram, Disturbance in attention, Dizziness, Head discomfort, Headache, Hypertension, Ultrasound scan
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Noninfectious encephalopathy/delirium (broad), Hypertension (narrow), 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? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Blood test, CT scan - April 18 More blood tests - April 22 Leg ultrasound - April 25
CDC Split Type:

Write-up: Severe pressure headache, lightheaded, trouble concentrating, elevated blood pressure


VAERS ID: 1257415 (history)  
Form: Version 2.0  
Age: 43.0  
Sex: Female  
Location: California  
Vaccinated:2021-04-09
Onset:2021-04-12
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-04-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 LA / SYR

Administered by: Private       Purchased by: ?
Symptoms: Erythema, Injected limb mobility decreased, Pain, Skin warm
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (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: Metformin, vitamin e, collagen+ c.
Current Illness: N/a
Preexisting Conditions: N/a
Allergies: N/a
Diagnostic Lab Data: Emergency room on 4/20/2021, day 11 after shot. Unable to move arm.
CDC Split Type:

Write-up: Severe pain, redness, warmth. Unable to move arm/ shoulder on day 4 after shot. Unable to lift, carry, raise arm above head. Increasing pain, warmth and redness continue on day 15 after shot. Continued immobility on day 15 after shot.


VAERS ID: 1257459 (history)  
Form: Version 2.0  
Age: 69.0  
Sex: Female  
Location: Unknown  
Vaccinated:2021-04-12
Onset:2021-04-12
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-04-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 043A21A / 1 LA / IM

Administered by: Private       Purchased by: ?
Symptoms: Incorrect dose administered
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: Was giving injection in left deltoid and syringe came off and leaked some down arm . Sticker was close to needle and safety guard. Part of the dose leaked out during the injection. Patient received a partial dose of vaccine.


VAERS ID: 1257650 (history)  
Form: Version 2.0  
Age: 25.0  
Sex: Female  
Location: Texas  
Vaccinated:2021-04-10
Onset:2021-04-12
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-04-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 206A21A / 1 RA / SYR

Administered by: Pharmacy       Purchased by: ?
Symptoms: Mouth ulceration
SMQs:, Severe cutaneous adverse reactions (broad), Systemic lupus erythematosus (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Hypersensitivity (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Sertraline Hydroxyzine Esomeprazole Vitamin D Loratidine
Current Illness: None
Preexisting Conditions: None
Allergies: None
Diagnostic Lab Data:
CDC Split Type:

Write-up: First mouth ulcer developed after two days, healed in about 6 days, and then developed a different ulcer and the cycle has repeated through the date of this report.


VAERS ID: 1257873 (history)  
Form: Version 2.0  
Age: 46.0  
Sex: Female  
Location: Indiana  
Vaccinated:2021-04-11
Onset:2021-04-12
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-04-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 207A21A / 1 LA / SYR

Administered by: Private       Purchased by: ?
Symptoms: Cerebrovascular accident, Glycosylated haemoglobin normal, Headache, Immediate post-injection reaction, Influenza like illness, Intensive care
SMQs:, Ischaemic central nervous system vascular conditions (narrow), Haemorrhagic central nervous system vascular conditions (narrow), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Hypersensitivity (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, 3 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: N/A
Current Illness: N/A
Preexisting Conditions: N/A
Allergies: Sulfa Allergy
Diagnostic Lab Data: Hemoglobin A1c was 5.8%: No other lab results were given with discharge paperwork.
CDC Split Type:

Write-up: Immediately following vaccination: Flu like symptoms. 24 Hours after vaccination: Very severe headaches started and continued. 12 Days after vaccination severe Stroke/Hospitalization/ICU


VAERS ID: 1258374 (history)  
Form: Version 2.0  
Age: 62.0  
Sex: Male  
Location: California  
Vaccinated:2021-04-08
Onset:2021-04-12
   Days after vaccination:4
Submitted: 0000-00-00
Entered: 2021-04-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 042A21A / UNK LA / SYR

Administered by: Private       Purchased by: ?
Symptoms: Abdominal pain upper, Chest X-ray, Chills, Computerised tomogram head, Confusional state, Fracture, Laboratory test, Magnetic resonance imaging abnormal, Pain, Retching, Seizure, Venous thrombosis, Vomiting, X-ray
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Dementia (broad), Convulsions (narrow), Embolic and thrombotic events, venous (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Accidents and injuries (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Osteoporosis/osteopenia (broad), Generalised convulsive seizures following immunisation (narrow), 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: Flomax 0.4mg, lipitor 40mg, lisinopril 20mg, melatonin 5mg, red rice yeast 600mg, CoQ10 30mg
Current Illness: none
Preexisting Conditions: controlled hypertension
Allergies: none
Diagnostic Lab Data: 4/12, labs, chest x-ray, shoulder x-ray, 4/13 CT head, and Adomnal MRI with contrast. 4/ 15 Head MRI with contrast
CDC Split Type:

Write-up: 4/9 thru 4/12, body aches, chills. 4/12 0400 throwing up stomach pain from dry heaving throughout the day, confusion starting at 6pm on 4/12. Seizure on 4/12 at 8 pm. 911, ambulance. to Hospital Seizure so severe caused a Fracture in the Right Scapula. MRI on 4/15 showed a venous thrombosis partial occlusion in the brain.


VAERS ID: 1258608 (history)  
Form: Version 2.0  
Age: 18.0  
Sex: Male  
Location: Washington  
Vaccinated:2021-04-11
Onset:2021-04-12
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-04-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 202A21A / 1 RA / SYR

Administered by: Other       Purchased by: ?
Symptoms: Blood creatine phosphokinase normal, Blood magnesium normal, Blood test normal, Differential white blood cell count normal, Erythema, Fatigue, Fibrin D dimer normal, Full blood count normal, Headache, Metabolic function test
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: n/a
Current Illness: n/a
Preexisting Conditions: n/a
Allergies: n/a
Diagnostic Lab Data: Blood test for blood clots - negative result on 4/21/2021 These test were normal: CBC w/ auto diff, CPK, Comprehensive Metabolic Panel, D DIMER, Mg. D DIMER, QUANTITATIVE Magnesium Test results are negative.
CDC Split Type:

Write-up: He has had the following symptoms from the 4/12/2021 till present time: constant headache and fatigue. Intermittent low fever (99F). On 4/21/2021, his primary care doctor recommended that we take him to Emergency Room because she was concerned about thrombosis as side effects from the vaccine. His legs had some red patches on the back of the ankles area. At ER, doctor did blood test for blood clot and result was negative. He got an IV injection less headache.


VAERS ID: 1258850 (history)  
Form: Version 2.0  
Age: 60.0  
Sex: Female  
Location: New Hampshire  
Vaccinated:2021-04-11
Onset:2021-04-12
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-04-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 202A21A / 1 LA / SYR

Administered by: Other       Purchased by: ?
Symptoms: Chills, Feeling hot, Gait disturbance, Headache, Loss of personal independence in daily activities, Mobility decreased, Night sweats, Pain, Pain in extremity
SMQs:, Peripheral neuropathy (broad), Anticholinergic syndrome (broad), Dementia (broad), Parkinson-like events (broad), Guillain-Barre syndrome (broad), Tendinopathies and ligament disorders (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: CALCIUM 1200MG,VITAMIN C WILD ROSE HIPS 500 MG, ALIVE WOMEN''S 50 PLUS COMPLETE MULTIVITAMINS
Current Illness: NONE
Preexisting Conditions: NONE
Allergies: NONE
Diagnostic Lab Data: NONE
CDC Split Type:

Write-up: AT 2:00 A.M.HAD THE SWEATS BURNING UP NEEDED TO TAKE SHOWER TO COOL DOWN THAN HAD CHILLS AND BODY ACHES, AND HEADACHE STARTED, HAD A HARD TIME FUNCTIONING. THIS WENT ON FOR TWO DAYS THEN HEADACHE FOR A WEEK AND LEGS WERE PAINFUL TO WALK STILL ARE HEADACHE GONE BUT PAIN IN LEGS, STILL TAKING ADVIL ITS BEEN TWO WEEKS SINCE THE SHOT.


VAERS ID: 1259705 (history)  
Form: Version 2.0  
Age: 60.0  
Sex: Female  
Location: Illinois  
Vaccinated:2021-04-12
Onset:2021-04-12
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-04-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 201A21A / 1 RA / SYR
COVID19: COVID19 (COVID19 (UNKNOWN)) / UNKNOWN MANUFACTURER 201A21A / 1 RA / SYR

Administered by: Public       Purchased by: ?
Symptoms: Contusion, Induration, Injection site haemorrhage, Pain in extremity, Swelling
SMQs:, Anaphylactic reaction (broad), Angioedema (broad), Haemorrhage terms (excl laboratory terms) (narrow), Accidents and injuries (narrow), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Tendinopathies and ligament disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Amnestic MCI
Allergies: Codiene, seafood, Clinimyicine
Diagnostic Lab Data: Follow up with doctor 4/26. Steroid shot and strong antibiotics given
CDC Split Type:

Write-up: Extreme swelling 2 weeks after vaccine. A lot of bruising. Left hard very sore size of quarter place on right arm. Blood a lot when injection was done.


VAERS ID: 1260019 (history)  
Form: Version 2.0  
Age: 43.0  
Sex: Male  
Location: New York  
Vaccinated:2021-04-12
Onset:2021-04-12
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-04-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK LA / -

Administered by: Unknown       Purchased by: ?
Symptoms: Arthralgia, Hyperhidrosis, Myalgia, Pain in extremity, Swelling, Ultrasound scan
SMQs:, Rhabdomyolysis/myopathy (broad), Anaphylactic reaction (broad), Angioedema (broad), Neuroleptic malignant syndrome (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Eosinophilic pneumonia (broad), Arthritis (broad), Tendinopathies and ligament disorders (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: mulitvitamin, Deluxotime, pioglitazine, lamotragen, valsartan/amlodapine, symvastartin
Current Illness: na
Preexisting Conditions: high blood pressure, pre diabities
Allergies: na
Diagnostic Lab Data: joint specialist 4/27/21 Exam, sonar gram. Evidence of fluid build up, swelling
CDC Split Type:

Write-up: extreme sweating, joint pain and swelling, leg pain, muscle pain


VAERS ID: 1260378 (history)  
Form: Version 2.0  
Age: 54.0  
Sex: Female  
Location: Vermont  
Vaccinated:2021-03-31
Onset:2021-04-12
   Days after vaccination:12
Submitted: 0000-00-00
Entered: 2021-04-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / 1 LA / SYR

Administered by: Other       Purchased by: ?
Symptoms: Abdominal pain upper, Ageusia, Headache, Oropharyngeal discomfort, Pain in extremity, Rhinorrhoea, SARS-CoV-2 test negative
SMQs:, Acute pancreatitis (broad), Taste and smell disorders (narrow), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), 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: Estrace
Current Illness: None
Preexisting Conditions: Back pain
Allergies: Amoxicillin
Diagnostic Lab Data: Went to doctors and had me have a covid test,came back negative,and they told me it was a viral infection and gave me a antibiotic for five days but still don''t feel any better.
CDC Split Type:

Write-up: Had severe headache, runny nose , scratchy throat,bad leg pain, stomach pain,and loss of taste on certain things,and still have symptoms to this day,and very tired all the time


VAERS ID: 1260776 (history)  
Form: Version 2.0  
Age: 34.0  
Sex: Female  
Location: Massachusetts  
Vaccinated:2021-03-31
Onset:2021-04-12
   Days after vaccination:12
Submitted: 0000-00-00
Entered: 2021-04-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / 1 RA / SYR

Administered by: Unknown       Purchased by: ?
Symptoms: Pain in extremity
SMQs:, 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:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: I?ve had pain in both legs off and on since the Janssen shot. Had an issue with clots and blood supply in previous and recent pregnancies


VAERS ID: 1261002 (history)  
Form: Version 2.0  
Age: 25.0  
Sex: Female  
Location: Washington  
Vaccinated:2021-04-11
Onset:2021-04-12
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-04-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 042A21A / 1 LA / UN

Administered by: Pharmacy       Purchased by: ?
Symptoms: Chills, Culture wound negative, Pyrexia, Sexually transmitted disease test, Smear vaginal normal, Vaginal ulceration, Vulval ulceration, Vulvovaginal discomfort
SMQs:, Severe cutaneous adverse reactions (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: SPIRONOLACTONE, ESTARYLLA
Current Illness: none
Preexisting Conditions: acne vulgaris
Allergies: none
Diagnostic Lab Data: All STD & STI tests were done on 4/15 to rule out disease - all negative. Wound culture taken 4/15. Wet mount taken 4/15 - negative/no fungi, Anime, clue cells, Trichomonas.
CDC Split Type:

Write-up: 4/11/2021: chills, fever 4/12/2021: Lipschütz ulcer; vaginal ulcerations that lasted for ~2 weeks. Noticed discomfort on 4/12. First saw nurse practitioner on 4/15 and saw ob/gyn on 4/20. Never experienced before.


VAERS ID: 1261180 (history)  
Form: Version 2.0  
Age: 32.0  
Sex: Female  
Location: Florida  
Vaccinated:0000-00-00
Onset:2021-04-12
Submitted: 0000-00-00
Entered: 2021-04-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 1805025 / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Chills, Decreased appetite, Dizziness, Headache, Nausea, Neck pain, Pain, Syncope, Vomiting
SMQs:, Torsade de pointes/QT prolongation (broad), Acute pancreatitis (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Vestibular disorders (broad), Hypotonic-hyporesponsive episode (broad), Arthritis (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:
Current Illness: Dependence on opiates; Depression; Hepatitis C; HIV infection; Penicillin allergy; Polysubstance abuse
Preexisting Conditions: Comments: Unknown
Allergies:
Diagnostic Lab Data:
CDC Split Type: USJNJFOC20210425865

Write-up: SYNCOPE EPISODE; NECK PAIN; LOSS OF APPETITE; BODY ACHE; DIZZINESS; VOMITING; CHILLS; HEADACHE; NAUSEA; This spontaneous report received from a health care professional concerned a 32 year old female. The patient''s height, and weight were not reported. The patient''s concurrent conditions included penicillin allergy, hepatitis C, HIV, opioid dependence, polysubstance abuse, and depression. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1805025, and expiry: UNKNOWN) dose was not reported, administered on 12-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 12-APR-2021 about one hour after the vaccination, the patient experienced neck pain, loss of appetite, body ache, dizziness, vomiting, chills, headache, and nausea. On 13-APR-2021, the patient experienced syncope episode and other symptoms got worsened. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from syncope episode, chills, neck pain, loss of appetite, headache, nausea, vomiting, body ache, and dizziness. This report was serious (Other Medically Important Condition). This case, from the same reporter is linked.; Sender''s Comments: V0- covid-19 vaccine ad26.cov2.s-syncope. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: MEDICAL HISTORY, UNDERLYING DISEASE


VAERS ID: 1261202 (history)  
Form: Version 2.0  
Age: 61.0  
Sex: Female  
Location: Virginia  
Vaccinated:0000-00-00
Onset:2021-04-12
Submitted: 0000-00-00
Entered: 2021-04-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 1808609 / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Raynaud's phenomenon
SMQs:, Immune-mediated/autoimmune 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: Arthritis; High cholesterol
Preexisting Conditions: Medical History/Concurrent Conditions: Raynaud''s phenomenon
Allergies:
Diagnostic Lab Data:
CDC Split Type: USJNJFOC20210429048

Write-up: RAYNAUD''S PHENOMENON; This spontaneous report received from a patient concerned a 61 year old female. The patient''s height, and weight were not reported. The patient''s past medical history included raynaud''s phenomenon, and concurrent conditions included high cholesterol, and arthritis in hands. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808609, and expiry: UNKNOWN) dose was not reported, administered on 29-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 12-APR-2021, the subject experienced raynaud''s phenomenon. Treatment medications (dates unspecified) included: acetylsalicylic acid. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of raynaud''s phenomenon was not reported. This report was non-serious.; Sender''s Comments: V0: Medical assessment comment not required as per standard procedure since case was assessed as non serious.


VAERS ID: 1261213 (history)  
Form: Version 2.0  
Age: 60.0  
Sex: Male  
Location: Michigan  
Vaccinated:0000-00-00
Onset:2021-04-12
Submitted: 0000-00-00
Entered: 2021-04-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 1805020 / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Abdominal pain, Aphonia, Chest discomfort, Headache, Nausea, Oropharyngeal pain
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Retroperitoneal fibrosis (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (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? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Comments: Unknown
Allergies:
Diagnostic Lab Data:
CDC Split Type: USJNJFOC20210429791

Write-up: LOSS OF VOICE; CHEST TIGHTNESS; CRAMPS IN THE STOMACH; SORE THROAT; BAD HEADACHE IN THE BACK OF THE NECK; NAUSEA; This spontaneous report received from a patient concerned a 60 year old male. The patient''s weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805020 expiry: UNKNOWN) dose was not reported, administered on 02-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 12-APR-2021, the subject experienced loss of voice. On 12-APR-2021, the subject experienced chest tightness. On 12-APR-2021, the subject experienced cramps in the stomach. On 12-APR-2021, the subject experienced sore throat. On 12-APR-2021, the subject experienced bad headache in the back of the neck. On 12-APR-2021, the subject experienced nausea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from bad headache in the back of the neck, sore throat, nausea, loss of voice, cramps in the stomach, and chest tightness. This report was non-serious.; Sender''s Comments: V0: Medical Assessment comment was not required as per standard procedure as the case assessed as non-serious.


VAERS ID: 1261227 (history)  
Form: Version 2.0  
Age: 44.0  
Sex: Female  
Location: Oklahoma  
Vaccinated:0000-00-00
Onset:2021-04-12
Submitted: 0000-00-00
Entered: 2021-04-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 1808978 / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure measurement, Body temperature, COVID-19, Dizziness, Haemoptysis, Hypertension, Paraesthesia, SARS-CoV-2 test, SARS-CoV-2 test negative
SMQs:, Peripheral neuropathy (broad), Haemorrhage terms (excl laboratory terms) (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Guillain-Barre syndrome (broad), Hypertension (narrow), Vestibular disorders (broad), Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Hypertension; Hysterectomy (Patient was in hospital overnight and discharged the next day.); Type II diabetes mellitus
Preexisting Conditions: Comments: Unknown
Allergies:
Diagnostic Lab Data: Test Date: 202104; Test Name: Body temperature; Result Unstructured Data: 99.8 F; Test Date: 20210406; Test Name: COVID-19 virus test negative; Result Unstructured Data: Negative; Test Date: 20210412; Test Name: COVID-19 PCR test; Result Unstructured Data: Positive; Test Date: 20210414; Test Name: Blood pressure; Result Unstructured Data: 156/81; Test Name: Blood pressure; Result Unstructured Data: 175/83
CDC Split Type: USJNJFOC20210430662

Write-up: TINGLY/NUMB HANDS; DIZZINESS; HIGH BLOOD PRESSURE; COUGHED UP 3 DARK GREEN CHUNKS THAT HAD SOME BLOOD; COVID-19 INFECTION; This spontaneous report received from a patient concerned a 44 year old female. The patient''s height, and weight were not reported. The patient''s concurrent conditions included hysterectomy, type 2 diabetes, and hypertension. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808978, and batch number: 1808978 expiry: UNKNOWN) dose was not reported, administered on 30-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, Laboratory data included: Body temperature (NR: not provided) 99.8 F. On 06-APR-2021, Laboratory data included: COVID-19 virus test negative (NR: not provided) Negative. On 12-APR-2021, the subject experienced covid-19 infection. On 12-APR-2021, the subject experienced coughed up 3 dark green chunks that had some blood. Laboratory data included: COVID-19 PCR test (NR: not provided) Positive. On 14-APR-2021, the subject experienced tingly/numb hands. On 14-APR-2021, the subject experienced dizziness. On 14-APR-2021, the subject experienced high blood pressure. Laboratory data included: Blood pressure (NR: not provided) 156/81. Laboratory data (dates unspecified) included: Blood pressure (NR: not provided) 175/83. Treatment medications (dates unspecified) included: guaifenesin, and oxycodone hydrochloride/paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from dizziness, tingly/numb hands, and covid-19 infection, and the outcome of high blood pressure and coughed up 3 dark green chunks that had some blood was not reported. This report was non-serious.; Sender''s Comments: V0: Medical assessment comments not required as per standard procedure as the case is considered non serious.


VAERS ID: 1261235 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Unknown  
Vaccinated:0000-00-00
Onset:2021-04-12
Submitted: 0000-00-00
Entered: 2021-04-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN UNKNOWN / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Chills, Dehydration, Fatigue, Feeling abnormal, Headache, Nausea, Pain, Pain in extremity, Pyrexia
SMQs:, Acute pancreatitis (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Dehydration (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: Unknown
Allergies:
Diagnostic Lab Data:
CDC Split Type: USJNJFOC20210430950

Write-up: CHILLS; FEVER; HEADACHE; NAUSEA; FATIGUE; FOGGY FEELING IN HEAD; BODY SORENESS/MILD PAIN; DEHYDRATION; SORE ARM; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient''s weight was 140 pounds, and height was 65 inches. 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 12-APR-2021 16:00 for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On 12-APR-2021, the subject experienced sore arm. On 13-APR-2021, the subject experienced foggy feeling in head. On 13-APR-2021, the subject experienced body soreness/mild pain. On 13-APR-2021, the subject experienced dehydration. On 13-APR-2021, the subject experienced fever. On 13-APR-2021, the subject experienced headache. On 13-APR-2021, the subject experienced nausea. On 13-APR-2021, the subject experienced fatigue. On 13-APR-2021 03:00, the subject experienced chills. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from foggy feeling in head, body soreness/mild pain, dehydration, chills, fever, headache, nausea, and fatigue on 13-APR-2021, and was recovering from sore arm. This report was non-serious.; Sender''s Comments: V0: Medical assessment comment not required as per standard procedure as case assessed as non-serious.


VAERS ID: 1261256 (history)  
Form: Version 2.0  
Age: 51.0  
Sex: Male  
Location: Arizona  
Vaccinated:0000-00-00
Onset:2021-04-12
Submitted: 0000-00-00
Entered: 2021-04-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 203A21A / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Dizziness, Heart rate, Heart rate decreased, Hyperhidrosis
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (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:
Current Illness: Alcohol use; Non-smoker
Preexisting Conditions: Comments: No known drug allergies
Allergies:
Diagnostic Lab Data: Test Date: 20210412; Test Name: Pulse rate; Result Unstructured Data: 36-37 beats/minutes
CDC Split Type: USJNJFOC20210431941

Write-up: HEART RATE DROPPED TO 36-37 BEATS/MINUTES; SWEATING PROFUSELY; DIZZINESS/ LIGHTHEADEDNESS; This spontaneous report received from a patient concerned a 51 year old male. The patient''s height, and weight were not reported. The patient''s concurrent conditions included alcohol user, and non-smoker, and other pre-existing medical conditions included no known drug allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 203A21A, and expiry: UNKNOWN) dose was not reported, 1 total administered on 12-APR-2021 at left arm for prophylactic vaccination. No concomitant medications were reported. Patient reported that, he got the Janssen vaccine on Monday 12-April -2021.Right after vaccination patient started experiencing lightheadedness, sweating profusely, heart rate dropped to 36-37 beats/minutes.he did not see his MD and did not go to ED(emergency department) Patient was feeling much better right now. He was not on any chronic medications. Laboratory data included: Pulse rate (NR: not provided) 36-37 beats/minutes. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from heart rate dropped to 36-37 beats/minutes, sweating profusely, and dizziness/ lightheadedness. This report was serious (Other Medically Important Condition).; Sender''s Comments: 20210431941-covid-19 vaccine ad26.cov2. s-heart rate dropped. This event is considered unassessable. The event 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.


VAERS ID: 1261275 (history)  
Form: Version 2.0  
Age: 60.0  
Sex: Female  
Location: New Jersey  
Vaccinated:0000-00-00
Onset:2021-04-12
Submitted: 0000-00-00
Entered: 2021-04-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 041A21A / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Abdominal pain, Contusion, Muscle spasms
SMQs:, Acute pancreatitis (broad), Haemorrhage terms (excl laboratory terms) (narrow), Retroperitoneal fibrosis (broad), Dystonia (broad), Accidents and injuries (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? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Abstains from alcohol; Allergy to antibiotic; Lyme disease; Non-smoker; Shellfish allergy
Preexisting Conditions: Comments: The patient had no history of drug abuse or illicit drug use.
Allergies:
Diagnostic Lab Data:
CDC Split Type: USJNJFOC20210435525

Write-up: ABDOMINAL PAIN; BRUISES ON LEG AND RIGHT ARM; CRAMPING ON LEG; This spontaneous report received from a consumer concerned a 60 year old female. The patient''s height, and weight were not reported. The patient''s concurrent conditions included Lyme disease, shellfish allergy, allergy to an unknown antibiotic, non alcohol user, and non-smoker, and other pre-existing medical conditions included the patient had no history of drug abuse or illicit drug use. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 041A21A expiry: UNKNOWN) dose was not reported, administered on 03-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 12-APR-2021, the subject experienced abdominal pain. On 12-APR-2021, the subject experienced bruises on leg and right arm. On 12-APR-2021, the subject experienced cramping on leg. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from abdominal pain, bruises on leg and right arm, and cramping on leg. This report was non-serious.; Sender''s Comments: v0-Medical assessment comment is not required as the case is assessed as non-serious.


VAERS ID: 1261315 (history)  
Form: Version 2.0  
Age: 42.0  
Sex: Female  
Location: New Jersey  
Vaccinated:0000-00-00
Onset:2021-04-12
Submitted: 0000-00-00
Entered: 2021-04-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood test, Body temperature, Headache, Injection site pain, Limb discomfort, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Extravasation events (injections, infusions and implants) (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Comments: patient does not have diabetes, circulation problems, and is not overweight. She is not taking birth control pills.
Allergies:
Diagnostic Lab Data: Test Date: 20210413; Test Name: Body temperature; Result Unstructured Data: 100.1 (unit unspecified); Test Date: 20210414; Test Name: Blood test; Result Unstructured Data: UNKNOWN
CDC Split Type: USJNJFOC20210439354

Write-up: LEGS FELT "HEAVY" BILATERALLY, LEFT MORE THAN RIGHT; PAIN IN THE ARM; FEVERISH; HEADACHE; This spontaneous report received from a consumer concerned a 42 year old female. The patient''s height, and weight were not reported. The patient''s pre-existing medical conditions included patient does not have diabetes, circulation problems, and is not overweight. she is not taking birth control pills. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on 12-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 12-APR-2021, the subject experienced pain in the arm. On 12-APR-2021, the subject experienced feverish. On 12-APR-2021, the subject experienced headache. On 13-APR-2021, the subject experienced legs felt "heavy" bilaterally, left more than right. Laboratory data included: Body temperature (NR: not provided) 100.1 (unit unspecified). Treatment medications included: paracetamol. On 14-APR-2021, Laboratory data included: Blood test (NR: not provided) UNKNOWN (units unspecified). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from feverish on 16-APR-2021, had not recovered from legs felt "heavy" bilaterally, left more than right, and the outcome of pain in the arm and headache was not reported. This report was non-serious. This case, from the same reporter is linked to 20210425979.


VAERS ID: 1261320 (history)  
Form: Version 2.0  
Age: 42.0  
Sex: Female  
Location: Unknown  
Vaccinated:0000-00-00
Onset:2021-04-12
Submitted: 0000-00-00
Entered: 2021-04-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood test, Body temperature, Headache, Impaired work ability, Injection site pain, Limb discomfort, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Extravasation events (injections, infusions and implants) (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Comments: No medications prior to the Janssen Covid-19 vaccine. The patient had no diabetes, no circulation problems, and was not overweight. The patient was not taking birth control pills.
Allergies:
Diagnostic Lab Data: Test Date: 20210413; Test Name: Body temperature; Result Unstructured Data: 100.1; Test Date: 20210414; Test Name: Blood test; Result Unstructured Data: Not reported
CDC Split Type: USJNJFOC20210439458

Write-up: HEAVINESS IN LEGS; MISSED WORK DUE TO THE FEVER; PAIN AT INJECTION SITE; FEVER; HEADACHE; This spontaneous report received from a consumer concerned a 42 year old female. The patient''s height, and weight were not reported. The patient''s pre-existing medical conditions included no medications prior to the janssen covid-19 vaccine. the patient had no diabetes, no circulation problems, and was not overweight. the patient was not taking birth control pills. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on 12-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 12-APR-2021, the subject experienced pain at injection site. On 12-APR-2021, the subject experienced fever. On 12-APR-2021, the subject experienced headache. On 13-APR-2021, the subject experienced heaviness in legs. On 13-APR-2021, the subject experienced missed work due to the fever. Laboratory data included: Body temperature (NR: not provided) 100.1. On 14-APR-2021, Laboratory data included: Blood test (NR: not provided) Not reported. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from missed work due to the fever, and fever on APR-2021, had not recovered from heaviness in legs, and the outcome of pain at injection site and headache was not reported. This report was non-serious. This case, from the same reporter is linked to 20210425979.; Sender''s Comments: V0: Medical assessment comment not required as per standard procedure as the case assessed as non-serious.


VAERS ID: 1261335 (history)  
Form: Version 2.0  
Age: 25.0  
Sex: Male  
Location: New York  
Vaccinated:0000-00-00
Onset:2021-04-12
Submitted: 0000-00-00
Entered: 2021-04-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN UNKNOWN / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Chills, Facial pain, Nausea, Pain, Pyrexia
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Glaucoma (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? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Comments: Unknown
Allergies:
Diagnostic Lab Data:
CDC Split Type: USJNJFOC20210441476

Write-up: PAIN IN LEFT SIDE OF FACE; BODY ACHE; CHILLS; FEVER; NAUSEA; This spontaneous report received from a parent concerned a 25 year old male. The patient''s weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: Unknown) dose was not reported, administered on 12-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 12-APR-2021, the subject experienced body ache. On 12-APR-2021, the subject experienced chills. On 12-APR-2021, the subject experienced fever. On 12-APR-2021, the subject experienced nausea. On 19-APR-2021, the subject experienced pain in left side of face. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from body ache, chills, fever, and nausea on 14-APR-2021, and had not recovered from pain in left side of face. This report was non-serious.; Sender''s Comments: V0:As per standard protocol ,no MAC comment is required for non-serious case


VAERS ID: 1261404 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: New Jersey  
Vaccinated:0000-00-00
Onset:2021-04-12
Submitted: 0000-00-00
Entered: 2021-04-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 206A21A / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Fatigue, Hypersomnia, Rash
SMQs:, Anaphylactic reaction (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Depression (excl suicide and self injury) (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:
Current Illness:
Preexisting Conditions: Comments: Unknown
Allergies:
Diagnostic Lab Data:
CDC Split Type: USJNJFOC20210445651

Write-up: MOSQUITO LIKE BITES / BUMP; SLEPT A LOT; TIRED; This spontaneous report received from a patient concerned a 55 year old female. The patient''s weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 206A21A, and expiry: UNKNOWN) dose was not reported, administered on 12-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 12-APR-2021, the subject experienced slept a lot. On 12-APR-2021, the subject experienced tired. On 15-APR-2021, the subject experienced mosquito like bites / bump. Treatment medications (dates unspecified) included: cortisone, and ethanol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the mosquito like bites / bump, tired and slept a lot was not reported. This report was non-serious.


VAERS ID: 1261446 (history)  
Form: Version 2.0  
Age: 56.0  
Sex: Female  
Location: North Carolina  
Vaccinated:0000-00-00
Onset:2021-04-12
Submitted: 0000-00-00
Entered: 2021-04-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN UNKNOWN / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Fatigue, Lethargy
SMQs:, Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Diabetes
Preexisting Conditions: Comments: Unknown
Allergies:
Diagnostic Lab Data:
CDC Split Type: USJNJFOC20210448492

Write-up: EXTREME LETHARGY; INTERMITTENT FATIGUE; This spontaneous report received from a patient concerned a 56 year old female. The patient''s height, and weight were not reported. The patient''s concurrent conditions included diabetes. The patient experienced nausea and vomiting when treated with sulfamethoxazole/trimethoprim, and itching and swelling when treated with neomycin. 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 10-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 12-APR-2021, the subject experienced extreme lethargy. On 12-APR-2021, the subject experienced intermittent fatigue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from extreme lethargy, and the outcome of intermittent fatigue was not reported. This report was non-serious.


VAERS ID: 1261454 (history)  
Form: Version 2.0  
Age: 43.0  
Sex: Female  
Location: New Jersey  
Vaccinated:0000-00-00
Onset:2021-04-12
Submitted: 0000-00-00
Entered: 2021-04-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 205A21A / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Headache, Pain in extremity
SMQs:, Tendinopathies and ligament disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Comments: Unknown
Allergies:
Diagnostic Lab Data:
CDC Split Type: USJNJFOC20210448587

Write-up: HEADACHE; SORE ARM; This spontaneous report received from a patient concerned a 43 year old female. The patient''s weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 205A21A, expiry: UNKNOWN) dose was not reported, administered on 12-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 12-APR-2021, the subject experienced sore arm. On 13-APR-2021, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from sore arm on 13-APR-2021, and headache on 20-APR-2021. This report was non-serious.


VAERS ID: 1261720 (history)  
Form: Version 2.0  
Age: 33.0  
Sex: Female  
Location: Wisconsin  
Vaccinated:2021-04-12
Onset:2021-04-12
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-04-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 RA / -

Administered by: Unknown       Purchased by: ?
Symptoms: Tricuspid valve incompetence
SMQs:, Pulmonary hypertension (narrow)

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: Seizures; Stroke
Allergies:
Diagnostic Lab Data:
CDC Split Type: USPFIZER INC2021400362

Write-up: the tv (tricuspid valve incompetence); This is a spontaneous report from a contactable physician. A 33-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm Right on 12Apr2021 at 13:15 (Batch/Lot number was not reported) as single dose for COVID-19 immunization. Medical history included Stroke, and seizure. The patient''s concomitant medications were not reported. On 12Apr2021 at 13:15, the patient experienced the tv (tricuspid valve incompetence). The patient did not received treatment for the event. The outcome of the event was unknown. The patient did not had COVID prior to vaccination and not tested for COVID post vaccination. Information about lot/batch has been requested.; Sender''s Comments: Based on the information currently available, the event is considered most likely associated with intercurrent or underlying medical conditions, appears unrelated to the suspect drug.


VAERS ID: 1261791 (history)  
Form: Version 2.0  
Age: 58.0  
Sex: Male  
Location: New York  
Vaccinated:2021-04-11
Onset:2021-04-12
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-04-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0153 / 2 LA / -

Administered by: Private       Purchased by: ?
Symptoms: Bell's palsy
SMQs:, 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? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: BYSTOLIC
Current Illness: Hypertension (when he was about 45, probably 10 years); Overweight (Onset unknown other than over 10 years ago.)
Preexisting Conditions: Medical History/Concurrent Conditions: Leukemia (Recovering from Leukemia since about 2020)
Allergies:
Diagnostic Lab Data:
CDC Split Type: USPFIZER INC2021404655

Write-up: Bells Palsy; This is a spontaneous report from a contactable consumer reporting for husband. A 58-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) (lot number EW0153/expiration date: 31Jul2021), via an unspecified route of administration, on 11Apr2021 (at the age of 58 years old) as a single dose in the left arm for COVID-19 IMMUNIZATION. The patient previously patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) (lot number EM8727/expiration date: 31Jul2021), via an unspecified route of administration, on 21Mar2021 (at the age of 58 years old) as a single dose for COVID-19 IMMUNIZATION. Relevant medical history included ongoing hypertension, when he was about 45, probably 10 years and was recovering from leukemia onset 2 years ago, in 2019 and he has been recovering from leukemia since about 2020; the patient had an ongoing history of being a little overweight, with onset unknown other than over 10 years ago. Concomitant medication included nebivolol hydrochloride (BYSTOLIC) 10mg tablet taken by mouth once daily for hypertension. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 12Apr2021, late afternoon the patient experienced swelling in his face, couldn''t blink, drooping and was diagnosed with Bells Palsy which required an emergency room visit. He was not admitted to the hospital for this event, was kept under observation only in the emergency room on 12Apr2021. He was given some medication and then discharged. Bell''s Palsy affected his right side of his face. The outcome was improved, the pain was a little less; but he still does not have, nothing works on the right side of his face. His right eye does not blink, eyebrow does not move, and he still can''t speak very good. Treatment was received for the event. The outcome of the events Bells Palsy was recovering. Since the vaccination, the patient had not been tested for COVID-19.


VAERS ID: 1261962 (history)  
Form: Version 2.0  
Age: 29.0  
Sex: Female  
Location: Rhode Island  
Vaccinated:2021-04-11
Onset:2021-04-12
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-04-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK RA / SYR

Administered by: Pharmacy       Purchased by: ?
Symptoms: Chills, Dizziness, Enuresis, Feeling cold, Hot flush, Myalgia
SMQs:, Rhabdomyolysis/myopathy (broad), Anticholinergic syndrome (broad), Eosinophilic pneumonia (broad), Vestibular disorders (broad), Tendinopathies and ligament disorders (broad)

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

Write-up: Day after shot was intense muscle pains/chills/hot and cold flashes abs dizziness. Took vitamins b,c,d and slept for 5hours and felt so much better. Then on Friday the 24th around 7am peed in bed for the fiirst time since 2years old (didn?t have water/alcohol etc) haven?t done so Again (today is 4/27)


VAERS ID: 1262096 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Texas  
Vaccinated:0000-00-00
Onset:2021-04-12
Submitted: 0000-00-00
Entered: 2021-04-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN UNKNOWN / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Back pain, Blood pressure decreased, Chest discomfort, Dizziness, Dysphonia, Dyspnoea, Fatigue, Feeling hot, Headache, Oropharyngeal pain, Pain, Peripheral swelling
SMQs:, Cardiac failure (broad), Anaphylactic reaction (narrow), Angioedema (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Retroperitoneal fibrosis (broad), Parkinson-like events (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad), Vestibular disorders (broad), Dehydration (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Comments: Unknown
Allergies:
Diagnostic Lab Data:
CDC Split Type: USJNJFOC20210427636

Write-up: BLOOD PRESSURE DROPPED; HEADACHE; FATIGUE; BODY PAIN; BACK PAIN LIKE WHERE MY LUNG IS; IT HURTS WHEN I BREATHE; SWELLING OF MY FEET; VOICE CHANGES; DIZZINESS; HOT FEELING IN FEET; FELT LIKE CHEST WAS ACCELARATING; THROAT PAIN; This spontaneous report received from a patient concerned a female of unspecified age. The patient''s weight, height, and medical history were not 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 09-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 12-APR-2021, the subject experienced blood pressure dropped. On an unspecified date, the subject experienced body pain, back pain like where my lung is, it hurts when i breathe, swelling of my feet, voice changes, dizziness, hot feeling in feet, felt like chest was accelarating, throat pain, headache, and fatigue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from felt like chest was accelarating, and headache, and the outcome of body pain, back pain like where my lung is, it hurts when i breathe, swelling of my feet, voice changes, fatigue, dizziness, hot feeling in feet, throat pain and blood pressure dropped was not reported. This report was non-serious.


VAERS ID: 1262129 (history)  
Form: Version 2.0  
Age: 47.0  
Sex: Female  
Location: California  
Vaccinated:2021-04-09
Onset:2021-04-12
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-04-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 039821A / 1 LA / IM

Administered by: Private       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? Yes
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: amlodipine 5mg daily, benazepril 40mg daily, tamoxifen 20mg daily
Current Illness: urinary tract infection, candida vaginitis
Preexisting Conditions: hypertension, history of left breast carcinoma s/p left partial mastectomy w/ sentinel lymphadenopathy
Allergies: tramadol, acetaminophen, hydrocodone, oxycontin, norco, sulfa
Diagnostic Lab Data:
CDC Split Type:

Write-up: Patient reports hives occuring over all of her body about 3 days after receiving the Moderna COVID vaccine.


VAERS ID: 1262433 (history)  
Form: Version 2.0  
Age: 53.0  
Sex: Female  
Location: Virginia  
Vaccinated:2021-04-10
Onset:2021-04-12
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-04-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (UNKNOWN)) / UNKNOWN MANUFACTURER 202A21A / 1 LA / SYR

Administered by: Unknown       Purchased by: ?
Symptoms: Hypoacusis, Tinnitus
SMQs:, Hearing impairment (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: Simvastatin 20mg Vitamin D Melatonin (very rarely)
Current Illness: None
Preexisting Conditions: Cholesterol
Allergies: None
Diagnostic Lab Data: None
CDC Split Type:

Write-up: I had the COVID 19 Vaccine from Johnson and Johnson on April 10, 2021. (Note that this vaccine is not on your drop down list on item #17. You only list Phizer, Moderna and JANSSEN (not J&J) - this seems like an error in your database.) Anyhow, shortly thereafter I developed or started to notice tinnitus, or a hissing sound in my head. I cannot point to the exact time that I experienced the symptoms. I had been experiencing this for the last couple of weeks, and didn''t even think that it could be a possible association with the vaccine. But then I saw an article in the newspaper about a possible association. So I thought I would report this. I am not sure that there is causation on this, but I did not have tinnitus symptoms 24/7 before I had the vaccine, and now I do. So....maybe if there are enough reports of this there is some correlation ????


VAERS ID: 1262665 (history)  
Form: Version 2.0  
Age: 43.0  
Sex: Female  
Location: Wisconsin  
Vaccinated:2021-04-05
Onset:2021-04-12
   Days after vaccination:7
Submitted: 0000-00-00
Entered: 2021-04-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 1808980 / 1 LA / SYR

Administered by: Private       Purchased by: ?
Symptoms: Blood test, Computerised tomogram, Headache, Limb discomfort, Pain, Pain in extremity, Pelvic pain, Ultrasound scan
SMQs:, 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? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Daily multivitamin
Current Illness: Between 7 hours and 14 hours after having vaccine on 4/5/21, I had severe chills, severe headache, internal sharp pain in my pelvis (right and left side).
Preexisting Conditions: None
Allergies: Levofloxacin (Levaquin)
Diagnostic Lab Data: Wed 4/14/21 - Sought medical attention at ED. Was evaluated for blood clots, none found on this day. CT scan, ultrasound of both legs, blood tests. Returned home with directions to take Extra Strength Tylenol for headache.
CDC Split Type:

Write-up: Mon 4/12/21 - Headaches started and have continued daily. Tue 4/13/21 - Soreness in right calf muscle, continued for 4 days. Headache continued. Wed 4/14/21 - Sharp pain in pelvis (right and left side) same location I experienced pain the day of receiving vaccine. Occasionally felt this pain 2 or 3 times / day for 2 days. Sought medical attention at ED on the advice of our Nurse Call Center. Was evaluated for blood clots, none found on this day. CT scan, ultrasound of both legs, blood tests. Returned home with directions to take Extra Strength Tylenol for headache. Thu 4/15/21 - Shooting pain in random parts of my body, mostly legs and arms. Experienced throughout this day only. As of 4/27/21, 22 days after being vaccinated, I am still experiencing headaches. More noticeable when I am exerting myself - walking outside for 1-2 minutes triggers the headache. Headaches are usually located in the lower back of my head. Before being vaccinated, I would experience less than 1 headache per month, and they go away within the day.


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