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From the 6/4/2021 release of VAERS data:

Found 323,133 cases where Vaccine is COVID19 and Patient Did Not Die



Case Details (Reverse Sorted by Onset Date)

This is page 187 out of 3,232

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VAERS ID: 1310294 (history)  
Form: Version 2.0  
Age: 48.0  
Sex: Female  
Location: Pennsylvania  
Vaccinated:2021-04-21
Onset:2021-05-01
   Days after vaccination:10
Submitted: 0000-00-00
Entered: 2021-05-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (UNKNOWN)) / UNKNOWN MANUFACTURER UNKNOWN? NA0079 / 1 LA / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: Haematochezia, Petechiae
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Gastrointestinal haemorrhage (narrow), Ischaemic colitis (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: tylenol, ibuprofen, duloxetine, Wellbutrin
Current Illness:
Preexisting Conditions:
Allergies: latex
Diagnostic Lab Data:
CDC Split Type:

Write-up: fresh red blood in stool ongoing for about 4 days (never happened before), also petechiae around left ankle (has happened in the past).


VAERS ID: 1310363 (history)  
Form: Version 2.0  
Age: 26.0  
Sex: Female  
Location: South Dakota  
Vaccinated:2021-04-23
Onset:2021-05-01
   Days after vaccination:8
Submitted: 0000-00-00
Entered: 2021-05-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 2 - / IM

Administered by: Unknown       Purchased by: ?
Symptoms: Abortion spontaneous, Exposure during pregnancy, Full blood count, Human chorionic gonadotropin, Metabolic function test, Serum ferritin
SMQs:, Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Termination of pregnancy and risk of abortion (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: prenatal vitamin
Current Illness:
Preexisting Conditions:
Allergies: NKDA
Diagnostic Lab Data: 5/1/21 Hcg quant lab, 5/3 Hcg quant, ferritin, CBC, BMP labs
CDC Split Type:

Write-up: G2 P1 Patient with LMP of 4/2/21, EDD 1/7/21 received 2nd dose of covid vaccine and within a week experienced her first miscarriage. patient regrets getting vaccine and is upset/frustrated with the loss and concerned about future fertility


VAERS ID: 1310703 (history)  
Form: Version 2.0  
Age: 38.0  
Sex: Male  
Location: Massachusetts  
Vaccinated:2021-04-28
Onset:2021-05-01
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-05-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

Administered by: Pharmacy       Purchased by: ?
Symptoms: Atrial fibrillation, Blood test, Burning sensation, C-reactive protein, Condition aggravated, Dizziness, Facial discomfort, Fatigue, Feeling abnormal, Full blood count, Headache, Hepatitis C antibody, Hyperhidrosis, Metabolic function test, Muscle tightness, Musculoskeletal stiffness, Paraesthesia, Peripheral coldness, Polymerase chain reaction, Red blood cell sedimentation rate normal
SMQs:, Peripheral neuropathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Supraventricular tachyarrhythmias (narrow), Dementia (broad), Dystonia (broad), Parkinson-like events (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious meningitis (broad), Vestibular disorders (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: Pepcid, C-complex, fish oil, vitamin D, magnesium, tumeric
Current Illness: earache
Preexisting Conditions: a fib
Allergies: minocycline
Diagnostic Lab Data: Hepatitis C antibody, qualitative Ehrlichia/anaplasma PCR Lyme screen with reflex to Western blot, blood LFTs (hepatic panel) C-Reactive Protein Sedimentation rate (ESR CBC and differential Basic metabolic panel
CDC Split Type:

Write-up: description from patient: 1.. On Wed, Apr 28, I got the JnJ vaccine. Other than fatigue the following day no major issues. 2. On Sat, May 1, I had an afib episode in the morning. Reset to sinus rhythm the next morning around 2:30am. I spoke with you during the episode. 3. On Mon, May 3, I had brain fog. I?m usually tired after an afib episode. But this seemed different. I?ve never experienced something like this before. But I chalked it out to the after effects of the afib and moved on. 4. On Fri, May 7, I started having the stiffness in my right calf. I checked in with you that weekend to make sure it wasn?t a clot. After we spoke I think we ruled out a clot. 5. In addition, I?ve developed some added symptoms since then: (i) Sweaty feet. (ii) Pins and needles sensation in feet. (iii) Tightness in the arch of the right foot. (iv) Feet and hands feel sensitive to cold. (v) Burning sensation in feet and left hand. (vi) Mild headache mostly felt in the left temple. (vii) A pulling feeling on the left side of the face. (viii) A feeling that if I close my eyes, I may faint.


VAERS ID: 1310732 (history)  
Form: Version 2.0  
Age: 72.0  
Sex: Male  
Location: Unknown  
Vaccinated:2021-03-01
Onset:2021-05-01
   Days after vaccination:61
Submitted: 0000-00-00
Entered: 2021-05-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (UNKNOWN)) / UNKNOWN MANUFACTURER - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Deep vein thrombosis, Peripheral swelling, Ultrasound Doppler abnormal
SMQs:, Cardiac failure (broad), Angioedema (broad), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Embolic and thrombotic events, venous (narrow), Thrombophlebitis (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), 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: unknown
Current Illness: unknown
Preexisting Conditions: BPH and GERD
Allergies: NKDA
Diagnostic Lab Data: Doppler ultrasound 05/11/21 - confirmed blood clot
CDC Split Type:

Write-up: Patient received both doses of the Astra Zeneca COVID-19 while in another country. Exact administration dates are unknown. First dose late March/early April, 2nd dose early May. Patient reports that leg swelling happened while he was in another country about 1 week following 2nd dose of Astra Zeneca covid vaccine. Went to doctor in other country and prescribed Xarelto 10mg/day, no imaging at that time. Sent for imaging after presenting to our clinic on 05/11/21. Doppler ultrasound confirmed blood clot in left leg. Patient currently being treated with xarelto 15mg twice daily x 3 weeks, then continuing at 20mg once daily.


VAERS ID: 1310741 (history)  
Form: Version 2.0  
Age: 22.0  
Sex: Male  
Location: California  
Vaccinated:2021-04-30
Onset:2021-05-01
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-05-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / UNK - / -

Administered by: Private       Purchased by: ?
Symptoms: Angiogram, Angiogram normal, Chest pain, Muscular weakness, Neck pain, Pain in extremity, Skin burning sensation
SMQs:, Rhabdomyolysis/myopathy (broad), Peripheral neuropathy (broad), Guillain-Barre syndrome (broad), Noninfectious encephalopathy/delirium (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad), Arthritis (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? Yes, 2 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: none
Current Illness: none
Preexisting Conditions: none
Allergies: none
Diagnostic Lab Data: all imaging negative (CTA)
CDC Split Type:

Write-up: Presented with left neck, chest and upper extremity weakness, pain and burning that started on 5/1. Stroke protocol followed and alteplase given 5/2. By morning of 5/3 all symptoms had resolved.


VAERS ID: 1311019 (history)  
Form: Version 2.0  
Age: 78.0  
Sex: Male  
Location: Ohio  
Vaccinated:2021-04-27
Onset:2021-05-01
   Days after vaccination:4
Submitted: 0000-00-00
Entered: 2021-05-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 1808980 / 1 RA / SYR

Administered by: Public       Purchased by: ?
Symptoms: Asthenia, Blood test, Bradykinesia, Chills, Confusional state, Electrocardiogram, Fatigue, Feeling abnormal, Hypersomnia, Loss of personal independence in daily activities, SARS-CoV-2 test negative, Sinus headache, Urine analysis
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Parkinson-like events (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Depression (excl suicide and self injury) (broad), Hypoglycaemia (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Metformin Hcl Er Tbas 500mg Glimepiride tabs 4 mg Losartan tabs 50mg ezetimibe 10 mg fenofibrate tabs 145 mg steglatro bats 15 mg Vitamin D3 50 mcg Vitamin B complex + B17 Zinc Chelate 30mg Vitamin E 400iu
Current Illness: None
Preexisting Conditions: Diabetes Type II
Allergies: None known
Diagnostic Lab Data: Blood draw and urinalysis done May 11, 2021. Ekg, BP, etc done May 11. Also did a rapid Covid test May 5 at a health clinic which was negative. He already had minor Covid in early December 2020.
CDC Split Type:

Write-up: Husband began expressing "I''m tired" which was out of the ordinary on May 1, 2021. Again on May 2 and 3. On May 4 he was really weak, moving much more slowly than normal, complaining of sinus headache above left eye, sleeping longer and more than normal, brain fog and confusion, not able to do normal activities. This impairment has continued through May 11 with no improvement from one day to the next. Visited his Dr to get checked on May 11 due to our concern over how long this was lasting. He has had no fever but some chills here and there. Dr checked everything she could think of and requested blood tests which we have not heard about yet. Extreme fatigue was the major symptom. Today, May 12, he feels better, moving around faster and doing some normal activities but still tires easily and must rest.


VAERS ID: 1312616 (history)  
Form: Version 2.0  
Age: 55.0  
Sex: Male  
Location: Alabama  
Vaccinated:2021-05-01
Onset:2021-05-01
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-05-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / SYR

Administered by: Private       Purchased by: ?
Symptoms: Gait inability, Guillain-Barre syndrome, Immunoglobulin therapy
SMQs:, Peripheral neuropathy (narrow), Anticholinergic syndrome (broad), Dystonia (broad), Guillain-Barre syndrome (narrow), Demyelination (narrow), 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? Yes, 8 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Gillian barre syndrome was diagnosed by the Hospital doctor. Patient lost the ability to walk. Is being treated with intravenous IVIG for 7 days and slowly recovering in the hospital.


VAERS ID: 1312764 (history)  
Form: Version 2.0  
Age: 75.0  
Sex: Female  
Location: Arizona  
Vaccinated:0000-00-00
Onset:2021-05-01
Submitted: 0000-00-00
Entered: 2021-05-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 202A21A / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, Heart rate, Heart rate increased, Oxygen saturation, Oxygen saturation decreased, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Acute central respiratory depression (broad), Respiratory failure (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (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: Test Date: 202105; Test Name: Heart rate; Result Unstructured Data: 91 bpm; Test Date: 202105; Test Name: Oxygen saturation; Result Unstructured Data: 91 %; Test Date: 20210504; Test Name: Body temperature; Result Unstructured Data: 99.0 F; Test Date: 20210504; Test Name: Heart rate; Result Unstructured Data: increased to 130
CDC Split Type: USJNJFOC20210507816

Write-up: INCREASED HEART RATE; FEVER; OXYGEN SATURATION 91%; This spontaneous report received from a consumer concerned a 75 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: 202A21A expiry: Unknown) dose was not reported, administered on 04-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On MAY-2021, the subject experienced oxygen saturation 91%. Laboratory data included: Heart rate (NR: not provided) 91 bpm, and Oxygen saturation (NR: not provided) 91 %. On 04-MAY-2021, the subject experienced increased heart rate. On 04-MAY-2021, the subject experienced fever. Laboratory data included: Body temperature (NR: not provided) 99.0 F, and Heart rate (NR: not provided) increased to 130. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the increased heart rate, fever and oxygen saturation 91% was not reported. This report was non-serious.; Sender''s Comments: V0: Medical assessment comment not required as per standard procedure as the case was assessed as non-serious.


VAERS ID: 1312767 (history)  
Form: Version 2.0  
Age: 25.0  
Sex: Female  
Location: Arizona  
Vaccinated:0000-00-00
Onset:2021-05-01
Submitted: 0000-00-00
Entered: 2021-05-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 203A21A / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Abdominal pain upper, Diarrhoea, Dizziness, Erythema, Feeling abnormal, Feeling cold, Flushing, Formication, Headache, Hyperhidrosis, Injection site swelling, Malaise, Mobility decreased, Pain, Pain assessment, Pain in extremity, Pruritus
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Peripheral neuropathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Pseudomembranous colitis (broad), Parkinson-like events (broad), Extravasation events (injections, infusions and implants) (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Haemodynamic oedema, effusions and fluid overload (narrow), Vestibular disorders (broad), Hypersensitivity (broad), Noninfectious diarrhoea (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:
Current Illness: Ehlers-Danlos syndrome (A connective tissue disorder resulting in high copper issues and GI issues.)
Preexisting Conditions: Comments: No breastfeeding
Allergies:
Diagnostic Lab Data: Test Date: 20210504; Test Name: Pain scale; Result Unstructured Data: 4/10; Test Date: 20210505; Test Name: Pain scale; Result Unstructured Data: 6/10 (headache worsened)
CDC Split Type: USJNJFOC20210509097

Write-up: VERY BAD DIARRHEA; UNABLE TO TO MOVE HER ARM; FELT COLD; BODY ACHES; CRAWLING SKIN SENSATION; SWEATING; FELT SICK; HEADACHE; SORE ARM; DIZZINESS; RED FACE; FLUSHING OF FACE; ITCHY FACE; DID NOT FEEL GREAT; BURNING PAIN IN UPPER LEFT ABDOMEN; NODE/SWELLING AT INJECTION SITE; This spontaneous report received from a patient concerned a 25 year old female. The patient''s height, and weight were not reported. The patient''s concurrent conditions included ehlers-danlos syndrome, and other pre-existing medical conditions included no breastfeeding. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 203A21A, and expiry: 23-JUN-2021) dose was not reported, administered on 03-MAY-2021 17:00 for prophylactic vaccination. No concomitant medications were reported. On MAY-2021, the subject experienced burning pain in upper left abdomen. On MAY-2021, the subject experienced node/swelling at injection site. On 03-MAY-2021, the subject experienced dizziness. On 03-MAY-2021, the subject experienced red face. On 03-MAY-2021, the subject experienced flushing of face. On 03-MAY-2021, the subject experienced itchy face. On 03-MAY-2021, the subject experienced did not feel great. On 03-MAY-2021, the subject experienced sore arm. On 04-MAY-2021, the subject experienced body aches. On 04-MAY-2021, the subject experienced crawling skin sensation. On 04-MAY-2021, the subject experienced sweating. On 04-MAY-2021, the subject experienced unable to to move her arm. On 04-MAY-2021, the subject experienced felt cold. On 04-MAY-2021, the subject experienced felt sick. On 04-MAY-2021, the subject experienced headache. Laboratory data included: Pain scale (NR: not provided) 4/10. On 05-MAY-2021, the subject experienced very bad diarrhea. Laboratory data included: Pain scale (NR: not provided) 6/10 (headache worsened). Treatment medications (dates unspecified) included: diphenhydramine hydrochloride. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from red face, flushing of face, and itchy face on 03-MAY-2021, and crawling skin sensation on 05-MAY-2021, was recovering from unable to to move her arm, had not recovered from dizziness, sore arm, felt sick, body aches, headache, burning pain in upper left abdomen, very bad diarrhea, and node/swelling at injection site, and the outcome of sweating, felt cold and did not feel great was not reported. This report was non-serious. This case, from the same reporter is linked to 20210509350.; Sender''s Comments: V0: Medical assessment comment not required as per standard procedure as case assessed as non-serious.


VAERS ID: 1312785 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Unknown  
Vaccinated:0000-00-00
Onset:2021-05-01
Submitted: 0000-00-00
Entered: 2021-05-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN UNKNOWN / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Chills, Fatigue, Headache, Pain in extremity, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (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: Comments: Unknown
Allergies:
Diagnostic Lab Data:
CDC Split Type: USJNJFOC20210516405

Write-up: ARM IS STILL VERY SORE; CHILLS AND SHIVERS; FEVER; HEADACHE; FATIGUE; This spontaneous report received from a patient concerned a patient of unspecified age and 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, batch number: Unknown) dose was not reported, administered on 04-MAY-2021 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 MAY-2021, the subject experienced arm is still very sore. On MAY-2021, the subject experienced chills and shivers. On MAY-2021, the subject experienced fever. On MAY-2021, the subject experienced headache. On MAY-2021, the subject experienced fatigue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chills and shivers, fever, headache, and fatigue on MAY-2021, and had not recovered from arm is still very sore. This report was non-serious.


VAERS ID: 1312811 (history)  
Form: Version 2.0  
Age: 77.0  
Sex: Female  
Location: North Carolina  
Vaccinated:0000-00-00
Onset:2021-05-01
Submitted: 0000-00-00
Entered: 2021-05-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 206AZ1A / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Arthralgia, Pain
SMQs:, 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: Medical History/Concurrent Conditions: Pain; Comments: The patient had experienced something similar to the adverse event in past but that did not last long.
Allergies:
Diagnostic Lab Data:
CDC Split Type: USJNJFOC20210517578

Write-up: SHOOTING PAIN; PAIN IN LEFT SHOULDER THAT STARTS FROM END OF THE NECK AND GOES ALL THE WAY DOWN TO LEFT ARM AND ELBOW AND COMES BACK AND HARDLY COULD RAISE ARM UP; This spontaneous report received from a patient concerned a 77 year old female. The patient''s height, and weight were not reported. The patient''s past medical history included pain, and other pre-existing medical conditions included the patient had experienced something similar to the adverse event in past but that did not last long. The patient was previously treated with ibuprofen for pain. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 206AZ1A expiry: UNKNOWN) dose was not reported, administered on 08-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On MAY-2021, the subject experienced shooting pain. On MAY-2021, the subject experienced pain in left shoulder that starts from end of the neck and goes all the way down to left arm and elbow and comes back and hardly could raise arm up. On 09-MAY-2021, treatment medications included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from pain in left shoulder that starts from end of the neck and goes all the way down to left arm and elbow and comes back and hardly could raise arm up, and shooting pain. This report was non-serious.


VAERS ID: 1312813 (history)  
Form: Version 2.0  
Age: 61.0  
Sex: Male  
Location: New Jersey  
Vaccinated:0000-00-00
Onset:2021-05-01
Submitted: 0000-00-00
Entered: 2021-05-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 203AZIA / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: 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: The patient had no known allergies.
Allergies:
Diagnostic Lab Data:
CDC Split Type: USJNJFOC20210518102

Write-up: MILD ARM SORENESS THAT GOT SPIKED; This spontaneous report received from a patient concerned a 61 year old male. The patient''s height, and weight were not reported. The patient''s pre-existing medical conditions included the patient had no known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 203AZIA, expiry: 23/JUN/2021) dose was not reported, administered on 08-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On MAY-2021, the subject experienced mild arm soreness that got spiked. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from mild arm soreness that got spiked on MAY-2021. This report was non-serious. This case, from the same reporter is linked to 20210518415.


VAERS ID: 1312818 (history)  
Form: Version 2.0  
Age: 31.0  
Sex: Female  
Location: South Carolina  
Vaccinated:0000-00-00
Onset:2021-05-01
Submitted: 0000-00-00
Entered: 2021-05-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 207A21A / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Abdominal distension, Abdominal pain, Chills, Decreased appetite, Headache, Muscle spasms, Pyrexia
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Retroperitoneal fibrosis (broad), Dystonia (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: VITAMINS NOS
Current Illness: Abstains from alcohol; Non-smoker; Penicillin allergy
Preexisting Conditions: Comments: The patient has no abuse or illicit drug usage.
Allergies:
Diagnostic Lab Data:
CDC Split Type: USJNJFOC20210518323

Write-up: BLOATING; CRAMPS; CHILLS; FEVER; HEADACHE; LOSS OF APPETITE; ABDOMINAL PAIN; This spontaneous report received from a patient concerned a 31 year old female. The patient''s height, and weight were not reported. The patient''s concurrent conditions included penicillin allergy, non alcohol, and non smoker, and other pre-existing medical conditions included the patient has no abuse or illicit drug usage. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 207A21A, and expiry: 07/MAY/2021) dose was not reported, administered on 07-MAY-2021 for prophylactic vaccination. Concomitant medications included vitamins nos. On MAY-2021, the subject experienced abdominal pain. On MAY-2021, the subject experienced loss of appetite. On 07-MAY-2021, the subject experienced chills. On 07-MAY-2021, the subject experienced fever. On 07-MAY-2021, the subject experienced headache. On 08-MAY-2021, the subject experienced cramps. On 08-MAY-2021, the subject experienced bloating. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chills, fever, and headache, and had not recovered from abdominal pain, cramps, loss of appetite, and bloating. This report was non-serious.


VAERS ID: 1312834 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Unknown  
Vaccinated:0000-00-00
Onset:2021-05-01
Submitted: 0000-00-00
Entered: 2021-05-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN UNKNOWN / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Comments: Unknown
Allergies:
Diagnostic Lab Data:
CDC Split Type: USJNJFOC20210519572

Write-up: MILD NEGATIVE EFFECTS; This spontaneous report received from a patient 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 MAY-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On MAY-2021, the subject experienced mild negative effects. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of mild negative effects was not reported. This report was non-serious.


VAERS ID: 1312845 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Unknown  
Vaccinated:0000-00-00
Onset:2021-05-01
Submitted: 0000-00-00
Entered: 2021-05-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN UNKNOWN / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Feeling abnormal
SMQs:, Dementia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: COVID-19
Allergies:
Diagnostic Lab Data:
CDC Split Type: USJNJFOC20210520774

Write-up: ABSOLUTELY MISERABLE EXPERIENCE FOR 24 TO 36 HOURS; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient''s height, and weight were not reported. The patient''s past medical history included already had corona. 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 07-MAY-2021 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 MAY-2021, the subject experienced absolutely miserable experience for 24 to 36 hours. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from absolutely miserable experience for 24 to 36 hours on MAY-2021. This report was non-serious.


VAERS ID: 1312852 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: North Carolina  
Vaccinated:0000-00-00
Onset:2021-05-01
Submitted: 0000-00-00
Entered: 2021-05-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Bedridden, Chest discomfort, Cough, Dyspnoea exertional
SMQs:, Anaphylactic reaction (broad), Pulmonary hypertension (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: USJNJFOC20210521020

Write-up: DOWN IN BED/BED-RIDDEN; TIGHTNESS IN CHEST; WINDED TO WALK; COUGH; This spontaneous report received from a patient 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, and batch number were not reported) dose was not reported, administered on MAY-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 MAY-2021, the subject experienced tightness in chest. On MAY-2021, the subject experienced winded to walk. On MAY-2021, the subject experienced cough. On 07-MAY-2021, the subject experienced down in bed/bed-ridden. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from winded to walk, and the outcome of tightness in chest, cough and down in bed/bed-ridden was not reported. This report was non-serious.


VAERS ID: 1312854 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Unknown  
Vaccinated:0000-00-00
Onset:2021-05-01
Submitted: 0000-00-00
Entered: 2021-05-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (UNKNOWN)) / UNKNOWN MANUFACTURER UNKNOWN / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure decreased, Blood pressure measurement, Therapeutic response unexpected
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant 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:
Current Illness: Blood pressure high
Preexisting Conditions: Medical History/Concurrent Conditions: Erectile dysfunction; Frequency urinary; Leg pain; Neck pain; Comments: Patient took medicine for frequent urination or bathroom use.
Allergies:
Diagnostic Lab Data: Test Date: 202105; Test Name: Blood pressure; Result Unstructured Data: 120/79 mmHg, Decreased
CDC Split Type: USJNJFOC20210521134

Write-up: UNEXPECTED THERAPEUTIC BENEFIT/BP WENT DOWN, NO NECK AND LEG PAIN, NO ERECTION PROBLEM, NO FREQUENT URINATION; BLOOD PRESSURE WENT DOWN TO 120/79; This spontaneous report received from a patient concerned a male of unspecified age. The patient''s height, and weight were not reported. The patient''s past medical history included leg pain, neck pain, erection problem, and frequent urination, and concurrent conditions included high blood pressure, and other pre-existing medical conditions included patient took medicine for frequent urination or bathroom use. 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-MAY-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 MAY-2021, the subject experienced unexpected therapeutic benefit/bp went down, no neck and leg pain, no erection problem, no frequent urination. On MAY-2021, the subject experienced blood pressure went down to 120/79. Laboratory data included: Blood pressure (NR: not provided) 120/79 mmHg. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the unexpected therapeutic benefit/bp went down, no neck and leg pain, no erection problem, no frequent urination and blood pressure went down to 120/79 was not reported. This report was non-serious.


VAERS ID: 1312856 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Texas  
Vaccinated:0000-00-00
Onset:2021-05-01
Submitted: 0000-00-00
Entered: 2021-05-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN UNKNOWN / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Abnormal behaviour
SMQs:, Dementia (broad), Psychosis and psychotic disorders (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Hostility/aggression (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: USJNJFOC20210521685

Write-up: OUT OF SORTS; 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 01-MAY-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 01-MAY-2021, the subject experienced out of sorts. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of out of sorts was not reported. This report was non-serious. This case, from the same reporter is linked to 20210520625 and 20210520722.


VAERS ID: 1312879 (history)  
Form: Version 2.0  
Age: 28.0  
Sex: Female  
Location: Georgia  
Vaccinated:2021-04-30
Onset:2021-05-01
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-05-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 023C21A / 1 LA / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Loss of consciousness, Road traffic accident
SMQs:, Torsade de pointes/QT prolongation (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Accidents and injuries (narrow), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (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:
Preexisting Conditions: Comments: No medical history reported by reporter.
Allergies:
Diagnostic Lab Data:
CDC Split Type: USMODERNATX, INC.MOD20211

Write-up: This spontaneous case was reported by a consumer and describes the occurrence of LOSS OF CONSCIOUSNESS (blacked out) in a 28-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 023C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No medical history reported by reporter. On 30-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-May-2021, the patient experienced LOSS OF CONSCIOUSNESS (blacked out) (seriousness criterion medically significant) and ROAD TRAFFIC ACCIDENT (car accident). At the time of the report, LOSS OF CONSCIOUSNESS (blacked out) and ROAD TRAFFIC ACCIDENT (car accident) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. She is taking concomitant medication not otherwise specified. 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: 1312886 (history)  
Form: Version 2.0  
Age: 69.0  
Sex: Male  
Location: New York  
Vaccinated:2021-03-31
Onset:2021-05-01
   Days after vaccination:31
Submitted: 0000-00-00
Entered: 2021-05-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 044A21A / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Muscle spasms, Pain in extremity, Ultrasound scan, X-ray
SMQs:, Dystonia (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? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210502; Test Name: Ultrasound; Result Unstructured Data: studies were ok; Test Date: 20210502; Test Name: X-rays; Result Unstructured Data: studies were ok
CDC Split Type: USMODERNATX, INC.MOD20211

Write-up: pain was in back of right leg, up into thigh/Pain in right leg continued to get worse/pain was very excruciating; Developed right leg muscle cramps; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PAIN IN EXTREMITY (pain was in back of right leg, up into thigh/Pain in right leg continued to get worse/pain was very excruciating) and MUSCLE SPASMS (Developed right leg muscle cramps) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 001C21A and 044A21A) for COVID-19 vaccination. No Medical History information was reported. On 31-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 01-May-2021, the patient experienced PAIN IN EXTREMITY (pain was in back of right leg, up into thigh/Pain in right leg continued to get worse/pain was very excruciating) (seriousness criterion hospitalization) and MUSCLE SPASMS (Developed right leg muscle cramps) (seriousness criterion hospitalization). The patient was hospitalized on 02-May-2021 due to MUSCLE SPASMS and PAIN IN EXTREMITY. At the time of the report, PAIN IN EXTREMITY (pain was in back of right leg, up into thigh/Pain in right leg continued to get worse/pain was very excruciating) and MUSCLE SPASMS (Developed right leg muscle cramps) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 02-May-2021, Ultrasound scan: (normal) studies were ok. On 02-May-2021, X-ray: ok (normal) studies were ok. On the evening of 01-May-2021, the patient states he developed cramps and pain in his right leg, which continued to get worse. The patient stated The patient states that the hospital gave him medications to help the pain, and he left the hospital. The patient took the medicine and it eased for a while, but keeps recurring. The patient stated that he then went to another hospital due to the persistent pain, where he was admitted for observation. The pain is in the back of right leg, up into the thigh. Treatment included pain medicine, Tylenol, Ibuprofen, nerve tablets, and a muscle relaxer. The doctors were trying to find out what the pain was from. The action taken with mRNA-1273 in response to the event was not applicable. 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: 1313242 (history)  
Form: Version 2.0  
Age: 78.0  
Sex: Male  
Location: Virginia  
Vaccinated:0000-00-00
Onset:2021-05-01
Submitted: 0000-00-00
Entered: 2021-05-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 205A21A / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Arthralgia, Back pain, Body temperature, Decreased appetite, Fatigue, Hyperhidrosis, Insomnia, Muscle spasms, Muscle tightness, Nausea, Pyrexia, Swelling, Tenderness
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Angioedema (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Retroperitoneal fibrosis (broad), Dystonia (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Haemodynamic oedema, effusions and fluid overload (narrow), Arthritis (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:
Current Illness: Disability
Preexisting Conditions: Comments: Unknown
Allergies:
Diagnostic Lab Data: Test Date: 202105; Test Name: Body temperature; Result Unstructured Data: 98.4 F
CDC Split Type: USJNJFOC20210517106

Write-up: TENDERNESS; LOSS OF APPETITE; PROFUSE SWEATING; BACK TIGHTENING; MUSCLE SPASM; SWELLING; BACK SORENESS; LACK OF SLEEP; HIP SORENESS; TIREDNESS; NAUSEOUS; FEVER; This spontaneous report received from a patient concerned a 78 year old male. The patient''s height, and weight were not reported. The patient''s concurrent conditions included disabled. 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 06-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On MAY-2021, the subject experienced tenderness. On MAY-2021, the subject experienced loss of appetite. On MAY-2021, the subject experienced profuse sweating. On MAY-2021, the subject experienced back tightening. On MAY-2021, the subject experienced muscle spasm. On MAY-2021, the subject experienced swelling. On MAY-2021, the subject experienced back soreness. On MAY-2021, the subject experienced lack of sleep. On MAY-2021, the subject experienced hip soreness. On MAY-2021, the subject experienced tiredness. On MAY-2021, the subject experienced nauseous. On MAY-2021, the subject experienced fever. Laboratory data included: Body temperature (NR: not provided) 98.4 F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the tenderness, loss of appetite, tiredness, profuse sweating, fever, hip soreness, nauseous, back tightening, muscle spasm, swelling, back soreness and lack of sleep was not reported. This report was non-serious.


VAERS ID: 1313250 (history)  
Form: Version 2.0  
Age: 81.0  
Sex: Male  
Location: Ohio  
Vaccinated:0000-00-00
Onset:2021-05-01
Submitted: 0000-00-00
Entered: 2021-05-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN UNKNOWN / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Joint swelling, Nodule
SMQs:, Haemodynamic oedema, effusions and fluid overload (narrow), Arthritis (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:
Current Illness:
Preexisting Conditions: Comments: Unknown
Allergies:
Diagnostic Lab Data:
CDC Split Type: USJNJFOC20210520608

Write-up: SWELLING OF THE LEFT ELBOW; SOFT KNOT IN LEFT ELBOW; This spontaneous report received from a patient concerned an 81 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: Unk) dose was not reported, administered on 10-MAY-2021 for prophylactic vaccination. Batch number was not reported and has been requested. No concomitant medications were reported. On MAY-2021, the subject experienced swelling of the left elbow. On MAY-2021, the subject experienced soft knot in left elbow. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the swelling of the left elbow and soft knot in left elbow was not reported. This report was non-serious.


VAERS ID: 1313251 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Texas  
Vaccinated:0000-00-00
Onset:2021-05-01
Submitted: 0000-00-00
Entered: 2021-05-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 204A21A / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Nausea, Pruritus, Rash
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Comments: Unknown
Allergies:
Diagnostic Lab Data:
CDC Split Type: USJNJFOC20210520625

Write-up: ITCHY; RASH ON BOTH LEGS, MORE ON THE LEFT AND ON BACK; BOUTS OF NAUSEA; This spontaneous report received from a patient concerned a 75 year old female. The patient''s weight, height, and medical history were not reported. The patient received covid-19 vaccine (suspension for injection, route of admin not reported and batch number: 204A21A expiry: 23-JUN-2021) dose was not reported, administered on 01-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 01-MAY-2021, the patient experienced bouts of nausea. On 11-MAY-2021, the patient experienced itchy. On 11-MAY-2021, the patient experienced rash on both legs, more on the left and on back. The action taken with covid-19 vaccine was not applicable. The patient had not recovered from rash on both legs, more on the left and on back, itchy, and bouts of nausea. This report was non-serious. This case, from the same reporter is linked to 20210521685.


VAERS ID: 1313679 (history)  
Form: Version 2.0  
Age: 34.0  
Sex: Female  
Location: Florida  
Vaccinated:2021-04-28
Onset:2021-05-01
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-05-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 027A21A / 2 LA / SYR

Administered by: Private       Purchased by: ?
Symptoms: Biopsy skin, Rash, Skin swelling, Swelling face
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Synthroid, cytomel, Wellbutrin, cbd
Current Illness:
Preexisting Conditions: hypo thyroid , selective IgA deficiency disorder
Allergies:
Diagnostic Lab Data: The dermatologist popped one of the stops on my scalp and swabbed on Monday, May 10th. I am still waiting for the resutls.
CDC Split Type:

Write-up: I started to get a sore spot on my scalp. It as spread to most of my scalp now and side of face. Sometimes it burns, does not itch very much, but it is swollen. I went to the dermatologist. They asked if I had any stress and when it started. I completely forgot that I had gotten my vaccine right before the symptoms started.


VAERS ID: 1313753 (history)  
Form: Version 2.0  
Age: 36.0  
Sex: Female  
Location: Florida  
Vaccinated:2021-04-01
Onset:2021-05-01
   Days after vaccination:30
Submitted: 0000-00-00
Entered: 2021-05-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

Administered by: Unknown       Purchased by: ?
Symptoms: Psoriasis
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:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Patient stated that she started taking Kesimpta in October and has never stopped taking it. She stated that 5 weeks ago she received the Johnson & Johnson vaccine. She said 2-3 weeks after the vaccine she developed psoriasis.


VAERS ID: 1313871 (history)  
Form: Version 2.0  
Age: 48.0  
Sex: Female  
Location: Florida  
Vaccinated:2021-05-01
Onset:2021-05-01
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-05-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0164 / 2 LA / IM

Administered by: Other       Purchased by: ?
Symptoms: Chills, Diarrhoea, Headache, Nausea, Pain, Pyrexia
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Pseudomembranous colitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Noninfectious diarrhoea (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

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

Write-up: within 24 hours of the second vaccine i have felt body aches, shivers, mild fever, head ache, nauseous diarrhea


VAERS ID: 1313997 (history)  
Form: Version 2.0  
Age: 17.0  
Sex: Female  
Location: Texas  
Vaccinated:2021-05-12
Onset:2021-05-01
Submitted: 0000-00-00
Entered: 2021-05-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 201A21A / 1 LA / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: Product administered to patient of inappropriate age
SMQs:, Medication errors (narrow)

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

Write-up: Patient came to get a covid 19 shot of Johnson and Johnson and realized after the shot was given that she was not 18 years old until 3 more months. She was currently 17 years and 9 months old when receiving the shot. No adverse side effects have been reported to the pharmacy since the shot was given and tried to follow up with the patient as well.


VAERS ID: 1314464 (history)  
Form: Version 2.0  
Age: 55.0  
Sex: Female  
Location: Ohio  
Vaccinated:2021-05-01
Onset:2021-05-01
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-05-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 1808982 / 1 RA / SYR

Administered by: Other       Purchased by: ?
Symptoms: Chills, Feeling abnormal, Headache, Immediate post-injection reaction, Impaired work ability, Pain, Pyrexia, Tremor
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Parkinson-like events (broad), Noninfectious encephalopathy/delirium (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Tylenol, One A Day women''s vitamins
Current Illness: None
Preexisting Conditions: Sciatica, osteoporosis arthritis ,degeneration of the spine, sinus disease, migraines
Allergies: Contrast , seasonal allergies
Diagnostic Lab Data: None
CDC Split Type:

Write-up: Severe headache which was immediate. chills & fever for 3 days, tremors lasted an hour or two day of vaccine, body aches a day, brain fog example trouble concentrating, forgetfulness hard to focus still have but is improving. I called my Doctor and was prescribed a Migraine medication which seems to helping greatly. Missed two days of work due to fever and headache.


VAERS ID: 1315723 (history)  
Form: Version 2.0  
Age: 58.0  
Sex: Male  
Location: Unknown  
Vaccinated:0000-00-00
Onset:2021-05-01
Submitted: 0000-00-00
Entered: 2021-05-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN UNKNOWN / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Asthenia, Chills, Diarrhoea, Formication, Headache, Illusion, Palpitations
SMQs:, Peripheral neuropathy (broad), Arrhythmia related investigations, signs and symptoms (broad), Dementia (broad), Pseudomembranous colitis (broad), Psychosis and psychotic disorders (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Noninfectious diarrhoea (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Comments: unknown
Allergies:
Diagnostic Lab Data:
CDC Split Type: USJNJFOC20210517407

Write-up: GENERAL PERCEPTION FELT DIFFERENT; POUNDING/RACING HEART PALPITATIONS; A WEIRD, HOT CRAWLING SENSATION INSIDE HEAD; DIARRHEA; WEAKNESS; WORST HEADACHE; CHILLS; This spontaneous report received from a patient via a company representative concerned a 58 year old male. The patient''s height, and weight were not reported. The patient''s pre-existing medical conditions included unknown. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on MAY-2021 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 MAY-2021, the subject experienced general perception felt different. On MAY-2021, the subject experienced pounding/racing heart palpitations. On MAY-2021, the subject experienced a weird, hot crawling sensation inside head. On MAY-2021, the subject experienced diarrhea. On MAY-2021, the subject experienced weakness. On MAY-2021, the subject experienced worst headache. On MAY-2021, the subject experienced chills. The action taken with covid-19 vaccine was not applicable. The patient recovered from pounding/racing heart palpitations, a weird, hot crawling sensation inside head, diarrhea, worst headache, and chills on 08-MAY-2021, and had not recovered from weakness, and general perception felt different. This report was non-serious.


VAERS ID: 1315744 (history)  
Form: Version 2.0  
Age: 55.0  
Sex: Male  
Location: New Jersey  
Vaccinated:0000-00-00
Onset:2021-05-01
Submitted: 0000-00-00
Entered: 2021-05-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 1816022 / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Asthenia, Dizziness, Fatigue
SMQs:, Anticholinergic syndrome (broad), Guillain-Barre syndrome (broad), Vestibular disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Comments: Unknown
Allergies:
Diagnostic Lab Data:
CDC Split Type: USJNJFOC20210519896

Write-up: LIGHT HEADED; FATIGUE; WEAK; This spontaneous report received from a patient concerned a 55 year old male. The patient''s weight, height, and medical history were not reported. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: 1816022, and batch number: 1816022 expiry: UNKNOWN) dose was not reported, administered on 07-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On MAY-2021, the subject experienced light headed. On MAY-2021, the subject experienced fatigue. On MAY-2021, the subject experienced weak. The action taken with covid-19 vaccine was not applicable. The outcome of the fatigue, light headed and weak was not reported. This report was non-serious.


VAERS ID: 1315752 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Texas  
Vaccinated:0000-00-00
Onset:2021-05-01
Submitted: 0000-00-00
Entered: 2021-05-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN UNKNOWN / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Pain, Pyrexia, Vomiting
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Comments: Unknown
Allergies:
Diagnostic Lab Data:
CDC Split Type: USJNJFOC20210520722

Write-up: ACHY BODY; VOMITED; FEVER; This spontaneous report received from a parent concerned a male of unspecified age. The patient''s weight, height, and medical history were not reported. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 01-MAY-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On MAY-2021, the subject experienced achy body. On MAY-2021, the subject experienced vomited. On MAY-2021, the subject experienced fever. The action taken with covid-19 vaccine was not applicable. The outcome of the fever, achy body and vomited was not reported. This report was non-serious. This case, from the same reporter is linked to 20210521685.


VAERS ID: 1315763 (history)  
Form: Version 2.0  
Age: 47.0  
Sex: Male  
Location: Oregon  
Vaccinated:0000-00-00
Onset:2021-05-01
Submitted: 0000-00-00
Entered: 2021-05-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 205ANA / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Anxiety, Diarrhoea haemorrhagic, Dyspnoea, Fatigue, Flushing, Gout, Pain in extremity
SMQs:, Anaphylactic reaction (narrow), Haemorrhage terms (excl laboratory terms) (narrow), Pseudomembranous colitis (broad), Gastrointestinal haemorrhage (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Ischaemic colitis (broad), Cardiomyopathy (broad), Hypersensitivity (broad), Arthritis (narrow), Noninfectious diarrhoea (narrow), 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: ALLOPURINOL
Current Illness: Gout
Preexisting Conditions: Comments: Unknown
Allergies:
Diagnostic Lab Data:
CDC Split Type: USJNJFOC20210522256

Write-up: FLUSHED; MINOR GOUT SWELLS; SORE ARM/THROBBING ARM; TIRED; SHORTNESS OF BREATH; ANXIETY; DIARRHEA WITH BLOOD; This spontaneous report received from a consumer concerned a 47 year old. The patient''s height, and weight were not reported. The patient''s concurrent conditions included chronic gout. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 205ANA, expiry: UNKNOWN) dose was not reported, 1 total administered on 08-MAY-2021 vaccination at left arm 16:30 for prophylactic vaccination. Concomitant medications included allopurinol for gout. On 08-May-2021, The patient experienced Shortness of breath shortly after vaccination, but this resolved in 15 minutes. He waited for 20 minutes after getting the vaccine. Patient noted that it could have been anxiety driven. On 08-May-2021 night (10 hours after), patient experienced diarrhea in the middle of the night and progressed to blood in the stool. The patient also very tired. Patient slept for almost 24 hours from Saturday to Sunday night, but now feels better. Patient felt very flushed, also experienced arm super sore for 1 day after vaccination, and throbbing for about an hour. The patient suffers from chronic gout and experienced minor gout swells (unsure if it is related to the vaccine or not) The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from shortness of breath, and anxiety on 08-MAY-2021, and sore arm/throbbing arm, and tired on 09-MAY-2021, was recovering from diarrhea with blood, had not recovered from minor gout swells, and the outcome of flushed was not reported. This report was serious (Other Medically Important Condition).; Sender''s Comments: V0 20210522256-COVID-19 VACCINE AD26.COV2.S-diarrhea with blood. 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: 1315766 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Unknown  
Vaccinated:0000-00-00
Onset:2021-05-01
Submitted: 0000-00-00
Entered: 2021-05-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Dizziness, Feeling abnormal, Headache, Nausea
SMQs:, Acute pancreatitis (broad), Anticholinergic syndrome (broad), Dementia (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Vestibular disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? 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: USJNJFOC20210522353

Write-up: LIGHTHEADED; NOT FEELING RIGHT; NAUSEA; HEADACHE; This spontaneous report received from a patient concerned a patient of unspecified age and 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, and batch number were not reported) dose was not reported, administered on 05-MAY-2021 for prophylactic vaccination. Batch number was not reported and has been requested. No concomitant medications were reported. On MAY-2021, the subject experienced lightheaded. On MAY-2021, the subject experienced not feeling right. On MAY-2021, the subject experienced nausea. On MAY-2021, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the nausea, headache, lightheaded and not feeling right was not reported. This report was non-serious.


VAERS ID: 1315781 (history)  
Form: Version 2.0  
Age: 55.0  
Sex: Female  
Location: Alaska  
Vaccinated:0000-00-00
Onset:2021-05-01
Submitted: 0000-00-00
Entered: 2021-05-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, Cough, Fatigue, Fibromyalgia, Myalgia, Pyrexia
SMQs:, Rhabdomyolysis/myopathy (broad), Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Eosinophilic pneumonia (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

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: NAPROXEN
Current Illness: Rheumatoid arthritis (very little flare ups)
Preexisting Conditions: Comments: Patient had no known drug allergies.
Allergies:
Diagnostic Lab Data: Test Date: 20210510; Test Name: Body temperature; Result Unstructured Data: 99.5 F; Test Date: 20210511; Test Name: Body temperature; Result Unstructured Data: 100.2 F
CDC Split Type: USJNJFOC20210523242

Write-up: COUGH WITH DEEP INSPIRATION; GENERAL TIREDNESS; MUSCLE ACHES; FEVER; FIBROMYALGIA; This spontaneous report received from a patient concerned a 55 year old female. The patient''s height, and weight were not reported. The patient''s concurrent conditions included rheumatoid arthritis, and other pre-existing medical conditions included patient had no known drug allergies. The patient received covid-19 vaccine (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on 10-MAY-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. Concomitant medications included naproxen for rheumatoid arthritis. On 10-MAY-2021, the subject experienced cough with deep inspiration. On 10-MAY-2021, the subject experienced general tiredness. On 10-MAY-2021, the subject experienced muscle aches. On 10-MAY-2021, the subject experienced fever. Laboratory data included: Body temperature (NR: not provided) 99.5 F. On 11-MAY-2021, Laboratory data included: Body temperature (NR: not provided) 100.2 F. On an unspecified date, the subject experienced fibromyalgia. The action taken with covid-19 vaccine was not applicable. The outcome of the general tiredness, muscle aches, cough with deep inspiration, fever and fibromyalgia was not reported. This report was non-serious.


VAERS ID: 1315782 (history)  
Form: Version 2.0  
Age: 66.0  
Sex: Male  
Location: Michigan  
Vaccinated:0000-00-00
Onset:2021-05-01
Submitted: 0000-00-00
Entered: 2021-05-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 20A21A / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Ear swelling, Erythema, Pruritus, Rash, Rash papular, Skin exfoliation, Swelling
SMQs:, Severe cutaneous adverse reactions (broad), Anaphylactic reaction (broad), Angioedema (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Comments: Unknown
Allergies:
Diagnostic Lab Data:
CDC Split Type: USJNJFOC20210523244

Write-up: SKIN PEELING/SKIN FLUFFING; SEVERE RED RAISED LARGE PAPULAR RASH ON UPPER TORSO AND UPPER ARM; RASH ON BILATERAL INNER THIGHS; EAR LOBES SWELLED UP; UPPER NECK SWELLED UP; NECK DOWN RED; ITCHY SKIN; This spontaneous report received from a consumer concerned a 66 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: 20A21A expiry: UNKNOWN) dose was not reported, administered on 05-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On MAY-2021, the subject experienced ear lobes swelled up. On MAY-2021, the subject experienced upper neck swelled up. On MAY-2021, the subject experienced neck down red. On MAY-2021, the subject experienced itchy skin. On 08-MAY-2021, the subject experienced severe red raised large papular rash on upper torso and upper arm. On 08-MAY-2021, the subject experienced rash on bilateral inner thighs. On 09-MAY-2021, treatment medications included: diphenhydramine hydrochloride. On 10-MAY-2021, the subject experienced skin peeling/skin fluffing. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from severe red raised large papular rash on upper torso and upper arm, upper neck swelled up, itchy skin, and rash on bilateral inner thighs on MAY-2021, and skin peeling/skin fluffing on 12-MAY-2021, and was recovering from ear lobes swelled up, and neck down red. This report was non-serious.


VAERS ID: 1315784 (history)  
Form: Version 2.0  
Age: 58.0  
Sex: Male  
Location: Washington  
Vaccinated:0000-00-00
Onset:2021-05-01
Submitted: 0000-00-00
Entered: 2021-05-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 205A21A / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Chest discomfort, Dyspnoea, Fatigue, Headache, Insomnia, Oxygen saturation, Pain
SMQs:, Anaphylactic reaction (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? 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: Test Date: 202105; Test Name: Oxygen saturation; Result Unstructured Data: ranging from 90 to 96
CDC Split Type: USJNJFOC20210523275

Write-up: DIDN''T SLEEP WELL; BODY ACHES; FATIGUE; HEADACHE WITH NO FEVER; FELT LIKE NOT ABLE TO TAKE DEEP BREATH; FELT LIKE HEAVY WEIGHT ON CHEST; This spontaneous report received from a patient concerned a 58 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, and batch number: 205A21A expiry: UNKNOWN) dose was not reported, administered on 11-MAY-2021 to Left Arm for prophylactic vaccination. No concomitant medications were reported. On MAY-2021, the subject experienced felt like not able to take deep breath. On MAY-2021, the subject experienced felt like heavy weight on chest. On 11-MAY-2021, the subject experienced didn''t sleep well. On 11-MAY-2021, the subject experienced body aches. On 11-MAY-2021, the subject experienced fatigue. On 11-MAY-2021, the subject experienced headache with no fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from didn''t sleep well, body aches, fatigue, and headache with no fever, and the outcome of felt like not able to take deep breath and felt like heavy weight on chest was not reported. This report was non-serious.


VAERS ID: 1315801 (history)  
Form: Version 2.0  
Age: 33.0  
Sex: Female  
Location: California  
Vaccinated:0000-00-00
Onset:2021-05-01
Submitted: 0000-00-00
Entered: 2021-05-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 206A21A / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Dizziness, Dyspnoea, Headache, Heart rate, Heart rate decreased, Migraine, Pain
SMQs:, Anaphylactic reaction (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Vestibular disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Comments: Unknown
Allergies:
Diagnostic Lab Data: Test Date: 202105; Test Name: Heart rate; Result Unstructured Data: Low
CDC Split Type: USJNJFOC20210524295

Write-up: BODY ACHES; HARD TO BREATHE; DIZZINESS; HIGH HEADACHE; LOW HEART RATE; MIGRAINE; This spontaneous report received from a consumer concerned a 33 year old female. The patient''s weight, height, and medical history were not reported. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: 206A21A, expiry: UNKNOWN) dose was not reported, administered on 07-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On MAY-2021, the subject experienced migraine. On MAY-2021, the subject experienced low heart rate. Laboratory data included: Heart rate (NR: not provided) Low. On 07-MAY-2021, the subject experienced body aches. On 07-MAY-2021, the subject experienced hard to breathe. On 07-MAY-2021, the subject experienced dizziness. On 07-MAY-2021, the subject experienced high headache. The action taken with covid-19 vaccine was not applicable. The patient had not recovered from migraine, and the outcome of high headache, body aches, hard to breathe, low heart rate and dizziness was not reported. This report was non-serious.


VAERS ID: 1316351 (history)  
Form: Version 2.0  
Age: 38.0  
Sex: Female  
Location: Florida  
Vaccinated:0000-00-00
Onset:2021-05-01
Submitted: 0000-00-00
Entered: 2021-05-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 205A21A / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Chills, Contusion, Hypoaesthesia, Muscle spasms, Muscular weakness, Musculoskeletal stiffness, Pain, Peripheral coldness, Pyrexia, Thrombosis
SMQs:, Rhabdomyolysis/myopathy (broad), Peripheral neuropathy (broad), Haemorrhage terms (excl laboratory terms) (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Dystonia (broad), Parkinson-like events (broad), Thrombophlebitis (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Accidents and injuries (narrow), Arthritis (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: Comments: Unknown
Allergies:
Diagnostic Lab Data:
CDC Split Type: USJNJFOC20210516231

Write-up: THROMBOSIS IN RIGHT HAND MIDDLE FINGER KNUCKLE; RIGHT ARM AND HAND COLD; RIGHT ARM AND HAND NUMB,LEFT HAND NUMB; WEAK LEFT HAND AND WEAK LEGS; CRAMP IN INNER MIDDLE FOOT LEFT FOOT; PAIN ALL OVER BODY; CHILLS; FEVER; HAND AND LEG STIFFNESS,STIFF NECK; RED/BLUE BRUISE; This spontaneous report received from a patient concerned a 38 year old white and Hispanic or Latino 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 and batch number: 205A21A expiry: UNKNOWN) dose was not reported, 1 total administered on 03-MAY-2021 to left arm for prophylactic vaccination. No concomitant medications were reported. On MAY-2021, the patient experienced red/blue bruise. On 03-MAY-2021, the patient experienced pain all over body, hand and leg stiffness for 10 minutes, stiff neck, chills and fever. On 04-MAY-2021, the patient experienced cramp in inner middle foot left foot. On 09-MAY-2021, the patient experienced thrombosis in right hand middle finger knuckle, right arm and hand cold, right arm and hand numb, left hand numb and weak left hand and weak legs. Treatment medications (dates unspecified) included: acetylsalicylic acid. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from cramp in inner middle foot left foot on 04-MAY-2021, pain all over body on MAY-2021, and chills, and fever on 03-MAY-2021, was recovering from right arm and hand cold, right arm and hand numb, left hand numb, and weak left hand and weak legs, had not recovered from thrombosis in right hand middle finger knuckle, and hand and leg stiffness, stiff neck, and the outcome of red/blue bruise was not reported. This report was serious (Other Medically Important Condition).; Sender''s Comments: V0: 20210516231-covid-19 vaccine ad26.cov2.s - thrombosis in right hand middle finger in Hispanic or Latino patient. 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: 1316534 (history)  
Form: Version 2.0  
Age: 40.0  
Sex: Male  
Location: Ohio  
Vaccinated:2021-04-07
Onset:2021-05-01
   Days after vaccination:24
Submitted: 0000-00-00
Entered: 2021-05-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 1808980 / 1 RA / SYR

Administered by: Public       Purchased by: ?
Symptoms: Computerised tomogram abnormal, Electrocardiogram, Fibrin D dimer, Pulmonary embolism, Pulmonary infarction
SMQs:, Embolic and thrombotic events, venous (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Multi-vitamin
Current Illness: n/a
Preexisting Conditions: n/a
Allergies: Pennicillan, Ampicillan, Amoxicillan
Diagnostic Lab Data: EKG, D Dymer Levels, CT
CDC Split Type:

Write-up: Pulmonary Embolism and Lung Infarction. Signs began 5/1, to E.R. 5/3. Obviously, doctors unsure if from vaccine.


VAERS ID: 1317065 (history)  
Form: Version 2.0  
Age: 56.0  
Sex: Female  
Location: Virginia  
Vaccinated:2021-04-28
Onset:2021-05-01
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-05-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW01796 / UNK LA / IM

Administered by: Private       Purchased by: ?
Symptoms: Computerised tomogram, Electrocardiogram, Pulmonary thrombosis, Ultrasound Doppler
SMQs:, Embolic and thrombotic events, venous (narrow)

Life Threatening? Yes
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, 3 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: Valsartan, B12 and calcium supplements
Current Illness: HBP- treated with meds
Preexisting Conditions: none
Allergies: Penicillin and clindamycin
Diagnostic Lab Data: EKG, Doppler and CT scan 5/3/2021
CDC Split Type:

Write-up: blood clots in lungs


VAERS ID: 1317078 (history)  
Form: Version 2.0  
Age: 17.0  
Sex: Female  
Location: Minnesota  
Vaccinated:2021-05-01
Onset:2021-05-01
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-05-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / SYR

Administered by: Unknown       Purchased by: ?
Symptoms: Headache, Pyrexia, SARS-CoV-2 test negative
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: unknown
Current Illness: unknown
Preexisting Conditions: none
Allergies: NKDA
Diagnostic Lab Data: negative rapid covid test on 5/10/2021
CDC Split Type:

Write-up: fever and headache since second pfizer COVID vaccine that was given on 5/1/2021, noted at urgent care appt on 5/10/2021


VAERS ID: 1317541 (history)  
Form: Version 2.0  
Age: 91.0  
Sex: Female  
Location: Pennsylvania  
Vaccinated:2021-04-30
Onset:2021-05-01
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-05-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 046B21A / 2 LA / IM

Administered by: Private       Purchased by: ?
Symptoms: Asthenia, Heart rate increased, Illness, Mobility decreased, Unresponsive to stimuli, Vomiting
SMQs:, Acute pancreatitis (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Parkinson-like events (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hypotonic-hyporesponsive episode (broad), Tendinopathies and ligament disorders (broad), Hypoglycaemia (broad), Dehydration (broad)

Life Threatening? Yes
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, 6 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: Eliquis Bumetanide Lovastatin Protonix Allopurinol Levothyroxine Miacalcin Lopressor Calcium 600 + D Tylenol as needed
Current Illness:
Preexisting Conditions: A-Fib Kidney Disease
Allergies: Penicillin Levaquin Macrobid
Diagnostic Lab Data: Heart Rate was at 200, In ER they were all running around and gave her medications to get her heart rate down Advised that she was very sick and they were doing all they could She was very weak
CDC Split Type:

Write-up: Vomiting, became unresponsive, couldn''t move off of recliner


VAERS ID: 1317652 (history)  
Form: Version 2.0  
Age: 14.0  
Sex: Female  
Location: Oregon  
Vaccinated:2021-05-01
Onset:2021-05-01
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-05-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0173 / 1 RA / IM

Administered by: Other       Purchased by: ?
Symptoms: 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: Unknown
Current Illness: None
Preexisting Conditions: None
Allergies: None known
Diagnostic Lab Data: None
CDC Split Type:

Write-up: No signs or symptoms


VAERS ID: 1317998 (history)  
Form: Version 2.0  
Age: 88.0  
Sex: Male  
Location: Florida  
Vaccinated:2021-05-01
Onset:2021-05-01
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-05-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

Administered by: Unknown       Purchased by: ?
Symptoms: Diarrhoea, Hypotension, Vomiting
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Pseudomembranous colitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Noninfectious diarrhoea (narrow), Dehydration (broad), Hypokalaemia (broad)

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

Write-up: pt was hospitalized for diarrhea, vomiting, and low blood pressure


VAERS ID: 1318204 (history)  
Form: Version 2.0  
Age: 13.0  
Sex: Female  
Location: Missouri  
Vaccinated:2021-05-14
Onset:2021-05-01
Submitted: 0000-00-00
Entered: 2021-05-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0185 / 1 LA / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: Dizziness, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Cardiomyopathy (broad), Vestibular disorders (broad), Hypotonic-hyporesponsive episode (broad), Hypoglycaemia (broad)

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

Write-up: Pt exhibited an episode of syncope/lightheadedness directly after the vaccination. Counseled patient about the risks of standing after a vaccination. Immediately gave Benadryl to the patient upon initial assessment.


VAERS ID: 1318546 (history)  
Form: Version 2.0  
Age: 42.0  
Sex: Male  
Location: Arizona  
Vaccinated:2021-04-23
Onset:2021-05-01
   Days after vaccination:8
Submitted: 0000-00-00
Entered: 2021-05-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 037A21B / 2 LA / SYR

Administered by: Pharmacy       Purchased by: ?
Symptoms: Computed tomographic gastrography, Computerised tomogram kidney, Computerised tomogram liver, Computerised tomogram neck, Computerised tomogram thorax, Injection site reaction, Renal function test, Thrombosis, Ultrasound scan abnormal
SMQs:, Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Malignancy related therapeutic and diagnostic procedures (narrow), Thrombophlebitis (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, 2 days
   Extended hospital stay? No
Previous Vaccinations: BELLS PALSY. Moderna first dose,
Other Medications: None
Current Illness: No illnesses. Developed Bell?s palsy after first vaccine dose
Preexisting Conditions: None
Allergies: None
Diagnostic Lab Data: Sonogram of the arm, May 12 - indicated clot. Ct scan of the neck and chest, May 12 - identify clot in upper bicep near injection site. Ct scan of the kidney, stomach, liver, May 12 - no other clots visible. Blood work, May 12 - check for generic clotting disease, kidney function, etc
CDC Split Type:

Write-up: Blood clot formed.


VAERS ID: 1318622 (history)  
Form: Version 2.0  
Age: 17.0  
Sex: Male  
Location: Maine  
Vaccinated:2021-05-01
Onset:2021-05-01
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-05-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 014C21A / 2 RA / IM

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

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

Write-up: 17-year-old male showed up to the Mobile Vaccination Unit for dose number 2 of the Moderna COVID-19 Vaccine. He had received the first dose 28 days prior (also from the Mobile Vaccination Unit), at which time this dose was given inappropriately due to the patient being less than 18 years of age. When he showed up for dose number 2, the Agency was consulted by telephone and a decision was made to go ahead and complete the two-dose series even though he was still about 6 weeks shy of his 18th birthday. This report is being made due to the inappropriate vaccine administration to an underage recipient, but he otherwise suffered no adverse effects.


VAERS ID: 1319784 (history)  
Form: Version 2.0  
Age: 57.0  
Sex: Female  
Location: Massachusetts  
Vaccinated:0000-00-00
Onset:2021-05-01
Submitted: 0000-00-00
Entered: 2021-05-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 205A21A / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Body temperature, Contusion, Dehydration, Dysphonia, Headache, Hyperaesthesia, Myalgia, Pain, Pain of skin, Pollakiuria, Pyrexia, Rhinorrhoea, Tinnitus
SMQs:, Rhabdomyolysis/myopathy (broad), Haemorrhage terms (excl laboratory terms) (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Parkinson-like events (broad), Accidents and injuries (narrow), Eosinophilic pneumonia (broad), Hearing impairment (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: Medical History/Concurrent Conditions: Allergy to nuts; Migraine; Comments: no known previous medical conditions.
Allergies:
Diagnostic Lab Data: Test Date: 20210506; Test Name: Body temperature; Result Unstructured Data: 100 F
CDC Split Type: USJNJFOC20210516282

Write-up: CONSTANT URINATION; DEHYDRATION; SENSITIVE TO TOUCH; BODY IS BRUISED; SCALP AND HAIR HURTS; EXTREME ACHE LIKE HIT BY BUS AND RUN OVER BY BUS; MUSCLE ACHE ON INJECTION ARM OTHER ARM AND THE WHOLE BODY; FEVER; SEVERE HEADACHE FELT LIKE PRESSURE FROM THE INSIDE OUT; RUNNY NOSE; VOICE HOARSENESS; EARS RINGING; This spontaneous report received from a patient concerned a 57 year old female. The patient''s height, and weight were not reported. The patient''s past medical history included migraine headaches, and allergy to mixed nuts, and other pre-existing medical conditions included no known previous medical conditions. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: 205A21A, and batch number: 205A21A expiry: 23-JUN-2021) dose was not reported, administered on 06-MAY-2021 09:30 for prophylactic vaccination. No concomitant medications were reported. On MAY-2021, the subject experienced runny nose. On MAY-2021, the subject experienced voice hoarseness. On MAY-2021, the subject experienced ears ringing. On 06-MAY-2021, the subject experienced severe headache felt like pressure from the inside out. Laboratory data included: Body temperature (NR: not provided) 100 F. On 06-MAY-2021 17:00, the subject experienced muscle ache on injection arm other arm and the whole body. On 06-MAY-2021 17:00, the subject experienced fever. On 06-MAY-2021 20:00, the subject experienced extreme ache like hit by bus and run over by bus. On 07-MAY-2021, the subject experienced constant urination. On 07-MAY-2021, the subject experienced dehydration. On 07-MAY-2021, the subject experienced sensitive to touch. On 07-MAY-2021, the subject experienced body is bruised. On 07-MAY-2021, the subject experienced scalp and hair hurts. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine was not applicable. The patient was recovering from muscle ache on injection arm other arm and the whole body, and severe headache felt like pressure from the inside out, and the outcome of fever, runny nose, voice hoarseness, ears ringing, constant urination, dehydration, sensitive to touch, body is bruised, scalp and hair hurts and extreme ache like hit by bus and run over by bus was not reported. This report was non-serious. This report was associated with product quality complaint: 90000178841 The suspected product quality complaint has been confirmed to be management approval - confirmed nothing was identified within the reported complaint reported. complaint is approved for void based on the evaluation/investigation performed..


VAERS ID: 1319785 (history)  
Form: Version 2.0  
Age: 56.0  
Sex: Female  
Location: Texas  
Vaccinated:0000-00-00
Onset:2021-05-01
Submitted: 0000-00-00
Entered: 2021-05-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN UNKNOWN / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Ageusia, Anosmia, Antibody test, Colitis, Decreased immune responsiveness, Diarrhoea, Influenza, Myalgia, Pain in extremity, Rash, Vomiting
SMQs:, Rhabdomyolysis/myopathy (broad), Anaphylactic reaction (broad), Acute pancreatitis (broad), Taste and smell disorders (narrow), Pseudomembranous colitis (broad), Gastrointestinal nonspecific inflammation (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Ischaemic colitis (broad), Eosinophilic pneumonia (broad), Hypersensitivity (narrow), Noninfectious diarrhoea (narrow), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (broad), Opportunistic infections (broad), Immune-mediated/autoimmune disorders (broad)

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: Alcohol allergy; Drug allergy
Preexisting Conditions: Medical History/Concurrent Conditions: COVID-19; Comments: The patient was not pregnant at the time of vaccination.
Allergies:
Diagnostic Lab Data: Test Date: 202105; Test Name: Antibody test; Result Unstructured Data: Positive
CDC Split Type: USJNJFOC20210516491

Write-up: FLU SYMPTOMS; DIARRHEA; COLITIS ATTACH; VOMITING; LOSS OF TASTE; LOSS OF SMELL; RASH; SORE ARM; MYALGIA; IMMUNITY DOWN; 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 past medical history included covid-19 infection, and concurrent conditions included alcohol allergy, and codeine allergy, and other pre-existing medical conditions included the patient was not pregnant at the time of vaccination. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 03-MAY-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On MAY-2021, the subject experienced immunity down. Laboratory data included: Antibody test (NR: not provided) Positive. On 03-MAY-2021, the subject experienced flu symptoms. On 03-MAY-2021, the subject experienced diarrhea. On 03-MAY-2021, the subject experienced colitis attach. On 03-MAY-2021, the subject experienced vomiting. On 03-MAY-2021, the subject experienced loss of taste. On 03-MAY-2021, the subject experienced loss of smell. On 03-MAY-2021, the subject experienced rash. On 03-MAY-2021, the subject experienced sore arm. On 03-MAY-2021, the subject experienced myalgia. The action taken with covid-19 vaccine was not applicable. The patient recovered from rash on 04-MAY-2021, was recovering from flu symptoms, colitis attach, vomiting, and myalgia, had not recovered from diarrhea, sore arm, loss of taste, and loss of smell, and the outcome of immunity down was not reported. This report was non-serious.


VAERS ID: 1319813 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Unknown  
Vaccinated:0000-00-00
Onset:2021-05-01
Submitted: 0000-00-00
Entered: 2021-05-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN UNKNOWN / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Abnormal dreams, Chills, Feeling abnormal, Insomnia, Pain, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (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? 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: USJNJFOC20210524891

Write-up: FELT LIKE A TRUCK HIT ME; ACHY; CHILLS; HIGH FEVER; HORRIBLE NIGHT SLEEP; FEVER DREAMS; This spontaneous report received from a patient via social media concerned a patient of unspecified age and sex. The patient''s weight, height, and medical history were not reported. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 12-MAY-2021 for prophylactic vaccination. Th e batch number was not reported. Per procedure, no follow up will be requested for this case. No concomitant medications were reported. On MAY-2021, the subject experienced horrible night sleep. On MAY-2021, the subject experienced fever dreams. On 12-MAY-2021, the subject experienced felt like a truck hit me. On 12-MAY-2021, the subject experienced achy. On 12-MAY-2021, the subject experienced chills. On 12-MAY-2021, the subject experienced high fever. The action taken with covid-19 vaccine was not applicable. The patient had not recovered from felt like a truck hit me, high fever, chills, achy, horrible night sleep, and fever dreams. This report was non-serious. This case, from the Others is linked to 20210524906.


VAERS ID: 1319831 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Michigan  
Vaccinated:0000-00-00
Onset:2021-05-01
Submitted: 0000-00-00
Entered: 2021-05-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN UNKNOWN / 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: USJNJFOC20210526083

Write-up: SEVERE HEADACHE; This spontaneous report received from a patient concerned a male of unspecified age. The patient''s weight, height, and medical history were not reported. The patient received covid-19 vaccine (suspension for injection, route of admin not reported) dose was not reported, administered on 13-MAY-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On MAY-2021, the subject experienced severe headache. The action taken with covid-19 vaccine was not applicable. The outcome of severe headache was not reported. This report was non-serious.


VAERS ID: 1320155 (history)  
Form: Version 2.0  
Age: 24.0  
Sex: Female  
Location: California  
Vaccinated:2021-05-01
Onset:2021-05-01
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-05-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0173 / 1 LA / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: USPFIZER INC2021488056

Write-up: passed out; sweating; turned blue; This is a spontaneous report from a contactable other healthcare professional (hcp reporting for self). A 24-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection, Lot Number: EW0173, expiry date not reported) via an unspecified route of administration, administered in left arm on 01May2021 18:00 (at the age of 24 years old) as first dose, single for covid-19 immunization. The patient''s medical history was not reported. Prior to vaccination, the patient was not diagnosed with COVID-19. There were no concomitant medications. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. There were no other medications the patient received within 2 weeks of vaccination. On 01May2021 18:00, patient immediately started sweating after getting the shot then passed out within a couple minutes. Pharmacist told the patient that she turned blue and they injected her with Epipen. Patient woke up after and felt fine. The events resulted in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. The events were reported as serious medically significant. Since the vaccination, the patient was not tested for COVID-19. The patient recovered from the events reported on an unspecified date in May2021.; Sender''s Comments: Based on temporal association, the causal relationship between BNT162B2 and the events loss of consciousness, hyperhidrosis and skin discolouration cannot be excluded. The information available in this report is limited and does not allow a medically meaningful assessment. This case will be reassessed once additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.


VAERS ID: 1320157 (history)  
Form: Version 2.0  
Age: 30.0  
Sex: Male  
Location: New York  
Vaccinated:2021-04-30
Onset:2021-05-01
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-05-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0167 / 1 LA / -

Administered by: Pharmacy       Purchased by: ?
Symptoms: Dyspnoea, 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? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Allergy to antibiotic
Allergies:
Diagnostic Lab Data:
CDC Split Type: USPFIZER INC2021488159

Write-up: This is a spontaneous report from a contactable consumer (patient). A 30-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EW0167), via an unspecified route of administration, administered in left arm on 30Apr2021 15:00 as 1st dose, single for COVID-19 immunization. Medical history included amoxicillin allergy. The patient''s concomitant medications were not reported. Facility where the most recent COVID-19 vaccine was administered was pharmacy or drug store. The patient did not receive any other vaccines within 4 weeks prior to COVID vaccine. The patient did not received any other medications within 2 weeks of vaccination. The patient experienced difficulty breathing, feverish on 01May2021 23:00. The events resulted in emergency room/department or urgent care visit. The patient was hospitalized due to the events. Therapeutic measures were taken as a result of the events and included treatment with prednisone 20 mg for 5 days. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The outcome of the events was not recovered. Seriousness of the events was reported as non-serious. Information on lot/batch number was available. Additional information has been requested.


VAERS ID: 1320277 (history)  
Form: Version 2.0  
Age: 23.0  
Sex: Female  
Location: Massachusetts  
Vaccinated:2021-02-17
Onset:2021-05-01
   Days after vaccination:73
Submitted: 0000-00-00
Entered: 2021-05-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 LA / -

Administered by: Work       Purchased by: ?
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
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: 20210504; Test Name: PCR test; Test Result: Positive ; Comments: Nasal Swab
CDC Split Type: USPFIZER INC2021503870

Write-up: COVID-19 confirmed by positive COVID-19 test; COVID-19 confirmed by positive COVID-19 test; This is a spontaneous report from a contactable consumer (patient). A 23-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date not provided), 1st dose via an unspecified route of administration, administered in arm left on 28Jan2021 as a single dose, 2nd dose via an unspecified route of administration, administered in arm left on 17Feb2021 as a single dose; both at age of 23 years old for COVID-19 immunisation. The patient''s medical history and concomitant medications were not reported. The patient contracted COVID-19 after being fully vaccinated on 01May2021. No treatment was received for the events. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. And the patient had no COVID-19 prior vaccination. The report was reported as non-serious. The patient underwent lab tests and procedures which included PCR test: positive (nasal swab) on 04May2021. The outcome of the events was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained.


VAERS ID: 1320284 (history)  
Form: Version 2.0  
Age: 35.0  
Sex: Female  
Location: North Carolina  
Vaccinated:2021-04-10
Onset:2021-05-01
   Days after vaccination:21
Submitted: 0000-00-00
Entered: 2021-05-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 LA / -

Administered by: Military       Purchased by: ?
Symptoms: Neuropathy peripheral
SMQs:, Peripheral neuropathy (narrow), Guillain-Barre syndrome (broad), Immune-mediated/autoimmune disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: INDOMETHACIN [INDOMETACIN]; BENADRYL; ALLEGRA
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Ganglion cyst (since 2018 in hands.); Lyme disease (at 12 yrs old, treated with amoxicillan and tested negative for Lymes in 2019.)
Allergies:
Diagnostic Lab Data:
CDC Split Type: USPFIZER INC2021504276

Write-up: After the 1st shot, my right great toe had sudden onset of chronic neuropathy with sensation as if a cord is tied tightly around it and that sensation has not gone away and has stayed constant; This is a spontaneous report from a contactable consumer. A 35-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Left on 10Apr2021 13:30 (Batch/Lot number was not reported) as 1st dose, single (at the age of 35 years) for covid-19 immunization. The patient''s medical history included Lymes disease (prior TBI, Lymes disease at 12 yrs old and treated with amoxicillan and tested negative for Lymes in 2019) and ganglion cysts (since 2018 in hands). Concomitant medications included indomethacin; diphenhydramine hydrochloride (BENADRYL); and fexofenadine hydrochloride (ALLEGRA) taken for an unspecified indication, start and stop date were not reported. The patient previously took hydrocortisone and had allergies (as an adolescent, had inflammatory response to hydrocortisone topical cream). The patient experienced after the 1st shot, her right great toe had sudden onset of chronic neuropathy with sensation as if a cord is tied tightly around it and that sensation has not gone away and has stayed constant on 01May2021 16:00. Patient was not treated for the event. It was reported that the event was mild and further reported as, after the 1st shot, her right great toe had sudden onset of chronic neuropathy with sensation as if a cord is tied tightly around it and that sensation has not gone away and has stayed constant. Shr never had this condition prior. After the second shot same evening, her left ankle was swollen without pain, which was not a normal condition for her and she did not recall any recent bumps or twists which would have caused it. Patient would seek treatment if conditions worsen and/or after the weekend. The patient diagnosed with COVID-19 prior to vaccination. Patient was tested for COVID-19 since the vaccination. The outcome of the event was not recovered.


VAERS ID: 1320294 (history)  
Form: Version 2.0  
Age: 38.0  
Sex: Male  
Location: Unknown  
Vaccinated:2021-05-01
Onset:2021-05-01
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-05-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Pharmacy       Purchased by: ?
Symptoms: Dyspnoea, Headache, Influenza like illness, Myalgia, Myocarditis, Pleuritic pain
SMQs:, Rhabdomyolysis/myopathy (broad), Anaphylactic reaction (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (broad), Immune-mediated/autoimmune disorders (broad)

Life Threatening? Yes
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: USPFIZER INC2021504667

Write-up: Myocarditis; Pleuritic Chest Pain; Difficulty breathing; Myalgia; Headache; Flu-like symptoms; This is a spontaneous report from a contactable physician. A 38-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number was not reported), via an unspecified route of administration on 01May2021 as second dose, single for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient previously received the first dose of BNT162B2, on an unknown date, for COVID-19 immunization. The patient experienced myocarditis on 05May2021, and in May2021 (reported as started 2 and a half days after receiving the second dose) experienced pleuritic chest pain, difficulty breathing, myalgia, headache, and flu-like symptoms. The patient was hospitalized for the events from 05May2021 to an unknown date. The reporter assessed the events as life-threatening. The adverse events required a visit to Emergency Room. The reporter assessed that the patient''s events were caused by the vaccine. The outcome of the events was unknown. No follow-up attempts are possible. Information about batch/lot number cannot be obtained. No further information is expected.; Sender''s Comments: Based on the limited information currently available, a possible association of the suspect drug administration with the reported events cannot be excluded, due to a plausible temporal relationship. This case will be reassessed when additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.


VAERS ID: 1320310 (history)  
Form: Version 2.0  
Age: 18.0  
Sex: Male  
Location: North Carolina  
Vaccinated:2021-05-01
Onset:2021-05-01
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-05-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Unknown       Purchased by: ?
Symptoms: Bedridden, Expired product administered, Fatigue, Pain
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: USPFIZER INC2021505956

Write-up: body aches; Fatigue; laying around; vaccine expired two hours before he got it; This is a spontaneous report from a contactable physician. A 18-years-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: unknown), via an unspecified route of administration, administered in arm on 01May2021 (at the age of 18 years) as 2nd dose, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: unknown), via an unspecified route of administration on an unspecified date as 1st dose, single for COVID-19 immunization and meningococcal vaccine b (MENB) taken on Feb2021. The patient had no other vaccinations the dates he got his Pfizer COVID-19 vaccine or in the four weeks prior. On 01May2021, saturday patient received second dose of vaccine which was expired two hours before he got, which the patient should not had got and was called back in. On 02May2021 patient experienced side effects such as body aches, laying around, and fatigue. The reporter informed about seriousness that she felt it is significant, in that there was already hesitancy, so for them to mess up on this is significant. The outcome of event was unknown. Information on the lot/batch number has been requested.; Sender''s Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the event Expired vaccine used, fatigue and the suspect drug BNT162B2. Also, there is limited information in the case provided, the causal association between the event pain, bedridden and the suspect drug BNT162B2 cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.


VAERS ID: 1320358 (history)  
Form: Version 2.0  
Age: 48.0  
Sex: Female  
Location: Florida  
Vaccinated:2021-01-11
Onset:2021-05-01
   Days after vaccination:110
Submitted: 0000-00-00
Entered: 2021-05-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EL1284 / 2 LA / -

Administered by: Private       Purchased by: ?
Symptoms: Ageusia, Anosmia, COVID-19, Dyspnoea, Loss of personal independence in daily activities, Nasal congestion, SARS-CoV-2 test, SARS-CoV-2 test positive, Vaccination failure
SMQs:, Anaphylactic reaction (broad), Lack of efficacy/effect (narrow), Taste and smell disorders (narrow), Dementia (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Infective pneumonia (broad), Opportunistic infections (broad), Immune-mediated/autoimmune disorders (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Hypertension; Hyperthyroidism; Seasonal allergy (Stated she has had seasonal allergies since she was a kid.)
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210505; Test Name: Covid-19 PCR test; Test Result: Positive ; Test Date: 20210505; Test Name: Covid-19 rapid POC test positive; Test Result: Positive
CDC Split Type: USPFIZER INC2021515729

Write-up: she started to have shortness of breath in the evening; She realized she couldn''t do as much as she normally does. She said she tried; Tested positive for Covid-19 after both doses of Covid-19 Vaccine; she tested positive for the COVID-19 Virus on 05May2021; Now she had zero taste and smell; Now she had zero taste and smell; she had congestion; This is a spontaneous report from a contactable other-HCP. A 48-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EL1284 and expiration date was not reported), via an unspecified route of administration in deltoid left on 11Jan2021 as 2nd single dose, for COVID-19 immunization. Medical history included hypertension from 2015 and ongoing, hyperthyroidism from Aug2019 and ongoing, ongoing seasonal allergy stated she has had seasonal allergies since she was a kid. The patient''s concomitant medications were not reported. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution injection, Lot number-EH9899 and expiration date was not reported), via unspecified route of administration on 20Dec2021 for COVID-19 immunization. On 05May2021 the patient experienced tested positive for COVID-19 after both doses of covid-19 vaccine. Upon follow-up received on 07May2021, she tested positive for the covid-19 virus on 05May2021. The patient now she had zero taste and smell (ageusia) (medically significant) the patient the patient with outcome of not recovered, On May2021 the patient experienced now she had zero taste and smell, she said she had congestion and couldn''t taste and smell. She said on 06May2021 she started to have shortness of breath in the evening. She said because she was a cardiopulmonary specialist, she thought her shortness of breath was mild, but her family members thought she sounded winded. She said yesterday, she realized she couldn''t do as much as she normally does. She said she tried to mop the floor yesterday and couldn''t finish mopping the floor because she was short of breath. She said she doesn''t feel sick. She realized she couldn''t do as much as she normally does. She said she tried to mop the floor yesterday and couldn''t finish mopping the floor-Activities of daily living impaired. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on 05May2021, sars-cov-2 test positive: positive on 05May2021. Therapeutic measures were taken as a result of now she had zero taste and smell (ageusia), now she had zero taste and smell (anosmia), she had congestion (nasal congestion), she started to have shortness of breath in the evening (dyspnoea), she realized she couldn''t do as much as she normally does. she said she tried (loss of personal independence in daily activities). The outcome of event was Not recovered. Follow-up(07May2021): New Information received from the contactable consumer includes updated events and dates, Past drug events and allergy and questions regarding events. Information on Lot/Batch number was available. Additional information has been requested.; Sender''s Comments: Based on the information available and a close temporal association, a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported events of Vaccination failure,Covid19,loss of smell,taste. The case will be reassessed once new information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate


VAERS ID: 1320522 (history)  
Form: Version 2.0  
Age: 46.0  
Sex: Female  
Location: South Carolina  
Vaccinated:2021-02-01
Onset:2021-05-01
   Days after vaccination:89
Submitted: 0000-00-00
Entered: 2021-05-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EN6200 / 2 LA / IM

Administered by: Public       Purchased by: ?
Symptoms: Chills, Fatigue, Haemorrhage urinary tract, Heavy menstrual bleeding, Menstruation irregular, Pain, Pyrexia
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Fertility 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: None
Current Illness: None
Preexisting Conditions: Htn/ hypothyroidism
Allergies: None
Diagnostic Lab Data:
CDC Split Type:

Write-up: Chills, fever , body aches the first few days. Next two periods not normal. Having extremely heavy menses with large blood clots that are not usual for me. Extreme fatigue due to blood loss. Still have not stopped bleeding


VAERS ID: 1321120 (history)  
Form: Version 2.0  
Age: 54.0  
Sex: Female  
Location: Florida  
Vaccinated:2021-02-04
Onset:2021-05-01
   Days after vaccination:86
Submitted: 0000-00-00
Entered: 2021-05-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 025J20A / 1 LA / SYR

Administered by: Private       Purchased by: ?
Symptoms: Ischaemic stroke
SMQs:, Ischaemic central nervous system vascular conditions (narrow), Embolic and thrombotic events, arterial (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, 2 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: Levothyroxine, Amlodipine, Calcium , Vit D
Current Illness: None
Preexisting Conditions: None
Allergies: None
Diagnostic Lab Data:
CDC Split Type:

Write-up: Minor stroke


VAERS ID: 1322495 (history)  
Form: Version 2.0  
Age: 44.0  
Sex: Female  
Location: Virginia  
Vaccinated:2021-04-12
Onset:2021-05-01
   Days after vaccination:19
Submitted: 0000-00-00
Entered: 2021-05-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 LA / SYR

Administered by: Other       Purchased by: ?
Symptoms: Menstrual disorder
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: Synthroid
Current Illness:
Preexisting Conditions: Hashimoto''s Autoimmune disease
Allergies:
Diagnostic Lab Data: None yet.
CDC Split Type:

Write-up: I had a normal menstrual period on April 19 (27 days after the previous one) but then I started bleeding again on May 1, only 11 days later. The bleeding has been light on some days, then it switched to medium, then back to light, then medium again... and it continued for 17 days now. I searched for possible explanations for this, and found that other women are noticing this after their covid vaccine, so I decided to report it. I will see my ObGyn in three days for this issue. This type of long, 2+ week vaginal bleeding has never happened to me before.


VAERS ID: 1322514 (history)  
Form: Version 2.0  
Age: 35.0  
Sex: Female  
Location: California  
Vaccinated:2021-05-01
Onset:2021-05-01
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-05-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 LA / SYR

Administered by: Private       Purchased by: ?
Symptoms: Foetal death, Ultrasound abdomen
SMQs:, Termination of pregnancy and risk of abortion (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Prenatal Vitamins, prenatal omegas, iron
Current Illness: None
Preexisting Conditions: Long-Covid asides that nothing
Allergies: None
Diagnostic Lab Data: Ultrasound 5/16
CDC Split Type:

Write-up: Fetal Death/ Intrauterine fetal death


VAERS ID: 1322568 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Unknown  
Vaccinated:0000-00-00
Onset:2021-05-01
Submitted: 0000-00-00
Entered: 2021-05-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN UNKNOWN / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Asthenia, Chills, Night sweats, Pain
SMQs:, Guillain-Barre syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Comments: Unknown
Allergies:
Diagnostic Lab Data:
CDC Split Type: USJNJFOC20210524935

Write-up: NIGHT SWEATS; BODY ACHES; CHILLS; DECREASED STAMINA; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and 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, batch number: unknown) dose was not reported, administered on 08-MAY-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 MAY-2021, the subject experienced night sweats. On MAY-2021, the subject experienced body aches. On MAY-2021, the subject experienced chills. On MAY-2021, the subject experienced decreased stamina. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from decreased stamina, and the outcome of chills, night sweats and body aches was not reported. This report was non-serious.


VAERS ID: 1322570 (history)  
Form: Version 2.0  
Age: 59.0  
Sex: Female  
Location: Unknown  
Vaccinated:0000-00-00
Onset:2021-05-01
Submitted: 0000-00-00
Entered: 2021-05-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN UNKNOWN / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Hot flush
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: Menopause (by age 55)
Preexisting Conditions: Medical History/Concurrent Conditions: Hot flashes
Allergies:
Diagnostic Lab Data:
CDC Split Type: USJNJFOC20210524971

Write-up: HOT FLASHES; This spontaneous report received from a patient concerned a 59 year old female. The patient''s height, and weight were not reported. The patient''s past medical history included hot flashes, and concurrent conditions included menopause.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: unknown, expiry: unknown) dose was not reported, administered on 30-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On MAY-2021, the subject experienced hot flashes. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from hot flashes. This report was non-serious.


VAERS ID: 1322571 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Unknown  
Vaccinated:0000-00-00
Onset:2021-05-01
Submitted: 0000-00-00
Entered: 2021-05-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN UNKNOWN / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Asthenia, Chills, Pain
SMQs:, Guillain-Barre 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: USJNJFOC20210524978

Write-up: EXTREME BODY ACHES; CHILLS; WEAK; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and 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, batch number: Unknown) dose, start therapy date were not reported 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 MAY-2021, the subject experienced extreme body aches. On MAY-2021, the subject experienced chills. On MAY-2021, the subject experienced weak. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from extreme body aches, chills, and weak on MAY-2021. This report was non-serious.


VAERS ID: 1322580 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Pennsylvania  
Vaccinated:0000-00-00
Onset:2021-05-01
Submitted: 0000-00-00
Entered: 2021-05-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 202A21A / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Eye pain, Eye swelling, Oropharyngeal pain
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Glaucoma (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: USJNJFOC20210526117

Write-up: SORE THROAT; LEFT EYE PAIN; LEFT EYE SWELLING UPTO EYEBROWS / FELT LIKE IT WAS SEALED SHUT; This spontaneous report received from a patient concerned a 50 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: 202A21A, and batch number: 205AZIA expiry: UNKNOWN) dose was not reported, administered on 08-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On MAY-2021, the subject experienced left eye pain. On MAY-2021, the subject experienced left eye swelling up to eyebrows / felt like it was sealed shut. On 11-MAY-2021, the subject experienced sore throat. Treatment medications (dates unspecified) included: sodium chloride, and paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from left eye pain, sore throat, and left eye swelling up to eyebrows / felt like it was sealed shut. This report was non-serious.


VAERS ID: 1322593 (history)  
Form: Version 2.0  
Age: 60.0  
Sex: Female  
Location: Michigan  
Vaccinated:0000-00-00
Onset:2021-05-01
Submitted: 0000-00-00
Entered: 2021-05-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 204A21A / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Dizziness, Fatigue, Feeling abnormal, Headache, Nausea
SMQs:, Acute pancreatitis (broad), Anticholinergic syndrome (broad), Dementia (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Vestibular disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? 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: USJNJFOC20210526818

Write-up: LIGHTHEADED; HEADACHE THAT GOES FROM NECK AROUND THE SKULL, AROUND FACE AND HAIR AREA; NAUSEA; FATIGUE; DOESN''T FEEL LIKE HERSELF; This spontaneous report received from a patient concerned a 60 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: 204A21A, and batch number: 204A21A expiry: UNKNOWN) dose was not reported, administered on 12-MAY-2021 14:45 for prophylactic vaccination. No concomitant medications were reported. On MAY-2021, the subject experienced doesn''t feel like herself. On 13-MAY-2021, the subject experienced lightheaded. On 13-MAY-2021, the subject experienced headache that goes from neck around the skull, around face and hair area. On 13-MAY-2021, the subject experienced nausea. On 13-MAY-2021, the subject experienced fatigue. Treatment medications included: paracetamol. Additional treatment medications (dates unspecified) included: dimenhydrinate. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from nausea, and lightheaded, had not recovered from headache that goes from neck around the skull, around face and hair area, and fatigue, and the outcome of doesn''t feel like herself was not reported. This report was non-serious.


VAERS ID: 1322601 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Unknown  
Vaccinated:0000-00-00
Onset:2021-05-01
Submitted: 0000-00-00
Entered: 2021-05-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN UNKNOWN / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Chills, Nausea, Pain, Pyrexia
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Comments: Unknown
Allergies:
Diagnostic Lab Data:
CDC Split Type: USJNJFOC20210527439

Write-up: ACHY; CHILLS; FEVER; NAUSEOUS; This spontaneous report received from a parent via a company representative 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: Unk) dose was not reported, administered on 12-MAY-2021 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 MAY-2021, the subject experienced achy. On MAY-2021, the subject experienced chills. On MAY-2021, the subject experienced fever. On MAY-2021, the subject experienced nauseous. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the fever, chills, achy and nauseous was not reported. This report was non-serious.


VAERS ID: 1322602 (history)  
Form: Version 2.0  
Age: 23.0  
Sex: Unknown  
Location: Unknown  
Vaccinated:0000-00-00
Onset:2021-05-01
Submitted: 0000-00-00
Entered: 2021-05-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN UNKNOWN / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Chills, Restless legs syndrome, Tremor
SMQs:, Neuroleptic malignant syndrome (broad), Parkinson-like events (broad), Noninfectious encephalopathy/delirium (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Comments: Unknown
Allergies:
Diagnostic Lab Data:
CDC Split Type: USJNJFOC20210527453

Write-up: VIOLENT SHAKES; INTENSE RESTLESS LEGS SYNDROME; CHILLS; This spontaneous report received from a patient via a company representative concerned a 23 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) dose was not reported, administered on 12-MAY-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 MAY-2021, the subject experienced violent shakes. On MAY-2021, the subject experienced intense restless legs syndrome. On MAY-2021, the subject experienced chills. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the violent shakes, intense restless legs syndrome and chills was not reported. This report was non-serious.


VAERS ID: 1322794 (history)  
Form: Version 2.0  
Age: 25.0  
Sex: Female  
Location: Unknown  
Vaccinated:2021-04-13
Onset:2021-05-01
   Days after vaccination:18
Submitted: 0000-00-00
Entered: 2021-05-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK LA / SYR

Administered by: Unknown       Purchased by: ?
Symptoms: Heavy menstrual bleeding, Polymenorrhoea
SMQs:, Haemorrhage terms (excl laboratory terms) (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: Paroxetine
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Unusually heavy menstrual bleeding. Periods occurring frequently, only 5-9 days apart, with bleeding lasting up to eleven days. This is not normal for her.


VAERS ID: 1322935 (history)  
Form: Version 2.0  
Age: 28.0  
Sex: Male  
Location: Georgia  
Vaccinated:2021-04-02
Onset:2021-05-01
   Days after vaccination:29
Submitted: 0000-00-00
Entered: 2021-05-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 18786 / 1 LA / SYR

Administered by: Other       Purchased by: ?
Symptoms: Alopecia
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: None
Current Illness: None
Preexisting Conditions: None
Allergies: None
Diagnostic Lab Data: None
CDC Split Type:

Write-up: Hair loss, bald spot on head. No history of hair loss ever before


VAERS ID: 1323240 (history)  
Form: Version 2.0  
Age: 16.0  
Sex: Female  
Location: North Carolina  
Vaccinated:2021-05-11
Onset:2021-05-01
Submitted: 0000-00-00
Entered: 2021-05-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 003C21A / 2 RA / IM

Administered by: Public       Purchased by: ?
Symptoms: Inappropriate schedule of product administration, Incorrect dose administered, Interchange of vaccine products, 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:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: This was patient''s second dose vaccine. It should have been Pfizer, as her first vaccine administered was Pfizer. Pt is also 16 years old, which is not age approved for Moderna.


VAERS ID: 1323441 (history)  
Form: Version 2.0  
Age: 61.0  
Sex: Male  
Location: Virginia  
Vaccinated:2021-04-15
Onset:2021-05-01
   Days after vaccination:16
Submitted: 0000-00-00
Entered: 2021-05-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / IM

Administered by: Private       Purchased by: ?
Symptoms: Asthenia, Balance disorder, Blood test, Cerebrovascular accident, Computerised tomogram, Dysarthria, Gait disturbance, Magnetic resonance imaging head
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 (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? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Parkinson''s disease, diabetes, high blood pressure
Allergies: Latex
Diagnostic Lab Data: CT scan, MRI of the brain, bloodwork 5-2-21 through 5-5-21. Transferred to facility for rehabilitation.
CDC Split Type:

Write-up: Started with slurred speech, difficulty with balance, weakness on 5-1-21. Symptoms worsened on 5-2-21 with garbled speech, inability to walk without assistance, weakness. Admitted to hospital and was diagnosed with stroke.


VAERS ID: 1323630 (history)  
Form: Version 2.0  
Age: 41.0  
Sex: Female  
Location: Texas  
Vaccinated:2021-03-31
Onset:2021-05-01
   Days after vaccination:31
Submitted: 0000-00-00
Entered: 2021-05-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 1808609 / UNK - / -

Administered by: Private       Purchased by: ?
Symptoms: Blood test, Computerised tomogram, Diarrhoea, Dizziness, Ear infection, Fatigue, Headache, Loss of personal independence in daily activities, Nausea, Pharyngitis, Vomiting, X-ray
SMQs:, Acute pancreatitis (broad), Agranulocytosis (broad), Anticholinergic syndrome (broad), Dementia (broad), Pseudomembranous colitis (broad), Oropharyngeal infections (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Vestibular disorders (broad), Noninfectious diarrhoea (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? Yes
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Celecoxib Bupropion xl Baclofen
Current Illness: None
Preexisting Conditions: None
Allergies: Codiene Latex
Diagnostic Lab Data: X-rays, cat-scan, blood work
CDC Split Type:

Write-up: Ear infection Throat infection Nausea/vomiting Fatigue Diarrhea Then after antibiotics and Mucinex treatment with no improvements Severe headache sent me to ER with no findings other then doctors are thinking it is Viral meningitis that could be causing it. I am still having headache nausea and diarrhea and Almost passed out yesterday from cooking My activities are very light or I pass out.


VAERS ID: 1323645 (history)  
Form: Version 2.0  
Age: 50.0  
Sex: Female  
Location: Unknown  
Vaccinated:2021-04-16
Onset:2021-05-01
   Days after vaccination:15
Submitted: 0000-00-00
Entered: 2021-05-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0153 / 1 LA / IM

Administered by: Unknown       Purchased by: ?
Symptoms: Acute kidney injury, Back pain, Chest pain, Nausea, Vomiting
SMQs:, Rhabdomyolysis/myopathy (broad), Acute renal failure (narrow), Acute pancreatitis (broad), Retroperitoneal fibrosis (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (broad), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (broad), Toxic-septic shock conditions (broad), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Tumour lysis syndrome (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? Yes
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: N17.9 - Acute kidney failure, unspecified CHEST PAIN BACK PAIN NAUSEA VOMITING


VAERS ID: 1323748 (history)  
Form: Version 2.0  
Age: 41.0  
Sex: Female  
Location: California  
Vaccinated:2021-01-27
Onset:2021-05-01
   Days after vaccination:94
Submitted: 0000-00-00
Entered: 2021-05-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH GJ1686 / UNK AR / SYR

Administered by: Work       Purchased by: ?
Symptoms: Exposure during pregnancy, Prenatal screening test abnormal, Ultrasound scan abnormal
SMQs:, Malignancy related therapeutic and diagnostic procedures (narrow), Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Foetal disorders (narrow)

Life Threatening? No
Birth Defect? Yes
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Prenatal vitamins
Current Illness: None
Preexisting Conditions: None
Allergies: Avocados
Diagnostic Lab Data: On 4/19/21 I received my second trimester blood test for prenatal screening On 5/11/2021 I received an anatomy ultrasound by Dr.
CDC Split Type:

Write-up: At the time I received my 1st Pfizer vaccine I was pregnant. I recently found out my unborn child has a birth defect called spina bifida. I am 18 weeks pregnant and my due date is 10/18/2021.


VAERS ID: 1324544 (history)  
Form: Version 2.0  
Age: 22.0  
Sex: Female  
Location: California  
Vaccinated:2021-04-01
Onset:2021-05-01
   Days after vaccination:30
Submitted: 0000-00-00
Entered: 2021-05-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

Administered by: Unknown       Purchased by: ?
Symptoms: Vasculitis
SMQs:, Vasculitis (narrow), 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? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: None
Preexisting Conditions: None
Allergies: Tylenol
Diagnostic Lab Data: None
CDC Split Type:

Write-up: Vasculitis


VAERS ID: 1324556 (history)  
Form: Version 2.0  
Age: 30.0  
Sex: Male  
Location: Texas  
Vaccinated:2021-04-30
Onset:2021-05-01
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-05-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 207A21A / 1 LA / -

Administered by: Private       Purchased by: ?
Symptoms: Chest pain, Disorientation, Dizziness, Electrocardiogram abnormal, Headache, Heart rate increased, Nausea, Pyrexia
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (narrow), Arrhythmia related investigations, signs and symptoms (broad), Dementia (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Vestibular disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (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:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: cardiology has been requested as an EKG was performed and physician noticed an abnormality in the EKG report.
CDC Split Type:

Write-up: Symptoms began on 05/01/21 with fever, rapid heart rate, headache, chest pains, disorientation, nauseous and dizzy spells. I have kept a log of symptoms of when they occur, the time they occur and what the symptom is.


VAERS ID: 1325011 (history)  
Form: Version 2.0  
Age: 15.0  
Sex: Male  
Location: Unknown  
Vaccinated:2021-05-01
Onset:2021-05-01
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-05-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH UNKNOWN / UNK - / IM

Administered by: Unknown       Purchased by: ?
Symptoms: Product administered to patient of inappropriate age
SMQs:, Medication errors (narrow)

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

Write-up: at the time, patient was underage before the EUA changed age


VAERS ID: 1325441 (history)  
Form: Version 2.0  
Age: 59.0  
Sex: Female  
Location: New York  
Vaccinated:2021-05-15
Onset:2021-05-01
Submitted: 0000-00-00
Entered: 2021-05-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 LA / SYR

Administered by: School       Purchased by: ?
Symptoms: Chills, Feeling cold, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Arrhythmia related investigations, signs and symptoms (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Hypoglycaemia (broad)

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

Write-up: Uncontrollable shivering and freezing cold, 14 hours after shot. Fainting, 20 hours after shot.


VAERS ID: 1325898 (history)  
Form: Version 2.0  
Age: 67.0  
Sex: Male  
Location: Oregon  
Vaccinated:0000-00-00
Onset:2021-05-01
Submitted: 0000-00-00
Entered: 2021-05-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 1805018 / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Poor quality product administered
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: USJNJFOC20210530438

Write-up: VACCINE GIVEN NEXT DAY AFTER TEMPERATURE EXCURSION FROM 46.2-46.7F FOR ABOUT 31 MINUTES; This spontaneous report received from a health care professional concerned a 67 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 and batch number: 1805018 expiry: 25-MAY-2021) dose was not reported, administered on 13-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On MAY-2021, the subject experienced vaccine given next day after temperature excursion from 46.2-46.7f for about 31 minutes. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of vaccine given next day after temperature excursion from 46.2-46.7f for about 31 minutes was not reported. This report was non-serious.


VAERS ID: 1325899 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Unknown  
Vaccinated:0000-00-00
Onset:2021-05-01
Submitted: 0000-00-00
Entered: 2021-05-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN UNKNOWN / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Skin irritation
SMQs:

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: USJNJFOC20210530441

Write-up: ARM FELT IRRITATED LIKE SUNBURN; 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 08-MAY-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 MAY-2021, the subject experienced arm felt irritated like sunburn. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from arm felt irritated like sunburn on MAY-2021. This report was non-serious.


VAERS ID: 1325931 (history)  
Form: Version 2.0  
Age: 38.0  
Sex: Male  
Location: Pennsylvania  
Vaccinated:2021-04-23
Onset:2021-05-01
   Days after vaccination:8
Submitted: 0000-00-00
Entered: 2021-05-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 2 LA / SYR

Administered by: Private       Purchased by: ?
Symptoms: Blood pressure increased, Computerised tomogram normal, Head discomfort, Headache
SMQs:, Neuroleptic malignant syndrome (broad), 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? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Whey protein, vitamins
Current Illness:
Preexisting Conditions:
Allergies: Cipro
Diagnostic Lab Data: Ct scan was good
CDC Split Type:

Write-up: Severe sudden headache squeezing and vibrating of the brain, spikes blood pressure,dibilitizing headache. Gets headache when doing anything even peeing and ejaculating and just sleeping l. Tried two medications from doctor nothing helping. Please advise what to do.


VAERS ID: 1326099 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: New Jersey  
Vaccinated:0000-00-00
Onset:2021-05-01
Submitted: 0000-00-00
Entered: 2021-05-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 1805018 / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: SARS-CoV-2 antibody test, Therapy non-responder
SMQs:, Lack of efficacy/effect (narrow), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Comments: Unknown
Allergies:
Diagnostic Lab Data: Test Date: 202105; Test Name: SARS-CoV-2 IgG antibody test; Result Unstructured Data: Negative with a level of 5.87 when <12 is considered negative
CDC Split Type: USJNJFOC20210523786

Write-up: CONFIRMED IMMUNOLOGICAL VACCINE FAILURE; This spontaneous report received from a health care professional concerned a male of unspecified age, race and ethnicity. Initial information was processed along with the additional information received on 14-MAY-2021. 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: 1805018, and expiry: 25-MAY-2021) dose was not reported, 1 total administered on MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On MAY-2021, the patient experienced confirmed immunological vaccine failure. On MAY-2021, Laboratory data included: SARS-CoV-2 IgG antibody test (NR: not provided) Negative with a level of 5.87 when <12 is considered negative. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of confirmed immunological vaccine failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint: 90000179590.; Sender''s Comments: V0: 20210523786-covid-19 vaccine ad26.cov2.s-confirmed immunological vaccine failure. 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: SPECIAL SITUATIONS


VAERS ID: 1326102 (history)  
Form: Version 2.0  
Age: 63.0  
Sex: Male  
Location: Michigan  
Vaccinated:0000-00-00
Onset:2021-05-01
Submitted: 0000-00-00
Entered: 2021-05-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN UNKNOWN / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Blister, Blood pressure measurement, Body temperature increased, Cardiogenic shock, Chills, Diarrhoea, Hepatic function abnormal, Hypertension, Oxygen saturation, Pyrexia, Renal failure, SARS-CoV-2 test, Scan, White blood cell count, White blood cell disorder
SMQs:, Rhabdomyolysis/myopathy (broad), Acute renal failure (narrow), Cardiac failure (narrow), Liver related investigations, signs and symptoms (narrow), Severe cutaneous adverse reactions (broad), Haematopoietic leukopenia (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Retroperitoneal fibrosis (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), 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), Pseudomembranous colitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hypertension (narrow), Chronic kidney disease (narrow), Hypersensitivity (broad), Noninfectious diarrhoea (narrow), Tumour lysis syndrome (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), COVID-19 (broad)

Life Threatening? Yes
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 6 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Comments: Unknown
Allergies:
Diagnostic Lab Data: Test Date: 202105; Test Name: Blood pressure; Result Unstructured Data: 200/100 mmHg; Test Date: 202105; Test Name: Body temperature increased; Result Unstructured Data: 104 F; Test Date: 202105; Test Name: COVID-19 virus test; Result Unstructured Data: Negative; Test Date: 202105; Test Name: Oxygen saturation; Result Unstructured Data: Not good; Test Date: 202105; Test Name: WBC count; Result Unstructured Data: 16000; Test Date: 20210508; Test Name: Scan; Result Unstructured Data: No blockages were found
CDC Split Type: USJNJFOC20210525538

Write-up: DIARRHEA; CHILLS; UNBREAKABLE FEVER OF 104F; CARDIOGENIC SHOCK; KIDNEY FAILURE; IMPAIRED LIVER FUNCTION; HIGH BLOOD PRESSURE (200/100); ABNORMAL WHITE BLOOD CELL COUNT (16000); BLISTERS ON CONJUNCTIVA OF BOTH EYES; This spontaneous report received from a physician concerned a 63 year old white 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 administration not reported, batch number: Unknown) frequency one total, dose was not reported, administered on 07-MAY-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. The physician reported that one day after receiving vaccine, on 08-MAY-2021, the patient experienced nausea, vomiting, shortness of breath, diarrhea, fever, chills, sweats, and severe chest pain. The patient was admitted to hospital for suspicion of heart attack. He was checked and no blockages were found. Laboratory data included: Scan (NR: not provided) No blockages were found. On 10-MAY-2021, he was transferred to another hospital where he was currently on a ventilator. The doctor reported that he had had fever of 104 f that was unbreakable. His blood pressure was 200/100 mmHg and his pulse oxygen was not good. His white blood cell count was 16000 and he was tested negative for covid-19. The doctor also reported that patient was in cardiogenic shock and was in kidney failure. He reported that the patient''s liver function was getting better and patient''s face and chest was very red. The patient also had blisters on conjunctiva of both eyes. It was unknown where patient received the vaccine as of this time. No further information was available since doctor had patients to see. Laboratory data included: Blood pressure (NR: not provided) 200/100 mmHg, Covid-19 virus test (NR: not provided) Negative, Body temperature increased (NR: not provided) 104 f, Pulse Oxygen (NR: not provided) Not good, and White blood cell count (NR: not provided) 16000. The patient was admitted to the hospital on 08-MAY-2021 and the duration of hospitalization was 6 days. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from impaired liver function, had not recovered from blisters on conjunctiva of both eyes, kidney failure, abnormal white blood cell count (16000), high blood pressure (200/100), cardiogenic shock, and unbreakable fever of 104f, and the outcome of diarrhea and chills was not reported. This report was serious (Hospitalization Caused / Prolonged and Life Threatening).; Sender''s Comments: V0: 20210525538-covid-19 vaccine ad26.cov2.s-cardiogenic shock, kidney failure, impaired liver function, high blood pressure (200/100), abnormal white blood cell count (16000), blisters on conjunctiva of both eyes, diarrhea, chills, unbreakable fever of 104f. 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: 1326108 (history)  
Form: Version 2.0  
Age: 55.0  
Sex: Female  
Location: Texas  
Vaccinated:0000-00-00
Onset:2021-05-01
Submitted: 0000-00-00
Entered: 2021-05-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 203A21A / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Abdominal pain upper, Chills, Dizziness, Nausea, Pain, Pain in extremity, Palpitations, Pyrexia, Somnolence
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Dementia (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Vestibular disorders (broad), 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:
Current Illness:
Preexisting Conditions: Comments: Unknown
Allergies:
Diagnostic Lab Data:
CDC Split Type: USJNJFOC20210530824

Write-up: STOMACH CRAMPING; NAUSEA; VERY SLEEPY; ACHY EVERYWHERE; SORE ARM; CHILLS; DIZZINESS; HEART RACING; FEVER; 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: 203A21A, expiry: UNKNOWN) dose was not reported, administered on 11-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On MAY-2021, the subject experienced dizziness. On MAY-2021, the subject experienced heart racing. On MAY-2021, the subject experienced fever. On 11-MAY-2021, the subject experienced very sleepy. On 11-MAY-2021, the subject experienced achy everywhere. On 11-MAY-2021, the subject experienced sore arm. On 11-MAY-2021, the subject experienced chills. On 14-MAY-2021, the subject experienced stomach cramping. On 14-MAY-2021, the subject experienced nausea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from very sleepy on 15-MAY-2021, and dizziness, heart racing, nausea, and fever on MAY-2021, and had not recovered from achy everywhere, chills, stomach cramping, and sore arm. This report was non-serious.


VAERS ID: 1326122 (history)  
Form: Version 2.0  
Age: 66.0  
Sex: Female  
Location: South Carolina  
Vaccinated:2021-05-01
Onset:2021-05-01
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-05-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK LA / -

Administered by: Unknown       Purchased by: ?
Symptoms: Asthma, Back pain, Blood cholesterol, Blood pressure increased, Blood pressure measurement, Blood test, Chest discomfort, Chest pain, Dyspnoea, Feeling abnormal, Gastrooesophageal reflux disease, Laboratory test, Malaise, Pain, Wheezing
SMQs:, Anaphylactic reaction (broad), Angioedema (broad), Asthma/bronchospasm (narrow), Neuroleptic malignant syndrome (broad), Retroperitoneal fibrosis (broad), Dementia (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Gastrointestinal nonspecific dysfunction (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Hypertension (narrow), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Hypersensitivity (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: Acid reflux (esophageal); Asthma; Heart disorder; Hiatal hernia; Hypersensitivity
Allergies:
Diagnostic Lab Data: Test Name: cholesterol; Result Unstructured Data: Test Result:unknown results; Test Date: 20210501; Test Name: blood pressure; Result Unstructured Data: Test Result:up to like 185 over 186; Test Name: routine blood work; Result Unstructured Data: Test Result:unknown results; Test Name: lab test; Result Unstructured Data: Test Result:unknown results
CDC Split Type: USPFIZER INC2021488055

Write-up: Heaviness in Breathing/breathing problems; felt different; not feeling good; Aggravated Asthma; horrible acid reflux/ Aggravated Acid reflux; was in pain last night/she was really hurting; blood pressure was sort of up to like 185 over 186; Chest pain; back for stabbing pain; Pressure chest; Wheezy; This is a spontaneous report received a contactable consumer (the patient). A 66-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number not reported), via unspecified route of administration in the left arm on 01May2021 (at the age of 66 years-old) as a single dose for COVID-19 immunization. The patient''s medical history included a "heart condition", asthma, acid reflux, hiatal hernia, and being "allergic to a lot of medications", reporting that she previously had to carry an epinephrine (EPIPEN). The patient had unspecified concomitant medications. The patient stated that immediately after the first dose, she started not feeling good (01May2021), and by the time she got home, she was really having some breathing problems (01May2021). She was monitored at the vaccination site for 30 minutes after administration, but did not report to them, because she did not know what to tell them. She a history of asthma, so she treated with her inhalers, and "it eased off a little bit". She reported she was really hurting, so she took a 5 mg dose of prednisone tablet. She also reported horrible acid reflux later that night (01May2021), which can trigger her asthma, she took some aluminum hydroxide/ magnesium hydroxide/ simethicone MYLANTA and felt much better. She slept propped up, took another dose of MYLANTA this morning, and was feeling better today, but not 100%. She wanted to know if the vaccine can cause acid reflux or asthma exacerbations? And if she should expect the same, but more severe reactions after the second dose? It was also reported, that after the vaccine, the patient stated for fifty minutes maybe she had what was like pressure in her chest (unspecified date May2021). She did not know what she was feeling, so she did not say anything. So she came home, and just as the day got work more the pressure, she had asthma and saw what was happening was an asthma attack, which started hurting really bad like an asthma attack, so she took her inhalers, and it eased it off a little bit. Then it just kept worsening. She was also a heart patient, so when she had asthma, some times it mimicked a chest pain. She was thinking if it was affecting chest pain or was it asthma, so had some prednisone, 5mg of prednisone (treatment) that she had to take for her asthma. It did not help last night (further clarification unknown). She was trying to get to the hospital. She was wondering if this shot had aggravated her acid reflux and aggravated her asthma (both 01May2021). When the patient went to bed, she got some aluminum oxide/ magnesium hydroxide (MAALOX), big dose of MYLANTA, and that eased it off. Before she got the shot, she felt fine; she would have no symptoms, and then when she got the shot "mean it went 30 minutes later and I just felt this and I still did not know what it was". Her husband told her to sit down. She did not know what was wrong, she just felt different. She thought it caused her asthma to act up. The patient stated that last night (01May2021), her blood pressure was sort of up to like 185 over 186, "but I think it was because I am extreme so bad by then I am and my chest in my chest and then I finally said okay let me take so (incomplete sentence) my acid reflux so let me take some MYLANTA so I take calcium carbonate/ magnesium hydroxide (ROLAIDS) and I immediately stop that pain that must be my acid reflux making triggering my asthma it is, I was like, I was in pain last night (01May2021), just administered for my asthma between my chest and my back for stabbing pain (01May2021) and that caused sometimes when I have heart condition, I always like it is my heart or it is my asthma what is it? and I got this one okay I will take a dose of MYLANTA just to make sure see that will help come down". The patient felt a lot better today, but still felt sort of wheezy (May2021) "like you know when you have asthma". Her bad asthma she would just get a wheezy sort of just heaviness in breathing. The patient was due to get the second shot on 22May2021. On an unspecified date, the patient had: a lab test "but have results before I had the following to chest by giving lastly", and routine blood work-cholesterol and all. The outcome of the events wheezy, heaviness in breathing/ breathing problems, horrible acid reflux/ aggravated acid reflux was recovering. The outcome of other events was unknown. Information about lot number has been requested.


VAERS ID: 1326130 (history)  
Form: Version 2.0  
Age: 17.0  
Sex: Male  
Location: Florida  
Vaccinated:2021-04-28
Onset:2021-05-01
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-05-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0171 / 1 LA / -

Administered by: Unknown       Purchased by: ?
Symptoms: Biopsy, Disease recurrence, IgA nephropathy, Urine analysis
SMQs:, Systemic lupus erythematosus (broad), Chronic kidney disease (broad), Immune-mediated/autoimmune disorders (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: ENALAPRIL
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: IgA nephropathy
Allergies:
Diagnostic Lab Data: Test Date: 201908; Test Name: biopsy; Result Unstructured Data: Test Result:IGa Nephropathy; Test Date: 20210501; Test Name: urine test; Result Unstructured Data: Test Result:large amounts of blood and protein; Comments: His urine was bright red
CDC Split Type: USPFIZER INC2021492224

Write-up: Diagnoses with IGa Nephropathy in Aug2019 / 2 days after taking the vaccine it triggered his symptoms; Diagnoses with IGa Nephropathy in Aug2019 / 2 days after taking the vaccine it triggered his symptoms; This is a spontaneous report from a contactable consumer. A 17-year-old male patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration in left arm at age of 17-years, on 28Apr2021 16:00 (Lot Number: EW0171) as single dose for COVID-19 immunisation. Medical history included IgA nephropathy from Aug2019. Concomitant medication included enalapril (received within 2 weeks of vaccination). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was diagnosed with IgA Nephropathy in Aug2019 - dx confirmed through biopsy. 2 days after taking the vaccine it triggered his symptoms of large amounts of blood and protein in his urine. His urine was bright red. Labs were ordered by his nephrologist and would be done today (on 03May2021). The adverse event result in "Doctor or other healthcare professional office/clinic visit". Adverse event started at 18:30 on 01May2021. There was no treatment for events. The patient did not diagnose with COVID-19 prior to vaccination and not test for COVID-19 since the vaccination. Events outcome was not recovered.


VAERS ID: 1326155 (history)  
Form: Version 2.0  
Age: 21.0  
Sex: Male  
Location: California  
Vaccinated:2021-04-29
Onset:2021-05-01
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-05-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Unknown       Purchased by: ?
Symptoms: Myocarditis, Pericarditis
SMQs:, Systemic lupus erythematosus (broad), Cardiomyopathy (broad), Chronic kidney disease (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Immune-mediated/autoimmune disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: PFIZER INC2021494277

Write-up: acute myocarditis; Pericarditis; This is a spontaneous report from a contactable a physician. A 21-year-old male patient started to receive 2nd dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, LOT/Batch number and expiration date unknown) via an unspecified route of administration on 29Apr2021 at age of 21-year-old at single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. Patient previously received 1st dose of BNT162B2 on an unspecified date for COVID-19 immunization. Prior to vaccination, the patient wasn''t diagnosed with COVID-19. Since the vaccination, the patient hasn''t been tested for COVID-19. Acute myocarditis/pericarditis started on 01May2021, 2 days post vaccination, diagnosed on 03May2021, 4 days post vaccination (second dose vaccine). The events resulted in emergency room/department or urgent care visit. Events were serious as hospitalization. Patient received anti inflammatory medications for the events. Outcome of the events was unknown. Information on the lot/batch number has been requested.; Sender''s Comments: A possible contributory effect of suspect BNT162B2 on reported events cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.


VAERS ID: 1326198 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Connecticut  
Vaccinated:2021-01-01
Onset:2021-05-01
   Days after vaccination:120
Submitted: 0000-00-00
Entered: 2021-05-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Unknown       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: 20210501; Test Name: COVID-19; Test Result: Positive
CDC Split Type: USPFIZER INC2021504094

Write-up: Received first and second doses of BNT162B2; tested positive for COVID-19; Received first and second doses of BNT162B2; tested positive for COVID-19; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number was not reported), via an unspecified route of administration, in Dec2020 as first dose, single, and then in Jan2021 as second dose, single, for COVID-19 immunization. The patient''s medical history and concomitant medications were not reported. The patient received the vaccine, the first dose in Dec2020 and the second dose in Jan2021. It is now May2021. On 01May2021, the patient tested positive for COVID-19. The patient was not sure where he/she should report this, but the patient believed this is important for further development for the science. The outcome of the events was unknown. Information about lot number and expiration date for the suspect product will be requested in follow-up attempts.


VAERS ID: 1326206 (history)  
Form: Version 2.0  
Age: 51.0  
Sex: Male  
Location: Connecticut  
Vaccinated:2021-05-01
Onset:2021-05-01
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-05-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0171 / 1 - / -

Administered by: Unknown       Purchased by: ?
Symptoms: Blood test, Faeces discoloured, Somnolence, Stool DNA test
SMQs:, Anticholinergic syndrome (broad), Dementia (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Noninfectious diarrhoea (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: FENOFIBRATE; METFORMIN; GABAPENTIN; LOSARTAN; JARDIANCE; JANUVIA [SITAGLIPTIN PHOSPHATE]; ATORVASTATIN; FISH OIL; GLIMEPIRIDE; ASPIRIN CHILDREN
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Back disorder; Blood pressure high (Verbatim: High blood pressure); Diabetic (Verbatim: Diabetic); High cholesterol (Verbatim: High cholesterol)
Allergies:
Diagnostic Lab Data: Test Name: Blood work; Result Unstructured Data: Test Result:Unknown Results; Test Name: cologuard test; Test Result: Positive ; Comments: I had a Cologuard test recently. And the test came back positive
CDC Split Type: USPFIZER INC2021504615

Write-up: he had bowel movement and it came out red; feeling drowsy from the shot; This is a spontaneous report from a contactable consumer (patient) reported for himself. A 51-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EW0171) via an unspecified route of administration on 01May2021 13:00 at first dose, single for covid-19 immunisation. Medical history included Diabetes mellitus, High blood pressure, Blood cholesterol increased, back disorder. Concomitant medications included fenofibrate; metformin; gabapentin for his back; losartan; empagliflozin (JARDIANCE); sitagliptin phosphate (JANUVIA [SITAGLIPTIN PHOSPHATE]); atorvastatin; fish oil; glimepiride, acetylsalicylic acid (ASPIRIN CHILDREN) (St. Joseph Children Aspirin) and multivitamin once a day. patient stated he went to get the first vaccine shot yesterday around 1 O''clock in the afternoon and then late at night on around 8 O''clock he had bowel movement and it came out red and that''s never happened to him before. And he have been feeling kind of, every time he sit up for he go for a walk he feel drowsy. He was still, its the next day and he was still feeling drowsy from the shot. He went through this pamphlet they gave him after the shot and it didn''t say anything about having any effects on his bowel movement. he want to know if there is something he should worry about. Consumer stated, Blood work was couple of months before. He had a Cologuard test recently. And the test came back positive. He called last night when he was on the phone for like almost two hours and nobody picked up and he felt asleep. No treatment received for the events. Outcome of feeling drowsy from the shot was not recovered and outcome of the other event was unknown. No Follow-up needed; information about lot/batch no. cannot be obtained. No further information is expected.


VAERS ID: 1326603 (history)  
Form: Version 2.0  
Age: 25.0  
Sex: Female  
Location: Unknown  
Vaccinated:2021-05-01
Onset:2021-05-01
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-05-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 LA / IM

Administered by: Unknown       Purchased by: ?
Symptoms: Pyrexia, Rhinorrhoea
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:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: After vaccine had 24 hours of fever and runny nose.


VAERS ID: 1326632 (history)  
Form: Version 2.0  
Age: 48.0  
Sex: Male  
Location: Michigan  
Vaccinated:2021-04-30
Onset:2021-05-01
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-05-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 2 LA / SYR

Administered by: Work       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: Testosterone, Cabergoline
Current Illness: None
Preexisting Conditions: None
Allergies: None
Diagnostic Lab Data:
CDC Split Type:

Write-up: Tinnitus in both ears.


VAERS ID: 1326824 (history)  
Form: Version 2.0  
Age: 47.0  
Sex: Female  
Location: Florida  
Vaccinated:2021-04-09
Onset:2021-05-01
   Days after vaccination:22
Submitted: 0000-00-00
Entered: 2021-05-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 043A21A / 1 LA / SYR

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

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: Levonorgestrel and Ethinyl Estradiol (birth control)- taken for 6 days prior to adverse affects
Current Illness: none
Preexisting Conditions: none
Allergies: none
Diagnostic Lab Data: Ultrasound and CT
CDC Split Type:

Write-up: 3 weeks plus 1 day following vaccine, i developed pain in my left calf. After having an ultrasound, two blood clots were discovered in my left leg (one DTV and one superficial). I was sent to the ER, a CT was performed, blood work was taken, and I was sent home with a prescription for Xarelto blood thinner. I have to be on this for 3 months, and we will evaluate to make sure I''m no longer at risk. My medical bills for the date of 5/3/21 were over $11,000, and my portion so far is over $3300 after insurance.


VAERS ID: 1326938 (history)  
Form: Version 2.0  
Age: 49.0  
Sex: Female  
Location: New Hampshire  
Vaccinated:2021-04-10
Onset:2021-05-01
   Days after vaccination:21
Submitted: 0000-00-00
Entered: 2021-05-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 202A21A / 1 RA / IM

Administered by: Other       Purchased by: ?
Symptoms: Hypoaesthesia, Loss of personal independence in daily activities, Muscle spasms, Pain in extremity, Paraesthesia, Vertigo
SMQs:, Peripheral neuropathy (broad), Dementia (broad), Dystonia (broad), Guillain-Barre syndrome (broad), Vestibular disorders (narrow), Tendinopathies and ligament disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Omeprazole, tylenol
Current Illness: None
Preexisting Conditions: GERD
Allergies: None known
Diagnostic Lab Data: I have seen my primary care physician, Dr. and I am awaiting a referral and appointment scheduling to a neurologist.
CDC Split Type:

Write-up: Three weeks after vaccination woke up with aching pain in legs and feet. Within 48 hours it progressed to roaming pain in arms, legs, hands, and feet which includes general aching pain, occasional muscle cramp, numb sensations that come and go - hours at a time, some tingling, very significant pain in feet when trying to walk barefoot on sand. About 10 or 11 days after that onset, I developed vertigo, having the feeling of being tipped to the left nearly constantly. Symptoms are interfering with my ability to go about daily activities, slowing me down, especially the vertigo. The pain persists even in the night. It has been 18 days with no improvement and I am waiting for an appointment with a neurologist.


VAERS ID: 1327119 (history)  
Form: Version 2.0  
Age: 37.0  
Sex: Male  
Location: New Hampshire  
Vaccinated:2021-05-01
Onset:2021-05-01
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-05-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 042B212A / 1 LA / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: Malaise, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Arrhythmia related investigations, signs and symptoms (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Amolodipine 5mg
Current Illness:
Preexisting Conditions: High blood pressure
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: I fainted while sitting in the chair about 5 minutes or less after the shot. I felt myself not feeling well immediately after the shot.


VAERS ID: 1327382 (history)  
Form: Version 2.0  
Age: 71.0  
Sex: Male  
Location: Georgia  
Vaccinated:2021-03-12
Onset:2021-05-01
   Days after vaccination:50
Submitted: 0000-00-00
Entered: 2021-05-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 026A21A / 1 UN / IM
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 0191521A / 2 UN / IM

Administered by: Private       Purchased by: ?
Symptoms: Dizziness, Dyspnoea, Fatigue, Nausea
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Anticholinergic syndrome (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Vestibular disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 4 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Diabetes Mellitus Cardiovascular disease Hypertension
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Hospitalization: PT WITH SOB, FATIGUE, LIGHTHEADED OVER PAST MONTH. STATES NAUSEA, NO VOMITING/DIARRHEA/FEVER. SYMPTOMS STARTED AFTER 1ST COVID VACCINE, IMPROVED AND RETURNED AFTER 2ND COVID SHOT ON 4/9


VAERS ID: 1327812 (history)  
Form: Version 2.0  
Age: 17.0  
Sex: Female  
Location: Wisconsin  
Vaccinated:2021-05-01
Onset:2021-05-01
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-05-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0179 / 2 LA / IM

Administered by: Public       Purchased by: ?
Symptoms: Inappropriate schedule of product administration
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: Given too early


VAERS ID: 1328997 (history)  
Form: Version 2.0  
Age: 25.0  
Sex: Female  
Location: Arizona  
Vaccinated:2021-05-01
Onset:2021-05-01
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-05-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW 0179 / 1 LA / SYR

Administered by: Work       Purchased by: ?
Symptoms: Hypoaesthesia, Injection site pain
SMQs:, Peripheral neuropathy (broad), Guillain-Barre syndrome (broad), Extravasation events (injections, infusions and implants) (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: depo-provera
Current Illness: N/A
Preexisting Conditions: N/A
Allergies: Benadryl, amoxicillin
Diagnostic Lab Data:
CDC Split Type:

Write-up: About an hour after receiving the vaccine my left leg and left arm were numb. The numbness continued for at least an hour before I fell asleep for the day and the numbness on my left side was gone. Only the expected arm soreness around the shot remained.


VAERS ID: 1329096 (history)  
Form: Version 2.0  
Age: 21.0  
Sex: Female  
Location: Virginia  
Vaccinated:0000-00-00
Onset:2021-05-01
Submitted: 0000-00-00
Entered: 2021-05-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 203A21A / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Dysphagia, Fatigue, Headache, Hypoaesthesia oral, Insomnia, Nasopharyngitis, Neck pain, Odynophagia, Pharyngeal swelling, Swelling
SMQs:, Anaphylactic reaction (narrow), Angioedema (narrow), Anticholinergic syndrome (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (narrow), Arthritis (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:
CDC Split Type: USJNJFOC20210529708

Write-up: LEFT SIDE LIPS NUMBNESS; LEFT SIDE OF NECK AREA HURTS; THROAT SWELLING; SWOLLEN LEFT SIDE OF THE NECK; HARD TIME TO SWALLOW; COLD; TIRED; HEADACHES; DIDN''T SLEEP VERY WELL; SWALLOWING HURTS A LOT; This spontaneous report received from a patient concerned a 21 year old female. The patient''s height, and weight were not reported. The patient''s pre-existing medical conditions included unknown.The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: 203A21A, and batch number: 203A21A expiry: UNKNOWN) dose was not reported, administered on 12-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On MAY-2021, the subject experienced swallowing hurts a lot. On 12-MAY-2021, the subject experienced didn''t sleep very well. On 12-MAY-2021, the subject experienced tired. On 12-MAY-2021, the subject experienced headaches. On 13-MAY-2021, the subject experienced cold. On 14-MAY-2021, the subject experienced throat swelling. On 14-MAY-2021, the subject experienced hard time to swallow. On 14-MAY-2021, the subject experienced left side of neck area hurts. On 14-MAY-2021, the subject experienced swollen left side of the neck. On 15-MAY-2021, the subject experienced left side lips numbness. The action taken with covid-19 vaccine was not applicable. The patient recovered from didn''t sleep very well, and cold on MAY-2021, tired on 12-MAY-2021, and headaches on 13-MAY-2021, and had not recovered from throat swelling, hard time to swallow, left side lips numbness, left side of neck area hurts, swallowing hurts a lot, and swollen left side of the neck. This report was non-serious.


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