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

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



Case Details (Reverse Sorted by Onset Date)

This is page 86 out of 1,889

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VAERS ID: 1249231 (history)  
Form: Version 2.0  
Age: 67.0  
Sex: Female  
Location: Virginia  
Vaccinated:0000-00-00
Onset:2021-04-10
Submitted: 0000-00-00
Entered: 2021-04-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 042A21A / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Injection site bruising, Injection site pain
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Extravasation events (injections, infusions and implants) (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: Arthritis; Penicillin allergy; Sulfonamide allergy
Preexisting Conditions: Medical History/Concurrent Conditions: Overweight
Allergies:
Diagnostic Lab Data:
CDC Split Type: USJNJFOC20210426947

Write-up: TINY BRUISE AT RIGHT ARM AT INJECTION SITE; RIGHT ARM AT INJECTION SITE HURTING AND IT IS HOT; This spontaneous report received from a patient concerned a 67 year old female. The patient''s height, and weight were not reported. The patient''s past medical history included overweight, and concurrent conditions included arthritis, penicillin allergy, and sulfa drug allergy. The patient experienced drug allergy when treated with sulfamethoxazole/trimethoprim, and morphine. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 042A21A expiry: UNKNOWN) dose was not reported, administered on 10-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 10-APR-2021, the subject experienced tiny bruise at right arm at injection site. On 10-APR-2021, the subject experienced right arm at injection site hurting and it is hot. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from tiny bruise at right arm at injection site, and right arm at injection site hurting and it is hot. This report was non-serious.


VAERS ID: 1249287 (history)  
Form: Version 2.0  
Age: 37.0  
Sex: Female  
Location: California  
Vaccinated:0000-00-00
Onset:2021-04-10
Submitted: 0000-00-00
Entered: 2021-04-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 043A21A / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Back pain, Breast pain, Pain in extremity
SMQs:, Retroperitoneal fibrosis (broad), Lipodystrophy (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: The patient have no known drug allergies
Allergies:
Diagnostic Lab Data:
CDC Split Type: USJNJFOC20210431774

Write-up: LEFT BREAST OR CHEST PAIN/BURNING; BACK PAIN; BILATERAL LEG PAIN; This spontaneous report received from a patient concerned a 37 year old female. The patient''s height, and weight were not reported. The patient''s pre-existing medical conditions included the patient have no known drug allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 043A21A, expiry: UNKNOWN) dose was not reported, administered on 08-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 10-APR-2021, the subject experienced left breast or chest pain/burning. On 10-APR-2021, the subject experienced back pain. On 10-APR-2021, the subject experienced bilateral leg pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from bilateral leg pain, left breast or chest pain/burning, and back pain. This report was non-serious.; Sender''s Comments: V0:As per standard protocol, MAC comment is not required for non-serious cases.


VAERS ID: 1249413 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Utah  
Vaccinated:0000-00-00
Onset:2021-04-10
Submitted: 0000-00-00
Entered: 2021-04-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / 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? 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: USJNJFOC20210438350

Write-up: PAIN IN ARM AND PAIN IN LEFT LEG; This spontaneous report received from a consumer 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: unknown) dose was not reported, administered on 10-APR-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On 10-APR-2021, the subject experienced pain in arm and pain in left leg. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of pain in arm and pain in left leg was not reported. This report was non-serious.


VAERS ID: 1249499 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Pennsylvania  
Vaccinated:0000-00-00
Onset:2021-04-10
Submitted: 0000-00-00
Entered: 2021-04-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 202A21A / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Heart rate, Heart rate increased
SMQs:, Neuroleptic malignant syndrome (broad), Arrhythmia related investigations, signs and symptoms (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: Gout; High cholesterol; Hypothyroidism; Penicillin allergy
Preexisting Conditions: Comments: Unknown
Allergies:
Diagnostic Lab Data: Test Date: 202104; Test Name: Heart rate; Result Unstructured Data: Fluctuates around mid 90s in the afternoon and nights; Test Date: 20210410; Test Name: Heart rate increased; Result Unstructured Data: 115 beats per minute
CDC Split Type: USJNJFOC20210442494

Write-up: HEART RATE INCREASED; This spontaneous report received from a patient concerned a 64 year old male. The patient''s height, and weight were not reported. The patient''s concurrent conditions included high cholesterol, hypothyroid, gout, and penicillin allergy. 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 10-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, Laboratory data included: Heart rate (NR: not provided) Fluctuates around mid 90s in the afternoon and nights. On 10-APR-2021, the subject experienced heart rate increased. Laboratory data included: Heart rate increased (NR: not provided) 115 beats per minute. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from heart rate increased. This report was non-serious.; Sender''s Comments: V0:Medical assessment comment not required as per standard procedure as case assessed as non serious.


VAERS ID: 1249535 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Unknown  
Vaccinated:0000-00-00
Onset:2021-04-10
Submitted: 0000-00-00
Entered: 2021-04-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 043A21A / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Asthenia, Bone pain, Bronchitis, Chest X-ray, Influenza like illness, Nasal oedema, SARS-CoV-2 test
SMQs:, Angioedema (broad), Guillain-Barre syndrome (broad), Osteonecrosis (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: LUPRON DEPOT
Current Illness:
Preexisting Conditions: Comments: Unknown
Allergies:
Diagnostic Lab Data: Test Date: 20210415; Test Name: Chest X-ray; Result Unstructured Data: bronchitis; Test Date: 20210415; Test Name: COVID-19 virus test; Result Unstructured Data: negative
CDC Split Type: USJNJFOC20210443557

Write-up: BRONCHITIS; WEAKNESS THROUGHOUT ENTIRE BODY; RIGHT NOSE SWELLED; BONES BEGAN TO ACHE; FLU LIKE SYMPTOMS; This spontaneous report received from a patient concerned a 38 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: 043A21A expiry: UNKNOWN) dose was not reported, administered on 09-APR-2021 for prophylactic vaccination. Concomitant medications included leuprorelin acetate. On 10-APR-2021, the subject experienced flu like symptoms. On 12-APR-2021, the subject experienced bones began to ache. On 13-APR-2021, the subject experienced right nose swelled. On 14-APR-2021, the subject experienced bronchitis. On 14-APR-2021, the subject experienced weakness throughout entire body. On 15-APR-2021, Laboratory data included: COVID-19 virus test (NR: not provided) negative, and Chest X-ray (NR: not provided) bronchitis. Treatment medications (dates unspecified) included: salbutamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from bronchitis, and the outcome of bones began to ache, right nose swelled, weakness throughout entire body and flu like symptoms was not reported. This report was non-serious.


VAERS ID: 1249555 (history)  
Form: Version 2.0  
Age: 82.0  
Sex: Female  
Location: Arizona  
Vaccinated:2021-03-08
Onset:2021-04-10
   Days after vaccination:33
Submitted: 0000-00-00
Entered: 2021-04-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 032M20A / 1 - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Abdominal pain upper, Hepatic enzyme increased, Laboratory test
SMQs:, Liver related investigations, signs and symptoms (narrow), Acute pancreatitis (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? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: COVID-19 (in Nov or Dec 2020)
Allergies:
Diagnostic Lab Data: Test Date: 20210410; Test Name: laboratory test; Result Unstructured Data: elevated liver enzymes
CDC Split Type: USMODERNATX, INC.MOD20210

Write-up: elevated/abnormal liver enzymes; epigastric pain; This spontaneous case was reported by a nurse (subsequently medically confirmed) and describes the occurrence of HEPATIC ENZYME INCREASED (elevated/abnormal liver enzymes) and ABDOMINAL PAIN UPPER (epigastric pain) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 027B21A and 032M20A) for COVID-19 vaccination. The patient''s past medical history included COVID-19 (in Nov or Dec 2020) in 2020. On 08-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 10-Apr-2021, the patient experienced HEPATIC ENZYME INCREASED (elevated/abnormal liver enzymes) (seriousness criterion hospitalization) and ABDOMINAL PAIN UPPER (epigastric pain) (seriousness criterion hospitalization). The patient was hospitalized on 10-Apr-2021 due to ABDOMINAL PAIN UPPER and HEPATIC ENZYME INCREASED. At the time of the report, HEPATIC ENZYME INCREASED (elevated/abnormal liver enzymes) and ABDOMINAL PAIN UPPER (epigastric pain) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 10-Apr-2021, Laboratory test: elevated lver enzymes (High) elevated liver enzymes. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Concomitant product use was not provided. On 10 Apr 2021, the patient visited a hospital with epigastric pain. Diagnostic testing revealed elevated liver enzymes. The patient was transferred to a different medical center due to the abnormal liver enzymes and admitted for more diagnostic testing. Diagnostic tests at this medical center also revealed elevated liver enzymes. Treatment information was not provided. Very limited information regarding these events has been provided at this time. Further information has been requested.; Sender''s Comments: Very limited information regarding these events has been provided at this time. Further information has been requested.


VAERS ID: 1249599 (history)  
Form: Version 2.0  
Age: 59.0  
Sex: Female  
Location: California  
Vaccinated:2021-04-09
Onset:2021-04-10
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-04-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 042A21A / 1 LA / SYR

Administered by: Pharmacy       Purchased by: ?
Symptoms: Blood creatinine increased, Eye pain, Full blood count, Headache, Metabolic function test, Prothrombin time normal
SMQs:, Rhabdomyolysis/myopathy (broad), Acute renal failure (broad), Retroperitoneal fibrosis (broad), Glaucoma (broad), Chronic kidney disease (broad), Tumour lysis 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? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Lumegin
Current Illness: None
Preexisting Conditions: Asthma
Allergies: Betadine
Diagnostic Lab Data: Cbc, cmp, prothombin time all normal. Except bun creatinine ration high.
CDC Split Type:

Write-up: Bad headache day after shot. Then headache came and went, not too bad until 4.21.21. Sharp pain behind right eye. Dr ran labs, and all look ok. But today, 2 weeks to the day of shot, my headache came roaring back ad bad as day 1. Most pain is behind forehead and eyes. Finally took advil...But pain is not gone. Worst pain is behind right eye. I''ve never had migraines before. I''m tired of the pain.


VAERS ID: 1249622 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Minnesota  
Vaccinated:2021-03-23
Onset:2021-04-10
   Days after vaccination:18
Submitted: 0000-00-00
Entered: 2021-04-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 - / -

Administered by: Unknown       Purchased by: ?
Symptoms: Chest pain, Dyspnoea, Nausea, SARS-CoV-2 test, SARS-CoV-2 test negative, SARS-CoV-2 test positive, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Acute pancreatitis (broad), Arrhythmia related investigations, signs and symptoms (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Hypoglycaemia (broad), Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: STATIN [ATORVASTATIN CALCIUM]; PLAVIX; MULTIVITAMIN [VITAMINS NOS]
Current Illness: Drug therapy (patient was on heart medications); Drug therapy (patient was on antibiotic)
Preexisting Conditions: Medical History/Concurrent Conditions: Atherosclerosis (blockage of artery was noted.); Heart disease, unspecified
Allergies:
Diagnostic Lab Data: Test Date: 20210410; Test Name: SARS-CoV-2; Test Result: Positive ; Test Date: 20210414; Test Name: SARS-CoV-2; Test Result: Negative
CDC Split Type: USMODERNATX, INC.MOD20210

Write-up: Negative COVID test; nausea; passed out; chest pain; shortness of breath; Tested positive for COVID; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of SYNCOPE (passed out) in a 77-year-old male patient who received mRNA-1273 for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient''s past medical history included Heart disease, unspecified and Atherosclerosis (blockage of artery was noted.). Concurrent medical conditions included Drug therapy (patient was on heart medications) and Drug therapy (patient was on antibiotic). Concomitant products included ATORVASTATIN CALCIUM (STATIN [ATORVASTATIN CALCIUM]), CLOPIDOGREL BISULFATE (PLAVIX) and MULTIVITAMIN [VITAMINS NOS] for an unknown indication. On 23-Mar-2021, the patient received first dose of mRNA-1273 (unknown route) 1 dosage form. On 10-Apr-2021, the patient experienced SYNCOPE (passed out) (seriousness criterion medically significant), CHEST PAIN (chest pain), DYSPNOEA (shortness of breath), SARS-COV-2 TEST POSITIVE (Tested positive for COVID) and NAUSEA (nausea). On an unknown date, the patient experienced SARS-COV-2 TEST NEGATIVE (Negative COVID test). At the time of the report, SYNCOPE (passed out), CHEST PAIN (chest pain), DYSPNOEA (shortness of breath), SARS-COV-2 TEST POSITIVE (Tested positive for COVID), SARS-COV-2 TEST NEGATIVE (Negative COVID test) and NAUSEA (nausea) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 10-Apr-2021, SARS-CoV-2 test: positive Positive. On 14-Apr-2021, SARS-CoV-2 test: negative Negative. The action taken with mRNA-1273 (Unknown Route) was unknown. This case concerns a 77-year-old male with a serious unexpected event of syncope, and nonserious unexpected chest pain, dyspnea, and expected nausea. SARS-CoV-2 test positive. Treatment with Regeneron antibodies. Event onset 19 days after first dose mRNA-1273. Event outcomes unknown. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.; Sender''s Comments: This case concerns a 77-year-old male with a serious unexpected event of syncope, and nonserious unexpected chest pain, dyspnea, and expected nausea. SARS-CoV-2 test positive. Treatment with Regeneron antibodies. Event onset 19 days after first dose mRNA-1273. Event outcomes unknown. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.


VAERS ID: 1249707 (history)  
Form: Version 2.0  
Age: 60.0  
Sex: Male  
Location: Massachusetts  
Vaccinated:2021-04-02
Onset:2021-04-10
   Days after vaccination:8
Submitted: 0000-00-00
Entered: 2021-04-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 1808978 / 1 LA / IM

Administered by: Unknown       Purchased by: ?
Symptoms: Abdominal pain, Malaise
SMQs:, Acute pancreatitis (broad), Retroperitoneal fibrosis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (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: Vitamin D, Calcium, testosterone cypionate, metroNIDAZOLE 0.75 % Cream, ibuprofen
Current Illness: None
Preexisting Conditions: Bicep tendonitis
Allergies: None
Diagnostic Lab Data: None
CDC Split Type:

Write-up: Abdominal pain that lasted about an hour. Did not feel well, went to sleep, the pain was gone when I awoke.


VAERS ID: 1249741 (history)  
Form: Version 2.0  
Age: 55.0  
Sex: Male  
Location: Georgia  
Vaccinated:2021-04-10
Onset:2021-04-10
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-04-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 041A21A / 1 LA / UN

Administered by: Pharmacy       Purchased by: ?
Symptoms: Blood fibrinogen normal, Computerised tomogram thorax normal, Electrocardiogram normal, Fibrin D dimer increased, Full blood count normal, Headache, International normalised ratio normal, Palpitations, Prothrombin time normal, Ultrasound Doppler, Venogram normal
SMQs:, Haemorrhage laboratory terms (broad), Arrhythmia related investigations, signs and symptoms (broad), Cardiomyopathy (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies: Sulpha (No known personal reaction but Dad had reaction to this), Bactrim
Diagnostic Lab Data: 1. Normal CBC, PT/INR, Fibrinogen 2. Abnormal D-dimer (875) 3. Normal US VAS DUPLEX LOWER EXT VENOUS BILAT 4. Normal CT Venogram of head 5. Normal CT of chest - no PE
CDC Split Type:

Write-up: 04/12 - Palpitations early morning and couple of times during day 04/13 - Palpitations early morning and bed time 04/14 - Palpitations on and off - severe early morning and bed time 04/15 - Mild to moderate headache (mostly left side) throughout the day, palpitations early morning and few long lasting during the day and bed time 04/16 - Continued mild headache, early morning and night time palpitations. Went to see Dr. Did bloodiest and EKG (normal) 04/17 - Continued mild headache. Dr. called with abnormal D-dimer (875). Prescribed Eliquis 2.5mg and ordered Ultrasound and CT scans of head and chest 04/19 - Continued mild headache. Did Ultrasound (lower extremities), CT scans of head and chest 04/21 - Mild headache most of the day. Received rest of blood tests - (normal Plates, PT, INR, Fibrinogen). CT scans of head and chest results show no signs PE or thrombosis 04/22 - Very light head during day. Mild headache evening. 04/23 - Mild headache (Tylenol provided temp relief but not completely) - Ultrasound is clear - no DVT


VAERS ID: 1249699 (history)  
Form: Version 2.0  
Age: 57.0  
Sex: Female  
Location: New York  
Vaccinated:2021-03-08
Onset:2021-04-10
   Days after vaccination:33
Submitted: 0000-00-00
Entered: 2021-04-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 010A21A / 1 - / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Breast cancer; Lung cancer (Has not been operated on as of yet)
Preexisting Conditions: Medical History/Concurrent Conditions: Mastectomy bilateral; Radiation therapy
Allergies:
Diagnostic Lab Data:
CDC Split Type: USMODERNATX, INC.MOD20210

Write-up: Blood Clot in the Lower Left Lung; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PULMONARY EMBOLISM (Blood Clot in the Lower Left Lung) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 008B21-2A and 010A21A) for COVID-19 vaccination. The patient''s past medical history included Mastectomy bilateral on 20-Jan-2021 and Radiation therapy. Concurrent medical conditions included Breast cancer and Lung cancer (Has not been operated on as of yet). On 08-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 10-Apr-2021, the patient experienced PULMONARY EMBOLISM (Blood Clot in the Lower Left Lung) (seriousness criterion hospitalization). The patient was hospitalized on 10-Apr-2021 due to PULMONARY EMBOLISM. At the time of the report, PULMONARY EMBOLISM (Blood Clot in the Lower Left Lung) outcome was unknown. No concomitant medications reported. The patient developed a blood clot in the lower left lung, and was hospitalized. The doctor told her that because of cancer, radiation and recent mastectomy surgery she was at risk of developing blood clots. Treatment medication included apixaban for six months. The patient received both scheduled doses of mRNA-1273 prior to the event, therefore action taken with the drug in response to the event is not applicable. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Company Comment: Based on the current available information and temporal association between the use of the product and the onset date of the reported event, a causal relationship cannot be excluded. Patient''s underlying cancer, radiation and recent mastectomy surgery were considered to be risk factors for developing blood clots.; Sender''s Comments: Based on the current available information and temporal association between the use of the product and the onset date of the reported event, a causal relationship cannot be excluded. Patient''s underlying cancer, radiation and recent mastectomy surgery were considered to be risk factors for developing blood clots.


VAERS ID: 1251012 (history)  
Form: Version 2.0  
Age: 39.0  
Sex: Male  
Location: Unknown  
Vaccinated:2021-04-10
Onset:2021-04-10
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-04-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / 1 LA / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: Chills, Cough, Dyspnoea, Fatigue, Headache, Injection site pain, Pain, Pain in extremity, Pyrexia, Tinnitus
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Extravasation events (injections, infusions and implants) (broad), Cardiomyopathy (broad), Hearing impairment (narrow), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

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

Write-up: Chills and Fever the first day a few hours after injection along with Fatigue, Multi-day Headache, Slight Body Ache, and Injection Site Pain all for about 2 or 3 days. Some leg pain was noticed the 2nd or 3rd day. And I have experienced ear ringing randomly about a week and a half after vaccination. Those may or may not be related. Also I feel it important to note in March of 2020 (before testing was available) I experienced a very similar set of symptoms: fever, chills, fatigue, multi-day headache, body ache, 6 weeks of slight cough, leg pain, and a day a few weeks after the coughing started where I had shortness of breath. I wasn''t tested back then as it was not available. But based on the symptoms I experienced, I truly believe I had COVID-19 last year prior to vaccination.


VAERS ID: 1251298 (history)  
Form: Version 2.0  
Age: 54.0  
Sex: Female  
Location: Colorado  
Vaccinated:2021-03-26
Onset:2021-04-10
   Days after vaccination:15
Submitted: 0000-00-00
Entered: 2021-04-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 1805020 / N/A LA / IM

Administered by: Other       Purchased by: ?
Symptoms: Headache, Limb discomfort, Ultrasound scan normal
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: Estroven OTC - menopause pill; Multi-Vitamin -Smarty pants for Women; Immune support antioxidant capsule 2 times a day; 50,000 IU of Vit D - was taking one per week (I was on my 9th week of that)
Current Illness: no
Preexisting Conditions: no
Allergies: sulpha
Diagnostic Lab Data: Ultrasound done - 4/23/2021 - Health Images at hospital- nurse told me it looked 100% good - blood is flowing cleanly through my veins
CDC Split Type: vsafe

Write-up: The day after the vaccine I had a little bit of a headache but it went away after four hours. My left leg - I started feeling some pressure behind my knee when I was walking. It happened two days in a row and then it happened a week later (April 22th). I called the doctor and they sent me to get an ultrasound done. I''m a carrier for Factor V Leiden which I knew.


VAERS ID: 1251315 (history)  
Form: Version 2.0  
Age: 18.0  
Sex: Female  
Location: Nebraska  
Vaccinated:2021-04-09
Onset:2021-04-10
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-04-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / 1 LA / SYR

Administered by: Other       Purchased by: ?
Symptoms: Electric shock sensation
SMQs:, Peripheral neuropathy (broad), Guillain-Barre syndrome (broad)

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

Write-up: Jolting shocks through body randomly for two weeks now. Happens multiple times per day.


VAERS ID: 1251914 (history)  
Form: Version 2.0  
Age: 50.0  
Sex: Female  
Location: California  
Vaccinated:2021-04-09
Onset:2021-04-10
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-04-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

Administered by: Pharmacy       Purchased by: ?
Symptoms: Hangover, Headache, Limb discomfort, Pain, Pain in extremity
SMQs:, Tendinopathies and ligament disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Fish Oil, Flax Seed Oil
Current Illness: Occasional Rash
Preexisting Conditions: None
Allergies: Allergic to Grass, Turkey & Seriods
Diagnostic Lab Data: None yet
CDC Split Type:

Write-up: Headache that feels like I drank hard alcohol (which I don''t) and have a bad hangover starting the morning after the vaccination and it has not stopped after 14 days. Leg pain is off and on which feels heavy and with shooting pain.


VAERS ID: 1251975 (history)  
Form: Version 2.0  
Age: 41.0  
Sex: Female  
Location: Unknown  
Vaccinated:2021-04-09
Onset:2021-04-10
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-04-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / 1 LA / SYR

Administered by: Unknown       Purchased by: ?
Symptoms: Dyspepsia, Pain
SMQs:, Gastrointestinal nonspecific dysfunction (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: multivitamin, calcium supplement, probiotic
Current Illness: None
Preexisting Conditions: None
Allergies: Tegretol
Diagnostic Lab Data:
CDC Split Type:

Write-up: J&J COVID-19 Vaccine EUA. I experienced severe heartburn for 12 days following the Janssen vaccination. Heartburn was painful and continuous but exaggerated by certain foods. Normally I never have heartburn.


VAERS ID: 1251982 (history)  
Form: Version 2.0  
Age: 39.0  
Sex: Male  
Location: Georgia  
Vaccinated:2021-04-10
Onset:2021-04-10
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-04-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 042A21A / 1 RA / IM

Administered by: Other       Purchased by: ?
Symptoms: Arthralgia, Body temperature increased, Chills, Fatigue, Headache, Injection site pain, Insomnia, Night sweats, Pain
SMQs:, Neuroleptic malignant syndrome (broad), Extravasation events (injections, infusions and implants) (broad), Arthritis (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations: Teatnus - arm pain at injection site
Other Medications: Bayer low dose aspirin 81 mg (4 tablets each dose time) 11:45 AM and 9:45 PM on 4/10/21 and 8:00 AM on 4/11/21
Current Illness: none
Preexisting Conditions: asthma - mild/exercise induced
Allergies: chocolate and Keflex
Diagnostic Lab Data:
CDC Split Type:

Write-up: 4/10/21 - I took 4 low dose Bayer aspirin about 11:45 AM on 4/10/21. I received the Janseen COVID19 vaccine about 12:45 PM on 4/10/21. I cleared the 15 minute monitor period at 1:05 PM. About 8:00 PM on 4/10/21 I felt slight chills and left wrist was achy. About 9:00 PM on 4/10/21 chills persisted and I felt fatigued. About 9:45 PM on 4/10/21 I felt more body aches and took 4 low dose Bayer aspirin at 81 mg. About 10:15 PM I had a temp of 100.4 F and body chills. 4/11/21 - About 2:35 AM I had a body temp of 101.6 F with body chills and night sweats. About 11:25 AM body temp decreased to 99.9 F and had a headache. I took another dose of 4 low dose Bayer aspirin. I slept a total of about 3 hours from 10 PM on 4/10 to 10 AM on 4/11. About 9:00 PM body temp was 99.6 F. 4/12/21 - About 8:30 AM body temp was 97.9 and slept more than 5 hours with light to moderate night sweats. Experienced injection site pain from 4/10/21 to 4/13/21.


VAERS ID: 1253825 (history)  
Form: Version 2.0  
Age: 55.0  
Sex: Male  
Location: Hawaii  
Vaccinated:2021-04-10
Onset:2021-04-10
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-04-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 201A21A / UNK RA / IM

Administered by: Private       Purchased by: ?
Symptoms: Asthenia, Chest X-ray, Chest discomfort, Dizziness, Electrocardiogram, Laboratory test, Peripheral swelling
SMQs:, Cardiac failure (broad), Anaphylactic reaction (broad), Angioedema (broad), Anticholinergic syndrome (broad), Guillain-Barre syndrome (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), 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? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: facial injury 4/1/2021
Preexisting Conditions: aortic valve repair. asthma
Allergies:
Diagnostic Lab Data: EKG, lab, CXR
CDC Split Type:

Write-up: Patient had weakness, chest discomfort, dizziness, weakness, moderate severity. same day of the vaccination. pt complained of left leg swelling.


VAERS ID: 1253981 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Maine  
Vaccinated:0000-00-00
Onset:2021-04-10
Submitted: 0000-00-00
Entered: 2021-04-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN UNKNOWN / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Conjunctival haemorrhage, Eye pruritus, Headache
SMQs:, Anaphylactic reaction (broad), Haemorrhage terms (excl laboratory terms) (narrow), Conjunctival 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:
Current Illness: Alcohol use (3 drinks a week); Seasonal allergy; Sulfonamide allergy
Preexisting Conditions: Comments: The patient did not have any drug abuse or illicit drug usage
Allergies:
Diagnostic Lab Data:
CDC Split Type: USJNJFOC20210425458

Write-up: LEFT EYE BLEEDING; ITCHY EYE; HEADACHE; This spontaneous report received from a patient concerned a male of unspecified age. The patient''s weight was 195 pounds, and height was 175 centimeters. The patient''s concurrent conditions included sulfonamide allergy, seasonal allergy, and alcohol user, and other pre-existing medical conditions included the patient did not have any drug abuse or illicit drug usage. The patient experienced drug allergy when treated with Aspirin (acetylsalicylic acid), erythromycin, and Tylenol (paracetamol). The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 203A21A expiry: UNKNOWN) dose was not reported, 1 total, administered on 09-APR-2021 at Left deltoid for prevention of covid-19 disease. No concomitant medications were reported. On 10-APR-2021, the patient experienced headache and the pain was tolerable but did not take medication for it. On the same day, the patient''s left eye was bleeding and it was spreading but later on it got better because the spreading stopped. The patient also reported that the bleeding might be because of the seasonal allergy and rubbed the eye because it was itchy. The patient had never experience eye bleeding before. The patient''s attending physician did not inform about the situation. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from eye bleeding, and itchy eye, and had not recovered from headache. This report was serious (Other Medically Important Condition).; Sender''s Comments: V0: 20210425458-COVID-19 VACCINE AD26.COV2.S-Left eye bleeding. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: MEDICAL HISTORY, UNDERLYING DISEASE


VAERS ID: 1253988 (history)  
Form: Version 2.0  
Age: 19.0  
Sex: Female  
Location: Florida  
Vaccinated:0000-00-00
Onset:2021-04-10
Submitted: 0000-00-00
Entered: 2021-04-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN UNKNOWN / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Chills, Dizziness, Headache, Nausea, Pain, Tunnel vision, Vomiting
SMQs:, Acute pancreatitis (broad), Anticholinergic syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Optic nerve disorders (broad), Retinal disorders (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? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Comments: Unknown
Allergies:
Diagnostic Lab Data:
CDC Split Type: USJNJFOC20210428952

Write-up: TUNNEL VISION; EXTREME BODY ACHE; DIZZINESS; VOMITING; CHILLS; HEADACHE; NAUSEA; This spontaneous report received from a parent concerned a 19 year old female. The patient''s weight was 112 pounds and height was 66 inches. No past medical history or concurrent conditions were 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 10-APR-2021 at11:30a.m.in left arm for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. The parent reported that the patient on 10-APR-2021 experienced tunnel vision, extreme body ache, dizziness, vomiting, chills, headache and nausea for which eight hours later patient went to the emergency room where the patient was given two bags of intravenous fluid and rotated ibuprofen and paracetamol when awake. The patient was also given Benadryl at evenings. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from tunnel vision on 11-APR-2021, and vomiting, and chills on 10-APR-2021, was recovering from extreme body ache, headache, and dizziness, and had not recovered from nausea. This report was serious (Other Medically Important Condition).; Sender''s Comments: V0:20210428952- covid-19 vaccine ad26.cov2.s-Tunnel vision, extreme body ache, dizziness, vomiting. These events are considered unassessable. The events have a compatible/suggestive temporal relationship, are unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the events. 20210428952- covid-19 vaccine ad26.cov2.s-chills, headache, nausea. These events are labeled per RSI and are therefore considered potentially related.


VAERS ID: 1255234 (history)  
Form: Version 2.0  
Age: 65.0  
Sex: Male  
Location: New York  
Vaccinated:2021-04-10
Onset:2021-04-10
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-04-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EP6955 / 2 RA / OT

Administered by: Work       Purchased by: ?
Symptoms: Blood glucose, 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? Yes
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Nervous
Allergies:
Diagnostic Lab Data: Test Date: 20210410; Test Name: glucose; Result Unstructured Data: Test Result:130; Comments: glucose stick was 130.
CDC Split Type: USPFIZER INC2021392910

Write-up: vasovagal syncope; This is a spontaneous report from a non-contactable consumer (patient). A 65-year-old male patient received the second dose of bnt162b2 (BNT162B2, Solution for injection, lot number: EP6955), intramuscular, administered in Arm Right on 10Apr2021 11:00 (received at 65-years-old) as SINGLE DOSE for COVID-19 immunization. The vaccine was administered at a clinic. It was unknown if patient received any other vaccines within four weeks prior to receiving bnt162b2. Medical history included always gets nervous. Concomitant medications were not reported. The patient had no known allergies and denied having other medical history. The patient previously received the first dose of bnt162b2 (BNT162B2, Solution for injection, lot number: EP6955), intramuscular, administered in Arm Right on 20Mar2021 (received at 65-years-old) as SINGLE DOSE for COVID-19 immunization. On 10Apr2021 11:00 AM, 1-2 (unspecified) after receiving vaccine #2, the patient became pale and diaphoretic and then lost consciousness. He was taken out of car and medics evaluated person and family stated he had not eaten or drank anything and glucose stick was 130. When patient became conscious, he stated he had a similar episode when he was a child and received a vaccine. States he was very anxious receiving both vaccines and always gets nervous. The reported adverse event resulted in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. The patient was evaluated in emergency and diagnosed with vasovagal syncope. Therapeutic measures were taken as a result of the event. Outcome of the event was recovered on an unspecified date. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1255265 (history)  
Form: Version 2.0  
Age: 22.0  
Sex: Female  
Location: California  
Vaccinated:2021-04-10
Onset:2021-04-10
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-04-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 LA / -

Administered by: Pharmacy       Purchased by: ?
Symptoms: Breast pain, Hemiparesis, Musculoskeletal pain, Pain in extremity
SMQs:, Rhabdomyolysis/myopathy (broad), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Noninfectious encephalitis (broad), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (narrow), Lipodystrophy (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: Medical History/Concurrent Conditions: Food allergy
Allergies:
Diagnostic Lab Data:
CDC Split Type: USPFIZER INC2021393102

Write-up: Left arm, breast, butt cheek, and thigh feel sore/weak - left side only!; Left arm, breast, butt cheek, and thigh feel sore/weak - left side only!; Left arm, breast, butt cheek, and thigh feel sore/weak - left side only!; Left arm, breast, butt cheek, and thigh feel sore/weak - left side only!; Left arm, breast, butt cheek, and thigh feel sore/weak - left side only!; This is a spontaneous report from a contactable consumer via COVID-19 . A 22-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) dose 1 (at the age of 22 years old) via an unspecified route of administration, administered in Arm Left on 10Apr2021 10:30 (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunization. Medical history included shrimp allergy from an unknown date and unknown if ongoing. The patient did not have any vaccine in four weeks. Other medications in two weeks: ADHD medication and birth control. The patient experienced "left arm, breast, butt cheek, and thigh feel sore/weak - left side only" (as reported) on 10Apr2021 15:00 with outcome of not recovered . No treatment was received. The patient did not have covid prior to vaccination, was not tested post vaccination Information on Lot/Batch number has been requested.


VAERS ID: 1255286 (history)  
Form: Version 2.0  
Age: 53.0  
Sex: Female  
Location: Florida  
Vaccinated:2021-04-10
Onset:2021-04-10
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-04-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 LA / -

Administered by: Unknown       Purchased by: ?
Symptoms: Dizziness, Dry mouth, Headache, Pain, Palpitations, Swelling
SMQs:, Anaphylactic reaction (broad), Angioedema (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad), Vestibular disorders (broad), Dehydration (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, 1 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: METFORMIN; ATORVASTATIN; LISINOPRIL
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Diabetes; High cholesterol
Allergies:
Diagnostic Lab Data:
CDC Split Type: USPFIZER INC2021394841

Write-up: Severe headaches; swelling; heavy dizziness; Heart palpitations; heavy body aches and pain; dry mouth; This is a spontaneous report from a contactable consumer (Patient herself). A 53-year-old female patient received first dose of BNT162B2 (Pfizer COVID-19 Vaccine, Formulation: Solution for injection, Lot number: Unknown, Expiry date: Unknown), via an unspecified route of administration in left arm on 10Apr2021 at 14:15 as single dose for COVID-19 immunisation. The patient was not pregnant at the time of vaccination. Medical history included diabetes, high cholesterol. There were no known allergies. Concomitant medication included metformin 100 mg, atorvastatin 20 mg and lisinopril for unknown indication. The patient not had COVID prior vaccination. The patient had not taken any other vaccines four weeks prior vaccination. On 10Apr2021 at 14:30 (15-minutes after vaccination), patient experienced severe headaches, swelling, heavy dizziness, heart palpitations, heavy body aches and pain, dry mouth. The patient visited emergency room/ department or urgent care and was hospitalized for the events for one day on unspecified date. The patient was not tested for COVID post vaccination. Therapeutic measures taken as a result of events included intravenous drip, Prednisone. The outcome of all the events was recovering. Information about Lot/Batch number is requested.


VAERS ID: 1255293 (history)  
Form: Version 2.0  
Age: 24.0  
Sex: Female  
Location: Minnesota  
Vaccinated:2021-04-07
Onset:2021-04-10
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-04-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 RA / -

Administered by: Pharmacy       Purchased by: ?
Symptoms: Dizziness, Seizure, Syncope, Tachycardia
SMQs:, Torsade de pointes/QT prolongation (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Convulsions (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Cardiomyopathy (broad), Vestibular disorders (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (narrow), Hypoglycaemia (broad), Dehydration (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Postural orthostatic tachycardia syndrome
Allergies:
Diagnostic Lab Data:
CDC Split Type: USPFIZER INC2021395033

Write-up: fainting; seizure; Tachycardia; dizziness; This is a spontaneous report from a contactable consumer. This 24-year-old non-pregnant female consumer (Patient) reported that she received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 Vaccine; Solution for injection; Lot number: unknown; Expiry date: Unknown) via an unspecified route of administration in the right arm on 07Apr2021 at 12:45 PM. The patients past medical history included Postural orthostatic tachycardia syndrome. The patient was allergic to Phenergan and Zofran. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since vaccination, patient had not tested for COVID-19. Concomitant medication was not reported. On 10Apr2021, at 12:00PM the patient developed Tachycardia, dizziness, fainting and seizure. The patient did not receive any treatment for the events. The outcome for the events was recovering. Information about Lot/batch number is requested.


VAERS ID: 1255347 (history)  
Form: Version 2.0  
Age: 43.0  
Sex: Female  
Location: Unknown  
Vaccinated:2021-04-06
Onset:2021-04-10
   Days after vaccination:4
Submitted: 0000-00-00
Entered: 2021-04-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 LA / -

Administered by: Private       Purchased by: ?
Symptoms: Dysmenorrhoea, Haemorrhage, Menstrual disorder
SMQs:, Haemorrhage terms (excl laboratory terms) (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: LISINOPRIL; MIRENA
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Birth control (I use an iud for birth control and have not had a period in four years, five days after my second shot); IUD embedded (I use an iud for birth control and have not had a period in four years, five days after my second shot)
Allergies:
Diagnostic Lab Data:
CDC Split Type: USPFIZER INC2021398232

Write-up: bleeding; have not had a period in four years, five days after my second shot and I am having terrible menstrual pain and bleeding; have not had a period in four years, five days after my second shot and I am having terrible menstrual pain and bleeding; This is a spontaneous report from a contactable consumer (patient) reported for herself. A 43-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE Formulation: Solution for injection) via unspecified route of administration on arm left at a SINGLE DOSE on 06Apr2021 15:15 for COVID-19 immunization. The patient was not pregnant at the time of vaccination. Previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE Formulation: Solution for injection) via unspecified route of administration as a SINGLE DOSE on 16Mar2021 14:15 for COVID-19 immunization. The patient had no relevant medical history. Patient received other medications in two weeks are Lisinopril and LEVONORGESTREL (mirena). On 10Apr2021 patient use an iud for birth control and have not had a period in four years, five days after my second shot and I am having terrible menstrual pain and bleeding. Patient didn''t received treatment for the events. The clinical outcome of the events not recovered. No follow-up attempts are possible; information about lot/batch number cannot be obtained.


VAERS ID: 1255514 (history)  
Form: Version 2.0  
Age: 43.0  
Sex: Female  
Location: Maryland  
Vaccinated:2021-04-08
Onset:2021-04-10
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-04-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK LA / -

Administered by: Other       Purchased by: ?
Symptoms: Lymphoma
SMQs:, Malignant lymphomas (narrow), Haematological malignant tumours (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: Allergic reaction to bee sting; Fibrocystic breast; Penicillin allergy
Allergies:
Diagnostic Lab Data:
CDC Split Type: USPFIZER INC2021405215

Write-up: Left underarm lymphoma 2 days after vaccine; This is a spontaneous report from a contactable other healthcare professional (patient). A 43-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number was unknown and expiration date was not reported), via an unspecified route of administration, in left arm on 08Apr2021 at 10:15 (at the age of 43-year-old) at single dose for COVID-19 immunization. Medical history included fibrous breast, known penicillin allergy and bee allergy; patient was not pregnant. Concomitant medications were not reported. Prior to vaccination, the patient was not diagnosed with COVID-19, did not receive any vaccines within four weeks nor any other medications within two weeks prior. The patient received the vaccine at a Public Health Clinic/Veterans Administration facility. The patient experienced left underarm lymphoma, two days after vaccination, on 10Apr2021. Since the vaccination, patient has not been tested for COVID-19. No treatment was received for the event. Outcome of the event was not resolved. Information about the Lot/batch number has been requested.; Sender''s Comments: Considering a plausible temporal association, a causal relationship between the suspect drug bnt162b2 and event ''lymphoma'' 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: 1255553 (history)  
Form: Version 2.0  
Age: 18.0  
Sex: Female  
Location: Unknown  
Vaccinated:2021-04-09
Onset:2021-04-10
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-04-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 LA / -

Administered by: Pharmacy       Purchased by: ?
Symptoms: Blindness, Chills, Dizziness, Headache, Loss of consciousness, Pain, Pyrexia, Vaccination site pain
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), Glaucoma (broad), Optic nerve disorders (broad), Retinal disorders (broad), Vestibular disorders (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (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:
Allergies:
Diagnostic Lab Data:
CDC Split Type: USPFIZER INC2021406609

Write-up: losing vision; almost passing out; After second dose: fever; chills; headache; body ache; pain at injection site; dizziness; This is a spontaneous report from a non-contactable consumer (patient). An 18-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in Arm Left on 09Apr2021 (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunisation, at 18 years old. The patient medical history was not reported. There were no concomitant medications. No other vaccines if four weeks. Patient received the first dose of bnt162b2 at 12Mar2021 16:30, arm left for covid-19 immunisation, at 18 years old. Patient is not pregnant. The patient experienced after second dose: losing vision, almost passing out, dizziness, fever, chills, headache, body ache, pain at injection site on 10Apr2021 00:00 (12AM). Treatment was not given. Outcome of the events was recovering. No follow-up attempts are possible; information about lot/batch number cannot be obtained.


VAERS ID: 1255684 (history)  
Form: Version 2.0  
Age: 34.0  
Sex: Female  
Location: California  
Vaccinated:2021-04-10
Onset:2021-04-10
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-04-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ER8734 / 1 LA / -

Administered by: Pharmacy       Purchased by: ?
Symptoms: Exposure during pregnancy, Haemorrhage
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow)

Life Threatening? Yes
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Penicillin allergy
Allergies:
Diagnostic Lab Data:
CDC Split Type: USPFIZER INC2021422932

Write-up: This is a spontaneous report from a contactable consumer. A 34-year-old female (patient) (pregnant) received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: ER8734), via an unspecified route of administration administered in left arm on 10Apr2021 as single dose for COVID-19 immunisation. The patient LMP Was on 24Feb2021 and 5 weeks of gestational period. Patient medical history included Known Allergies: Penicillin. Concomitant medications included Prenatal vitamins within 2 weeks of vaccination. There were no allergies to medications, food, or other products. Known allergies to Penicilin. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 12 Apr2021, 48 hours after the vaccine patient started bleeding that has progress from a brown color to a bright red and from a small amount to a moderate amount for 5 days. The adverse event resulted in emergency room. The outcome of the event hemorrhage was not recovered and other event was unknown.


VAERS ID: 1255702 (history)  
Form: Version 2.0  
Age: 50.0  
Sex: Male  
Location: Wisconsin  
Vaccinated:2021-04-08
Onset:2021-04-10
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-04-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 LA / -

Administered by: Private       Purchased by: ?
Symptoms: SARS-CoV-2 test, Seizure
SMQs:, Systemic lupus erythematosus (broad), Convulsions (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Generalised convulsive seizures following immunisation (narrow), Hypoglycaemia (broad), COVID-19 (broad)

Life Threatening? Yes
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: CELEXA [CELECOXIB]
Current Illness:
Preexisting Conditions: Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None, Comment: other medical history: No
Allergies:
Diagnostic Lab Data: Test Date: 20210410; Test Name: Nasal Swab; Test Result: Negative
CDC Split Type: USPFIZER INC2021425357

Write-up: Generalized seizures without ever having a seizure before; This is a spontaneous report from a contactable consumer (patient). A 50-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number and expiry date not available), via an unspecified route of administration, Left arm on 08Apr2021 at 09:00 AM (at the age of 50-years-old) at a single dose for COVID-19 immunization. The patient''s medical history was reported as none. The patient had no known allergies. Concomitant medication included celecoxib (CELEXA). The patient was vaccinated at a hospital. No other vaccine was given in four weeks. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient experienced generalized seizures without ever having a seizure before on 10Apr2021 at 15:00. The event caused hospitalization in Apr2021 and was also reported as life-threatening. The patient underwent lab tests and procedures which included nasal swab test: negative on 10Apr2021. Therapeutic measures taken as a result of the event included hospitalization and med flight, as reported. The outcome of the event was not recovered. Information about lot/batch number has been requested.


VAERS ID: 1256615 (history)  
Form: Version 2.0  
Age: 32.0  
Sex: Female  
Location: California  
Vaccinated:2021-04-10
Onset:2021-04-10
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-04-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

Administered by: Unknown       Purchased by: ?
Symptoms: Dizziness, Lip swelling, Rash
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Anticholinergic syndrome (broad), Vestibular disorders (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

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

Write-up: "I received the Johnson & Johnson COVID-19 vaccine on April 10. I felt a little bit woozy a few hours after getting the vaccine. About 2 days after the vaccine, my upper lip was swollen for a few hours after I woke up. This week (about 9-10 days after the vaccine), I noticed red spots and very small bumps on my body, specifically on my left breast, below breasts, and lower stomach areas. It does not itch or hurt. I dont seem to have any other symptoms. I have not had any new foods or used any new products on the affected areas. "


VAERS ID: 1256882 (history)  
Form: Version 2.0  
Age: 40.0  
Sex: Male  
Location: Puerto Rico  
Vaccinated:2021-04-09
Onset:2021-04-10
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-04-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 042A21A / 1 LA / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: Pain, 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: N/A
Current Illness: N/A
Preexisting Conditions: N/A
Allergies: N/A
Diagnostic Lab Data:
CDC Split Type:

Write-up: FEVER, BODY PAIN, FINGER PAIN, WHOLE BODY IN PAIN.


VAERS ID: 1256960 (history)  
Form: Version 2.0  
Age: 44.0  
Sex: Female  
Location: California  
Vaccinated:2021-04-10
Onset:2021-04-10
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-04-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 202A21A / 1 LA / IM

Administered by: Private       Purchased by: ?
Symptoms: Abdominal discomfort, Abdominal pain, Amylase normal, Anxiety, Asthenia, Blood ketone body, Blood lactate dehydrogenase normal, Blood urine, Chest X-ray normal, Chills, Diarrhoea, Dizziness, Dysgeusia, Electrocardiogram normal, Erythema, Faeces pale, Fatigue, Feeding disorder, Flushing, Full blood count normal, Headache, Hyperhidrosis, Laboratory test normal, Lipase normal, Metabolic function test, Myalgia, Nausea, Pallor, Palpitations, Pyrexia, Skin discolouration, Syncope, Taste disorder, Urine analysis, Vomiting, Weight decreased, Yellow skin
SMQs:, Torsade de pointes/QT prolongation (broad), Rhabdomyolysis/myopathy (broad), Cholestasis and jaundice of hepatic origin (broad), Anaphylactic reaction (broad), Acute pancreatitis (broad), Haemorrhage terms (excl laboratory terms) (narrow), Haemorrhage laboratory terms (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Taste and smell disorders (narrow), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Retroperitoneal fibrosis (broad), Pseudomembranous colitis (broad), Gastrointestinal perforation, ulcer, haemorrhage, obstruction non-specific findings/procedures (broad), Biliary system related investigations, signs and symptoms (broad), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Vestibular disorders (broad), Hypotonic-hyporesponsive episode (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? Yes
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: probiotics
Current Illness: had been having recurrent hypoglycemia and perimenopausal symptoms
Preexisting Conditions: migraines controlled
Allergies: none
Diagnostic Lab Data: Labs Quest 4/16/2021-normal cbc, cmp, amylase, lipase, LD, U/A just trace ketones and blood ER 4/17/2021-similar
CDC Split Type:

Write-up: Within 24hours pt with fever, myalgia, chills, rigors, weakness and extreme dizziness with headache and episode of syncope. Had waves of flushing in body with central abdominal pain and redness and pale extremities. Abdominal pain "burning" recurrent for 6 days with diarrhea, nausea and vomiting and stools pale. In clinic 4/16/2021 pt appeared greenish/yellowish on day 6 and had weight loss from baseline 4lbs in 9 days when she was last seen. Pt labs done and normal. Night of 4/16/2021 started with palpitations racing heart. 4/17/2021 presented to ER for worsening palpitations with flushing and diaphoresis. Labs CXR normal. send home. Anxiety like symptoms fluctuating. Was given diazepam. 4/21/2021 seen in clinic again feeling slightly better. Still with nausea and also now dysgeusia. EKG normal. palpitations better. 4/23/2021 seen on video appt doing better. able to keep food down but still tired and weak. no longer needing diazepam. Taste improving.


VAERS ID: 1257351 (history)  
Form: Version 2.0  
Age: 51.0  
Sex: Male  
Location: North Carolina  
Vaccinated:2021-03-27
Onset:2021-04-10
   Days after vaccination:14
Submitted: 0000-00-00
Entered: 2021-04-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 LA / SYR

Administered by: Public       Purchased by: ?
Symptoms: Acoustic stimulation tests, Sudden hearing loss, Tinnitus
SMQs:, Hearing impairment (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Valtrex, fish oil, vitamin d, multivitamin, flonase
Current Illness: None
Preexisting Conditions: Hsv Ii
Allergies: None
Diagnostic Lab Data: Hearing evaluation by audiologist and ent
CDC Split Type:

Write-up: Tinnitus, sudden hearing loss.


VAERS ID: 1258077 (history)  
Form: Version 2.0  
Age: 32.0  
Sex: Male  
Location: Unknown  
Vaccinated:2021-04-10
Onset:2021-04-10
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-04-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 201A21A / 1 LA / IM

Administered by: Private       Purchased by: ?
Symptoms: Fall
SMQs:, Accidents and injuries (narrow)

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

Write-up: Member fell to floor after covid vaccine. Member alert and oriented to time and plce. member denies distress and brought to holding room. Member states had similar reaction when getting tattoo. Member observed x1hr and d/c''d by Dr.


VAERS ID: 1258211 (history)  
Form: Version 2.0  
Age: 18.0  
Sex: Female  
Location: Unknown  
Vaccinated:2021-04-10
Onset:2021-04-10
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-04-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 201A21A / 1 LA / IM

Administered by: Private       Purchased by: ?
Symptoms: Anxiety, Dizziness, Hyperventilation, Hypoaesthesia, Pallor
SMQs:, Anaphylactic reaction (broad), Asthma/bronchospasm (broad), Peripheral neuropathy (broad), Anticholinergic syndrome (broad), Guillain-Barre syndrome (broad), Eosinophilic pneumonia (broad), Vestibular disorders (broad), Hypotonic-hyporesponsive episode (broad), Hypoglycaemia (broad)

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

Write-up: During obs, member became pale, felt faint, appeared to be hyperventilating and was obviously very anxious. Adult emergency called. Moved to holding room. BP 80s/40s O2 sats 60%, patient hyperventilating, c/o numbness in her hands and fingers. Alert and oriented, talking the whole time and very anxious. Member improved with O2 sats 100% BP 120/56. Observed x1 hr.


VAERS ID: 1258778 (history)  
Form: Version 2.0  
Age: 42.0  
Sex: Female  
Location: Minnesota  
Vaccinated:2021-04-09
Onset:2021-04-10
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-04-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK AR / -

Administered by: Unknown       Purchased by: ?
Symptoms: Ageusia, Chills, Decreased appetite, Dry mouth, Fatigue, Headache, Pain, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Taste and smell disorders (narrow), Anticholinergic syndrome (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Dehydration (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Ambien 5 mg sumatriptan 50 mg tab
Current Illness: None known
Preexisting Conditions: None known
Allergies: None known
Diagnostic Lab Data: None
CDC Split Type:

Write-up: Headache, body aches, fever, fatigue, chills, dry mouth, no appetite, loss of taste, fatigue


VAERS ID: 1258987 (history)  
Form: Version 2.0  
Age: 59.0  
Sex: Male  
Location: Arizona  
Vaccinated:2021-04-07
Onset:2021-04-10
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-04-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 202AZ1A / 1 RA / IM

Administered by: Private       Purchased by: ?
Symptoms: Back pain
SMQs:, Retroperitoneal fibrosis (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: Omeprazole for GERD
Current Illness: None.
Preexisting Conditions: Hx of Back Pain.
Allergies: None.
Diagnostic Lab Data: None.
CDC Split Type:

Write-up: Patient reports hx of back pain. States an episode began on 4/4/2021. His usual back pain episodes last 3 days, maximum. This round of back pain has continued. Patient reports only variance was receiving the Janssen COVID vaccine on 4/7/2021. Patient contacted his PCP for evaluation and is unable to be evaluated until July.


VAERS ID: 1259170 (history)  
Form: Version 2.0  
Age: 47.0  
Sex: Female  
Location: New Jersey  
Vaccinated:2021-04-07
Onset:2021-04-10
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-04-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 041A21A / 1 LA / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: Headache, Vision blurred
SMQs:, Anticholinergic syndrome (broad), Glaucoma (broad), Lens disorders (broad), Retinal disorders (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Trulicity, Lotrisone cream, januvia, lexapro, amlodipine, losartan, hydrochlorothiazide, gabapentin, carvedilol
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Persistent severe headache along with blurred vision. The headache has not resolved since a few days after getting the vaccine.


VAERS ID: 1259536 (history)  
Form: Version 2.0  
Age: 25.0  
Sex: Female  
Location: Illinois  
Vaccinated:2021-04-10
Onset:2021-04-10
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-04-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 203721A / 1 LA / SYR

Administered by: School       Purchased by: ?
Symptoms: Fatigue, Injection site pain, Mobility decreased, Pain
SMQs:, Parkinson-like events (broad), Extravasation events (injections, infusions and implants) (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: Drospirenone and Ethinyl Estradiol tablets
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: It has been just over 2 weeks now and I have continued pain in my arm around the injection site. I had no other effects from the vaccination except for some fatigue the following 6 hours after vaccination. I had severe arm pain for 5 days after injection where I could not move my arm. Today I still feel pain lifting it over my head.


VAERS ID: 1260371 (history)  
Form: Version 2.0  
Age: 62.0  
Sex: Male  
Location: California  
Vaccinated:2021-04-01
Onset:2021-04-10
   Days after vaccination:9
Submitted: 0000-00-00
Entered: 2021-04-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 042A21A / 1 UN / IM

Administered by: Unknown       Purchased by: ?
Symptoms: Angiotensin converting enzyme, Antibody test, Antinuclear antibody negative, Back pain, Bacterial test negative, Bell's palsy, Borrelia test negative, CSF glucose increased, CSF protein increased, CSF red blood cell count positive, CSF white blood cell count increased, Constipation, Dysarthria, Dysphagia, Epstein-Barr virus test negative, Facet joint syndrome, Facial paralysis, Facial paresis, Feeling of body temperature change, Gait disturbance, Herpes simplex test negative, Hypoaesthesia, Magnetic resonance imaging head abnormal, Magnetic resonance imaging spinal normal, Magnetic resonance imaging thoracic normal, Meningioma, Multipathogen PCR test, Mycoplasma test negative, Pain, Pain in extremity, Radiculopathy, Rheumatoid factor negative, Scan with contrast normal, Sensory disturbance, Sensory loss, Varicella virus test negative, Vision blurred
SMQs:, Peripheral neuropathy (narrow), Anticholinergic syndrome (broad), Retroperitoneal fibrosis (broad), Parkinson-like events (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Glaucoma (broad), Lens disorders (broad), Retinal disorders (broad), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (broad), Hearing impairment (broad), Arthritis (narrow), Tendinopathies and ligament disorders (broad), Hypoglycaemia (broad), Immune-mediated/autoimmune disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 6 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: amphetamine-dextroamphetamine, amlodipine, benazepril, simvastatin, valacyclovir
Current Illness: Denies any illnesses at time of vaccination or in the preceding month
Preexisting Conditions: hypertension, chronic HSV in suppression for 30 years, ADHD, GERD
Allergies: None
Diagnostic Lab Data: Lyme neg, ANA<1:40, M. Pneumoniae Ab 0.44 (H), GQ1 Ab pending, RF neg, EBV neg, ACE pending CSF: protein 136, glucose 96, RBC 84, WBC 46 (1N, 74L, 22M, 1E, 2B), gram stain many WBC rare RBC, bacterial cx neg, HSV 1/2 pcr neg, OCB neg, VZV pcr neg, lyme pending, meningoencephalitis panel pending, WNV pending, 4/20/21 MRI c-spine w/w/out contrast No spinal canal stenosis. No focal cervical spinal cord abnormality or abnormal enhancement. 4/20/21 MRI T-spine w/w/out contrast No convincing spinal cord abnormality. No abnormal enhancement.. 4/20/21 MRI L-spine w/w/out contrast Degenerative changes without high-grade spinal canal or foraminal stenosis at any lumbar level. No clumping or abnormal enhancement of the nerve roots of the cauda equina. 4/20/21 MRI brain w/w/out contrast No acute infarction, intracranial hemorrhage or mass effect. Abnormal enhancement of the bilateral facial nerves. This is a nonspecific finding and can be seen in the setting of Guillain-Barre syndrome, Lyme disease, sarcoidosis/other granulomatous processes, meningitis, leukemia, carcinomatosis as well as other intracranial processes. Recommend comparison with CSF studies. Incidental left sphenoid wing meningioma. No vasogenic edema in the adjacent left temporal lobe.
CDC Split Type:

Write-up: Patient states he received J&J vaccine on 4/1; on 4/10 he had nonradiating persistent low back pain. A few days after that (on 4/13) he felt numbness and pain in his legs, in addition to ?decreased sensation in his inner thighs. These sensations were migratory and intermittent. Also noted in his upper extremities as well. He also had issues with temperature sensation in his lower extremities. On 4/14 he had slight haziness in vision while driving which resolved after 30-60min and has not recurred. He also had slight difficulty walking. On 4/15 he had an appointment with his PMD; had L-spine XR which revealed moderate lower lumbar facet arthritis, and was thought that change in sensation was likely d/t radiculopathy - was prescribed ibuprofen, muscle relaxant, oxycodone (took oxy x1, ibuprofen for a few days). Since then he has also had intermittent stabbing pains in various parts of his body which resolved spontaneously. On 4/17-4/18 his back pain resolved. On 4/18 at 4:30am he woke up with R-sided facial weakness. He has not had focal weakness aside from the face. Was seen in ED that morning for this R-sided facial droop involving the forehead, diagnosed with Bell''s palsy and given prednisone/valacyclovir. Yesterday 4/19 around mid-day he started having L-sided facial weakness and slurred speech. This has progressed since yesterday. Reports ability to swallow, though a little difficult d/t cheek weakness. Low back pain has returned as well. Does report constipation and possible poor bladder emptying for the last few days. He was seen by a Doctor and referred to ED to rule out AIDP and other diseases after J&J vaccine.


VAERS ID: 1260567 (history)  
Form: Version 2.0  
Age: 43.0  
Sex: Male  
Location: Minnesota  
Vaccinated:2021-04-08
Onset:2021-04-10
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-04-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 043A21A / 1 RA / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: Dyspepsia, Nausea
SMQs:, Acute pancreatitis (broad), Gastrointestinal nonspecific dysfunction (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow)

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

Write-up: Heartburn, indigestion, nausea,


VAERS ID: 1260988 (history)  
Form: Version 2.0  
Age: 42.0  
Sex: Female  
Location: California  
Vaccinated:2021-03-09
Onset:2021-04-10
   Days after vaccination:32
Submitted: 0000-00-00
Entered: 2021-04-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0151 / 1 LA / SYR

Administered by: Pharmacy       Purchased by: ?
Symptoms: Burning sensation, Chills, Lymph node pain, Malaise, Paraesthesia, Peripheral coldness, Tinnitus, Vertigo
SMQs:, Peripheral neuropathy (broad), Guillain-Barre syndrome (broad), Hearing impairment (narrow), Vestibular disorders (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: Wellbutrin Sr 150, multivitamin
Current Illness:
Preexisting Conditions: Lichen sclerosis, hay fever/animal allergies
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Prickly feeling on skin started after about 3 days, mostly on legs but traveling around the body, went away after about 4 days, then came back around day 12 with chills and feeling run down/sick, but as more of a pins and needles/cold burn feeling, again mostly around legs, went away after a few days, came back again 4/26 as pins and needles and cold burning feeling with chills every now then, also experiencing off and on vertigo since vaccine and tinnitus, as well as painful lymph nodes in chest mostly on vaccine side starting in day 12ish post vaccine.


VAERS ID: 1261191 (history)  
Form: Version 2.0  
Age: 52.0  
Sex: Female  
Location: North Dakota  
Vaccinated:0000-00-00
Onset:2021-04-10
Submitted: 0000-00-00
Entered: 2021-04-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN EL043A21A / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Dysgeusia, Feeling abnormal, Hypoacusis, Injection site mass, Injection site swelling, Mixed incontinence, Mobility decreased, Pain, Pain in extremity, Somnolence, Visual impairment
SMQs:, Taste and smell disorders (narrow), Anticholinergic syndrome (broad), Dementia (broad), Parkinson-like events (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Glaucoma (broad), Optic nerve disorders (broad), Lens disorders (broad), Retinal disorders (broad), Hearing impairment (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:
Current Illness: Diabetic; Taste altered
Preexisting Conditions: Medical History/Concurrent Conditions: Thyroid electron radiation therapy
Allergies:
Diagnostic Lab Data:
CDC Split Type: USJNJFOC20210427971

Write-up: WHOLE BODY HURTS; LUMP AT INJECTION SITE; ARM SORE; ARM SWOLLEN AT INJECTION SITE; FEELING LIKE IN A FOG; COULD NOT HEAR DISTANT SOUND; COULD NOT MOVE; VISION WAS BLINDED IN MIDDLE; EXTREME SLEEPINESS; BOWEL MOVEMENTS AND URINATION AT SAME TIME; TASTE SWEET; This spontaneous report received from a patient concerned a 52 year old female. The patient''s height, and weight were not reported. The patient''s past medical history included thyroid radiation, and concurrent conditions included diabetic, and sensitive to taste in her mouth. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: EL043A21A and expiry: UNKNOWN) dose was not reported, administered on 10-APR-2021 17:50 for prophylactic vaccination. No concomitant medications were reported. On 10-APR-2021, the subject experienced taste sweet. On 11-APR-2021, the subject experienced extreme sleepiness. On 11-APR-2021, the subject experienced bowel movements and urination at same time. On 11-APR-2021 08:00, the subject experienced could not hear distant sound. On 11-APR-2021 08:00, the subject experienced could not move. On 11-APR-2021 08:00, the subject experienced vision was blinded in middle. On 11-APR-2021 08:00, the subject experienced feeling like in a fog. On 12-APR-2021, the subject experienced whole body hurts. On 12-APR-2021, the subject experienced lump at injection site. On 12-APR-2021, the subject experienced arm sore. On 12-APR-2021, the subject experienced arm swollen at injection site. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from could not hear distant sound, could not move, and extreme sleepiness on 11-APR-2021, and bowel movements and urination at same time on 13-APR-2021, was recovering from vision was blinded in middle, and whole body hurts, and had not recovered from arm sore, lump at injection site, arm swollen at injection site, feeling like in a fog, and taste sweet. This report was non-serious.; Sender''s Comments: V0: Medical Assessment Comment not required as per standard procedure as the case assessed as non-serious.


VAERS ID: 1261219 (history)  
Form: Version 2.0  
Age: 60.0  
Sex: Male  
Location: Tennessee  
Vaccinated:0000-00-00
Onset:2021-04-10
Submitted: 0000-00-00
Entered: 2021-04-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 207A21A / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Asthenia, Balance disorder, Blood test, Chest discomfort, Condition aggravated, Fatigue, Flushing, Headache, Lethargy, Myalgia, Nausea, Poor quality sleep, Pyrexia
SMQs:, Rhabdomyolysis/myopathy (broad), Anaphylactic reaction (narrow), Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Eosinophilic pneumonia (broad), Depression (excl suicide and self injury) (broad), Vestibular disorders (broad), Hypersensitivity (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? Yes
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: LISINOPRIL; ALEVE; ALLEGRA; ADVIL [IBUPROFEN]
Current Illness: Alcohol use (rarely-occasional beer); Allergic reaction; Arthritis; Blood pressure high; Lyme disease; Non-smoker; Seasonal allergy
Preexisting Conditions: Comments: The patient was non smoker.
Allergies:
Diagnostic Lab Data: Test Date: 20210413; Test Name: Blood test; Result Unstructured Data: unknown
CDC Split Type: USJNJFOC20210430054

Write-up: LETHARGIC; FLUSHED; FEELS WORSE EVERY DAY; WOOZY AND UNSTEADY; A BIT TIGHT IN THE BOTTOM OF HIS CHEST; NO ENERGY; PAIN IN ALL MAJOR MUSCLES, HURTS EVERYWHERE; NAUSEA; LOW GRADE FEVER UNDER 99F; SPLITTING HEADACHE; TIRED; RESTLESS SLEEP; This spontaneous report received from a patient concerned a 60 year old male. The patient''s weight was 350 pounds, and height was 75 inches. The patient''s concurrent conditions included high blood pressure, chronic lyme disease, seasonal allergies, arthritis, hives allergy, non smoker, and alcohol user. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 207A21A, expiry: UNKNOWN) dose was not reported, administered on 10-APR-2021 for prophylactic vaccination. Concomitant medications included ibuprofen for arthritis, naproxen sodium for arthritis pain, lisinopril for high blood pressure, and fexofenadine hydrochloride for seasonal allergies. On 11-APR-2021, the subject experienced flushed. On 11-APR-2021, the subject experienced feels worse every day. On 11-APR-2021, the subject experienced woozy and unsteady. On 11-APR-2021, the subject experienced a bit tight in the bottom of his chest. On 11-APR-2021, the subject experienced no energy. On 11-APR-2021, the subject experienced pain in all major muscles, hurts everywhere. On 11-APR-2021, the subject experienced nausea. On 11-APR-2021, the subject experienced low grade fever under 99 F. On 11-APR-2021, the subject experienced splitting headache. Treatment medications included: paracetamol. On 12-APR-2021, treatment medications included: acetylsalicylic acid/caffeine/paracetamol/salicylamide. On 13-APR-2021, Laboratory data included: Blood test (NR: not provided) unknown. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from tired, restless sleep, splitting headache, pain in all major muscles, hurts everywhere, no energy, lethargic, nausea, low grade fever under 99 F, flushed, feels worse every day, woozy and unsteady, and a bit tight in the bottom of his chest. This report was non-serious.; Sender''s Comments: V0: Medical Assessment Comment not required as per standard procedure as the case assessed as non-serious


VAERS ID: 1261236 (history)  
Form: Version 2.0  
Age: 22.0  
Sex: Male  
Location: California  
Vaccinated:0000-00-00
Onset:2021-04-10
Submitted: 0000-00-00
Entered: 2021-04-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN UNKNOWN / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Constipation, Decreased immune responsiveness, Feeling abnormal, Nausea, Viral infection
SMQs:, Acute pancreatitis (broad), Dementia (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Pneumonia (The patient had pneumonia at the age of 12.); Comments: The patient has no known drug allergies and was not on any medications.
Allergies:
Diagnostic Lab Data:
CDC Split Type: USJNJFOC20210431111

Write-up: POSSIBLE INFECTION DUE TO LOW IMMUNITY; CAUGHT ANOTHER VIRUS; CONSTIPATION; FELT VERY BAD; NAUSEA; This spontaneous report received from a parent concerned a 22 year old male. The patient''s height, and weight were not reported. The patient''s past medical history included pneumonia, and other pre-existing medical conditions included no known drug allergies and was not on any medications. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown, and expiry: Unknown) dose was not reported, 1 total administered on 10-APR-2021 10:00 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 10-APR-2021, the patient felt very bad, had some constipation followed by nausea and it continued until 12-APR-2021. On 13-APR-2021, the patient felt better, then On 15-APR-2021, the patient got admitted to the hospital for possible infection due to low immunity and caught another virus. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from constipation, felt very bad, and nausea on 13-APR-2021, and the outcome of possible infection due to low immunity, caught another virus was not reported. This report was serious (Hospitalization Caused / Prolonged).; Sender''s Comments: 20210431111-Covid-19 vaccine ad26.cov2.s-Possible infection due to low immunity and caught another virus. These events are considered unassessable. The events has a compatible/suggestive temporal relationship, are unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the events.


VAERS ID: 1261299 (history)  
Form: Version 2.0  
Age: 25.0  
Sex: Female  
Location: Pennsylvania  
Vaccinated:0000-00-00
Onset:2021-04-10
Submitted: 0000-00-00
Entered: 2021-04-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN UNKNOWN / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Abdominal discomfort, Blood test, Chills, Contusion, Fatigue, Headache, Pain, Paraesthesia, Peripheral swelling
SMQs:, Cardiac failure (broad), Angioedema (broad), Peripheral neuropathy (broad), Haemorrhage terms (excl laboratory terms) (narrow), Gastrointestinal perforation, ulcer, haemorrhage, obstruction non-specific findings/procedures (broad), Guillain-Barre syndrome (broad), Accidents and injuries (narrow), Extravasation events (injections, infusions and implants) (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Haemodynamic oedema, effusions and fluid overload (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: ADHD; Hay fever
Preexisting Conditions: Comments: Unknown
Allergies:
Diagnostic Lab Data: Test Date: 20210414; Test Name: Blood test; Result Unstructured Data: Normal
CDC Split Type: USJNJFOC20210437954

Write-up: BRUISE ON BOTTOM OF RIGHT LEG; TINGLING IN LEGS; SWELLING OF LEGS; UPSET STOMACH; BODY ACHES; CHILLS; EXHAUSTION; HEADACHE; 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 ADHD, and hay fever. 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-APR-2021 for prophylactic vaccination. No concomitant medications were reported. Batch number was not reported and has been requested. On 10-APR-2021, the patient experienced upset stomach. On 10-APR-2021, the patient experienced body aches. On 10-APR-2021, the patient experienced chills. On 10-APR-2021, the patient experienced exhaustion. On 10-APR-2021, the patient experienced headache. On 14-APR-2021, the patient experienced bruise on bottom of right leg. On 14-APR-2021, the patient experienced tingling in legs. On 14-APR-2021, the patient experienced swelling of legs. Laboratory data included: Blood test (NR: not provided) Normal. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from tingling in legs, and swelling of legs, and upset stomach, body aches, chills, exhaustion, and headache on 11-APR-2021, and had not recovered from bruise on bottom of right leg. This report was non-serious.


VAERS ID: 1261318 (history)  
Form: Version 2.0  
Age: 40.0  
Sex: Female  
Location: Michigan  
Vaccinated:0000-00-00
Onset:2021-04-10
Submitted: 0000-00-00
Entered: 2021-04-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 043A21A / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Dizziness, Headache, Vision blurred
SMQs:, Anticholinergic syndrome (broad), Glaucoma (broad), Lens disorders (broad), Retinal disorders (broad), Vestibular disorders (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Abstains from alcohol; Non-smoker
Preexisting Conditions: Comments: The patient had no drug abuse or illicit drug use.
Allergies:
Diagnostic Lab Data:
CDC Split Type: USJNJFOC20210439424

Write-up: BLURRY VISION; DIZZINESS; HEADACHE; This spontaneous report received from a patient concerned a 40 year old female. The patient''s height, and weight were not reported. The patient''s concurrent conditions included abstains from alcohol, and non smoker, and other pre-existing medical conditions included the patient had no drug abuse or illicit drug use. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 043A21A, expiry: UNKNOWN) dose was not reported, administered on 09-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 10-APR-2021, the subject experienced blurry vision. On 10-APR-2021, the subject experienced dizziness. On 10-APR-2021, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from headache, blurry vision, and dizziness. This report was non-serious.


VAERS ID: 1261376 (history)  
Form: Version 2.0  
Age: 64.0  
Sex: Male  
Location: Washington  
Vaccinated:2021-04-08
Onset:2021-04-10
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-04-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / 1 LA / IM

Administered by: Military       Purchased by: ?
Symptoms: Headache, Pain, Vision blurred
SMQs:, Anticholinergic syndrome (broad), Glaucoma (broad), Lens disorders (broad), Retinal 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: Nexium, venlafaxine hcl, atvoristatin, Advair hfa, Spiriva, celebrex, Proair, multivitamin, fish oil, zinc, vitamin D
Current Illness: None
Preexisting Conditions: Asthma, Barrett''s esophagus, GERD, DDD,
Allergies: N/A
Diagnostic Lab Data: None
CDC Split Type:

Write-up: Mild aches and headache, mild blurred vision for 2+ weeks


VAERS ID: 1261712 (history)  
Form: Version 2.0  
Age: 53.0  
Sex: Female  
Location: Pennsylvania  
Vaccinated:2021-04-09
Onset:2021-04-10
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-04-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ER8729 / 2 RA / -

Administered by: Unknown       Purchased by: ?
Symptoms: Disease recurrence, Loss of consciousness, Syncope
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), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Hypothyroidism; Penicillin allergy; Vegetable allergy
Allergies:
Diagnostic Lab Data:
CDC Split Type: USPFIZER INC2021394846

Write-up: pass out; Vasovagal syncope; passed out again; This is a spontaneous report from a contactable consumer (Patient). A 53-year-old female patient (Non-pregnant) received second dose of BNT162B2 (Pfizer Covid-19 vaccine, Lot number ER8729 expiry date: unknown) via an unspecified route of administration at right arm as a single dose on 09Apr2021 03:00 PM, for Covid-19 immunization. Medical history included Hypothyroid, She had known allergies to Anti-Inflammatory, aspirin, penicillin, codein, ginger and horse radish. Concomitant medications were not reported. The patient received first dose of BNT162B2 (Pfizer Covid-19 vaccine, Lot number: EP7534 expiry date: unknown) via an unspecified route of administration at right arm as a single dose on 19Mar2021 04:00 PM, for Covid-19 immunization. On 10Apr2021 at 03:00 am, she woke to go to the bathroom feeling fine, after getting up from the toilet she saw stars and felt and had a Vasovagal syncope. When she woke up, she tried to get and pass out again. She woke up and was able to walk to my bed and passed out again when she reached the bed. She did not receive treatment for the events. She did not have any other vaccine in four weeks prior to suspect. She did not have Covid prior vaccination nor was she tested for Covid post vaccination. The patient had recovered from the events of pass out, vasovagal syncope and passed out again. No further information was available.


VAERS ID: 1261736 (history)  
Form: Version 2.0  
Age: 71.0  
Sex: Female  
Location: Missouri  
Vaccinated:2021-04-10
Onset:2021-04-10
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-04-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EN6207 / 1 - / -

Administered by: Unknown       Purchased by: ?
Symptoms: Arthropod sting, Erythema, Eyelids pruritus, Feeling abnormal, Haemorrhage, Insomnia, Pain, Peripheral swelling, Pruritus, Scab, Urticaria
SMQs:, Cardiac failure (broad), Anaphylactic reaction (broad), Angioedema (narrow), Haemorrhage terms (excl laboratory terms) (narrow), Dementia (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Periorbital and eyelid disorders (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: ELIQUIS; TAMSULOSIN; IRON
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: USPFIZER INC2021400961

Write-up: Blood was coming through; Slight bee stings all over and thigh; Scabs on me; my eyelids have been a little itchy too; that was the only way that I am able to get some sleep; was miserable; consumer was in pain; hives; the same day I started to itch, it was mild across my breast and my stomach but my thighs and my bottom legs were turning red, swelling; but my thighs and my bottom legs were turning red/Thighs/Legs turned red; but my thighs and my bottom legs were turning red, swelling; This is a spontaneous report from a contactable consumer (patient). A 71-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) at the age of 71-year-old, via an unspecified route of administration on 10Apr2021 13:30 (Lot Number: EN6207) as single dose for COVID-19 immunisation. The patient''s medical history was not reported. Concomitant medications included apixaban (ELIQUIS), tamsulosin, and iron. The patient got her first injection on Saturday, 10Apr2021 at 1:30 pm in the afternoon around 7 o''clock the same day she started to itch, it was mild across her breast and stomach but her thighs and bottom legs were turning red, swelling, hives there too, and she rubbed alcohol (treatment) on this to stop the itch, that seems to helped a little bit, but the swelling was not that bad today but the redness was still there. She has scabs on her, blood was coming through, and slight bee stings all over and thigh on an unspecified date, she used hydrocortisone cream (treatment), she was lucky she have some of that here because she keep that when going or here but she rubbed that on last night and that was the only way that she was able to get some sleep. The patient doesn''t think that she was going to get the second shot, she doesn''t want to experience that again. It feels like that today it was not that bad itching today but at 71 that was miserable yesterday so probably she would not get the second shot. She hopes that the first one can protect her to a point, but she cannot subject herself to that again, that would be senseless for her to experience that again and get a second shot. The patient also stated that her eyelids have been a little itchy too so hopefully you all understand it was 71 years old was suffering from that kind of misery second time. The patient was unable to probe the more question, patient was in pain and not willing to proceed. The outcome of the events was unknown.


VAERS ID: 1261765 (history)  
Form: Version 2.0  
Age: 20.0  
Sex: Female  
Location: Pennsylvania  
Vaccinated:2021-04-08
Onset:2021-04-10
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-04-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EP6955 / 2 RA / -

Administered by: Unknown       Purchased by: ?
Symptoms: Genital herpes, Vulvovaginal pain
SMQs:, Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: USPFIZER INC2021403764

Write-up: extreme pain in the vaginal area and noticed I had some bumps; vaginal area noticed had some bumps/ herpes; This is a spontaneous report from a contactable consumer (patient). A 20-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EP6955) via unspecified route on right arm single dose for COVID-19 immunisation on 08Apr2021, 05:30 PM, at 20-year-old. Medical history included: allergies: sulfamethoxazole, trimethoprim (BACTRIM). Concomitant medication was not reported. The patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EP6955) on right arm for COVID-19 immunization on 20Mar2021, 10:30 AM, at 20-year-old. Two days after having second shot (10Apr2021, 08:00 PM), the patient started to experience extreme pain in the vaginal area and noticed had some bumps. The patient went to the hospital and the doctors believed it to be herpes. No test results have not come back yet. They Believed the virus had been asymptomatic prior and getting the vaccine triggered an outbreak. Emergency room/department or urgent care visited and was reported as hospitalized. Treatment received included: antiviral medication and pain medications. Outcome of the events was not resolved.


VAERS ID: 1261792 (history)  
Form: Version 2.0  
Age: 60.0  
Sex: Male  
Location: Maryland  
Vaccinated:2021-03-30
Onset:2021-04-10
   Days after vaccination:11
Submitted: 0000-00-00
Entered: 2021-04-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0150 / 1 RA / -

Administered by: School       Purchased by: ?
Symptoms: Sudden visual loss, Visual acuity tests
SMQs:

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: SYNTHROID; LATANOPROST; TIMOLOL; GLATIRAMER ACETATE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: MS
Allergies:
Diagnostic Lab Data: Test Name: vision; Result Unstructured Data: Test Result:normal; Comments: Previous day/night vision was normal; Test Date: 20210410; Test Name: vision; Result Unstructured Data: Test Result:vision in his left eye deteriorated 90 %
CDC Split Type: USPFIZER INC2021404692

Write-up: Significant sudden lost of vision on left eye.; This is a spontaneous report from a contactable consumer (patient). A 60-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot EW0150), via an unspecified route of administration, administered in right arm on 30Mar2021 02:30 as single dose for COVID-19 immunisation. Medical history included remitting multiple sclerosis (MS). The patient had no known allergies. Concomitant medications included levothyroxine sodium (SYNTHROID), latanoprost, timolol and glatiramer acetate. On 10Apr2021 09:30, the patient experienced significant sudden lost of vision on left eye. Previous day/night vision was normal then all of the sudden, after a week and a half from first dose of Covid-19 vaccination, vision in his left eye deteriorated 90 percent. The event resulted in disability or permanent damage. The patient did not receive therapy for the event. The patient had no covid prior vaccination and was not covid tested post vaccination. Outcome of event was not recovered.


VAERS ID: 1262037 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Puerto Rico  
Vaccinated:0000-00-00
Onset:2021-04-10
Submitted: 0000-00-00
Entered: 2021-04-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN UNKNOWN / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Abortion spontaneous, Exposure during pregnancy, Pain, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Termination of pregnancy and risk of abortion (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: PRJNJFOC20210430100

Write-up: MISCARRIAGE; VACCINE EXPOSURE DURING PREGNANCY; BODY ACHES; FEVER; This spontaneous report received from a consumer (company representative) concerned an female of unspecified age. The patient''s height, and weight were not reported. The patient was gravida 1, para 0. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, 1 total administered on 10-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 10-APR-2021, the patient experienced body aches and fever. On 10-APR-2021, the patient was pregnant when she had vaccine. On 12-APR-2021, the patient experienced hemorrhage, miscarriage (spontaneous abortion) and was hospitalized (date unspecified). The duration of hospitalization was not reported. The date of patient''s last menstrual period and expected delivery date were not reported. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the fever, body aches, miscarriage and vaccine exposure during pregnancy was not reported. This report was serious (Other Medically Important Condition). .; Sender''s Comments: V0: -covid-19 vaccine ad26.cov2.s-miscarriage, vaccine exposure during pregnancy. 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: 1262220 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Washington  
Vaccinated:0000-00-00
Onset:2021-04-10
Submitted: 0000-00-00
Entered: 2021-04-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 202A21A / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Anxiety, Chills, Fatigue, Headache, Nausea, Vomiting
SMQs:, Acute pancreatitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Graves'' disease; Headache; Penicillin allergy
Preexisting Conditions: Medical History/Concurrent Conditions: Radioactive iodine therapy
Allergies:
Diagnostic Lab Data:
CDC Split Type: USJNJFOC20210431848

Write-up: HEADACHE; ANXIETY ATTACK; VOMITING; CHILLS; FATIGUE; NAUSEA; This spontaneous report received from a patient concerned a female of unspecified age. The patient''s height, and weight were not reported. The patient''s past medical history included radioactive iodine, and concurrent conditions included penicillin allergy, graves disease, and headache. 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 09-APR-2021 11:15 for prophylactic vaccination. No concomitant medications were reported. On 10-APR-2021, the subject experienced vomiting. On 10-APR-2021, the subject experienced chills. On 10-APR-2021, the subject experienced fatigue. On 10-APR-2021, the subject experienced nausea. On 11-APR-2021, the subject experienced anxiety attack. On an unspecified date, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from anxiety attack on 12-APR-2021, vomiting, chills, and nausea on 10-APR-2021, and fatigue on 11-APR-2021, and had not recovered from headache. This report was non-serious.; Sender''s Comments: MAC; V0: Medical assessment comment not required as per standard procedure as case assessed as non-serious


VAERS ID: 1262382 (history)  
Form: Version 2.0  
Age: 67.0  
Sex: Male  
Location: Michigan  
Vaccinated:2021-04-06
Onset:2021-04-10
   Days after vaccination:4
Submitted: 0000-00-00
Entered: 2021-04-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

Administered by: Pharmacy       Purchased by: ?
Symptoms: SARS-CoV-2 test
SMQs:, 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? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Zoloft, Prevacid
Current Illness:
Preexisting Conditions:
Allergies: Sulfa
Diagnostic Lab Data:
CDC Split Type:

Write-up: Tested for Covid 8 days after vaccination


VAERS ID: 1262525 (history)  
Form: Version 2.0  
Age: 59.0  
Sex: Male  
Location: Texas  
Vaccinated:2021-04-06
Onset:2021-04-10
   Days after vaccination:4
Submitted: 0000-00-00
Entered: 2021-04-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

Administered by: Unknown       Purchased by: ?
Symptoms: Abdominal pain upper, Disturbance in attention, Feeling abnormal, Headache
SMQs:, Acute pancreatitis (broad), Dementia (broad), Noninfectious encephalopathy/delirium (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Depression (excl suicide and self injury) (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: Fluvastatin, L-thyroxine, Lorazepam, Amlodipine, Vitamin D
Current Illness: none
Preexisting Conditions:
Allergies: none
Diagnostic Lab Data:
CDC Split Type:

Write-up: headache, brain fog, stomach craps, lack of concentration (symptoms of POTS)


VAERS ID: 1262640 (history)  
Form: Version 2.0  
Age: 68.0  
Sex: Male  
Location: South Dakota  
Vaccinated:2021-04-09
Onset:2021-04-10
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-04-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

Administered by: Private       Purchased by: ?
Symptoms: Arthralgia, Blood pressure increased, Chills, Computerised tomogram head, Computerised tomogram neck, Dyspnoea, Enlarged uvula, Fatigue, Full blood count, Laboratory test, Neck pain, Oropharyngeal pain, Oxygen saturation decreased, Rash erythematous
SMQs:, Anaphylactic reaction (narrow), Neuroleptic malignant syndrome (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Hypertension (narrow), Cardiomyopathy (broad), Hypersensitivity (narrow), Arthritis (broad), Respiratory failure (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (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: lisinopril, levothyroxin, rosovastatin, vitamin D, tumeric, zinc, fish oil, protandim
Current Illness: None
Preexisting Conditions: hypertension,
Allergies: None
Diagnostic Lab Data: CT head and neck and CBC and chemistries in ER.
CDC Split Type:

Write-up: Flat red rash with bumps started on back day after vaccine. About one week later shoulder and neck pain. A few days after that chills and fatigue and increased neck pain requiring emergency room visit. Had fever, elevated BP and decreased oxygen level with extreme neck pain. Treated and released with medication. Negative CT of head and neck. Next day had extremely swollen uvula and sore throat requiring sleeping elevated to breath. Throat was not examined in ER night before. Unable to get up by himself and slept for 27 hrs except for occasional trip to bathroom. He is recovering now.


VAERS ID: 1262820 (history)  
Form: Version 2.0  
Age: 49.0  
Sex: Male  
Location: Michigan  
Vaccinated:2021-04-02
Onset:2021-04-10
   Days after vaccination:8
Submitted: 0000-00-00
Entered: 2021-04-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / 1 LA / SYR

Administered by: Private       Purchased by: ?
Symptoms: Muscle spasms
SMQs:, Dystonia (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: Emghality shot, Verapamil, Montelucast, Xyzol, immatrex (as needed), tamasulusin.
Current Illness:
Preexisting Conditions: Migraines
Allergies: beta blockers Penicillin all forms of MSG
Diagnostic Lab Data:
CDC Split Type:

Write-up: about 8 days after receiving my shot, i noticed muscle cramping in my hands, legs and feet. As of today, I still have some cramping but not as bad.


VAERS ID: 1263002 (history)  
Form: Version 2.0  
Age: 27.0  
Sex: Female  
Location: Washington  
Vaccinated:2021-04-10
Onset:2021-04-10
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-04-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / N/A RA / SYR

Administered by: Pharmacy       Purchased by: ?
Symptoms: Abdominal pain upper, Arthralgia, Blood test normal, Body temperature increased, Chills, Dehydration, Diarrhoea, Dizziness, Fatigue, Headache, Myalgia, Nausea, Sleep disorder, Urine analysis normal
SMQs:, Rhabdomyolysis/myopathy (broad), Acute pancreatitis (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Pseudomembranous colitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Eosinophilic pneumonia (broad), Vestibular disorders (broad), Arthritis (broad), Noninfectious diarrhoea (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: Birth control - Lo lo estrogen SE; fish oil; Vit D
Current Illness: none
Preexisting Conditions: none
Allergies: allergies to amoxicillin (potential)
Diagnostic Lab Data: Ran a full blood panel; regular diagnostic testing and a urine sample - all came back normal.
CDC Split Type: vsafe

Write-up: The first night, around 06:00-07:00 pm, I had pretty intense muscle pain/myalgia. Joint pain; 101 degrees, chills and headache - these lessened but still continued into unspecified day- Fatigue and Muscle pain lasted the whole 12 days. (. Unspecified date in the night into the next day - I had stomach pain ,nausea, diarrhea, dizziness and I decided to go to unspecified hospital - symptoms were getting worse. They gave me an IV treatment. They provided my the IV because I was dehydrated and then told me to wait it out.


VAERS ID: 1263026 (history)  
Form: Version 2.0  
Age: 17.0  
Sex: Male  
Location: Minnesota  
Vaccinated:2021-04-10
Onset:2021-04-10
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-04-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 203A21A / N/A LA / 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? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Unknown
Current Illness: Unknown
Preexisting Conditions: Unknown
Allergies: None listed
Diagnostic Lab Data:
CDC Split Type:

Write-up: Client presented for covid vaccination. J & J vaccine was being administered at this site. Client put age "18" on the registration form. Nurse verified age by circling age per our process and verbally asked client who stated "18" and vaccinated client. Data entry discovered that client''s birthdate was 4/11/2003 so he was actually one day shy of being 18.


VAERS ID: 1263160 (history)  
Form: Version 2.0  
Age: 63.0  
Sex: Female  
Location: Florida  
Vaccinated:2021-04-10
Onset:2021-04-10
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-04-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 20121A / N/A RA / IM

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Cromolyn Sodium, Levocetirizine, Lisinopril -HCTZ, Montelukast, Omeprazole,
Current Illness:
Preexisting Conditions: Cannabis use, chronic Fatigue, cocaine use, GERD, Hypertension, Tobacco Use, Cardiac Murmur
Allergies: Aspirin
Diagnostic Lab Data:
CDC Split Type:

Write-up: From patient to after hours provider with c/o head and leg pain after Johnson & Johnson CVD19 vaccine. She states symptoms started 24 hours after vaccine and has not resolved. Patient advised to proceed to the nearest ER for evaluation for potential side effect due to J&J vaccine. Patient states understanding.


VAERS ID: 1263318 (history)  
Form: Version 2.0  
Age: 41.0  
Sex: Female  
Location: Unknown  
Vaccinated:2021-04-10
Onset:2021-04-10
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-04-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

Administered by: Unknown       Purchased by: ?
Symptoms: Chills, Decreased appetite, Diarrhoea, Nausea, Pyrexia, Rash, Skin burning sensation
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Peripheral neuropathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Pseudomembranous colitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hypersensitivity (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? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Non-urticarial rash on upper body. Fever of 102. Burning/paresthesia in arms/neck/back. Nausea. Chills. Diarrhea. Decreased appetite.


VAERS ID: 1263321 (history)  
Form: Version 2.0  
Age: 42.0  
Sex: Male  
Location: Minnesota  
Vaccinated:2021-04-02
Onset:2021-04-10
   Days after vaccination:8
Submitted: 0000-00-00
Entered: 2021-04-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / 1 LA / SYR

Administered by: Private       Purchased by: ?
Symptoms: Back pain, Eye pain, Facial paralysis, Facial paresis, Fatigue, Myalgia, Ocular discomfort, Oropharyngeal pain, Pain of skin, Photophobia, Plasmapheresis, Sciatica, Sensitive skin
SMQs:, Rhabdomyolysis/myopathy (broad), Retroperitoneal fibrosis (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious meningitis (narrow), Glaucoma (broad), Corneal disorders (broad), Eosinophilic pneumonia (broad), Retinal disorders (broad), Hearing impairment (broad), Tendinopathies and ligament disorders (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, 10 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: None
Current Illness: None
Preexisting Conditions: None
Allergies: Coconut flesh/milk BHA BHT TBHA food preservatives
Diagnostic Lab Data: I am still in the hospital. If this is important I can provide my medical records.
CDC Split Type:

Write-up: On 4/10 I started feeling tired with muscle aches. A few days later my skin started to hurt. Clothing was uncomfortable when it moved across my skin. Those symptoms lasted about a week. Then as they started to lessen I had some back pain (Sciatic) and a sore throat. Also the muscles behind my eyes were slightly painful and bright lights were uncomfortable. Then about 4/21 most of the symptoms reduced and I was feeling close to normal. Then on 4/22 I was brushing my teeth and noticed that I couldn?t spit water like normal. I called my GP doc and she recommended I head to the ER. After thinking about it I also remember on 4/21 while drinking something I had some water squirt out of my lips. At the time I thought I was just being clumsy but in hindsight the muscle weakness in my face started on 4/20. I checked into the ER on 4/22. When I checked into the hospital my facial weakness was very difficult to notice. By the evening of 4/22 it was noticeable if I tried to ?show my teeth? or make a big smile. By the morning of 4/23 it was very noticeable. The morning of 4/24 I couldn?t move my lips, nose or eyebrows. My tongue, jaw and throat were not impacted at all. I was started on plasmapheresis on 4/24. I had another treatment on 4/25. I noticed facial weakness was very slightly recovering the evening of 4/25. By 4/27 my facial weakness is still healing with noticeable improvement day to day.


VAERS ID: 1263828 (history)  
Form: Version 2.0  
Age: 54.0  
Sex: Male  
Location: New Mexico  
Vaccinated:2021-04-08
Onset:2021-04-10
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-04-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / 1 RA / SYR

Administered by: Other       Purchased by: ?
Symptoms: Anticoagulant therapy, Auditory disorder, Chest pain, Computerised tomogram abnormal, Computerised tomogram thorax abnormal, Deep vein thrombosis, Dizziness, Dyspnoea, Fibrin D dimer increased, Peripheral coldness, Peripheral swelling, Pulmonary embolism, Vertigo
SMQs:, Cardiac failure (broad), Anaphylactic reaction (broad), Angioedema (broad), Haemorrhage laboratory terms (broad), Anticholinergic syndrome (broad), Embolic and thrombotic events, venous (narrow), Thrombophlebitis (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Extravasation events (injections, infusions and implants) (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad), Hearing impairment (narrow), Vestibular disorders (narrow)

Life Threatening? Yes
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Moringa Maca Beet powder Bee pollen Spirulina Elderberry concentrate Allegra-D
Current Illness: N/A
Preexisting Conditions: N/A
Allergies: Erythromycin
Diagnostic Lab Data: I was admitted to the ER on 4/12/21. Was tested for D-Dimer and high level found.
CDC Split Type:

Write-up: I was admitted to the ER on 4/12/21 with dizziness, lightheadedness, vertigo, some auditory issues, shortness of breath, swelling/puffiness of legs and feet, unusual coldness in extremities, and some minor pain in chest. CT-Scan revealed DVT in left leg and PEs in both lungs. Was given two shots of heparin over a 24-hour period and then Xarelto 15mg (oral) the following day.


VAERS ID: 1264141 (history)  
Form: Version 2.0  
Age: 60.0  
Sex: Female  
Location: Florida  
Vaccinated:2021-04-10
Onset:2021-04-10
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-04-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / 1 LA / SYR

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

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

Write-up: Headache everyday for over 2 weeks now, has not gone away. Arm is still sore


VAERS ID: 1264332 (history)  
Form: Version 2.0  
Age: 50.0  
Sex: Female  
Location: Wyoming  
Vaccinated:2021-04-10
Onset:2021-04-10
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-04-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 043A21A / 1 LA / IM

Administered by: Public       Purchased by: ?
Symptoms: Blood test normal, Dizziness, Electrocardiogram normal, Fall, Fatigue, Hypertension, Injection site hypoaesthesia, Limb discomfort, Movement disorder, Nausea, Pain, Pain in extremity, Paraesthesia, Syncope, Ultrasound scan normal, Vision blurred
SMQs:, Torsade de pointes/QT prolongation (broad), Acute pancreatitis (broad), Peripheral neuropathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Akathisia (broad), Dyskinesia (broad), Dystonia (broad), Parkinson-like events (broad), Guillain-Barre syndrome (broad), Accidents and injuries (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Glaucoma (broad), Hypertension (narrow), Cardiomyopathy (broad), Lens disorders (broad), Retinal disorders (broad), Vestibular disorders (broad), Hypotonic-hyporesponsive episode (broad), Tendinopathies and ligament disorders (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: propanol 10mg for HTN
Current Illness:
Preexisting Conditions: hx HTN
Allergies: NKA
Diagnostic Lab Data: 04/14/21- U/S, blood work, EKG-all WNL
CDC Split Type:

Write-up: 04/10/221-post vaccination-syncopy episode, supported fall to the ground, dizziness, blurred vision, nausea, high BP 194/118, stabilized at 187/110 ( already on propanol 10mg), BS 82, Pox 97,Medics responded, tx w/ Zofran, sent home wi/ family support/supervision. Instruc to be seen by MD on Mon 4/12, as ct has hx significant HTN, if increase H/A, dizziness or blurred vision to go to ER. 04/14/2021-4 days post vaccination-ct c/o pain, tingling, heaviness L arm (arm vaccine given in)numbness L side, fatigue, achy all over, instructed to go to ER r/t high BP, ER reported-EKG, blood work, ultrasound all negative. Instructed to take Ibuprofan alternated with Tylenol x 24 hrs for arm pain, and to make appt with


VAERS ID: 1264401 (history)  
Form: Version 2.0  
Age: 57.0  
Sex: Female  
Location: Georgia  
Vaccinated:0000-00-00
Onset:2021-04-10
Submitted: 0000-00-00
Entered: 2021-04-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 042A21A / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Abdominal pain, Diarrhoea, Insomnia, Nausea, Oropharyngeal pain, Pain, Peripheral swelling, Rash pruritic, Swelling, Vomiting
SMQs:, Cardiac failure (broad), Anaphylactic reaction (broad), Acute pancreatitis (broad), Angioedema (broad), Retroperitoneal fibrosis (broad), Pseudomembranous colitis (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Extravasation events (injections, infusions and implants) (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (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? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Comments: patient had No underlying medical conditions.
Allergies:
Diagnostic Lab Data:
CDC Split Type: USJNJFOC20210436541

Write-up: SWELLING OF FACE, TONGUE, ARMS AND HANDS; VOMITING; NAUSEA; ABDOMINAL PAIN; SWELLING OF FEET; COULDN''T SLEEP; ITCHY RASH; DIARRHEA; PAIN ALL OVER; SORE THROAT; 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 pre-existing medical conditions included patient had no underlying medical conditions. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 042A21A, and expiry: UNKNOWN) dose was not reported, administered on 08-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 10-APR-2021, the patient experienced pain all over the body, sore throat. On 12-APR-2021, the patient experienced rash. On 13-APR-2021, the patient experienced diarrhea, itching. On 14-APR-2021, the patient experienced abdominal pain, swelling of feet, could not sleep. On 15-APR-2021, the patient experienced swelling of face, tongue, arms and hands, nausea and vomiting. She went to clinic to see a doctor and doctor told the patient to go to ER. In Emergency room, they gave her intravenous fluids and medicine for the nausea and vomiting. All her symptoms were improving but she was worried that she will still have swelling and rash with the itching. She only slept for about 4 hours at night. She did not have insurance and medical bills got expensive and was worried. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from vomiting, and nausea on 15-APR-2021, was recovering from abdominal pain, diarrhea, pain all over, sore throat, and couldn''t sleep, and had not recovered from swelling of face, tongue, arms and hands, swelling of feet, and itchy rash. This report was serious (Other Medically Important Condition). .; Sender''s Comments: V0;-covid-19 vaccine ad26.cov2. s-swelling of face, tongue, arms, hands and abdominal pain. This events are considered unassessable. The events had a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the events.


VAERS ID: 1264409 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Unknown  
Vaccinated:0000-00-00
Onset:2021-04-10
Submitted: 0000-00-00
Entered: 2021-04-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN UNKNOWN / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Epistaxis, Migraine, Nausea, Pyrexia, Visual impairment
SMQs:, Acute pancreatitis (broad), Haemorrhage terms (excl laboratory terms) (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Glaucoma (broad), Optic nerve disorders (broad), Lens disorders (broad), Retinal 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: Stevens-Johnson syndrome
Preexisting Conditions: Comments: Unknown
Allergies:
Diagnostic Lab Data:
CDC Split Type: USJNJFOC20210438162

Write-up: CHRONIC MIGRAINE; VISUAL DISTURBANCE/AFFECTED VISION; BAD NOSE BLEED; LOW FEVER; NAUSEA; This spontaneous report received from a patient concerned a 37 year old female. The patient''s height, and weight were not reported. The patient''s concurrent conditions included stevens johnson syndrome from med. The patient was previously treated with macrogol 4000. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 09-APR-2021 for prophylactic vaccination. The batch number was not reported an has been requested. No concomitant medications were reported. On 10-APR-2021, the subject experienced low fever. On 10-APR-2021, the subject experienced nausea. On 17-APR-2021, the subject experienced bad nose bleed. On an unspecified date, the subject experienced chronic migraine, and visual disturbance/affected vision. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the chronic migraine, low fever, nausea, bad nose bleed and visual disturbance/affected vision was not reported. This report was non-serious.; Sender''s Comments: V0:Medical assessment comment not required as per standard procedure as case assessed as non serious.


VAERS ID: 1264465 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Minnesota  
Vaccinated:0000-00-00
Onset:2021-04-10
Submitted: 0000-00-00
Entered: 2021-04-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 042A21A / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Abdominal pain upper, Chills, Headache, Night sweats, 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: USJNJFOC20210448627

Write-up: CHILLS SOMETIMES COME WITH NIGHT SWEATS; OCCASIONALLY CHILLS; OCCASIONALLY HEADACHE; FEVER; ABDOMINAL PAIN (STOMACH ACHE); 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: 042A21A, and batch number: 042A21A expiry: UNKNOWN) dose was not reported, administered on 10-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 10-APR-2021, the subject experienced abdominal pain (stomach ache). On an unspecified date, the subject experienced chills sometimes come with night sweats, occasionally chills, occasionally headache, and fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from fever, and had not recovered from abdominal pain (stomach ache), occasionally headache, occasionally chills, and chills sometimes come with night sweats. This report was non-serious.


VAERS ID: 1264477 (history)  
Form: Version 2.0  
Age: 40.0  
Sex: Female  
Location: Ohio  
Vaccinated:0000-00-00
Onset:2021-04-10
Submitted: 0000-00-00
Entered: 2021-04-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN UNKNOWN / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Paraesthesia
SMQs:, Peripheral neuropathy (broad), 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: No known medical history
Allergies:
Diagnostic Lab Data:
CDC Split Type: USJNJFOC20210450010

Write-up: SENSATION OF TICKLING PINS AND NEEDLES ON BOTH ARM TO HANDS; This spontaneous report received from a patient via a company representative concerned a 40 decade old female. The patient''s height, and weight were not reported. The patient''s pre-existing medical conditions included no known medical history. 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-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 10-APR-2021, the subject experienced sensation of tickling pins and needles on both arm to hands. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from sensation of tickling pins and needles on both arm to hands on APR-2021. This report was non-serious.


VAERS ID: 1264610 (history)  
Form: Version 2.0  
Age: 61.0  
Sex: Female  
Location: Pennsylvania  
Vaccinated:2021-04-09
Onset:2021-04-10
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-04-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / 1 RA / IM

Administered by: Private       Purchased by: ?
Symptoms: Abnormal faeces, Headache, Pyrexia, Taste disorder
SMQs:, Neuroleptic malignant syndrome (broad), Taste and smell disorders (narrow), Anticholinergic syndrome (broad), Biliary system related investigations, signs and symptoms (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Noninfectious diarrhoea (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: Wellbutrin 150 mg, Lamotrigine, Premarin, Buspirone Trazadone, Atorvistatin, Omeprazole, Bupropion, VitaminD, Docusate Sodium 100 mg
Current Illness: None
Preexisting Conditions: Chronic pain issues, several shoulder and back surgeries
Allergies: Lyrica, Generic Fentynal patches (no longer on) Hydrocodone, Aspirin, Paroxetine, Betamethasone, Gabapentin, Pregabalin, Mitrazapine, Oxycodone
Diagnostic Lab Data: None
CDC Split Type:

Write-up: Fever and headache for several days. Day of vaccine I started with a funny taste in my mouth. I still have it almost 3 weeks later. I continue to taste it with whatever I eat.. This same taste/odor can be smelled when I have a bowel movement. The smell is so awful! That is why I am reporting this.


VAERS ID: 1265596 (history)  
Form: Version 2.0  
Age: 35.0  
Sex: Female  
Location: Ohio  
Vaccinated:2021-04-10
Onset:2021-04-10
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-04-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 1808982 / UNK RA / SYR

Administered by: Public       Purchased by: ?
Symptoms: Chest discomfort, Dizziness, Fatigue, Head discomfort, Headache, Malaise
SMQs:, Anaphylactic reaction (broad), Anticholinergic 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: None
Current Illness: None
Preexisting Conditions: Migraines and IBS
Allergies: Cipro-neurological: confusion, numbness in arm.
Diagnostic Lab Data: Not treated at a facility as no symptoms have matched the emergency symptoms for the rare blood clots associated with this vaccine. Checked my blood pressure and blood sugar at home due to light-headedness and all numbers within normal range.
CDC Split Type:

Write-up: About 4 hours after the vaccine I felt light-headed, got a mild headache, and felt generally unwell. Days 2-4 I had further episodes of light-headedness, fatigue, and felt pressure in my head (no headache, just pressure) Days 4-6 I had fatigue and tired very easily with physical activity, some episodes of light-headedness, and chest tightness (but no pain when taking a deep breath) Days 7-17 Fatigue similar to when I had mononucleosis, tire very easily with physical activity, less frequent episodes of light-headedness. No severe headaches, no sharp pains in chest or abdomen, no pain in legs. No excessive bleeding.


VAERS ID: 1265628 (history)  
Form: Version 2.0  
Age: 21.0  
Sex: Female  
Location: Texas  
Vaccinated:2021-04-09
Onset:2021-04-10
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-04-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA I DONT KNOW / 1 LA / SYR

Administered by: Unknown       Purchased by: ?
Symptoms: Burning sensation, Pruritus genital, Urinary incontinence
SMQs:, Peripheral neuropathy (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: Birth control, zoloft.
Current Illness: None
Preexisting Conditions: Nine
Allergies: Pineapple
Diagnostic Lab Data:
CDC Split Type:

Write-up: I woke up with a very itchy and burning sensation in my private area. My mom suggested it was a uti, but I have never had one before and didnt do anything that could have caused it. Im better now, still leaking some urine. I have found 100s of women my age online who say they got their first ever uti after the covid vaccine, but I cant find any data on it as a possible effect.


VAERS ID: 1265643 (history)  
Form: Version 2.0  
Age: 41.0  
Sex: Female  
Location: California  
Vaccinated:2021-04-10
Onset:2021-04-10
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-04-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ER8734 / 1 AR / IM

Administered by: Other       Purchased by: ?
Symptoms: Arthralgia, Blood test, Erythema, Motor dysfunction, Periorbital swelling, Pruritus, Pyrexia, Swelling
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Peripheral neuropathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Akathisia (broad), Dyskinesia (broad), Dystonia (broad), Parkinson-like events (broad), Guillain-Barre syndrome (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Periorbital and eyelid disorders (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? Yes
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: albuterol inhaler, as needed.
Current Illness: none
Preexisting Conditions: mild asthma allergic rhinitis
Allergies: Amoxicillin Aspirin Latex Banana Kiwi Shellfish
Diagnostic Lab Data: visit to allergist 4/27/21. Polyethylene glycol testing scheduled for 4/30/21.
CDC Split Type:

Write-up: She received the vaccine via drive through at the local fairgrounds. Notes she developed swelling around her eyes within an hour. After 24 hours, she turned red, developed swelling on her entire body, and itchiness on her entire body. Notes her joints were painful; unable to make a fist with her hands. Also had a fever. No asthma symptoms. She called Urgent Care for advice, was recommended to take cetirizine or other antihistamines and pain medications. Patient took cetirizine and ibuprofen, symptoms resolved within a few hours. Still has some residual swelling around her eyes but notes it isn''t itchy.


VAERS ID: 1265950 (history)  
Form: Version 2.0  
Age: 60.0  
Sex: Female  
Location: Alabama  
Vaccinated:2021-04-09
Onset:2021-04-10
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-04-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 RA / -

Administered by: Unknown       Purchased by: ?
Symptoms: Cerebrovascular accident, Muscle spasms
SMQs:, Ischaemic central nervous system vascular conditions (narrow), Haemorrhagic central nervous system vascular conditions (narrow), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Dystonia (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 (diagnosed about 7-8 years ago.)
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: USPFIZER INC2021405868

Write-up: thought she was having a stroke; severe cramp in her left leg below the knee to her toes and it is extremely painful; This is a spontaneous report from a contactable consumer (patient). A 60-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration in the right arm on 09Apr2021 (Batch/Lot number was not reported) as single dose for covid-19 immunisation. Medical history included ongoing blood pressure high diagnosed about 7-8 years ago. The patient''s concomitant medications were not reported. The patient got her first dose of the Pfizer Covid vaccine on 09Apr2021. On Saturday, 10Apr2021, she got this severe cramp in her left leg below the knee to her toes and it is extremely painful and thought she was having stroke. She stated that she was treating with a warm cloth and was going to go to the emergency room; rubbing down in case there is a blood clot. She wanted to know if this could be from the vaccine. The outcome of the events was not recovered. Information on the lot/batch number has been requested.


VAERS ID: 1265960 (history)  
Form: Version 2.0  
Age: 40.0  
Sex: Female  
Location: Florida  
Vaccinated:2021-04-08
Onset:2021-04-10
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-04-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0153 / 1 LA / -

Administered by: Pharmacy       Purchased by: ?
Symptoms: Heavy menstrual bleeding
SMQs:, Haemorrhage terms (excl laboratory terms) (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: Medical History/Concurrent Conditions: Hypothyroidism; Progesterone decreased
Allergies:
Diagnostic Lab Data:
CDC Split Type: USPFIZER INC2021406150

Write-up: Super heavy period/bleeding through an overnight pad every 2-3 hours; This is a spontaneous report from a contactable consumer (patient) reported that a 40-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EW0153), via an unspecified route of administration, administered in arm left on 08Apr2021 14:45 (at the age of 40-years-old) as a single dose for covid-19 immunisation. The vaccine was administered at the Pharmacy/drug store. The patient was not pregnant at the time of vaccination. The patient medical history included low progesterone and low thyroid both from an unknown date. The patient did not had covid-19 prior vaccination. The patient''s concomitant medications were not reported. On 10Apr2021, the patient had super heavy period. She was bleeding through an overnight pad every 2-3 hours. They were supposed to last between 10-12 hours. This lasted for almost 2 days, unfortunately if was during the weekend or she would have sought medical help from her doctor. The patient did not received any treatment for the reported event. Not covid-19 tested post vaccination. The outcome of the event was recovered on 12Apr2021.


VAERS ID: 1265967 (history)  
Form: Version 2.0  
Age: 30.0  
Sex: Female  
Location: Nevada  
Vaccinated:2021-04-10
Onset:2021-04-10
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-04-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0162 / 1 LA / OT

Administered by: Public       Purchased by: ?
Symptoms: Hypersensitivity, Pruritus, Vaccination site hypoaesthesia
SMQs:, Anaphylactic reaction (broad), Angioedema (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Sulfonamide allergy
Allergies:
Diagnostic Lab Data:
CDC Split Type: USPFIZER INC2021406551

Write-up: Instant allergic reaction to injection; itchy; arm is numb where they injected the vaccine; This is a spontaneous report from a contactable consumer, the patient. A 30-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot Ew0162, first dose) solution for injection intramuscular in the left arm on 10Apr2021 at 11:30 (at the age of 30-years-old) as a single dose for COVID-19 immunization. The patient was not pregnant at the time of vaccination. Medical history included sulfa allergy. Concomitant medications were not reported. The patient did not receive any other vaccine within 4 weeks prior to the vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient had an instant allergic reaction to injection, it''s still very itchy, also my arm was numb where they injected the vaccine on 10Apr2021. The events resulted in doctor or other healthcare professional office/clinic visit. Treatment for the events included diphenhydramine (BENADRYL). The outcome of the events was unknown. Since the vaccination, the patient has not been tested for COVID-19. No follow-up attempts are needed. No further information is expected.


VAERS ID: 1265981 (history)  
Form: Version 2.0  
Age: 46.0  
Sex: Female  
Location: New Jersey  
Vaccinated:2021-04-01
Onset:2021-04-10
   Days after vaccination:9
Submitted: 0000-00-00
Entered: 2021-04-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ER8733 / 1 LA / -

Administered by: Unknown       Purchased by: ?
Symptoms: Dyspnoea, Pain, Pulmonary thrombosis
SMQs:, Anaphylactic reaction (broad), Embolic and thrombotic events, venous (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: ISIBLOOM
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: USPFIZER INC2021408266

Write-up: This is a spontaneous report from a contactable pharmacist (patient''s husband). A 46-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 1 via an unspecified route of administration, administered in left arm on 01Apr2021 (lot number: ER8733) at the age of 46 years old, as single dose for COVID-19 immunization. The patient''s medical history was not reported. Concomitant medication included desogestrel, ethinylestradiol (ISIBLOOM) taken for birth control from an unspecified start date and ongoing. On Saturday, 10Apr2021, she was fine, but she had some pain on the left side of her body. On Sunday (11Apr2021), the pain was much "much" worse, and her breathing was affected. On Monday (12Apr2021), she had the same symptoms and was taken to the Emergency Department for her problems breathing. On 13Apr2021, she had blood clots, 2 of them in both lungs. She is on pain medication and it is improving for her. The only medication she is taking is birth control pills. She has been taking them for years with no complications. The reporter added not long ago, she was in the doctor for a physical and all was fine. The patient was hospitalized due to the events and was still admitted. The events resulted in emergency room visit. The patient was recovering from the events. Event assessment by the reporter for the events blood clot in both lungs, problem breathing and left side pain was reported as related to the Pfizer COVID-19 vaccine. 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: 1265994 (history)  
Form: Version 2.0  
Age: 61.0  
Sex: Female  
Location: Maryland  
Vaccinated:2021-04-09
Onset:2021-04-10
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-04-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0158 / 1 LA / -

Administered by: Unknown       Purchased by: ?
Symptoms: Anaphylactic reaction, Body temperature, Body temperature increased, Burning sensation, Condition aggravated, Ear pain, Fatigue, Insomnia, Oropharyngeal pain, Pain, Pharyngeal swelling, Pruritus, Rash, Skin exfoliation, Swelling
SMQs:, Severe cutaneous adverse reactions (broad), Anaphylactic reaction (narrow), Angioedema (narrow), Peripheral neuropathy (broad), Neuroleptic malignant syndrome (broad), Anaphylactic/anaphylactoid shock conditions (narrow), Oropharyngeal conditions (excl neoplasms, infections and allergies) (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: CRESTOR; ATENOLOL/CHLORTHALIDONE; METFORMIN; SERTRAL
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Asthma; Blood pressure high; High cholesterol; Peanut allergy (known allergies: Penicillin, Sulfa, Peanuts); Penicillin allergy (known allergies: Penicillin, Sulfa, Peanuts); Prediabetes; Sulfonamide allergy (known allergies: Penicillin, Sulfa, Peanuts)
Allergies:
Diagnostic Lab Data: Test Date: 20210412; Test Name: temp; Result Unstructured Data: Test Result:100.2
CDC Split Type: USPFIZER INC2021410045

Write-up: I took my temp, which was 100.2; anaphylactic reactions; The neck itching/burning and throat/ear pain got worse; tired; earache; swelling; itching; stinging; peeling; hurt my throat; throat was swelling; couldn''t sleep; rash; burning; This is a spontaneous report from a contactable consumer (patient). A 61-years-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm Left on 09Apr2021 09:15 (Batch/Lot Number: EW0158) as SINGLE DOSE for covid-19 immunization. Medical history included Asthma, HBP, High Cholesterol, prediabetes. Known allergies: Penicillin, Sulfa, Peanuts. Concomitant medication(s) included rosuvastatin calcium (CRESTOR) taken for an unspecified indication, start and stop date were not reported; atenolol, chlortalidone (ATENOLOL/CHLORTHALIDONE) taken for an unspecified indication, start and stop date were not reported; metformin (METFORMIN) taken for an unspecified indication, start and stop date were not reported; sertraline hydrochloride (SERTRAL) taken for an unspecified indication, start and stop date were not reported. No other vaccine in four weeks. No covid prior vaccination. No covid tested post vaccination. On 10Apr2021, the patient experienced anaphylactic reactions, tired, earache, swelling, itching, stinging, peeling, hurt my, throat was swelling, couldn''t sleep, rash, burning, the neck itching/burning and throat/ear pain got worse. It was reported that 09Apr2021- got her 1st Pfizer COVID shot. Left arm. Felt okay afterward, got a little tired later on. On Sunday, she woke up w/an earache on her left side, which moved down into her neck - near her lymph nodes. Later, her neck started swelling/itching/stinging/feeling warm, and it hurt her throat to swallow anything. She went to get Benadryl and anti-itch creams, but they didn''t work. The neck itching/burning and throat/ear pain got worse, and at one point it felt like her throat was swelling and getting narrow, and she wondered if this was one of those anaphylactic reactions. So she took 2 Benadryl, and that seemed to help. That night she couldn''t sleep for the neck heat, itching and throat pain. Monday AM (12Apr2021), she took her temp, which was 100.2. She did a Teladoc Zoom so the doc could see the situation, and he said that it could be a severe vaccine reaction, or some kind of infection. He prescribed prednisone & clindimycin. The rash left scars, which are peeling. Ae resulted in: Doctor or other healthcare professional office/clinic visit. AE treatment: Prescription drugs. Outcome of the events was recovering.


VAERS ID: 1265997 (history)  
Form: Version 2.0  
Age: 53.0  
Sex: Male  
Location: Georgia  
Vaccinated:2021-03-28
Onset:2021-04-10
   Days after vaccination:13
Submitted: 0000-00-00
Entered: 2021-04-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 LA / -

Administered by: Pharmacy       Purchased by: ?
Symptoms: Blindness transient, Investigation, Retinal vascular thrombosis
SMQs:, Anticholinergic syndrome (broad), Embolic and thrombotic events, arterial (narrow), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Glaucoma (broad), Optic nerve disorders (broad), Retinal 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? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: additional testing; Result Unstructured Data: Test Result:unknown result
CDC Split Type: USPFIZER INC2021410457

Write-up: This is a spontaneous report from a contactable consumer, the patient. This 53-year-old male patient reported that he received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: UNKNOWN) via an unspecified route in the left arm on 28Mar2021 at 12:00 (at the age of 53-years-old) as a single dose for COVID-19 immunization. Medical history was reported as healthy. The patient had a known allergy to amoxicillin/clavulanic acid (AUGMENTIN). The patient did not receive any other vaccines within four weeks. The patient did not have COVID prior to the vaccination. Concomitant medication included over the counter (OTC) product (unspecified). Ten days after (as reported), on 10Apr2021, the patient had blood clot in retina of eye which caused temporary blindness. The events resulted in: Doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. The patient was doing additional testing to see what damage occurred (test name and results not provided). The patient was not treated for blood clot in retina of eye and temporary blindness. The clinical outcomes of blood clot in retina of eye and temporary blindness was unknown. The patient was not tested for COVID-19 post vaccination. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.


VAERS ID: 1266095 (history)  
Form: Version 2.0  
Age: 41.0  
Sex: Female  
Location: Florida  
Vaccinated:2021-04-10
Onset:2021-04-10
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-04-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / 1 LA / SYR

Administered by: School       Purchased by: ?
Symptoms: Abdominal pain upper, Computerised tomogram normal, Contusion, Decreased appetite, Deep vein thrombosis, Dyspnoea, Erythema, Flank pain, Headache, Heart rate increased, Hypertension, Hypoaesthesia, Immediate post-injection reaction, Laboratory test normal, Magnetic resonance imaging normal, Migraine, Mobility decreased, Nodule, Pain, Pain in extremity, Paraesthesia, Peripheral swelling, Pyrexia, Skin warm, Tenderness, Thrombosis, Tinnitus, Vision blurred, Vomiting
SMQs:, Cardiac failure (broad), Anaphylactic reaction (narrow), Acute pancreatitis (broad), Angioedema (broad), Peripheral neuropathy (broad), Haemorrhage terms (excl laboratory terms) (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Retroperitoneal fibrosis (broad), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Embolic and thrombotic events, venous (narrow), Parkinson-like events (broad), Thrombophlebitis (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Accidents and injuries (narrow), Extravasation events (injections, infusions and implants) (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Haemodynamic oedema, effusions and fluid overload (narrow), Glaucoma (broad), Hypertension (narrow), Cardiomyopathy (broad), Lens disorders (broad), Retinal disorders (broad), Hearing impairment (narrow), Hypersensitivity (narrow), Tendinopathies and ligament 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? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, 8 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: Whelchol, Symbicort, Vitamin C, blackseed Oil
Current Illness: Asthma, IBS
Preexisting Conditions: IBS, Asthma
Allergies: Depakote
Diagnostic Lab Data: Labs, MRI, Catscan
CDC Split Type:

Write-up: As soon as I took the vaccine shot I had an immediate headache, after taking the vaccine I took Tylenol and slept in the rest of the day. The next day I woke up and my arm was red and swollen. I was running fever, still had the headache and now blurry vision. My entire body was hurting. My left side of my body felt numb and tingling. The next two days the pain became worse. I did not really have an appetite. When I did eat I could barely hold my food down. On Wednesday morning I could barely get out of bed, I also felt extreme pain in my lower legs, stabbing pain in stomach and right lower side. I also had ringing in my ears, more in the right ear. I then notice a bruise on my left leg, that it was not originally there, and was also tender to touch. I went to the emergency room on the same day and I was admitted. I was in there for 4 days, they tested my leg and stated it was not a blood clot, although it look and felt like one. They discharge me and advise me that it was a migraine that was causing all my pain. This was on Sunday, I had a follow up with my PCP on the Friday, however to being in so much pain and shortness of breath, and arm pain I was advise to go to the ER on the Thursday and was admitted again. I was told in the ER I had a blood clot in my right arm and it was most likely from the IV from the previous visit. My blood pressure and heart rate was so high that they put me on medication. No matter the pain medication they gave me, it would not completely take the pain away. They discharge me again on Monday and after me begging them to get run any and all test, they said they found nothing. I''m still in the same amount of pain and same symptoms, still having trouble keeping my food down. The only thing that changed is my left arm is not as sore, however I still have a huge knot and its still warm to touch. I don''t know what else to do that is why im contacting the CDC for help. I''m in a extreme amount of pain and pounding headaches. Please help


VAERS ID: 1266332 (history)  
Form: Version 2.0  
Age: 26.0  
Sex: Male  
Location: Illinois  
Vaccinated:2021-04-10
Onset:2021-04-10
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-04-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 201A21A / 1 LA / IM

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

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

Write-up: Patient experienced hypotension and vomiting post vaccination, recovered and released


VAERS ID: 1266353 (history)  
Form: Version 2.0  
Age: 33.0  
Sex: Female  
Location: Illinois  
Vaccinated:2021-04-10
Onset:2021-04-10
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-04-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 201A21A / 1 LA / IM

Administered by: Other       Purchased by: ?
Symptoms: Tachycardia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Dehydration (broad)

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

Write-up: Pt experienced feeling of tachycardia post vaccination, recovered and released


VAERS ID: 1266696 (history)  
Form: Version 2.0  
Age: 37.0  
Sex: Female  
Location: North Carolina  
Vaccinated:2021-04-07
Onset:2021-04-10
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-04-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / 1 LA / IM

Administered by: Private       Purchased by: ?
Symptoms: Contusion, Limb discomfort, Musculoskeletal pain
SMQs:, Rhabdomyolysis/myopathy (broad), Haemorrhage terms (excl laboratory terms) (narrow), Accidents and injuries (narrow), 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: ibuprofen 200mg once morning on April 8th 2021
Current Illness: None
Preexisting Conditions:
Allergies: None
Diagnostic Lab Data: None completed.
CDC Split Type:

Write-up: Multiple contusions on bilateral legs, buttocks ~3 days after vaccine. Resolved over next week. No other associated symptoms.


VAERS ID: 1267232 (history)  
Form: Version 2.0  
Age: 17.0  
Sex: Unknown  
Location: Louisiana  
Vaccinated:2021-04-10
Onset:2021-04-10
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-04-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 1808982 / UNK OT / 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:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Vaccine given outside of age recommendation


VAERS ID: 1267408 (history)  
Form: Version 2.0  
Age: 59.0  
Sex: Male  
Location: Massachusetts  
Vaccinated:2021-04-03
Onset:2021-04-10
   Days after vaccination:7
Submitted: 0000-00-00
Entered: 2021-04-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK UN / SYR

Administered by: Private       Purchased by: ?
Symptoms: Back pain, Cerebral haemorrhage, Guillain-Barre syndrome, Hypoaesthesia
SMQs:, Peripheral neuropathy (narrow), Haemorrhage terms (excl laboratory terms) (narrow), Haemorrhagic central nervous system vascular conditions (narrow), Retroperitoneal fibrosis (broad), Guillain-Barre syndrome (narrow), Demyelination (narrow), Immune-mediated/autoimmune disorders (narrow)

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

Write-up: 10 days after the vaccine my perfectly healthy husband began developing terrible back pain and abdominal numbness, went to the ER, had a brain bleed and was daignosed with Guillain-Barre Syndrome. He has been in the hospital for a week. He is not being released yet.


VAERS ID: 1267941 (history)  
Form: Version 2.0  
Age: 17.0  
Sex: Female  
Location: California  
Vaccinated:2021-04-10
Onset:2021-04-10
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-04-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 203A21A / N/A 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? 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: patient is 17 yo, did not meet minimum age requirement


VAERS ID: 1267961 (history)  
Form: Version 2.0  
Age: 17.0  
Sex: Female  
Location: California  
Vaccinated:2021-04-10
Onset:2021-04-10
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-04-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 203A21A / N/A LA / 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? 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: patient is 17 yo, did not meet age requirement


VAERS ID: 1268004 (history)  
Form: Version 2.0  
Age: 29.0  
Sex: Female  
Location: Texas  
Vaccinated:2021-04-08
Onset:2021-04-10
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-04-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 201A21A / 1 LA / SYR

Administered by: Unknown       Purchased by: ?
Symptoms: Aggression, Anger, Chills, Depressed mood, Fatigue, Hyperhidrosis, Irritability, Lethargy, Major depression, Mood swings, Pyrexia, Sleep disorder
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Psychosis and psychotic disorders (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hostility/aggression (narrow), Depression (excl suicide and self injury) (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Lexapro 5mg, Spironolactone 100mg.
Current Illness:
Preexisting Conditions: Depression, controlled at time of Vaccination
Allergies: Penicillin
Diagnostic Lab Data: None
CDC Split Type:

Write-up: Within 12 hours of vaccine, I experienced fever, chills and sweats. I awoke from my sleep at this point, which was 4AM Friday morning. During the day on Friday, I experienced major fatigue and lethargy and had no emotional symptoms, save for being slightly annoyed/irritated about my condition. I began menstruation on Friday, April 9. Further, I slept 4pm-8pm, did some computer work from 9pm-3am, and went back to sleep. These symptoms were expected. Saturday''s symptoms were not expected, regardless of onset of menstruation, and are what I would consider the adverse event. All day Saturday, I experienced massive melancholy, sadness, hopelessness, and general emotional angst. This is not normal for me, even during my period; I experienced this affect consistently years ago, from 2015-2017, when I was originally diagnosed with depression. Since 2017/2018, I have been in a much healthier emotional state, and have used an SSRI for the last 6 months with success. The following day, Sunday, I began a monophasic combination birth control, which was an original plan prescribed by a physician. Following this, I experienced roughly 7-10 days of adverse emotional response, namely anger and aggression and mood swings, until I stopped using the new birth control on April 22. My emotional wellbeing took this roughly 7-10 days to recover. The mood change I experienced on Saturday, April 10, based on my previous experiences, was more similar to the mood change I experienced while being depressed rather than the mood change I experience from menstruation and PMS. I strongly request thoughtful consideration of the impact of the vaccine on short-term emotional and mental health changes. I was able to recover from it, and I believe that was because of my experience dealing with depression and mood swings in years past.


VAERS ID: 1268111 (history)  
Form: Version 2.0  
Age: 20.0  
Sex: Male  
Location: New York  
Vaccinated:2021-04-09
Onset:2021-04-10
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-04-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 207A21A / 1 LA / IM

Administered by: School       Purchased by: ?
Symptoms: Injection site pain, Pain in extremity
SMQs:, Extravasation events (injections, infusions and implants) (broad), Tendinopathies and ligament disorders (broad)

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

Write-up: Left arm pain onset following vaccination/injection, but persistent for 3 weeks. States pain to deltoid area with moving arm/shoulders, but no shoulder pain. Full rom to shoulder joint. No redness or swelling, no induration or pain to deltoid area with palpation


VAERS ID: 1268116 (history)  
Form: Version 2.0  
Age: 25.0  
Sex: Female  
Location: Illinois  
Vaccinated:2021-04-10
Onset:2021-04-10
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-04-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 201A21A / 1 LA / IM

Administered by: Other       Purchased by: ?
Symptoms: Anxiety, Tachycardia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Hypoglycaemia (broad), Dehydration (broad)

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

Write-up: Patient experienced anxiety and tachycardia post vaccination, recovered and released


VAERS ID: 1268181 (history)  
Form: Version 2.0  
Age: 49.0  
Sex: Female  
Location: Illinois  
Vaccinated:2021-04-10
Onset:2021-04-10
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-04-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 201A21A / 1 LA / IM

Administered by: Other       Purchased by: ?
Symptoms: Feeling hot, Hyperhidrosis
SMQs:, Neuroleptic malignant syndrome (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: Uknown
Current Illness: Unknown
Preexisting Conditions: Unknown
Allergies: Unknown
Diagnostic Lab Data: None
CDC Split Type:

Write-up: Patient became hot and sweaty post vaccination, recovered and released


VAERS ID: 1268263 (history)  
Form: Version 2.0  
Age: 20.0  
Sex: Male  
Location: Illinois  
Vaccinated:2021-04-10
Onset:2021-04-10
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-04-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 201A21A / 1 AR / IM

Administered by: Other       Purchased by: ?
Symptoms: Dizziness, Hypotension
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Vestibular disorders (broad), Dehydration (broad), Hypokalaemia (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: Unknown
Current Illness: Unknown
Preexisting Conditions: Unknown
Allergies: Unknown
Diagnostic Lab Data: None
CDC Split Type:

Write-up: Patient experienced lightheadedness and hypotension post vaccination, recovered and released


VAERS ID: 1268381 (history)  
Form: Version 2.0  
Age: 28.0  
Sex: Female  
Location: Illinois  
Vaccinated:2021-04-10
Onset:2021-04-10
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-04-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 201A21A / 1 LA / IM

Administered by: Other       Purchased by: ?
Symptoms: Nausea, Vomiting
SMQs:, Acute pancreatitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (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: Unknown
Preexisting Conditions: Unknown
Allergies: Unknown
Diagnostic Lab Data: None
CDC Split Type:

Write-up: Patient experienced nausea and vomiting post vaccination, recovered and released


VAERS ID: 1268669 (history)  
Form: Version 2.0  
Age: 42.0  
Sex: Female  
Location: Wisconsin  
Vaccinated:2021-04-08
Onset:2021-04-10
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-04-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 7808980 / UNK LA / SYR

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: B-12, dulcolax, buspirone, calcium, vitamin D, cranberry, cymbalta, emgality, allegra, fish oil, flonase, gabapentin, hydrocodone-acetaminophen, levothyroxine, lithium, mucinex do, multivitamin, naratriptan, macrobid, omeprazole, ondansetro
Current Illness: ENT related symptoms, neuropathy, migraines.
Preexisting Conditions: ENT related symptoms, neuropathy, migraines, chronic UTI''s, GI problems, Bipolar Disorder.
Allergies: Bacitracin, ciprofloxacin (only IV), dexamethasone, sulfa antibiotics, paper tape, and tetracyclines.
Diagnostic Lab Data: D - Dimer, ultrasound for diagnoses of DVT
CDC Split Type:

Write-up: Ended up with a blood clot in left leg, not a dvt clot.


VAERS ID: 1269251 (history)  
Form: Version 2.0  
Age: 51.0  
Sex: Female  
Location: California  
Vaccinated:2021-04-09
Onset:2021-04-10
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-04-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / 1 LA / IM

Administered by: Public       Purchased by: ?
Symptoms: Arthralgia, Burning sensation, Ultrasound scan, X-ray
SMQs:, Peripheral neuropathy (broad), Arthritis (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Valsartan HCT 160/12.5 Metoprolol 25 mg Tylenol (as needed)
Current Illness:
Preexisting Conditions: Hypertension Arthritic knee
Allergies: Tetracycline Amlodipine
Diagnostic Lab Data: Ultrasound of left calf X-ray of left knee
CDC Split Type:

Write-up: Severe arthritic pain in full body. Notably in left calf. Negative ultrasound for blood clot in leg. Intermediate burning sensation is limbs. Prednisone issued by Rheumatologist for 6 days beginning 4/27/21.


VAERS ID: 1269409 (history)  
Form: Version 2.0  
Age: 21.0  
Sex: Female  
Location: Colorado  
Vaccinated:2021-04-10
Onset:2021-04-10
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-04-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK RA / SYR

Administered by: Other       Purchased by: ?
Symptoms: Chills, Fatigue, Injection site haemorrhage, Nausea, Oropharyngeal pain, Pain, Pain in extremity, Paraesthesia, Peripheral swelling, Pyrexia
SMQs:, Cardiac failure (broad), Acute pancreatitis (broad), Angioedema (broad), Peripheral neuropathy (broad), Haemorrhage terms (excl laboratory terms) (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Guillain-Barre syndrome (broad), Extravasation events (injections, infusions and implants) (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Haemodynamic oedema, effusions and fluid overload (narrow), Tendinopathies and ligament disorders (broad), 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: Nexplanon birth control
Current Illness: No
Preexisting Conditions: Immune issues
Allergies: No
Diagnostic Lab Data:
CDC Split Type:

Write-up: A lot of bleeding at injection site when given the shot. The day of began 102 degree fever. Severe chills. Body aches. Sore throat. Fatigue. Swollen arm. Pain in arm. Nausea. Lasted about 5 days. 3 weeks later still have tingling and pain in right arm.


VAERS ID: 1269516 (history)  
Form: Version 2.0  
Age: 24.0  
Sex: Female  
Location: Florida  
Vaccinated:2021-04-10
Onset:2021-04-10
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-04-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0153 / 1 LA / -

Administered by: Pharmacy       Purchased by: ?
Symptoms: Chest discomfort, Dyspnoea, Feeling hot, Pharyngeal swelling, SARS-CoV-2 test, Swelling, Throat tightness
SMQs:, Anaphylactic reaction (narrow), Angioedema (narrow), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: COVID-19 (if covid prior vaccination: Yes)
Allergies:
Diagnostic Lab Data: Test Date: 20200501; Test Name: SARS-CoV-2 test; Test Result: Positive ; Comments: Nasal Swab; Test Date: 202104; Test Name: SARS-CoV-2 test; Result Unstructured Data: Test Result:unknown results
CDC Split Type: USPFIZER INC2021410643

Write-up: Tightening; heating up; swelling of throat; swelling of throat and chest; throat closing; shortness of breath; This is a spontaneous report from a contactable consumer, the patient. A 24-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EW0153), dose 1 via an unspecified route of administration, administered in Arm Left on 10Apr2021 at 14:00 (at the age of 24-years-old) as a single dose for COVID-19 immunization. Medical history included COVID-19 diagnosis in May2020, COVID-19 test taken via nasal swab on 01May2020 was positive. The patient had never had an allergic reaction in her life and she was not allergic to anything that she knew of. There were no concomitant medications (no medications within 2 weeks prior to vaccination). The patient did not receive any other vaccine within 4 weeks prior to the COVID-19 vaccine.The patient received her first vaccine on 10Apr2021. After the shot she felt her throat closing. She experienced Tightening, heating up, swelling of throat and chest within 10 minutes of vaccine administration, also reported as at 14:15. They called the Paramedics, who gave her Benadryl injection when they picked her up from the site where she received her vaccination, which was a drug store. She was then transported to the emergency department. She was hospitalized and treated with Benadryl injection for the Tightening, heating up, swelling of throat and chest. She was monitored for 3-4 hours, and her symptoms were not worsening and she was able to leave the hospital. Ever since, this is the 9th day, everyday she had severe shortness of breath. She had no wheezing. Her chest clenches. It scared her so she had gone to the Emergency Department 2 more times for it. She had gone there 3 times in total. She had been to the Emergency Room a few times and saw doctors there. Her throat closing stopped later that evening and had come back about 4 times. Since then, she was not sure if it was just the sensation of the throat closing because it is coupled with shortness of breath. She had the sensation of throat closing about 4 times. She was short of breath every day since receiving the vaccine and up to 4 times each day. Sometimes it was worse than others. She had it while on the call (19Apr2021) and rated it 4/10. On 14Apr2021 she went to the Emergency Department in the middle of the night. She rated that episode as 9/10. Episodes of symptoms had been ongoing and reoccurring since the day of vaccine administration. She had a COVID-19 test post vaccination in Apr2021 (unknown results). The outcome of Tightening/ Chest tightness, heating up, swelling of throat and chest, throat closing and severe shortness of breath was not recovered.


VAERS ID: 1269530 (history)  
Form: Version 2.0  
Age: 49.0  
Sex: Female  
Location: North Carolina  
Vaccinated:2021-04-09
Onset:2021-04-10
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-04-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ER8737 / 2 LA / -

Administered by: Unknown       Purchased by: ?
Symptoms: Abdominal pain, Chest discomfort, Confusional state, Dizziness, Dyspnoea, Fatigue, Pain, Paraesthesia, Paraesthesia oral, Pruritus, Pyrexia, Syncope, Tachycardia, Vomiting
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (narrow), Acute pancreatitis (broad), Peripheral neuropathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (narrow), Arrhythmia related investigations, signs and symptoms (broad), Retroperitoneal fibrosis (broad), Dementia (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Vestibular disorders (broad), Hypotonic-hyporesponsive episode (broad), Hypersensitivity (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? Yes
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: ZYRTEC [CETIRIZINE HYDROCHLORIDE]; INDERAL; ATIVAN; HCTZ; SEROQUEL; GABAPENTIN
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Allergy to plants
Allergies:
Diagnostic Lab Data:
CDC Split Type: USPFIZER INC2021411891

Write-up: This is a spontaneous report from a contactable consumer reporting for a patient. A 49-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in Arm Left on 09Apr2021 11:00 (Batch/Lot Number: ER8737) as SINGLE DOSE for covid-19 immunisation, at 49 years old at other facility type. The patient is not pregnant at time of vaccination. Medical history included allergies to Rosemary from an unknown date. No other vaccine in four weeks were noted. Patient did not have COVID prior vaccination and was not tested for COVID post vaccination. Concomitant medications included cetirizine hydrochloride (ZYRTEC); propranolol hydrochloride (INDERAL); lorazepam (ATIVAN); hctz; quetiapine fumarate (SEROQUEL); gabapentin taken for an unspecified indication, start and stop date were not reported. The patient previously took macrobid [nitrofurantoin] and experienced allergies. The patient previously received the first dose of BNT162B2 (Lot number: ER8727) on 17Mar2021 13:00 (left arm) for COVID-19 immunisation. On 10 Apr2021, the patient experienced Itchy palms (reported as within hours), tachycardia, tightness in chest, difficulty breathing, tingling tongue and fingers, vomiting, confusion, dizzy, fainting, abdominal pain, severe pain everywhere, too fatigued to move. Patient tried to call ambulance but could not get phone or unlock the door. She stated she tried from 1 AM to 07:30 AM. After 07:30 AM she had expected effects of fever as well as fatigue and pain. The events resulted in Doctor or other healthcare professional office/clinic visit. Treatment was not given. Outcome of the events was recovered on an unspecified date.


VAERS ID: 1269537 (history)  
Form: Version 2.0  
Age: 22.0  
Sex: Female  
Location: Ohio  
Vaccinated:2021-04-10
Onset:2021-04-10
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-04-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0150 / 1 LA / -

Administered by: Unknown       Purchased by: ?
Symptoms: Hypersensitivity, Influenza like illness, Investigation, Nasal congestion
SMQs:, Angioedema (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, 1 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: LUTERA
Current Illness:
Preexisting Conditions: Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: None
Allergies:
Diagnostic Lab Data: Test Date: 20210414; Test Name: testing; Result Unstructured Data: Test Result:nothing came back abnormal
CDC Split Type: USPFIZER INC2021412067

Write-up: being kind of stuffed up; flu-like symptoms; severe allergic reaction/allergic reaction; This is a spontaneous report from a contactable consumer (patient) reported that a 22-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EW0150), via an unspecified route of administration, administered in arm left on 10Apr2021 12:30 (at the age of 22-years-old) as a single dose for covid-19 immunisation. The patient medical history included was reported as none. Concomitant medication included ethinylestradiol, levonorgestrel (LUTERA) taken for birth control from Jan2018 and ongoing. No prior vaccination within four weeks. This consumer is the patient who reported severe adverse reaction/allergic reaction to the first dose of Pfizer-BioNTech Covid-19 Vaccine she was administered. She called to ask if there are any recommendations of whether it is or is not advised to get the second dose of the Pfizer-BioNTech Covid-19 Vaccine after having severe adverse reaction/allergic reaction. On 11Apr2021 approximately 24 hours after the first dose of Pfizer-BioNTech Covid-19 Vaccine was administered-which would have been about 12:30. Severe adverse reaction/allergic reaction was further described to include swollen face, hands were like tingling, then shortness of breath, and lightheadedness. Then on top of that a lot the normal vaccine side effects like being kind of stuffed up, flu-like symptoms as well. She reported she was just in the emergency room where she was hospitalized related to severe adverse reaction/allergic reaction. She clarified that she was actually admitted to the hospital today (14Apr2021), and was also discharged from the hospital today (14Apr2021). She reported that the events as improved, but she has also taken some medicine for it. She does not plan to get the second dose, she did not want to and the doctor at the Emergency Room said not to get the second dose, but advised her to contact Pfizer regarding recommendations for that, so unknown at this time. She will be going out of the country for her honeymoon in Nov2021. Regarding testing/investigations she reported that they did all the testing in the emergency room and nothing came back abnormal, everything came back fine so no relevant results to provide for report. The events did require to visit an emergency room. The outcome of the events was recovering.


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