National Vaccine
Information Center

Your Health. Your Family. Your Choice.

MedAlerts Home
Search Results

From the 9/10/2021 release of VAERS data:

Found 686,636 cases where Vaccine is COVID19 and Patient Did Not Die



Case Details (Reverse Sorted by Onset Date)

This is page 368 out of 6,867

Result pages: prev   269 270 271 272 273 274 275 276 277 278 279 280 281 282 283 284 285 286 287 288 289 290 291 292 293 294 295 296 297 298 299 300 301 302 303 304 305 306 307 308 309 310 311 312 313 314 315 316 317 318 319 320 321 322 323 324 325 326 327 328 329 330 331 332 333 334 335 336 337 338 339 340 341 342 343 344 345 346 347 348 349 350 351 352 353 354 355 356 357 358 359 360 361 362 363 364 365 366 367 368 369 370 371 372 373 374 375 376 377 378 379 380 381 382 383 384 385 386 387 388 389 390 391 392 393 394 395 396 397 398 399 400 401 402 403 404 405 406 407 408 409 410 411 412 413 414 415 416 417 418 419 420 421 422 423 424 425 426 427 428 429 430 431 432 433 434 435 436 437 438 439 440 441 442 443 444 445 446 447 448 449 450 451 452 453 454 455 456 457 458 459 460 461 462 463 464 465 466 467   next


VAERS ID: 1490847 (history)  
Form: Version 2.0  
Age: 32.0  
Sex: Female  
Location: Virginia  
Vaccinated:2021-07-14
Onset:2021-07-14
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 037C21A / 2 LA / IM

Administered by: Senior Living       Purchased by: ?
Symptoms: Poor quality product administered, Product storage error
SMQs:, Medication errors (narrow)

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

Write-up: A vaccine that was drawn up into a syringe on 7/7/21 and placed into a refrigerator was accidentally used on 7/14/21. It should have been discarded on 7/7/21, after a no show appointment. It was placed into the refrigerator and then accidentally used on 7/14/21. The nurse thought it was a fresh syringe from 7/14/21.


VAERS ID: 1490867 (history)  
Form: Version 2.0  
Age: 57.0  
Sex: Female  
Location: Indiana  
Vaccinated:2021-02-23
Onset:2021-07-14
   Days after vaccination:141
Submitted: 0000-00-00
Entered: 2021-07-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 AR / -

Administered by: Private       Purchased by: ?
Symptoms: Chest pain, Dyspnoea, Pulmonary embolism, Tachycardia
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Embolic and thrombotic events, venous (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad), Dehydration (broad)

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

Write-up: Massive bilateral pulmonary embolism. Tachycardia, chest pain, shortness of breath


VAERS ID: 1490881 (history)  
Form: Version 2.0  
Age: 56.0  
Sex: Female  
Location: Washington  
Vaccinated:2021-02-02
Onset:2021-07-14
   Days after vaccination:162
Submitted: 0000-00-00
Entered: 2021-07-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 011L20A / 2 - / SYR

Administered by: Private       Purchased by: ?
Symptoms: COVID-19, Infection, SARS-CoV-2 test positive
SMQs:, Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (narrow)

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

Write-up: Breakthrough COVID case


VAERS ID: 1490896 (history)  
Form: Version 2.0  
Age: 25.0  
Sex: Male  
Location: Texas  
Vaccinated:2021-07-14
Onset:2021-07-14
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 048C21A / 1 RA / IM

Administered by: Private       Purchased by: ?
Symptoms: Feeling abnormal, Feeling cold, Gait disturbance, Loss of consciousness, Mobility decreased, Tremor, Vomiting
SMQs:, Torsade de pointes/QT prolongation (broad), Acute pancreatitis (broad), Peripheral neuropathy (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Dementia (broad), Parkinson-like events (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Tendinopathies and ligament disorders (broad), Hypoglycaemia (broad)

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

Write-up: Pt was administered Moderna on 07/14/2021. Pt called on 7/20/2021, left a Voice Mail stating he would like a call back to discuss side effects to the vaccine. I called patient back the morning of 07/21/2021, the patient states to me that two hours after the vaccine was administered he started to shake uncontrollably and was very cold, then he blacked out (Patient states he may have had a seizure.) Pt woke up outside behind his vehicle in a pool of his own vomit. I asked if 911 was called and the patient said no because he could not move or walk. The patient also stated that he felt bad all day, Thursday (07/15/2021), the day after the vaccine was administered, woke up on Friday (07/16/2021) feeling relatively normal still feels the urge to vomit when eating certain foods.


VAERS ID: 1490951 (history)  
Form: Version 2.0  
Age: 62.0  
Sex: Female  
Location: Texas  
Vaccinated:2021-06-23
Onset:2021-07-14
   Days after vaccination:21
Submitted: 0000-00-00
Entered: 2021-07-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 009D21A / 1 RA / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: Erythema, Pruritus
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

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

Write-up: Patient stated her arm was a little red and itchy right away, then the redness and a lot of itchiness occurred again 3 weeks later.


VAERS ID: 1490992 (history)  
Form: Version 2.0  
Age: 35.0  
Sex: Male  
Location: Texas  
Vaccinated:2021-07-13
Onset:2021-07-14
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-07-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 047C21A / 2 LA / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: Rash, Rash erythematous, Skin warm
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

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

Write-up: DIFFUSE RED RASH FROM UPPER ARM TO ELBOW. WARM TO THE TOUCH, NO PAIN OR FEVER.


VAERS ID: 1491005 (history)  
Form: Version 2.0  
Age: 58.0  
Sex: Female  
Location: California  
Vaccinated:0000-00-00
Onset:2021-07-14
Submitted: 0000-00-00
Entered: 2021-07-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0187 / 2 RA / IM

Administered by: Private       Purchased by: ?
Symptoms: Dizziness, Erythema, Feeling abnormal, Rash
SMQs:, Anaphylactic reaction (broad), Anticholinergic syndrome (broad), Dementia (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? Yes
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies: Epinephrine
Diagnostic Lab Data:
CDC Split Type:

Write-up: Approximately 7 minutes after pt received her 2nd Covid Vaccine, pt reported that she felt dizzy. Also noted pt was red in the face. Instructed pt to lay back and we put her legs up. Vital signs taken, elevated (96 pulse and 156/90 bp). Her breathing was fine and she was alert. As we were speaking, her redness started to subside, but her dizziness persisted. I went to get her a bottle of water. RN then went to call Rapid Response who evaluated pt, administered Benadryl, and observed for extra time. Pt was then released and walked out on her own 2 feet. Call to RRT at the vaccination clinic. Patient had sudden onset of dizziness/fogginess and left facial/neck rash a few minutes after taking the second Covid vaccine. Patient stated she had similar rash a few hours later with her first Covid vaccine that self resolved. She reported no chest pain, shortness of breath, throat/tongue swelling. She reports no cardiac history/risk factors. Patient noted to be lying supine face/with a rash on her face and neck. Vitals were noted to be stable(please see RN note). Blood sugar 107. She was given 50 mg p.o. Benadryl and symptoms significantly improved as per RN. Allergy to epinephrine. She had a chaperone take her home. Advised to continue benadryl Q6-8 hrs and follow-up with PCP. ER precaution explained.


VAERS ID: 1492838 (history)  
Form: Version 2.0  
Age: 60.0  
Sex: Female  
Location: Louisiana  
Vaccinated:0000-00-00
Onset:2021-07-14
Submitted: 0000-00-00
Entered: 2021-07-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 1805018 / UNK - / -

Administered by: Military       Purchased by: ?
Symptoms: COVID-19, Ear pain, Laryngitis, Suspected COVID-19, Vaccination failure
SMQs:, Lack of efficacy/effect (narrow), Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Alcohol use (Consumes wine twice a week); Non-smoker
Preexisting Conditions: Comments: The patient was healthy
Allergies:
Diagnostic Lab Data: Test Date: 20210713; Test Name: COVID-19; Result Unstructured Data: positive
CDC Split Type: USJNJFOC20210733616

Write-up: EAR ACHE; LARYNGITIS; SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID-19 INFECTION; This spontaneous report received from a patient concerned a 60 year old female. Initial information was processed along with the additional information received on 16-JUL-2021 and 19-JUL-2021. The patient''s weight was 137 pounds, and height was 64 inches. The patient''s concurrent conditions included alcohol user and non smoker and also the patient was healthy. The patient experienced drug allergy when treated with codeine for drug used for unknown indication. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805018 and expiry: unknown) dose was not reported, 1 total administered on 05-MAR-2021 to left arm for prophylactic vaccination. No concomitant medications were reported. On 13-JUL-2021, the patient underwent a covid-19 test and on 14-JUL-2021, the results came as positive (suspected clinical vaccination failure and suspected covid-19 infection). It was reported that the patient''s covid-19 symptoms started with an ear ache, scratchy throat and laryngitis. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from suspected covid-19 infection, and the outcome of suspected clinical vaccination failure, ear ache and laryngitis was not reported. This report was serious (Other Medically Important Condition). This report was associated with Product Quality Complaint -90000186156.; Sender''s Comments: V0:20210733616-COVID-19 VACCINE AD26.COV2.S-Suspected clinical vaccination failure. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS


VAERS ID: 1492844 (history)  
Form: Version 2.0  
Age: 62.0  
Sex: Male  
Location: New York  
Vaccinated:0000-00-00
Onset:2021-07-14
Submitted: 0000-00-00
Entered: 2021-07-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN UNKNOWN / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Abstains from alcohol; Non-smoker
Preexisting Conditions: Comments: The patient had no known allergies and the patient was not a drug abuse or illicit drug user.
Allergies:
Diagnostic Lab Data:
CDC Split Type: USJNJFOC20210738424

Write-up: SUDDEN SENSORY NEURAL HEARING LOSS LEFT EAR; This spontaneous report received from a consumer concerned a 63 year old male. The patient''s height, and weight were not reported. The patient''s concurrent conditions included non-alcohol user, and non smoker, and he had no known allergies and he was not a drug abuse or illicit drug user. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: unknown, expiry: unknown) dose was not reported, 1 total, administered on 18-MAR-2021 to right deltoid for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 14-JUL-2021, the patient experienced sudden sensory neural hearing loss left ear (ringing in left ear) and which was still ongoing and she visited physician''s office. On an unspecified date, the patient experienced ringing in left ear. The patient was treated with prednisone 50 mg first 2 days and taper over 10 days. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from sudden sensory neural hearing loss left ear. This report was serious (Other Medically Important Condition).; Sender''s Comments: V0- 20210738424 - Covid-19 vaccine ad26.cov2.s-sudden sensory neural hearing loss left ear. This event is considered unassessable. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event.


VAERS ID: 1492847 (history)  
Form: Version 2.0  
Age: 78.0  
Sex: Female  
Location: Missouri  
Vaccinated:0000-00-00
Onset:2021-07-14
Submitted: 0000-00-00
Entered: 2021-07-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 202A21A / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure decreased, Blood pressure fluctuation, Blood pressure measurement, Blood pressure systolic, Heart rate irregular, Injection site pain, Injection site swelling, Pruritus, Rash, Urticaria, Vision blurred
SMQs:, Anaphylactic reaction (narrow), Angioedema (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Glaucoma (broad), Hypertension (broad), Cardiomyopathy (broad), Lens disorders (broad), Retinal disorders (broad), Cardiac arrhythmia terms, nonspecific (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Dehydration (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Abstains from alcohol; Drug allergy; Heart disorder; Non-smoker; Penicillin allergy; Renal disease
Preexisting Conditions: Comments: She had no history of drug abuse or illicit drug usage
Allergies:
Diagnostic Lab Data: Test Date: 20210714; Test Name: Blood pressure; Result Unstructured Data: dropped; Test Date: 20210715; Test Name: Blood pressure; Result Unstructured Data: fluctuating; Test Date: 20210715; Test Name: Systolic blood pressure; Result Unstructured Data: went down below 100
CDC Split Type: USJNJFOC20210738751

Write-up: BLOOD PRESSURE FLUCTUATING; RIGHT EYE VISION BLURRINESS; BLOOD PRESSURE DROPPED; RASH ON LEGS, BACK, AND IN PLACES; SWELLING AT SITE OF INJECTION; HIVES; SORENESS AT SITE OF INJECTION; ITCHING ALL OVER BODY; IRREGULAR HEART BEAT; This spontaneous report received from a patient concerned a 78 year old female. The patient''s height, and weight were not reported. The patient''s concurrent conditions included high risk heart patient, stage 3 kidney patient, penicillin allergy, all different kinds of erythro allergy and allergic to 37 different types of medications (unspecified), non alcoholic, and non-smoker, and other pre-existing medical conditions included she had no history of drug abuse or illicit drug usage. The patient experienced drug allergy when treated with codeine for drug used for unknown indication. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 202A21A, and expiry: UNKNOWN) dose was not reported, administered on 14-JUL-2021 for prophylactic vaccination. No concomitant medications were reported. On 14-JUL-2021, the subject experienced itching all over body. On 14-JUL-2021, the subject experienced irregular heart beat. On 14-JUL-2021, the subject experienced right eye vision blurriness. On 14-JUL-2021, the subject experienced blood pressure dropped. On 14-JUL-2021, the subject experienced rash on legs, back, and in places. On 14-JUL-2021, the subject experienced swelling at site of injection. On 14-JUL-2021, the subject experienced hives. On 14-JUL-2021, the subject experienced soreness at site of injection. Laboratory data included: Blood pressure (NR: not provided) dropped. On 15-JUL-2021, the subject experienced blood pressure fluctuating. Laboratory data included: Blood pressure (NR: not provided) fluctuating, and Systolic blood pressure (NR: not provided) went down below 100. Treatment medications (dates unspecified) included: diphenhydramine hydrochloride. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from rash on legs, back, and in places, itching all over body, right eye vision blurriness, swelling at site of injection, hives, soreness at site of injection, and irregular heart beat, and the outcome of blood pressure dropped and blood pressure fluctuating was not reported. 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: 1492910 (history)  
Form: Version 2.0  
Age: 74.0  
Sex: Female  
Location: West Virginia  
Vaccinated:2021-04-01
Onset:2021-07-14
   Days after vaccination:104
Submitted: 0000-00-00
Entered: 2021-07-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / UNK - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Myocardial infarction
SMQs:, Myocardial infarction (narrow), Embolic and thrombotic events, arterial (narrow)

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

Write-up: Heart Attack after vaccination; This spontaneous case was reported by a consumer and describes the occurrence of MYOCARDIAL INFARCTION (Heart Attack after vaccination) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. In April 2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Jul-2021, the patient experienced MYOCARDIAL INFARCTION (Heart Attack after vaccination) (seriousness criterion medically significant). At the time of the report, MYOCARDIAL INFARCTION (Heart Attack after vaccination) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Concomitant medication use was not reported. Treatment information was not reported. Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.; Sender''s Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.


VAERS ID: 1493591 (history)  
Form: Version 2.0  
Age: 53.0  
Sex: Male  
Location: Kentucky  
Vaccinated:2021-03-12
Onset:2021-07-14
   Days after vaccination:124
Submitted: 0000-00-00
Entered: 2021-07-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 030A21A / 2 LA / IM

Administered by: Public       Purchased by: ?
Symptoms: COVID-19, SARS-CoV-2 test positive
SMQs:, Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (narrow)

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

Write-up: positive for covid-19


VAERS ID: 1493610 (history)  
Form: Version 2.0  
Age: 33.0  
Sex: Female  
Location: New York  
Vaccinated:2021-06-24
Onset:2021-07-14
   Days after vaccination:20
Submitted: 0000-00-00
Entered: 2021-07-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 006C21A / 1 RA / SYR

Administered by: Private       Purchased by: ?
Symptoms: Ageusia, Anosmia, Exposure during pregnancy, Oropharyngeal pain, Productive cough, Rhinorrhoea, SARS-CoV-2 test negative, Sputum discoloured, Streptococcus test negative, Viral infection
SMQs:, Taste and smell disorders (narrow), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Infective pneumonia (broad), Immune-mediated/autoimmune disorders (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Prenatal vitamins
Current Illness: None
Preexisting Conditions: None
Allergies: None
Diagnostic Lab Data: Strep test- negative Covid 19 test- negative
CDC Split Type:

Write-up: Runny nose, sore throat, cough with yellow phlegm, loss of taste and smell. Currently 32 weeks pregnant. Still no sense of taste or smell to date. No medications prescribed. No OTC medications taken. Diagnosed as viral infection.


VAERS ID: 1493613 (history)  
Form: Version 2.0  
Age: 65.0  
Sex: Female  
Location: New York  
Vaccinated:2021-07-12
Onset:2021-07-14
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-07-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0196 / 2 UN / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: Acute respiratory failure, Bladder catheterisation, Blood culture negative, Blood glucose increased, Blood lactic acid decreased, Blood sodium decreased, Body temperature increased, Brain natriuretic peptide increased, C-reactive protein increased, Chest X-ray abnormal, Computerised tomogram head normal, Confusional state, Differential white blood cell count abnormal, Dyspnoea, Echocardiogram normal, Ejection fraction normal, Encephalopathy, Facial paralysis, Fatigue, Fibrin D dimer, Full blood count abnormal, Haematocrit increased, Haemoglobin increased, Headache, Hyponatraemia, Hypophagia, Hypoxia, Inflammatory marker increased, Influenza virus test negative, Lactic acidosis, Lethargy, Lymphocyte percentage decreased, Lymphopenia, Neutrophil percentage increased, Neutrophilia, Pericardial effusion, Polycythaemia, Pulmonary oedema, Pyrexia, Red blood cell sedimentation rate increased, SARS-CoV-2 test negative, Somnolence, Systemic inflammatory response syndrome, Tachycardia, Tachypnoea, Tremor, Urine sodium decreased, Vaccination complication, White blood cell count normal
SMQs:, Cardiac failure (narrow), Anaphylactic reaction (broad), Asthma/bronchospasm (broad), Haematopoietic leukopenia (narrow), Lactic acidosis (narrow), Hyperglycaemia/new onset diabetes mellitus (narrow), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (narrow), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (broad), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (broad), Toxic-septic shock conditions (broad), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Dementia (broad), Parkinson-like events (broad), Acute central respiratory depression (narrow), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (narrow), Noninfectious meningitis (broad), Hyponatraemia/SIADH (narrow), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Hearing impairment (broad), Chronic kidney disease (broad), Hypersensitivity (broad), Myelodysplastic syndrome (broad), Tumour lysis syndrome (broad), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (narrow), Hypoglycaemia (broad), Infective pneumonia (broad), Dehydration (broad), Sepsis (broad), Opportunistic infections (broad), Immune-mediated/autoimmune disorders (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, 2 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: Lantus, Metoprolol, Eliquis, Requip, Lexapro, hydrocodone prn, lipitor, torsemide, gabapentin
Current Illness: None
Preexisting Conditions: DM-2, Tobacco use, COPD/oxygen dep at 3L, Diabetic neuropathy, ckd stage 3, restless leg syndrome, depression, atrial fib, diastolic CHFHTN, Hyperlipidemia, hx CAD
Allergies: PCN, Naproxen
Diagnostic Lab Data: As above
CDC Split Type:

Write-up: Pt was admitted with a suspected Covid vaccine reaction on 7/14/21 < 48 hrs after her second covid vaccine was received resulting in systemic inflammatory response syndrome resulting in acute encephalopathy, pulmonary edema with small pericardial effusion, high fever, lactic acidosis, acute respiratory failure and high inflammatory markers. Pt received her 2nd covid vaccine at 6pm on 7/12 and was in her normal state of heath and was just on vacation a week ago. On 7/13 she complained of being fatigued and went to bed for a nap at 3pm. At 6pm she was witnessed as tremoring all over by family. At 7:45 pm she progressed to severe confusion and EMS was called. She was found hypoxic at 80% on room air. She had a right facial droop and was confused. Her BP was 159/103, pulse 100, rr 20, glucose 307 Her temp was 100 at the scene. She went to an ER and her temp was 103.5 with RR 25-30 hr 110 and bp 122/66-161/91 with o2 sats of 89% on 4L. Her cxr showed diffuse pulm edema, CT head neg for acute abnl. Cbc with lymphopenia, hgb 17.8, lactic of 2.2, bnp 367, flu and covid neg. She was transferred to our emergency room and admitted on 7/14/21. she was noted by her family after waking up from a nap to be confused, lethargic with a right facial droop. This occurred around 6 PM on the evening of 7/14. Per the family the patient had received her second dose of the Covid vaccine at 6 PM just the day before. She had COVID-19 infection back in November 2020. She underwent work-up in the emergency room and was noted to be encephalopathic and persistently febrile with a temperature of 103 she was tachycardic and tachypneic and hypoxic. CT of the head was unremarkable chest x-ray showed pulmonary edema there was a question of a urinary tract infection and a Foley catheter was placed. CT of the brain was negative she was given IV fluids antipyretics and IV Cipro and was transferred to our hospital for further evaluation. She was treated with Ancef. She also was given IV Lasix. The following morning Patient was complaining of severe fatigue and a headache. Patient''s labs were notable for polycythemia which was new with a hemoglobin of 17.1 hematocrit of 53 white blood cell count of 5.76 as well as neutrophilia and lymphopenia of 85% and 7% respectively. These were new findings compared to her previous CBCs. She also have an elevated sedimentation rate of 79 a D-dimer of 395 and a high-sensitivity CRP of 38.8. Patient''s lactic acidosis resolved. By the second day of her hospitalization patient''s differential improved with improvement of her lymphopenia and neutropenia and slowly improving polycythemia. Patient was noted to have hyponatremia of 130 post IV Lasix likely due to poor p.o. intake the day before. Her urine sodium was 15. Patient''s blood cultures are no growth to date Covid testing was negative. She has no complaints of dysuria, or frequency. She did have a CT of the chest which revealed pulmonary edema and trace pericardial effusion. Patient''s echocardiogram done the following day showed resolution of the pericardial effusion and ejection fraction of 70-75%. She was feeling better and her fatigue improved and her headache is improved and her shortness of breath is back to normal and she denies any shortness of breath and her oxygen saturation is 95% on her normal 3 L and she is felt stable for discharge to home.on 7/15/21


VAERS ID: 1493721 (history)  
Form: Version 2.0  
Age: 17.0  
Sex: Female  
Location: Idaho  
Vaccinated:2021-07-14
Onset:2021-07-14
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0176 / 2 LA / IM

Administered by: Private       Purchased by: ?
Symptoms: Expired product administered
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: none known
Current Illness: none known
Preexisting Conditions: none known
Allergies: none known
Diagnostic Lab Data: none
CDC Split Type:

Write-up: The vaccine was beyond its 6 hours in the syringe, thus making it expired


VAERS ID: 1493790 (history)  
Form: Version 2.0  
Age: 39.0  
Sex: Female  
Location: Georgia  
Vaccinated:2021-07-12
Onset:2021-07-14
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-07-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH 8721 / 2 LA / SYR

Administered by: Pharmacy       Purchased by: ?
Symptoms: Vulvovaginal mycotic infection
SMQs:

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

Write-up: Vaginal Yeast Infection started 2 days after second Covid vaccine. Purchased cream but it is not helping. Going to Dr. tomorrow. I have never had a yeast infection in my life, so the Covid vaccine definitely caused this.


VAERS ID: 1493886 (history)  
Form: Version 2.0  
Age: 18.0  
Sex: Female  
Location: Maryland  
Vaccinated:2021-07-14
Onset:2021-07-14
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 202A21A / 1 LA / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: Fall, Head injury, 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), Accidents and injuries (narrow), 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? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Sertraline 25mg
Current Illness:
Preexisting Conditions: Anxiety, AR, Eczema, hx of syncope, hx of concussion
Allergies: NKDA
Diagnostic Lab Data:
CDC Split Type:

Write-up: Patient had syncope within 5-15 minutes after shot. After LOC, fell and hit head.


VAERS ID: 1493938 (history)  
Form: Version 2.0  
Age: 78.0  
Sex: Male  
Location: Indiana  
Vaccinated:2021-02-10
Onset:2021-07-14
   Days after vaccination:154
Submitted: 0000-00-00
Entered: 2021-07-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 013M20A / 2 RA / IM

Administered by: Public       Purchased by: ?
Symptoms: COVID-19, Respiratory distress, SARS-CoV-2 test positive
SMQs:, Anaphylactic reaction (broad), Acute central respiratory depression (broad), Hypersensitivity (broad), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? Yes
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: unknow
Current Illness: unknown
Preexisting Conditions: smoker, wt 280
Allergies: unknown
Diagnostic Lab Data: unkown
CDC Split Type:

Write-up: ER visit with positive COVID antigen test. Back home but back to hospital by EMS for respiratory distress.


VAERS ID: 1494085 (history)  
Form: Version 2.0  
Age: 30.0  
Sex: Male  
Location: D.C.  
Vaccinated:2021-07-14
Onset:2021-07-14
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0180 / 1 LA / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: Poor quality product administered, Product storage error
SMQs:, Medication errors (narrow)

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

Write-up: Pt received vaccine that was stored improperly. Vaccine was moved from ultra-cold freezer to freezer on 6/17/21. According to Pfizer, vaccine stored in the freezer after day 17 is considered improperly stored, and the pt will need to be re-vaccinated.?


VAERS ID: 1494186 (history)  
Form: Version 2.0  
Age: 68.0  
Sex: Female  
Location: Oregon  
Vaccinated:2021-07-13
Onset:2021-07-14
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-07-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 038C21A / 2 LA / IM

Administered by: Private       Purchased by: ?
Symptoms: Blood creatine phosphokinase, Blood creatinine, Condition aggravated, Laboratory test, Renal failure, Rhabdomyolysis
SMQs:, Rhabdomyolysis/myopathy (narrow), Acute renal failure (narrow), Neuroleptic malignant syndrome (broad), Retroperitoneal fibrosis (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (broad), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (broad), Toxic-septic shock conditions (broad), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Chronic kidney disease (narrow), 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: s/p 1st COVID vaccine, had worsening of renal function as well
Other Medications: acetaminophen 300 mg-codeine 30 mg tablet TAKE 1 TO 2 TABLETS BY MOUTH EVERY 6 HOURS AS NEEDED FOR PAIN (TRY TO AVOID DAILY USE) amitriptyline 10 mg tablet TAKE 1 TO 2 TABLETS BY MOUTH AT BEDTIME amLODIPine 5 mg tablet Take 1 tablet by
Current Illness: Otitis externa
Preexisting Conditions: Hx BR CA Essential hypertension asthma gastroesophageal reflux disease overweight osteopenia vitamin D deficiency Major depressive disorder, recurrent, unspecified migraine Migraine osteoarthritis hypothyroidism hyperlipidemia allergic rhinitis diabetes mellitus
Allergies: morphine oxycodone Sulfa (Sulfonamide Antibiotics) tramadol
Diagnostic Lab Data: Creatinine jumped from 1.18 baseline to 3.03. CK at 20988 1 wk out. Rechecking labs today, no other changes to medications or health to account for creatinine jump. Had some elevated CK and renal failure s/p 1st vaccine and COVID infection as well. May be hospitalized s/p recheck today if not improving.
CDC Split Type:

Write-up: Rhabdomyolysis with resultant acute on chronic renal failure


VAERS ID: 1494197 (history)  
Form: Version 2.0  
Age: 60.0  
Sex: Male  
Location: Wisconsin  
Vaccinated:2021-03-10
Onset:2021-07-14
   Days after vaccination:126
Submitted: 0000-00-00
Entered: 2021-07-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EN6205 / 1 RA / IM

Administered by: Unknown       Purchased by: ?
Symptoms: COVID-19, Cough, Nasal congestion, Rhinorrhoea, SARS-CoV-2 test positive
SMQs:, Anaphylactic reaction (broad), Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (narrow)

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

Write-up: Got Pfizer vaccine on 3/10/21 and 3/31/21. Symptom onset on 7/15 with cough, runny nose and nasal congestion. Tested positive for Covid-19 on 7/21/21.


VAERS ID: 1494202 (history)  
Form: Version 2.0  
Age: 60.0  
Sex: Male  
Location: Wisconsin  
Vaccinated:2021-03-31
Onset:2021-07-14
   Days after vaccination:105
Submitted: 0000-00-00
Entered: 2021-07-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0150 / 2 RA / IM

Administered by: Unknown       Purchased by: ?
Symptoms: COVID-19, Cough, Nasal congestion, Rhinorrhoea, SARS-CoV-2 test positive
SMQs:, Anaphylactic reaction (broad), Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (narrow)

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

Write-up: Got Pfizer vaccine on 3/10/21 and 3/31/21. Symptom onset on 7/15 with cough, runny nose and nasal congestion. Tested positive for Covid-19 on 7/21/21.


VAERS ID: 1494239 (history)  
Form: Version 2.0  
Age: 59.0  
Sex: Female  
Location: California  
Vaccinated:2021-04-07
Onset:2021-07-14
   Days after vaccination:98
Submitted: 0000-00-00
Entered: 2021-07-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 043A21A / 1 LA / SYR

Administered by: Other       Purchased by: ?
Symptoms: Condition aggravated, Fatigue, Myalgia
SMQs:, Rhabdomyolysis/myopathy (broad), Eosinophilic pneumonia (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: None
Current Illness: None
Preexisting Conditions: Chronic Fatigue Syndrome (not suffering from effects st time of vaccination)
Allergies: Penicillin
Diagnostic Lab Data:
CDC Split Type:

Write-up: Egregious fatigue, muscle aches. Symptoms have not abated, they are ongoing.


VAERS ID: 1494314 (history)  
Form: Version 2.0  
Age: 16.0  
Sex: Female  
Location: Illinois  
Vaccinated:2021-07-10
Onset:2021-07-14
   Days after vaccination:4
Submitted: 0000-00-00
Entered: 2021-07-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0217 / 1 LA / IM

Administered by: Other       Purchased by: ?
Symptoms: Hypoaesthesia, Paraesthesia, Presyncope, Vision blurred
SMQs:, Peripheral neuropathy (broad), Anticholinergic syndrome (broad), Guillain-Barre syndrome (broad), Glaucoma (broad), Lens disorders (broad), Retinal disorders (broad), Hypotonic-hyporesponsive episode (broad), Hypoglycaemia (broad), Sexual dysfunction (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: Multivitamin, Rescue inhaler
Current Illness: Bruising. PCP did blood test revealing elevated bilirubin
Preexisting Conditions: Asthma
Allergies: Seasonal allergies, seafood, nuts
Diagnostic Lab Data: PCP is out of town and mother did not want to take child to the ED since she was eventually back to baseline.
CDC Split Type:

Write-up: Three days after vaccine,case reported blurry vision, hands and legs numbness and tingling, near syncope. Ten days after vaccine case reported near syncope while riding bike.


VAERS ID: 1494388 (history)  
Form: Version 2.0  
Age: 41.0  
Sex: Female  
Location: Unknown  
Vaccinated:2021-07-12
Onset:2021-07-14
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-07-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 1 LA / IM

Administered by: Unknown       Purchased by: ?
Symptoms: C-reactive protein increased, Cardiac discomfort, Chest X-ray normal, Chest pain, Diarrhoea, Electrocardiogram, Orthostatic intolerance, Palpitations, Pyrexia, SARS-CoV-2 test negative, Tachycardia, White blood cell count decreased
SMQs:, Haematopoietic leukopenia (narrow), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Pseudomembranous colitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Noninfectious diarrhoea (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Dehydration (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: nortriptyline, zopiclone
Current Illness: none
Preexisting Conditions:
Allergies: iodine, tree nuts, maxeran
Diagnostic Lab Data: CRP 8.2 (elevated from below 1) WBC low at 3.7 (was normal prior) Chest xray clear Borderline ECG Covid19 test negative
CDC Split Type:

Write-up: Palpitations, tachycardia, chest pains after 2 days, orthostatic intolerance requiring wheelchair. 6 days post-vaccine fever 38C, diarrhea with cardiac sx. Outcome to be monitored still.


VAERS ID: 1497166 (history)  
Form: Version 2.0  
Age: 18.0  
Sex: Female  
Location: Colorado  
Vaccinated:0000-00-00
Onset:2021-07-14
Submitted: 0000-00-00
Entered: 2021-07-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN UNKNOWN / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Headache, Malaise, Pyrexia, Vision blurred
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Glaucoma (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:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: USJNJFOC20210740917

Write-up: BLURRED VISION; FEELING GENERALLY UNWELL; LOW GRADE FEVER; HEADACHE; This spontaneous report received from a patient concerned an 18 year old female. The patient''s height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 14-JUL-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 JUL-2021, treatment medications included: paracetamol. On 14-JUL-2021, the subject experienced blurred vision. On 14-JUL-2021, the subject experienced feeling generally unwell. On 14-JUL-2021, the subject experienced low grade fever. On 14-JUL-2021, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from blurred vision, low grade fever, headache, and feeling generally unwell. This report was non-serious.


VAERS ID: 1497171 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Arizona  
Vaccinated:0000-00-00
Onset:2021-07-14
Submitted: 0000-00-00
Entered: 2021-07-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN UNKNOWN / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Chills, Cough, Headache, Malaise, Pain, Pain in extremity, Productive cough, Pyrexia, SARS-CoV-2 test, Sinus congestion, Sneezing
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Hypersensitivity (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Alcohol use (once a week); Smoker (once a week)
Preexisting Conditions: Medical History/Concurrent Conditions: COVID-19; Dry cough; Fever; Generalised aching; Mucosal discoloration; Sickness; Comments: Patient had no drug abuse or illicit drug usage.
Allergies:
Diagnostic Lab Data: Test Name: COVID-19 virus test; Result Unstructured Data: Not Provided
CDC Split Type: USJNJFOC20210741093

Write-up: DRY COUGH; SNEEZING; FEELING REALLY CRUDDY; PAIN IN MY ARM; LOW GRADE FEVER; HEADACHE; CHILLS; CONGESTED; CLEAR MUCOUS; BODY ACHE; This spontaneous report received from a patient concerned a 38 year old male. The patient''s weight was 209 pounds, and height was 67 inches. The patient''s past medical history included covid-19, got really sick, fever, body ache, dry cough, and mucus was really green, and concurrent conditions included alcohol user, and smoker, and other pre-existing medical conditions included patient had no drug abuse or illicit drug usage. The patient experienced drug allergy when treated with hydrocodone bitartrate/paracetamol. 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 13-JUL-2021 for prophylactic vaccination. No concomitant medications were reported. The batch number was not reported and has been requested. On 14-JUL-2021, the subject experienced body ache. On 14-JUL-2021, the subject experienced congested. On 14-JUL-2021, the subject experienced clear mucous. On 14-JUL-2021, the subject experienced chills. On 14-JUL-2021, the subject experienced pain in my arm. On 14-JUL-2021, the subject experienced low grade fever. On 14-JUL-2021, the subject experienced headache. On 15-JUL-2021, the subject experienced dry cough. On 15-JUL-2021, the subject experienced sneezing. On 15-JUL-2021, the subject experienced feeling really cruddy. Laboratory data (dates unspecified) included: COVID-19 virus test (NR: not provided) Not Provided. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from low grade fever, body ache, headache, dry cough, congested, clear mucous, chills, feeling really cruddy, pain in my arm, and sneezing. This report was non-serious.


VAERS ID: 1497693 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Unknown  
Vaccinated:0000-00-00
Onset:2021-07-14
Submitted: 0000-00-00
Entered: 2021-07-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN UNKNOWN / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Hypersensitivity, SARS-CoV-2 test, Suspected COVID-19, Vaccination failure
SMQs:, Angioedema (broad), Lack of efficacy/effect (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Hernia repair
Allergies:
Diagnostic Lab Data: Test Date: 20210719; Test Name: COVID-19 virus test; Result Unstructured Data: Positive
CDC Split Type: USJNJFOC20210742023

Write-up: SUSPECTED VACCINE FAILURE; SUSPECTED COVID 19; ALLERGY SYMPTOMS; This spontaneous report received from a patient concerned a male of unspecified age, race and ethnic origin. Initial information was processed with additional information received on 20-Jul-2021. The patient''s height, and weight were not reported. The patient''s past medical history included hernia surgery. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) .5 ml, 1 total, administered on 07-JUN-2021 for prophylactic vaccination. The batch number was not reported and has been requested. Patient had concomitant therapy of other therapeutic products unspecified. Patient thought that he had allergy symptoms which started on 14-JUL-2021. He also had hernia surgery on 16-JUL-2021. He lost taste and smell on 19-JUL-2021. On 19-JUL-2021, he was tested was positive for COVID. Laboratory data included: COVID-19 virus test (NR: not provided) Positive. Patient had suspected clinical vaccination failure and suspected covid-19 infection. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the suspected clinical vaccination failure, suspected covid-19 infection and allergy symptoms was not reported. This report was serious (Other Medically Important Condition). This case, from the same reporter is linked to 20210741495. This report was associated with product quality complaint: 90000186465. .; Sender''s Comments: 20210742023-COVID-19 VACCINE AD26.COV2.S-suspected clinical vaccine failure. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS


VAERS ID: 1498107 (history)  
Form: Version 2.0  
Age: 60.0  
Sex: Male  
Location: Washington  
Vaccinated:2021-07-13
Onset:2021-07-14
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-07-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 040C21A / 1 LA / IM

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

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

Write-up: within 24 hours, the patient developed diarrhea, fever, chills, dizziness, headaches, fatigue, muscle cramps, vomiting, aches, and pains throughout the entire body. Symptoms subsided after 48 hours after the shot was administered. Symptoms were most prevalent from 14-30 hours after initial vaccine. Hot showers alleviated pain, and aided vomiting Bed rest when possible. Oral medication to relieve fevers/chills were ineffective due to vomiting.


VAERS ID: 1498234 (history)  
Form: Version 2.0  
Age: 34.0  
Sex: Female  
Location: Kansas  
Vaccinated:2021-07-14
Onset:2021-07-14
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 041BZ1A / 2 LA / SYR

Administered by: Public       Purchased by: ?
Symptoms: Blood pressure increased, Condition aggravated, Dizziness, Fatigue, Feeling abnormal, Headache, Heart rate increased, Hepatic function abnormal, Influenza like illness, Laboratory test, Limb discomfort, Liver function test abnormal
SMQs:, Liver related investigations, signs and symptoms (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Dementia (broad), Hypertension (narrow), Vestibular disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Dehydration (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Latuda - 20 mg; Lisinopril - 2.5 mg; Xanax - 1 mg twice a day; Feverfew - to help with headaches - 400 mg; Magnesium - 500 mg a day; inhaler I use as needed - Albuterol, I think. I take Tylenol as needed and Naproxen as needed.
Current Illness: I had a migraine five days before my vaccination that I went in for a short for. Toradol - and it did not help. The migraine lasted two days. And five days after that ended I had my vaccination.
Preexisting Conditions: High blood pressure and I have headaches and I do have anxiety and depression and bipolar.
Allergies: Loratav; I can''t take anything that is like Imitrex, at all.
Diagnostic Lab Data: July 12th and results the next day - Labs before the vaccine - Doctor told me when I called him about my symptoms after the vaccine that my lab results had came back and not to take Tylenol anymore- it has affected my liver .
CDC Split Type: vsafe

Write-up: Headache that night of the vaccine and for the last seven days I have been taking 2000 mg of Tylenol every day for seven days and 220-440 mg of Naproxen for the headache pain. I found out that is too much Tylenol. It took the edge off the headache. The next day after vaccine, I felt like I had the flu - like every muscle in my body ached really, really bad. That lasted one day. I do still have fatigue. I also have dizziness and feeling spacy for about eight days. My arms and legs feel really heavy now too. I went to the doctor''s office on the 20th I have had doctor visit. I was going to go in to get a shot for my headache but my headache kind of eased up just a little. My body is building immunity to the vaccine - the doctor said it could take some time before it to go away and said it would not be permanent. But it feels permanent. He said to diet, exercise and push a lot of fluids. I took a Naproxen 220 mg last night which did not help my help my headache but I am not taking Tylenol anymore. If the doctor''s office would have been open last night I would have gone for a shot for it because it was bad enough. I also notice that my pulse is running a little higher - mid 90''s to 103. And my blood pressure is running a little higher - 129/88 one day which is higher for me. At the doctor''s visit it was 130/82 which is higher for me. Note (I had the 1st Moderna vaccine on April 2nd - I waited because I was nervous about getting the 2nd one.)


VAERS ID: 1498292 (history)  
Form: Version 2.0  
Age: 20.0  
Sex: Female  
Location: North Carolina  
Vaccinated:2021-03-12
Onset:2021-07-14
   Days after vaccination:124
Submitted: 0000-00-00
Entered: 2021-07-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 1802070 / 1 RA / SYR

Administered by: Unknown       Purchased by: ?
Symptoms: COVID-19, SARS-CoV-2 test positive
SMQs:, Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (narrow)

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

Write-up: Tested positive with COVID-19


VAERS ID: 1498541 (history)  
Form: Version 2.0  
Age: 46.0  
Sex: Male  
Location: Florida  
Vaccinated:2021-01-13
Onset:2021-07-14
   Days after vaccination:182
Submitted: 0000-00-00
Entered: 2021-07-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EL3302 / 2 RA / IM
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EL0140 / 1 RA / IM

Administered by: Unknown       Purchased by: ?
Symptoms: COVID-19, SARS-CoV-2 test positive
SMQs:, Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: bupropion,rosuvastatin,Afrin,lisinopril,benzonatate,albuterol
Current Illness:
Preexisting Conditions: HTN, HLD, and depression
Allergies: penicillin
Diagnostic Lab Data: SARS CoV 2 PCR Detected 7/14/2021
CDC Split Type:

Write-up: Hospitalization due to COVID-19 infection


VAERS ID: 1498583 (history)  
Form: Version 2.0  
Age: 46.0  
Sex: Male  
Location: Kentucky  
Vaccinated:2021-06-23
Onset:2021-07-14
   Days after vaccination:21
Submitted: 0000-00-00
Entered: 2021-07-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0180 / 1 AR / SYR
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EWO196 / 1 AR / -

Administered by: Work       Purchased by: ?
Symptoms: Illness
SMQs:

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Nothing at all
CDC Split Type:

Write-up: after takeing the shots one day latter i got sick for only one day but after that day i have never got the covd19 again it works


VAERS ID: 1498611 (history)  
Form: Version 2.0  
Age: 27.0  
Sex: Female  
Location: Iowa  
Vaccinated:2021-07-14
Onset:2021-07-14
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0198 / 3 RA / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: Extra dose administered, No adverse event
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: Clonazepam
Current Illness: none
Preexisting Conditions: none
Allergies: cephalosporins
Diagnostic Lab Data: None
CDC Split Type:

Write-up: Pharmacy was notified by agent from agency that patient was given 3 covid vaccines. Called patient to verify and she said she received 1 pifzer vaccine on 1/14/21. Patient never came back and got her second dose after the 21 days. She was told by a health care professional that she would need to start over with the vaccine series since it was over 42 days since her first dose. She came up and got another dose on 6/23/21 from pharmacy and got another dose on 7/14/21 from pharmacy. Patient told the pharmacy that it was only her first dose at the time on 6/23/21 and never mentioned to dose she received on 1/14/21. When I talked to the Patient she has had no Adverse effects from all three doses given to her.


VAERS ID: 1498632 (history)  
Form: Version 2.0  
Age: 62.0  
Sex: Female  
Location: Georgia  
Vaccinated:2021-04-06
Onset:2021-07-14
   Days after vaccination:99
Submitted: 0000-00-00
Entered: 2021-07-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0150 / 2 - / -

Administered by: Public       Purchased by: ?
Symptoms: COVID-19
SMQs:, Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (narrow)

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

Write-up: Patient is hospitalized due to COVID-19. Patient is fully vaccinated.


VAERS ID: 1498657 (history)  
Form: Version 2.0  
Age: 49.0  
Sex: Female  
Location: Michigan  
Vaccinated:2021-07-09
Onset:2021-07-14
   Days after vaccination:5
Submitted: 0000-00-00
Entered: 2021-07-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EWO172 / UNK LA / -

Administered by: Private       Purchased by: ?
Symptoms: Blood test, Dyspnoea, Fatigue, Heart rate increased, Pain in extremity
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Tendinopathies and ligament 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? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Lots if asthma meds ,high blood, meforme
Current Illness: Asthma meds
Preexisting Conditions: Asthma
Allergies: Lots of medicine
Diagnostic Lab Data: Blood work, breathing treatments and much more meds
CDC Split Type:

Write-up: Very tired, heat beating fast,. Short of breath. Sore arm.


VAERS ID: 1498874 (history)  
Form: Version 2.0  
Age: 34.0  
Sex: Female  
Location: Idaho  
Vaccinated:2021-07-14
Onset:2021-07-14
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 205A21A / 1 LA / SYR

Administered by: Public       Purchased by: ?
Symptoms: Dysstasia, Feeling abnormal, Hyperhidrosis, Vision blurred
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Glaucoma (broad), Lens disorders (broad), Retinal disorders (broad), Hypoglycaemia (broad)

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

Write-up: Blurry vision. Unable to stand. Extreme sweating. Able to have similar blood pressure standing and sitting by ~ 12:30. Felt off the day and a half.


VAERS ID: 1500700 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Florida  
Vaccinated:2020-09-21
Onset:2021-07-14
   Days after vaccination:296
Submitted: 0000-00-00
Entered: 2021-07-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Unknown       Purchased by: ?
Symptoms: Diarrhoea, Exposure to SARS-CoV-2, Malaise, Oropharyngeal pain, Paranasal sinus discomfort, Pulmonary congestion
SMQs:, Cardiac failure (broad), Pseudomembranous colitis (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Noninfectious diarrhoea (narrow), Infective pneumonia (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: USPFIZER INC2021893213

Write-up: Been staying with his girlfriends parents and the girlfriends father tested positive for COVID-19.; Has not been feeling well; Little chest congestion; Sore throat; Sinus pressure; Loose bowel but not diarrhea; This is a spontaneous report from a contactable consumer or other non hcp(patient). A 43-years-old male patient received bnt162b2 (Pfizer-BioNTech COVID-19 Vaccine, formulation: solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 21Sep2020 (at the age of 43-years-old) as DOSE 2, SINGLE for covid-19 immunisation. The patient''s medical history was and concomitant medications were not reported. The patient previously took BNT162B2 (Pfizer-BioNTech COVID-19 Vaccine, formulation: solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 31Aug2020 as DOSE1, SINGLE for covid 19 immunisation. On 14Jul2021, the patient experienced little chest congestion, sore throat, sinus pressure, loose bowel but not diarrhea, been staying with his girlfriends parents and the girlfriends father tested positive for covid-19, has not been feeling well. Reporter and his girlfriend had been staying with his girlfriend''s parents and the girlfriend''s father tested positive for COVID-19. He has not been feeling well. Reporter had sore throat and a little chest congestion today (sinus pressure, loose bowel but not diarrhea got this from the callback). Reporter got the self swab, and he wants information on the clinical trial in area so he can give them a call and see if he can get in and for someone to come and pick up his swab for the study and the center. The outcome of all the events was unknown. Information about lot/batch number has been requested.


VAERS ID: 1500955 (history)  
Form: Version 2.0  
Age: 73.0  
Sex: Female  
Location: Colorado  
Vaccinated:2021-07-09
Onset:2021-07-14
   Days after vaccination:5
Submitted: 0000-00-00
Entered: 2021-07-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / UNK - / -

Administered by: Private       Purchased by: ?
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling, Injection site vesicles, Pain in extremity, Pruritus, Rash
SMQs:, Anaphylactic reaction (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (narrow), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Losarton, Levothyroxine, Metoprolol, Eliquis, aspirin
Current Illness: none
Preexisting Conditions: thyroid, chronic acute congestive heart failure, scoliosis, high blood pressure and cholesteral. Prior blood clots, sepsis
Allergies: none known
Diagnostic Lab Data: none
CDC Split Type:

Write-up: Swelling, pain, blisters, pain, redness, itching around shot area. Spreading up and down and around arm. Itching through out body. Pain in legs


VAERS ID: 1501122 (history)  
Form: Version 2.0  
Age: 50.0  
Sex: Female  
Location: Florida  
Vaccinated:2021-07-10
Onset:2021-07-14
   Days after vaccination:4
Submitted: 0000-00-00
Entered: 2021-07-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 939676 / 2 LA / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: Injection site pain
SMQs:, 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:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Site: Pain at Injection Site-Medium, Additional Details: called to complain about pain that persisted from the shoulder down to the area of where the vaccine was given on 7/10/21. She said the pain did not occur until the Wednesday after the vaccine was given which was on 7/14/21. She is able to raise her arm and perform regular activities but she says it does hurt.


VAERS ID: 1501722 (history)  
Form: Version 2.0  
Age: 47.0  
Sex: Female  
Location: Colorado  
Vaccinated:2021-04-01
Onset:2021-07-14
   Days after vaccination:104
Submitted: 0000-00-00
Entered: 2021-07-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / UNK - / -

Administered by: Private       Purchased by: ?
Symptoms: Hypoaesthesia, Swelling
SMQs:, Anaphylactic reaction (broad), Angioedema (broad), Peripheral neuropathy (broad), Guillain-Barre syndrome (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Sexual dysfunction (broad)

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

Write-up: Patient received J&J vaccine in April. No detail on the exact date and lot number is available in system. Patient reported developing bilateral ulnar numbness and swelling at night.


VAERS ID: 1501898 (history)  
Form: Version 2.0  
Age: 14.0  
Sex: Female  
Location: Illinois  
Vaccinated:2021-07-14
Onset:2021-07-14
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 053C21A / UNK LA / IM

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

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

Write-up: None


VAERS ID: 1501909 (history)  
Form: Version 2.0  
Age: 14.0  
Sex: Male  
Location: Illinois  
Vaccinated:2021-07-14
Onset:2021-07-14
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 053C21A / 2 LA / IM

Administered by: Private       Purchased by: ?
Symptoms: Interchange of vaccine products
SMQs:, Medication errors (broad)

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

Write-up: Patient was injected with moderna instead of pfizer


VAERS ID: 1501925 (history)  
Form: Version 2.0  
Age: 12.0  
Sex: Female  
Location: California  
Vaccinated:2021-07-14
Onset:2021-07-14
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH FA6780 / 1 LA / SYR

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: no
Current Illness: no
Preexisting Conditions: no
Allergies: no
Diagnostic Lab Data: No, patient to scared for blood test now.
CDC Split Type:

Write-up: 12 year old daughter a few minutes after vaccine, says she didn''t feel well and eyes closed and she dropped. I quickly grabbed and held her as she would have hit her head from passing out. The paramedics came and she lost 20 points of blood pressure and then ambulance took her to the hospital where she was released.


VAERS ID: 1502012 (history)  
Form: Version 2.0  
Age: 16.0  
Sex: Male  
Location: Texas  
Vaccinated:2021-07-14
Onset:2021-07-14
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EWO177 / 1 LA / IM

Administered by: Other       Purchased by: ?
Symptoms: Blood glucose normal, Chest discomfort, Chest pain, Costochondritis, Dizziness, Injection site pain, Mental status changes, Nausea
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Anticholinergic syndrome (broad), Dementia (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Extravasation events (injections, infusions and implants) (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Vestibular disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness: 07/04 COVID test neg; c/o abd pain for one month; stool tested positive for parasites; treated 07/09 c/o stomach ache and headache, treated 0710 c/o headache -glasses broken; treated 07/13 c/o headache; treated 07/14 c/o leg pain and sl headache in am. treated and advised safe to be given COVID vaccine
Preexisting Conditions: poor vision
Allergies: No known allergies
Diagnostic Lab Data: None to report
CDC Split Type:

Write-up: Pt c/o lightheadness and nausea. vs 98.4, BP 102/74, HR 82, Bld sugar 115 evaluated by Physician and Nurse Practitioner; sent to the Clinic for further evaluation; given fluids. Pt emphasized some change in mental status and sent to the Hospital for evaluation; evaluated treated with fluids and released back to the clinic. 7/15 vital signs stable, c/o slight pain at injection site; no other c/o any issues Later on 7/15 pt c/o sl chest pain and discomfort-examined. vital signs stables dx with controchondritis-treated. No further c/o any problems after COVID injection 7/8 left the clinic and reunified with family


VAERS ID: 1502078 (history)  
Form: Version 2.0  
Age: 29.0  
Sex: Female  
Location: Tennessee  
Vaccinated:2021-07-13
Onset:2021-07-14
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-07-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EVV0177 / 1 LA / SYR

Administered by: Pharmacy       Purchased by: ?
Symptoms: Asthenia, Dysmenorrhoea, Fatigue, Heavy menstrual bleeding, Intermenstrual bleeding, Menstrual disorder
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), 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? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Levothyroxine
Current Illness: N/a
Preexisting Conditions: Hypothyroidism
Allergies: N/a
Diagnostic Lab Data: N/a
CDC Split Type:

Write-up: The following day after receiving the vaccine, I started spotting and cramping. Within hours this became more intense and the bleeding became very heavy. This was outside of my usual menstrual cycle as well as very abnormal for me. I became extremely weak and fatigued. Combined my symptoms lasted for 12days and counting. My doctor eventually prescribed me a very low dose of Provera to take for 5days in order to control the heavy bleeding and hopefully return my cycle back to normal.


VAERS ID: 1502192 (history)  
Form: Version 2.0  
Age: 56.0  
Sex: Female  
Location: Florida  
Vaccinated:2021-03-16
Onset:2021-07-14
   Days after vaccination:120
Submitted: 0000-00-00
Entered: 2021-07-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 007M20A / 1 - / IM
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 032M20A / 2 - / IM

Administered by: Unknown       Purchased by: ?
Symptoms: Acute respiratory failure, Blood pressure increased, COVID-19, COVID-19 pneumonia, Cough, Diarrhoea, Dizziness, Hypotension, SARS-CoV-2 test positive
SMQs:, Anaphylactic reaction (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (broad), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (broad), Toxic-septic shock conditions (broad), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Pseudomembranous colitis (broad), Acute central respiratory depression (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hypertension (narrow), Vestibular disorders (broad), Hypersensitivity (broad), Noninfectious diarrhoea (narrow), Respiratory failure (narrow), Infective pneumonia (narrow), Dehydration (broad), Hypokalaemia (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? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: carvedilol, levothyroxine, mag ox, aspirin, nifedipine, predni prednisone, diclofenac, tacrolimus, mycophenolate mofetil
Current Illness:
Preexisting Conditions: Kidney transplant in 2020, hypothyroidism, Hashimoto thyroiditis, hypertension, SLE
Allergies: Ceclor, cephalosporins, penicillins, shellfish
Diagnostic Lab Data: tested positive for COVID on 7/15/21
CDC Split Type:

Write-up: 7/20/2021: Patient came to ER due to coughing, diarrhea and feeling lightheaded. While in the ED patient had a hypotensive episode, her blood pressure increased and she was started on broad spectrum antibiotics. Patient stated she tested positive for COVID on 7/15/21. Diagnosed with: COVID-19 pneumonia, acute hypoxic respiratory failure 7/26/21: patent is still admitted the day of this report submission. Note: patient received 2 shots of Moderna COVID19 vaccines, second dose in March 2021.


VAERS ID: 1502211 (history)  
Form: Version 2.0  
Age: 35.0  
Sex: Female  
Location: South Carolina  
Vaccinated:2021-07-09
Onset:2021-07-14
   Days after vaccination:5
Submitted: 0000-00-00
Entered: 2021-07-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 037C21A / 1 LA / SYR

Administered by: Pharmacy       Purchased by: ?
Symptoms: Blister, Nasopharyngitis, Rash
SMQs:, Severe cutaneous adverse reactions (broad), Anaphylactic reaction (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Vitamin C; Green Tea Pill; Vitamin D; Folic acid
Current Illness: No
Preexisting Conditions: Asthma
Allergies: Latex
Diagnostic Lab Data:
CDC Split Type:

Write-up: After the second dose 09/07/21 I started with a rash on both arms. A lot of blisters covered the top of my hands and arms. three days later I had a bad cold.


VAERS ID: 1502239 (history)  
Form: Version 2.0  
Age: 17.0  
Sex: Male  
Location: Wisconsin  
Vaccinated:2021-05-18
Onset:2021-07-14
   Days after vaccination:57
Submitted: 0000-00-00
Entered: 2021-07-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0179 / 1 LA / IM

Administered by: Private       Purchased by: ?
Symptoms: Ageusia, Anosmia, COVID-19, Cough, Fatigue, Headache, Myalgia, Oropharyngeal pain, SARS-CoV-2 test positive, Vaccine breakthrough infection
SMQs:, Rhabdomyolysis/myopathy (broad), Anaphylactic reaction (broad), Taste and smell disorders (narrow), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Eosinophilic pneumonia (broad), Tendinopathies and ligament disorders (broad), Infective pneumonia (broad), Opportunistic infections (broad), Immune-mediated/autoimmune disorders (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Specimen Collection Date: 07/24/21 Specimen Source: nasopharyngeal swab Test Performed: SARS CoV-2 RNA, / SARS Cornavirus-2 RNA, V Result: DETECTED
CDC Split Type:

Write-up: Sx onset 7/14/21 cough, sore throat, muscle aches, headache, fatigue, loss of smell & loss of taste.


VAERS ID: 1502241 (history)  
Form: Version 2.0  
Age: 17.0  
Sex: Male  
Location: Wisconsin  
Vaccinated:2021-06-08
Onset:2021-07-14
   Days after vaccination:36
Submitted: 0000-00-00
Entered: 2021-07-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0191 / 2 LA / IM

Administered by: Private       Purchased by: ?
Symptoms: Ageusia, Anosmia, COVID-19, Cough, Fatigue, Headache, Myalgia, Oropharyngeal pain, SARS-CoV-2 test positive
SMQs:, Rhabdomyolysis/myopathy (broad), Anaphylactic reaction (broad), Taste and smell disorders (narrow), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Eosinophilic pneumonia (broad), Tendinopathies and ligament disorders (broad), Infective pneumonia (broad), Opportunistic infections (broad), Immune-mediated/autoimmune disorders (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Specimen Collection Date: 07/24/21 Specimen Source: nasopharyngeal swab Test Performed: SARS CoV-2 RNA, TMA / SARS Cornavirus-2, Result: DETECTED
CDC Split Type:

Write-up: Mother positive, Sx onset 7/14/21 cough, sore throat, muscle aches, headache, fatigue, loss of smell & loss of taste.


VAERS ID: 1502275 (history)  
Form: Version 2.0  
Age: 69.0  
Sex: Male  
Location: California  
Vaccinated:2021-07-14
Onset:2021-07-14
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0178 / 1 LA / IM

Administered by: Private       Purchased by: ?
Symptoms: Rash
SMQs:, Anaphylactic reaction (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

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

Write-up: I have developed a small rash on my upper left thigh... about the size of a quarter.


VAERS ID: 1502343 (history)  
Form: Version 2.0  
Age: 42.0  
Sex: Male  
Location: Wisconsin  
Vaccinated:2021-02-01
Onset:2021-07-14
   Days after vaccination:163
Submitted: 0000-00-00
Entered: 2021-07-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 025A21A / 2 UN / UN

Administered by: Unknown       Purchased by: ?
Symptoms: Chills, Cough, Headache, Myalgia, Nasal congestion, Pyrexia, Vomiting
SMQs:, Rhabdomyolysis/myopathy (broad), Anaphylactic reaction (broad), Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Eosinophilic pneumonia (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

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

Write-up: cough,chills,muscle aches,nasal congestion,fever,headache,vomitting


VAERS ID: 1502789 (history)  
Form: Version 2.0  
Age: 16.0  
Sex: Male  
Location: Texas  
Vaccinated:2021-07-14
Onset:2021-07-14
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EWO177 / 1 RA / IM

Administered by: Other       Purchased by: ?
Symptoms: Blood glucose normal, Fall
SMQs:, Accidents and injuries (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: 07/04 c/o cough and tiredness-given cough drops and advised to increase fluid intaKE
Current Illness: 07/03 c/o cough, no fever no medications given 07/04 c/o cough and tiredness-given cough drops and advised to increase fluid intake
Preexisting Conditions: None known
Allergies: No known allergies identified
Diagnostic Lab Data: Glucose 130
CDC Split Type:

Write-up: Pt was about to sit in a child when he fell to his knees, caught by medical provider and placed in a cot. Temp 97.8, Resp 24, BP 126/83, P 88, glucose 130 Child transferred to medical clinic where he was monitored, provided fluids-child improved and was released


VAERS ID: 1502934 (history)  
Form: Version 2.0  
Age: 14.0  
Sex: Male  
Location: Texas  
Vaccinated:2021-07-14
Onset:2021-07-14
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EWO177 / 1 RA / IM

Administered by: Other       Purchased by: ?
Symptoms: Blood glucose normal, Bradycardia, Condition aggravated, Dizziness, Electrocardiogram normal, Headache, Mental disorder, Pain
SMQs:, Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Dementia (broad), Vestibular disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: 07/04 c/o abd pain, stool positive for parasites, prescribed cours of Flagyl BID for 7 days 07/10 c/o headache prescribed Ibuprofen prn for 3 days
Current Illness: 07/04 Parasites in stool 07/10 Headache
Preexisting Conditions: Known identified by child
Allergies: None known
Diagnostic Lab Data: 07/14 at Hospital EKG done and WNL, normal orthostatic vital signs
CDC Split Type:

Write-up: PT c/o headache, pain 6/10, and dizziness. vitals temp 98.5, pulse 66, BP 125/66, resp 17, pO2 98, glucose 94 seen earler in day for headache but no c/o headache on assessment,, apparent change in mental state, health care provider decided to transfer child, transported via EMS to Hospital- dx bradycardia, treated and realeased back to EIS


VAERS ID: 1504952 (history)  
Form: Version 2.0  
Age: 39.0  
Sex: Male  
Location: Michigan  
Vaccinated:2021-07-13
Onset:2021-07-14
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-07-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 043A21 / 1 RA / IM

Administered by: Other       Purchased by: ?
Symptoms: Contusion, Haemoglobin decreased, Immunoglobulin therapy, Petechiae, Platelet count decreased, Thrombocytopenic purpura, Ultrasound Doppler normal, White blood cell count increased
SMQs:, Haematopoietic erythropenia (broad), Haematopoietic thrombocytopenia (narrow), Haemorrhage terms (excl laboratory terms) (narrow), Haemorrhage laboratory terms (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Accidents and injuries (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Immune-mediated/autoimmune disorders (narrow)

Life Threatening? Yes
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, 2 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: Vitamin C 500mg BID L-Lysine 500mg BID Vitamin D3 50mcg Daily
Current Illness: No Illnesses at time of vaccination or one month prior
Preexisting Conditions: Herpes Simplex Type 1 HSV-1
Allergies: No Allergies
Diagnostic Lab Data: March 2020 Annual Physical (BASELINE) platelets 246,000 Saturday July 17, 2021 - white count 6.7; hemoglobin 16; platelets 7,000; bilateral lower extremity ultrasound negative for thrombi Sunday July 18, 2021 - white count 6.3; hemoglobin 15.6; platelets 29,000 Tuesday July 20, 2021 - white count 14; hemoglobin 13.7; platelets 198,000 Friday July 23, 2021 - white count 8.7; hemoglobin 14.7; platelets 264,000 Monday July 26, 2021 - platelets 45,000
CDC Split Type:

Write-up: Janssen Lot #043A21A COVID-19 vaccine administered Tuesday July 13, 2021 at 12:15pm. Wednesday July 14, 2021 - quarter sized spontaneous bruising to bilateral calves Thursday July 15, 2021 - dollar sized spontaneous bruising to bilateral calves; petechial rash noted to bilateral ankles and calves Friday July 16, 2021 - continued bilateral calf bruising; petechial rash spread from ankles to mid thigh bilaterally and bilateral shoulders and back Saturday July 17, 2021 - patient presented to urgent care and referred directly to Emergency Department; platelets found to be 7,000; bilateral lower extremity ultrasound negative for thrombi; admitted to Hospital Sunday July 18, 2021 - platelets improved to 29,000; patient discharged to home for outpatient follow-up of new diagnosis of Immune Thrombocytopenia Purpura Tuesday July 20, 2021 - outpatient lab (see medical tests and laboratory results) - platelets 198,000 Friday July 23, 2021 - outpatient lab (see medical tests and laboratory results) - platelets 264,000 Monday July 26, 2021 - outpatient lab (see medical tests and laboratory results); platelets 45,000 initiated 40mg daily oral Prednisone


VAERS ID: 1505513 (history)  
Form: Version 2.0  
Age: 63.0  
Sex: Female  
Location: Indiana  
Vaccinated:2021-07-14
Onset:2021-07-14
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0191 / 2 LA / IM

Administered by: Private       Purchased by: ?
Symptoms: Product preparation error
SMQs:, Medication errors (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Wellbutrin XL 150 mg Amlodipine 5 mg hyrdoxyzine 25 mg candersartan-hydrochlorothiazde 32 mg-12.5mg metoprolol 50 mg extended release
Current Illness: Hand tremor Memory loss
Preexisting Conditions: Hypertension Anxiety GERD Insomnia Fatigue
Allergies: No known allergies
Diagnostic Lab Data:
CDC Split Type:

Write-up: Nurse administering vaccine used incorrect diluent when mixing vaccine. Nurse used diluent for varicella vaccine and not normal saline.


VAERS ID: 1505643 (history)  
Form: Version 2.0  
Age: 37.0  
Sex: Female  
Location: Maryland  
Vaccinated:2021-06-25
Onset:2021-07-14
   Days after vaccination:19
Submitted: 0000-00-00
Entered: 2021-07-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0196 / 1 RA / -
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0196 / 2 RA / -

Administered by: Unknown       Purchased by: ?
Symptoms: Chest discomfort, Chest pain, Cough, Dyspnoea, Dyspnoea exertional, Ear swelling, Erythema, External ear pain, Fatigue, Feeling hot, Headache, Loss of consciousness, Nausea, Pain, SARS-CoV-2 test negative, Sinus congestion
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (narrow), Acute pancreatitis (broad), Angioedema (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypersensitivity (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Kariva- birth control Omega Three Essential Fatty Acids Melatonin Vitamin D
Current Illness: Acid Reflux
Preexisting Conditions: Asthma Acid Reflux Migraines
Allergies: Lactose intolerance Allergic to Depakote
Diagnostic Lab Data: Covid-19 test- negative done on 6/17
CDC Split Type:

Write-up: For the first week following second dose- extreme fatigue. The first few days also included body aches, nausea, and headaches. Then on July 14 I woke up in the middle of the night with pain in my left ear cartilage- it was extremely swollen, red, and hot. In 24 hours the redness and heat decreased fully and the swelling decreased a lot, however, the cartilage is still swollen and painful. I also became congested in my sinuses and developed a cough, pain in my chest, and shortness of breath. These symptoms were so bad I could not talk or walk up stairs without losing my breath and several times a day blacked out from shortness of breath or coughing. I have seen the doctor twice, was put on two inhalers, oral steroids, and tessalon perles, however, still have extreme tightness in my chest, shortness of breath, and a cough. I have not had extreme asthma symptoms requiring medical intervention in 6 years, was not exposed to anyone sick, and have not been sick in years.


VAERS ID: 1505650 (history)  
Form: Version 2.0  
Age: 76.0  
Sex: Male  
Location: North Carolina  
Vaccinated:2021-02-11
Onset:2021-07-14
   Days after vaccination:153
Submitted: 0000-00-00
Entered: 2021-07-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA - / 2 - / IM

Administered by: Unknown       Purchased by: ?
Symptoms: COVID-19
SMQs:, Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: Rituxan maintenance
Current Illness:
Preexisting Conditions: Low-grade follicular lymphoma
Allergies:
Diagnostic Lab Data: Cycle threshold on 7/14 = 22.8 Cycle threshold on 7/27 = 20.6
CDC Split Type:

Write-up: Hospitalization with COVID-19 Reported per vaccine EUA


VAERS ID: 1505937 (history)  
Form: Version 2.0  
Age: 33.0  
Sex: Female  
Location: Washington  
Vaccinated:2021-07-13
Onset:2021-07-14
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-07-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0198 / 2 LA / SYR

Administered by: Pharmacy       Purchased by: ?
Symptoms: Arthralgia, Chills, Condition aggravated, Exposure to SARS-CoV-2, Fatigue, Headache, Myalgia, Nausea, Pain, Pain in extremity, Pyrexia, Rash, Rash pruritic, SARS-CoV-2 test negative
SMQs:, Rhabdomyolysis/myopathy (broad), Anaphylactic reaction (broad), Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Eosinophilic pneumonia (broad), Hypersensitivity (narrow), Arthritis (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations: 6/22/2021 - COVID Dose 1 Pfizer - heart fluttering - the first day I got the shot to three or four days after, nausea, diarrhea,
Other Medications: NAC; Multi Vitamin; Vit D; L-Theanine
Current Illness: no
Preexisting Conditions: no
Allergies: no - sensitive to medications though - if there are side affects I have them for prescription drugs
Diagnostic Lab Data: I did get a COVID test - it came back negative. I had the test the day after my vaccine on the 14th due to exposure a day or two before the second vaccine.
CDC Split Type: vsafe

Write-up: I did have (starting after midnight) - a fever and body aches and joint pain, chills and headaches, arm pain. I had nausea a couple of times a couple of days after but I hadn''t eaten a whole lot. 15th I still felt it. I think my fever was gone on 15th. I had fatigue for a few days. Saturday or Sunday, I had a fever again and that time with nausea and with muscle aches. I have had a rash that I noticed a couple of days after the vaccine (the second time that I had the fever) - it was like a rash I had when I was on a certain birth control - I still have the rash - it is all over legs. It is itchy sometimes. It hasn''t been itchy for the last couple of days so maybe it''s starting to go away. I saw my doctor on either Saturday or Sunday. It was an acupuncture treatment-with general practitioner who does acupuncture. I had acupuncture for my headaches specifically. It helped with the general ongoing headache that I had had since the night I first started having symptoms.


VAERS ID: 1506232 (history)  
Form: Version 2.0  
Age: 43.0  
Sex: Female  
Location: Missouri  
Vaccinated:2021-07-14
Onset:2021-07-14
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 RA / IM

Administered by: Work       Purchased by: ?
Symptoms: Hypoaesthesia, Paraesthesia, Swelling face
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Peripheral neuropathy (broad), Guillain-Barre syndrome (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Sexual dysfunction (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: none
Current Illness: none
Preexisting Conditions: none
Allergies: none
Diagnostic Lab Data: i went to my primary care physician who referred me to an allergist. an evaluation was performed. no difinitive tests were performed. I was told I could see a neurologist if I chose to.
CDC Split Type:

Write-up: About an hour after I was given the shot the right side of my face swelled and went numb and tingly. My right arm became numb and tingly too. it lasted for about 4 hours. it subsided around 7pm that evening. The next day I had the same occurrence as the previous day but it lasted for about 6 hours, from around 11 am till 5pm or so.


VAERS ID: 1509077 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Unknown  
Vaccinated:2021-07-13
Onset:2021-07-14
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-07-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Unknown       Purchased by: ?
Symptoms: Headache, Illness, Nausea, Pain in extremity
SMQs:, Acute pancreatitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Tendinopathies and ligament disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: COVID-19 (note: she had COVID in December, but she just feels really sick.)
Allergies:
Diagnostic Lab Data:
CDC Split Type: USPFIZER INC2021894356

Write-up: nausea/completely nauseous; bad headache; felt really sick; arm was also sore; This is a spontaneous report from a contactable consumer (patient). A 56-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number, NDC number and Expiry Date were not provided), via an unspecified route of administration on 13Jul2021 at 12:30 in the afternoon as dose 2, single dose for covid-19 immunisation. Patient history he had COVID in December, but she just feels really sick. The patient''s concomitant medications were not reported. The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 1, on an unspecified date for covid-19 immunization. She stated that she got her 2nd dose of the Pfizer BioNTech Covid-19 vaccine yesterday 12:30 in the afternoon and on 14Jul2021, she felt really sick around 2 or 3 in the morning of the following day, her arm was also sore, it started out as a bad headache and had progressed to nausea. She took some Advil to relieve the headache, but she is still feeling the side effects of the vaccine. She states that she''s just feeling really sick after the second dose. She states she''s completely nauseous, she has a bad headache, she just feels really sick. She states she doesn''t know what to do. She asked, is it normal to feel nauseous after? she just wanted to know if what she''s feeling is normal, she just hates feeling like this. She wanted to know if feeling nausea, bad headache, and feeling unwell are among the commonly reported adverse events after getting the Pfizer BioNTech Covid-19 Vaccine. She confirmed that the product she received and is speaking of was the Pfizer Covid 19 Vaccine. She stated that it was the Pfizer 19, Covid Vaccine number two, she got it done. Reporter seriousness for nauseous, bad headache and just feels really sick was unspecified. The outcome of events was unknown. No follow-up attempts are possible. No further information is expected.


VAERS ID: 1509106 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Unknown  
Vaccinated:2021-07-14
Onset:2021-07-14
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Unknown       Purchased by: ?
Symptoms: Asthma
SMQs:, Anaphylactic reaction (broad), Asthma/bronchospasm (narrow), Eosinophilic pneumonia (broad), Hypersensitivity (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: SALBUTAMOL
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Asthma
Allergies:
Diagnostic Lab Data:
CDC Split Type: USPFIZER INC2021897070

Write-up: Asthma; This is a spontaneous report from a contactable consumer (mother). A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; solution for injection, lot number and expiry date not reported), via an unspecified route of administration on 14Jul2021 (also reported as in this morning) as dose number unknown, single for COVID-19 immunisation. Medical history included asthma. Concomitant medication included salbutamol (SALBUTAMOL) taken for asthma. The patient experienced asthma on 14Jul2021. The reporter was asking if the patient can use her Ventolin inhaler as she experienced asthma. The outcome for the event was unknown. Information on lot/batch number has been requested.


VAERS ID: 1509209 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Unknown  
Vaccinated:2021-07-13
Onset:2021-07-14
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-07-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0198 / 2 - / -

Administered by: Pharmacy       Purchased by: ?
Symptoms: Abdominal pain, Abdominal pain upper, Diarrhoea
SMQs:, Acute pancreatitis (broad), Retroperitoneal fibrosis (broad), Pseudomembranous colitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Noninfectious diarrhoea (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: USPFIZER INC2021906413

Write-up: Severe abdominal cramping; I never had a stomach ache like this before; Diarrhea; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received second dose of BNT162B2 (Pfizer COVID 19 Vaccine, solution for injection), via an unspecified route of administration on 13Jul2021 (Batch/Lot Number: EW0198) as DOSE 2, SINGLE for covid-19 immunization. The patient medical history and concomitant medications were not reported. Patient previously received first dose of BNT162B2 Batch/Lot Number: EW0217) on 22Jun2021 for covid-19 immunization; Not side effect. It was reported that, I am having, I had diarrhea yesterday (14Jul2021) and today (15Jul2021) and I am having severe abdominal cramping and I need to know if this is the side effect of this injection. Consumer was also informed about the role of Pfizer Drug Safety and requested to file a safety report, consumer stated, "It''s going to take 10 minutes? I can''t sit here for 10 minutes on the phone, I mean I have to go ''down'' (voice not clear) this is bad. But if you can''t transfer me, I will just call my doctor." LOT#: Consumer stated, "I never had a stomach ache like this before (15Jul2021), so the second dose was EW0198. The first one I had not side effect, the date here is (13Jul2021). The outcome of the events was unknown.


VAERS ID: 1509215 (history)  
Form: Version 2.0  
Age: 40.0  
Sex: Female  
Location: Oklahoma  
Vaccinated:2021-03-20
Onset:2021-07-14
   Days after vaccination:116
Submitted: 0000-00-00
Entered: 2021-07-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ER8727 / 2 RA / -

Administered by: Unknown       Purchased by: ?
Symptoms: Body temperature, Chills, Cough, Nasal congestion, Pyrexia, SARS-CoV-2 test, Sneezing
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Hypersensitivity (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), COVID-19 (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210714; Test Name: Body temperature; Result Unstructured Data: Test Result:99.5 Fahrenheit; Test Date: 20210714; Test Name: Covid-19 test; Result Unstructured Data: Test Result:Unknown
CDC Split Type: USPFIZER INC2021907685

Write-up: a little bit of a cough; stuffy nose; Sneezing; Chills; Fever/temperature has been fluctuating between the 98-99.5 degrees Fahrenheit neighborhood; has taken it a couple times today; This is a spontaneous report from a contactable consumer. A 40-years-old female patient received BNT162B2 (Formulation: Solution for injection; Batch/Lot Number: ER8727), dose 2 via an unspecified route of administration, administered in Arm Right on 20Mar2021 15:00 as DOSE 2, SINGLE for covid-19 immunisation. The patient medical history was not reported. The patient''s concomitant medications were not reported. The patient previously received first dose of BNT162B2 (Batch/Lot Number: EN6202) at right upper arm on 27Feb2021 for covid-19 immunisation. Caller reports she and wife both got the Covid vaccines completed in Mar2021 and she has the CDC cards. Caller wants to report that she has contracted Covid and does know Pfizer is working with the government to get a booster going. State she lives here in # which is a little wonky on their Covid management side of things are trying to do the right things. She wanted to report this and provide that she got her PCR test results today and it was positive. It took a lot just to get it done and she is getting on the medicines. Knows with the CDC they are not tracking cases unless they are for hospitalizations or death. It seems like if it''s not those reasons nobody is interested in the information on her vaccination card. So, she is calling to report this to Pfizer in case data is being tracked with Pfizer. Is trying to help. She started having symptoms on Saturday, 10Jul2021 and hasn''t spent time with anyone with Covid. Everyone she is associated with chose to get tested and have come up negative and she didn''t want to waste and not report this information. Does not provide any further details or details for those she was associated with. No further details provided. States her wife is also experiencing some symptoms and she has had both her shots. Her wife also was vaccinated the same day as her, but at a different time of day. Wife started experiencing symptoms yesterday and she also got a PCR test, and they are awaiting results. They are isolating and in separate rooms. Caller agrees to report for wife. Unable to provide details of primary care provider states her wife does not have one yet. On 14Jul2021 wife had symptoms that started last night as stuffy nose, sneezing, chills, fever of 99.5 degrees Fahrenheit that started last night about 6:30pm. Today she has the same symptoms with now a little bit of a cough on 15Jul2021 and her temperature has been fluctuating between the 98-99.5 degrees Fahrenheit neighborhood. Had taken it a couple times today. She did go to the pharmacy yesterday for PCR testing and they have not provided the results as of today. Has checked their email system and it says not available. Wife has gotten her well woman exam and they requested some blood work from her, but not sure what the panel is for. Has been trying to get this scheduled and then this happened. Clarifies the wants to get those blood work panels done, but they haven''t been done yet. No further details provided. The patient underwent lab tests and procedures which included body temperature: 99.5 Fahrenheit on 14Jul2021, sars-cov-2 test: unknown on 14Jul2021. The outcome of the event was not recovered. Information on Lot/Batch number was available. Additional information has been requested.


VAERS ID: 1509220 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Unknown  
Vaccinated:2021-07-14
Onset:2021-07-14
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 - / -

Administered by: Unknown       Purchased by: ?
Symptoms: Anxiety, Arthralgia, Body temperature, Influenza like illness, Pain in extremity, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arthritis (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210716; Test Name: Temperature; Result Unstructured Data: Test Result:102.9
CDC Split Type: USPFIZER INC2021907844

Write-up: Getting severe flu like symptoms; Started getting flu symptoms again were my joints ache and my fingers and everything; Anxiety attack; Running a temperature of about 102.9; She is running 4 degrees over what she supposed to be; Getting severe flu like symptoms; Started getting flu symptoms again were my joints ache and my fingers and everything; Getting severe flu like symptoms; Started getting flu symptoms again were my joints ache and my fingers and everything; This is a spontaneous report from a contactable consumer (patient herself). A female patient of an unspecified age received BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- UNKNOWN) via an unspecified route of administration on 14Jul2021 as dose 2, single for COVID-19 immunization. Patient medical history and concomitant medications were not reported. Historical vaccine included BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- UNKNOWN) via an unspecified route of administration as dose 1, single for COVID-19 immunization. Patient had this Pfizer vaccine the second dose the 14Jul2021 and two hours of doing great and then all of a sudden she started getting severe flu like symptoms and they were pretty severe. Today she woke up and felt pretty good and then after about 6 hours she started getting flu symptoms again with her joints ache and her fingers and everything and now she was monitoring her temperature, and then she had an anxiety attack and then right now she was running a temperature of about 102.9 and we were wondering is that how high temperature can be before it was dangerous. She was running 4 degrees over what she supposed to be, now are we able to tell her anything about that, she queried. The outcome of the events was unknown. Information about lot/batch number has been requested.


VAERS ID: 1509236 (history)  
Form: Version 2.0  
Age: 15.0  
Sex: Female  
Location: Indiana  
Vaccinated:2021-07-14
Onset:2021-07-14
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0176 / 1 LA / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: Product storage error
SMQs:, Medication errors (narrow)

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

Write-up: Error: Improper Storage (temperature)-


VAERS ID: 1509245 (history)  
Form: Version 2.0  
Age: 60.0  
Sex: Male  
Location: Indiana  
Vaccinated:2021-07-14
Onset:2021-07-14
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0176 / 2 LA / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: Product storage error
SMQs:, Medication errors (narrow)

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

Write-up: Error: Improper Storage (temperature)-


VAERS ID: 1509256 (history)  
Form: Version 2.0  
Age: 26.0  
Sex: Male  
Location: Indiana  
Vaccinated:2021-07-14
Onset:2021-07-14
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0176 / 2 LA / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: Product storage error
SMQs:, Medication errors (narrow)

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

Write-up: Error: Improper Storage (temperature)-


VAERS ID: 1509265 (history)  
Form: Version 2.0  
Age: 15.0  
Sex: Female  
Location: Indiana  
Vaccinated:2021-07-14
Onset:2021-07-14
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA EW0176 / 1 LA / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: Product storage error
SMQs:, Medication errors (narrow)

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

Write-up: Error: Improper Storage (temperature)-


VAERS ID: 1509562 (history)  
Form: Version 2.0  
Age: 17.0  
Sex: Female  
Location: Unknown  
Vaccinated:2021-07-14
Onset:2021-07-14
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0196 / 1 - / IM

Administered by: Unknown       Purchased by: ?
Symptoms: Expired product administered, Product storage error
SMQs:, Medication errors (narrow)

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

Write-up: Pfizer vaccine was administered after being discovered the vaccines were in the freezer for 11 days after the two-week standard time.


VAERS ID: 1509568 (history)  
Form: Version 2.0  
Age: 14.0  
Sex: Female  
Location: Unknown  
Vaccinated:2021-07-14
Onset:2021-07-14
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0196 / 1 RA / IM

Administered by: Unknown       Purchased by: ?
Symptoms: Expired product administered
SMQs:, Medication errors (narrow)

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

Write-up: Pfizer vaccine was administered after being discovered the vaccines were in the freezer for 11 days after the two-week standard time.


VAERS ID: 1509601 (history)  
Form: Version 2.0  
Age: 13.0  
Sex: Male  
Location: Unknown  
Vaccinated:2021-07-14
Onset:2021-07-14
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0196 / 2 LA / IM

Administered by: Unknown       Purchased by: ?
Symptoms: Product storage error
SMQs:, Medication errors (narrow)

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

Write-up: PFizer vaccine was administered after being discovered that the vaccines were kept in the freezer for 11 days longer than the two week standard time.


VAERS ID: 1509691 (history)  
Form: Version 2.0  
Age: 28.0  
Sex: Male  
Location: Unknown  
Vaccinated:2021-07-14
Onset:2021-07-14
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0196 / 2 LA / IM

Administered by: Unknown       Purchased by: ?
Symptoms: Product storage error
SMQs:, Medication errors (narrow)

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

Write-up: PFizer vaccine was administered after being discovered that the vaccines were kept in the freezer for 11 days longer than the two week standard time. Patient was notified and given option for additional dose.


VAERS ID: 1509820 (history)  
Form: Version 2.0  
Age: 48.0  
Sex: Female  
Location: North Carolina  
Vaccinated:2021-07-10
Onset:2021-07-14
   Days after vaccination:4
Submitted: 0000-00-00
Entered: 2021-07-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN - / 1 LA / SYR

Administered by: School       Purchased by: ?
Symptoms: Chills, Diarrhoea
SMQs:, Pseudomembranous colitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Noninfectious diarrhoea (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Juice Plus (have been taking for 20 years), Vitamin D
Current Illness: UTI 2 weeks before
Preexisting Conditions: none
Allergies: none
Diagnostic Lab Data: none
CDC Split Type:

Write-up: Chills 14 hours later; diarrhea starting a few days later and going on for nearly two weeks.


VAERS ID: 1509849 (history)  
Form: Version 2.0  
Age: 65.0  
Sex: Female  
Location: Indiana  
Vaccinated:2021-07-14
Onset:2021-07-14
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0176 / 1 LA / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: Product storage error
SMQs:, Medication errors (narrow)

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

Write-up: Error: Improper Storage (temperature)-


VAERS ID: 1509856 (history)  
Form: Version 2.0  
Age: 51.0  
Sex: Female  
Location: Indiana  
Vaccinated:2021-07-14
Onset:2021-07-14
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0176 / 1 RA / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: Product storage error
SMQs:, Medication errors (narrow)

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

Write-up: Error: Improper Storage (temperature)-


VAERS ID: 1509857 (history)  
Form: Version 2.0  
Age: 16.0  
Sex: Male  
Location: Unknown  
Vaccinated:2021-07-14
Onset:2021-07-14
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0196 / 2 LA / IM

Administered by: Unknown       Purchased by: ?
Symptoms: Expired product administered
SMQs:, Medication errors (narrow)

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

Write-up: PFizer vaccine was administered after being discovered that the vaccines were kept in the freezer for 11 days longer than the two week standard time. Patient was notified and given option for additional dose.


VAERS ID: 1509862 (history)  
Form: Version 2.0  
Age: 14.0  
Sex: Female  
Location: Indiana  
Vaccinated:2021-07-14
Onset:2021-07-14
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0176 / 1 LA / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: Product storage error
SMQs:, Medication errors (narrow)

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

Write-up: Error: Improper Storage (temperature)-


VAERS ID: 1509863 (history)  
Form: Version 2.0  
Age: 57.0  
Sex: Female  
Location: California  
Vaccinated:2021-04-30
Onset:2021-07-14
   Days after vaccination:75
Submitted: 0000-00-00
Entered: 2021-07-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ER8736 / 2 LA / IM

Administered by: Private       Purchased by: ?
Symptoms: COVID-19, Malaise, Oxygen saturation decreased, SARS-CoV-2 test positive
SMQs:, Acute central respiratory depression (broad), Respiratory failure (broad), Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (narrow)

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

Write-up: Felt ill ~7/5/21, tested positive for COVID 7/14/21; ED visit on 7/21/21 d/t dec O2 sats & admitted to hospital, discharged on 7/24/21


VAERS ID: 1509866 (history)  
Form: Version 2.0  
Age: 12.0  
Sex: Female  
Location: Unknown  
Vaccinated:2021-07-14
Onset:2021-07-14
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0196 / 2 LA / IM

Administered by: Unknown       Purchased by: ?
Symptoms: Expired product administered
SMQs:, Medication errors (narrow)

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

Write-up: PFizer vaccine was administered after being discovered that the vaccines were kept in the freezer for 11 days longer than the two week standard time. Patient was notified and given option for additional dose.


VAERS ID: 1509874 (history)  
Form: Version 2.0  
Age: 15.0  
Sex: Male  
Location: Indiana  
Vaccinated:2021-07-14
Onset:2021-07-14
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0176 / 1 LA / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: Poor quality product administered, Product storage error
SMQs:, Medication errors (narrow)

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

Write-up: Error: Improper Storage (temperature)-


VAERS ID: 1509878 (history)  
Form: Version 2.0  
Age: 38.0  
Sex: Male  
Location: Indiana  
Vaccinated:2021-07-14
Onset:2021-07-14
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0176 / 2 LA / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: Poor quality product administered, Product storage error
SMQs:, Medication errors (narrow)

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

Write-up: Error: Improper Storage (temperature)-


VAERS ID: 1509909 (history)  
Form: Version 2.0  
Age: 54.0  
Sex: Female  
Location: Indiana  
Vaccinated:2021-07-14
Onset:2021-07-14
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0176 / 1 LA / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: Product storage error
SMQs:, Medication errors (narrow)

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

Write-up: Error: Improper Storage (temperature)-


VAERS ID: 1510072 (history)  
Form: Version 2.0  
Age: 13.0  
Sex: Male  
Location: Unknown  
Vaccinated:2021-07-14
Onset:2021-07-14
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0196 / 1 LA / IM

Administered by: Unknown       Purchased by: ?
Symptoms: Product storage error
SMQs:, Medication errors (narrow)

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

Write-up: Pfizer vaccine was administered after being discovered the vaccines were in the freezer for 11 days after the two-week standard time. Patient notified and given the option for an additional dose.


VAERS ID: 1510087 (history)  
Form: Version 2.0  
Age: 34.0  
Sex: Female  
Location: Minnesota  
Vaccinated:2021-04-23
Onset:2021-07-14
   Days after vaccination:82
Submitted: 0000-00-00
Entered: 2021-07-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0175 / 2 LA / IM

Administered by: Private       Purchased by: ?
Symptoms: COVID-19, SARS-CoV-2 test positive
SMQs:, Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (narrow)

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

Write-up: Patient tested positive for COVID while traveling. Symptom onset 7/14. Completed 10 day quarantine. She is fully vaccinated.


VAERS ID: 1510095 (history)  
Form: Version 2.0  
Age: 29.0  
Sex: Female  
Location: Unknown  
Vaccinated:2021-07-14
Onset:2021-07-14
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0196 / 1 LA / IM

Administered by: Unknown       Purchased by: ?
Symptoms: Product storage error
SMQs:, Medication errors (narrow)

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

Write-up: Pfizer vaccine was administered after being discovered the vaccines were in the freezer for 11 days after the two-week standard time. Patient notified and given the option for an additional dose.


VAERS ID: 1510097 (history)  
Form: Version 2.0  
Age: 18.0  
Sex: Female  
Location: Unknown  
Vaccinated:2021-07-14
Onset:2021-07-14
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0196 / 1 RA / IM

Administered by: Unknown       Purchased by: ?
Symptoms: Product storage error
SMQs:, Medication errors (narrow)

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

Write-up: Pfizer vaccine was administered after being discovered the vaccines were in the freezer for 11 days after the two-week standard time. Patient notified and given the option for an additional dose.


VAERS ID: 1510189 (history)  
Form: Version 2.0  
Age: 54.0  
Sex: Female  
Location: California  
Vaccinated:2021-05-07
Onset:2021-07-14
   Days after vaccination:68
Submitted: 0000-00-00
Entered: 2021-07-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 1821286 / 1 RA / IM

Administered by: Private       Purchased by: ?
Symptoms: Balance disorder, Fibromyalgia, Loss of personal independence in daily activities, Lumbar puncture, Magnetic resonance imaging head normal, Magnetic resonance imaging spinal normal, Muscular weakness, Pain, Pain in extremity, Urinary incontinence, Walking aid user
SMQs:, Rhabdomyolysis/myopathy (broad), Peripheral neuropathy (broad), Anticholinergic syndrome (broad), Dementia (broad), Guillain-Barre syndrome (broad), Noninfectious encephalopathy/delirium (broad), Vestibular disorders (broad), Tendinopathies and ligament disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Ativan, 0.5 mg, 1 tab, PO, q4hr, PRN Dulcolax, 10 mg, 1 supp, Rectal, qDay, PRN Fleet Enema, 133 mL, Rectal, qDay, PRN Flovent Diskus 100 mcg inhalation powder, 1 puff, Inhalation, BID Heparin SubQ 5,000 units/mL, 5000 Units, 1 mL, SubQ
Current Illness: Anemia Anxiety Asthma Depression
Preexisting Conditions: Anemia Anxiety Asthma Depression
Allergies: Latex (Rash) Milk Products (ASTHMA) erythromycin (Rash) sulfa drugs (Rash) tetracycline
Diagnostic Lab Data:
CDC Split Type:

Write-up: pain starting in legs, spreading through body. rec''d vaccine in May, believes she has Guillan-Barre. states she normally walks w/out a cane and has some episodes of urinary incontinence. 54 years old with past history of asthma came in for with lower extremity weakness and pain after she was given the Johnson & Johnson COVID-19 vaccine on May 7, 2021. Patient thinks this is related to the vaccine, she thought it was progressive pain and worsening of weakness which has become unsteady. Admitted to the hospital to rule out Gilliam Barr? and other progressive post viral infection myelopathies. We will also worried about multiple sclerosis. She did have a spinal tap which is completely normal with no evidence of encephalitis, meningitis or evidence of Gilliam Barre, she did also have MRI of the brain, cervical, thoracic and lumbar spines which is also completely negative. Seen by neurology and think this is likely fibromyalgia because of the weakness and pain together not clinically fitting with any post viral infection neuropathy. Patient was put on Cymbalta but this will take at least about 1-2 weeks to get the effect of improvement. She was seen by PT and OT and has some improvement to her weakness and was able to walk with assistance and recommend that she''ll go home with home health to continue therapy and she''ll follow-up with neurology. She may also benefit from Tizanidine if Cymbalta is not making a lot of difference.?


VAERS ID: 1510233 (history)  
Form: Version 2.0  
Age: 63.0  
Sex: Male  
Location: Idaho  
Vaccinated:2021-06-23
Onset:2021-07-14
   Days after vaccination:21
Submitted: 0000-00-00
Entered: 2021-07-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (JANSSEN)) / JANSSEN 205A21A / N/A LA / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: Fluid retention, Ventricular fibrillation
SMQs:, Torsade de pointes/QT prolongation (broad), Ventricular tachyarrhythmias (narrow), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Haemodynamic oedema, effusions and fluid overload (narrow)

Life Threatening? Yes
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: allopurinol, Eliquis, gabapentin, furosemide, potassium
Current Illness:
Preexisting Conditions:
Allergies: hydrocodone, metoprolol, coreg, prednisone
Diagnostic Lab Data:
CDC Split Type:

Write-up: 3 OCCURENCES OF V. FIB FROM WHICH HIS IMPLANT SAVED HIM. HE HAS ALSO HAD SIGNIFICANT WATER RETENTION


VAERS ID: 1511088 (history)  
Form: Version 2.0  
Age: 50.0  
Sex: Male  
Location: New Jersey  
Vaccinated:2021-03-01
Onset:2021-07-14
   Days after vaccination:135
Submitted: 0000-00-00
Entered: 2021-07-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 028A21A / 2 LA / SYR

Administered by: Private       Purchased by: ?
Symptoms: Magnetic resonance imaging head normal, SARS-CoV-2 test negative, Vertigo
SMQs:, Vestibular disorders (narrow), COVID-19 (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: Synthroid
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: MRI 7/15/21 came out negative for mini stroke. PCR 7/14/21 came out negative.
CDC Split Type:

Write-up: Severe vertigo 3 months after second shot.


VAERS ID: 1511988 (history)  
Form: Version 2.0  
Age: 70.0  
Sex: Female  
Location: Maryland  
Vaccinated:2021-07-09
Onset:2021-07-14
   Days after vaccination:5
Submitted: 0000-00-00
Entered: 2021-07-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0198 / 2 LA / -

Administered by: Unknown       Purchased by: ?
Symptoms: Erythema, Pruritus, Skin swelling, Vaccination site warmth
SMQs:, Anaphylactic reaction (broad), Angioedema (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: USPFIZER INC2021893123

Write-up: scratchy and also the area feels warm; redness and tiny bit of puffiness and itching below injection site in left arm; redness and tiny bit of puffiness and itching below injection site in left arm; redness and tiny bit of puffiness and itching below injection site in left arm; This is a spontaneous report from a contactable consumer (patient). A 70-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, lot number: EW0198, patient was 70-year-old at the time of vaccination), via an unspecified route of administration, administered in Arm Left on 09Jul2021 as single dose for covid-19 immunisation. The patient''s medical history was not reported. There were no concomitant medications. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, lot number: EW0191), via an unspecified route of administration, administered in Arm right on 18Jun2021 as single dose for covid-19 immunisation. It was reported that patient got the second dose of the Pfizer- BioNTech COVID-19 vaccine on friday, 09Jul2021, states she was looking at her arm today, states it is not at penetration site of the needle, but down below it, there is some redness, itchiness and it is a tiny bit puffy. She said that it is getting better, but it is "scratchy" and also the area feels warm. and it has been very minimal looking at in now and the redness may be due to her scratching. States it is itchy and she has scratched so that could be contributing to the redness, wants to know if this is related to the vaccine or may be a blood clot. She is also asking if these symptoms doesn''t go away when will she need to consult her doctor. On 14Jul2021, the patient experienced redness and tiny bit of puffiness and itching below injection site in left arm, on an unspecified date, the patient experienced scratchy and also the area feels warm. The outcomes of events (redness and tiny bit of puffiness and itching below injection site in left arm) were not recovered, and the outcome of event (scratchy and also the area feels warm) was unknown.


VAERS ID: 1512036 (history)  
Form: Version 2.0  
Age: 25.0  
Sex: Female  
Location: California  
Vaccinated:0000-00-00
Onset:2021-07-14
Submitted: 0000-00-00
Entered: 2021-07-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EL1283 / 2 - / -

Administered by: Private       Purchased by: ?
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
SMQs:, Lack of efficacy/effect (narrow), Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210714; Test Name: COVID-19; Test Result: Positive ; Comments: Nasal Swab
CDC Split Type: USPFIZER INC2021900965

Write-up: Tested positive for Covid; Tested positive for Covid; This is a spontaneous report received from a non-contactable other health care professional (patient). A 25-year-old non pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID 19 VACCINE, Solution for injection, Lot Number: EL1283) dose 2 via an unspecified route of administration on an unspecified date and received BNT162B2 (PFIZER-BIONTECH COVID 19 VACCINE, Solution for injection, Lot Number: EL1284) dose 1 via an unspecified route of administration on 20Dec2020 both as single dose (at the age of 25-year-old) for covid-19 immunisation. The patient was not pregnant at the time of vaccination. The patient medical history and concomitant medications were not reported. It was unknown if the patient received any other vaccines within 4 weeks prior to the COVID vaccine or not. Patient did not diagnose with COVID-19 prior to vaccination. Patient was not tested positive for COVID-19 since vaccination. On 14Jul2021, the patient tested positive for covid and the drug was ineffective. The events were reported as non-serous by the reporter. The patient visited physicians office as a result of adverse events. It was unknown if patient received any treatment as a result of adverse events. The patient underwent lab tests and procedures which included sars-cov-2 test (Nasal Swab): positive on 14Jul2021. The outcome of tested positive for covid was not recovered and outcome of drug ineffective was unknown. No follow-up attempts are possible. No further information is expected.; Sender''s Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the events covid-19 and drug ineffective and the suspect drug BNT162B2.


VAERS ID: 1512047 (history)  
Form: Version 2.0  
Age: 46.0  
Sex: Male  
Location: Florida  
Vaccinated:2021-04-29
Onset:2021-07-14
   Days after vaccination:76
Submitted: 0000-00-00
Entered: 2021-07-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH ER8736 / 2 RA / -

Administered by: Private       Purchased by: ?
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
SMQs:, Lack of efficacy/effect (narrow), Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: COZAAR; HYDROCHLOROTHIAZIDE
Current Illness: Hypertension (Verbatim: high blood pressure)
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20210714; Test Name: rapid test; Test Result: Positive
CDC Split Type: USPFIZER INC2021902809

Write-up: This is a spontaneous report from a Contactable consumer. This consumer reported for a 46-year-old male patient (husband) who received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: EN6204) via an unspecified route of administration on 08Apr2021 on right arm (at 46-year-old) as dose 1, single and the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: ER8736) via an unspecified route of administration on 29Apr2021 at 08:00 hours on right arm (at 46-year-old) as dose 2, single for COVID-19 immunization. Medical history included ongoing hypertension. Concomitant medications included losartan potassium (Cozaar) taken for hypertension and hydrochlorothiazide taken for hypertension. It was mentioned that history of all previous immunization with the Pfizer vaccine considered as suspect and additional vaccines administered on same date of the pfizer suspect were reported as none. The prior vaccinations (within 4 weeks), events following prior vaccinations and family medical history relevant to events were reported as no. On 14Jul2021 the patient underwent lab tests and procedures which included sars-cov-2 test: positive, it was mentioned that patient had come down with covid after having been vaccinated also (vaccination failure) and covid-19 (medically significant). The patient did not require emergency Room visit, but needed urgent care at physician office. It was mentioned that COVID diagnosis was given to him yesterday using a rapid test. The also had a PSRN molecular test but that will take a few days, those results are not back yet. It was assumed he has it though, since she was already positive. He was given steroids to treat. The patient had not recovered. Product Complaint:This report included that: This is a notification generated from the gQTS system. As part of the LOE simplification process, the following Complaint Records were classified as Product Use Attributes // Lack of Effect and have been moved to Closed (No Investigation) state referencing a previously completed investigation for the same product and lot as per the ''One and Done'' business process according to in PQS Q1215 and/or Q1252. Refer to the below table for details: Conclusion of Previously Completed Investigation (FCI/SI/OffCI): The complaint for lack of effect of the PFIZER BIONTECH COVID-19 VACCINE lot EN6204 was investigated. The investigation included a review of manufacturing and packaging batch records, deviation investigations, and an analysis of complaint history for the reported lot. The final scope included the reported finished goods lot EN6204, fill lot EN5335, and the formulated drug product lot EN5325. A complaint sample was not returned, and photographs were not received. No related quality issues were id. It was mentioned that investigation was required. Description of complaint: Covid 19 Vaccine, Lack of Effect: Caller calling for information, but reports that she tested positive to Covid after the second vaccinations. Evaluation Comment: Pfizer (site name) reviewed this complaint and agrees with the site assignment, investigation decision, classification, sub-classification, and priority. The reported lot number is valid and an investigation will be performed. The complaint and its classification have been reviewed. No immediate containment action is required. The complaint, its priority, and its classification have been reviewed and determined to be appropriate. A full investigation will be performed. This is a complaint for lack of effect related to lot EN6204 of PFIZER-BIONTECH COVID-19 VACCINE. The initial scope of this investigation is limited to the reported finished goods lot EN6204 pending review of lot genealogy. The investigation will include a include a review of the returned complaint sample (if received) and reserve samples, if necessary. Investigation findings: Summary of Investigation: The initial scope of the investigation was limited to the reported finished goods lot. The final scope was expanded to include the reported finished goods lot EN6204, fill lot EN5335, and the formulated drug product lot EN5325. Manufacturing and packaging batch records were reviewed for the reported complaint lot. Pfizer (site name) QO did not receive photographs or a complaint sample for examination. The complaint was not confirmed. There were no planned or unplanned deviations recorded during the manufacture of the complaint lot and associated manufacturing lots that may have caused a complaint of this nature. A review of the manufacturing records confirmed processing steps were performed within pre-established parameters. All raw materials and amounts used in the manufacture of the batch were of the correct weight and identity. The drug product is stored at controlled refrigeration throughout the manufacturing process and a log is maintained documenting the elapsed time out of refrigeration. A review of the logs confirmed that all times were within allowable limits. The product also requires storage in ultra-low temperature freezers following the packaging of the product. A review of the freezer temperature log for the reported batch confirmed that all freezer temperatures were within allowable limits. The results of all analytical tests performed at the time of lot release confirmed that the batch continues to meet potency specifications. Company Quality Operations could not indicate a probable root cause for the complaint to be related to the production process of the involved batch. Review of the manufacturing and packaging batch records and release test results confirmed that the batch continues to meet potency specifications. It is unknown how the product was handled, stored, or administered after it left the Company site. Impact Analysis: Based on the results of this investigation, the manufacturing and packaging batches remain acceptable and the reported complaint is not representative of the lot. No regulatory notification is needed. Special or Common Cause: Common Cause Root Cause is always present to some degree in the process. Special Cause Root Cause is something different happening at a certain time or place in the process. There were no corrective actions as a result of this complaint investigation. The results of all tests, inspections, and in-process controls have been reviewed and all results met the established requirements prior to the release of the reported batch for distribution. Conclusion: The complaint for lack of effect of the PFIZER-BIONTECH COVID-19 VACCINE lot EN6204 was investigated. The investigation included a review of manufacturing and packaging batch records, deviation investigations, and an analysis of complaint history for the reported lot. The final scope included the reported finished goods lot EN6204, fill lot EN5335, and the formulated drug product lot EN5325. A complaint sample was not returned, and photographs were not received. No related quality issues were identified during the investigation. There is no impact to product quality. No root cause or corrective/preventative actions were identified as the complaint was not confirmed. All release testing performed prior to the release of the reported batch was within specifications. The scope of this investigation included the reported finished goods lot EN6204, fill lot EN5335, and the formulated drug product lot EN5325. Acceptable review of related documentation, including manufacturing batch records and review of release test results at the time of lot release confirmed that there were no issues which may have resulted in a complaint of this nature. Review Q9 Findings: The results of all tests and inspections met required specifications at the time of release for distribution on 18Feb2021. DEVIATIONS: Complete -Acceptable There were no deviations or unusual incidents associated with the manufacture of the lot which may have resulted in a complaint of this nature. MANUFACTURING BATCH RECORDS: Complete -Acceptable The manufacturing batch records for the complaint batch were reviewed as part of this investigation and were found to be acceptable. All processing steps were performed within pre-established parameters. The review of the manufacturing record confirmed that all in process checks, all line startup and end of batch challenges, and all line clearance and cleaning activities were completed satisfactorily. All raw materials used in the complaint batch were of the correct weight and identity. All the manufacturing temperatures, mix speeds, and mixing times were within acceptable ranges. A review of the solution filtration documentation confirmed that all materials, filters, and Water for Injection (WFI) were used within their expiration dates, and that all the filtration times, pH results, and pressure specifications were met. The manufacturing processes of raw material usage, solution formulation and filtration were all found to be acceptable. All manufacturing parameters met established requirements. A log is maintained throughout the manufacturing process of the amount of elapsed time that the product is out of refrigeration. A review of the elapsed time tracking logs confirmed that all times were within allowable limits. PACKAGING BATCH RECORDS: Complete -Acceptable The review of the packaging record confirmed that all in process checks, all line startup and end of batch challenges, and all line clearance and cleaning activities were completed satisfactorily. Audits are performed on the finished packaged units by Packaging Operations personnel at regular intervals throughout the final packaging process. This is done in order to ensure that all required labeling and packaging is present, complete, and meets all establishments requirements. During the audits, inspectors visually check the appearance of the finished product for defects. A review of the audit results for the reported lot confirmed that all specifications were met. All labeler, tray label grader, and barcode grader checks and challenges passed at the beginning and end of the lot. The Pfizer-BioNTech COVID-19 Vaccine vials are loaded into trays containing 195 vials each. Five trays are then banded together into a bundle. The vaccine requires ultra-low temperature freezer storage. Prior to loading, freezer temperatures were verified to between -67?C and -73?C. Freezer shelves were loaded with bundles of product. During the freezing phase, which occurs 60 hours after loading, the temperature of the freezers is monitored. If the temperature is warmer than the previously recorded temperature, supervision was notified. Additionally, after the freezer temperature drops below -60?C, the temperature recorded may be warmer due to the freezer operation caused by the freezer cycling to maintain the freezer set point, which is acceptable. A review of the log for the reported batch confirmed that all freezer temperatures were acceptable. Samples are then stored until the product is released for distribution. There were no issues recorded during the packaging or storage process which may have impacted the potency of the drug product. LOT HISTORY: Complete -Acceptable The results of all tests and inspections met required specifications at the time of release for distribution on 18Feb2021. Reserve Sample Testing Result: A reserve sample was not sent to the QC-Lab to determine the amount of active ingredient since the complaint was received within six months of the release date of the involved batch. The results of all analytical tests performed at the time of lot release were confirmed to be within registered specifications. All available stability results for this product were within registered specification and stability studies (including accelerated studies) are ongoing for this product. Lot Trend Assmt. & Rationale: The complaint history for the reported PFIZER-BIONTECH COVID-19 VACCINE lot EN6204 was reviewed. As of 7Apr2021, there are a total of 2 complaints for this lot and classification. No lot specific trend was identified that would require additional investigation. Lot Trend Actions Taken: There were no lot trend actions taken as a result of this investigation. Follow-up attempts are completed. No further information was expected.


VAERS ID: 1512055 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: North Carolina  
Vaccinated:0000-00-00
Onset:2021-07-14
Submitted: 0000-00-00
Entered: 2021-07-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH EW0180 / 1 RA / -

Administered by: Pharmacy       Purchased by: ?
Symptoms: Blood test, Chest pain, Dyspnoea, Myocardial infarction
SMQs:, Anaphylactic reaction (broad), Myocardial infarction (narrow), Embolic and thrombotic events, arterial (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: KEPPRA
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Heart disorder
Allergies:
Diagnostic Lab Data: Test Date: 20210714; Test Name: Lab work; Result Unstructured Data: Test Result:Unknown results
CDC Split Type: USPFIZER INC2021906268

Write-up: Heart attack; Chest pain; Shortness of breath; This is a spontaneous report from a contactable consumer (patient). A 47-year-old female patient received bnt162b2, first single dose via an unspecified route of administration, administered in arm right on an unspecified date (Batch/Lot Number: EW0180) as for covid-19 immunisation. Medical history included heart problem. Concomitant medication included levetiracetam (KEPPRA). The patient had a serious reaction to your product. The patient was started having chest pain and shortness of breath after medical on 14Jul2021. She had lab work done at the hospital to check her heart and stuff on 14Jul2021. The patient was kept in hospital for 15 hours after she had heart ''attack'' on 14Jul2021. The patient received ''Retinol'' and Nitroglycerin last night and then received the Nitro drip and fluids last night and in this morning and this afternoon. At the time of this report, it''s better since she had Nitro drip. Outcome of the events was recovering. Follow-up attempts are completed. No further information is expected.


VAERS ID: 1512059 (history)  
Form: Version 2.0  
Age: 57.0  
Sex: Female  
Location: Oklahoma  
Vaccinated:2021-07-14
Onset:2021-07-14
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 2 LA / -

Administered by: Military       Purchased by: ?
Symptoms: Condition aggravated, Vaccination site erythema, Vaccination site mass
SMQs:

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: USPFIZER INC2021907469

Write-up: Little worse than the first day; Knot on left arm size of a quarter; Red spot size of half a dollar on left arm; This is a spontaneous report from a contactable consumer (patient). A 57-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; formulation: solution for injection; Lot/batch no: unspecified) via unspecified route of administration in the left arm as dose 2, single on 14Jul2021 14:45 PM (at the age of 57-years) for COVID-19 immunization at Facility Health Department. The patient medical history and concomitant medications were not reported. No Investigation Assessment was provided. Historical vaccine included first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; formulation: solution for injection; Lot/batch no: unspecified) via unspecified route of administration on an unspecified date in Jun2021 for COVID-19 immunization and had no problems. It was reported as first dose taken Three weeks before second dose (14Jul2021). No additional vaccines administered on same date of the Pfizer suspect. No Prior Vaccinations within 4 weeks to the administration date of the suspect vaccine and no AE reported prior vaccination. Family Medical History Relevant to AE reported as None. It was reported that 30 minutes after receiving the second shot on 14Jul2021, patient experienced a knot on left arm size of a quarter developed as well as a red spot the size of half a dollar. On 15July201, reported as it was little worse than the first day. The patient asked if these complaints had been previously reported. Relevant tests done were none. Events did not require to visit Emergency Room or Physician Office. The clinical outcome for the events was not recovered except for event little worse than first day was unknown. Information about lot/batch number is requested.


VAERS ID: 1512447 (history)  
Form: Version 2.0  
Age: 15.0  
Sex: Female  
Location: Texas  
Vaccinated:2021-07-14
Onset:2021-07-14
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 048C21A / 1 RA / IM

Administered by: Public       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: None
Current Illness: None
Preexisting Conditions: None
Allergies: None
Diagnostic Lab Data: None
CDC Split Type:

Write-up: Patient less than 18 years of age received the 1st dose of Moderna''a Covid-19 Vaccine. Parent present, educated, and gave consent.


VAERS ID: 1512701 (history)  
Form: Version 2.0  
Age: 41.0  
Sex: Female  
Location: Ohio  
Vaccinated:2021-01-25
Onset:2021-07-14
   Days after vaccination:170
Submitted: 0000-00-00
Entered: 2021-07-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 026L20A / 2 RA / IM

Administered by: Private       Purchased by: ?
Symptoms: Arthralgia, COVID-19, Diarrhoea, Fatigue, Feeling abnormal, Feeling cold, Headache, Hyperhidrosis, Malaise, Nasopharyngitis, Nausea, Pain, Respiratory tract congestion, SARS-CoV-2 test positive, Throat irritation
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Dementia (broad), Pseudomembranous colitis (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Arthritis (broad), Noninfectious diarrhoea (narrow), Hypoglycaemia (broad), Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Multi-Vitamin; Levothyroxine; Atorvastatin; Lyrica; Cymbalta; Tanazidine
Current Illness: No
Preexisting Conditions: Chronic nerve pain - Fibromyalgia; High cholesterol - genetic
Allergies: No
Diagnostic Lab Data: A plastic surgeon''s office - I tested positive for COVID on the 20th of July - I''m quarantined until tomorrow.
CDC Split Type: vsafe

Write-up: I started feeling sick on the 14th - tickle in my throat and feeling rundown. And the next day, headache and my head felt cloudy and I was congested. I thought I had a head cold. The next day, I was sweating so profusely - my shirt was wet and I couldn''t stop sweating but went from sweating to freezing and back and forth. I did not have a fever. I had awful body aches. It hurt standing up - joints hurt. Not normal for me. The headache and body aches continued and I was nauseous and I had diarrhea. By Sunday, I felt okay. I was alright. I was still really tired but I wasn''t like I was like I was the week prior. By Monday, I was doing pretty good and then Tuesday, I had a pre-op appt. I had to get tested before the operation and they tested it and it was positive. I had to cancel my surgery. 10 day quarantine from the 20th. I''ve been symptom free during quarantine. I just used OTC - ibuprofen and took a sinus medication: a Tylenol, cold and sinus OTC to help during the time of they symptoms. I did contact my primary care doctor on the 20th when I had the positive test because I had seen her on the 12th. So it was remote - email visit.


VAERS ID: 1512821 (history)  
Form: Version 2.0  
Age: 51.0  
Sex: Male  
Location: Georgia  
Vaccinated:2021-06-05
Onset:2021-07-14
   Days after vaccination:39
Submitted: 0000-00-00
Entered: 2021-07-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 009D21A / 2 LA / IM

Administered by: Pharmacy       Purchased by: ?
Symptoms: Anticoagulant therapy, Echocardiogram, Pain in extremity, Ultrasound Doppler
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? Yes, 1 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: b12 injection monthly
Current Illness: n/a
Preexisting Conditions: n/a
Allergies: nkda
Diagnostic Lab Data: Patient had echo and ultrasound to view heart etc.
CDC Split Type:

Write-up: Experienced sharp pain in leg presenting as a "charlie horse". Patient was admitted to hospital after worsening symptoms and is currently taking eliquis daily.


VAERS ID: 1513007 (history)  
Form: Version 2.0  
Age: 66.0  
Sex: Female  
Location: Florida  
Vaccinated:2021-07-14
Onset:2021-07-14
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (MODERNA)) / MODERNA 046B21A / 1 LA / SYR

Administered by: Public       Purchased by: ?
Symptoms: Breast pain, Breast swelling, Lymph node pain, Lymphadenopathy, Pain in extremity, Peripheral swelling, Pyrexia
SMQs:, Cardiac failure (broad), Angioedema (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Lipodystrophy (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Rosuvastatin Calcium 5 mg 1 x day Topiramate 100 mg 2 x day Spironolactone 25 mg 1 x day Aspirin 81 mg Ajovy migraine shot 1 x each month
Current Illness: None
Preexisting Conditions: Left temporal lobe mass
Allergies: Latex Bacitracin ointment Kefkex
Diagnostic Lab Data:
CDC Split Type:

Write-up: Swelling left arm, left breast, pain in left arm, breast area, lymph nodes, fever of 101.9


VAERS ID: 1513022 (history)  
Form: Version 2.0  
Age: 48.0  
Sex: Female  
Location: New York  
Vaccinated:2021-01-20
Onset:2021-07-14
   Days after vaccination:175
Submitted: 0000-00-00
Entered: 2021-07-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / UNK - / -

Administered by: Private       Purchased by: ?
Symptoms: COVID-19, Cough, Pyrexia, SARS-CoV-2 test positive
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (broad), Opportunistic infections (broad), COVID-19 (narrow)

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

Write-up: VAERS completed because of being Tested positive for COVID-19 infection 14 or more days after being fully vaccinated. 1st dose 12/30/20pfizer,Lot#EL0142 2nd dose: 01/20/21,Pfizer,Lot# EL3247 Symptoms began:07/14/21 Diagnosed covid positive:07/18/21 Exposure:Unknown Symptoms:Fever, cough


Result pages: prev   269 270 271 272 273 274 275 276 277 278 279 280 281 282 283 284 285 286 287 288 289 290 291 292 293 294 295 296 297 298 299 300 301 302 303 304 305 306 307 308 309 310 311 312 313 314 315 316 317 318 319 320 321 322 323 324 325 326 327 328 329 330 331 332 333 334 335 336 337 338 339 340 341 342 343 344 345 346 347 348 349 350 351 352 353 354 355 356 357 358 359 360 361 362 363 364 365 366 367 368 369 370 371 372 373 374 375 376 377 378 379 380 381 382 383 384 385 386 387 388 389 390 391 392 393 394 395 396 397 398 399 400 401 402 403 404 405 406 407 408 409 410 411 412 413 414 415 416 417 418 419 420 421 422 423 424 425 426 427 428 429 430 431 432 433 434 435 436 437 438 439 440 441 442 443 444 445 446 447 448 449 450 451 452 453 454 455 456 457 458 459 460 461 462 463 464 465 466 467   next

New Search

Link To This Search Result:

https://medalerts.org/vaersdb/findfield.php?EVENTS=ON&PAGENO=368&PERPAGE=100&ESORT=ONSET-DATE&REVERSESORT=ON&VAX=COVID19&DIED=No


Copyright © 2021 National Vaccine Information Center. All rights reserved.
21525 Ridgetop Circle, Suite 100, Sterling, VA 20166