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From the 1/14/2022 release of VAERS data:

Found 62,317 cases where Vaccine is DTAP

Government Disclaimer on use of this data



Case Details (Reverse Sorted by Appearance Date)

This is page 20 out of 3,116

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VAERS ID: 1527355 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2020-08-12
Onset:2020-08-13
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-08-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (INFANRIX) / GLAXOSMITHKLINE BIOLOGICALS AC14B257AA / UNK - / IM

Administered by: Unknown       Purchased by: ?
Symptoms: Eczema, Pruritus, Pyrexia, Scab, Vomiting
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Atopic dermatitis
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: HRGLAXOSMITHKLINEHR202116

Write-up: Eczema on the skin; Itching; Skin scabs; Vomiting; Temperature; This case was reported by a consumer via regulatory authority and described the occurrence of fever in a 5-year-old female patient who received DTPa (Infanrix) (batch number AC14B257AA, expiry date unknown) for prophylaxis. Co-suspect products included dtpa vaccine pre-filled syringe device injection syringe for prophylaxis. Concurrent medical conditions included atopic dermatitis. On 12th August 2020, the patient received Infanrix (intramuscular) .5 ml and dtpa vaccine pre-filled syringe device. On 13th August 2020, 1 days after receiving Infanrix and dtpa vaccine pre-filled syringe device, the patient experienced fever (serious criteria other: serious as per reporter), eczema (serious criteria other: serious as per reporter), pruritus (serious criteria other: serious as per reporter), scab (serious criteria other: serious as per reporter) and vomiting (serious criteria other: serious as per reporter). In August 2020, the outcome of the fever and vomiting were recovered/resolved. On an unknown date, the outcome of the eczema, pruritus and scab were recovering/resolving. The reporter considered the fever and vomiting to be probably related to Infanrix and dtpa vaccine pre-filled syringe device. The reporter considered the eczema, pruritus and scab to be possibly related to Infanrix and dtpa vaccine pre-filled syringe device.This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional details were provided as follows: The age at vaccination was unknown. Duration for the events eczema, itch and scab was reported as 1 year, however event outcome was given as recovering. The duration of events pyrexia and vomiting was 2 days. WHO causal assessment was reported as Probably in association to the pyrexia and vomiting for Infanrix. WHO causal assessment was reported as possibly in association to the eczema, pruritus and scab for Infanrix. Initial information received from consumer via regulatory authority on 29th July 2021: Temperature, Eczema on the skin, Itching, Skin scabs and Vomiting.


VAERS ID: 1527357 (history)  
Form: Version 2.0  
Age: 5.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-07-02
Onset:2021-07-02
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (INFANRIX) / GLAXOSMITHKLINE BIOLOGICALS AC14B257AA / UNK - / IM

Administered by: Unknown       Purchased by: ?
Symptoms: Body temperature increased, Headache, Paralysis, Pyrexia, Unresponsive to stimuli
SMQs:, Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (broad), Hypotonic-hyporesponsive episode (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? 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: 20210704; Test Name: Body temperature; Result Unstructured Data: (Test Result:38.1,Unit:degree C,Normal Low:36,Normal High:37)
CDC Split Type: HRGLAXOSMITHKLINEHR202116

Write-up: paralysis / could not move arm and leg; was not contactable; Fever up to 38.1 � C; headache; This case was reported by a physician via regulatory authority and described the occurrence of paralysis in a 5-year-old male patient who received DTPa (Infanrix) (batch number AC14B257AA, expiry date unknown) for prophylaxis. Co-suspect products included dtpa vaccine pre-filled syringe device injection syringe for prophylaxis. On 2nd July 2021, the patient received Infanrix (intramuscular) .5 ml and dtpa vaccine pre-filled syringe device. On 2nd July 2021, less than a day after receiving Infanrix and dtpa vaccine pre-filled syringe device, the patient experienced headache. On 4th July 2021, the patient experienced paralysis (serious criteria GSK medically significant and other: Serious as per reporter), unresponsive to stimuli (serious criteria GSK medically significant and other: Serious as per reporter) and pyrexia. On 4th July 2021, the outcome of the paralysis and unresponsive to stimuli were recovered/resolved. On 5th July 2021, the outcome of the pyrexia and headache were recovered/resolved. The reporter considered the paralysis, unresponsive to stimuli, pyrexia and headache to be probably related to Infanrix and dtpa vaccine pre-filled syringe device. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional details were provided as follows: On 04th July 2021, the patient''s body temperature was measured and result was reported as 38.1 degrees Celsius. The duration of the events paralysis and unresponsive to stimuli were reported as 15 minutes, for pyrexia was reported as 2 days and for headache was reported as 4 days The agency Causal assessment was reported as Probable/Likely in association to the paralysis, unresponsive to stimuli, pyrexia and headache for Infanrix. Initial information received from physician via regulatory authority on 30th July 2021: paralysis / could not move arm and leg, he was not contactable, Fever up to 38.1 degree C, headache.


VAERS ID: 1525761 (history)  
Form: Version 2.0  
Age: 12.0  
Sex: Male  
Location: Maine  
Vaccinated:2021-01-05
Onset:2021-02-01
   Days after vaccination:27
Submitted: 0000-00-00
Entered: 2021-08-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (DAPTACEL) / SANOFI PASTEUR - / 6 AR / IM

Administered by: Private       Purchased by: ?
Symptoms: Blood glucose increased, Dark circles under eyes, Diabetic ketoacidosis, Full blood count, Laboratory test, Lethargy, Metabolic function test, Nocturia, Pallor, Personality change, Pollakiuria, Red blood cell sedimentation rate, Thirst, Type 1 diabetes mellitus, Urine analysis abnormal
SMQs:, Hyperglycaemia/new onset diabetes mellitus (narrow), Anticholinergic syndrome (broad), Dementia (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hostility/aggression (broad), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Hypoglycaemia (broad), Dehydration (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, 3 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: None.
Current Illness: None.
Preexisting Conditions: None.
Allergies: amoxicillin
Diagnostic Lab Data: March 5th, 2021 he had labs done at Hospital. I believe the labs were CMP (glucose) and CBC and Sed Rate.
CDC Split Type:

Write-up: Patient, otherwise healthy his whole life. We noticed that sometime shortly after his vaccination, Patients pallor and demeanor changed. He was pale, dark circles under his eyes, lethargic. We noticed that he was constantly thirsty and then he started getting up multiple times a night to go to the bathroom. Finally, I noticed when I went to wipe his urine off the toilet seat, it was sticky. On March 5th, he was rushed to the emergency room; he was in Diabetic Ketoacidosis and when we arrived in the ER, his blood glucose was 900+. Patient is now a insulin dependent Type One Diabetic - with NO family history of Type one Diabetes.


VAERS ID: 1525919 (history)  
Form: Version 2.0  
Age: 4.0  
Sex: Male  
Location: Texas  
Vaccinated:2021-08-02
Onset:2021-08-02
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (INFANRIX) / GLAXOSMITHKLINE BIOLOGICALS 237C4 / 5 LL / IM

Administered by: Private       Purchased by: ?
Symptoms: Injection site erythema, Injection site induration
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: tyenol
Current Illness: none
Preexisting Conditions: nummular eczema
Allergies: none
Diagnostic Lab Data: none
CDC Split Type:

Write-up: Mom reports pal- sized redness and induration surrounding the injection site.


VAERS ID: 1521900 (history)  
Form: Version 2.0  
Age: 12.0  
Sex: Male  
Location: Texas  
Vaccinated:2021-07-28
Onset:2021-07-28
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (INFANRIX) / GLAXOSMITHKLINE BIOLOGICALS 5RM39 / UNK - / -
TDAP: TDAP (BOOSTRIX) / GLAXOSMITHKLINE BIOLOGICALS 575HC / UNK - / -

Administered by: Unknown       Purchased by: ?
Symptoms: Incorrect dose administered, Product administered to patient of inappropriate age, Wrong 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: USGLAXOSMITHKLINEUS202116

Write-up: same day / administered /Boostrix; 12 year old patient received Infanrix; received Infanrix when Boostrix was intended; This case was reported by a other health professional via call center representative and described the occurrence of accidental overdose in a 12-year-old male patient who received DTPa (Infanrix) (batch number 5RM39, expiry date 25th November 2022) for prophylaxis. Co-suspect products included dtpa vaccine pre-filled syringe device (Infanrix Pre-Filled Syringe Device) injection syringe for prophylaxis, DTPa (Reduced antigen) (Boostrix) (batch number 575hc, expiry date 28th February 2023) for prophylaxis and dtpa vaccine. pre-filled syringe device (Boostrix Pre-Filled Syringe Device) injection syringe for prophylaxis. On 28th July 2021, the patient received Infanrix, Infanrix Pre-Filled Syringe Device, Boostrix and Boostrix Pre-Filled Syringe Device. On 28th July 2021, not applicable after receiving Infanrix and Infanrix Pre-Filled Syringe Device and unknown after receiving Boostrix and Boostrix Pre-Filled Syringe Device, the patient experienced accidental overdose, inappropriate age at vaccine administration and wrong vaccine administered. On an unknown date, the outcome of the accidental overdose, inappropriate age at vaccine administration and wrong vaccine administered were unknown. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional details were provided as follows: A 12 year old patient received Infanrix when Boostrix was intended to be given, which led to inappropriate age at vaccine administration and wrong vaccine administered. The same day patient was administered the correct vaccine, Boostrix in different arm, which led to overdose. The reporter consented to follow up.


VAERS ID: 1523392 (history)  
Form: Version 2.0  
Age: 66.0  
Sex: Female  
Location: Massachusetts  
Vaccinated:2020-09-10
Onset:2020-09-11
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-08-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (INFANRIX) / GLAXOSMITHKLINE BIOLOGICALS - / 1 LA / IM
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH - / 1 RA / IM

Administered by: Private       Purchased by: ?
Symptoms: Arthralgia, Blood test, C-reactive protein, Disturbance in attention, Gait disturbance, Grip strength decreased, Joint injection, Magnetic resonance imaging joint, Mobility decreased, Musculoskeletal stiffness, Myalgia, Neck pain, Night sweats, Nuchal rigidity, Pain, Polymyalgia rheumatica, Red blood cell sedimentation rate, X-ray
SMQs:, Rhabdomyolysis/myopathy (broad), Peripheral neuropathy (broad), Anticholinergic syndrome (broad), Dystonia (broad), Parkinson-like events (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Eosinophilic pneumonia (broad), Depression (excl suicide and self injury) (broad), Vasculitis (narrow), Arthritis (broad), Tendinopathies and ligament disorders (broad), Hypoglycaemia (broad), Immune-mediated/autoimmune disorders (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Advil 200 mg as needed
Current Illness: None
Preexisting Conditions:
Allergies: Diludid, oxycodone
Diagnostic Lab Data: X-rays: MRI of joints. Blood tests.
CDC Split Type:

Write-up: Severe total body muscle and joint pain.. Rigid/stiff neck with pain. Inability to pick simple objects up. Unable to get out of bed without assistance. Extreme difficulty to walk. Intermittent night sweats. Inability to concentrate. Repeated visits to orthopedic doctor, and spine specialist. No Diagnosis or advanced testing Orthopedic doc RX: cortisone injections to knees and hips. 10/6 / 2020 & 11/25/2020. DX: Dec. 15, 2020, blood work included Sed rate & non-cardio CRP. DX with Polymyalgia Rheumatica . RX : Oral corticosteroids. Patient remains on Predisone as of 08/3/2021


VAERS ID: 1889295 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Kentucky  
Vaccinated:2021-07-27
Onset:2021-07-25
Submitted: 0000-00-00
Entered: 2021-08-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (DAPTACEL) / SANOFI PASTEUR C5765BA / UNK LL / -
IPV: POLIO VIRUS, INACT. (IPOL) / SANOFI PASTEUR T1D48 / UNK LL / -
MMR: MEASLES + MUMPS + RUBELLA (MMR II) / MERCK & CO. INC. T010205 / UNK - / UN

Administered by: Private       Purchased by: ?
Symptoms: Injection site swelling, Injection site warmth
SMQs:, Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? 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: Patients mother called office & stated that his Left thigh was swollen & warm to touch. Dad brought him in for it to be checked out the next morning. Left thigh was still swollen and warm to touch. But was better than the picture they had from the night before. Dr. saw him in office.


VAERS ID: 1521263 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2019-11-21
Submitted: 0000-00-00
Entered: 2021-08-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (NO BRAND NAME) / UNKNOWN MANUFACTURER - / 3 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Autopsy, Corynebacterium infection, Corynebacterium test positive, Death, Hyperpyrexia, Laryngitis, Pneumonia, Respiratory distress
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Acute central respiratory depression (broad), Eosinophilic pneumonia (broad), Hypersensitivity (broad), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (narrow), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2019-11-26
   Days after onset: 5
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 4 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: Elek assay; Result Unstructured Data: C. diphtheria expression of the toxin gene; Test Name: bronchial secretion; Result Unstructured Data: C. diphtheriae was isolated
CDC Split Type: GRSA2021SA251494

Write-up: Corynebacterium diphtheriae/ C. diphtheriae was isolated during laboratory testing; respiratory distress; hyperpyrexia; laryngitis; pneumonia; Initial information received on 27-Jul-2021 regarding an unsolicited valid serious case issued from a literature article from a other health care professional. This case involves an eight year old male patient who experienced hyperpyrexia, laryngitis, pneumonia and died due to respiratory distress and Corynebacterium diphtheriae was isolated during laboratory testing (corynebacterium infection) after he received DIPHTHERIA, TETANUS AND ACELLULAR PERTUSSIS VACCINE. It was reported that patient had a burdened individual medical history, details were not provided. The patient''s past medical treatments, previous vaccinations, family history, concomitant diseases and other risk factors were not provided. Patient had no epidemiological history, no history of reported travel or contact with a person returning from an endemic country. On unknown dates, the patient received three doses of suspect DIPHTHERIA, TETANUS AND ACELLULAR PERTUSSIS VACCINE produced by unknown manufacturer (lot number and expiry date not reported) via an unknown route at an unknown administration site for prophylactic vaccination. On 21-Nov-2019, the patient developed serious hyperpyrexia, laryngitis, pneumonia, respiratory distress and was diagnosed with corynebacterium diphtheriae during laboratory testing (corynebacterium infection) (unknown latency) following the administration of DIPHTHERIA and TETANUS AND ACELLULAR PERTUSSIS VACCINE.These events were assessed as medically significant and patient was hospitalised for these events one day after these events occurred. It was identified with Corynebacterium diphtheriae polymerase chain reaction (PCR) and the expression of the toxin gene with Elek assay. The patient was treated with antimicrobial treatment, but condition aggravated and patient passed away (on 26-Nov-2019 due to respiratory distress), before DAT(Diphtheria Antitoxin) could be detected and administered. Other laboratory details were not reported. The event outcome was fatal for all the events. The cause of death was reported as respiratory distress. It was unknown, if an autopsy was done. The reporter assessment with causal relationship for events with the DIPHTHERIA, TETANUS AND ACELLULAR PERTUSSIS VACCINE was not reported. Batch number has been requested for suspect product for this case.; Sender''s Comments: Sanofi company comment for information received on 27-Jul-2021: This case concerns an eight year old male patient who experienced hyperpyrexia, laryngitis, pneumonia, respiratory distress and corynebacterium infection after vaccination with DIPHTHERIA, TETANUS AND ACELLULAR PERTUSSIS VACCINE (unknown manufacturer). This appears as a case of possible vaccination failure. However, information regarding vaccination schedule, time lapsed between vaccination administration of last dose and symptoms, immune status of the patient were not provided. Based upon the reported information, the role of the suspect vaccine cannot be assessed.; Reported Cause(s) of Death: respiratory distress


VAERS ID: 1519145 (history)  
Form: Version 2.0  
Age: 0.17  
Sex: Male  
Location: Colorado  
Vaccinated:2000-12-27
Onset:2001-01-01
   Days after vaccination:5
Submitted: 0000-00-00
Entered: 2021-08-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DT: DT ADSORBED (NO BRAND NAME) / SANOFI PASTEUR - / 1 - / -
DTAP: DTAP (DAPTACEL) / SANOFI PASTEUR - / 1 - / -
DTAPIPVHIB: DTAP + IPV + HIB (PENTACEL) / SANOFI PASTEUR - / 1 - / -
HEP: HEP B (HEPLISAV-B) / DYNAVAX TECHNOLOGIES CORPORATION - / 1 - / -
HIBV: HIB (PEDVAXHIB) / MERCK & CO. INC. - / 1 - / -

Administered by: Private       Purchased by: ?
Symptoms: Muscle rigidity, Sudden infant death syndrome
SMQs:, Neuroleptic malignant syndrome (broad), Parkinson-like events (narrow), Neonatal disorders (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2001-01-01
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Nothing was ever prescribed or any medical conditions.
Current Illness: No
Preexisting Conditions: No
Allergies: No
Diagnostic Lab Data: Not sure
CDC Split Type:

Write-up: I was living with my friend and I had my first baby, She got me in touch with a doctor''s office near by. He signed his name M.D. I had only been to his office that one time, I think. My son''s 3 month shots appointment. It was December 27, 2000. He got all four of his injections and everything was okay. 3 days later on January 01, 2001, our neighbor friend tried to pick him up to play because it was still m orning, and she stated that he was hard. Patient had passed away. I did not see any signs. I always had these feelings of what if he had a reaction to his shots. I never went back to that doctor again. Patient was born by c-section because i was in labor then the umbilical cord started going around his neck. He was fine right after delivery. He was 3 days late. He was a good happy baby, no medical concerns. No pregnancy issues. I was told that it was SIDS.


VAERS ID: 1519291 (history)  
Form: Version 2.0  
Age: 2.0  
Sex: Female  
Location: Texas  
Vaccinated:2021-07-26
Onset:2021-07-26
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (DAPTACEL) / SANOFI PASTEUR - / UNK - / -
HEPA: HEP A (VAQTA) / MERCK & CO. INC. - / UNK - / -
HIBV: HIB (ACTHIB) / SANOFI PASTEUR UJ356AAB / 4 RL / OT

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: USSA2021SA250872

Write-up: Patient was administered an expired vaccine/ no AE; Initial information was received on 26-Jul-2021 regarding an unsolicited valid non-serious case received from an Other healthcare professional via Agency (Reference number- 00697308) and transmitted to Sanofi on 26-Jul-2021. This case involves a two-year-old female patient reported that the patient was administered an expired HIB (PRP/T) VACCINE [ACT-HIB] vaccine with no adverse event (expired product administered). The patient''s past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included HEPATITIS A VACCINE INACT (VAQTA) for prophylactic vaccination and DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR, TETANUS VACCINE TOXOID (DAPTACEL) for prophylactic vaccination. On 26-Jul-2021, the patient received 0.5 mL (once) fourth dose of suspect HIB (PRP/T) VACCINE [lot UJ356AAB and expiry date 25-Jul-2021] via intramuscular route in right thigh for prophylactic vaccination. It was reported that, "Clinical Supervisor called to report that ACTHIB was administered to a patient on 26JUL2021, but it expired on 25JUL2021. Caller would like to know if this dose is considered valid and whether the dose should be repeated? Product used: Used". It was a case of actual medication error due to expired vaccine used (latency was on same day). At the time of reporting, patient had no adverse event. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder''s compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.


VAERS ID: 1519999 (history)  
Form: Version 2.0  
Age: 1.25  
Sex: Female  
Location: California  
Vaccinated:2015-03-09
Onset:2015-03-09
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (INFANRIX) / GLAXOSMITHKLINE BIOLOGICALS - / 4 LG / SYR

Administered by: Private       Purchased by: ?
Symptoms: Abnormal behaviour, Anxiety, Condition aggravated, Crying, Decreased appetite, Depressed mood, Discomfort, Ear infection, Fatigue, Fluid intake reduced, Food refusal, Infection, Lethargy, Pyrexia, Sleep disorder, Tympanic membrane perforation
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Psychosis and psychotic disorders (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Accidents and injuries (broad), Hostility/aggression (broad), Depression (excl suicide and self injury) (narrow), Hearing impairment (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: NONE
Current Illness: Cold with low grade fever in month prior
Preexisting Conditions: post vaccination, she began suffering from recurrent ear infections that would rupture her eardrum. Severe anxiety post vaccination.
Allergies: NONE
Diagnostic Lab Data: n/a
CDC Split Type:

Write-up: After receiving the Dtap vaccine on the morning of 3/9/15, Sage became very tired and went home to nap. After waking, we noticed she was lethargic and running a low grade fever. By bedtime that night, she wouldn''t eat and would not stop crying. Her fever increased, and she continued crying for 4 days. She was clearly uncomfortable and was not the happy, calm, baby we knew. She barely ate or drank, barely slept, and when i brought it up to her pediatrician, they told me it was normal. Shortly thereafter I left that doctor''s office to find one that would believe me when I told them about her adverse reaction to the vaccine. She began getting recurrent ear infections after never having one before. They were so severe they would rupture her eardrum.She also started having severe anxiety that would inhibit her normal day to lay life. We have since collected medical history and allergy information from our families and discovered autoimmune diseases, anyphalactic allergies, thyroid disease, and MTHFR gene mutations that are all contraindicated for further vaccines.


VAERS ID: 1520038 (history)  
Form: Version 2.0  
Age: 11.0  
Sex: Male  
Location: Illinois  
Vaccinated:2021-08-02
Onset:2021-08-02
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (INFANRIX) / GLAXOSMITHKLINE BIOLOGICALS 4L9E4 / 6 LA / IM

Administered by: Private       Purchased by: ?
Symptoms: Wrong 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: Wrong vaccine given. Vaccine ordered was Tdap, vaccine administered was DtaP.


VAERS ID: 1520242 (history)  
Form: Version 2.0  
Age: 6.0  
Sex: Female  
Location: Texas  
Vaccinated:2021-08-02
Onset:2021-08-02
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (INFANRIX) / GLAXOSMITHKLINE BIOLOGICALS J947T / 4 LA / IM

Administered by: Public       Purchased by: ?
Symptoms: Expired product 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: n/a
Current Illness: No
Preexisting Conditions: No
Allergies: NKDA
Diagnostic Lab Data: n/a
CDC Split Type:

Write-up: Client was given an expired vaccine. No adverse reactions/ s/s noted


VAERS ID: 1520279 (history)  
Form: Version 2.0  
Age: 11.0  
Sex: Female  
Location: Texas  
Vaccinated:2021-07-26
Onset:2021-07-26
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (INFANRIX) / GLAXOSMITHKLINE BIOLOGICALS 4L9E4 / 6 LA / IM

Administered by: Private       Purchased by: ?
Symptoms: Extra dose administered, Wrong 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
Current Illness: none
Preexisting Conditions: none
Allergies: none
Diagnostic Lab Data: none
CDC Split Type:

Write-up: patient was given Dtap instead of Tdap


VAERS ID: 1519134 (history)  
Form: Version 2.0  
Age: 1.25  
Sex: Female  
Location: Illinois  
Vaccinated:2021-07-26
Onset:2021-07-26
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (DAPTACEL) / SANOFI PASTEUR - / 4 LG / IM
HIBV: HIB (PEDVAXHIB) / MERCK & CO. INC. - / 4 LG / IM
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH - / 4 LG / IM

Administered by: Private       Purchased by: ?
Symptoms: Decreased appetite, Irritability, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hostility/aggression (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

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

Write-up: Fever of 102�F or greater began on the night of vaccination. Temperatures normalized after giving Tylenol dosed based on weight. Fever free for 15 hours then recurred. Persistent fevers for 6 days and ongoing. Fevers spacing out more since day 5. Slowly becoming low grade fevers. Child has been irritable during fever, but active otherwise. Decreased appetite in first 4 days after vaccination. Highest temperature recorded was 104.9�F.


VAERS ID: 1517857 (history)  
Form: Version 2.0  
Age: 7.0  
Sex: Male  
Location: Virginia  
Vaccinated:2014-10-01
Onset:2014-10-01
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (INFANRIX) / GLAXOSMITHKLINE BIOLOGICALS 49TM3 / 3 - / -
DTAP: DTAP (INFANRIX) / GLAXOSMITHKLINE BIOLOGICALS - / 2 - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Infanrix
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: USGLAXOSMITHKLINEUS202115

Write-up: received / 2nd dose / October 2014 / receiving "catch up doses" (16-JUN-2021); administration / to 7/o old; 1st dose / in August 2014, 2nd dose / October 2014 / receiving "catch up doses" (16-JUN-2021); This case was reported by a nurse via call center representative and described the occurrence of drug dose administration interval too long in a 7-year-old male patient who received DTPa (Infanrix) (batch number 49TM3, expiry date 28th May 2022) for prophylaxis. Co-suspect products included dtpa vaccine pre-filled syringe device (Infanrix Pre-Filled Syringe Device) injection syringe for prophylaxis, DTPa (Infanrix) for prophylaxis and dtpa vaccine pre-filled syringe device (Infanrix Pre-Filled Syringe Device) injection syringe for prophylaxis. Concomitant products included DTPa (Infanrix). On 16th June 2021, the patient received the 3rd dose of Infanrix and Infanrix Pre-Filled Syringe Device. In October 2014, the patient received the 2nd dose of Infanrix and Infanrix Pre-Filled Syringe Device. In October 2014, not applicable after receiving Infanrix and Infanrix Pre-Filled Syringe Device, unknown after receiving Infanrix and Infanrix Pre-Filled Syringe Device and an unknown time after receiving Infanrix, the patient experienced drug dose administration interval too long. On 16th June 2021, the patient experienced drug dose administration interval too long and inappropriate age at vaccine administration. The action taken with Infanrix Pre-Filled Syringe Device was unknown. On an unknown date, the outcome of the drug dose administration interval too long, inappropriate age at vaccine administration and drug dose administration interval too long were unknown. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional details were provided as follows: The reporter stated that, the patient received catch up doses. The patient received 1st dose of Infanrix in August 2014 and 2nd dose of Infanrix October 2014, which led to lengthening of vaccination schedule. The patient received 3rd dose late than the recommended time interval at the age of 7 years old, which led to drug dose administration interval too long, inappropriate age at vaccine administration. The reporter consented to follow up.


VAERS ID: 1518326 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: New York  
Vaccinated:2021-07-01
Onset:2021-07-01
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (DAPTACEL) / SANOFI PASTEUR - / UNK - / OT

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: USSA2021SA250537

Write-up: Expired daptacel was administer to a patient with no reported adverse event; Initial information regarding an unsolicited valid non-serious case was received on 26-Jul-2021 from pharmacist via global medical information (GMI) (Reference number- 00697188) and transmitted to Sanofi on 26-Jul-2021. This case involves a patient of unknown demographics who was vaccinated with an expired dose of DIPHTHERIA, TETANUS AND ACELLULAR PERTUSSIS VACCINE [DAPTACEL] (expired product administered). Medical history, past medical treatment, vaccination, family history and concomitant medications were not reported. On an unknown date in Jul-2021, the patient received a 0.5 mL (once) [total] dose of suspect DIPHTHERIA, TETANUS AND ACELLULAR PERTUSSIS VACCINE [DAPTACEL] (lot number and expiry date 17-Jul-2021) via an unknown route at an unknown administration site for prophylactic vaccination (expired product administered). It was reported that "pharmacist is looking for information regarding precautions on administration of an expired product". It was a case of actual medication error due to expired vaccine used (latency was on same day). At the time of report, no adverse event was reported. Event outcome was unknown. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder''s compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. There will be no information available on the batch number for this case.


VAERS ID: 1515165 (history)  
Form: Version 2.0  
Age: 12.0  
Sex: Male  
Location: Texas  
Vaccinated:2021-07-28
Onset:2021-07-28
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (INFANRIX) / GLAXOSMITHKLINE BIOLOGICALS 5RM39 / UNK LA / IM
TDAP: TDAP (BOOSTRIX) / GLAXOSMITHKLINE BIOLOGICALS 575HC / 1 RA / IM

Administered by: Private       Purchased by: ?
Symptoms: Inappropriate schedule of product administration
SMQs:, Medication errors (narrow)

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

Write-up: DTAP and TDAP administered on the same day. No side effects reported by parent


VAERS ID: 1515534 (history)  
Form: Version 2.0  
Age: 1.25  
Sex: Female  
Location: Ohio  
Vaccinated:2021-07-19
Onset:2021-07-19
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-07-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (DAPTACEL) / SANOFI PASTEUR C5829BA / 4 LL / IM
HIBV: HIB (ACTHIB) / SANOFI PASTEUR UJ404AA / 4 RL / IM

Administered by: Private       Purchased by: ?
Symptoms: Athetosis, Body temperature increased, C-reactive protein, Computerised tomogram head, Electroencephalogram, Eye movement disorder, Foaming at mouth, Full blood count, Hyporesponsive to stimuli, Metabolic function test, Postictal paralysis, Red blood cell sedimentation rate, Seizure, Vomiting
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Convulsions (narrow), Dyskinesia (narrow), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Ocular motility disorders (narrow), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? Yes, 2 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: none
Current Illness: not known
Preexisting Conditions: none
Allergies: nkda
Diagnostic Lab Data: CBC, Chem 7, ESR/CRP, CT head, EEG
CDC Split Type:

Write-up: 7/29/21 Pt with 100F temporal temp at home post vaccines. Episode of emesis at 1800 after waking from nap. Less responsive and at 1830 started foaming at the mouth and looking up with writhing arm movements. Arrived at urgent care by car at 1850 still seizing. EMS arrived- placed on blowby, 2 mg versed given to abort seizure. Transported to ED and temp of 104.7F on arrival. +Todd''s paralysis. Given fluids, tylenol and admitted for obs. Discharge 7/20/21.


VAERS ID: 1515759 (history)  
Form: Version 2.0  
Age: 5.0  
Sex: Female  
Location: California  
Vaccinated:2021-06-29
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-07-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (DAPTACEL) / SANOFI PASTEUR C5765BA / 5 LL / IM

Administered by: Private       Purchased by: ?
Symptoms: Culture positive, Furuncle, Injection site erythema, Injection site swelling, Staphylococcal infection
SMQs:, Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Infective pneumonia (broad), Opportunistic infections (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: None.
Preexisting Conditions: Allergic rhinitis.
Allergies: No known allergies.
Diagnostic Lab Data: positive wound culture
CDC Split Type:

Write-up: redness/swelling to the injection site, boil present, positive for staph


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