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

Found 62,317 cases where Vaccine is DTAP

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Case Details (Reverse Sorted by Appearance Date)

This is page 7 out of 3,116

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VAERS ID: 1870904 (history)  
Form: Version 2.0  
Age: 1.25  
Sex: Female  
Location: Ohio  
Vaccinated:2021-11-15
Onset:2021-11-15
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-11-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (DAPTACEL) / SANOFI PASTEUR - / UNK LL / SYR
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH - / UNK LL / SYR

Administered by: Private       Purchased by: ?
Symptoms: Crying, Gait disturbance
SMQs:, Peripheral neuropathy (broad), Anticholinergic syndrome (broad), Parkinson-like events (broad), Guillain-Barre syndrome (broad), Depression (excl suicide and self injury) (broad), Hypoglycaemia (broad)

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

Write-up: Inconsolable. Limping. Fever of 99 - 101� (so far). Won?t leave my lap. In no way is this normal for her she doesn?t cry about anything ever.


VAERS ID: 1864361 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: California  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-11-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (DAPTACEL) / SANOFI PASTEUR - / UNK - / OT
HIBV: HIB (ACTHIB) / SANOFI PASTEUR - / UNK - / OT
IPV: POLIO VIRUS, INACT. (IPOL) / SANOFI PASTEUR - / UNK - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Inappropriate schedule of product administration, No adverse event
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: USSA2021SA366874

Write-up: child receives vaccines on delayed schedule; Initial information received on 01-Nov-2021 regarding an unsolicited valid non-serious case received from a consumer or non-healthcare professional. This case involves child male patient who receives vaccines on delayed schedule while receiving vaccines HIB (PRP/T) VACCINE [ACT-HIB], DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL] and IPV (VERO) [IPOL] (inappropriate schedule of vaccine administered). The patient''s medical history, past medical treatment, vaccination, concomitant medication and family history were not provided. On an unknown date, the patient received a dose of suspect IPV (VERO), DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE and HIB (PRP/T) VACCINE lot number not reported via an unknown route at an unknown administration site for prophylactic vaccination. It was an actual medication error case due to inappropriate schedule of product administration. It was reported ''''asks if there is a maximum length of time between vaccine schedule for Daptacel, ActHIB, Ipol. She asks why is it not necessary to get ActHIB vaccine if not completed series at age 5. She reports child receives vaccines on delayed schedule, individually, not as combined products like Pentacel.'''' At the time of reporting, no adverse event was reported. 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. There will be no information available on the batch number for this case.


VAERS ID: 1864364 (history)  
Form: Version 2.0  
Age: 3.0  
Sex: Male  
Location: Minnesota  
Vaccinated:2021-10-21
Onset:2021-10-21
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-11-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (DAPTACEL) / SANOFI PASTEUR - / UNK - / OT
TDAP: TDAP (ADACEL) / SANOFI PASTEUR U7184AA / UNK LL / OT

Administered by: Unknown       Purchased by: ?
Symptoms: No adverse event, 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: USSA2021SA367781

Write-up: patient received Tdap/ADACEL instead of the DTaP/DAPTACEL with no reported adverse event.; Adacel was mistakenly given to a 3-year old patient with no adverse event reported; Initial information was regarding an unsolicited valid non serious case was received from an other health professional via Medical Information (MI) (Reference number- 00838697) and transmitted to Sanofi on 02-Nov-2021. This case involves a three-year-old male patient who received DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] instead of the DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL] (wrong product administered and product administered to patient of inappropriate age). The patient''s past vaccination(s) included DAPTACEL on 16-MAY-2018, on 16-JUL-2018 and on 17-SEP-2018. The patient''s medical history, past medical treatment(s), concomitant medications and family history were not provided. On 21-Oct-2021, the patient received a 0.5 mL dose of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE (Suspension for injection, lot U7184AA, expiry date unknown) via an unknown route in the left thigh for prophylactic vaccination. It was an actual medication error due to wrong product administered and product administered to patient of inappropriate age. (latency: same day). It was reported "Adacel was mistakenly given to a 3-year-old patient as the fourth dose in the diphtheria/tetanus/pertussis pediatric series. A patient received doses of Daptacel on 16May2018, 16Jul2018, and 17Sep2018. Then on 21Oct2021 for his fourth dose, Daptacel was intended, but instead Adacel was mistakenly administered in the left thigh." At time of reporting, no adverse event reported. 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.


VAERS ID: 1865394 (history)  
Form: Version 2.0  
Age: 5.0  
Sex: Male  
Location: Oklahoma  
Vaccinated:2021-10-12
Onset:2021-10-14
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-11-12
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (INFANRIX) / GLAXOSMITHKLINE BIOLOGICALS 7EC55 / 5 LA / IM

Administered by: Private       Purchased by: ?
Symptoms: Injection site swelling
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: None
Preexisting Conditions:
Allergies: None
Diagnostic Lab Data: Physical examination of left deltoid
CDC Split Type:

Write-up: Swelling had occurred around the area of immunization.


VAERS ID: 1860703 (history)  
Form: Version 2.0  
Age: 0.17  
Sex: Male  
Location: South Carolina  
Vaccinated:2021-10-29
Onset:2021-10-29
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-11-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (INFANRIX) / GLAXOSMITHKLINE BIOLOGICALS 23T73 / 1 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? Yes
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: None
Diagnostic Lab Data: None
CDC Split Type:

Write-up: Pt was to receive combination vaccine of Dtap/hepB/IPV. Pt was given Dtap (infanrix) only.


VAERS ID: 1860830 (history)  
Form: Version 2.0  
Age: 42.0  
Sex: Female  
Location: Pennsylvania  
Vaccinated:2021-10-21
Onset:2021-10-22
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-11-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (DAPTACEL) / SANOFI PASTEUR - / UNK LA / IM

Administered by: Private       Purchased by: ?
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
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? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Albuterol inhaler, Amlodipine, Ascorbic Acid, Calcium Carbonate with Vitamin D, Flonase, Hydrochlorothiazide, Singular, Multivitamins.
Current Illness: no
Preexisting Conditions: Hypertension
Allergies: none
Diagnostic Lab Data: None
CDC Split Type:

Write-up: Painful injection site, swollen, red.


VAERS ID: 1859474 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-11-03
Onset:2021-11-04
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-11-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / OT
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Exposure during pregnancy, Eye swelling, Incorrect route of product administration
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Drug abuse and dependence (broad), Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Hypersensitivity (narrow), Medication errors (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: Pregnancy (The due date for the baby is 18-Apr-2022)
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBSA2021SA368621

Write-up: Eye swelling; Initial information regarding this unsolicited valid serious case received from Health Authorities from consumer (reference number-GB-MHRA-EYC 00265349) was transmitted to Sanofi on 07-Nov-2021. This case involved a 39 years old female patient (162 cm and 80 kg) who developed eye swelling while receiving INFLUENZA VACCINE and DIPHTHERIA, TETANUS, AC PERTUSSIS AND IPV VACCINE (DTPA IPV VACCINE) The patient''s medical history, past medical treatment(s), vaccination(s) and family history were not provided. At the time of the event, the patient had ongoing Pregnancy with the due date for the baby would be 18-Apr-2022. On 03-Nov-2021, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer lot Unknown via parenteral route in unknown administration site for Prophylactic vaccination and DIPHTHERIA, TETANUS, AC PERTUSSIS AND IPV VACCINE (DTPA IPV VACCINE) produced by unknown manufacturer lot Unknown via parenteral route in unknown administration site for Prophylactic vaccination. On 04-Nov-2021 the patient developed a serious event eye swelling 1 day following the administration of INFLUENZA VACCINE and DTPA IPV VACCINE. This event was assessed as medically significant as per reporter. No relevant laboratory data was reported. It was not reported if the patient received a corrective treatment for the event (Eye swelling). At time of reporting, the outcome was Not Recovered for the event. No further relevant information was provided.; Sender''s Comments: This case involved a 39 year old female patient who had eye swelling after vaccination with INFLUENZA VACCINE and DTPA IPV VACCINE (produced by unknown manufacture).The time to onset is compatible. However, information on patient''s health condition at the time of vaccination, past medication ,relevant medical history, concomitants, and other relevant laboratory data was not provided. Based upon the reported information, the role of an individual suspect vaccine cannot be assessed.


VAERS ID: 1859700 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2019-11-21
Submitted: 0000-00-00
Entered: 2021-11-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (NO BRAND NAME) / UNKNOWN MANUFACTURER UNK / 3 - / -
DTAP: DTAP (NO BRAND NAME) / UNKNOWN MANUFACTURER UNK / 4 - / -

Administered by: Unknown       Purchased by: ?
Symptoms: Breath sounds abnormal, C-reactive protein increased, Corynebacterium infection, Corynebacterium test positive, Culture throat positive, Death, Endotracheal intubation, Epiglottic oedema, Haemodynamic instability, Hypoxia, Increased bronchial secretion, Intensive care, Laboratory test abnormal, Laryngeal oedema, Laryngitis, Lung infiltration, Mechanical ventilation, Metabolic acidosis, Oxygen saturation decreased, Polymerase chain reaction positive, Pyrexia, Respiratory distress, Respiratory failure, Tonsillar exudate, Use of accessory respiratory muscles, Vaccination failure, Wheezing, White blood cell count increased
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Asthma/bronchospasm (broad), Lack of efficacy/effect (narrow), Lactic acidosis (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Interstitial lung disease (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), Oropharyngeal allergic conditions (narrow), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Acute central respiratory depression (narrow), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Eosinophilic pneumonia (broad), Chronic kidney disease (broad), Hypersensitivity (narrow), Tumour lysis syndrome (broad), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (narrow), Infective pneumonia (broad), Hypokalaemia (broad), 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, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Down''s syndrome; Pulmonary hypertension
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20191122; Test Name: Blood pressure; Result Unstructured Data: (Test Result:110/60,Unit:mmHg,Normal Low:,Normal High:); Test Date: 20191122; Test Name: Body temperature; Result Unstructured Data: (Test Result:39.9,Unit:degree C,Normal Low:,Normal High:); Test Date: 20191122; Test Name: Breath sound; Result Unstructured Data: (Test Result:Decreased,Unit:unknown,Normal Low:,Normal High:); Test Date: 20191122; Test Name: C-reactive protein; Result Unstructured Data: (Test Result:93,Unit:mg/L,Normal Low:,Normal High:); Test Date: 20191122; Test Name: culture; Result Unstructured Data: (Test Result:C. diphtheriae,Unit:unknown,Normal Low:,Normal High:); Test Date: 20191122; Test Name: Pulse rate; Result Unstructured Data: (Test Result:150,Unit:/min,Normal Low:,Normal High:); Test Date: 20191122; Test Name: Laboratory test; Result Unstructured Data: (Test Result:Corynebacterium diphtheriae was isolated,Unit:unknown,Normal Low:,Normal High:); Test Date: 20191122; Test Name: Oxygen saturation (Sat O2); Result Unstructured Data: (Test Result:Less than 90,Unit:percent,Normal Low:,Normal High:); Test Date: 20191122; Test Name: PCR; Result Unstructured Data: (Test Result:C. diphtheriae,Unit:unknown,Normal Low:,Normal High:); Test Date: 20191122; Test Name: Respiratory Rate; Result Unstructured Data: (Test Result:60,Unit:/minute,Normal Low:,Normal High:); Test Date: 20191122; Test Name: Mechanical ventilation; Result Unstructured Data: (Test Result:bronchorrhea,Unit:unknown,Normal Low:,Normal High:); Test Date: 20191122; Test Name: White blood cell count; Result Unstructured Data: (Test Result:34,600,Unit:/mcL,Normal Low:,Normal High:)
CDC Split Type: GRGLAXOSMITHKLINEGR2021EM

Write-up: Fever/ hyperpyrexia; Laryngitis; Pneumonia; inspiratory and expiratory wheezing; chest indrawing; edema of the epiglottis; Vocal cord edema; exudative tonsils; Bronchorrhea; hypoxic; pulmonary infiltrations; respiratory failure; hemodynamic instability; metabolic acidosis; Respiratory distress/ deteriorated and died on 26th November 2019 due to respiratory distress; Corynebacterium diphtheriae; Incompletely vaccinated (DTaP 3/5 doses); This case was reported in a literature article and described the occurrence of death in a 8-year-old male patient who received DTPa (DTaP vaccine) for prophylaxis. Co-suspect products included DTPa (DTaP vaccine) for prophylaxis and DTPa (DTaP vaccine) for prophylaxis. Concurrent medical conditions included down''s syndrome and pulmonary hypertension. On an unknown date, the patient received the 1st dose of DTaP vaccine, the 2nd dose of DTaP vaccine and the 3rd dose of DTaP vaccine. On 26th November 2019, unknown after receiving DTaP vaccine, DTaP vaccine and DTaP vaccine, the patient experienced death (serious criteria death and GSK medically significant). On an unknown date, the patient experienced vaccination failure (serious criteria hospitalization and GSK medically significant), corynebacterium diphtheriae infection (serious criteria hospitalization and GSK medically significant), fever (serious criteria hospitalization), laryngitis (serious criteria hospitalization), respiratory distress (serious criteria hospitalization and GSK medically significant), wheezing (serious criteria hospitalization), retractive breathing (serious criteria hospitalization), epiglottic edema (serious criteria hospitalization and GSK medically significant), vocal cord edema (serious criteria hospitalization and GSK medically significant), tonsillar exudate (serious criteria hospitalization), bronchorrhea (serious criteria hospitalization), hypoxia (serious criteria hospitalization and GSK medically significant), pulmonary infiltration (serious criteria hospitalization), respiratory failure (serious criteria hospitalization and GSK medically significant), hemodynamic instability (serious criteria hospitalization) and metabolic acidosis (serious criteria hospitalization). The patient was treated with vancomycin, ceftriaxone, norepinephrine (Noradrenaline), sildenafil, milrinone and dobutamine. On an unknown date, the outcome of the death was fatal and the outcome of the vaccination failure, corynebacterium diphtheriae infection, fever, laryngitis, respiratory distress, wheezing, retractive breathing, epiglottic edema, vocal cord edema, tonsillar exudate, bronchorrhea, hypoxia, pulmonary infiltration, respiratory failure, hemodynamic instability and metabolic acidosis were unknown. The patient died on 26th November 2019. The reported cause of death was unknown cause of death. It was unknown if the reporter considered the death, vaccination failure, corynebacterium diphtheriae infection, fever, laryngitis, respiratory distress, wheezing, retractive breathing, epiglottic edema, vocal cord edema, tonsillar exudate, bronchorrhea, hypoxia, pulmonary infiltration, respiratory failure, hemodynamic instability and metabolic acidosis to be related to DTaP vaccine, DTaP vaccine and DTaP vaccine. Additional details were reported as follows: This case was reported in a literature article and described the suspected vaccination failure in a 8-years old male patient, who was vaccinated with unspecified diphtheria, tetanus, and pertussis (DTaP) (manufacturer unknown) for prophylaxis. The patient had Down syndrome and pulmonary hypertension. No information on patient''s family history, or concomitant medication was provided. On an unspecified date, the patient received 3/5 doses of unspecified diphtheria, tetanus, and pertussis (DTaP) (administration route and site unspecified, dosage unknown; batch number not provided). The age of vaccination was not provided. The patient was not fully vaccinated with 3/5 doses of DTaP vaccine [Patient was not fully vaccinated (DTaP 3/5 doses)]. On 22nd November 2019, an unknown period after the vaccination, the patient was admitted to the ICU due to fever up to 39.9 degree Celsius, laryngitis, and respiratory distress. At the time of admission, the patient presented with decreased breath sounds, inspiratory and expiratory wheezing with chest indrawing, Oxygen saturation (Sat O2) less than 90%, respiratory rate (RR) 60/min, pulse 150/min, blood pressure (BP) 110/60 mmHg. During intubation, edema of the epiglottis and the vocal cords was observed, as well as exudative tonsils. The patient was placed under mechanical ventilation, presented with bronchorrhea, and remained hypoxic throughout. The lab tests upon admission were: white blood cell count (WBC)= 34,600/micro liter and C-reactive protein (CRP)= 93 mg/l. Vancomycin and ceftriaxone were administered due to pulmonary infiltrations, along with noradrenaline (up to 1 mg/kg/min), sildenafil, milrinone, and dobutamine due to respiratory failure and hemodynamic instability. On 26th November 2019, while severely hypoxic, hemodynamically unstable, and experiencing metabolic acidosis, the patient died. It was unknown whether the patient''s autopsy was performed or not. Bronchial secretion examination: several leukocytes and Gram positive (+) coryneform bacteria in the direct specimen and Gram positive (+) bacterium growth in the culture, identified as Corynebacterium diphtheriae with Vitek2-ANC and with MALDI-TOF MS. The case was reported, and the strain was sent to WHO Collaborating Center for Reference and Research on Diphtheria and Streptococcal Infections, where it was identified as C. diphtheriae biovar mitis, toxigenic (positive modified Elek test) and standardized with MLST as single locus variant (SLV) ST-574. Insufficient humoral immunity, indicative of primary immunodeficiency, was found by retrospective serological testing. This case has been considered as suspected vaccination failure being the time to onset was unknown. This case has been considered serious due to death, hospitalization and suspected vaccination failure. The authors commented, "An asymptomatic carrier (classmate) with the same strain (SLV ST-574) was detected by extensive search of the pathogen in throat cultures of 104 people [family environment (n=6), hospital staff who came in contact with the patient (n=50), school environment (n=48)]. They all received clarithromycin (30 mg/kg p.o. for children and 1 g p.o. for adults for seven days), were vaccinated accordingly with Tdap/DTaP, and monitored daily for any symptoms." The authors concluded, "Asymptomatic carriage of toxigenic strains is responsible for causing disease in vulnerable persons. Monitoring on an epidemiological and microbiological level, global vaccination without omission of the booster dose, and sufficient diphtheria antitoxin [supplies] are required to prevent such cases in the future." Follow up information received from physician on 6th October 2021: Citation updated- The patient was with burdened individual history. The patient had no epidemiological history or reported trip or contact with a person who returned from an endemic country. On an unspecified date, the patient was vaccinated with 3 (three) doses of unspecified diphtheria, tetanus, and pertussis (DTaP) vaccine (administration route and site unspecified; batch number not provided).( The WHO recommends initial vaccination with 3 doses of the vaccine, followed by 3 booster doses (12-23 months, 4-7 years, and 9-15 years).) The patient did not received booster dose which led to incomplete course of vaccination. On 21st November 2019, an unknown period after the vaccination, the patient had symptoms of diphtheria. The following day (next day), the patient was admitted to the ICU of a pediatric hospital with hyperpyrexia and clinical presentation of laryngitis, pneumonia and respiratory distress. The patient received antimicrobial treatment, but then deteriorated and died on 26th November 2019 due to respiratory distress, before diphtheria antitoxin (DAT) could be found and administered. During laboratory testing of the bronchial secretion, Corynebacterium diphtheriae was isolated; the strain was then sent to the reference Laboratory of Corynebacterium, where C. diphtheriae was also identified by PCR as well as the expression of the toxin gene by Elek test. The authors commented, "This is the first native case of diphtheria in our country after 30 years. Immediately after the case declaration, an epidemiological investigation started by a team of scientists, in order to identify his close contacts in the family and school environment as well as in the Hospital where he had been hospitalized, and to implement the necessary preventive measures based on the relevant WHO protocol. All close contacts were identified and a throat swab was taken for carrier testing, and after their vaccination status was tested, a booster dose of the vaccine was administered to those who were incompletely vaccinated. At the same time, they were administered chemoprophylaxis (clarithromycin) for seven days and daily monitoring for the presence of clinical symptoms was recommended. The results of the laboratory testing on the contacts showed a sample of throat swab positive for toxicogenic C. diphtheriae, the same as the case strain, in a school classmate. The child belonged to a special population group, was incompletely vaccinated and remained an asymptomatic carrier throughout the whole duration of the investigation. The detection of a carrier led to a second cycle of investigation of contacts in his family, during which no other asymptomatic carrier was identified. This was followed by administration of the antimicrobial treatment to the carrier for 10 days and a booster dose of vaccine, while at the same time all members of his family were given chemoprophylaxis and additional vaccinations were administered. The carrier remained isolated throughout his treatment and returned to school after presenting negative results in two consecutive throat swabs within a period of 24 hours. A causal agent of diphtheria is mainly the toxicogenic strain of Corynebacterium diphtheriae, a Gram-positive bacillus. The production of toxin is only apparent when the bacillus is contaminated by a lysogenic corynebacteriophage beta that carries genetic information about the toxin (toxicogenic gene). It is mainly transmitted by droplets emitted by sick and healthy microbial carriers as well as by contact with skin and other lesions. The main pathogenic factor for the serious cases of diphtheria is the exotoxin produced by the toxigenic strain, which can be absorbed by the site of infection and cause tissue damage to various systems and especially the heart, nervous system, and kidneys as complication. Despite the fact that not all C. diphtheriae are toxicogenic, the non-toxicogenic strains may also cause severe disease, such as endocarditis. The differential diagnosis of respiratory disease should basically include other diseases that cause membranous pharyngitis. The diagnosis of diphtheria is usually made on the basis of the clinical presentation, as it is imperative to start treatment immediately. Timely laboratory testing is extremely important to confirm diagnosis and for the implementation of appropriate prevention and control measures." The authors concluded, "Prior to treatment, the mortality of diphtheria was almost 50%. In the latest years, following the application of treatment and systemic vaccinations, mortality was limited to 10%, but still remains significant. The occurrence of a case of diphtheria after 30 years in our country with a fatal outcome in an incompletely vaccinated child who was among a population with high vaccination coverage is not unexpected, as relevant cases were recorded. The objective of the implementation of the coordinated preventive measures is the detection of a possible, future diphtheria case as soon as possible, in order to implement treatment and immediately administer diphtheria antitoxin (DAT). Due to the significant deficiencies observed in many countries, public health authorities should ensure the existence of reserves to ensure optimum therapeutic treatment for patients. Asymptomatic carriage of the respiratory system in vaccinated individuals remains a significant route of transmission of diphtheria and is a public health problem particularly for the vulnerable groups of the population with incomplete vaccination or immunosuppression. The application of the basic vaccination and booster doses against diphtheria in children and adults remains extremely important, since immunity weakens over time. Maintaining high-level epidemiological surveillance, implementing systematic vaccination programs with basic and booster vaccine doses in children and adults, and making DAT reserves available are the cornerstone to avoid the appearance of similar cases in the future." Upon internal review, following corrections were performed: The event vaccination failure was deleted. Co suspect 1st and 2nd dose of DTaP vaccine were deleted. Follow up information was received from author on 14th October 2021: The reporter stated that the patient was partially vaccinated but not with GlaxoSmithKline''s vaccine. Hence, the case was considered as invalid due to non GSK suspect.; Reported Cause(s) of Death: Respiratory distress


VAERS ID: 1856898 (history)  
Form: Version 2.0  
Age: 11.0  
Sex: Female  
Location: New Jersey  
Vaccinated:2021-10-28
Onset:2021-10-28
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-11-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (DAPTACEL) / SANOFI PASTEUR 65829BA / UNK - / OT
TDAP: TDAP (ADACEL) / SANOFI PASTEUR - / UNK - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: No adverse event, 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: USSA2021SA362556

Write-up: DAPTACEL was inadvertently given instead of Adacel with no reported adverse event; DAPTACEL was inadvertently given instead of Adacel with no adverse event; Initial information received on 28-Oct-2021 regarding an unsolicited valid non-serious case from consumer/non-health care professional via Media Information (under reference 00833274). This case involves an 11 year old female patient who was inadvertently given DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL] instead of DIPHTHERIA, TETANUS AND ACELLULAR PERTUSSIS VACCINE (ADACEL) [wrong product administered and product administered to patient of inappropriate age]. The patient''s medical history, medical treatment(s), vaccination(s) and family history were not provided. The patient had no other concomitant vaccines. 28-Oct-2021, the patient received a 0.5 mL dose of suspect DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE (Total, lot 65829BA and expiration date: 01-Mar-2022) via unknown route in an unknown administration site for prophylactic vaccination. It was a case of an actual medication error due to wrong vaccine administered and inappropriate age at vaccine administration (same day latency). At time of reporting, no adverse event reported. 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.


VAERS ID: 1857572 (history)  
Form: Version 2.0  
Age: 11.0  
Sex: Male  
Location: Colorado  
Vaccinated:2021-07-28
Onset:2021-07-28
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-11-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (DAPTACEL) / SANOFI PASTEUR C5774AA / 6 LA / IM
HPV9: HPV (GARDASIL 9) / MERCK & CO. INC. T025370 / 1 RA / IM
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA) / SANOFI PASTEUR U6919AA / 1 LA / IM

Administered by: Private       Purchased by: ?
Symptoms: No adverse event
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: Flonase, Singulair, Allegra and fexofenadine
Current Illness: Constipation
Preexisting Conditions: None
Allergies: Seasonal Allergies
Diagnostic Lab Data: none
CDC Split Type:

Write-up: no symptoms at time of vaccine


VAERS ID: 1858221 (history)  
Form: Version 2.0  
Age: 11.0  
Sex: Male  
Location: Michigan  
Vaccinated:2021-10-08
Onset:2021-10-08
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-11-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (INFANRIX) / GLAXOSMITHKLINE BIOLOGICALS 4L9E4 / 6 RA / IM
HPV9: HPV (GARDASIL 9) / MERCK & CO. INC. T028583 / 1 RA / IM
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA) / SANOFI PASTEUR U7140BA / 1 LA / IM
VARCEL: VARICELLA (VARIVAX) / MERCK & CO. INC. T032930 / 2 LA / SC

Administered by: Private       Purchased by: ?
Symptoms: 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? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: hydroxyzine 10 mg.
Current Illness: none
Preexisting Conditions: none
Allergies: PCN
Diagnostic Lab Data: none required.
CDC Split Type:

Write-up: No adverse event patient was given and infant dose (Dtap) instead of a (Tdap) given to our 11 yr olds.


VAERS ID: 1858334 (history)  
Form: Version 2.0  
Age: 1.83  
Sex: Female  
Location: Massachusetts  
Vaccinated:2021-11-09
Onset:2021-11-10
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-11-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (INFANRIX) / GLAXOSMITHKLINE BIOLOGICALS 4L9E4 / UNK LL / IM
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH EE3119 / UNK RL / IM

Administered by: Private       Purchased by: ?
Symptoms: Injection site erythema
SMQs:, Extravasation events (injections, infusions and implants) (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: Intolerance to milk, developmental delay, sensory disorder, failure to gain weight
Allergies: Milk allergy
Diagnostic Lab Data:
CDC Split Type:

Write-up: RIGHT THIGH 1.5 CM REDNESS LOCAL RX


VAERS ID: 1859130 (history)  
Form: Version 2.0  
Age: 16.0  
Sex: Male  
Location: Foreign  
Vaccinated:2006-04-07
Onset:2006-04-07
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-11-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (INFANRIX) / GLAXOSMITHKLINE BIOLOGICALS A21CA157A / UNK - / IM

Administered by: Unknown       Purchased by: ?
Symptoms: Febrile convulsion, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Convulsions (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Generalised convulsive seizures following immunisation (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEGLAXOSMITHKLINEDE202122

Write-up: Febrile convulsions after receiving the vaccine; Febrile convulsions after receiving the vaccine; This case was reported by a consumer via regulatory authority and described the occurrence of fever in a 16-year-old male patient who received DTPa (Infanrix) (batch number A21CA157A, expiry date unknown) for prophylaxis. Co-suspect products included dtpa vaccine pre-filled syringe device injection syringe for prophylaxis. On 7th April 2006, the patient received Infanrix (intramuscular). On 7th April 2021, the patient started dtpa vaccine pre-filled syringe device. On 7th April 2006, less than a day after receiving Infanrix and dtpa vaccine pre-filled syringe device, the patient experienced fever (serious criteria hospitalization) and febrile convulsion (serious criteria hospitalization and GSK medically significant). On 7th April 2006, the outcome of the fever and febrile convulsion were resolved with sequelae. It was unknown if the reporter considered the fever and febrile convulsion to be 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 patient was hospitalized in 7th April 2006. The Indeterminate causality was reported for pyrexia and Unclassifiable reported for febrile convulsion Initial information received from consumer via regulatory authority on 5th November 2021: Febrile convulsions after receiving the vaccine and fever. Sender''s comment:Are you or the person concerned known of any allergies,If yes, which,no / strength fever fight.


VAERS ID: 1853423 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Iowa  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-11-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (DAPTACEL) / SANOFI PASTEUR - / UNK - / OT
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA) / SANOFI PASTEUR - / UNK - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: No adverse event, 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: USSA2021SA363320

Write-up: the products reached 30.9 Fahrenheit for five hours with no AE; Initial information regarding an unsolicited valid non-serious case was received from other healthcare professional via Medical Information (MI) (Reference number- 00833419) and transmitted to Sanofi on 28-Oct-2021. This case involves an unknown age and unknown gender patient for whom it was reported the products reached 30.9 Fahrenheit for five hours while receiving MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] and DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL]. The patient medical history, medical treatment(s), vaccination(s), concomitant medication and family history were not provided. On an unknown date, the patient received a dose of suspect DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [lot number and expiry date not reported] via an unknown route in unknown administration site for Prophylactic vaccination. On an unknown date, the patient received a dose of suspect MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [lot number and expiry date not reported] via an unknown route in unknown administration site for Prophylactic vaccination. It was a of actual medication error due to product storage error [Latency: on the same day]. It was reported "Caller reporting a temperature excursion caused by human error; facility employee thought she was making the temperature warmer and turned the temperature down instead; the products reached 30.9 Fahrenheit for five hours". Details of laboratory data not reported. It was not reported if the patient received any corrective treatment for the event. At time of reporting, the outcome was unknown for the 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 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: 1853424 (history)  
Form: Version 2.0  
Age: 7.0  
Sex: Male  
Location: California  
Vaccinated:2014-10-30
Onset:2014-10-30
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-11-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (DAPTACEL) / SANOFI PASTEUR C4644AA / UNK - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Fatigue, Injection site erythema, Injection site pain, Pruritus, Pyrexia, Rash, Vaccination site inflammation
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Extravasation events (injections, infusions and implants) (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20141030; Test Name: body temperature; Result Unstructured Data: 103.0 Fahrenheit
CDC Split Type: USSA2021SA365482

Write-up: tiredness; generalized rash and itchiness all over body; high fever (103.0Fahrenheit); injection site redness and soreness; Initial information regarding an unsolicited valid non-serious case was received from a consumer/non-health care professional via Medical Information (MI) (Reference number- 00835143) and transmitted to Sanofi on 29-Oct-2021. This case is linked to case 2021SA366585 (same patient). This case involves a 7 year old male patient who had high fever (103.0 fahrenheit) (pyrexia), injection site redness and soreness (vaccination site inflammation), generalized rash and itchiness all over body (rash pruritic) and tiredness (fatigue) after receiving DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL]. The patient''s past vaccination(s) included Ipol on 09-AUG-2010 for prophylactic vaccination. The patient had pyrexia, vaccination site inflammation, rash pruritic and fatigue as a reaction to the vaccine. The patient''s medical history, medical treatment(s), concomitant medication(s) and family history were not provided. On 30-Oct-2014, the patient received a dose of suspect DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE (lot C4644AA, expiry not reported) via unknown route in unknown administration site for prophylactic vaccination. On 30-Oct-2014 the patient developed non-serious high fever (103.0fahrenheit) (pyrexia), injection site redness and soreness (vaccination site inflammation), generalized rash and itchiness all over body (rash pruritic) and tiredness (fatigue) on the same day following the administration of DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE. No other relevant test was reported. It was not reported if the patient received a corrective treatment for the events. On an unknown date, the events were resolved. The reporter did not report the causality of events with suspect.


VAERS ID: 1849865 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: California  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-11-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (DAPTACEL) / SANOFI PASTEUR - / UNK - / OT
DTAPIPVHIB: DTAP + IPV + HIB (PENTACEL) / SANOFI PASTEUR - / UNK - / OT
HIBV: HIB (ACTHIB) / SANOFI PASTEUR - / UNK - / OT
IPV: POLIO VIRUS, INACT. (IPOL) / SANOFI PASTEUR - / UNK - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Inappropriate schedule of product administration, No adverse event
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: USSA2021SA365852

Write-up: receives vaccines on delayed schedule, individually, not as combined products but like one a month with no adverse event; Initial information received on 01-Nov-2021 regarding an unsolicited valid non-serious case from consumer/ non health care professional via Health Authority (under reference: 00837153). This case involved an unknown age male patient who experienced received vaccines on delayed schedule, individually, not as combined products but like one a month with no adverse event (inappropriate schedule of product administration) while receiving vaccines DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL], IPV (VERO) [IPOL], HIB (PRP/T) VACCINE [ActHIB] and DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL]. The patient''s past medical history, medical treatment(s), vaccination(s) and family history were not provided. On an unknown date, the patient received a dose of suspect products DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL], IPV (VERO) [IPOL], HIB (PRP/T) VACCINE [ActHIB] and DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL] lot number not reported via unknown route On an unknown date, unknown latency after starting the suspect products, the patient developed a non-serious received vaccines on delayed schedule, individually, not as combined products but like one a month with no adverse event (inappropriate schedule of product administration). No laboratory data reported. It was not reported if the patient received a corrective treatment for the event. At time of reporting, the outcome was Unknown for the event. This suspected adverse reaction report was 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 was 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 had contributed to or is to be held liable for the occurrence of this medication error. There would be no information on the batch number for this case.


VAERS ID: 1849866 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: California  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-11-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (DAPTACEL) / SANOFI PASTEUR - / UNK - / OT
DTAPIPVHIB: DTAP + IPV + HIB (PENTACEL) / SANOFI PASTEUR - / UNK - / OT
HIBV: HIB (ACTHIB) / SANOFI PASTEUR - / UNK - / OT
IPV: POLIO VIRUS, INACT. (IPOL) / SANOFI PASTEUR - / UNK - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Inappropriate schedule of product administration, Medication error, No adverse event
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: USSA2021SA366506

Write-up: child receives vaccines on delayed schedule, individually, not as combined products like Pentacel with no reported adverse event; Initial information regarding an unsolicited valid non-serious case was received from a consumer and transmitted to Sanofi on 01-Nov-2021. This case involved a child male patient who received vaccines on delayed schedule, individually, not as combined products like pentacel (Inappropriate schedule of product administration) with no reported adverse event while receiving vaccines diphtheria, tetanus, ac pertussis, ipv and hib vaccine (Pentacel), poliomyelitis vaccine (inactivated) (IPOL), diphtheria, tetanus and acellular pertussis vaccine (Daptacel) and haemophilus type b (hib) vaccine (ACT-HIB). The patient''s medical history, past medical treatment(s), vaccination(s), concomitants and family history were not provided. On an unknown date, the patient received a dose of diphtheria, tetanus, ac pertussis, ipv and hib vaccine, poliomyelitis vaccine (inactivated), diphtheria, tetanus and acellular pertussis vaccine and haemophilus type b (hib) vaccine, all with (unknown frequency and dosage) via unknown route (with an unknown batch number and expiry date) for an unknown indication. On an unknown date, (unknown latency) the patient received vaccines on delayed schedule, individually, not as combined products like pentacel (Inappropriate schedule of product administration). It was reported "Caregiver asks if there is a maximum length of time between vaccine schedule for Daptacel, ActHIB, Ipol? She asks why is it not necessary to get ActHIB vaccine if not completed series at age 5? She reports child receives vaccines on delayed schedule, individually, not as combined products like Pentacel. Additional Description of event Adverse events : She reports child receives vaccines on delayed schedule, individually, not as combined products. She states her child gets one vaccine monthly." No adverse event was reported. No relevant laboratory details were provided. Action taken with all the suspects were not applicable. It was not reported if the patient received a corrective treatment for the event. At time of reporting, the outcome was unknown for inappropriate schedule of product administration. This suspected adverse reaction report was 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 was 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 had contributed to or is to be held liable for the occurrence of this medication error. No further details were provided. Initial information regarding an unsolicited valid non-serious case was received from a consumer and transmitted to Sanofi on 01-Nov-2021. This case involved a child male patient who received vaccines on delayed schedule, individually, not as combined products like pentacel (Inappropriate schedule of product administration) with no reported adverse event while receiving vaccines diphtheria, tetanus, ac pertussis, ipv and hib vaccine (Pentacel), poliomyelitis vaccine (inactivated) (IPOL), diphtheria, tetanus and acellular pertussis vaccine (Daptacel) and haemophilus type b (hib) vaccine (ACT-HIB). The patient''s medical history, past medical treatment(s), vaccination(s), concomitants and family history were not provided. On an unknown date, the patient received a dose of diphtheria, tetanus, ac pertussis, ipv and hib vaccine, poliomyelitis vaccine (inactivated), diphtheria, tetanus and acellular pertussis vaccine and haemophilus type b (hib) vaccine, all with (unknown frequency and dosage) via unknown route (with an unknown batch number and expiry date) for an unknown indication. On an unknown date, (unknown latency) the patient received vaccines on delayed schedule, individually, not as combined products like pentacel (Inappropriate schedule of product administration). It was reported Caregiver asks if there is a maximum length of time between vaccine schedule for Daptacel, ActHIB, Ipol? She asks why is it not necessary to get ActHIB vaccine if not completed series at age 5? She reports child receives vaccines on delayed schedule, individually, not as combined products like Pentacel. Additional Description of event Adverse events : She reports child receives vaccines on delayed schedule, individually, not as combined products. She states her child gets one vaccine monthly. No relevant laboratory details were provided. Action taken with all the suspects were not applicable. It was not reported if the patient received a corrective treatment for the event. At time of reporting, the outcome was unknown for inappropriate schedule of product administration. This suspected adverse reaction report was 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 was 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 had contributed to or is to be held liable for the occurrence of this medication error. No further details were provided.


VAERS ID: 1849881 (history)  
Form: Version 2.0  
Age: 1.25  
Sex: Female  
Location: Unknown  
Vaccinated:2021-11-02
Onset:2021-11-02
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-11-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (DAPTACEL) / SANOFI PASTEUR - / 1 RL / SYR

Administered by: Private       Purchased by: ?
Symptoms: Feeling abnormal, Glare, Insomnia, Pain, Screaming, Vomiting projectile
SMQs:, Acute pancreatitis (broad), Dementia (broad), Gastrointestinal perforation, ulcer, haemorrhage, obstruction non-specific findings/procedures (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Hostility/aggression (broad), Glaucoma (broad), Ocular motility disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations: 14 months. Vomiting, screaming, sleeplessness, restlessness, pain
Other Medications: None
Current Illness: None
Preexisting Conditions:
Allergies: Unknown
Diagnostic Lab Data:
CDC Split Type:

Write-up: Zoned out and passive with blank stares, then projectile Vomiting, fussiness, loss of sleep, screaming/pain


VAERS ID: 1850181 (history)  
Form: Version 2.0  
Age: 65.0  
Sex: Female  
Location: Michigan  
Vaccinated:2021-11-02
Onset:2021-11-02
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-11-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (INFANRIX) / GLAXOSMITHKLINE BIOLOGICALS 23T73 / UNK LA / IM

Administered by: Public       Purchased by: ?
Symptoms: No adverse event, 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: 81mg ASA 10mg ZyrTec 300mg Gabapentin 25-12.5mg Zestoric 500mg Metformin 5,000unit Vit D3
Current Illness: None verbalized
Preexisting Conditions: DM, GERD, HTN
Allergies: Penicillins
Diagnostic Lab Data: N/A
CDC Split Type:

Write-up: staff administered wrong vaccine. Administered Dtap for the ordered Tdap vaccine. No immediate adverse side effect noted from the vaccine administration. Incorrect administration not noted until MA was documenting and patient had left. Dr. attempted to reach patient to advise of incorrect vaccine and discuss return to clinic for correct vaccine.


VAERS ID: 1850390 (history)  
Form: Version 2.0  
Age: 45.0  
Sex: Female  
Location: Georgia  
Vaccinated:2021-10-28
Onset:2021-10-29
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-11-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (DAPTACEL) / SANOFI PASTEUR - / UNK LA / IM

Administered by: Private       Purchased by: ?
Symptoms: Contusion, Nodule, Skin warm, Swelling
SMQs:, Anaphylactic reaction (broad), Angioedema (broad), Haemorrhage terms (excl laboratory terms) (narrow), Accidents and injuries (narrow), Haemodynamic oedema, effusions and fluid overload (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations: Tdap
Other Medications: Ibuprofen
Current Illness: None
Preexisting Conditions: None
Allergies: None
Diagnostic Lab Data: None- reported on 11/1/2021 was ordered 10am course of Keflex
CDC Split Type:

Write-up: Raised swilled knot measuring 2in wide and about 2 in long. Warm to touch and bruising


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