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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 15 out of 3,116

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VAERS ID: 1691271 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Illinois  
Vaccinated:2021-09-01
Onset:2021-08-31
Submitted: 0000-00-00
Entered: 2021-09-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (INFANRIX) / GLAXOSMITHKLINE BIOLOGICALS UNK / UNK - / SC

Administered by: Unknown       Purchased by: ?
Symptoms: Incorrect route of product administration, Product administered at inappropriate site
SMQs:, Drug abuse and dependence (broad), 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: USGLAXOSMITHKLINEUS202118

Write-up: infanrix administered below deltoid muscle / administered below the deltoid; Infanrix administered subcutaneouslyy; Havrix administered below deltoid muscle / administered below the deltoid; Havrix administered subcutaneously; This case was reported by a nurse via call center representative and described the occurrence of vaccine administered at inappropriate site in a patient who received HAV (Havrix) for prophylaxis. Co-suspect products included hepatitis A vaccine pre-filled syringe device (Havrix 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. On 31st August 2021, the patient received Havrix and Havrix Pre-Filled Syringe Device. On 1st September 2021, the patient received Infanrix (subcutaneous) and Infanrix Pre-Filled Syringe Device. On 31st August 2021, unknown after receiving Havrix and Havrix Pre-Filled Syringe Device and not applicable after receiving Infanrix and Infanrix Pre-Filled Syringe Device, the patient experienced vaccine administered at inappropriate site and intramuscular formulation administered by other route. On 1st September 2021, the patient experienced vaccine administered at inappropriate site and intramuscular formulation administered by other route. The action taken with Havrix Pre-Filled Syringe Device was unknown. On an unknown date, the outcome of the vaccine administered at inappropriate site, intramuscular formulation administered by other route, vaccine administered at inappropriate site and intramuscular formulation administered by other route 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 reported as follows: Registered nurse reported that Havrix was administered below deltoid muscle to a pediatric patient and also administered subcutaneously which led to vaccine administered at inappropriate site and intramuscular formulation administered by other route. The reporter declined for providing demographic details from patient. Reporter provided limited information. Health care professional noted the product Infanrix was also administered below the deltoid also stated it was likely subcutaneously administered which led to vaccine administered at inappropriate site and intramuscular formulation administered by other route. Health care professional did not provide lot number or expiration date of product. The reporter did not consent to follow-up.


VAERS ID: 1692823 (history)  
Form: Version 2.0  
Age: 5.0  
Sex: Female  
Location: Unknown  
Vaccinated:2021-08-12
Onset:2021-08-12
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (DAPTACEL) / SANOFI PASTEUR C5643AA / 2 RL / OT

Administered by: Unknown       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? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: HEPATITIS A VACCINE
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: USSA2021SA290302

Write-up: expired DAPTACEL was administered with no reported adverse event; Initial information regarding an unsolicited valid non-serious case was received from nurse and physician via Medical Information (Reference number- 00748869) and transmitted to Sanofi on 31-Aug-2021. This case is linked to case 2021SA290049 (same reporter). This case involved 5-year-old female patient who administered expired DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL] (expired product administered) Relevant medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included HEPATITIS A VACCINE for prophylactic vaccination. On 12-Aug-2021, the patient received second 0.5ml dose of suspect DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE (lot: C5643AA and expiry date: 17-Jul-2021) (Frequency: Once) (Strength: Standard) via intramuscular route in the right thigh for prophylactic vaccination (expired product administered). It was reported,"Nurse asks if there are any recommendations for when expired DAPTACEL is administered". This case was an actual medication error due to (expired vaccine used) (latency: same day). At the time of reporting, 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 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: 1692826 (history)  
Form: Version 2.0  
Age: 12.0  
Sex: Male  
Location: Ohio  
Vaccinated:2021-07-21
Onset:2021-07-21
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (DAPTACEL) / SANOFI PASTEUR U6628AA / UNK - / OT
TDAP: TDAP (ADACEL) / SANOFI PASTEUR - / UNK - / OT

Administered by: Unknown       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? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: MENACTRA
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: USSA2021SA293418

Write-up: Patient accidentally received DAPTACEL instead of ADACEL in the office; Initial information was received on 01-Sep-2021 regarding an unsolicited valid non-serious case received from physician and other health care professional via Medical information (under reference number - 00750742). This case involves a 12-year-old male patient who was accidentally vaccinated with DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL] instead of the DIPHTHERIA, TETANUS AND ACELLULAR PERTUSSIS VACCINE [ADACEL] with no adverse event (Wrong product administered). The patient''s past vaccination(s) included DTAP VACCINE with Patient has already received 4 DTAP vaccinations. The patient''s past medical treatments, concomitant therapy and family history were not provided. Concomitant medications included MENINGOCOCCAL VACCINE A/C/Y/W CONJ (DIP TOX) (MENACTRA) for prophylactic vaccination. On 21-Jul-2021, the patient received a 0.5ml dose of suspect DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL] (lot number U6628AA and expiry date 04-Apr-2022) via intramuscular route in the deltoid NOS for prophylactic vaccination (Wrong product administered). There were no laboratory data/results available. It was case of an actual medication error due to Wrong vaccine administered (latency was on same day) At the time of report, 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 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: 1684996 (history)  
Form: Version 2.0  
Age: 7.0  
Sex: Female  
Location: Michigan  
Vaccinated:2021-08-26
Onset:2021-08-26
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (INFANRIX) / GLAXOSMITHKLINE BIOLOGICALS 4L7E4 / 4 RL / IM

Administered by: Private       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? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: none known
Current Illness: none
Preexisting Conditions: none
Allergies: none
Diagnostic Lab Data: none
CDC Split Type:

Write-up: 7 year old patient received inappropriate dose of DTAP. Pt should have received Td instead. She had no adverse reaction.


VAERS ID: 1685661 (history)  
Form: Version 2.0  
Age: 4.0  
Sex: Female  
Location: Georgia  
Vaccinated:2021-08-27
Onset:2021-08-27
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (DAPTACEL) / SANOFI PASTEUR - / UNK UN / SYR

Administered by: Private       Purchased by: ?
Symptoms: Nausea, Pallor, Pyrexia, Vomiting
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hypotonic-hyporesponsive episode (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

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

Write-up: 3 am fever 101 . Lost color nausea and vomiting. symptoms lasted 4 complete days .


VAERS ID: 1686605 (history)  
Form: Version 2.0  
Age: 29.0  
Sex: Female  
Location: Unknown  
Vaccinated:2021-09-08
Onset:2021-09-09
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-09-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (DAPTACEL) / SANOFI PASTEUR - / UNK RA / SYR

Administered by: Private       Purchased by: ?
Symptoms: Exposure during pregnancy, Fatigue, Hot flush, Nausea
SMQs:, Acute pancreatitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (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: Lovenox prenatal supplements
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: 8 months pregnant Nauseous, hot flashes, fatigue


VAERS ID: 1681428 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Illinois  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-09-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (INFANRIX) / GLAXOSMITHKLINE BIOLOGICALS 5RM39 / UNK - / -

Administered by: Unknown       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? 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: USGLAXOSMITHKLINEUS202118

Write-up: given a dose of Infanrix instead of Boostrix; given a dose of Infanrix instead of Boostrix; This case was reported by a other health professional via call center representative and described the occurrence of wrong vaccine administered in a 56-year-old female 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. On an unknown date, the patient received Infanrix and Infanrix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Infanrix and Infanrix Pre-Filled Syringe Device, the patient experienced wrong vaccine administered and inappropriate age at vaccine administration. On an unknown date, the outcome of the wrong vaccine administered and inappropriate age at vaccine administration 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 are as follows: The age at vaccination was not reported. Manager stated that a female patient was inadvertently given a dose of Infanrix instead of Boostrix, which led to wrong vaccine administered and inappropriate age at vaccine administration. The reporter consented to follow-up via email.


VAERS ID: 1683263 (history)  
Form: Version 2.0  
Age: 1.25  
Sex: Male  
Location: Nevada  
Vaccinated:2021-09-07
Onset:2021-09-07
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (DAPTACEL) / SANOFI PASTEUR C5765BA / 4 LL / IM
HIBV: HIB (ACTHIB) / SANOFI PASTEUR UJ661AA / 4 LL / IM
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH EE7120 / 4 RL / IM

Administered by: Private       Purchased by: ?
Symptoms: Erythema, Immune system disorder, Peripheral swelling
SMQs:, Cardiac failure (broad), Anaphylactic reaction (broad), Angioedema (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? 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:
CDC Split Type:

Write-up: Swelling and redness left thigh started that night, spread the next day so pt came into the doctor''s office. Skin only a light pink, so not concerned for infection, likely just the local immune response.


VAERS ID: 1678034 (history)  
Form: Version 2.0  
Age: 3.0  
Sex: Female  
Location: Kansas  
Vaccinated:2021-08-06
Onset:2021-08-06
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (DAPTACEL) / SANOFI PASTEUR C5643AA / 4 RL / OT

Administered by: Unknown       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? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: HEPATITIS A VACCINE
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: USSA2021SA290049

Write-up: expired daptacel was administered / no AE; Initial information was received on 31-Aug-2021 regarding an unsolicited valid non-serious case from nurse and physician via call center via Medical Information (Reference number- 00748845) This case is linked to 00748869 (same reporter). This case involves a three-year-old female patient who was vaccinated with an expired dose of suspect DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL] (expired product administered). The patient''s medical history, past medical treatments, vaccinations and family history were not provided. Concomitant medications included HEPATITIS A VACCINE (HEPATITIS A VACCINE) for prophylactic vaccination. On 06-Aug-2021, the patient received a fourth dose of 0.5 mL of suspect DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE (lot number: C5643AA and expiry date: 17-Jul-2021) via an intramuscular route in the right thigh for prophylactic vaccination. It was an actual medication error case due to expired vaccine used (latency: same day). It was reported "Nurse reports that expired DAPTACEL was administered to 2 patients. Nurse asks if there are any recommendations for when expired DAPTACEL is administered." 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.; Sender''s Comments: US-SA-2021SA290302:


VAERS ID: 1679039 (history)  
Form: Version 2.0  
Age: 4.0  
Sex: Female  
Location: Michigan  
Vaccinated:2021-09-03
Onset:2021-09-03
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (INFANRIX) / GLAXOSMITHKLINE BIOLOGICALS 7EC55 / 5 RL / IM
HIBV: HIB (ACTHIB) / SANOFI PASTEUR UJ604AAA / 5 LL / IM
IPV: POLIO VIRUS, INACT. (IPOL) / SANOFI PASTEUR U1A452M / 4 RL / IM
MMR: MEASLES + MUMPS + RUBELLA (MMR II) / MERCK & CO. INC. T020656 / 2 RA / SC
VARCEL: VARICELLA (VARIVAX) / MERCK & CO. INC. U010396 / 2 LA / SC

Administered by: Private       Purchased by: ?
Symptoms: Extra dose administered, 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: Multi-vitamin
Current Illness: None.
Preexisting Conditions: None.
Allergies: None.
Diagnostic Lab Data: N/A
CDC Split Type:

Write-up: Patient was due for 4 year vaccines (MMR, Varicella, IPV and DTaP) at her physical and was given an extra dose of HIB along with the 4 year vaccines. Nurse practitioner was immediately notified when the HIB was given instead of the IPV and she went and spoke with mom about the extra dose of HIB being given and the patient needed to receive one more vaccine which was the IPV. This was given that same day before they left the office. No reports of any side effects after vaccines were given. Nurse practitioner also spoke with mother later in the afternoon, Patient was doing well.


VAERS ID: 1919945 (history)  
Form: Version 2.0  
Age: 15.0  
Sex: Male  
Location: California  
Vaccinated:2021-08-27
Onset:2021-08-28
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-09-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (INFANRIX) / GLAXOSMITHKLINE BIOLOGICALS XG942 / 4 LL / -
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH D1Z1779 / 4 RL / -

Administered by: Private       Purchased by: ?
Symptoms: Injection site erythema, 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? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations: MMR vaccine, age 12 mos 14 days, given 5/28/21, Brand name Merck & CO rash on fe
Other Medications: Vitamin D drops
Current Illness: N/A
Preexisting Conditions: N/A
Allergies: sunscreen
Diagnostic Lab Data: N/A
CDC Split Type:

Write-up: Pt''s mother stated that the swelling started the next morning after given the vaccine on the LT thigh , mom stated it''s a size of a golfball, redness minimal , w/ warmth . Advised pt to apply cold compress and children''s benadryl 2.5 ML every 4hrs.


VAERS ID: 1675542 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-09-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Coma, Hypersensitivity
SMQs:, Angioedema (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: CASA2021SA287361

Write-up: a very bad allergic reaction; coma for a period of time; Initial information regarding an unsolicited valid serious case was received on 27-Aug-2021 from a Patient via Regulatory authority. This case involves a six-year-old female patient who experienced a very bad allergic reaction (hypersensitivity) and coma for a period of time (coma) while receiving DIPHTHERIA, TETANUS, AC PERTUSSIS AND IPV VACCINE. Medical history, medical treatment(s), vaccination(s), concomitant medications and family history were not provided. On an unknown date, the patient received a dose of suspect DIPHTHERIA, TETANUS, AC PERTUSSIS AND IPV VACCINE (produced by unknown manufacturer) [lot number not reported, and expiry date not provided] via unknown route in unknown administration site for prophylactic vaccination. On an unknown date the patient developed serious very bad allergic reaction (hypersensitivity) and coma for a period of time (coma) (unknown latency) following the administration of DIPHTHERIA, TETANUS and AC PERTUSSIS AND IPV VACCINE. These events were assessed as medically significant. The patient stated that, when she was 6 years old, she received a dose of DPT-OPV, and had a very bad allergic reaction, since then she has not received any vaccine. Now, she would like to get a dose of the COVID-19 vaccine, but her doctor wants me to be tested for the components of the DPT-OPV vaccine prior to administration. Other relevant tests were not reported. It was not reported if the patient received any corrective treatment. On an unknown date, patient had recovered from the events. Information on the batch number was requested.; Sender''s Comments: This case involves a six-year-old female patient who experienced hypersensitivity and coma after receiving DIPHTHERIA, TETANUS, AC PERTUSSIS AND IPV VACCINE. The time to onset is unknown. Further information regarding patient''s medical history, concomitant medications, concurrent condition during vaccination, previous vaccination and tolerance, laboratory data excluding alternative etiologies for the reported event are needed to fully assess this case. Based upon the reported information, the role of the suspect vaccine cannot be assessed.


VAERS ID: 1674421 (history)  
Form: Version 2.0  
Age: 12.0  
Sex: Male  
Location: California  
Vaccinated:2021-07-31
Onset:2021-07-31
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (DAPTACEL) / SANOFI PASTEUR U6900AA / 1 LA / OT
TDAP: TDAP (ADACEL) / SANOFI PASTEUR - / UNK - / OT

Administered by: Unknown       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? 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: USSA2021SA281773

Write-up: 2 patients inadvertently received DAPTACEL instead of ADACEL with no reported adverse event; Initial information regarding an unsolicited valid non serious case was received from a other health professional via Medical Information (Reference number- 00736452). This case is linked with the 2021SA282217 (same reporter). This case involves a 12-year-old male patient who received DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL] instead of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] (wrong product administered). The patient''s medical history, past medical treatment(s), vaccination(s), concomitant medications and family history were not provided. On 31-Jul-2021, the patient received a first dose of 0.5 mL of suspect DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE (lot U6900A, expiry date-18-Nove-2022) via an intramuscular route in the left deltoid for prophylactic vaccination (wrong product administered). It was a case of actual medication error due to wrong vaccine administered (latency same day). It was reported, "2 patients inadvertently received DAPTACEL instead of ADACEL. Caller with question on whether a dose of ADACEL now needs to be administered. Caller also with question on when the patients will be due for a booster dose of ADACEL". At the 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. 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: 1674433 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: New Jersey  
Vaccinated:2021-08-26
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-09-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (DAPTACEL) / SANOFI PASTEUR C5774AA / UNK RA / OT
TDAP: TDAP (ADACEL) / SANOFI PASTEUR - / UNK - / OT

Administered by: Unknown       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? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: MENACTRA; HPV VACCINE
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: USSA2021SA285831

Write-up: mistakenly received DAPTACEL in the office on 26AUG2021 instead of ADACEL (with no reported adverse event); Initial information received on 26-Aug-2021 regarding an unsolicited valid non-serious case from a other health professional and consumer/non healthcare professional via Medical Information (under reference number 00741869). This case involves an 11 years old female patient who mistakenly received DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL] instead of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] (wrong product administered). Medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included MENINGOCOCCAL VACCINE A/C/Y/W CONJ (DIP TOX) (MENACTRA) for Prophylactic vaccination; and HPV VACCINE (HPV VACCINE) for Prophylactic vaccination. On 26-Aug-2021, the patient received a 0.5 mL dose of suspect DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE lot C5774AA, expiry date- 18-Sep-2022 via intramuscular route in the right deltoid for Prophylactic vaccination instead of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL]. It was a case of an actual medication error due to wrong product administered (latency same day) It was reported, Caller asked what they needed to do at this point. Caller asked to receive information related to this occurrence. At 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. 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: 1674437 (history)  
Form: Version 2.0  
Age: 21.0  
Sex: Male  
Location: Florida  
Vaccinated:2021-08-27
Onset:2021-08-27
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (DAPTACEL) / SANOFI PASTEUR C5624AA / UNK RL / OT

Administered by: Unknown       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? 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: USSA2021SA287356

Write-up: patient was given an expired vaccine/ no AE; Initial information regarding an unsolicited valid non-serious case was received on 27-Aug-2021 from a Physician via Medical Information (Reference number- 00743910) and transmitted to Sanofi on 27-Aug-2021. This case involves a 21-year-old male patient who was given an expired DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL] with no adverse event (Expired product administered). Medical history, medical treatment(s), vaccination(s), concomitant medications and family history were not provided. On 27-Aug-2021, the patient received 0.5 mL (total) dose of suspect DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [lot C5624AA and expiry date 10-Jun-2021] via unknown route in right thigh for prophylactic vaccination. It was reported, "A patient was given expired vaccine this morning. Caller wanted to know the recommendations on what to do". It was a case of actual medication error due to expired vaccine used (latency was on the 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: 1669533 (history)  
Form: Version 2.0  
Age: 12.0  
Sex: Female  
Location: Colorado  
Vaccinated:2021-08-24
Onset:2021-08-24
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (INFANRIX) / GLAXOSMITHKLINE BIOLOGICALS 5RM39 / UNK - / -

Administered by: Unknown       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? 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: USGLAXOSMITHKLINEUS202117

Write-up: received Infanrix instead of Boostrix; received Infanrix; This case was reported by a other health professional via call center representative and described the occurrence of wrong vaccine administered in a 12-year-old female 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. On 24th August 2021, the patient received Infanrix and Infanrix Pre-Filled Syringe Device. On 24th August 2021, unknown after receiving Infanrix and Infanrix Pre-Filled Syringe Device, the patient experienced wrong vaccine administered and inappropriate age at vaccine administration. On an unknown date, the outcome of the wrong vaccine administered and inappropriate age at vaccine administration 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 patient received Infanrix instead of Boostrix, which led to wrong vaccine administered and inappropriate age at vaccine administration. The reporter consented to follow up.


VAERS ID: 1669535 (history)  
Form: Version 2.0  
Age: 47.0  
Sex: Male  
Location: Kansas  
Vaccinated:2021-08-12
Onset:2021-08-12
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (INFANRIX) / GLAXOSMITHKLINE BIOLOGICALS 49TM3 / UNK - / -

Administered by: Unknown       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? 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: USGLAXOSMITHKLINEUS202118

Write-up: 47 year old was administrated Infanrix.; meant to receive Boostrix; This case was reported by a other health professional via call center representative and described the occurrence of inappropriate age at vaccine administration in a 47-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. On 12th August 2021, the patient received Infanrix and Infanrix Pre-Filled Syringe Device. On 12th August 2021, unknown after receiving Infanrix and Infanrix Pre-Filled Syringe Device, the patient experienced inappropriate age at vaccine administration and wrong vaccine administered. On an unknown date, the outcome of the 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: The patient was meant to receive a dose of Boostrix but inadvertently administrated with Infanrix, which led to wrong vaccine administered and inappropriate age at vaccine administration. No further events was reported The reporter consented to follow up. The HCP (Health care professional) agreed to be contacted for follow up.


VAERS ID: 1670949 (history)  
Form: Version 2.0  
Age: 0.33  
Sex: Male  
Location: D.C.  
Vaccinated:2021-08-31
Onset:2021-08-31
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (DAPTACEL) / SANOFI PASTEUR C5829BA / 2 RL / SYR
IPV: POLIO VIRUS, INACT. (IPOL) / SANOFI PASTEUR U1A45 / 2 LA / SYR

Administered by: Private       Purchased by: ?
Symptoms: Diarrhoea, Frequent bowel movements, Vomiting
SMQs:, Acute pancreatitis (broad), Pseudomembranous colitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Noninfectious diarrhoea (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Iron/Vitamin D supplement had been taking for a few weeks with no adverse reaction
Current Illness: None
Preexisting Conditions: None
Allergies: None that I know of
Diagnostic Lab Data:
CDC Split Type:

Write-up: Vaccine given at 4pm on 8/31. At 10:30pm that night, baby vomited. The next day, 9/1, baby had four BMs (two were very runny). Two days later, baby had five BMs (very runny), Three days later, 9/3, baby has already had five BMs and it?s only 7pm. Baby has always had only one bowel movement a day. He is now having five bowel movements a day and the BMs are all very loose/runny.


VAERS ID: 1666708 (history)  
Form: Version 2.0  
Age: 5.0  
Sex: Female  
Location: Colorado  
Vaccinated:2013-12-17
Onset:2013-12-17
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (INFANRIX) / GLAXOSMITHKLINE BIOLOGICALS - / 5 UN / UN

Administered by: Private       Purchased by: ?
Symptoms: Anxiety, Fear, Fine motor skill dysfunction, Head banging, Hypoaesthesia, Illiteracy, Obsessive thoughts, Pyrexia, Screaming, Sleep disorder
SMQs:, Peripheral neuropathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Parkinson-like events (broad), Guillain-Barre syndrome (broad), Hostility/aggression (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Sexual dysfunction (broad)

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

Write-up: screaming, head banging, poop smearing, regression with verbal skills, regression with fine motor skills, anxiety, fear, fever, sleep issues, decreased pain sensitivity, obsessive tendencies, oppositional tylenol for initial treatment still same issues after years of ABA, OT, SLP, and meds


VAERS ID: 1661883 (history)  
Form: Version 2.0  
Age: 4.0  
Sex: Male  
Location: Pennsylvania  
Vaccinated:2021-08-03
Onset:2021-08-03
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (DAPTACEL) / SANOFI PASTEUR C5643BA / 5 LA / OT

Administered by: Unknown       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? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: POLIO VACCINE
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: USSA2021SA276134

Write-up: the patient was inadvertently administered an expired dose of Daptacel with no reported adverse event; Initial information received on 18-Aug-2021 regarding an unsolicited valid non-serious case received from a other health professional and consumer/ non healthcare professional via Media information (under reference 00730173). This case is linked to case 2021SA276926(CLUSTER). This case involves a 4 years old male patient who was inadvertently administered with an expired dose of DIPHTHERIA, TETANUS AND ACELLULAR PERTUSSIS VACCINE (DAPTACEL) [expired product administered]. Concomitant medication included POLIO VACCINE (lot number and expiration date not reported) via unknown route in an unknown administration site for prophylactic vaccination. The patient''s past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 03-Aug-2021, the patient received 0.5mL fifth dose of suspect DIPHTHERIA, TETANUS AND ACELLULAR PERTUSSIS VACCINE (DAPTACEL) [total, lot C5643BA and expiration date: 17-Jul-2021] via intramuscular route in the left deltoid for prophylactic vaccination. It was an actual medication error due to expired vaccine used (same day latency). At time of reporting, no adverse event was reported and the outcome was unknown for the reported 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. 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.


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