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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 16 out of 3,116

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VAERS ID: 1661884 (history)  
Form: Version 2.0  
Age: 5.0  
Sex: Female  
Location: Pennsylvania  
Vaccinated:2021-08-13
Onset:2021-08-13
   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
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: USSA2021SA276926

Write-up: the patient was inadvertently administered dose of Daptacel that had expired on 17 July 2021/no AE; Initial information regarding an unsolicited valid non-serious case was received from the other Healthcare Professional (HCP) via medical information (Reference number- 00730261). This case involves a five-year-old female patient who received an expired DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL] (expired product administered). The patient''s medical history, past medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included POLIO VACCINE for prophylactic vaccination. On 13-Aug-2021, the patient received a fifth dose 0.5 mL of suspect DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE (lot C5643BA, expiry date-17-Jul-2021) via an intramuscular route in the left deltoid for prophylactic vaccination (expired product administered). It was a case of actual medication error due to expired vaccine used (same day). It was reported, "HCP called to ask for information on managing 3 patients who had inadvertently been administered an expired dose of Daptacel. Two of the patients were administered the expired dose on 03 Aug 2021, and the other patient was administered the expired dose on 13 Aug 2021". 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. 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: 1661888 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: New Jersey  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-09-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (DAPTACEL) / SANOFI PASTEUR - / UNK - / 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: USSA2021SA285774

Write-up: expired DAPTACEL had been administered to a patient with no reported adverse event; Initial information regarding an unsolicited valid non-serious case was received from other health care professional and consumer/non-health care professional via Medical Information (Reference number- 00739683). This case involved an unknown (age and gender) patient who administered expired DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL] (expired product administered) Relevant 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 was not reported and expiry date: 23-May-2021) via unknown route in unknown administration site for prophylactic vaccination (expired product administered). It was reported,"Caller reports that they had 6 vials of DAPTACEL that expired 23MAY2021. Caller asking if this is okay or if they should re-administer. Called declined to provided information for AE (adverse event)/safety report at time of call. Caller states she would like to speak to her office manager and the provider first. Caller given case reference number and phone number to reach for Information. Caller states she will call back if she is able to provide information for AE/safety report." 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. 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: 1662021 (history)  
Form: Version 2.0  
Age: 47.0  
Sex: Female  
Location: Illinois  
Vaccinated:2021-08-26
Onset:2021-08-26
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (INFANRIX) / GLAXOSMITHKLINE BIOLOGICALS - / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? 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: adult patient received a dose of Infanrix; 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 female patient who received DTPa (Infanrix) for prophylaxis. Co-suspect products included dtpa vaccine pre-filled syringe device (Infanrix Pre-Filled Syringe Device) injection syringe for prophylaxis. On 26th August 2021, the patient received Infanrix and Infanrix Pre-Filled Syringe Device. On 26th August 2021, unknown after receiving Infanrix and Infanrix Pre-Filled Syringe Device, the patient experienced inappropriate age at vaccine administration. The action taken with Infanrix Pre-Filled Syringe Device was unknown. On an unknown date, the outcome of the inappropriate age at vaccine administration was 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: Medical assistant reported that, an adult patient received a dose of Infanrix, which led to inappropriate age at vaccine administration. The reporter consented to follow up.


VAERS ID: 1662769 (history)  
Form: Version 2.0  
Age: 2.0  
Sex: Male  
Location: Oklahoma  
Vaccinated:2021-08-30
Onset:2021-08-31
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-09-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (INFANRIX) / GLAXOSMITHKLINE BIOLOGICALS 49TM3 / 4 LA / IM
HEPA: HEP A (VAQTA) / MERCK & CO. INC. T031201 / 2 LA / IM

Administered by: Public       Purchased by: ?
Symptoms: Erythema, Peripheral swelling, Skin warm
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? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: NONE
Current Illness: NONE
Preexisting Conditions: NONE
Allergies: NKA
Diagnostic Lab Data: NONE
CDC Split Type:

Write-up: REDNESS AND SWELLING TO LEFT UPPER ARM ,WARM TO TOUCH MOM APPLIED COOL COMPRESS


VAERS ID: 1916136 (history)  
Form: Version 2.0  
Age: 11.0  
Sex: Female  
Location: Massachusetts  
Vaccinated:2021-08-02
Onset:2021-08-03
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-09-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (INFANRIX) / GLAXOSMITHKLINE BIOLOGICALS 4L9E4 / 6 RA / IM
HPV9: HPV (GARDASIL 9) / MERCK & CO. INC. U6919AA / 1 LA / IM
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA) / SANOFI PASTEUR T02623 / 1 LA / IM

Administered by: Private       Purchased by: ?
Symptoms: Peripheral swelling
SMQs:, Cardiac failure (broad), Angioedema (broad), 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? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Albuterol, Epi pen
Current Illness: no
Preexisting Conditions: RAD, constipation
Allergies: Peanut containing Products , Cat hair
Diagnostic Lab Data: 0
CDC Split Type:

Write-up: We could not get in touch with the patient mother via phone . letter mailed out to the home. Pt c mild swelling to her R arm. Mom thought Regular reaction.


VAERS ID: 1657925 (history)  
Form: Version 2.0  
Age: 10.0  
Sex: Female  
Location: California  
Vaccinated:2021-07-30
Onset:2021-07-30
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-31
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: 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: USSA2021SA282217

Write-up: patient inadvertently received DAPTACEL instead of ADACEL/ no AE; 10-year-old patient received DAPTACEL/ no AE; Initial information was received on 23-Aug-2021 regarding an unsolicited valid non-serious case from other healthcare professional and consumer/ non healthcare professional via call center via Medical Information (Reference number- 00736487). This case is linked to case 2021SA281773(CLUSTER). This case involves a 10-year-old female patient who received DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL] instead of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] (wrong product administered and Product administered to patient of inappropriate age). The patient''s past medical history, medical treatments, vaccinations, concomitant medication and family history were not provided. On 30-Jul-2021, the patient received a first dose of 0.5 mL of suspect DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE (lot number: U6900AA and expiry date: 18-Nov-2022) via an intramuscular route in the left deltoid for prophylactic vaccination. It was a case of actual medication error due to wrong vaccine administered and inappropriate age at vaccine administration (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 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: 1657928 (history)  
Form: Version 2.0  
Age: 7.0  
Sex: Male  
Location: New Jersey  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-08-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (DAPTACEL) / SANOFI PASTEUR C5621AA / UNK LA / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: USSA2021SA284042

Write-up: The patient was administered an expired vaccine with no reported adverse event; A 7 year old patient was vaccinated with DAPTACEL, no AE; Initial information regarding an unsolicited valid non-serious case was received from a other health care professional via consumer/non-health care professional via Medical Information (Reference number- 00739783). This case involves a 7-year-old male patient who was administered an expired DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL] [expired product administered and product administered to patient of inappropriate age]. Medical history, medical treatment(s), vaccination(s) and family history were not provided. The patient had no concomitant medication. On an unknown date, the patient received a 0.5 ml dose of suspect DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE (lot C5621AA, strength: 0.5 mL, expiry: 23-May-2021) via intramuscular route in the left deltoid for prophylactic vaccination. It was a case of an actual medication error due to Expired vaccine used and Inappropriate age at vaccine administration (latency same day). It was reported, "Medical office manager calling back to provide additional details surrounding an expired vaccine that was administered; she stated that the product was expired and given to a patient from the certified medical assistant (CMA). Pasteur adverse event (AE) Reporting Refunds/Credits will not be issued due to adverse events." 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: 1924452 (history)  
Form: Version 2.0  
Age: 4.0  
Sex: Female  
Location: Michigan  
Vaccinated:2021-08-26
Onset:2021-08-26
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (INFANRIX) / GLAXOSMITHKLINE BIOLOGICALS 4L9E4 / 3 RL / IM
DTAPIPV: DTAP + IPV (KINRIX) / GLAXOSMITHKLINE BIOLOGICALS 7P5J5 / 4 RL / IM
HEPA: HEP A (HAVRIX) / GLAXOSMITHKLINE BIOLOGICALS YR532 / 2 LL / IM
HIBV: HIB (PEDVAXHIB) / MERCK & CO. INC. T030710 / 1 LL / IM

Administered by: Private       Purchased by: ?
Symptoms: Inappropriate schedule of product administration, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Medication errors (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: NONE
Current Illness: None
Preexisting Conditions: None
Allergies: NKDA
Diagnostic Lab Data: No workeup required per doctor
CDC Split Type:

Write-up: The patient received infanrix on 8/26/21 in addition to Kinrix. Mother was notified of error per Dr and was informed of minimal rash or increased side effects. No effects from imm and stable child had a fever of 101.4 on 8/26/21 that responded to tylenol


VAERS ID: 1653315 (history)  
Form: Version 2.0  
Age: 3.0  
Sex: Male  
Location: Tennessee  
Vaccinated:2021-08-02
Onset:2021-08-02
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (DAPTACEL) / SANOFI PASTEUR C5624AA / 4 - / 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: USSA2021SA259459

Write-up: nurse gave an injection of expired DAPTACEL to a child, no adverse event; Initial information regarding an unsolicited valid non-serious case was received from the other healthcare professional via Medical Information (Reference number- 00708308). This case involves a three-year-old male patient who was given an injection of expired DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL], no adverse event (expired product administered). The patient''s medical history, past medical treatment(s), vaccination(s) and family history were not provided. No concomitant vaccines was received by the patient. On 02-Aug-2021, the patient received a 0.5ml dose (dose 4) of suspect DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE (lot number: C5624AA; expiry date: 10-Jun-2021) via intramuscular route in unknown administration site for prophylactic vaccination. It was case of actual medication error due to expired vaccine used (latency: same day). It was reported, "Office manager reports that a nurse gave an injection of expired DAPTACEL to a child; asking if this child would need to receive another dose of DAPTACEL. DAPTACEL had expired 10JUN2021." No adverse events were reported at the time of reporting. 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: 1653342 (history)  
Form: Version 2.0  
Age: 12.0  
Sex: Male  
Location: Missouri  
Vaccinated:2021-08-06
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-08-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (DAPTACEL) / 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: USSA2021SA263231

Write-up: DAPTACEL was given to a 12-year-old patient instead of Adacel with no reported adverse event; DAPTACEL was given to a 12-year-old patient instead of ADACEL With No Reported Adverse Event; Initial information was received on 06-Aug-2021 regarding an unsolicited valid non-serious case from other health professional via call center via Medical Information (Reference number- 00714231). This case involves a 12 years old male patient who administered DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL] instead of ADACEL with no reported adverse event (wrong product administered and product administered to patient of inappropriate age). The patient''s medical history, medical treatments, vaccinations, concomitant medications and family history were not provided. On 06-Aug-2021, the patient received a 0.5 ml dose of suspect DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE (frequency: once, strength: standard, lot number and expiry date not reported) via an intramuscular route in the deltoid not otherwise specified (NOS) for prophylactic vaccination. It was of actual medication error due to wrong vaccine administered (latency: same day). At the time of reporting, no adverse event reported. It was reported as Caller stated that she had a nurse give DTap instead of a Tdap and she need to know the correct interval before she can give the correct vaccine. Caller states that they need to know the interval for when they can safely give the Adacel. 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. There will be no information available on the batch number for this case.


VAERS ID: 1653344 (history)  
Form: Version 2.0  
Age: 11.0  
Sex: Male  
Location: Illinois  
Vaccinated:2021-07-28
Onset:2021-07-28
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (DAPTACEL) / SANOFI PASTEUR C5765BA / UNK LA / OT
TDAP: TDAP (ADACEL) / SANOFI PASTEUR - / UNK - / OT

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: USSA2021SA265859

Write-up: A patient administered the DAPTACEL instead of Adacel, no AE; A 11 year old patient administered Daptacel , no AE; Initial information regarding an unsolicited valid non-serious case was received from other healthcare professional via Medical Information (Reference number- 00714481) and transmitted to Sanofi on 06-Aug-2021. This case involves a 11-year-old male patient who was administered DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL] instead of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] (wrong product administered and product administered to patient of inappropriate age). The patient''s medical history, past medical treatment(s), vaccination(s), concomitant medications and family history were not provided. On 28-Jul-2021, the patient received a dose of suspect DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE (lot C5765BA and expiry date: 28-Aug-2021) via an intramuscular route in the left deltoid for prophylactic vaccination instead of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] (wrong product administered and product administered to patient of inappropriate age). It was reported that "Will there be any harm related to this or will the patient require revaccination?" This was a case of actual medication error due to Inappropriate age at vaccine administration and Wrong vaccine administered (latency same day). At time of reporting, no adverse events were 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: 1653363 (history)  
Form: Version 2.0  
Age: 1.5  
Sex: Female  
Location: Utah  
Vaccinated:2021-08-12
Onset:2021-08-12
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (DAPTACEL) / SANOFI PASTEUR - / UNK - / OT
TDAP: TDAP (ADACEL) / SANOFI PASTEUR C5757AA / 1 RL / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Medication error, 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: USSA2021SA268806

Write-up: mistakenly given an Adacel vaccination instead of Daptacel with no reported adverse event; Initial information regarding an unsolicited valid non-serious case was received from the other health professional via Medical Information (Reference number- 00721986). This case involves an 18-month-old female patient who mistakenly given a DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] instead of DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL]. Medical history, medical treatment, vaccination, family history and concomitant medications were not provided. On 12-Aug-2021, the patient mistakenly received a 0.5 mL first dose of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [lot C5757AA, 22-Jul-2022] via an intramuscular route at the right thigh for prophylactic vaccination instead of DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [lot number, expiry date and other dosing details not applicable] (wrong product administered). It was a case of actual medication error due to wrong vaccine administered to patient. It was reported that, "caller asked if it was alright to administer the DAPTACEL or if the ADACEL would be sufficient. Caller also asked if there is anything that she should be watching for with regard to administering the incorrect vaccine". 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. 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: 1653398 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Pennsylvania  
Vaccinated:2021-07-20
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-08-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (DAPTACEL) / SANOFI PASTEUR - / UNK - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Expired product administered, 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: USSA2021SA275914

Write-up: daughter was given DAPTACEL on Friday, when the vaccine expired on 17Jul2021 with no reported adverse event; Initial information received on 18-Aug-2021 regarding an unsolicited valid non-serious case received from a consumer/ Non-Healthcare Professional (mother). This case involves an unknown age female patient who was expired DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL]. Medical history, medical treatment(s), vaccination(s), concomitant medication and family history were not provided. On 20-Jul-2021, the patient received a dose of suspect DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE lot number not reported, expiry date 17-Jul-2021 via unknown route in unknown administration site. It was a case of actual medication error due to expired product administered (latency same day). It was reported that, "The caller stated, I find it unsettling you only provide information to providers. I don''t feel safe with the provider who gave this expired vaccine to my child. Why can''t you tell me if another dose should be given? I want to file a complaint. It is not good enough to talk to you, how do I file a formal complaint? Will I receive follow-up that something has changed? What is the efficacy of vaccine that is expired by a certain amount of time? Do you have that information? What is the risk of getting more than one dose of the vaccine too close together? (Agent addressed 2nd to last question by saying we do not have studies at all that look at amount of efficacy v of days expired. During hold time for research of the last question, could not reconnect to the caller after hold. Had to disconnect the call. Outbound call at 14:35 and reached voicemail. Left message apologizing for technical difficulties, instructed to call back and ask for MIS III. If I am not available, find out best time for me to call her back)." 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. 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: 1653399 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Pennsylvania  
Vaccinated:2021-08-03
Onset:2021-08-03
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (DAPTACEL) / SANOFI PASTEUR C5643BA / UNK LA / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Expired product administered, Medication 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: POLIO
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: USSA2021SA275876

Write-up: had inadvertently been 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 via Consumer/ Non-Healthcare Professional.. This case involves a 5 years old (unknown gender) patient who had inadvertently been administered an expired dose of DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL]. Medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included POLIO VACCINE (POLIO) for prophylactic vaccination. On 03-Aug-2021, the patient received a 0.5 mL dose of suspect DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE lot C5643BA, expiry date-17-July-2021 via intramuscular route in the left deltoid for prophylactic vaccination. It was a case of actual medication error due to expired product administered (latency same day). 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. 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: 1653402 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Virginia  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-08-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / OT
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA) / SANOFI PASTEUR - / UNK - / 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: USSA2021SA276688

Write-up: practice had given 2 vaccines the MENACTRA and the TDAP that had been expired for 3 month/no AE; Initial information regarding an unsolicited valid non-serious case was received from the physician assistant via medical information (Reference number- 00730400) and transmitted to Sanofi on 18-Aug-2021. This case involves two patients (of an unknown demographics) to whom practice had given 2 vaccines the MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] and the DIPHTHERIA, TETANUS AND ACELLULAR PERTUSSIS VACCINE that had been expired for 3 months (expired product administered). The patient''s medical history, past medical treatment(s), vaccination(s), concomitant medications and family history were not provided. On an unknown date, the patients received a dose of suspect MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE and DIPHTHERIA, TETANUS AND ACELLULAR PERTUSSIS VACCINE (produced by unknown manufacturer) that had been expired for three months (lot number and expiry date not reported) via an unknown route at an unknown administration site for prophylactic vaccination. It was a case of actual medication error due to expired vaccine used (same day). It was reported, "calling to report their practice had given 2 vaccines the MENACTRA and the TDAP That had been expired for 3 months. She wants to know from a healthcare standpoint should they be on the watch for anything and does the patient need to be re-vaccinated. physicians assistant states the expired MENACTRA was given to 2 patients and she doesn''t know what brand of Tdap was used". 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. There will be no information available on the batch number for this case.


VAERS ID: 1653409 (history)  
Form: Version 2.0  
Age: 11.0  
Sex: Male  
Location: California  
Vaccinated:2021-08-18
Onset:2021-08-18
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (DAPTACEL) / SANOFI PASTEUR C5743AA / UNK LA / 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: GARDASIL; MENACTRA
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: USSA2021SA279589

Write-up: an 11 year old was given Daptacel instead of Adacel with no adverse event; an 11 year old was given Daptacel instead of Adacel with no adverse event; Initial information regarding an unsolicited valid non-serious case was received from other healthcare professional via Medical Information (Reference number- 00732363). This case involves a 11-year-old male patient who was administered DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL] instead of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] (wrong product administered and product administered to patient of inappropriate age). The patient''s medical history, past medical treatment(s), vaccination(s), and family history were not provided. Concomitant medications included HPV VACCINE VLP RL1 4V (YEAST) (GARDASIL) and MENINGOCOCCAL VACCINE A/C/Y/W CONJ (DIP TOX) (MENACTRA). On 18-Aug-2021, the patient received a 0.5 ml dose of suspect DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE (lot C5743AA and expiry date: 06-Jun-2022) via an intramuscular route in the left deltoid for prophylactic vaccination instead of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] (wrong product administered and product administered to patient of inappropriate age). It was reported that "the child received Daptacel instead of Adacel and they knows "there is more in there" but wanted to know what to look for and if they should do anything?" This was a case of actual medication error due to inappropriate age at vaccine administration and wrong vaccine administered (latency same day). At time of reporting, no adverse events were 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: 1653412 (history)  
Form: Version 2.0  
Age: 1.25  
Sex: Male  
Location: California  
Vaccinated:2021-08-19
Onset:2021-08-19
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (DAPTACEL) / SANOFI PASTEUR C5624AA / UNK LL / 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: ACT-HIB; PREVNAR
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: USSA2021SA279458

Write-up: 15-month-old male patient had inadvertently received an expired dose of Daptacel, with no reported AE; Initial information received on 20-Aug-2021 regarding an unsolicited valid non-serious case from a nurse via Medical Information (Reference number- 00733906). This case involves a 15 month old male patient who was inadvertently vaccinated with the expired dose of suspect DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL] (expired product administered). Medical history, medical treatment, vaccination and family history were not provided. Concomitant medications included HIB VACCINE CONJ (TET TOX) (ACT-HIB) and PNEUMOCOCCAL VACCINE CONJ 7V (CRM197) (PREVNAR) for Prophylactic vaccination. On 19-Aug-2021, the patient received a 0.5 ml dose of suspect DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE (lot C5624AA and expiry date: 10-Jun-2021) (Strength: Standard, Frequency: once) via an unknown route in the left thigh for prophylactic vaccination. It was an actual medication error case due to expired vaccine used (latency on same day). 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: 1653792 (history)  
Form: Version 2.0  
Age: 0.17  
Sex: Female  
Location: Florida  
Vaccinated:2021-07-16
Onset:2021-07-16
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (INFANRIX) / GLAXOSMITHKLINE BIOLOGICALS - / UNK LG / SYR
HEP: HEP B (HEPLISAV-B) / DYNAVAX TECHNOLOGIES CORPORATION - / UNK LG / SYR
HIBV: HIB (PEDVAXHIB) / MERCK & CO. INC. - / UNK LG / SYR
IPV: POLIO VIRUS, INACT. (IPOL) / SANOFI PASTEUR - / UNK LG / SYR
RV1: ROTAVIRUS (ROTARIX) / GLAXOSMITHKLINE BIOLOGICALS - / UNK MO / PO

Administered by: Private       Purchased by: ?
Symptoms: Decreased eye contact, Diet refusal, Feeling abnormal, Fluid intake reduced, Immediate post-injection reaction, Infantile back arching, Lethargy, Movement disorder, Screaming
SMQs:, Dementia (broad), Akathisia (broad), Dyskinesia (broad), Dystonia (broad), Parkinson-like events (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hostility/aggression (broad), Neonatal disorders (narrow), Hypersensitivity (narrow), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness: None
Preexisting Conditions: None
Allergies: N/A
Diagnostic Lab Data: None - I knew after having children injured by vaccinations before that the doctors wouldn''t help me. So I used some detox regiments and chiropractic care.
CDC Split Type:

Write-up: Immediately after vaccination, pt. wouldn''t make eye contact and was staring off into space. She didn''t cry or make any sound for hours. I gave her a detox bath in bentonite clay, fulvic acid, and essential oils. After 30 minutes of soaking she started to make eye contact and smile. Shortly after, she started arching her back and screaming inconsolably and refusing to drink her bottles. I took her to a chiropractor for an adjustment and she slept 13 hours straight. She was extremely lethargic and didn''t want to eat or move. She drank a total of 7 ounces in the 24 hours after her vaccinations. We did several detox baths in the next few days and slowly her appetite and crying got better. However, she kept the strange ear piercing cry - she still cries that way when upset to this day, but the other negative effects seem to have waned.


VAERS ID: 1654064 (history)  
Form: Version 2.0  
Age: 1.5  
Sex: Male  
Location: Illinois  
Vaccinated:2015-06-01
Onset:2015-06-01
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (INFANRIX) / GLAXOSMITHKLINE BIOLOGICALS - / UNK - / -
MMRV: MEASLES + MUMPS + RUBELLA + VARICELLA (PROQUAD) / MERCK & CO. INC. - / UNK - / -

Administered by: Private       Purchased by: ?
Symptoms: Aphasia, Autism spectrum disorder, Decreased eye contact, Emotional distress, Incontinence, Learning disability, Loss of personal independence in daily activities, Screaming
SMQs:, Dementia (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Hostility/aggression (broad), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (broad), Depression (excl suicide and self injury) (broad)

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

Write-up: Started screaming inconsolable that night, took to er they said it was ?normal? the next day he could no longer talk or make eye contact. He is now 8 and cannot speak. Is in diapers. Can?t feed or bath himself and attends special education school.


VAERS ID: 1642948 (history)  
Form: Version 2.0  
Age: 52.0  
Sex: Female  
Location: California  
Vaccinated:2021-08-20
Onset:2021-08-20
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (INFANRIX) / GLAXOSMITHKLINE BIOLOGICALS 7EC55 / UNK LA / -

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: Inappropriate age at vaccine administration; Infanrix was given to an adult patient 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 52-year-old female patient who received DTPa (Infanrix) (batch number 7ec55, expiry date unknown) for prophylaxis. Co-suspect products included dtpa vaccine pre-filled syringe device (Infanrix Pre-Filled Syringe Device) injection syringe for prophylaxis. On 20th August 2021, the patient received Infanrix and Infanrix Pre-Filled Syringe Device. On 20th August 2021, unknown after receiving Infanrix and Infanrix Pre-Filled Syringe Device, the patient experienced wrong vaccine administered. On an unknown date, the patient experienced 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: Medical Assistant reported that a dose of Infanrix was given to an adult patient instead of Boostrix, which led to wrong vaccine administered and inappropriate age at vaccine administration. The reporter consented to follow up via email.


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