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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)

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VAERS ID: 1710774 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Utah  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-09-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (INFANRIX) / GLAXOSMITHKLINE BIOLOGICALS UNK / UNK - / -
DTAPHEPBIP: DTAP + HEPB + IPV (PEDIARIX) / GLAXOSMITHKLINE BIOLOGICALS UNK / UNK - / -
DTAPIPV: DTAP + IPV (KINRIX) / GLAXOSMITHKLINE BIOLOGICALS UNK / UNK - / -
HEP: HEP B (ENGERIX-B) / GLAXOSMITHKLINE BIOLOGICALS UNK / UNK - / -
HEPA: HEP A (HAVRIX) / GLAXOSMITHKLINE BIOLOGICALS UNK / UNK - / -
HEPAB: HEP A + HEP B (TWINRIX) / GLAXOSMITHKLINE BIOLOGICALS UNK / UNK - / -
HIBV: HIB (HIBERIX) / GLAXOSMITHKLINE BIOLOGICALS UNK / UNK - / -
MENB: MENINGOCOCCAL B (BEXSERO) / NOVARTIS VACCINES AND DIAGNOSTICS UNK / UNK - / -
MNQ: MENINGOCOCCAL CONJUGATE (MENVEO) / NOVARTIS VACCINES AND DIAGNOSTICS UNK / UNK - / -
TDAP: TDAP (BOOSTRIX) / GLAXOSMITHKLINE BIOLOGICALS UNK / UNK - / -
VARZOS: ZOSTER (SHINGRIX) / GLAXOSMITHKLINE BIOLOGICALS UNK / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: USGLAXOSMITHKLINEUS202119

Write-up: Administration of vx after temperature excursion; This case was reported by a other health professional via call center representative and described the occurrence of incorrect storage of drug in an unspecified number of patients who received Herpes zoster (Shingrix) for prophylaxis. Co-suspect products included Hib (Hiberix) for prophylaxis, Men ACWY-CRM NVS (Menveo) for prophylaxis, DTPa (Reduced antigen) (Boostrix) for prophylaxis, Men B NVS (Bexsero) for prophylaxis, meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis, DTPa-IPV (Kinrix) for prophylaxis, dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis, HBV (Engerix B) for prophylaxis, HAB (Twinrix) for prophylaxis, hepatitis A and hepatitis B vaccine pre-filled syringe device (Twinrix Pre-Filled Syringe Device) injection syringe for prophylaxis, DTPa-HBV-IPV (Pediarix) for prophylaxis, dtpa-hbv-ipv vaccine pre-filled syringe device (Pediarix Pre-Filled Syringe Device) injection syringe for prophylaxis, DTPa (Infanrix) for prophylaxis, dtpa vaccine pre-filled syringe device (Infanrix Pre-Filled Syringe Device) injection syringe for prophylaxis, HAV (Havrix) for prophylaxis and hepatitis A vaccine pre-filled syringe device (Havrix Pre-Filled Syringe Device) injection syringe for prophylaxis. On an unknown date, the patient received Shingrix, Hiberix, Menveo, Boostrix, Bexsero, Bexsero Pre-Filled Syringe Device, Kinrix, Kinrix Pre-Filled Syringe Device, Engerix B, Twinrix, Twinrix Pre-Filled Syringe Device, Pediarix, Pediarix Pre-Filled Syringe Device, Infanrix, Infanrix Pre-Filled Syringe Device, Havrix and Havrix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Shingrix, Hiberix, Menveo, Boostrix, Bexsero, Bexsero Pre-Filled Syringe Device, Kinrix, Kinrix Pre-Filled Syringe Device, Engerix B, Twinrix, Twinrix Pre-Filled Syringe Device, Pediarix, Pediarix Pre-Filled Syringe Device, Infanrix, Infanrix Pre-Filled Syringe Device, Havrix and Havrix Pre-Filled Syringe Device, the patient experienced incorrect storage of drug. On an unknown date, the outcome of the incorrect storage of drug 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 provided as follows: The age at vaccination was not reported. The American Martial Arts Society(AMAS) reported that, Shingrix, Hiberix, Menveo, Boostrix, Bexsero, Bexsero Pre-Filled Syringe Device, Kinrix, Kinrix Pre-Filled Syringe Device, Engerix B, Twinrix, Twinrix Pre-Filled Syringe Device, Pediarix, Pediarix Pre-Filled Syringe Device, Infanrix, Infanrix Pre-Filled Syringe Device, Havrix and Havrix Pre-Filled Syringe Device were reached 24C on and off with an approximate time between 15 to 100 hours, which led to incorrect storage of drug. The health care professional had no information about the patients vaccinated with this vaccines or how many they were. The requested stability information was to clarify that, there were over a 10000 patients. After explaining the situation, AMAS gave consent to call her back to gather the patients data if needed. The reporter consented to follow up.


VAERS ID: 1710775 (history)  
Form: Version 2.0  
Age: 1.25  
Sex: Female  
Location: Pennsylvania  
Vaccinated:2021-09-14
Onset:2021-09-14
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (INFANRIX) / GLAXOSMITHKLINE BIOLOGICALS 5RN39 / UNK - / -

Administered by: Unknown       Purchased by: ?
Symptoms: Accidental underdose
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: USGLAXOSMITHKLINEUS202119

Write-up: received less than half a dose; This case was reported by a nurse via call center representative and described the occurrence of accidental underdose in a 15-month-old female patient who received DTPa (Infanrix) (batch number 5RN39, 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 14th September 2021, the patient received Infanrix and Infanrix Pre-Filled Syringe Device. On 14th September 2021, unknown after receiving Infanrix and Infanrix Pre-Filled Syringe Device, the patient experienced accidental underdose. On an unknown date, the outcome of the accidental underdose 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 provided as follows: The patient received less than half a dose of Infanrix vaccine because the patient was moving at the time of the injection, which led to accidental underdose. The reporter consented to follow up.


VAERS ID: 1713162 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: New York  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-09-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (DAPTACEL) / SANOFI PASTEUR C5829BA / UNK - / OT
DTAPIPVHIB: DTAP + IPV + HIB (PENTACEL) / SANOFI PASTEUR UJ528AAA / UNK - / OT
HIBV: HIB (ACTHIB) / SANOFI PASTEUR UJ661AAA / UNK - / -
IPV: POLIO VIRUS, INACT. (IPOL) / SANOFI PASTEUR R1F973M / UNK - / OT
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA) / SANOFI PASTEUR U6951AA / UNK - / -
TDAP: TDAP (ADACEL) / SANOFI PASTEUR CC5788BA / UNK - / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: USSA2021SA303817

Write-up: vaccine were exposed to 19.8 Fahrenheit and were out of range for 2 hour and 16 minutes/no ae; Initial information received on 10-Sep-2021 regarding an unsolicited valid non-serious case received from a other health care professional via under Medical Information Inquiry Number: 00764523. This case is linked to case US-SA-2021SA303376(CLUSTER). This case was considered as non-valid due to no involvement of patient. This case involved vaccines IPV (VERO) (lot number: R1F973M and expiry date: 10-MAR-2021), (lot number: T1E871M and expiry date: 10-OCT-2022), (lot number: T1D482M and expiry date: 25-FEB-2022), (lot number: R1F97 and expiry date: 10-MAR-2021), (lot number: T1E87 and expiry date: 10-OCT-2022) HIB (PRP/T) VACCINE (lot number: UJ661AAA and expiry date: 05-JUN-2022), (lot number: UJ526AAA and expiry date: 06-MAR-2022), (lot number: CC5788BA and expiry date: 14-OCT-2022) DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE (lot number C5829BA and expiry date: 03-JAN-2031) DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE (lot number: UJ528AAA and expiry date: 07-OCT-2022), (lot number: UJ435AAA and expiry date: 17-MAY-2022), (lot number: UJ421AAA and expiry date: 03-AUG-2022) DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE (lot number: CC5788BA and expiry date: 07-OCT-2022) MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE (lot number: U6951AA and expiry date: 06-JUN-2022) that were exposed to negative 19.8 degrees Fahrenheit degree for an undetermined period (product storage error). It was potential medication error case due to product storage error temperature too low. It was reported "Caller stated they had a temperature excursion of unknown cause". 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 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: 1710270 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-08-25
Onset:2021-08-25
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (NO BRAND NAME) / UNKNOWN MANUFACTURER U6616AASV / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Headache, Pain in extremity, Paraesthesia
SMQs:, Peripheral neuropathy (broad), Guillain-Barre syndrome (broad), Tendinopathies and ligament disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Migraine
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: ITSA2021SA306174

Write-up: Adult DTP vaccine, short-term appearance of pain in the left upper limb, limitation of the same symptom in the left lower limb, seen two days later, hospitalized, discharged on 03.09.; headache crisis in progress; paresthesia;Initial information was received on 14-Sep-2021 regarding an unsolicited valid serious case received from a physician via Health Authority (under reference number: IT-MINISAL02-780633). This case involves a 42-years old female patient (160 cm and 74 kg) who experienced short-term appearance of pain in the left upper limb, limitation of the same symptom in the left lower limb, seen two days later, hospitalized, discharged on 03- Sep (pain in extremity), headache crisis in progress (headache) and paresthesia (paraesthesia) while receiving vaccine DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [TRIAXIS]. On 25-AUG-2021, The patient''s past medical history included Migraine. The patient''s past medical treatments, concomitant medication vaccinations and family history were not provided. On 25-Aug-2021, the patient received a 0.5ml cyclic dose of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE (solution for injection) lot number: U6616AASV and expiry date not provided via intramuscular route in unknown administration site for prophylactic vaccination. On 25-AUG-2021, the patient developed a serious events short-term appearance of pain in the left upper limb, limitation of the same symptom in the left lower limb, seen two days later, (pain in extremity), headache crisis in progress (headache)and paresthesia (paraesthesia) following the administration of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE. The patient was hospitalized for these events. The patient was discharged on 03-Sep-2021. No lab data was provided. The patient was treated with ZOLMITRIPTAN (TRIPTAN [ZOLMITRIPTAN]) for Migraine and TOPIRAMATE (TOPAMAX SPRINKLE). At time of reporting, the patient was recovering from the events.; Reporter''s Comments: about half an hour after vaccination, he took triptan for migraine, took Topamax as a prophylaxis discharge: Left facio-brachio-crural hemisyndrome predominantly sensitive with favorable evolution with negative neurological findings Cervical discopathy C3-4 C5-6; Sender''s Comments: This case concerns 42-years old female patient who experienced pain in extremity, headache and paraesthesia after vaccination with TRIAXIS. The time to onset is compatible with the role of the vaccine. Additional information regarding patient''s condition at the time of vaccination, lab data excluding other predisposing etiologies would be needed for complete assessment of the case. Based upon the reported information, the role of the vaccine cannot be assessed.


VAERS ID: 1710288 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-03-18
Onset:2021-03-19
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-09-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (INFANRIX) / GLAXOSMITHKLINE BIOLOGICALS UNK / UNK - / IM

Administered by: Unknown       Purchased by: ?
Symptoms: Decreased appetite, Gastrointestinal disorder, Narcolepsy, Screaming, Unresponsive to stimuli
SMQs:, Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Convulsions (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hostility/aggression (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypoglycaemia (broad), Immune-mediated/autoimmune disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Allergy to chemicals
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: ITGLAXOSMITHKLINEIT202119

Write-up: First days narcolepsy, lack of appetite, fixity, non-response to stimuli, stop babbling for days. After a few days I start screaming every night, strangeness, strong intestinal problems; First days narcolepsy, lack of appetite, fixity, non-response to stimuli, stop babbling for days. After a few days I start screaming every night, strangeness, strong intestinal problems; First days narcolepsy, lack of appetite, fixity, non-response to stimuli, stop babbling for days. After a few days I start screaming every night, strangeness, strong intestinal problems; First days narcolepsy, lack of appetite, fixity, non-response to stimuli, stop babbling for days. After a few days I start screaming every night, strangeness, strong intestinal problems; This case was reported by a consumer via regulatory authority and described the occurrence of narcolepsy in a 8-month-old female patient who received DTPa (Infanrix) for prophylaxis. Co-suspect products included dtpa vaccine pre-filled syringe device injection syringe for prophylaxis. Concurrent medical conditions included allergy to chemicals. On 18th March 2021, the patient received Infanrix (intramuscular) and dtpa vaccine pre-filled syringe device. On 19th March 2021, 1 days after receiving Infanrix and dtpa vaccine pre-filled syringe device, the patient experienced narcolepsy (serious criteria disability and GSK medically significant), screaming (serious criteria disability), inappetence (serious criteria disability) and disorder gastrointestinal (serious criteria disability). Infanrix was discontinued. On an unknown date, the outcome of the narcolepsy, screaming, inappetence and disorder gastrointestinal were recovering/resolving. It was unknown if the reporter considered the narcolepsy, screaming, inappetence and disorder gastrointestinal 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: The age at vaccination was unknown. Initial information was received from a consumer via regulatory authority on 16th September 2021: First days narcolepsy, lack of appetite, fixity, non-response to stimuli, stop babbling for days. After a few days I start screaming every night, strangeness, strong intestinal problems Reporter''s comment: Chemical allergies (probably PEGs) contained in diaper creams that have created strong reactions and lesions in the external epithelium of the vagina from the first days of life Sender''s comment: suspected adverse reactions after administration of infanrix. It was not possible to contact the reporter and have information about the pc and consequently the batch number more plausible gravity for ime list.


VAERS ID: 1708226 (history)  
Form: Version 2.0  
Age: 50.0  
Sex: Female  
Location: Oklahoma  
Vaccinated:2021-09-14
Onset:2021-09-15
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-09-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (DAPTACEL) / SANOFI PASTEUR - / UNK - / -
FLU4: INFLUENZA (SEASONAL) (AFLURIA QUADRIVALENT) / SEQIRUS, INC. - / UNK - / -
VARZOS: ZOSTER (SHINGRIX) / GLAXOSMITHKLINE BIOLOGICALS - / UNK - / -

Administered by: Work       Purchased by: ?
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site streaking, Injection site swelling, Injection site warmth, Pain in extremity
SMQs:, Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Tendinopathies and ligament disorders (broad)

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

Write-up: Shots on Tuesday around 11 am. Sore arm on Wednesday. By Thursday all 3 injections sites (all upper left arm) were swollen and red. The flu site was minor and the tdap was a bit more, but the shingles was red, hot, and swollen. Friday flu site is normal, tdap still a little hard, shingles still hot, swollen and red. I have more tenderness and a few red streaks heading toward my inner arm.


VAERS ID: 1709866 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2021-04-20
Onset:2021-05-10
   Days after vaccination:20
Submitted: 0000-00-00
Entered: 2021-09-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (INFANRIX) / GLAXOSMITHKLINE BIOLOGICALS - / 1 - / OT
HIBV: HIB (ACTHIB) / SANOFI PASTEUR - / 1 - / OT
MMRV: MEASLES + MUMPS + RUBELLA + VARICELLA (NO BRAND NAME) / UNKNOWN MANUFACTURER - / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Cerebrovascular accident, Computerised tomogram head abnormal, Facial paralysis, Fall, Hemiparesis, Paralysis
SMQs:, Ischaemic central nervous system vascular conditions (narrow), Haemorrhagic central nervous system vascular conditions (narrow), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious meningitis (broad), Accidents and injuries (narrow), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (narrow), Hearing impairment (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: Medical History/Concurrent Conditions: Otomastoiditis; Viral infection NOS
Allergies:
Diagnostic Lab Data: Test Name: CT; Result Unstructured Data: CT evidence otomastoiditis; Test Name: CT; Result Unstructured Data: Constellation of altered neurology left sided flaccid paralysis / weakness +/- facial droop with no significant haemorrhage / infarcts / clots
CDC Split Type: AUSA2021SA304193

Write-up: Unwitnessed fall from standing and developed left sided hemiparesis.; Initial information was received on 10-Sep-2021 regarding an unsolicited valid serious case from other health care professional via (Therapeutic goods administration) TGA reconciliation (under reference number AU-TGA-0000605888). This case involved one-year-old female patient who experienced unwitnessed fall from standing and developed left sided hemiparesis (cerebrovascular accident) after receiving HIB (PRP/T) VACCINE [ACT-HIB], MEASLES VACCINE LIVE (SCHWARTZ), MUMPS VACCINE LIVE (RIT 4385), RUBELLA VACCINE LIVE (WISTAR RA 27/3), VARICELLA ZOSTER VACCINE LIVE (OKA) [PRIORIX TETRA] and DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR 3-COMPONENT, TETANUS VACCINE TOXOID [INFANRIX]. The patient''s medical history included recent viral illness with CT (Computed tomography) evidence otomastoiditis. On review of the case report and attached documentation, it appears that patient developed a stroke 3 weeks after receiving her 18-month vaccinations. Past medical treatment, concomitant medication, and family history were not provided. On 20-Apr-2021, the patient received first dose of suspect HIB (PRP/T) VACCINE (lot number and expiry date: not reported) via unknown route in unknown administration site for prophylactic vaccination. On 20-Apr-2021, the patient received first dose of suspect dose of suspect INFANRIX not produced by Sanofi Pasteur (lot number and expiry date: not reported) via unknown route in unknown administration site for prophylactic vaccination. On 20-Apr-2021, the patient received first dose of suspect dose of suspect PRIORIX TETRA not produced by Sanofi Pasteur (lot number and expiry date: not reported) via unknown route in unknown administration site for prophylactic vaccination. No issues or side effects reported to them any time following vaccination When case presented to hospital on 10-May-2021, the patient developed a serious unwitnessed fall from standing and developed left sided hemiparesis (cerebrovascular accident) 20 days following the administration of HIB (PRP/T) VACCINE, INFANRIX and PRIORIX TETRA. This event was assessed as medically significant, and patient was hospitalized for this event. Admitted to Hospital on 16-jun-2021 for cord de-tethering, discharge summary attached. Follow-up received: Impression: Constellation of altered neurology left sided flaccid paralysis / weakness +/- facial droop with no significant haemorrhage / infarcts / clots on CT/CTA (computed tomography angiography) Differentials at this stage less likely to be trauma related and lean more towards post viral condition such as GBS (Guillain-Barre syndrome)/transient myelitis. Relevant laboratory test results included: Computerised tomogram - On an unknown date: [CT (Computed tomography) evidence otomastoiditis]. It was not reported if the patient received a corrective treatment for the event. At time of reporting, the outcome of the event was unknown. The reporter assessed the causal relationship with suspect vaccine as possible. There will be no information available on the batch number for this case.; Sender''s Comments: This case involved one-year-old patient who had cerebrovascular accident after receiving ACT-HIB, INFANRIX and PRIORIX TETRA (other manufacture). The time to onset is compatible with the role of the vaccines. Patient''s medical history included viral illness and otomastoiditis. Laboratory data included computerised tomogram evidence otomastoiditis and Constellation of altered neurology left sided flaccid paralysis / weakness/facial droop with no significant haemorrhage / infarcts / clots. Additional information regarding condition at the time of the events, lab data excluding other predisposing etiologies would be needed for complete assessment of the case. Based upon the reported information, the role of an individual vaccine cannot be assessed.


VAERS ID: 1703455 (history)  
Form: Version 2.0  
Age: 12.0  
Sex: Male  
Location: Missouri  
Vaccinated:2021-09-07
Onset:2021-09-07
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-16
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, 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: USGLAXOSMITHKLINEUS202119

Write-up: 12-year-old received Infanrix; received Infanrix instead of Boostrix; This case was reported by a nurse via call center representative and described the occurrence of inappropriate age at vaccine administration in a 12-year-old male 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 7th September 2021, the patient received Infanrix and Infanrix Pre-Filled Syringe Device. On 7th September 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 reported as follows: Nurse reported that a 12-year-old patient received Infanrix instead of Boostrix which led to inappropriate age at vaccine administration and wrong vaccine administered. The reporter consented to follow up.


VAERS ID: 1704421 (history)  
Form: Version 2.0  
Age: 5.0  
Sex: Male  
Location: Michigan  
Vaccinated:2021-09-13
Onset:2021-09-13
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (DAPTACEL) / SANOFI PASTEUR C5774BA / 4 RA / IM
HEPA: HEP A (HAVRIX) / GLAXOSMITHKLINE BIOLOGICALS K4Y4L / 1 RA / IM
IPV: POLIO VIRUS, INACT. (IPOL) / SANOFI PASTEUR T1D482M / 4 RA / IM
MMRV: MEASLES + MUMPS + RUBELLA + VARICELLA (PROQUAD) / MERCK & CO. INC. T030945 / 2 LA / SC

Administered by: Public       Purchased by: ?
Symptoms: Incorrect dose administered, No adverse event
SMQs:, Medication errors (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: none
Current Illness: none
Preexisting Conditions: none
Allergies: none
Diagnostic Lab Data: none at this time Health System recorded .5 ml given from 1 ml dosage
CDC Split Type:

Write-up: Client received .5 ml of adult dose of HEP A vaccine No adverse reactions noted Attempted to notify parents of med error - unable to contact


VAERS ID: 1699853 (history)  
Form: Version 2.0  
Age: 42.0  
Sex: Male  
Location: Virginia  
Vaccinated:2021-09-12
Onset:2021-09-12
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (DAPTACEL) / SANOFI PASTEUR - / 1 RA / SYR

Administered by: Private       Purchased by: ?
Symptoms: Arthralgia, Hypoaesthesia, Mobility decreased, Paraesthesia, Product administered at inappropriate site, Shoulder injury related to vaccine administration
SMQs:, Peripheral neuropathy (broad), Parkinson-like events (broad), Drug abuse and dependence (broad), Guillain-Barre syndrome (broad), Arthritis (broad), Tendinopathies and ligament disorders (broad), Medication errors (narrow), Sexual dysfunction (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: Penicillin (veetids)
Diagnostic Lab Data: I haven?t received any yet. This injury just happened a couple days ago. Hoping to see an orthopedist this week.
CDC Split Type:

Write-up: I think I?m suffering from SIRVA. The nurse who administered the injection into my arm did it very high, just below the bone (acromion). I think she injected it into the shoulder capsule instead of the deltoid muscle. That night I had terrible shoulder pain, could barely lift my arm. Since then the pain has not gone away and has traveled to the back of my shoulder. I also have some numbness and tingling. I?m very worried that this pain may never go away!


VAERS ID: 1700359 (history)  
Form: Version 2.0  
Age: 1.5  
Sex: Female  
Location: South Carolina  
Vaccinated:2021-08-03
Onset:2021-08-04
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-09-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (DAPTACEL) / SANOFI PASTEUR C5765BA / 4 RL / IM
HEPA: HEP A (VAQTA) / MERCK & CO. INC. T037788 / 2 LL / IM

Administered by: Private       Purchased by: ?
Symptoms: Vaccination site induration, Vaccination site swelling
SMQs:

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

Write-up: large swelling and induration at vaccination site


VAERS ID: 1700691 (history)  
Form: Version 2.0  
Age: 4.0  
Sex: Female  
Location: California  
Vaccinated:2021-09-15
Onset:2021-09-15
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (INFANRIX) / GLAXOSMITHKLINE BIOLOGICALS 7EC55 / 5 LL / IM
IPV: POLIO VIRUS, INACT. (IPOL) / SANOFI PASTEUR U1A452M / 4 RL / IM

Administered by: Military       Purchased by: ?
Symptoms: Vaccination 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: None
Current Illness: None
Preexisting Conditions: None
Allergies: None
Diagnostic Lab Data: None
CDC Split Type:

Write-up: Vaccine Administration Error - Patient moved while Dtap was being administered and did not receive a full dose due to the needle coming back out (25Gx1) ; patient also moved while Polio was being administered and did not receive a full dose due to the needle bending (retractable Vanish Point needle). The vaccines are normally given together in a combination vaccine (Kinrix) at 4 years old, but we were out of stock for that vaccine. Patient received full Dtap dose in left deltoid with assistance and full Polio dose in the right deltoid with assistance.


VAERS ID: 1700701 (history)  
Form: Version 2.0  
Age: 36.0  
Sex: Female  
Location: Texas  
Vaccinated:2021-08-14
Onset:2021-09-14
   Days after vaccination:31
Submitted: 0000-00-00
Entered: 2021-09-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (DAPTACEL) / SANOFI PASTEUR - / UNK - / -
VARCEL: VARICELLA (VARIVAX) / MERCK & CO. INC. - / UNK - / -

Administered by: Pharmacy       Purchased by: ?
Symptoms: Abdominal pain upper, Headache, SARS-CoV-2 antibody test negative, SARS-CoV-2 test negative
SMQs:, Acute pancreatitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), COVID-19 (broad)

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

Write-up: Started having on and off headache and stomach pain after eating 2 weeks after taking the vaccine. Negative results in Covid19 PCR and antibody test taken 09/12 12nn.


VAERS ID: 1701379 (history)  
Form: Version 2.0  
Age: 0.83  
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-09-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Paralysis
SMQs:, Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRSA2021SA293626

Write-up: paralyzed;Initial information received on 01-Sep-2021 regarding an unsolicited valid serious case received from consumer/ non-healthcare professional via call center via Medical Information (Reference number- 00749718). This case is linked to case 2021SA293551(mother case). This case involves a 10-month-male patient who was paralyzed after receiving DIPHTHERIA, TETANUS, AC PERTUSSIS AND IPV VACCINE. The patient''s medical history, past medical treatments, vaccinations, concomitant vaccination 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 and expiry date not reported) via an unknown route at an unknown administration site for prophylactic vaccination. On an unknown date, the patient was paralyzed for life (paralysis) (unknown latency) following the administration of POLIOMYELITIS VACCINE (ORAL). This event was assessed as medically significant. It was reported that patient had six operations in total (muscle transplant) so that he could walk again. They received no help. After a few years an expertise took place which proved that his paralysis was indeed due to Polio following the vaccination and they received compensation of 140,000 euros which allowed the couple to pay for their son''s education. Despite his studies, their son struggled to find a stable job. She finds it hard to deprive a child of a normal future like that all at once, that he can do studies and that he cannot find a permanent job and nobody does anything we are compensated then that''s all. Laboratory details were not reported. It was not reported, if the patient received a corrective treatment for the event (paralyzed). The event outcome was unknown for paralysis. Batch number has been requested for suspect product for this case. Follow up information received on 09-Sep-2021 regarding an unsolicited valid serious case received from consumer/ non-healthcare professional via call center via Medical Information (Reference number- 00749718). Suspect and narrative updated.; Sender''s Comments: Follow up information received on 09-Sep-2021 changed the previous assessment. This case concerns a 10-month-male patient male patient who experienced paralysis (unknown latency) after vaccination with DIPHTHERIA, TETANUS, AC PERTUSSIS AND IPV VACCINE (unknown manufacturer). The time to onset is unknown. There is no further information regarding patient''s medical condition at the time of vaccination and laboratory tests ruling out other alternate etiologies were not reported. Based upon the reported information, the role of the suspect vaccine cannot be assessed.


VAERS ID: 1696136 (history)  
Form: Version 2.0  
Age: 8.0  
Sex: Female  
Location: California  
Vaccinated:2021-09-07
Onset:2021-09-07
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (DAPTACEL) / SANOFI PASTEUR U6968AA / 1 LA / SYR

Administered by: Private       Purchased by: ?
Symptoms: Dyschezia, Dysuria, Haemorrhage, Pain, Proctalgia
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Gastrointestinal nonspecific 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: no
Current Illness: no
Preexisting Conditions: no
Allergies: no
Diagnostic Lab Data: Went to doctor on 9/10 and urine test was done .
CDC Split Type:

Write-up: Started having stinging rectum pain. Moderate level pain . Moderate to high level when peeing or pooping . Lasted for 24hours . Family history of ulcerative colitis. On 9/10 had blood when wiping .


VAERS ID: 1694555 (history)  
Form: Version 2.0  
Age: 44.0  
Sex: Male  
Location: Massachusetts  
Vaccinated:2021-09-01
Onset:2021-09-02
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-09-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (INFANRIX) / GLAXOSMITHKLINE BIOLOGICALS U7055AA / UNK LA / IM

Administered by: Private       Purchased by: ?
Symptoms: Arthralgia, Back pain, Swelling
SMQs:, Anaphylactic reaction (broad), Angioedema (broad), Retroperitoneal fibrosis (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Arthritis (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: montelukast 10 mg , flovent FA 110mcg BID inhaled
Current Illness: none
Preexisting Conditions: mild persistent asthma
Allergies: childhood rash with PCN
Diagnostic Lab Data: none
CDC Split Type:

Write-up: bilateral swelling in axial areas, L upper back/shoulder pain


VAERS ID: 1694914 (history)  
Form: Version 2.0  
Age: 0.5  
Sex: Male  
Location: New Mexico  
Vaccinated:2020-01-21
Onset:2020-01-21
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (INFANRIX) / GLAXOSMITHKLINE BIOLOGICALS 7A533 / 3 LG / SYR
RV5: ROTAVIRUS (ROTATEQ) / MERCK & CO. INC. 1660932 / 3 MO / PO

Administered by: Military       Purchased by: ?
Symptoms: Head titubation, Seizure like phenomena, Tremor
SMQs:, Neuroleptic malignant syndrome (broad), Convulsions (narrow), Parkinson-like events (broad), Noninfectious encephalopathy/delirium (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: None
Preexisting Conditions: Hydronephrosis diagnosed in utero
Allergies: None
Diagnostic Lab Data:
CDC Split Type:

Write-up: Approximately 1 hour after receiving listed vaccinations, child''s head and body shook in a seizure-like manner while mother was holding him.


VAERS ID: 1695718 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: California  
Vaccinated:2012-01-24
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-09-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (NO BRAND NAME) / UNKNOWN MANUFACTURER C418AA / UNK - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Hypersensitivity, Injection site erythema, Injection site swelling, Vaccination site inflammation
SMQs:, Angioedema (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: USSA2021SA292852

Write-up: minor allergic reaction; Redness and swelling at the injection site; Redness at the injection site; Swelling at the injection site; Initial information was received on 31-Aug-2021 regarding an unsolicited valid non-serious case from a physician via other health care professional. This case involves a patient (demographics unknown) who had minor allergic reaction (hypersensitivity) and redness and swelling at the injection site (vaccination site inflammation) (with symptoms: vaccination site erythema and vaccination site swelling) after receiving DIPHTHERIA, TETANUS AND ACELLULAR PERTUSSIS VACCINE. It was unknown if the patient had any medical history, concomitant disease or risk factor. Medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided. On 24-Jan-2012, the patient received a dose of suspect DIPHTHERIA, TETANUS AND ACELLULAR PERTUSSIS VACCINE produced by unknown manufacturer (lot C418AA, form: suspension for injection, expiry: 14-Nov-2014) via unknown route in unknown administration site for prophylactic vaccination. On an unknown date the patient developed non-serious minor allergic reaction (hypersensitivity) and redness and swelling at the injection site (vaccination site inflammation) (with symptoms: vaccination site erythema and vaccination site swelling) (unknown latency) following the administration of DIPHTHERIA and TETANUS AND ACELLULAR PERTUSSIS VACCINE. It was reported, "She reported that on 24-Jan-2012 a patient received a dose of Sanofi DIPHTHERIA, TETANUS AND ACELLULAR PERTUSSIS VACCINE (TDAP) vaccine and had a minor allergic reaction consisting of redness and swelling at the injection site. She reported that the reaction did not require medical intervention" She did not have further adverse event (AE) details. No Product Quality Control (PQC). No additional AEs reported. No additional information provided. The caller was unable to provide the brand name of the TDAP vaccine but did confirm that it was manufactured by Sanofi It was unknown if the patient experienced any additional symptoms/events. It was unknown if there were lab data/results available. At time of reporting, the outcome of the events was unknown.


VAERS ID: 1691195 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-09-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (NO BRAND NAME) / UNKNOWN MANUFACTURER UNK / UNK - / -

Administered by: Unknown       Purchased by: ?
Symptoms: Cataract
SMQs:, Glaucoma (broad), Lens disorders (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: USGLAXOSMITHKLINEUS2021AM

Write-up: cataracts; This case was reported by a consumer via interactive digital media and described the occurrence of cataract in a male patient who received DTPa (DTaP vaccine) for prophylaxis. On an unknown date, the patient received DTaP vaccine. On an unknown date, unknown after receiving DTaP vaccine, the patient experienced cataract (serious criteria GSK medically significant). On an unknown date, the outcome of the cataract was unknown. It was unknown if the reporter considered the cataract to be related to DTaP vaccine. Additional details were reported as follows: The case was reported by the patient''s spouse. The age at vaccination was not reported. The patient developed cataracts after receiving the Dtap vaccine. As per the reporter, could not uninject the vaccine.


VAERS ID: 1691265 (history)  
Form: Version 2.0  
Age: 1.17  
Sex: Unknown  
Location: Nevada  
Vaccinated:2021-08-30
Onset:2021-08-30
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-09-11
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (INFANRIX) / GLAXOSMITHKLINE BIOLOGICALS UNK / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? 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: USGLAXOSMITHKLINEUS2021AM

Write-up: 1 year and 2 months old received IInfanrix and was supposed to be receiving at 15 months of age; This case was reported by a other health professional via call center representative and described the occurrence of drug dose administration interval too short in a 14-month-old 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. Previously administered products included Pediarix (received Dtap-Pediarix on unknown date at 2, 4 and 6 month of age). On 30th August 2021, the patient received Infanrix and Infanrix Pre-Filled Syringe Device. On 30th August 2021, unknown after receiving Infanrix and Infanrix Pre-Filled Syringe Device, the patient experienced drug dose administration interval too short. On an unknown date, the outcome of the drug dose administration interval too short 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 provided as follows: The medical assistant reported that, the patient of 1 year and 2 months old received Infanrix at an unknown location. The patient received Dtap-Pediarix at 2, 4 and 6 month of age and was supposed to receive Infanrix at 15 months of age but received at 14 months of age, which led to drug dose administration interval too short.


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