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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 17 out of 3,116

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VAERS ID: 1652769 (history)  
Form: Version 2.0  
Age: 5.0  
Sex: Female  
Location: New Jersey  
Vaccinated:2021-08-25
Onset:2021-08-26
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-08-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (DAPTACEL) / SANOFI PASTEUR - / 4 LA / SYR
IPV: POLIO VIRUS, INACT. (IPOL) / SANOFI PASTEUR - / 4 RA / SYR

Administered by: Private       Purchased by: ?
Symptoms: Injection site erythema, Injection site pruritus, Injection site rash, Injection site swelling, Injection site warmth, Rash papular
SMQs:, 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? Yes
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: None
Current Illness: None
Preexisting Conditions: None
Allergies: None
Diagnostic Lab Data: None
CDC Split Type:

Write-up: Swollen red hot bump and rash on arm at injection site. Very itchy. From the IPV.


VAERS ID: 1641321 (history)  
Form: Version 2.0  
Age: 1.25  
Sex: Female  
Location: Michigan  
Vaccinated:2021-08-27
Onset:2021-08-27
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-27
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (DAPTACEL) / SANOFI PASTEUR C5743AA / 4 LL / IM
HIBV: HIB (ACTHIB) / SANOFI PASTEUR UJ661AA / 4 LL / IM
MENB: MENINGOCOCCAL B (TRUMENBA) / PFIZER/WYETH ER2621 / 1 RL / IM

Administered by: Private       Purchased by: ?
Symptoms: Wrong product administered
SMQs:, Medication errors (narrow)

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

Write-up: Prevnar 13 was to be given. Due to staff error Trumenba was given.


VAERS ID: 1636982 (history)  
Form: Version 2.0  
Age: 5.0  
Sex: Male  
Location: Iowa  
Vaccinated:2021-08-24
Onset:2021-08-26
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-08-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (DAPTACEL) / SANOFI PASTEUR C5765BA / UNK - / -
MMR: MEASLES + MUMPS + RUBELLA (MMR II) / MERCK & CO. INC. T012808 / 1 RA / IM

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

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

Write-up: baseball sized localized swelling, redness, and pain at the injection site 48 hours post injection


VAERS ID: 1637194 (history)  
Form: Version 2.0  
Age: 1.25  
Sex: Female  
Location: Iowa  
Vaccinated:2021-08-24
Onset:2021-08-26
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-08-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (INFANRIX) / GLAXOSMITHKLINE BIOLOGICALS 4L9E4 / 4 LL / SYR

Administered by: Unknown       Purchased by: ?
Symptoms: Erythema, Swelling, Tenderness
SMQs:, Anaphylactic reaction (broad), Angioedema (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

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

Write-up: Redness and swelling the size of patient''s fist, red and painful to the touch


VAERS ID: 1636095 (history)  
Form: Version 2.0  
Age: 0.42  
Sex: Male  
Location: Foreign  
Vaccinated:2018-05-29
Onset:2018-05-29
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (INFANRIX) / GLAXOSMITHKLINE BIOLOGICALS AC14B240AZ / 2 LL / IM
HIBV: HIB (ACTHIB) / SANOFI PASTEUR N1G801M / 2 LL / IM
IPV: POLIO VIRUS, INACT. (POLIOVAX) / SANOFI PASTEUR M74982V / 1 RL / IM
PNC10: PNEUMO (SYNFLORIX) / GLAXOSMITHKLINE BIOLOGICALS ASPNA852AA / 2 RL / IM

Administered by: Unknown       Purchased by: ?
Symptoms: Electrocardiogram abnormal, Electrocardiogram ambulatory abnormal, Heart rate increased, Inflammatory marker increased, Pyrexia, Tachycardia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Cardiomyopathy (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Dehydration (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? Yes, 3 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Heart murmur (VSD, PFO, DA in echocardiogram.)
Allergies:
Diagnostic Lab Data: Test Date: 20180529; Test Name: Body temperature; Result Unstructured Data: (Test Result:39,Unit:degree C,Normal Low:,Normal High:); Test Date: 2018; Test Name: ECG; Result Unstructured Data: (Test Result:HR: 140, no other arrythmias,Unit:unknown,Normal Low:,Normal High:); Test Date: 2018; Test Name: Holter monitoring; Result Unstructured Data: (Test Result:abnormal,Unit:unknown,Normal Low:,Normal High:); Test Date: 20180529; Test Name: Heart rate; Result Unstructured Data: (Test Result:160,Unit:unknown,Normal Low:,Normal High:); Test Date: 20180529; Test Name: Inflammatory marker test; Result Unstructured Data: (Test Result:normal,Unit:unknown,Normal Low:,Normal High:); Test Date: 2018; Test Name: Inflammatory marker test; Result Unstructured Data: (Test Result:increased,Unit:unknown,Normal Low:,Normal High:); Test Date: 2018; Test Name: Inflammatory marker test; Result Unstructured Data: (Test Result:control test: normal,Unit:unknown,Normal Low:,Normal High:)
CDC Split Type: PLGLAXOSMITHKLINEPL202117

Write-up: Tachycardia (160/min); Fever 39�C lasting up to 48 hours; This case was reported by a physician via regulatory authority and described the occurrence of tachycardia in a 5-month-old male patient who received 10PN-PD-Dit (Synflorix) (batch number ASPNA852AA, expiry date 30th June 2018) for prophylaxis. Co-suspect products included DTPa (Infanrix DTPa) (batch number AC14B240AZ, expiry date May 2019) for prophylaxis, dtpa vaccine pre-filled syringe device injection syringe for prophylaxis, IMOVAX POLIO (batch number M74982V, expiry date September 2018) for prophylaxis and HAEMOPHILUS INFLUENZA B VACCINE (ACT-HIB) (batch number N1G801M, expiry date July 2019) for prophylaxis. Concurrent medical conditions included heart murmur (VSD, PFO, DA in echocardiogram.). On 29th May 2018 11:55, the patient received the 2nd dose of Synflorix (intramuscular) .5 ml and the 2nd dose of Infanrix DTPa (intramuscular) .5 ml. On 29th May 2018, the patient started dtpa vaccine pre-filled syringe device. On 29th May 2018 11:55, the patient received the 1st dose of IMOVAX POLIO (intramuscular) .5 ml and the 2nd dose of ACT-HIB (intramuscular) .5 ml. On 29th May 2018 21:00, 9 hrs 5 min after receiving Synflorix, Infanrix DTPa and dtpa vaccine pre-filled syringe device, the patient experienced tachycardia (serious criteria hospitalization) and fever (serious criteria hospitalization). In 2018, the outcome of the tachycardia and fever were recovered/resolved. The reporter considered the tachycardia to be unrelated to Synflorix, Infanrix DTPa and dtpa vaccine pre-filled syringe device. The reporter considered the fever to be probably related to Synflorix, Infanrix DTPa and dtpa vaccine pre-filled syringe device. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional details were reported as follows: On 29th May 2018, the patient''s body temperature was 39 degree C. In 2018, ECG was performed and result was heart rate 140, no other arrythmias. In 2018, Holter monitoring was found abnormal. On 29th May 2018, the heart rate was 160 beats per min. In 2018, inflammatory marker test was performed and result was increased and control test normal. On 29th May 2018, the inflammatory marker test was performed and result was normal. The patient received Infanrix DTPa in left thigh, Synflorix in right thigh, Imovax polio in right thigh and Act-HIB in left thigh. The fever lasted upto 48 hrs. On 29th May 2018 21:00, 9 hrs 5 min after receiving Act-HIB and Imovax polio, the patient experienced tachycardia and fever. In 2018, the patient was hospitalized for 3 days. WHO causal assessment was reported as no reasonable possibility in association to the tachycardia for Synflorix, Infanrix DTPa, Act-HIB, Imovax polio. WHO causal assessment was reported as probable in association to the fever for Synflorix, Infanrix DTPa, Act-HIB, Imovax polio. The unit for heart rate was reported as beats per min but was not captured as it leads to report failure. Initial information was reported by physician via regulatory authority on 20th August 2021: Tachycardia (160/min) Fever 39 degree C lasting up to 48 hours Sender''s comments: According to the SmPC, fever - the highest temperature 38.5 degree C - 38.9 degree C, the duration of fever up to 48 hours is an expected adverse reaction for all four vaccines: SYNFLORIX, INFANRIX DTPa, ACT-HiB, IMOVAX Polio, Tachycardia is an unexpected increase in heart rate over 100 beats per minute. Tachycardia is not always a symptom of a disease. Most often, the heart rate increases because of catecholamines produced by emotions or exercise (sinus tachycardia). The temporal relationship speaks for the existence of a cause-and-effect relationship. The person reporting qualified him as serious (hospitalization - 3 days); the Regulatory Authority assessed the adverse event as heavy.


VAERS ID: 1632613 (history)  
Form: Version 2.0  
Age: 7.0  
Sex: Female  
Location: Michigan  
Vaccinated:2021-08-24
Onset:2021-08-24
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (INFANRIX) / GLAXOSMITHKLINE BIOLOGICALS 49TM3 / 1 LA / IM

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

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

Write-up: Child at 7 years of age was supposed to receive Tdap but was given Dtap instead.


VAERS ID: 1632747 (history)  
Form: Version 2.0  
Age: 1.0  
Sex: Male  
Location: Unknown  
Vaccinated:1981-01-01
Onset:1981-01-01
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (INFANRIX) / GLAXOSMITHKLINE BIOLOGICALS - / UNK - / -

Administered by: Unknown       Purchased by: ?
Symptoms: Rash
SMQs:, Anaphylactic reaction (broad), 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? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: rash


VAERS ID: 1633577 (history)  
Form: Version 2.0  
Age: 4.0  
Sex: Female  
Location: Kentucky  
Vaccinated:2021-08-23
Onset:2021-08-23
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-25
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (DAPTACEL) / SANOFI PASTEUR - / UNK LA / SYR
MMR: MEASLES + MUMPS + RUBELLA (MMR II) / MERCK & CO. INC. - / UNK LA / SYR
VARCEL: VARICELLA (VARIVAX) / MERCK & CO. INC. - / UNK LA / SYR

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations: 11-9-18; redness, swelling, warmness for over a week after vaccine. Unknown brand or type. Injection in leg at 15 months old.
Other Medications: No
Current Illness: No
Preexisting Conditions: No
Allergies: No
Diagnostic Lab Data: None.
CDC Split Type:

Write-up: Large area of redness around dtap injection site. Slightly swollen. Warm to the touch. Started within hours of injection. Hasn?t went away within 48 hours, so I?m reporting.


VAERS ID: 1628737 (history)  
Form: Version 2.0  
Age: 12.0  
Sex: Male  
Location: California  
Vaccinated:2021-08-10
Onset:2021-08-10
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (INFANRIX) / GLAXOSMITHKLINE BIOLOGICALS D2KX9 / 4 LA / IM
IPV: POLIO VIRUS, INACT. (IPOL) / SANOFI PASTEUR T1D482M / 4 RA / IM
MMRV: MEASLES + MUMPS + RUBELLA + VARICELLA (PROQUAD) / MERCK & CO. INC. U002537 / 2 RA / SC

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

Write-up: Pt is 12yo who received a Dtap vaccine instead of a Tdap for his age. No complications to pt. Pt mother and MD were notified right away.


VAERS ID: 1924318 (history)  
Form: Version 2.0  
Age: 5.0  
Sex: Female  
Location: Ohio  
Vaccinated:2021-06-24
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-08-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (DAPTACEL) / SANOFI PASTEUR C5706AA / 5 LA / IM
IPV: POLIO VIRUS, INACT. (POLIOVAX) / SANOFI PASTEUR RIF801M / 4 RA / IM
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA) / SANOFI PASTEUR U6921AA / 1 LA / IM
VARCEL: VARICELLA (VARIVAX) / MERCK & CO. INC. T032317 / 2 RA / SC

Administered by: Private       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: n/a
Current Illness: n/a
Preexisting Conditions: n/a
Allergies: none
Diagnostic Lab Data: n/a
CDC Split Type:

Write-up: no Reaction Nor Symptoms. Received wrong vaccine accidentally MCV4.


VAERS ID: 1623038 (history)  
Form: Version 2.0  
Age: 32.0  
Sex: Male  
Location: South Carolina  
Vaccinated:2021-08-17
Onset:2021-08-17
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (INFANRIX) / GLAXOSMITHKLINE BIOLOGICALS XG942 / UNK RA / IM

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: 32 year old / received Infanrix; Intended vaccine was Boostrix; This case was reported by a other health professional via call center representative and described the occurrence of inappropriate age at vaccine administration in a 32-year-old male patient who received DTPa (Infanrix) (batch number XG942, expiry date 22nd August 2022) for prophylaxis. Co-suspect products included dtpa vaccine pre-filled syringe device (Infanrix Pre-Filled Syringe Device) injection syringe for prophylaxis. On 17th August 2021, the patient received Infanrix (intramuscular) and Infanrix Pre-Filled Syringe Device. On 17th August 2021, unknown after receiving Infanrix and Infanrix Pre-Filled Syringe Device, the patient experienced inappropriate age at vaccine administration and wrong vaccine administered. The action taken with Infanrix Pre-Filled Syringe Device was unknown. On an unknown date, the outcome of the inappropriate age at vaccine administration and wrong vaccine administered were unknown. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional details were provided as follows: The health care professional reported that the 32 years old patient inadvertently received Infanrix in the right deltoid, which led to inappropriate age at vaccine administration. The Intended vaccine was Boostrix , which led to wrong vaccine administered. The reporter consented to follow up. This is 1 of the 2 linked cases, reported by the same reporter.; Sender''s Comments: US-GLAXOSMITHKLINE-US2021173224:Same reporter


VAERS ID: 1623919 (history)  
Form: Version 2.0  
Age: 1.17  
Sex: Male  
Location: Unknown  
Vaccinated:2021-08-16
Onset:2021-08-20
   Days after vaccination:4
Submitted: 0000-00-00
Entered: 2021-08-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (INFANRIX) / GLAXOSMITHKLINE BIOLOGICALS 7EC55 / 4 RL / IM
HIBV: HIB (ACTHIB) / SANOFI PASTEUR 42EM3 / 4 RL / IM

Administered by: Private       Purchased by: ?
Symptoms: Erythema multiforme
SMQs:, Severe cutaneous adverse reactions (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Immune-mediated/autoimmune disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations: similar rash January 2021 within 1 week of receiving HIB and flu vaccines
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Erythema multiforme First reaction occurred within 1 week of HIB and flu vaccines in Jan. 2021 Second reaction occurred within 1 week of HIB and DTaP vaccines in August 2021


VAERS ID: 1624818 (history)  
Form: Version 2.0  
Age: 14.0  
Sex: Male  
Location: Minnesota  
Vaccinated:2021-08-20
Onset:2021-08-23
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-08-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (DAPTACEL) / SANOFI PASTEUR - / UNK - / -

Administered by: Private       Purchased by: ?
Symptoms: Cough, Dizziness, Fatigue, Oropharyngeal pain, Pain in jaw, Pyrexia
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Vestibular disorders (broad), Osteonecrosis (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: Digoxin, spironolactone, lasix, losartan
Current Illness: None.
Preexisting Conditions: Heart failure
Allergies: Red dye
Diagnostic Lab Data:
CDC Split Type:

Write-up: Cough, fever, sore throat, light headed, jaw soreness, fatigue.


VAERS ID: 1624769 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2021-06-21
Onset:2021-07-12
   Days after vaccination:21
Submitted: 0000-00-00
Entered: 2021-08-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (INFANRIX) / GLAXOSMITHKLINE BIOLOGICALS UNK / UNK - / IM
PPV: PNEUMO (PNEUMOVAX) / MERCK & CO. INC. UNK / UNK - / IM

Administered by: Unknown       Purchased by: ?
Symptoms: Thrombotic thrombocytopenic purpura
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Embolic and thrombotic events, arterial (narrow), Renovascular disorders (broad), Immune-mediated/autoimmune disorders (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? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: Sulfamethoxazole; Folinate de calcium; Valaciclovir; Oracilline; CICLOSPORINE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Gastritis (Unspecified gastritis and gastroduodenitis); Hemangioma of liver; Hepatic sclerosis; Hiatal hernia; Hypercholesterolemia; Localized tingling; Marrow dysplasia; Prostate neoplasia; Prostatectomy
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRGLAXOSMITHKLINEFR202117

Write-up: Thrombocytopenic purpura, thrombotic; This case was reported by a physician via regulatory authority and described the occurrence of thrombocytopenic purpura, thrombotic in a 63-year-old male patient who received DTPa (Infanrix) for prophylaxis. Co-suspect products included dtpa vaccine pre-filled syringe device injection syringe for prophylaxis and PNEUMOCOCCAL VACCINE POLYSACCHARIDE 23 VALENT (PNEUMOVAX) for prophylaxis. The patient''s past medical history included marrow dysplasia, hemangioma of liver, hiatal hernia, hepatic sclerosis, hypercholesterolemia, prostate neoplasia, gastritis (Unspecified gastritis and gastroduodenitis), prostatectomy and localized tingling. Concomitant products included sulphamethoxazole (Sulfamethoxazole), calcium folinate (Folinate De Calcium), valaciclovir hydrochloride (Valaciclovir), phenoxymethylpenicillin potassium (Oracilline) and ciclosporin (Ciclosporine). On 21st June 2021, the patient received Infanrix (intramuscular) 1 dosage form(s), dtpa vaccine pre-filled syringe device and PNEUMOVAX (intramuscular) 1 dosage form(s). On 12th July 2021, 21 days after receiving Infanrix and dtpa vaccine pre-filled syringe device, the patient experienced thrombocytopenic purpura, thrombotic (serious criteria hospitalization and GSK medically significant). In 2021, the outcome of the thrombocytopenic purpura, thrombotic was recovered/resolved. It was unknown if the reporter considered the thrombocytopenic purpura, thrombotic to be related to Infanrix and dtpa vaccine pre-filled syringe device.This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional details were reported as follows: The age at vaccination was unknown. On 12th July 2021, 21 days after receiving Pneumovax, the patient experienced thrombocytopenic purpura, thrombotic. It was unknown if the reporter considered the thrombocytopenic purpura, thrombotic to be related to Pneumovax. Note: Time to onset for event was reported as 22 days in drug event mapping, however it was captured as per vaccination date and event onset date. Initial information received from physician via regulatory authority on 17th August 2021: thrombocytopenic purpura, thrombotic.


VAERS ID: 1617844 (history)  
Form: Version 2.0  
Age: 3.0  
Sex: Male  
Location: Utah  
Vaccinated:2021-08-01
Onset:2021-08-18
   Days after vaccination:17
Submitted: 0000-00-00
Entered: 2021-08-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (DAPTACEL) / SANOFI PASTEUR - / UNK - / -
HEPA: HEP A (HAVRIX) / GLAXOSMITHKLINE BIOLOGICALS - / UNK - / -

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

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

Write-up: Swelling at injection site with surrounding erythema and swelling


VAERS ID: 1593212 (history)  
Form: Version 2.0  
Age: 30.0  
Sex: Female  
Location: Georgia  
Vaccinated:2016-07-19
Onset:2016-07-19
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (DAPTACEL) / SANOFI PASTEUR UNK / UNK UN / SYR

Administered by: Private       Purchased by: ?
Symptoms: Chest discomfort, Dyspnoea, Erythema, Feeling hot, Pain, Pharyngeal swelling, Skin irritation, Urticaria
SMQs:, Anaphylactic reaction (narrow), Angioedema (narrow), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Claritin, Pro Air, Pepcid, Dexamethasone possibly I need to notate administering clinic has me listed as female. Also, had medical fraud and birthdate discrepancy post this vaccine reaction with Clinic providers changing birthdate to 1995
Current Illness: Sinus infection, asthma car accident injuries on June 26, vertigo biggest health change was concussion and accident injuries around vaccine
Preexisting Conditions: Asthma, sinus problems, GERD at time of vaccine . Unsure if Clinic or ER reported. This is approximate date of adult Tdap Booster. I?ve had a traumatic brain injury so memory has issues, but feel it?s important to report because I had trouble with breathing with this booster and did not have reaction like this with prior vaccines. It was similar to my contrast allergy. I?d just like to make aware to protect patients better. I was never properly treated or counseled well by attending physician after reaction, but have better PCP now. It worries me with Aspirin sensitive asthma because pulmonologist mentioned correlation between pharmaceutical sensitivity.
Allergies: Benadryl, codeine, penicillin, rocephin, gabapentin, contrast mediums, gandilonium, doxycycline, Tiraspol, latex, metal, nickel, Gortex hernia mesh, dyes, mold, eggs, Aspirin, various NSAIDS, cows milk
Diagnostic Lab Data: Possibly a chest x-ray. I was very dismissed and ignored. I no longer attend this facility or health system for my allergic reactions.
CDC Split Type:

Write-up: Severe pain all over body with heat to the body. Turning red and hives on arms. Believe left arm was injection site. Feelings is throat swelling and labored breathing and odd chest discomfort not previously experienced with typical asthma trigger or flare. Shooting pains and skin irritation symptoms lasted throughout the week. I went to ER where I was brushed off after calling Dr. . I think I may have been treated with Dexamethasone eventually but relied on asthma meds to maintain breathing. I felt every effort was made to conceal and not address my reaction unfortunately. I?d never been treated like this with other adverse reactions to previous pharmaceuticals. I?ve not received further vaccination after this due to unknown and struggling to recover or understand how or why this happened.


VAERS ID: 1594057 (history)  
Form: Version 2.0  
Age: 4.0  
Sex: Female  
Location: California  
Vaccinated:2021-07-19
Onset:2021-07-19
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK RA / -
IPV: POLIO VIRUS, INACT. (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK LA / -
MMR: MEASLES + MUMPS + RUBELLA (MMR II) / MERCK & CO. INC. T010650 / UNK - / -
VARCEL: VARICELLA (VARIVAX) / MERCK & CO. INC. T035399 / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Pain in extremity, Product storage error
SMQs:, Tendinopathies and ligament disorders (broad), Medication errors (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Prophylaxis
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: US0095075132107USA007507

Write-up: Arm pain; temperature excursion that occurred on 17 /JUL/2021, 18/JUL/2021, and 19/JUL/2021. PROQUAD and V ARlV AX were both administered to the patient on 19/JUL/2021.; This spontaneous report as received from a certified medical assistant refers to a 4-year-old female patient. The patient''s concurrent condition, concomitant medication and medical history were not provided. On 19-JUL-2021, the patient was vaccinated with improperly stored doses of varicella virus vaccine live (oka/merck)(VARIVAX) "1 time dose", lot # T035399 was confirmed to be valid, expiration date 16-OCT-2022 and measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (recombinant Human albumin) (M-M-R II) "1 time dose", lot # T010650 was confirmed to be valid, expiration date 26-MAR-2022 (dose, route of administration, vaccination site were not specified for any of them); both for prophylaxis. On the same date, she received diphtheria vaccine toxoid, pertussis vaccine acellular, tetanus vaccine toxoid (DTAP) lot # reported as 5RM39, expiration date 25-NOV-2022 in the right arm and polio vaccine inact (IPV) lot # reported as TID448IM, expiration date 22-JUL-2022 in the left arm (dose, route of administration were not specified for any of them); both for prophylaxis. The administered doses underwent a temperature excursion of 55.4 degrees Fahrenheit for 33 hours. There were no previous temperature excursions. Digital data logger was involved. On 19-JUL-2021 the patient experienced pain in arm. The outcome of the event was unknown. The relatedness between the event and the suspect vaccines was not provided.


VAERS ID: 1594229 (history)  
Form: Version 2.0  
Age: 11.0  
Sex: Male  
Location: Virginia  
Vaccinated:2020-12-18
Onset:2020-12-18
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (INFANRIX) / GLAXOSMITHKLINE BIOLOGICALS 49TM3 / UNK LA / IM

Administered by: Other       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: Wrong Vaccine Administered; Administered to an elven year old child; This case was reported by a physician via call center representative and described the occurrence of inappropriate age at vaccine administration in a 11-year-old male patient who received DTPa (Infanrix) (batch number 49tm3, expiry date 28th May 2022) for prophylaxis. Co-suspect products included dtpa vaccine pre-filled syringe device (Infanrix Pre-Filled Syringe Device) injection syringe for prophylaxis. On 18th December 2020, the patient received Infanrix (intramuscular) and Infanrix Pre-Filled Syringe Device. On 18th December 2020, unknown after receiving Infanrix and Infanrix Pre-Filled Syringe Device, the patient experienced inappropriate age at vaccine administration. On an unknown date, the patient experienced wrong vaccine administered. On an unknown date, the outcome of the inappropriate age at vaccine administration and wrong vaccine administered were unknown. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional details were provided as follows: The physician called to report wrong vaccine administered to a 11 years old patient with Infanrix vaccine, which led to inappropriate age at vaccine administered and wrong vaccine administered. The reporter consented to follow up.


VAERS ID: 1594254 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Nebraska  
Vaccinated:2021-08-04
Onset:2021-08-04
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (INFANRIX) / GLAXOSMITHKLINE BIOLOGICALS NG5GS / 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: USGLAXOSMITHKLINEUS202117

Write-up: an 11 year old /on 04-Aug-2021 / 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 11-year-old patient who received DTPa (Infanrix) (batch number NG5GS, expiry date 26th November 2021) for prophylaxis. Co-suspect products included dtpa vaccine pre-filled syringe device (Infanrix Pre-Filled Syringe Device) injection syringe for prophylaxis. On 4th August 2021, the patient received Infanrix and Infanrix Pre-Filled Syringe Device. On 4th August 2021, unknown after receiving Infanrix and Infanrix Pre-Filled Syringe Device, the patient experienced inappropriate age at vaccine administration. 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 provided were as follows: The patient''s age at the time of vaccination was not confirmed to be 11 years but reporter commented so. The patient�s chart for an 11 year old showed that, the patient received a dose of Infanrix, which led to inappropriate age at vaccine administration. The reporter consented to follow-up.


VAERS ID: 1594281 (history)  
Form: Version 2.0  
Age: 17.0  
Sex: Female  
Location: Missouri  
Vaccinated:2021-08-16
Onset:2021-08-16
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (INFANRIX) / GLAXOSMITHKLINE BIOLOGICALS 5RM39 / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: USGLAXOSMITHKLINEUS202117

Write-up: received Infanrix / by mistake instead of Boostrix; received Infanrix / by mistake; This case was reported by a other health professional via call center representative and described the occurrence of wrong vaccine administered in a 17-year-old female patient who received DTPa (Infanrix) (batch number 5RM39, expiry date 25th November 2022) for prophylaxis. Co-suspect products included dtpa vaccine pre-filled syringe device (Infanrix Pre-Filled Syringe Device) injection syringe for prophylaxis. On 16th August 2021, the patient received Infanrix and Infanrix Pre-Filled Syringe Device. On 16th August 2021, unknown after receiving Infanrix and Infanrix Pre-Filled Syringe Device, the patient experienced wrong vaccine administered and inappropriate age at vaccine administration. On an unknown date, the outcome of the wrong vaccine administered and inappropriate age at vaccine administration were unknown. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional details were provided as follows: The patient received Infanrix by mistake instead of Boostrix, which led to wrong vaccine administered and inappropriate age at vaccine administration. The reporter consented to follow up.


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