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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 10 out of 3,116

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VAERS ID: 1804100 (history)  
Form: Version 2.0  
Age: 67.0  
Sex: Female  
Location: Ohio  
Vaccinated:2021-10-20
Onset:2021-10-20
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (DAPTACEL) / SANOFI PASTEUR U7055AA / 1 LA / IM

Administered by: Private       Purchased by: ?
Symptoms: Angiogram pulmonary, Chest discomfort, Dizziness, Hyperhidrosis, Hypersensitivity
SMQs:, Anaphylactic reaction (broad), Angioedema (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Vestibular disorders (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

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

Write-up: TDAP Given : 1513 Pt with allergic reaction, tightness in chest, dizziness, sweating, lungs CTA BP 160/100, HR 42''s, SPO2 93% 2 L Patient''s own EPI pen given at 1525 1530: HR 143, SPO2 2 L, lungs CTA 1533: HR 77, 91% SP02 Patient transferred to ED via nursing staff for monitoring


VAERS ID: 1804803 (history)  
Form: Version 2.0  
Age: 1.25  
Sex: Female  
Location: California  
Vaccinated:2020-07-01
Onset:2020-07-01
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (INFANRIX) / GLAXOSMITHKLINE BIOLOGICALS - / 3 LL / SYR

Administered by: Unknown       Purchased by: ?
Symptoms: Peripheral swelling, Skin warm
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? 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: Virtual visit due to covid.
CDC Split Type:

Write-up: Hot and swollen leg. Happened overnight. Child sleeps in a sleep sack. No exposure to other elements. Child had fevers with previous dtap.


VAERS ID: 1804865 (history)  
Form: Version 2.0  
Age: 55.0  
Sex: Female  
Location: New York  
Vaccinated:2021-08-03
Onset:2021-08-03
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (DAPTACEL) / SANOFI PASTEUR C5787AA / 1 LA / SYR

Administered by: Private       Purchased by: ?
Symptoms: Arthralgia, Injection site joint pain, Injection site pain
SMQs:, Extravasation events (injections, infusions and implants) (broad), Arthritis (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: Desoxyn, Wellbutrin, Lexapro,
Current Illness: Deep toe laceration
Preexisting Conditions: ADHD, depression, anxiety
Allergies: Penicillin, Peanuts, Soy
Diagnostic Lab Data:
CDC Split Type:

Write-up: Severe pain in upper arm at injection site, shoulder and joint. The pain began almost immediately but I didn?t realize how sever until around 5pm .


VAERS ID: 1800181 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Wisconsin  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-10-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (NO BRAND NAME) / UNKNOWN MANUFACTURER UNK / UNK - / -

Administered by: Unknown       Purchased by: ?
Symptoms: Laboratory test abnormal, Pertussis, Pyrexia, Vaccination failure
SMQs:, Lack of efficacy/effect (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (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:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: Body temperature; Result Unstructured Data: (Test Result:over 105,Unit:degree F,Normal Low:,Normal High:)
CDC Split Type: USGLAXOSMITHKLINEUS2021AM

Write-up: DPT shot, probably the pertussis/ suspected vaccination failure; probably the pertussis; had a temp of over 105; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a female 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 vaccination failure (serious criteria GSK medically significant), pertussis (serious criteria GSK medically significant) and fever. On an unknown date, the outcome of the vaccination failure, pertussis and fever were unknown. The reporter considered the vaccination failure, pertussis and fever to be related to DTaP vaccine. Additional details were provided as follows: This case was reported by patient''s parent. The age at vaccination was not reported. The patient had a temperature of over 105 degree F from the DPT shot. The reporter stated that they said it was probably the pertussis. This case was considered to be a suspected vaccination failure case, as the details regarding completion of primary vaccination schedule, laboratory confirmation for pertussis and time to onset were unknown.


VAERS ID: 1800753 (history)  
Form: Version 2.0  
Age: 4.0  
Sex: Male  
Location: Tennessee  
Vaccinated:2021-10-08
Onset:2021-10-09
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-10-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (DAPTACEL) / SANOFI PASTEUR - / UNK - / -
MMR: MEASLES + MUMPS + RUBELLA (MMR II) / MERCK & CO. INC. - / UNK - / IM

Administered by: Private       Purchased by: ?
Symptoms: Headache, Hypophagia, Influenza virus test negative, Injection site rash, Malaise, Pyrexia, Rash pruritic, Rhinorrhoea, SARS-CoV-2 test negative, Streptococcus test negative
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), 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: None.
Current Illness: None
Preexisting Conditions: None
Allergies: Amoxicillin
Diagnostic Lab Data:
CDC Split Type:

Write-up: The patient is otherwise healthy. Five days ago the patient received his MMR vaccine and DTaP. Four days ago the patient''s fever began. Three days ago the patient''s fever became higher to 100 to an a patient felt ill. He had a rash that began around the injection site. The rash was itchy. He also had a mild runny nose that was clear and requiring tissue. But he did not have a cough or a sore throat. Yesterday the patient was seen in his pediatricians office. He was negative for all of the following: COVID-19, influenza, and strep throat. His hematocrit, platelets and granulocytes were mildly high, Pediatrician was unsure of the diagnosis or the ideology. Last night the fever was 102 and patient complained of headache. Today, the patient is doing better and that he feels better. He is eating and drinking but not as much as he usually does. His runny nose has resolved. His fever tonight is lower, in the upper 99 range. However his rash persists as in the photographs and is itchy. Patient has had no diarrhea to suggest Coxsackie virus.


VAERS ID: 1801497 (history)  
Form: Version 2.0  
Age: 36.0  
Sex: Female  
Location: Georgia  
Vaccinated:2021-10-12
Onset:2021-10-13
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-10-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (DAPTACEL) / SANOFI PASTEUR - / UNK RA / SYR
FLUA4: INFLUENZA (SEASONAL) (FLUAD QUADRIVALENT) / SEQIRUS, INC. - / UNK LA / SYR

Administered by: Private       Purchased by: ?
Symptoms: Biopsy skin abnormal, Blister, Burning sensation, Culture, Exposure during pregnancy, Fatigue, Genital rash, Headache, Herpes simplex test, Oropharyngeal pain, Pain, Rash, Rash macular, Rash pruritic, Rash vesicular, Skin exfoliation, Streptococcus test negative, Tonsillar ulcer, Vaccination complication, Viral infection
SMQs:, Severe cutaneous adverse reactions (broad), Anaphylactic reaction (broad), Agranulocytosis (broad), Peripheral neuropathy (broad), Malignancy related therapeutic and diagnostic procedures (narrow), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Skin tumours of unspecified malignancy (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: Prescriptions: Zoloft 50 mg, Wellbutrin SR 200 mg, Flonase & Azelastine Allergy Nasal Spray, Labetalol 100 mg 2x daily, Aimovig Autoinjector 70 mL monthly, Cyclobenazaprine 5 mg (as needed for migraine), Fiorcet (bultalbital 40 mg, acetam
Current Illness: none
Preexisting Conditions: high blood pressure (well managed) scoliosis rhinitis and allergies to trees, grass, mold, dust mites, cats, dogs
Allergies: Septra, Phenergen, Sulfa drugs
Diagnostic Lab Data: Strep culture - negative 10/15 HSV 1 culture - pending 10/15 3 mm skin biopsy - 10/18; results received 10/20 and confirmed rash caused by viral eruption as suspected.
CDC Split Type:

Write-up: red blister like bumps developed on right index finger wed night post vaccine, then right middle and right pinky finger on thurs. Thurs night developed right tonsillar ulcer. Red spots on fingers were itchy and hands felt burning. OB asked me to follow up with PCP. PCP appointment friday, more spots appeared on hands. Continued to burn and itch. Negative strep test and HSV 1 culture ordered (result still pending). PCP stumped as I was not presenting typically for HSV infection, Hand Foot Mouth, or other but mentioned erthema multiforme as possibility. Had me follow up with dermatologist for monday appt. Saturday additional spots appeared on soles of feet, buttocks, and pubic area but not on mucous membranes. Sore throat and extreme fatigue all weekend. Treated with tylenol, benadryl, and topical cortizone cream for relief. Derm appt monday am. More spots developed by then, on shoulder, toes, hands. Derm suspected a viral eruption related to influenza vaccine. Took a 3mm core biopsy from spot on left wrist and prescribed clobetasol cream 0.05%. Today is wed... cream is making spots shrink, less red, no itching. Blisters now peeling. Still feeling fatigue, headache, and soreness. No new spots. At time of vaccine 10/12/21, was 29 weeks pregnant. As of 10/17, 30 weeks pregnant. Due Dec 26 2021. No prior history of adverse reactions to vaccines.


VAERS ID: 1802398 (history)  
Form: Version 2.0  
Age: 6.0  
Sex: Male  
Location: Washington  
Vaccinated:2021-07-29
Onset:2021-07-30
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-10-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (DAPTACEL) / SANOFI PASTEUR - / 5 RA / IM

Administered by: Private       Purchased by: ?
Symptoms: Ataxia, Depressed level of consciousness, Encephalitis, Muscular weakness, Pain, Rash, Swelling, Vertigo
SMQs:, Rhabdomyolysis/myopathy (broad), Anaphylactic reaction (broad), Angioedema (broad), Peripheral neuropathy (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (narrow), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Vestibular disorders (narrow), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (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? No
Hospitalized? No
Previous Vaccinations: DTap, pentacle; non stop crying for over 3 hours, fever, decreased level of consciousness, 9 months, date: 12/18/2015,
Other Medications: none
Current Illness: none
Preexisting Conditions: None
Allergies: none
Diagnostic Lab Data: physician consults 08/01/2021 08/02/2021 08/05/2021
CDC Split Type:

Write-up: Severe pain, swelling, and rash decreased level of consciousness severe muscle weakness vertigo ataxia encephalitis


VAERS ID: 1797090 (history)  
Form: Version 2.0  
Age: 1.0  
Sex: Female  
Location: Maryland  
Vaccinated:2020-08-14
Onset:2020-08-14
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (INFANRIX) / GLAXOSMITHKLINE BIOLOGICALS D2KX9 / UNK - / -
DTAP: DTAP (INFANRIX) / GLAXOSMITHKLINE BIOLOGICALS 5CK5K / 3 - / -

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: USGLAXOSMITHKLINEUS202121

Write-up: 4 months of age (administered on 29Jul2019 / 16 months of age (administered on 14Aug2020 / 19 months of age (administered on 13Nov2020; 4 months of age (administered on 29Jul2019 / 16 months of age (administered on 14Aug2020 / 19 months of age (administered on 13Nov2020; This case was reported by a nurse via call center representative and described the occurrence of drug dose administration interval too long in a 1-year-old female patient who received DTPa (Infanrix) (batch number D2KX9, 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, DTPa (Infanrix) (batch number 5CK5K, expiry date 17th January 2022) for prophylaxis and dtpa vaccine pre-filled syringe device (Infanrix Pre-Filled Syringe Device) injection syringe for prophylaxis. Previously administered products included Infanrix (received 1st dose on 29th May 2019 at 8 weeks of age, batch number and expiration date were unknown) and Infanrix (received 2nd dose on 29th July 2019 at 4 month of age, batch number and expiration date were unknown). On 13th November 2020, the patient received Infanrix and Infanrix Pre-Filled Syringe Device. On 14th August 2020, the patient received the 3rd dose of Infanrix and Infanrix Pre-Filled Syringe Device. On 14th August 2020, not applicable after receiving Infanrix and Infanrix Pre-Filled Syringe Device and unknown after receiving Infanrix and Infanrix Pre-Filled Syringe Device, the patient experienced drug dose administration interval too long. On 13th November 2020, the patient experienced drug dose administration interval too long. On an unknown date, the outcome of the drug dose administration interval too long and drug dose administration interval too long 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 nurse reported that patient received 3rd dose of Infanrix at 16 months of age and booster dose at 19 months of age longer than recommended schedule, which led to lengthening of vaccine schedule. The first two doses were administered at a different doctor''s office, the second two doses were administered at the reporter''s facility. The reporter consented to follow up.


VAERS ID: 1799473 (history)  
Form: Version 2.0  
Age: 1.92  
Sex: Female  
Location: Montana  
Vaccinated:2021-10-18
Onset:2021-10-18
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-19
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (INFANRIX) / GLAXOSMITHKLINE BIOLOGICALS XG942 / 1 RL / IM

Administered by: Private       Purchased by: ?
Symptoms: Abdominal pain, Diarrhoea
SMQs:, Acute pancreatitis (broad), Retroperitoneal fibrosis (broad), Pseudomembranous colitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Noninfectious diarrhoea (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? Yes
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: None at this time.
CDC Split Type:

Write-up: Abdominal pain, diarrhea. Symptoms started 30-60 minutes after receiving Dtap vaccine and lasted at least 24 hours.


VAERS ID: 1789829 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Minnesota  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-10-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (INFANRIX) / GLAXOSMITHKLINE BIOLOGICALS - / UNK - / -
DTAPHEPBIP: DTAP + HEPB + IPV (PEDIARIX) / GLAXOSMITHKLINE BIOLOGICALS - / UNK - / -
DTAPIPV: DTAP + IPV (KINRIX) / GLAXOSMITHKLINE BIOLOGICALS - / UNK - / -
FLU4: INFLUENZA (SEASONAL) (FLULAVAL QUADRIVALENT) / GLAXOSMITHKLINE BIOLOGICALS - / UNK - / -
MENB: MENINGOCOCCAL B (BEXSERO) / NOVARTIS VACCINES AND DIAGNOSTICS - / UNK - / -
MNQ: MENINGOCOCCAL CONJUGATE (MENVEO) / NOVARTIS VACCINES AND DIAGNOSTICS - / UNK - / -
RV1: ROTAVIRUS (ROTARIX) / GLAXOSMITHKLINE BIOLOGICALS - / UNK - / -
TDAP: TDAP (BOOSTRIX) / GLAXOSMITHKLINE BIOLOGICALS - / 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: USGLAXOSMITHKLINEUS202121

Write-up: went below freezing point; This case was reported by a nurse via call center representative and described the occurrence of incorrect storage of drug in an unspecified number of patients who received Rota (Rotarix lyophilized formulation) for prophylaxis. Co-suspect products included rotavirus vaccine oral applicator device (Rotarix Oral Applicator Device) oral applicator for prophylaxis, DTPa (Infanrix) for prophylaxis, dtpa vaccine pre-filled syringe device (Infanrix Pre-Filled Syringe Device) injection syringe for prophylaxis, DTPa (Reduced antigen) (Boostrix) 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-IPV (Kinrix) for prophylaxis, dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis, Flu Seasonal QIV Quebec (FluLaval Quadrivalent) for prophylaxis, flu seasonal qiv quebec pre-filled syringe device (Flulaval Tetra Pre-Filled Syringe Device) injection syringe for prophylaxis, Men ACWY-CRM NVS (Menveo) for prophylaxis, Men B NVS (Bexsero) for prophylaxis and meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis. On an unknown date, the patient received Rotarix lyophilized formulation, Rotarix Oral Applicator Device, Infanrix, Infanrix Pre-Filled Syringe Device, Boostrix, Pediarix, Pediarix Pre-Filled Syringe Device, Kinrix, Kinrix Pre-Filled Syringe Device, FluLaval Quadrivalent, Flulaval Tetra Pre-Filled Syringe Device, Menveo, Bexsero and Bexsero Pre-Filled Syringe Device. On an unknown date, unknown after receiving Rotarix lyophilized formulation, Rotarix Oral Applicator Device, Infanrix, Infanrix Pre-Filled Syringe Device, Boostrix, Pediarix, Pediarix Pre-Filled Syringe Device, Kinrix, Kinrix Pre-Filled Syringe Device, FluLaval Quadrivalent, Flulaval Tetra Pre-Filled Syringe Device, Menveo, Bexsero and Bexsero 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 applicable to this report. The nurse reported that, the several vaccines Bexsro, Menveo, Flulaval, Kinrix, Pediarix, Boostrix, Infanrix, Rotarix that went below freezing point was inadvertently administered to patient over a period of time, which led to incorrect storage of drug. The reporter consented to follow up. No details of patient or other vaccine details were available.


VAERS ID: 1789857 (history)  
Form: Version 2.0  
Age: 11.0  
Sex: Female  
Location: Colorado  
Vaccinated:2021-09-29
Onset:2021-09-29
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (INFANRIX) / GLAXOSMITHKLINE BIOLOGICALS 52M39 / 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: USGLAXOSMITHKLINEUS202121

Write-up: Infanrix to a 11 year old; 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 female patient who received DTPa (Infanrix) (batch number 52m39, 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 29th September 2021, the patient received Infanrix and Infanrix Pre-Filled Syringe Device. On 29th September 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 were provided as follows: The patient was administered Infanrix at 11 year of age, which led to inappropriate age at vaccine administration. No further events were reported. The reporter agreed to be contacted for follow-up.


VAERS ID: 1789858 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: California  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-10-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (INFANRIX) / GLAXOSMITHKLINE BIOLOGICALS - / UNK - / -
HEP: HEP B (ENGERIX-B) / GLAXOSMITHKLINE BIOLOGICALS - / UNK - / -
HEPA: HEP A (HAVRIX) / GLAXOSMITHKLINE BIOLOGICALS - / 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: USGLAXOSMITHKLINEUS202121

Write-up: were stored below temperature and not viable but administered; 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 patient who received HAV (Havrix) for prophylaxis. Co-suspect products included hepatitis A vaccine pre-filled syringe device (Havrix Pre-Filled Syringe Device) injection syringe for prophylaxis, DTPa (Infanrix) for prophylaxis, dtpa vaccine pre-filled syringe device (Infanrix Pre-Filled Syringe Device) injection syringe for prophylaxis, HBV (Engerix B) for prophylaxis and hepatitis B vaccine pre-filled syringe device (Engerix B Pre-Filled Syringe Device) injection syringe for prophylaxis. On an unknown date, the patient received Havrix, Havrix Pre-Filled Syringe Device, Infanrix, Infanrix Pre-Filled Syringe Device, Engerix B and Engerix B Pre-Filled Syringe Device. On an unknown date, unknown after receiving Havrix, Havrix Pre-Filled Syringe Device, Infanrix, Infanrix Pre-Filled Syringe Device, Engerix B and Engerix B 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 applicable to this report. The medical assistant reported that Havrix, Engerix, and Infanrix were stored below temperature and administered to unknown number of patients, which led to incorrect storage of drug. The vaccines were deemed not viable. The reporter consented to follow up.


VAERS ID: 1793482 (history)  
Form: Version 2.0  
Age: 11.0  
Sex: Male  
Location: Iowa  
Vaccinated:2021-09-20
Onset:2021-09-20
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (DAPTACEL) / SANOFI PASTEUR C5743AA / UNK LA / OT
TDAP: TDAP (ADACEL) / SANOFI PASTEUR - / UNK - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: No adverse event, Product administered to patient of inappropriate age, Wrong product administered
SMQs:, Medication errors (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: FLUZONE QUADRIVALENT; MMR VACCIN; VARIVAX [VARICELLA ZOSTER VACCINE LIVE (OKA/MERCK)]
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: USSA2021SA336743

Write-up: patient received DAPTACEL instead of ADACEL with no reported AE; 11 year patient received DAPTACEL instead of ADACEL with no reported AE; Initial information regarding an unsolicited valid non-serious case was received from the pharmacist via Medical Information (Reference number- 00805147) and transmitted to Sanofi on 08-Oct-2021. This case involves a 11-year-old male patient who received DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL] instead of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] [(wrong product administered) 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 INFLUENZA VACCINE INACT SPLIT 4V (FLUZONE QUADRIVALENT); MEASLES VACCINE, MUMPS VACCINE, RUBELLA VACCINE (MMR VACCIN) and VARICELLA ZOSTER VACCINE LIVE (OKA/MERCK) (VARIVAX [VARICELLA ZOSTER VACCINE LIVE (OKA/MERCK)]) for prophylactic vaccination. On 20-Sep-2021, the patient received a 0.5 mL dose of suspect DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE (Suspension for injection, lot number: C5743AA, expiry date unknown) via intramuscular route in the left deltoid instead of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE (lot number and expiry date not reported) for prophylactic vaccination. It was case of actual medication error due to wrong vaccine administered and inappropriate age at vaccine administration (latency: same day). It was reported "patient received DAPTACEL instead of ADACEL patient was 11 years old". At the time of this report, 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: 1787743 (history)  
Form: Version 2.0  
Age: 12.0  
Sex: Female  
Location: Pennsylvania  
Vaccinated:2021-09-22
Onset:2021-09-22
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (INFANRIX) / GLAXOSMITHKLINE BIOLOGICALS 49TM3 / 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: USGLAXOSMITHKLINEUS202120

Write-up: 12 years-old patient was administered INFANRIX; administered 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 female 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 22nd September 2021, the patient received Infanrix (intramuscular) .5 ml and Infanrix Pre-Filled Syringe Device. On 22nd 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 provided as follows: The reporter called from physician''s office. The 12 years old patient received dose of Infanrix in right deltoid instead of Boostrix, inappropriate age at vaccine administration and wrong vaccine administered. The reporter gave a consent to follow-up with herself.


VAERS ID: 1787962 (history)  
Form: Version 2.0  
Age: 2.0  
Sex: Female  
Location: D.C.  
Vaccinated:2021-10-08
Onset:2021-10-08
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (DAPTACEL) / SANOFI PASTEUR 4L9E4 / 1 RL / IM
HEPA: HEP A (VAQTA) / MERCK & CO. INC. T037329 / 2 LL / IM
HIBV: HIB (ACTHIB) / SANOFI PASTEUR DILUENT / 2 LL / IM
UNK: VACCINE NOT SPECIFIED (OTHER) / UNKNOWN MANUFACTURER EC6649 / 3 RL / IM

Administered by: Other       Purchased by: ?
Symptoms: No adverse event, Product preparation issue
SMQs:, Medication errors (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: No
Current Illness: No
Preexisting Conditions: No
Allergies: No
Diagnostic Lab Data: N/A
CDC Split Type:

Write-up: No advers effect noted, Medical Assistant administred only HIB vaccine diluent. No adverse effect to diluent noted


VAERS ID: 1788045 (history)  
Form: Version 2.0  
Age: 16.0  
Sex: Female  
Location: Arkansas  
Vaccinated:2021-10-07
Onset:2021-10-15
   Days after vaccination:8
Submitted: 0000-00-00
Entered: 2021-10-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (INFANRIX) / GLAXOSMITHKLINE BIOLOGICALS 49TM3 / 6 LA / IM
HEPA: HEP A (HAVRIX) / GLAXOSMITHKLINE BIOLOGICALS 7HJ74 / 1 LA / IM
MNQ: MENINGOCOCCAL CONJUGATE (MENQUADFI) / SANOFI PASTEUR U7087AA / 1 RA / IM

Administered by: Public       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: sertraline 50mg hydrocortisone 2.5% ointment
Current Illness: Depression
Preexisting Conditions:
Allergies: NKDA
Diagnostic Lab Data:
CDC Split Type:

Write-up: Patient came in for a 1 month office visit on 10.7.21, patient was due for Hep A, Mennigococcal, and Tdap vaccines. Patient was given Hep A, Mennigococcal, and Dtap vaccines. It was discovered today, 10.15.21 that she was given the wrong vaccine (Dtap instead of Tdap), I first contacted the health department and they informed me patient would need the correct vaccine charted, I spoke to our VFC rep, and she informed me that is not the case, I will need to make a medication error report per Health center''s policy and make a report to VAERS. That the patient was just given a stronger dose of diptheria than that is required for patients age. The tetanus part of either vaccine, Tdap or Dtap is the same strength/concentration, so patient is still covered. I informed pateint''s mother of the incident. RN


VAERS ID: 1788713 (history)  
Form: Version 2.0  
Age: 48.0  
Sex: Female  
Location: Virginia  
Vaccinated:2021-09-01
Onset:2021-10-01
   Days after vaccination:30
Submitted: 0000-00-00
Entered: 2021-10-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (INFANRIX) / GLAXOSMITHKLINE BIOLOGICALS MR5RK / 1 LA / IM

Administered by: Private       Purchased by: ?
Symptoms: Muscle twitching, Tic
SMQs:, Dyskinesia (broad), Dystonia (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: Wellbutrin Propranolol Xanax Nurtec Onpattro
Current Illness: Hattr Migraines Neuropathy Ed?s
Preexisting Conditions: Migraines Hattr Neuropathy
Allergies: Sulfa drug Penicillin Adhesive Nuvigil Lamictal
Diagnostic Lab Data: None
CDC Split Type:

Write-up: Starting 10/1/2021 I noticed my arm twitching very hard. The twitching moved to legs, abdomen, face. It comes on strong sometimes and others not as hard. I feel like my head has a Tik. Today is 10/15/21 and it continues. No treatment has been sought.


VAERS ID: 1784980 (history)  
Form: Version 2.0  
Age: 7.0  
Sex: Female  
Location: Michigan  
Vaccinated:2021-09-29
Onset:2021-09-29
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-14
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (INFANRIX) / GLAXOSMITHKLINE BIOLOGICALS 7EC55 / 5 RL / IM
IPV: POLIO VIRUS, INACT. (IPOL) / SANOFI PASTEUR T1E872M / 5 LL / IM
MMR: MEASLES + MUMPS + RUBELLA (MMR II) / MERCK & CO. INC. T025930 / 3 LL / SC
VARCEL: VARICELLA (VARIVAX) / MERCK & CO. INC. U015689 / 2 RL / SC

Administered by: Public       Purchased by: ?
Symptoms: Extra dose administered, 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? 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:

Write-up: The client was administered Dtap instead of Tdap, as she was 7 years old. She was given an extra dose of IPV, and an extra dose of MMR.


VAERS ID: 1782403 (history)  
Form: Version 2.0  
Age: 1.92  
Sex: Male  
Location: Virginia  
Vaccinated:2021-10-05
Onset:2021-10-10
   Days after vaccination:5
Submitted: 0000-00-00
Entered: 2021-10-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (DAPTACEL) / SANOFI PASTEUR - / UNK LG / -
HEPA: HEP A (HAVRIX) / GLAXOSMITHKLINE BIOLOGICALS - / UNK - / -
MMR: MEASLES + MUMPS + RUBELLA (MMR II) / MERCK & CO. INC. - / UNK LG / -
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH - / UNK LG / -

Administered by: Public       Purchased by: ?
Symptoms: Pyrexia, Rash, Rash erythematous
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (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? 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: Fever and red, bumpy rash covering legs and abdomen


VAERS ID: 1783181 (history)  
Form: Version 2.0  
Age: 1.67  
Sex: Female  
Location: California  
Vaccinated:2021-10-11
Onset:2021-10-12
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-10-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (INFANRIX) / GLAXOSMITHKLINE BIOLOGICALS - / UNK - / -
FLU4: INFLUENZA (SEASONAL) (FLUARIX QUADRIVALENT) / GLAXOSMITHKLINE BIOLOGICALS - / UNK - / -
HEPA: HEP A (HAVRIX) / GLAXOSMITHKLINE BIOLOGICALS - / UNK - / -
HIBV: HIB (PEDVAXHIB) / MERCK & CO. INC. - / UNK - / -

Administered by: Private       Purchased by: ?
Symptoms: Gaze palsy, Muscle rigidity, Postictal state, Seizure, Status epilepticus
SMQs:, Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Convulsions (narrow), Parkinson-like events (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Ocular motility disorders (narrow), Generalised convulsive seizures following immunisation (narrow), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 1 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: none
Current Illness: none
Preexisting Conditions: none
Allergies: none
Diagnostic Lab Data:
CDC Split Type:

Write-up: status epilepticus (eye deviation, rigid body) for 30m at home before being aborted with intranasal versed x1, IM ativan x1. post-ictal for following 4 hours. then returned to baseline without further seizure activity


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