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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: 1978322 (history)  
Form: Version 2.0  
Age: 0.08  
Sex: Male  
Location: Foreign  
Vaccinated:2021-10-01
Onset:2021-10-01
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-24
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (PFIZER-BIONTECH)) / PFIZER/BIONTECH - / 1 - / OT
DTAP: DTAP (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / -
PPV: PNEUMO (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / -
RVX: ROTAVIRUS (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood test, Crying, Disturbance in attention, Exposure via breast milk, Irregular breathing, Seizure, Urine analysis
SMQs:, Anaphylactic reaction (broad), Systemic lupus erythematosus (broad), Convulsions (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Cardiomyopathy (broad), Depression (excl suicide and self injury) (broad), Neonatal exposures via breast milk (narrow), Generalised convulsive seizures following immunisation (narrow), Respiratory failure (broad), Hypoglycaemia (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:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Reflux esophagitis
Allergies:
Diagnostic Lab Data: Test Date: 2021; Test Name: blood tests; Test Result: Negative ; Test Date: 2021; Test Name: urine tests; Test Result: Negative
CDC Split Type: NZPFIZER INC202101806688

Write-up: Exposure via breast milk; was not focused; breathing again but irregularly; unusually pitched sporadic cry; Seizure/rigid and jerking/ his lips to be blue, eyes rolled back and frothing at the mouth; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from Regulatory Authority. The reporter is the parent. An infant male patient was exposed to bnt162b2 (COMIRNATY), transmammary, administration date Oct2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation; received pneumococcal 13-val conj vac (dipht crm197 protein) (PNEUMOCOCCAL 13-VAL CONJ VAC (DIPHT CRM197 PROTEIN)), administration date Oct2021 (Batch/Lot number: unknown) at the age of 6 weeks as dose number unknown, single for immunisation; diphtheria vaccine toxoid, pertussis vaccine acellular, tetanus vaccine toxoid (DTAP), administration date Oct2021 (Batch/Lot number: unknown) for immunisation; rotavirus vaccine (ROTAVIRUS VACCINE), administration date Oct2021 (Batch/Lot number: unknown) for immunization. Relevant medical history included: "reflux" (unspecified if ongoing). The patient''s concomitant medications were not reported. The following information was reported: SEIZURE (medically significant) with onset 2021, outcome "recovered" (2021), described as "Seizure/rigid and jerking/ his lips to be blue, eyes rolled back and frothing at the mouth"; EXPOSURE VIA BREAST MILK (medically significant) with onset Oct2021, outcome "unknown", described as "Exposure via breast milk"; DISTURBANCE IN ATTENTION (non-serious) with onset 2021, outcome "recovered" (2021), described as "was not focused"; IRREGULAR BREATHING (non-serious) with onset 2021, outcome "recovered" (2021), described as "breathing again but irregularly"; CRYING (non-serious) with onset 2021, outcome "recovered" (2021), described as "unusually pitched sporadic cry". The events "seizure/rigid and jerking/ his lips to be blue, eyes rolled back and frothing at the mouth", "exposure via breast milk", "was not focused", "breathing again but irregularly" and "unusually pitched sporadic cry" were evaluated at the physician office visit and emergency room visit. The patient underwent the following laboratory tests and procedures: blood test: (2021) negative; urine analysis: (2021) negative. Clinical course: 3 days after her 1st vaccination, the patient had a seizure. He was breastfed. Approx 6: 20 Am that morning the mother awoke to him make a strange noise. She picked him out of his bassinet noting he was completely rigid and jerking. She turned on the light and noted his lips to be blue, eyes rolled back and frothing at the mouth. He had a history of reflux so she wondered if he was choking so administered some back blows and tried to clear the froth. After 2 minutes the jerking stopped, where he then started breathing again but irregularly, was not focused and had an unusually pitched sporadic cry. This odd behaviour lasted approx 40 minutes until he returned to his usual again. She had already called an ambulance and was taken to ED and spent 2 days for observation. Of note, on the same day the mother got her covid vaccine son had his 6 week immunisations including dtap, pneumococcal and rota virus. In hospital he had blood tests and urine tests that were negative. Nor at any time was he febrile, thus a febrile convulsion was ruled out. So the doctors at the hospital said his likely seizure was a result of a reaction to her vaccine, his vaccinations, a random one off event or perhaps the preclude to an epileptic diagnosis - impossible to tell with a one off event. Their instructions were to observe him and hope it doesn''t happen again. We didn''t report this as there were so many possibilities of what had caused the even he has been his normal happy self since with no causes of concern. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender''s Comments: Linked Report(s) : NZ-PFIZER INC-202101760454 same reporter/patient/product, different events/doses.


VAERS ID: 1973943 (history)  
Form: Version 2.0  
Age: 10.0  
Sex: Male  
Location: North Carolina  
Vaccinated:2021-12-10
Onset:2021-12-10
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (INFANRIX) / GLAXOSMITHKLINE BIOLOGICALS 23T73 / 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: USGLAXOSMITHKLINEUS202125

Write-up: 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 10-year-old male patient who received DTPa (Infanrix) (batch number 23T73, expiry date 30th April 2023) for prophylaxis. Co-suspect products included dtpa vaccine pre-filled syringe device (Infanrix Pre-Filled Syringe Device) injection syringe for prophylaxis. On 10th December 2021, the patient received Infanrix and Infanrix Pre-Filled Syringe Device. On 10th December 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 nurse manager reported that, the patient received infanrix vaccine instead of Boostrix, which led to inappropriate age at vaccine administration and wrong vaccine administered. The reporter consented to follow up.; Sender''s Comments: US-GLAXOSMITHKLINE-US2021071603:same reporter


VAERS ID: 1973947 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: New York  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-12-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (INFANRIX) / GLAXOSMITHKLINE BIOLOGICALS UNK / UNK - / -

Administered by: Unknown       Purchased by: ?
Symptoms: Incomplete course of vaccination
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: USGLAXOSMITHKLINEUS202125

Write-up: This case was reported by a nurse via call center representative and described the occurrence of incomplete course of vaccination in a 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 Infanrix (received unknown dose on an unknow date). On an unknown date, the patient received Infanrix and Infanrix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Infanrix and Infanrix Pre-Filled Syringe Device, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination 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 for this report. The patient had missing vaccination schedule regarding Infanrix.The reporter did not know how many doses were missing. Till the time of reporting, the patient did not receive remaining dose of Infanrix, which led to incomplete course of vaccination. The reporter wanted to proceed with Boostrix and asked which would it be the best option to proceed with vaccination schedule. The reporter did not consent to follow up.


VAERS ID: 1973950 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Wisconsin  
Vaccinated:2021-12-17
Onset:2021-12-17
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-23
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (INFANRIX) / GLAXOSMITHKLINE BIOLOGICALS YK2FF / 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: USGLAXOSMITHKLINEUS202125

Write-up: This case was reported by a nurse via call center representative and described the occurrence of inappropriate age at vaccine administration in a 24-year-old female patient who received DTPa (Infanrix) (batch number yk2ff, 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 17th December 2021, the patient received Infanrix and Infanrix Pre-Filled Syringe Device. On 17th December 2021, unknown after receiving Infanrix and Infanrix Pre-Filled Syringe Device, the patient experienced inappropriate age at vaccine administration and wrong vaccine administered. On an unknown date, the outcome of the inappropriate age at vaccine administration and wrong vaccine administered were unknown. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional details were provided as follows: The patient inadvertently administered Infanrix instead of Boostrix was intended to be given as a booster dose, which led to inappropriate age at vaccine administration and wrong vaccine administered. The reporter did not consent to follow up.


VAERS ID: 1970356 (history)  
Form: Version 2.0  
Age: 1.0  
Sex: Unknown  
Location: California  
Vaccinated:2009-04-23
Onset:2009-04-23
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (NO BRAND NAME) / UNKNOWN MANUFACTURER UNK / 2 - / -

Administered by: Unknown       Purchased by: ?
Symptoms: Inappropriate schedule of product administration, Peripheral swelling, Product administered to patient of inappropriate age
SMQs:, Cardiac failure (broad), Angioedema (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), 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: USGLAXOSMITHKLINEUS202125

Write-up: had a large local reaction, Upper leg swollen from the hip to the knee; dtap on 1/22/09 and 4/23/09; dtap on 1/22/09 and 4/23/09; This case was reported by a physician via sales rep and described the occurrence of swelling of legs in a 18-month-old patient who received DTPa (DTaP vaccine) for prophylaxis. Previously administered products included DTaP (received 1st dose on 22nd January 2009). On 23rd April 2009, the patient received the 2nd dose of DTaP vaccine. On 23rd April 2009, unknown after receiving DTaP vaccine, the patient experienced drug dose administration interval too short and inappropriate age at vaccine administration. On an unknown date, the patient experienced swelling of legs. On an unknown date, the outcome of the swelling of legs, drug dose administration interval too short and inappropriate age at vaccine administration were unknown. It was unknown if the reporter considered the swelling of legs to be related to DTaP vaccine. Additional details were provided as follows: The reporter stated that the patient received DTaP vaccine on 22nd Jan 2009 and 23rd April 2009, which led to drug dose administration interval too short and inappropriate age at vaccine administration. The patient reportedly had a large local reaction after the 2nd dose in the thigh, the patients upper leg was swollen from the hip to the knee. No additional information was available regarding product, patient, event, etc. The reporter consented to follow up.


VAERS ID: 1970357 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-12-22
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 - / -
HEP: HEP B (ENGERIX-B) / GLAXOSMITHKLINE BIOLOGICALS - / UNK - / -
HEPA: HEP A (HAVRIX) / GLAXOSMITHKLINE BIOLOGICALS - / UNK - / -
MENB: MENINGOCOCCAL B (BEXSERO) / NOVARTIS VACCINES AND DIAGNOSTICS - / 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: USGLAXOSMITHKLINEUS202125

Write-up: above temperature excursion, the highest being 52F; This case was reported by a nurse via call center representative and described the occurrence of incorrect storage of drug in a patient who received Men B NVS (Bexsero) for prophylaxis. Co-suspect products included meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis, HBV (Engerix B) for prophylaxis, DTPa (Infanrix) for prophylaxis, dtpa vaccine pre-filled syringe device (Infanrix 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, HAV (Havrix) for prophylaxis, DTPa-IPV (Kinrix) for prophylaxis, dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis and DTPa (Reduced antigen) (Boostrix) for prophylaxis. On an unknown date, the patient received Bexsero, Bexsero Pre-Filled Syringe Device, Engerix B, Infanrix, Infanrix Pre-Filled Syringe Device, Pediarix, Pediarix Pre-Filled Syringe Device, Havrix, Kinrix, Kinrix Pre-Filled Syringe Device and Boostrix. On an unknown date, unknown after receiving Bexsero, Bexsero Pre-Filled Syringe Device, Engerix B, Infanrix, Infanrix Pre-Filled Syringe Device, Pediarix, Pediarix Pre-Filled Syringe Device, Havrix, Kinrix, Kinrix Pre-Filled Syringe Device and Boostrix, 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 patients had received doses of Bexsero, Engerix B, Infanrix, Pediarix, Havrix, Kinrix and Boostrix after temperature excursion, which led to incorrect storage of drug. The nurse reported that above temperature excursion, with the highest being 52F for a total of an undetermined length of time starting from 22th November 2021. The nurse did not have exact excursion information and was unsure if vaccinations were far enough out of range to qualify. The nurse was referred to CDC regarding revaccination, if required after she completed more research on total time of excursion. The health care professional wished to remain anonymous. The reporter did not consent to follow-up.


VAERS ID: 1972664 (history)  
Form: Version 2.0  
Age: 1.25  
Sex: Male  
Location: Massachusetts  
Vaccinated:2021-05-21
Onset:2021-05-21
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-22
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (DAPTACEL) / SANOFI PASTEUR C5765BA / UNK - / SYR
HIBV: HIB (ACTHIB) / SANOFI PASTEUR - / UNK - / SYR
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH DN4219 / UNK - / SYR

Administered by: Private       Purchased by: ?
Symptoms: Developmental regression
SMQs:

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 known
Current Illness: None known
Preexisting Conditions: Speech delay - first noted at 12 months
Allergies: None known
Diagnostic Lab Data:
CDC Split Type:

Write-up: Vaccines were administer at the 15 month visit (5/19/21). In the past month, mom has reached out to clinic to share observation that Liam had regression in skills (language, eye contact) that she associates in timing with his 15 month vaccine. (The day of, immediately following). Patient had previous speech delay diagnosis at 12 months. Mom notes increasing concerns for his language and also for sensory sensitivities. He is followed by EI and being referred to developmental neuro pediatrics and further evaluations.


VAERS ID: 1966535 (history)  
Form: Version 2.0  
Age: 62.0  
Sex: Female  
Location: Iowa  
Vaccinated:2021-12-15
Onset:2021-12-15
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (INFANRIX) / GLAXOSMITHKLINE BIOLOGICALS UNK / 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: USGLAXOSMITHKLINEUS2021AM

Write-up: was administered Infanrix; was administered Infanrix instead of the Boostrix; This case was reported by a nurse via call center representative and described the occurrence of inappropriate age at vaccine administration in a 62-year-old female patient who received DTPa (Infanrix) for prophylaxis. Co-suspect products included dtpa vaccine pre-filled syringe device (Infanrix Pre-Filled Syringe Device) injection syringe for prophylaxis. On 15th December 2021, the patient received Infanrix and Infanrix Pre-Filled Syringe Device. On 15th December 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 Nurse reported a patient was administered the Infanrix vaccine instead of the Boostrix vaccine inadvertently, which led to wrong vaccine administered and inappropriate age at vaccine administration. The reporter consented to follow-up.; Sender''s Comments: US-GLAXOSMITHKLINE-US2021258434:same reporter


VAERS ID: 1963583 (history)  
Form: Version 2.0  
Age: 1.25  
Sex: Female  
Location: Ohio  
Vaccinated:2021-12-13
Onset:2021-12-13
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (DAPTACEL) / SANOFI PASTEUR C5706AA / 4 RL / IM
HEPA: HEP A (HAVRIX) / GLAXOSMITHKLINE BIOLOGICALS CE74N / 1 RL / IM
HIBV: HIB (ACTHIB) / SANOFI PASTEUR UJ635AA / 4 LL / IM
MMR: MEASLES + MUMPS + RUBELLA (MMR II) / MERCK & CO. INC. S037502 / 1 RA / IM
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH DL2860 / 4 LL / IM
VARCEL: VARICELLA (VARIVAX) / MERCK & CO. INC. T022315 / 1 LA / IM

Administered by: Private       Purchased by: ?
Symptoms: Expired product administered, No adverse event
SMQs:, Medication errors (narrow)

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

Write-up: No symptoms or reaction. Vaccine was expired


VAERS ID: 1964221 (history)  
Form: Version 2.0  
Age: 14.0  
Sex: Male  
Location: California  
Vaccinated:2021-08-02
Onset:2021-08-02
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (DAPTACEL) / SANOFI PASTEUR - / UNK - / -
HPV9: HPV (GARDASIL 9) / MERCK & CO. INC. - / 1 RA / SYR

Administered by: Private       Purchased by: ?
Symptoms: Loss of consciousness
SMQs:, Torsade de pointes/QT prolongation (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Hypoglycaemia (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:
CDC Split Type:

Write-up: Within one minute, my son passed out. was out for 30 seconds. I had to catch him from falling off of the exam table.


VAERS ID: 1964312 (history)  
Form: Version 1.0  
Age: 0.08  
Sex: Female  
Location: Missouri  
Vaccinated:2021-10-20
Onset:2021-10-20
   Days after vaccination:0
Submitted: 2021-12-20
   Days after onset:61
Entered: 2021-12-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (NO BRAND NAME) / UNKNOWN MANUFACTURER C5765BA / 1 LL / IM
HIBV: HIB (NO BRAND NAME) / UNKNOWN MANUFACTURER UJ585AA / 1 RL / IM
IPV: POLIO VIRUS, INACT. (NO BRAND NAME) / UNKNOWN MANUFACTURER UIA451M / 1 LL / SC
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH EE7117 / 1 RL / IM
RVX: ROTAVIRUS (NO BRAND NAME) / UNKNOWN MANUFACTURER T030493 / 1 MO / PO

Administered by: Private       Purchased by: Private
Symptoms: Crying, High-pitched crying
SMQs:, Depression (excl suicide and self injury) (broad), Neonatal disorders (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: None at the time of vaccine
Current Illness: No
Preexisting Conditions: GERD and milk allergy
Allergies:
Diagnostic Lab Data: None
CDC Split Type:

Write-up: 4 hours after vaccine of 2mo visit patient developed high pitch cry $g 3 hrs. Both parents detected unusual cry inconsolable seen in ER due to that. By the time seen in ER patient was acting normal.


VAERS ID: 1962748 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:2018-06-05
Onset:2018-06-01
Submitted: 0000-00-00
Entered: 2021-12-20
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (INFANRIX) / GLAXOSMITHKLINE BIOLOGICALS AC14B231AA / UNK LA / -

Administered by: Unknown       Purchased by: ?
Symptoms: Abdominal pain upper, Chromaturia, Hepatitis, Pyrexia
SMQs:, Rhabdomyolysis/myopathy (broad), Hepatitis, non-infectious (narrow), Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (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? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: PLGLAXOSMITHKLINEPL202125

Write-up: Hepatitis; Stomach pain; Fever; Urine colour abnormal; This case was reported by a physician via regulatory authority and described the occurrence of hepatitis in a 5-year-old patient who received DTPa (Infanrix DTPa) (batch number AC14B231AA, expiry date 30th June 2018) for prophylaxis. Co-suspect products included dtpa vaccine pre-filled syringe device injection syringe for prophylaxis. On 5th June 2018 18:30, the patient received Infanrix DTPa (unknown) .5 ml. On 5th June 2018, the patient started dtpa vaccine pre-filled syringe device. On 6th June 2018, 9 hrs 30 min after receiving Infanrix DTPa and dtpa vaccine pre-filled syringe device, the patient experienced hepatitis (serious criteria hospitalization and GSK medically significant), stomach pain (serious criteria hospitalization), fever (serious criteria hospitalization) and urine color abnormal (serious criteria hospitalization). On an unknown date, the outcome of the hepatitis, stomach pain, fever and urine color abnormal were unknown. It was unknown if the reporter considered the hepatitis, stomach pain and urine color abnormal to be related to Infanrix DTPa and dtpa vaccine pre-filled syringe device. The reporter considered the fever to be possibly related to Infanrix DTPa. It was unknown if the reporter considered the fever to be related to 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 provided as follow: The age at vaccination was unknown. The patient received the vaccine on left arm. In June 2018, patient was hospitalized. Time to onset for reported events were captured as per vaccination date and time and event onset date and time as 9 hours 30 minutes however, as per only dates it was 1 day. Causal assessment was reported as possible in association to the fever for Infanrix DTPa. Initial information received from physician via regulatory authority on 3rd August 2021: Hepatitis, abdominal pain, Fever, Dark urine, Sender''s comments: There is a temporal relationship between the side effect and the administration of the vaccine. Pyrexia is an expected adverse reaction with INFANRIX-DTPa. Association of hepatitis with vaccination unlikely, there was a temporary coincidence. Dark urine and abdominal pain may be related to hepatitis. The reporting person qualified NOP as mild, URPL, due to hospitalization, as severe.


VAERS ID: 1958098 (history)  
Form: Version 2.0  
Age: 1.0  
Sex: Female  
Location: Colorado  
Vaccinated:2021-12-09
Onset:2021-12-09
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-12-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (DAPTACEL) / SANOFI PASTEUR - / UNK - / OT
HIBV: HIB (ACTHIB) / CONNAUGHT LABORATORIES - / UNK - / -
TD: TD ADSORBED (TENIVAC) / SANOFI PASTEUR C5779AA / UNK LL / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Medication error, 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: USSA2021SA415170

Write-up: accidentally gave a TENIVAC vaccination to a 16 month old patient/ no AE; rash on the right cheek; accidentally gave a TENIVAC vaccination to a 16 month old patient instead of their fourth dose of DAPTACEL; Initial information received on 09-Dec-2021 regarding an unsolicited valid non-serious case received from a other health professional via Agency (under the reference: 00891947). This case involves a 1-year-old female patient who had rash on the right cheek (rash), accidentally gave a DIPHTHERIA-2/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE ADULT [TENIVAC] instead of their fourth dose of DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL] (wrong product administered, Product administered to patient of inappropriate age). The patient''s past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included HIB VACCINE CONJ (TET TOX) (ACTHIB). On 09-Dec-2021, the patient received a O.5 mL total dose of suspect DIPHTHERIA-2/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE ADULT [frequency once, strength: standard, lot C5779AA, expiry date: 02-Oct-2022] via intramuscular route in the left vastus lateralis for prophylactic vaccination. On 09-Dec-2021, the patient developed a non-serious rash on the right cheek (rash) same day following the administration of DIPHTHERIA-2/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE ADULT and DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE. It was reported "Caller states that a new employee accidentally gave a TENIVAC vaccination to a 16-month-old patient in the office on 09-Dec-2021 instead of their fourth dose of DAPTACEL. Caller states that the patient has returned to the clinic due to a rash on the right cheek and was given Benadryl 1mk/kg to treat this. Caller states that she has reported this incident to safety online." It was an actual medication error due to wrong vaccine administered and inappropriate age at vaccine administration (latency same day). No laboratory data reported. The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Rash. At time of reporting, the outcome was unknown for the events. 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: 1958963 (history)  
Form: Version 2.0  
Age: 12.0  
Sex: Male  
Location: Minnesota  
Vaccinated:2021-11-26
Onset:2021-12-17
   Days after vaccination:21
Submitted: 0000-00-00
Entered: 2021-12-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (INFANRIX) / GLAXOSMITHKLINE BIOLOGICALS 7EC55 / 1 LA / IM

Administered by: Private       Purchased by: ?
Symptoms: No adverse event, 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: na
Current Illness: na
Preexisting Conditions: na
Allergies: na
Diagnostic Lab Data: na
CDC Split Type:

Write-up: Patient had no issues with vaccine.


VAERS ID: 1959474 (history)  
Form: Version 2.0  
Age: 0.17  
Sex: Female  
Location: Alabama  
Vaccinated:2021-11-24
Onset:2021-11-27
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2021-12-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (INFANRIX) / GLAXOSMITHKLINE BIOLOGICALS 23773 / 1 LL / IM
HIBV: HIB (HIBERIX) / GLAXOSMITHKLINE BIOLOGICALS 5P244 / 1 LL / IM
IPV: POLIO VIRUS, INACT. (IPOL) / SANOFI PASTEUR U1A451M / 1 RL / IM
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH EE7120 / 1 RL / IM
RV5: ROTAVIRUS (ROTATEQ) / MERCK & CO. INC. 1742430 / 1 MO / PO

Administered by: Private       Purchased by: ?
Symptoms: Body temperature increased, Catheter culture, Culture urine, Dehydration, Diarrhoea, Diarrhoea haemorrhagic, Full blood count, Gastritis, Impaired gastric emptying, Infant irritability, Metabolic function test, Respiratory viral panel, Stool analysis, Ultrasound abdomen, Weight decreased
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Pseudomembranous colitis (broad), Gastrointestinal obstruction (narrow), Gastrointestinal haemorrhage (narrow), Gastrointestinal nonspecific inflammation (narrow), Gastrointestinal nonspecific dysfunction (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Ischaemic colitis (broad), Neonatal disorders (narrow), Noninfectious diarrhoea (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Dehydration (narrow)

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? Yes, 6 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: omeprazole
Current Illness: GERD
Preexisting Conditions: GERD
Allergies: NKA
Diagnostic Lab Data: abdominal ultrasound x 3, cbc, cmp, speech evaluation, cath urine with culture, iv fluids, stool specimens, respiratory panel, 11/29/21-12/17/21
CDC Split Type:

Write-up: blood & mucus diarrhea, temp 101.8 R, fussiness, dehydration, weight loss, gastritis, gastroparesis


VAERS ID: 1957095 (history)  
Form: Version 2.0  
Age: 44.0  
Sex: Male  
Location: Foreign  
Vaccinated:2021-12-04
Onset:2021-12-05
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-12-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
COVID19: COVID19 (COVID19 (UNKNOWN)) / UNKNOWN MANUFACTURER FM3802 / 3 - / OT
DTAP: DTAP (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Hypoaesthesia, SARS-CoV-2 test
SMQs:, Peripheral neuropathy (broad), Guillain-Barre syndrome (broad), COVID-19 (broad), Sexual dysfunction (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: Medical History/Concurrent Conditions: Clinical trial participant
Allergies:
Diagnostic Lab Data: Test Date: 20211210; Test Name: COVID-19 virus test; Test Result: Negative ; Result Unstructured Data: No - Negative COVID-19 test
CDC Split Type: GBSA2021SA416922

Write-up: Numbness in left leg; Initial information received on 12-Dec-2021 regarding an unsolicited valid serious case received from consumer/ non-health care professionals via Regulatory Authority (under reference: GB-MHRA-WEBCOVID-202112101707492410-WXGIM). This case involves a 44-year-old male patient who experienced numbness in left leg down (hypoaesthesia), while received DIPHTHERIA, TETANUS, AC PERTUSSIS AND IPV VACCINE (DTPA IPV VACCINE) and COVID-19 VACCINE MRNA (COVID-19 MRNA VACCINE BIONTECH). Concomitant medication, past medical treatment, vaccination and family history were not provided. The patient''s past medical history included clinical trial participant. On an unknown date, the patient received a dose of suspect DIPHTHERIA, TETANUS, AC PERTUSSIS AND IPV VACCINE (DTPA 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 04-Dec-2021, the patient received a third booster dose of suspect COVID-19 VACCINE MRNA (COVID-19 MRNA VACCINE BIONTECH) not produced by Sanofi Pasteur (lot FM3802, expiry date not reported) via an unknown route at an unknown administration site for prophylactic vaccination. On 05-Dec-2021, the patient developed a serious numbness in left leg (hypoaesthesia) (unknown latency) following the administration of DIPHTHERIA, TETANUS, AC PERTUSSIS AND IPV VACCINE (DTPA IPV VACCINE) and one day following the administration of COVID-19 VACCINE MRNA (COVID-19 MRNA VACCINE BIONTECH). This event was assessed as medically significant. It was reported that the patient had numbness in left leg (same side as vaccine booster given) radiating from hip down, pain in hip and tingling down leg. Patient has not tested positive for COVID-19 since having the vaccine. The report was not related to possible inflammation of the heart. On 10-Dec-2021, COVID-19 virus test was conducted which was negative. It was not reported if the patient received a corrective treatment for the event. At time of reporting, the patient had not recovered from the reported event. There will be no information available on batch number for this case.; Sender''s Comments: This case involves 44-year-old male patient who experienced hypoaesthesia, after vaccination with DIPHTHERIA, TETANUS, AC PERTUSSIS AND IPV VACCINE (unknown manufacturer) and COVID-19 VACCINE MRNA (non-company manufacturer). The time to onset was unknown. The patient''s past medical history included clinical trial participant. Further information regarding concurrent condition during vaccination, previous vaccination and tolerance, allergic history, laboratory investigations excluding alternative etiologies for the reported event are needed to fully assess this case. Based upon the reported information, the role of the suspect vaccine cannot be assessed.


VAERS ID: 1959591 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2020-12-16
Onset:2020-12-22
   Days after vaccination:6
Submitted: 0000-00-00
Entered: 2021-12-17
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (INFANRIX) / GLAXOSMITHKLINE BIOLOGICALS - / UNK - / -
HIBV: HIB (ACTHIB) / SANOFI PASTEUR - / UNK - / -
MMRV: MEASLES + MUMPS + RUBELLA + VARICELLA (PROQUAD) / MERCK & CO. INC. - / UNK - / -

Administered by: Unknown       Purchased by: ?
Symptoms: Adenovirus test positive, Conjunctivitis, Electrocardiogram normal, Enterovirus test positive, Human rhinovirus test positive, Hyperaemia, Immunoglobulin therapy, Kawasaki's disease, Lymphadenopathy, Oedema peripheral, Pyrexia, Rash, SARS-CoV-2 test negative
SMQs:, Cardiac failure (broad), Severe cutaneous adverse reactions (broad), Anaphylactic reaction (broad), Angioedema (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Vasculitis (narrow), Conjunctival disorders (narrow), Ocular infections (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (narrow), Infective pneumonia (broad), Opportunistic infections (broad), Immune-mediated/autoimmune disorders (narrow), COVID-19 (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:
Allergies:
Diagnostic Lab Data:
CDC Split Type: AU0095075132112AUS003984

Write-up: kawa; Pyrexia; This spontaneous report was received from a health care professional, via regulatory authority, referring to a 1-year-old male patient. Information regarding the patient''s medical history, concurrent conditions or concomitant medications was not provided. On 16-DEC-2020, the patient was vaccinated with measles, mumps, rubella and varicella (Oka-Merck) virus vaccine live (PROQUAD) injection, HIB vaccine conj (TET TOX) (ACT-HIB) and diphtheria vaccine toxoid, pertussis vaccine acellular 3-component, tetanus vaccine toxoid (INFANRIX) (doses, routes of administration, anatomical sites of injection, indications, lot numbers, and expiration dates were not reported). Pyrexia of unknown origin (PUO) from 22-DEC-2020 that was then consequently treated as Kawasaki disease (KD) on 27-DEC-2020 08-JAN-2021. As per discharge (D/C) summary- 8/7 febrile 40c 2/07 bilateral conjunctivitis 2/7 widespread blanching sandpaper-like rash to torso and limbs. No bruising or petechiae 1/7 peripheral oedema hyperemic palms and soles. Cervical LN present x1 large on L) hand side AH Initial fevers began 22-DEC-2020 with a subsequent KD admission (inconsistent information events were reported as non serious) treated with intravenous immunoglobulin (IVIG) on 29-DEC-2020 08-JAN-2021. AS per D/C summary- clinical feature consistent with Kawasaki disease. Resp swab: Rhinovirus/enterovirus & adenovirus detected Covid swab. negative ECG-NAD. The patient was discharged from the hospital on 31-DEC-2020. The outcome of Kawasaki''s disease and pyrexia was unknown. The reporter considered Kawasaki''s disease and pyrexia to be related to measles, mumps, rubella and varicella (Oka-Merck) virus vaccine live (PROQUAD). The causality assessment between the aforementioned events, HIB vaccine conj (TET TOX) (ACT-HIB) and diphtheria vaccine toxoid, pertussis vaccine acellular 3-component, tetanus vaccine toxoid (INFANRIX) was not provided.


VAERS ID: 1954079 (history)  
Form: Version 2.0  
Age: 11.0  
Sex: Male  
Location: Unknown  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-12-16
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
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: USGLAXOSMITHKLINEUS202125

Write-up: an eleven year old 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 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 an unknown date, the patient received Infanrix and Infanrix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Infanrix and Infanrix Pre-Filled Syringe Device, the patient experienced 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 medical assistant reported that an eleven year old patient received a dose of Infanrix, which led to inappropriate age at vaccine administration. The health care professional declined to provide demographic details, lot number, or expiration date. The reporter did not consent to follow-up.


VAERS ID: 1954427 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: California  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-12-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (DAPTACEL) / SANOFI PASTEUR - / UNK - / OT
DTAP: DTAP (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Exposure during pregnancy, No adverse event, Wrong product administered
SMQs:, Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), 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: USSA2021SA412183

Write-up: This case involves a female pregnant patient of an unknown age who was exposed to vaccines DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL] and was supposed to get DIPHTHERIA, TETANUS AND ACELLULAR PERTUSSIS VACCINE (wrong product administered) and (exposure during pregnancy). Data regarding this pregnancy were received prospectively. Patient was exposed to the vaccine at unknown gestation period. The date of last menstrual period was not reported. The estimated due date was not reported. The patient''s medical history, past medical treatment, vaccination, concomitant medication and family history were not provided. On an unknown date, the patient received a dose of suspect DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE (lot number and expiry date not reported) via an unknown route at an unknown administration site for prophylactic vaccination. It was an actual medication error due to wrong vaccine administered and vaccine exposure during pregnancy (same day). At the time of reporting, no adverse event reported. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder''s compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. There will be no information available on the batch number for this case.


VAERS ID: 1955712 (history)  
Form: Version 2.0  
Age: 1.25  
Sex: Male  
Location: Texas  
Vaccinated:2021-11-08
Onset:2021-11-09
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-12-16
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (DAPTACEL) / SANOFI PASTEUR C5743AA / 4 LL / IM

Administered by: Private       Purchased by: ?
Symptoms: Feeling abnormal
SMQs:, Dementia (broad)

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

Write-up: Extreme fussiness that lasted 2-3 days.


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