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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 8 out of 3,116

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VAERS ID: 1851346 (history)  
Form: Version 2.0  
Age: 1.5  
Sex: Female  
Location: Oregon  
Vaccinated:2021-11-04
Onset:2021-11-04
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-11-08
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (INFANRIX) / GLAXOSMITHKLINE BIOLOGICALS 7EC55 / 4 RL / IM
HIBV: HIB (PEDVAXHIB) / MERCK & CO. INC. U014485 / 3 LL / IM
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH EE7117 / 4 RL / IM

Administered by: Private       Purchased by: ?
Symptoms: Gaze palsy, Pyrexia, SARS-CoV-2 test, Seizure like phenomena
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Convulsions (narrow), Ocular motility disorders (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? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: NA
Current Illness: RIGHT EAR INFECTION DIAGNOSED AT TIME OF VACCINATION, PATIENT ALSO DIAGNOSED WITH COVID IN OCTOBER OF 2021.
Preexisting Conditions: NA
Allergies: NA
Diagnostic Lab Data: Various testing including COVID test, ED evaluation, tylenol given at ED
CDC Split Type:

Write-up: Pt vaccinated at routine wellness exam 11/4/21. Presented with fever later that day. Pt had episode of eyes rolling back and seizure like activity and proceeded to local emergency department for evaluation following this.


VAERS ID: 1848129 (history)  
Form: Version 2.0  
Age: 72.0  
Sex: Male  
Location: Michigan  
Vaccinated:2021-11-01
Onset:2021-11-01
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-11-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (INFANRIX) / GLAXOSMITHKLINE BIOLOGICALS 7EC55 / UNK RA / -

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: Infanrix Pre-Filled Syringe Device
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: USGLAXOSMITHKLINEUS202122

Write-up: administered infanrix instead of boostrix; 72 Y / administered infanrix; This case was reported by a nurse via call center representative and described the occurrence of wrong vaccine administered in a 72-year-old male patient who received DTPa (Infanrix) (batch number 7EC55, expiry date 29th April 2023) for prophylaxis. Co-suspect products included dtpa vaccine pre-filled syringe device (Infanrix Pre-Filled Syringe Device) injection syringe for prophylaxis. On 1st November 2021, the patient received Infanrix and Infanrix Pre-Filled Syringe Device. On 1st November 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 72 year old patient was administered the infanrix vaccine instead of the boostrix vaccine, which led to wrong vaccine administered and inappropriate age at vaccine administration. She stated she had not yet spoken to the patient. The reporter consented to follow up.


VAERS ID: 1848622 (history)  
Form: Version 2.0  
Age: 11.0  
Sex: Male  
Location: New Jersey  
Vaccinated:0000-00-00
Onset:2021-10-28
Submitted: 0000-00-00
Entered: 2021-11-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (DAPTACEL) / SANOFI PASTEUR 65829BA / UNK - / OT
TDAP: TDAP (ADACEL) / SANOFI PASTEUR - / UNK - / OT

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: USSA2021SA361885

Write-up: DAPTACEL was inadvertently given instead of Adacel with no reported adverse event; DAPTACEL was inadvertently given instead of Adacel with no reported adverse event; Initial information was received on 28-Oct-2021 regarding an unsolicited valid non-serious case from a consumer/non-healthcare professional. This case involves a 11-year-old male patient who was administered DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL] inadvertently instead of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] (wrong product administered and Product administered to patient of inappropriate age) The patient''s medical history, past medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided. On an unknown date, the patient received a dose of suspect DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL] (0.5mL, lot 65829BA, expiry date 01-Mar-2022) instead of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] (lot number and expiry date were not reported) via an unknown route at an unknown administration site for prophylactic vaccination. It was an actual case of medication error due to wrong vaccine administered and Inappropriate age at vaccine administration (latency: same day). It was reported "Medical office assistant reporting that DAPTACEL was inadvertently given instead of Adacel." At time of reporting, no adverse event was reported. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder''s compliance with the requirements 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 lot number for ADACEL in this case.


VAERS ID: 1847020 (history)  
Form: Version 2.0  
Age: 1.25  
Sex: Male  
Location: Utah  
Vaccinated:2021-10-18
Onset:2021-10-29
   Days after vaccination:11
Submitted: 0000-00-00
Entered: 2021-11-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (DAPTACEL) / SANOFI PASTEUR C5765BA / 4 LL / IM
FLU4: INFLUENZA (SEASONAL) (FLUZONE QUADRIVALENT) / SANOFI PASTEUR UT7383NA / 3 - / -
HIBV: HIB (PEDVAXHIB) / MERCK & CO. INC. UT574AA / 4 RL / IM
VARCEL: VARICELLA (VARIVAX) / MERCK & CO. INC. U010397 / 1 LL / SC

Administered by: Private       Purchased by: ?
Symptoms: Injection site induration, 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? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: none
Current Illness: None
Preexisting Conditions: Cystic Fibrosis
Allergies: none
Diagnostic Lab Data: None
CDC Split Type:

Write-up: Mom noticed a quarter size bump on the child''s leg. The bump was hard to touch. Mom noticed the bump 10/29/21. No treatment done at this time.


VAERS ID: 1847765 (history)  
Form: Version 2.0  
Age: 36.0  
Sex: Female  
Location: Illinois  
Vaccinated:2011-06-06
Onset:2011-06-07
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-11-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (DAPTACEL) / SANOFI PASTEUR U3956DA / 1 LA / IM

Administered by: Private       Purchased by: ?
Symptoms: Asthenia, Balance disorder, Coordination abnormal, Dysstasia, Fatigue, Gait disturbance, Grip strength decreased, Hemiplegia, Hypoaesthesia, Impaired self-care, Influenza like illness, Laboratory test, Lumbar puncture abnormal, Magnetic resonance imaging abnormal, Multiple sclerosis, Muscular weakness, Myelitis transverse, Pain, Restless legs syndrome, Scan with contrast abnormal, Sensitive skin
SMQs:, Rhabdomyolysis/myopathy (broad), Peripheral neuropathy (broad), Anticholinergic syndrome (broad), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Malignancy related therapeutic and diagnostic procedures (narrow), Parkinson-like events (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Optic nerve disorders (broad), Demyelination (narrow), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (narrow), Depression (excl suicide and self injury) (broad), Vestibular disorders (broad), Hypoglycaemia (broad), Immune-mediated/autoimmune disorders (narrow), Sexual dysfunction (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Gemfibrozil 600 mg Seasonale 0.15-0.03 mg Potassium Chloride 40 MEQ (20 MEQ ER tab twice per day) Multivitamin
Current Illness: None
Preexisting Conditions: Possible familial hypokalemic periodic paralysis High cholesterol
Allergies: None
Diagnostic Lab Data: July 6, 2011 - MRI with contrast Lab work Spinal tap Result: Transverse Myelitis
CDC Split Type:

Write-up: Adverse Reaction: The next day after receiving the vaccine, I woke up with terrible body aches and fatigue like a had the flu. Over the next week, on my right side, my scalp became hypersensitive, and numbness crept down my neck, shoulder and right arm. In the second and third weeks, my arm became weak and uncoordinated to the point where I could not hold things or do much with my right, dominant arm. I additionally felt weak, fatigued and had terrible restless legs. During the fourth week after the vaccine, I began to lose balance and could not stand without holding onto something. I also lost strength and coordination in my right leg. My gait was not normal, and I could only take small steps. I was so fatigued that I could hardly do anything for myself. My body was completely weak, and my right side was partially paralyzed. Treatment: After initially seeing a doctor, I was immediately sent to a neurologist, and I remain under care of a neurologist to this day. An MRI was performed on July 6, 2011 which revealed transverse myelitis. I was given a five-day 1000 mg treatment of IV steroids (methylprednisone). I elected to do this out-patient due to cost and family at home. I then did physical therapy over the next six months. Outcome: The steroid treatment did not improve symptoms but did stop further progression. With time and therapy, I have regained sensation that was lost. Strength has improved on my right side but remains weak, and my gait is not always normal. In 2016, I was diagnosed with multiple sclerosis.


VAERS ID: 1844711 (history)  
Form: Version 2.0  
Age: 0.75  
Sex: Female  
Location: New Jersey  
Vaccinated:2021-10-26
Onset:2021-10-30
   Days after vaccination:4
Submitted: 0000-00-00
Entered: 2021-11-04
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (DAPTACEL) / SANOFI PASTEUR C5828AA / 3 LL / IM

Administered by: Private       Purchased by: ?
Symptoms: Febrile convulsion, Human rhinovirus test positive, Pyrexia, Respiratory syncytial virus test
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Convulsions (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Generalised convulsive seizures following immunisation (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: N/a
Current Illness: N/a
Preexisting Conditions: N/a
Allergies: N/a
Diagnostic Lab Data: Respiratory virus panel; rhinovirus positive
CDC Split Type:

Write-up: Fever followed by febrile seizure starting on 10/30/21


VAERS ID: 1839370 (history)  
Form: Version 2.0  
Age: 4.0  
Sex: Female  
Location: Iowa  
Vaccinated:2021-10-14
Onset:2021-10-14
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-11-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / OT
TDAP: TDAP (ADACEL) / SANOFI PASTEUR - / 3 - / 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:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: USSA2021SA357631

Write-up: 4 years 2 month old female patient vaccinated with Adacel instead of Dtap vaccine with no reported adverse event; 4 years 2 month old female patient vaccinated with Adacel vaccine with no reported adverse event; Initial information received on 26-Oct-2021 regarding an unsolicited valid non-serious case from a Physician and other healthcare professional via Medical Information (MI) (Reference number- 00828641). This case involves a four year two month old female patient who inadvertently vaccinated with DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] instead of DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR, TETANUS VACCINE TOXOID [DTAP] (wrong product administered and product administered to patient of inappropriate age). The patient''s medical history, medical treatment, vaccination, concomitant medication and family history were not provided. On 14-Oct-2021, the patient received a 0.5 ml third dose of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE (lot number and expiry date: not reported) (Frequency: once) via an intramuscular route at an unknown administration site for prophylactic vaccination. It was an actual medication error case due to Wrong vaccine administered (with respect to use of ADACEL and DTAP) and inappropriate age at vaccine administration (with respect to use of ADACEL) (latency on same day). It was reported "Caller reported that a patient inadvertently received a dose of Adacel (TDap) instead of DTap, as her last dose of the three-dose series. She requested guidance on how to proceed". At the time of reporting, no adverse event was reported. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder''s compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. There will be no information available on the batch number for this case.


VAERS ID: 1839371 (history)  
Form: Version 2.0  
Age: 1.25  
Sex: Female  
Location: Unknown  
Vaccinated:2021-10-18
Onset:2021-10-18
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-11-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / OT
DTAPIPV: DTAP + IPV (QUADRACEL) / SANOFI PASTEUR C5851AA / 1 LL / 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: FLU; HIB
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: USSA2021SA358857

Write-up: 15 month old female patient who was inadvertently administered QUADRACEL instead of DTAP with no reported adverse event; 15 month old female patient who was inadvertently administered QUADRACEL with no reported adverse event; Initial information received on 26-Oct-2021 regarding an unsolicited valid non-serious case from a Physician via other healthcare professional and non-healthcare professional/consumer via Medical Information (MI) (Reference number- 00829028). This case involves a 15 month old female patient who inadvertently vaccinated with DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE [QUADRACEL] instead of DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR, TETANUS VACCINE TOXOID [DTAP], (wrong product administered and product administered to patient of inappropriate age). The patient''s medical history, medical treatment, vaccination and family history were not provided. Concomitant medications included Influenza Vaccine (Flu) and Hib Vaccine (Hib) for Prophylactic vaccination. On 18-Oct-2021, the patient received a 0.5 ml first dose of suspect DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE (lot C5851AA and expiry date: 25-Mar-2023) (Suspension for injection) via an intramuscular route in the left thigh for prophylactic vaccination. It was an actual medication error case due to Wrong vaccine administered (with respect to use of QUADRACEL and DTAP) and inappropriate age at vaccine administration (with respect to use of QUADRACEL) (latency on same day). It was reported "Call received from reporting a dose of QUADRACEL was inadvertently administered instead of DTAP to a 15 month old patient". At the time of reporting, no adverse event was reported. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder''s compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.


VAERS ID: 1835819 (history)  
Form: Version 2.0  
Age: 5.0  
Sex: Female  
Location: California  
Vaccinated:2021-10-26
Onset:2021-10-27
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-11-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (INFANRIX) / GLAXOSMITHKLINE BIOLOGICALS 7EC55 / 1 LL / IM
IPV: POLIO VIRUS, INACT. (IPOL) / SANOFI PASTEUR T1E87 / 1 LL / IM
MMRV: MEASLES + MUMPS + RUBELLA + VARICELLA (PROQUAD) / MERCK & CO. INC. U007506 / 1 RL / IM

Administered by: Private       Purchased by: ?
Symptoms: Injection site erythema, Injection site rash, Injection site urticaria, Injection site warmth, Urticaria
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Extravasation events (injections, infusions and implants) (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: Amoxicillin
Diagnostic Lab Data: N/A
CDC Split Type:

Write-up: Redness in the Left thigh, Hot to touch, Rash, Hives, Welts from hives. Started 24 hours after shot.


VAERS ID: 1836920 (history)  
Form: Version 2.0  
Age: 1.58  
Sex: Male  
Location: South Carolina  
Vaccinated:2021-11-01
Onset:2021-11-01
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-11-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (INFANRIX) / GLAXOSMITHKLINE BIOLOGICALS - / UNK RL / SYR
FLU4: INFLUENZA (SEASONAL) (AFLURIA QUADRIVALENT) / SEQIRUS, INC. - / UNK LL / SYR

Administered by: Private       Purchased by: ?
Symptoms: Chills, Injection site erythema, Injection site pain, Injection site swelling, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (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: High fever following other DTAP doses
Other Medications: N/A
Current Illness: cold
Preexisting Conditions:
Allergies: N/A
Diagnostic Lab Data:
CDC Split Type:

Write-up: Fever and chills, with a temp reaching 104 degrees by midnight. Injection site on right leg is very swollen, red, sore to the touch. Needed 2 doses of ibuprofen to bring temp down to 100


VAERS ID: 1837346 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2016-02-21
Submitted: 0000-00-00
Entered: 2021-11-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Back injury, Blood test normal, Chest X-ray normal, Confusional state, Decreased eye contact, Disturbance in attention, Educational problem, Electrocardiogram normal, Electroencephalogram, Epilepsy, Extremity contracture, Fatigue, Ketogenic diet, Lethargy, Loss of consciousness, Medical diet, Staring, Tonic convulsion
SMQs:, Torsade de pointes/QT prolongation (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Dementia (broad), Convulsions (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Accidents and injuries (narrow), Depression (excl suicide and self injury) (broad), Hypotonic-hyporesponsive episode (broad), 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? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: CASA2021SA355242

Write-up: first tonic seizure; epileptiform discharges; Initial information was received on 26-Oct-2021 regarding an unsolicited valid serious courtesy case (Pfizer) received from a consumer (patient''s mother)/ non-healthcare professional. This case involves a 14-years old male patient who had first tonic seizure (tonic convulsion) and he was having epileptiform discharges (epilepsy), after receiving DIPHTHERIA, TETANUS AND ACELLULAR PERTUSSIS VACCINE [DTAP]. The patient''s medical history, past medical treatments and vaccinations were not provided. The patient had no family history of epilepsy and there were no concomitant medications. In 2015, the patient received a dose of suspect DIPHTHERIA, TETANUS AND ACELLULAR PERTUSSIS VACCINE produced by unknown manufacturer (batch number and expiry date not reported) via an unknown route at an unknown administration site for prophylactic vaccination. On 21-Feb-2016, the patient developed a serious event first tonic seizure (tonic convulsion) 4.5 months following the administration of DIPHTHERIA and TETANUS AND ACELLULAR PERTUSSIS VACCINE. On an unknown date in 2016, the patient developed a serious event epileptiform discharges (epilepsy) 4.5 months following the administration of DIPHTHERIA and TETANUS AND ACELLULAR PERTUSSIS VACCINE. These events were assessed as medically significant. The patient was under achievement in school and started to do poorly in school which was educational problems. In 2016, the patient started ketogenic diet treatment and was being followed by a neurologist at the Clinic. The patient did the diet for three years and four months and did not had another seizure. The patient was recovered from the reported events. At age 18, the patient switched hospitals as he was of the age and was being currently followed by another neurologist and the patient started low glycemic diet treatment in 2019. Prior to vaccination, the patient was not diagnosed with Coronavirus disease 2019 (COVID-19), did not receive other vaccines four weeks prior. The vaccine was administered at hospital. It was reported that, when the patient finished his university final exams in April 2021, he came home and on 07-May-2021 16:55 PM, the patient received a first dose of Coronavirus disease 2019 (COVID-19) VACCINE (batch number: EW0193) via intramuscular in the left deltoid at 19 years of age. No concomitant drugs. The reporter noticed that something was wrong after receiving it. On 09-May-2021, the patient experienced staring spells and lethargy. The patient was making fists and curling his toes. The patient also experienced fatigue, impaired concentration, back injury, severe confusion and lack of eye contact. On 24-Jun-2021, the patient began ketogenic diet again, day after seizure to prevent brain inflammation after vaccine. On 23-Jul-2021, occasionally six weeks later the patient had another tonic seizure with loss of consciousness. The patient''s mother called the ambulance and they sent him to the hospital. They did an electrocardiogram (EKG), a chest X-Ray and some blood work that all came back normal on 23-Jul-2021. They were awaiting appointment for Magnetic Resonance Imaging (MRI) and was Electroencephalography (EEG) completed on 18-Aug-2021 results were pending. The patient was discharged after six hours and no medications were prescribed. The patient was diagnosed with epilepsy since that was his second seizure. The patient was now back on the keto diet to prevent more seizures. The event was reported as serious (medically significant)/ life threatening/ prolongation of hospitalization, persistent significant disability/ incapacity and the adverse events required visit to emergency room. The outcome of the event was unknown. There will be no information available on the batch number for this case.; Sender''s Comments: This case concerns a 14-years old male patient who had tonic convulsion and epilepsy after receiving DIPHTHERIA, TETANUS AND ACELLULAR PERTUSSIS VACCINE produced by unknown manufacturer. The time to onset is compatible. Furthermore, information regarding medical history, past medical treatment, vaccination, condition at the time of vaccination and laboratory data excluding other predisposing etiologies would be needed for complete assessment of the case. Based upon the reported information, the role of the suspect vaccine cannot be assessed.


VAERS ID: 1832997 (history)  
Form: Version 2.0  
Age: 13.0  
Sex: Male  
Location: Connecticut  
Vaccinated:2021-10-28
Onset:2021-10-28
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-11-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (DAPTACEL) / SANOFI PASTEUR C5774CA / 4 LA / 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? 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: None
CDC Split Type:

Write-up: No adverse reaction. Reporting due to the vaccine administration error. Patient should have been given Tdap not Dtap.


VAERS ID: 1833430 (history)  
Form: Version 2.0  
Age: 3.0  
Sex: Female  
Location: Minnesota  
Vaccinated:2021-10-28
Onset:2021-10-30
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2021-11-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (DAPTACEL) / SANOFI PASTEUR C5774AA / 3 RL / IM
FLU4: INFLUENZA (SEASONAL) (FLULAVAL QUADRIVALENT) / GLAXOSMITHKLINE BIOLOGICALS 3477H / 2 LL / IM

Administered by: Private       Purchased by: ?
Symptoms: Injection site erythema, Injection site oedema, 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: Mild cough
Preexisting Conditions: None
Allergies: None
Diagnostic Lab Data:
CDC Split Type:

Write-up: Patient given influenza vaccine and 2 days later, parent reported had raised red edematous area to injection site


VAERS ID: 1833762 (history)  
Form: Version 2.0  
Age: 11.0  
Sex: Female  
Location: California  
Vaccinated:2021-10-28
Onset:2021-10-28
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-11-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (DAPTACEL) / SANOFI PASTEUR C5774CA / 5 UN / IM

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? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies: NKA
Diagnostic Lab Data:
CDC Split Type:

Write-up: none reported


VAERS ID: 1833930 (history)  
Form: Version 2.0  
Age: 22.0  
Sex: Female  
Location: Unknown  
Vaccinated:2021-11-01
Onset:2021-11-01
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-11-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (DAPTACEL) / SANOFI PASTEUR - / UNK - / SYR
FLU4: INFLUENZA (SEASONAL) (AFLURIA QUADRIVALENT) / SEQIRUS, INC. - / UNK - / SYR

Administered by: Private       Purchased by: ?
Symptoms: Blindness transient, Hypoacusis, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Embolic and thrombotic events, arterial (narrow), Glaucoma (broad), Optic nerve disorders (broad), Cardiomyopathy (broad), Retinal disorders (broad), Hearing impairment (narrow), Hypotonic-hyporesponsive episode (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? No
Hospitalized? No
Previous Vaccinations:
Other Medications: OCP
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type:

Write-up: Fainted a couple minutes after shots received. Lost vision and partial hearing, but never fully unconscious. Lasted for a few minutes, asked to stay at office for 15 minutes to make sure ok.


VAERS ID: 1830651 (history)  
Form: Version 2.0  
Age: 85.0  
Sex: Male  
Location: New York  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-10-30
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: Medical History/Concurrent Conditions: Surgery (had stem cell surgery)
Allergies:
Diagnostic Lab Data:
CDC Split Type: USGLAXOSMITHKLINEUS202121

Write-up: infanrix/ Patient was 85.; This case was reported by a pharmacist via call center representative and described the occurrence of inappropriate age at vaccine administration in a 85-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. The patient''s past medical history included surgery (had stem cell surgery). 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 85 years old patient received Infanrix, which led to inappropriate age at vaccine administration. The reporter did not consent to follow up.


VAERS ID: 1827151 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: New York  
Vaccinated:2021-07-07
Onset:2021-07-07
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (INFANRIX) / GLAXOSMITHKLINE BIOLOGICALS 49TM3 / 2 - / -
DTAP: DTAP (INFANRIX) / GLAXOSMITHKLINE BIOLOGICALS 49TM3 / 1 - / -

Administered by: Unknown       Purchased by: ?
Symptoms: Inappropriate schedule of product administration, 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: Administration to a 76 year old patient; 1st dose on 7 july 2021 and 2nd dose on 21 sep 2021; Administration to a 76 year old patient; This case was reported by a pharmacist via call center representative and described the occurrence of inappropriate age at vaccine administration in a 76-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, DTPa (Infanrix) (batch number 49tm3, expiry date 28th May 2022) for prophylaxis and dtpa vaccine pre-filled syringe device (Infanrix Pre-Filled Syringe Device) injection syringe for prophylaxis. On 21st September 2021, the patient received the 2nd dose of Infanrix and Infanrix Pre-Filled Syringe Device. On 7th July 2021, the patient received the 1st dose of Infanrix and Infanrix Pre-Filled Syringe Device. On 7th July 2021, 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 inappropriate age at vaccine administration. On 21st September 2021, the patient experienced inappropriate age at vaccine administration and drug dose administration interval too short. On an unknown date, the outcome of the inappropriate age at vaccine administration, inappropriate age at vaccine administration and drug dose administration interval too short 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 76 year old male patient received 1st and 2nd dose of Infanrix, which led to inappropriate age at vaccine administration. The patient received 2nd dose later than the recommended time interval, which led to shortening of vaccination schedule. No further events were reported. The reporter consented to follow up.


VAERS ID: 1829430 (history)  
Form: Version 2.0  
Age: 1.5  
Sex: Male  
Location: Michigan  
Vaccinated:2021-10-26
Onset:2021-10-26
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (INFANRIX) / GLAXOSMITHKLINE BIOLOGICALS 5RM39 / UNK LL / IM
FLU4: INFLUENZA (SEASONAL) (FLULAVAL QUADRIVALENT) / GLAXOSMITHKLINE BIOLOGICALS CJ554 / UNK RL / IM
HEPA: HEP A (HAVRIX) / GLAXOSMITHKLINE BIOLOGICALS 532H4 / UNK RL / IM

Administered by: Private       Purchased by: ?
Symptoms: Crying, Injection site discomfort, Injection site erythema, Injection site induration, Injection site swelling, Irritability, Skin reaction
SMQs:, Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Extravasation events (injections, infusions and implants) (broad), Hostility/aggression (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Depression (excl suicide and self injury) (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? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations: DTAP-10/26/2020, 09/02/2020, 06/26/2020
Other Medications: None
Current Illness: Viral illness
Preexisting Conditions: None known
Allergies: None known
Diagnostic Lab Data: None currently ordered.
CDC Split Type:

Write-up: Patient developed local skin reaction of redness, swelling, induration, and discomfort at the injection site. Mom reports similar reaction in the past with worsening with subsequence injections. Mom reports that reaction started by 06:00 pm on the date of immunization and continued to worsen. Vaccination was given on 10/26/2021 and mom reports worsening until 10/28/2021. The redness, swelling, induration, and discomfort improved somewhat on 10/29/2021, but then patient became irritable and crying for unknown reason. Mom brought him into clinic to be assessed on 10/29/2021 due to vaccine reaction. She showed me images of redness and swelling of patient''s leg from prior days which was more red and swollen in the


VAERS ID: 1823343 (history)  
Form: Version 2.0  
Age: 12.0  
Sex: Male  
Location: Michigan  
Vaccinated:2021-10-15
Onset:2021-10-15
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (INFANRIX) / GLAXOSMITHKLINE BIOLOGICALS 49TM3 / 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: USGLAXOSMITHKLINEUS202122

Write-up: received Infanrix vaccination instead of Boostrix; Inappropriate age at vaccine administration; This case was reported by a other health professional via call center representative and described the occurrence of wrong vaccine administered in a 12-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 15th October 2021, the patient received Infanrix and Infanrix Pre-Filled Syringe Device. On 15th October 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 12 years old patient received Infanrix vaccination instead of Boostrix vaccine, which led to wrong vaccine administered and inappropriate age at vaccine administration. At the time of call, the patient had not received Boostrix vaccine. The reporter did not consent to follow-up.


VAERS ID: 1824746 (history)  
Form: Version 2.0  
Age: 12.0  
Sex: Male  
Location: New York  
Vaccinated:2021-09-20
Onset:2021-09-20
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-10-28
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / OT
MNQ: MENINGOCOCCAL CONJUGATE (MENACTRA) / SANOFI PASTEUR - / UNK LA / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Back pain, Blister, Burning sensation, Headache, Memory impairment, Migraine, Pyrexia, Urticaria, Vomiting
SMQs:, Severe cutaneous adverse reactions (broad), Anaphylactic reaction (broad), Acute pancreatitis (broad), Angioedema (narrow), Peripheral neuropathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Retroperitoneal fibrosis (broad), Dementia (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Depression (excl suicide and self injury) (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:
Current Illness: Food allergy (consumer has a history of allergies and sensitivities; that the allergist has always used acupuncture to treat the consumer''s food allergies.)
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: USSA2021SA353970

Write-up: severe head pain and with the pain he was forgetting everything; welts; blistering of the skin on the right side of the body; blisters as burning; migraine headaches; severe back pain; allergic reaction; high fever; vomiting;Initial information received on 19-Oct-2021 regarding an unsolicited valid non-serious case from consumer/non-health care professional and physician via Media Information (under reference 00818660). This case involves a 12 years old male patient who had allergic reaction (hypersensitivity) with the associated symptoms as high fever (pyrexia), vomiting, blistering of the skin on the right side of the body (blister), blisters as burning (burning sensation) and welts (urticaria). Also he had migraine headaches (migraine) with the symptom as severe head pain and with the pain he was forgetting everything (memory impairment) and another event, severe back pain (back pain), after receiving DIPHTHERIA, TETANUS AND ACELLULAR PERTUSSIS VACCINE and MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA]. The patient''s medical history, medical treatment(s), concomitant medication(s) and family history were not provided. The patient had no other concomitant vaccines. At the time of the event, the patient had ongoing medical history of food allergy and he also had a history of allergies and sensitivities; that the allergist had always used acupuncture to treat the food allergies. On 20-Sep-2021, the patient received a 0.5 mL dose of suspect MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE (Total, lot number and expiration date were not reported) via intramuscular route in the left arm for prophylactic vaccination. On an unknown date, the patient received a dose of suspect DIPHTHERIA, TETANUS AND ACELLULAR PERTUSSIS VACCINE produced by unknown manufacturer (lot number and expiration date were not reported) via unknown route in an unknown administration site for prophylactic vaccination. On 20-Sep-2021, the patient developed non-serious allergic reaction (hypersensitivity), high fever (pyrexia), vomiting, severe back pain (back pain), migraine headaches (migraine), blistering of the skin on the right side of the body (blister), blisters as burning (burning sensation), 30 minutes following the administration of MENACTRA and unknown latency following the administration of DIPHTHERIA, TETANUS AND ACELLULAR PERTUSSIS VACCINE. On an unknown date, the patient developed a non-serious welts (urticaria) and severe head pain and with the pain he was forgetting everything (memory impairment) [unknown latency] following the administration of vaccines. It was reported "caller states she knows the vaccine as "meningococcal/conjugate" as told to her by the administering RN (registered nurse), but does not know the brand name and can obtain information; caller states her son age 12 received the vaccination on 20SEP2021, within 30 mins a high fever, vomiting, severe back pain, migraine headaches and blistering of the skin began to happen; caller states the blister began on the right side of the body, vaccine administered on the left side; caller states that time of call, the patient''s back pain is gone, but headache and blisters remain; caller states blisters have become fewer and fewer each time of an outbreak; caller states patient describes the blisters as burning and not itching; caller states photos of blisters and welts are available; caller states patient has seen his Primary care doctor since the reaction as well as an allergist; caller states Primary Care suggest to call manufacturer for detail and to report incident; caller states patient had allergic reaction to "dTap vaccine" in the fifth grade; that during the first days of this the consumer could not eat for a couple of days; that 3-days after the vaccine the consumer went back to the prescriber; that the consumer still had one blister, when he went back to the prescriber; that the prescriber expressed that the reaction cannot be from the Menactra; that after the consumer left the office and still in the parking lot, the consumer began to blister all over the body; that the consumer was referred to an allergist; that with testing at the allergist the consumer was shown to be allergic to the MENACTRA vaccine; that the consumer did present with being hived out again with blisters; that the hives are not really hives but blisters with a purple tint and purple dots in the blisters; that the consumer has not had any other treatment; that the consume now had to be taken out of his normal school to accommodate the consumer status; that the consumer is on the couch at the time of this report." The patient was given DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL) and fever reducer at home as corrective treatment. Also, the patient was treated with needles described as getting acupuncture treatments; that the back pain seemed to go away; that the he was still having severe head pain and with the pain he was forgetting everything ; that the consumer went back to see the allergist again and treated with the needles again. The patient recovered from the event severe back pain on an unknown date. At time of reporting, the patient did not recover from the events blister, burning sensation, migraine headaches and memory impairment. At time of reporting, the outcome was unknown for the other reported events. There will be no information available on the batch number for this case.


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