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From the 7/16/2021 release of VAERS data:

Found 1,301,243 cases where Symptom is Immune system disorder or Immunodeficiency or Immunoglobulins decreased or Lymphadenopathy



Case Details (Sorted by Age)

This is page 253 out of 1,302

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VAERS ID: 854791 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2019-12-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPVX: HPV (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / -

Administered by: Unknown       Purchased by: ?
Symptoms: Epilepsy, Laboratory test, Psychogenic seizure
SMQs:, Systemic lupus erythematosus (broad), Convulsions (narrow), Generalised convulsive seizures following immunisation (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: BR0095075131912BRA011271

Write-up: had psychogenic epileptic seizures; This spontaneous report was received as online news from a consumer regarding an adolescent female patient of unknown age. The patient''s pertinent medical history, concurrent conditions, concomitant medications, previous drug reactions or allergies were not reported. On an unknown date, the patient was vaccinated with quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (manufacturer unknown) (strength, dose, route of administration, anatomical site of vaccination, vaccination scheme, lot number and expiration date were not reported) as prophylaxis. On an unspecified date, the patient had psychogenic epileptic seizures (epilepsy). According to the reporter, the patient had unspecified tests performed which showed no relationship between the symptoms and the vaccination, however, the patient''s parents did not agree with the diagnosis. The outcome of epilepsy was unknown (also reported as sequelae, inconsistent information). The causality assessment between human papillomavirus (types 6,11,16,18) recomb. vaccine (manufacturer unknown) and epilepsy, was unknown. Upon internal review, epilepsy was determined to be medically significant. This is one of several reports received from the same reporter.; Sender''s Comments: BR-009507513-1912BRA011270: BR-009507513-1912BRA011269: BR-009507513-1912BRA011268: BR-009507513-1912BRA011267: BR-009507513-1912BRA011266: BR-009507513-1912BRA011265: BR-009507513-1912BRA011264: BR-009507513-1912BRA011263: BR-009507513-1912BRA010837:


VAERS ID: 854792 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2019-12-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUN4: INFLUENZA (SEASONAL) (FLUENZ TETRA) / MEDIMMUNE VACCINES, INC. - / UNK - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Asthma, Chest pain, Condition aggravated, Cough, Infection via vaccinee, Nasopharyngitis
SMQs:, Anaphylactic reaction (broad), Asthma/bronchospasm (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Hypersensitivity (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: VENTOLIN; CLENIL MODULITE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Asthma
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBAstraZeneca2019SF87422

Write-up: COUGH; Worsened asthma symptoms, pains in chest and general cold/cough symptoms; ASTHMA AGGRAVATED; Worsened asthma symptoms, pains in chest and general cold/cough symptoms; CHEST PAIN; Worsened asthma symptoms, pains in chest and general cold/cough symptoms; INFECTION VIA VACCINEE; COLD SYMPTOMS; Worsened asthma symptoms, pains in chest and general cold/cough symptoms; A spontaneous report has been received from consumer via regulatory authority concerning a male patient of Unknown ethnic origin (age 7 years, weight 19 kg). The patient''s past and current medical history included asthma (dates not reported). Concomitant medication included salbutamol and beclometasone dipropionate. The patient received Fluenz Tetra (influenza virus vaccine live, intranasal) once/single administration, via nasal route, on an unknown date. It was reported that on an unknown date, the patient had cough (preferred term: Cough). On an unknown date, the patient had asthma aggravated (preferred term: Asthma). On an unknown date, the patient had chest pain (preferred term: Chest pain). On an unknown date, the patient had infection via vaccinee (preferred term: Infection via vaccinee). On an unknown date, the patient had cold symptoms (preferred term: Nasopharyngitis). At the time of reporting, the events of cough, asthma aggravated, chest pain and cold symptoms was improving. The outcome of the event(s) of infection via vaccinee were unknown. The events of cough, asthma aggravated, chest pain, infection via vaccinee and cold symptomswere considered serious due to seriousness criteria of important medical event by the reporter.; Sender''s Comments: Cough, asthma aggravated (preferred term: asthma), chest pain, infection via vaccine and nasopharyngitis are not listed in the company core data sheet for fluenz tetra. Underlying asthma could be contributory to asthma aggravation. Salbutamol could contribute to cough. Nasopharyngitis could be in connection with cough and chest pain. However, due to limited information on patient relevant medical history, onset date of the events, detailed description of Infection via vaccinee, circumstances leading to the events, treatment, other comorbidities and concomitant medications, onset date of suspect drug, detailed diagnostic and etiologic workup (such as infection work up, complete blood profile), it is not possible to make a conclusive assessment of the causal relationship of the event and the suspect drug.


VAERS ID: 854793 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2019-12-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPIPVHIB: DTAP + IPV + HIB (UNKNOWN) / UNKNOWN MANUFACTURER - / 1 - / -
MENB: MENINGOCOCCAL B (BEXSERO) / NOVARTIS VACCINES AND DIAGNOSTICS - / 1 - / -
PPV: PNEUMO (NO BRAND NAME) / UNKNOWN MANUFACTURER - / 1 - / -
RV1: ROTAVIRUS (ROTARIX) / GLAXOSMITHKLINE BIOLOGICALS - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Bacterial infection, Bacterial test negative, C-reactive protein increased, CSF glucose normal, CSF neutrophil count negative, CSF protein normal, CSF red blood cell count positive, CSF white blood cell count negative, Enterovirus test negative, Herpes simplex test negative, Irritability, Meningitis aseptic, Neutrophil count decreased, Pleocytosis, Polymerase chain reaction, Pyrexia, Septic screen, Varicella virus test negative, Viral test negative, White blood cell count normal
SMQs:, Agranulocytosis (broad), Haematopoietic leukopenia (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (narrow), Hostility/aggression (broad), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (broad), 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? No
Hospitalized? Yes, 3 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Gastroesophageal reflux
Allergies:
Diagnostic Lab Data: Test Name: Bacterial culture; Result Unstructured Data: Test Result: negative; Test Name: Glucose; Result Unstructured Data: Test Result: 2.5, Test Result Unit: mmol/l; Test Name: Body temperature; Result Unstructured Data: Test Result: 38.2, Test Result Unit: Centigrade; Test Name: C-reactive protein; Result Unstructured Data: Test Result: 32.5, Test Result Unit: mg/dl; Test Name: CSF neutrophil count; Result Unstructured Data: Test Result: 0, Test Result Unit: /mm3; Test Name: CSF red blood cell count; Result Unstructured Data: Test Result: 3, Test Result Unit: /mm3; Test Name: CSF white blood cell count; Result Unstructured Data: Test Result: 9, Test Result Unit: /mm3; Test Name: Enterovirus test; Result Unstructured Data: Test Result: negative; Test Name: Herpes simplex test; Result Unstructured Data: Test Result: negative; Test Name: Lumbar puncture; Result Unstructured Data: Test Result: Performed on admission. Clear, colourless fluid; Test Name: Neutrophil count; Result Unstructured Data: Test Result: 0.6, Test Result Unit: x10 9/l; Test Name: PCR; Result Unstructured Data: Test Result: negative; Test Name: PCR; Result Unstructured Data: Test Result: negative; Test Name: PCR; Result Unstructured Data: Test Result: negative; Test Name: PCR; Result Unstructured Data: Test Result: negative; Test Name: Protein; Result Unstructured Data: Test Result: 0.4, Test Result Unit: mg/dl; Test Name: Varicella virus test; Result Unstructured Data: Test Result: negative; Test Name: Viral test; Result Unstructured Data: Test Result: negative; Test Name: Viral PCR test; Result Unstructured Data: Test Result: negative; Test Name: WBC; Result Unstructured Data: Test Result: 12.1, Test Result Unit: /mm3
CDC Split Type: GBPFIZER INC2019551759

Write-up: Aseptic meningitis associated with routine infant immunisation; This is a literature report from the Archives entitled Aseptic meningitis associated with routine infant immunisation visits that include the group B meningococcal vaccine, 4CMenB. This author has reported similar event in three different patients. This is the first of three reports. Authors would however, like to report the experience of three cases of aseptic meningitis following primary immunisation (including 4CMenB) in infants. All three presented with fever and irritability within 24 hours of vaccination, had a full septic screen including lumbar puncture and received empiric intravenous antibiotics. Subsequent bacterial cultures were all negative as was PCR testing of CSF for meningococcus, pneumococcus and common viral causes of meningitis (enterovirus, parechovirus, herpes simplex and varicella zoster). Antibiotics were stopped after 36-48 hours, when bacterial cultures were reported negative. This cases met the AEFI case definition for aseptic meningitis developed by the Collaboration to standardise the assessment and improve comparability of cases. All were temporally associated with immunisation but it was not possible to confirm causality. Aseptic meningitis has been reported after immunisation with several live attenuated virus vaccines, including oral polio, combined measles-mumps- rubella, varicella, yellow fever and smallpox vaccines. This three cases, however, did not present with any specific features of meningitis, particularly seizures, had only mildly elevated blood CRP levels and mild pleocytosis (<100 WBC/mm3) in the CSF, with normal protein and glucose concentrations, clear microscopy and, ultimately, negative bacterial cultures and viral PCR tests. None were re-admitted shortly after these presentations with features suggesting partially treated bacterial infection. This cases highlight additional difficulties faced by frontline clinicians managing infants with post-vaccination fever. Given that $g7 million 4CMenB doses have now been administered to infants across the county, the occurrence of a serious underlying bacterial infection as described by So and colleagues must be considered very rare but, as the authors rightly conclude, warrants clinicians to remain highly vigilant. In cases where diagnostic uncertainty remains, empiric antibiotics until all investigations are completed may still be the safest option. A 2-month-old (62 days) patient of an unspecified gender received pneumococcal 13-val conj vac (dipht crm197 protein) (manufacture unknown) at single dose , rotavirus vaccine live oral 1v (ROTARIX) at unknown dose, meningococcal vaccine b rfhbp/nada/nhba omv (BEXSERO) at unknown dose, diphtheria vaccine, hib vaccine, pertussis vaccine, polio vaccine, tetanus vaccine (DIPHTHERIA VACCINE;HIB VACCINE;PERTUSSIS VACCINE;POLIO VACCINE;TETANUS) , at unknown dose, all as first dose via unknown route on unknown date for immunization. Medical history included gastrooesophageal reflux disease. The patient''s concomitant medications were not reported. The patient experienced aseptic meningitis associated with routine infant immunisation on an unspecified date with outcome of unknown. The patient was hospitalized for aseptic meningitis associated with routine infant immunisation for 3 days. The patient underwent lab tests and procedures which included bacterial cultures: negative, glu (blood glucose): 2.5 mmol/l, body temperature: 38.2 centigrade, CRP (c-reactive protein): 32.5 mg/dl, Nphil (csf neutrophil count): 0 /mm3, RBC (csf red blood cell count): 3 /mm3, WCC (csf white blood cell count): 9 /mm3, enterovirus: negative, herpes simplex: negative, lumbar puncture results: Performed on admission. Clear, colourless fluid. Neu (neutrophil count): 0.6 x10 9/l, PCR testing of CSF for meningococcus: negative; negative, PCR testing of CSF for pneumococcus: negative, negative. protein 0.4 mg/dl, varicella zoster negative, viral PCR tests negative, WBC 12.1 /mm3, Parechovirus negative. Pfizer is a marketing authorization holder of pneumococcal 13-val conj vac (dipht crm197 protein) in the country of incidence or the country where the product was purchased (if different). This may be a duplicate report if another marketing authorization holder of pneumococcal 13-val conj vac (dipht crm197 protein) has submitted the same report to the regulatory authorities.; Sender''s Comments: The association between the event aseptic meningitis with pneumococcal 13-valent conjugate vaccine can not be fully excluded based on close temporal relationship. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.,Linked Report(s) : GB-PFIZER INC-2019553524 Same article/drug/event different patient;GB-PFIZER INC-2019553525 Same article/drug/event different patient


VAERS ID: 854794 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2019-12-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTPIPV: DTP + IPV (NO BRAND NAME) / UNKNOWN MANUFACTURER - / 1 - / -
HIBV: HIB (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / -
MENB: MENINGOCOCCAL B (BEXSERO) / NOVARTIS VACCINES AND DIAGNOSTICS - / 1 - / -
PPV: PNEUMO (NO BRAND NAME) / UNKNOWN MANUFACTURER - / 1 - / -
RV1: ROTAVIRUS (ROTARIX) / GLAXOSMITHKLINE BIOLOGICALS - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Bacterial infection, Bacterial test negative, C-reactive protein increased, CSF glucose normal, CSF neutrophil count negative, CSF protein normal, CSF red blood cell count positive, CSF white blood cell count increased, Enterovirus test negative, Herpes simplex test negative, Irritability, Meningitis aseptic, Neutrophil count increased, Pleocytosis, Polymerase chain reaction, Pyrexia, Septic screen, Varicella virus test negative, Viral test negative, Vomiting, White blood cell count normal
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hostility/aggression (broad), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (broad), 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? No
Hospitalized? Yes, 2 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Comments: List of non-encoded Patient Relevant History: Patient Other Relevant History 1: none, Comment:
Allergies:
Diagnostic Lab Data: Test Name: Bacterial culture; Result Unstructured Data: Test Result: negative; Comments: Admission temperature (Unknown date): 38.4 degree C Neu (Neutrophil count) (Unknown date): 11.1 x 10^8/L Lumbar puncture results (Unknown date): Performed on admission. Clear, colourless fluid. WCC 18, Nphil 6, RBC 742, protein 0.45, Glu 3.4 Parechovirus (Unknown date): negative; Test Name: Glucose; Result Unstructured Data: Test Result: 3.4, Test Result Unit: mmol/l; Comments: Admission temperature (Unknown date): 38.4 degree C Neu (Neutrophil count) (Unknown date): 11.1 x 10^8/L Lumbar puncture results (Unknown date): Performed on admission. Clear, colourless fluid. WCC 18, Nphil 6, RBC 742, protein 0.45, Glu 3.4 Parechovirus (Unknown date): negative; Test Name: Body temperature; Result Unstructured Data: Test Result: 38.4, Test Result Unit: Centigrade; Comments: Admission temperature (Unknown date): 38.4 degree C Neu (Neutrophil count) (Unknown date): 11.1 x 10^8/L Lumbar puncture results (Unknown date): Performed on admission. Clear, colourless fluid. WCC 18, Nphil 6, RBC 742, protein 0.45, Glu 3.4 Parechovirus (Unknown date): negative; Test Name: C-reactive protein; Result Unstructured Data: Test Result: 5.5, Test Result Unit: mg/dl; Comments: Admission temperature (Unknown date): 38.4 degree C Neu (Neutrophil count) (Unknown date): 11.1 x 10^8/L Lumbar puncture results (Unknown date): Performed on admission. Clear, colourless fluid. WCC 18, Nphil 6, RBC 742, protein 0.45, Glu 3.4 Parechovirus (Unknown date): negative; Test Name: C-reactive protein; Result Unstructured Data: Test Result: 77.4, Test Result Unit: mg/dl; Comments: Admission temperature (Unknown date): 38.4 degree C Neu (Neutrophil count) (Unknown date): 11.1 x 10^8/L Lumbar puncture results (Unknown date): Performed on admission. Clear, colourless fluid. WCC 18, Nphil 6, RBC 742, protein 0.45, Glu 3.4 Parechovirus (Unknown date): negative; Test Name: CSF neutrophil count; Result Unstructured Data: Test Result: 6, Test Result Unit: /mm3; Comments: Admission temperature (Unknown date): 38.4 degree C Neu (Neutrophil count) (Unknown date): 11.1 x 10^8/L Lumbar puncture results (Unknown date): Performed on admission. Clear, colourless fluid. WCC 18, Nphil 6, RBC 742, protein 0.45, Glu 3.4 Parechovirus (Unknown date): negative; Test Name: CSF red blood cell count; Result Unstructured Data: Test Result: 742, Test Result Unit: /mm3; Comments: Admission temperature (Unknown date): 38.4 degree C Neu (Neutrophil count) (Unknown date): 11.1 x 10^8/L Lumbar puncture results (Unknown date): Performed on admission. Clear, colourless fluid. WCC 18, Nphil 6, RBC 742, protein 0.45, Glu 3.4 Parechovirus (Unknown date): negative; Test Name: CSF white blood cell count; Result Unstructured Data: Test Result: 18, Test Result Unit: /mm3; Comments: Admission temperature (Unknown date): 38.4 degree C Neu (Neutrophil count) (Unknown date): 11.1 x 10^8/L Lumbar puncture results (Unknown date): Performed on admission. Clear, colourless fluid. WCC 18, Nphil 6, RBC 742, protein 0.45, Glu 3.4 Parechovirus (Unknown date): negative; Test Name: Enterovirus test; Result Unstructured Data: Test Result: negative; Comments: Admission temperature (Unknown date): 38.4 degree C Neu (Neutrophil count) (Unknown date): 11.1 x 10^8/L Lumbar puncture results (Unknown date): Performed on admission. Clear, colourless fluid. WCC 18, Nphil 6, RBC 742, protein 0.45, Glu 3.4 Parechovirus (Unknown date): negative; Test Name: Herpes simplex test; Result Unstructured Data: Test Result: negative; Comments: Admission temperature (Unknown date): 38.4 degree C Neu (Neutrophil count) (Unknown date): 11.1 x 10^8/L Lumbar puncture results (Unknown date): Performed on admission. Clear, colourless fluid. WCC 18, Nphil 6, RBC 742, protein 0.45, Glu 3.4 Parechovirus (Unknown date): negative; Test Name: Lumbar puncture; Result Unstructured Data: Test Result: Performed on admission. Clear, colourless fluid. W; Comments: Admission temperature (Unknown date): 38.4 degree C Neu (Neutrophil count) (Unknown date): 11.1 x 10^8/L Lumbar puncture results (Unknown date): Performed on admission. Clear, colourless fluid. WCC 18, Nphil 6, RBC 742, protein 0.45, Glu 3.4 Parechovirus (Unknown date): negative; Test Name: Neutrophil count; Result Unstructured Data: Test Result: 11.1; Comments: Admission temperature (Unknown date): 38.4 degree C Neu (Neutrophil count) (Unknown date): 11.1 x 10^8/L Lumbar puncture results (Unknown date): Performed on admission. Clear, colourless fluid. WCC 18, Nphil 6, RBC 742, protein 0.45, Glu 3.4 Parechovirus (Unknown date): negative; Test Name: PCR; Result Unstructured Data: Test Result: negative; Comments: Admission temperature (Unknown date): 38.4 degree C Neu (Neutrophil count) (Unknown date): 11.1 x 10^8/L Lumbar puncture results (Unknown date): Performed on admission. Clear, colourless fluid. WCC 18, Nphil 6, RBC 742, protein 0.45, Glu 3.4 Parechovirus (Unknown date): negative; Test Name: PCR; Result Unstructured Data: Test Result: negative; Comments: Admission temperature (Unknown date): 38.4 degree C Neu (Neutrophil count) (Unknown date): 11.1 x 10^8/L Lumbar puncture results (Unknown date): Performed on admission. Clear, colourless fluid. WCC 18, Nphil 6, RBC 742, protein 0.45, Glu 3.4 Parechovirus (Unknown date): negative; Test Name: PCR; Result Unstructured Data: Test Result: negative; Comments: Admission temperature (Unknown date): 38.4 degree C Neu (Neutrophil count) (Unknown date): 11.1 x 10^8/L Lumbar puncture results (Unknown date): Performed on admission. Clear, colourless fluid. WCC 18, Nphil 6, RBC 742, protein 0.45, Glu 3.4 Parechovirus (Unknown date): negative; Test Name: PCR; Result Unstructured Data: Test Result: negative; Comments: Admission temperature (Unknown date): 38.4 degree C Neu (Neutrophil count) (Unknown date): 11.1 x 10^8/L Lumbar puncture results (Unknown date): Performed on admission. Clear, colourless fluid. WCC 18, Nphil 6, RBC 742, protein 0.45, Glu 3.4 Parechovirus (Unknown date): negative; Test Name: Protein; Result Unstructured Data: Test Result: 0.45, Test Result Unit: mg/dl; Comments: Admission temperature (Unknown date): 38.4 degree C Neu (Neutrophil count) (Unknown date): 11.1 x 10^8/L Lumbar puncture results (Unknown date): Performed on admission. Clear, colourless fluid. WCC 18, Nphil 6, RBC 742, protein 0.45, Glu 3.4 Parechovirus (Unknown date): negative; Test Name: Varicella virus test; Result Unstructured Data: Test Result: negative; Comments: Admission temperature (Unknown date): 38.4 degree C Neu (Neutrophil count) (Unknown date): 11.1 x 10^8/L Lumbar puncture results (Unknown date): Performed on admission. Clear, colourless fluid. WCC 18, Nphil 6, RBC 742, protein 0.45, Glu 3.4 Parechovirus (Unknown date): negative; Test Name: Viral PCR test; Result Unstructured Data: Test Result: negative; Comments: Admission temperature (Unknown date): 38.4 degree C Neu (Neutrophil count) (Unknown date): 11.1 x 10^8/L Lumbar puncture results (Unknown date): Performed on admission. Clear, colourless fluid. WCC 18, Nphil 6, RBC 742, protein 0.45, Glu 3.4 Parechovirus (Unknown date): negative; Test Name: WBC; Result Unstructured Data: Test Result: 15.8, Test Result Unit: /mm3; Comments: Admission temperature (Unknown date): 38.4 degree C Neu (Neutrophil count) (Unknown date): 11.1 x 10^8/L Lumbar puncture results (Unknown date): Performed on admission. Clear, colourless fluid. WCC 18, Nphil 6, RBC 742, protein 0.45, Glu 3.4 Parechovirus (Unknown date): negative
CDC Split Type: GBPFIZERINC2019553524

Write-up: aseptic meningitis associated with routine infant immunisation; This is a literature report. This author has reported similar event in three different patients. This is the second of three reports. Authors would however, like to report our experience of three cases of aseptic meningitis following primary immunisation (including 4CMenB) in infants. All three presented with fever and irritability within 24 hours of vaccination, had a full septic screen including lumbar puncture and received empiric intravenous antibiotics. Subsequent bacterial cultures were all negative as was PCR testing of CSF for meningococcus, pneumococcus and common viral causes of meningitis (enterovirus, parechovirus, herpes simplex and varicella zoster). Antibiotics were stopped after 36-48 hours, when bacterial cultures were reported negative. Our cases met the AEFI case definition for aseptic meningitis developed by the Brighton Collaboration to standardise the assessment and improve comparability of cases. All were temporally associated with immunisation but it was not possible to confirm causality. Aseptic meningitis has been reported after immunisation with several live attenuated virus vaccines, including oral polio, combined measles-mumps- rubella, varicella, yellow fever and smallpox vaccines. Our three cases, however, did not present with any specific features of meningitis, particularly seizures, had only mildly elevated blood CRP levels and mild pleocytosis (<100 WBC/mm3) in the CSF, with normal protein and glucose concentrations, clear microscopy and, ultimately, negative bacterial cultures and viral PCR tests. None were re-admitted shortly after these presentations with features suggesting partially treated bacterial infection. Our cases highlight additional difficulties faced by frontline clinicians managing infants with post-vaccination fever. Given that $g7 million 4CMenB doses have now been administered to infants the occurrence of a serious underlying bacterial infection as described by colleagues must be considered very rare but, as the authors rightly conclude, warrants clinicians to remain highly vigilant. In cases where diagnostic uncertainty remains, empiric antibiotics until all investigations are completed may still be the safest option. A 66-day-old patient of an unspecified gender received pneumococcal 13-val conj vac (dipht crm197 protein) at a single dose, rotavirus vaccine live oral 1v (ROTARIX), meningococcal vaccine b rfhbp/nada/nhba omv (BEXSERO) at unspecified dose, diphtheria vaccine, hib vaccine, pertussis vaccine, polio vaccine, tetanus vaccine (DIPHTHERIA VACCINE;HIB VACCINE;PERTUSSIS VACCINE;POLIO VACCINE;TETANUS) at unspecified dose; all were first dose via an unspecified route of administration on an unspecified date for immunisation. There was none of medical history. The patient''s concomitant medications were not reported. The patient experienced aseptic meningitis associated with routine infant immunisation on an unspecified date, seriousness of which was reported as hospitalization, medically significant. Length of hospital stay: 2 days. The patient underwent lab tests and procedures which included symptoms included fever irritable vomiting. Admission temperature: 38.4 degree C. Admission blood results: WBC (white blood cell count x 10^8/L) 15.8. Neu (neutrophil count x 10^8/L) 11.1. CRP (C reactive protein mg/dL) 5.5 (77.4 next day). Lumbar puncture results: Performed on admission. Clear, colourless fluid. WCC (cerebrospinal fluid white cell count per mm3) 18, Nphil (cerebrospinal fluid neutrophil count per mm3) 6, RBC (cerebrospinal fluid red blood cell count per mm3) 742, protein 0.45, Glu (glucose concentration mmol/L) 3.4. The outcome of event was unknown. Pfizer is a marketing authorization holder of pneumococcal 13-valent conjugated vaccine in the country of incidence or the country where the product was purchased (if different). This may be a duplicate report if another marketing authorization holder of pneumococcal 13-valent conjugated vaccine has submitted the same report to the regulatory authorities.; Sender''s Comments: The association between the event aseptic meningitis with pneumococcal 13-valent conjugate vaccine can not be fully excluded based on close temporal relationship. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.,Linked Report(s) : GB-PFIZER INC-2019551759 Same article/drug/event different patient;GB-PFIZER INC-2019553525 Same article/drug/event different patient


VAERS ID: 854795 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2019-12-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTPHIB: DTP + HIB (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / -
IPV: POLIO VIRUS, INACT. (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / -
MENB: MENINGOCOCCAL B (BEXSERO) / NOVARTIS VACCINES AND DIAGNOSTICS - / UNK - / -
PPV: PNEUMO (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Bacterial infection, Bacterial test negative, C-reactive protein increased, CSF glucose normal, CSF neutrophil count increased, CSF protein normal, CSF red blood cell count positive, CSF test normal, CSF white blood cell count increased, Enterovirus test negative, Herpes simplex test negative, Irritability, Meningitis aseptic, Neutrophil count decreased, Pleocytosis, Polymerase chain reaction, Pyrexia, Septic screen, Varicella virus test negative, Viral test negative, White blood cell count normal
SMQs:, Agranulocytosis (broad), Haematopoietic leukopenia (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (narrow), Hostility/aggression (broad), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (broad), 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? No
Hospitalized? Yes, 9 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Parechovirus infection (Parechovirus meningitis with seizures 2 months previously); Seizures (Infant was already suffering from seizures for 2 months prior to the immunisation visit)
Allergies:
Diagnostic Lab Data: Test Name: Bacterial culture; Result Unstructured Data: Test Result: negative; Test Name: Glucose; Result Unstructured Data: Test Result: 2.6, Test Result Unit: mmol/l; Test Name: Body temperature; Result Unstructured Data: Test Result: 38.7, Test Result Unit: Centigrade; Test Name: C-reactive protein; Result Unstructured Data: Test Result: less than 4, Test Result Unit: mg/dl; Test Name: C-reactive protein; Result Unstructured Data: Test Result: 52, Test Result Unit: mg/dl; Test Name: CSF neutrophil count; Result Unstructured Data: Test Result: 14, Test Result Unit: /mm3; Test Name: CSF red blood cell count; Result Unstructured Data: Test Result: 1320, Test Result Unit: /mm3; Test Name: CSF test; Result Unstructured Data: Test Result: negative; Test Name: CSF test; Result Unstructured Data: Test Result: negative; Test Name: CSF test; Result Unstructured Data: Test Result: negative; Test Name: CSF test; Result Unstructured Data: Test Result: negative; Test Name: CSF white blood cell count; Result Unstructured Data: Test Result: 86, Test Result Unit: /mm3; Test Name: Enterovirus test; Result Unstructured Data: Test Result: negative; Test Name: Herpes simplex test; Result Unstructured Data: Test Result: negative; Test Name: Lumbar puncture; Result Unstructured Data: Test Result: Performed next day. Clear, colourless fluid; Test Name: Neutrophil count; Result Unstructured Data: Test Result: 0.15, Test Result Unit: x10 9/l; Test Name: Protein; Result Unstructured Data: Test Result: 0.27, Test Result Unit: mg/dl; Test Name: Varicella virus test; Result Unstructured Data: Test Result: negative; Test Name: Viral test; Result Unstructured Data: Test Result: negative; Test Name: Viral PCR test; Result Unstructured Data: Test Result: negative; Test Name: WBC; Result Unstructured Data: Test Result: 9.2, Test Result Unit: /mm3
CDC Split Type: GBPFIZERINC2019553525

Write-up: Aseptic meningitis associated with routine infant immunisation; This is a literature report. This author has reported similar event in three different patients. This is the third of three reports. Authors would however, like to report the experience of three cases of aseptic meningitis following primary immunisation (including 4CMenB) in infants. All three presented with fever and irritability within 24 hours of vaccination, had a full septic screen including lumbar puncture and received empiric intravenous antibiotics. Subsequent bacterial cultures were all negative as was PCR testing of CSF for meningococcus, pneumococcus and common viral causes of meningitis (enterovirus, parechovirus, herpes simplex and varicella zoster). Antibiotics were stopped after 36-48 hours, when bacterial cultures were reported negative. This cases met the AEFI case definition for aseptic meningitis developed by the Brighton Collaboration to standardise the assessment and improve comparability of cases. All were temporally associated with immunisation but it was not possible to confirm causality. Aseptic meningitis has been reported after immunisation with several live attenuated virus vaccines, including oral polio, combined measles-mumps- rubella, varicella, yellow fever and smallpox vaccines. This three cases, however, did not present with any specific features of meningitis, particularly seizures, had only mildly elevated blood CRP levels and mild pleocytosis (<100 WBC/mm3) in the CSF, with normal protein and glucose concentrations, clear microscopy and, ultimately, negative bacterial cultures and viral PCR tests. None were re-admitted shortly after these presentations with features suggesting partially treated bacterial infection. Our cases highlight additional difficulties faced by frontline clinicians managing infants with post-vaccination fever. Given that $g7 million 4CMenB doses have now been administered to infants, the occurrence of a serious underlying bacterial infection as described by colleagues must be considered very rare but, as the authors rightly conclude, warrants clinicians to remain highly vigilant. In cases where diagnostic uncertainty remains, empiric antibiotics until all investigations are completed may still be the safest option. A 5-month-old (156 days) patient of an unspecified gender received pneumococcal 13-val conj vac (dipht crm197 protein) (manufacture unknown) at single dose, meningococcal vaccine b rfhbp/nada/nhba omv (BEXSERO) at unknown dose and diphtheria vaccine, hib vaccine, pertussis vaccine, polio vaccine, tetanus vaccine (DIPHTHERIA VACCINE;HIB VACCINE;PERTUSSIS VACCINE;POLIO VACCINE;TETANUS) at unknown dose, all via unknown route on unknown date for immunization. Medical history included seizures (Infant was already suffering from seizures for 2 months prior to the immunisation visit), Parechovirus meningitis (Parechovirus meningitis with seizures 2 months previously). The patient''s concomitant medications were not reported. The patient experienced aseptic meningitis associated with routine infant immunisation on an unspecified date with outcome of unknown. The patient was hospitalized for aseptic meningitis associated with routine infant immunisation for 9 days. The patient underwent lab tests and procedures which included bacterial cultures: negative, Glu (blood glucose): 2.6 mmol/l, Admission temperature: 38.7 centigrade, CRP (c-reactive protein): less than 4 mg/dl, 52 mg/dl, Nphil (csf neutrophil count): 14 /mm3, RBC (csf red blood cell count): 1320 /mm3, PCR testing of CSF for meningococcus: negative, negative, PCR testing of CSF for pneumococcus: negative, negative, WCC (csf white blood cell count): 86 /mm3, enterovirus: negative, herpes simplex: negative, lumbar puncture: Performed next day. Clear, colourless fluid, Neu (neutrophil count): 0.15 x10 9/l, protein: 0.27 mg/dl. varicella zoster negative, PCR testing of CSF for meningococcus, viral PCR tests negative, WBC (White blood cell count) 9.2 /mm3, Parechovirus negative. Pfizer is a marketing authorization holder of pneumococcal 13-val conj vac (dipht crm197 protein) in the country of incidence or the country where the product was purchased (if different). This may be a duplicate report if another marketing authorization holder of pneumococcal 13-val conj vac (dipht crm197 protein) has submitted the same report to the regulatory authorities.; Sender''s Comments: The association between the event aseptic meningitis with pneumococcal 13-valent conjugate vaccine can not be fully excluded based on close temporal relationship.,Linked Report(s) : GB-PFIZER INC-2019553524 Same article/drug/event different patient;GB-PFIZER INC-2019551759 Same article/drug/event different patient


VAERS ID: 854796 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:2017-09-13
Onset:2017-09-16
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2019-12-30
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH 22379 / 3 LL / OT

Administered by: Other       Purchased by: ?
Symptoms: Body temperature increased, Cough, Dyspnoea, Physical examination abnormal, Pneumonia
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Comments: None
Allergies:
Diagnostic Lab Data: Test Date: 20170916; Test Name: Body temperature; Result Unstructured Data: Test Result: 38.0-38.4, Test Result Unit: Centigrade; Comments: Body temperature (16Sep2017): 38.0c-38.4c lasting up to 24 hours
CDC Split Type: PLPFIZERINC2019545062

Write-up: Suspicion of pneumonia; Suspicion of pneumonia; Dyspnoea; Numerous auscultatory changes; Severe stertorous cough; 38.0c-38.4c lasting up to 24 hours; This is a spontaneous report from a contactable physician. This is a report received from the Regulatory Authority. Regulatory authority report number PLURPL- N3015/2017. The reporter is contactable to HA only. A 1-year-old patient of an unspecified gender received the first dose and second dose pneumococcal 13-val conj vac (dipht crm197 protein) (PREVENAR 13, lot number and expiry date unknown), via unspecified routes on unspecified dates at single dose for routine childhood immunization, and received the third dose pneumococcal 13-val conj vac (dipht crm197 protein) (PREVENAR 13, lot number: 22379, expiry date: Mar2019), intramuscularly into left thigh at 08:45 on 13Sep2017 at 0.5 ml, single for routine childhood immunization. The patient''s medical history and concomitant medications were not reported. The patient experienced severe stertorous cough, 38.0?c-38.4?c lasting up to 24 hours at 20:00 on 16Sep2017, dyspnea, numerous auscultatory changes, and suspicion of pneumonia on 17Sep2017. All events were reported as serious per hospitalization. The outcome of all events was resolved. Causality for events severe stertorous cough, dyspnea, numerous auscultatory changes, and suspicion of pneumonia was unlikely, causality for event 38.0?c-38.4?c lasting up to 24 hours was possible. SENDER COMMENT: Fever is a complication described in the SmPC of the PREVENAR vaccine, and may also have been associated with the developing infection in the described case. Shortness of breath, cough, auscultation (suspected pneumonia) was probably associated with the developing infection. The person reporting the unexpected postvaccination reaction classified him as serious. Due to hospitalization, Agency qualified an unexpected post-vaccination reaction as severe. No follow-up attempts possible, information about batch number cannot be obtained.


VAERS ID: 854855 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2019-12-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPVX: HPV (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / -

Administered by: Unknown       Purchased by: ?
Symptoms: Epilepsy, Laboratory test
SMQs:, Systemic lupus erythematosus (broad), Convulsions (narrow), Generalised convulsive seizures following immunisation (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: BR0095075131912BRA010781

Write-up: diagnosed with epilepsy; This spontaneous report was received as online news from a consumer via local clipping vendor, referring to an adolescent female patient. The patient''s pertinent medical history, concurrent conditions, previous drug reactions or allergies, and concomitant medications were not reported. On an unknown date, the patient was vaccinated with quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (manufacturer unknown) for prophylaxis (strength, dose number, route of administration, anatomical location, lot number, and expiration date were not reported). On an unknown date, the patient was diagnosed with epilepsy. Accordingly to the report, the patient was performed unspecified tests, that showed that there was no relationship between the symptoms and the vaccination, however the parents did not agree with the diagnosis and they wanted a decent treatment for the girls, therefore the causal relationship between the quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (manufacturer unknown) and the epilepsy was not provided by the consumer. The outcome of epilepsy was not reported. Upon internal review, epilepsy was determined to be medically significant. This is one of two reports received from the same reporter.; Sender''s Comments: BR-009507513-1912BRA011258:


VAERS ID: 854857 (history)  
Form: Version 2.0  
Age: 0.83  
Sex: Male  
Location: Foreign  
Vaccinated:2019-12-17
Onset:2019-12-21
   Days after vaccination:4
Submitted: 0000-00-00
Entered: 2019-12-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MENB: MENINGOCOCCAL B (BEXSERO) / NOVARTIS VACCINES AND DIAGNOSTICS - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Injection site abscess
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? Yes, 1 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: BRGLAXOSMITHKLINEBR2019AM

Write-up: application site abscess; This case was reported by a pharmacist via call center representative and described the occurrence of injection site abscess in a 10-month-old male patient who received Men B NVS (Bexsero) for prophylaxis. Previously administered products included Bexsero (1st dose received on an unknown date). On 17th December 2019, the patient received the 2nd dose of Bexsero. On 21st December 2019, 4 days after receiving Bexsero, the patient experienced injection site abscess (serious criteria hospitalization). The patient was treated with antibiotics nos (Antibiotic (Details Unknown)). On an unknown date, the outcome of the injection site abscess was unknown. It was unknown if the reporter considered the injection site abscess to be related to Bexsero. Additional details were provided as follows: After receiving the second dose of Bexsero vaccine, the patient experienced local site abscess. The mother of the patient took patient to the hospital. The patient was hospitalized on 21st December 2019 and 22nd December 2019. The patient needed to use antibiotic. On 23rd December 2019, the mother of the patient returned to the drug store to report it. The reporter consented to follow up. No other information was provided.


VAERS ID: 854870 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2019-12-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
VARZOS: ZOSTER (SHINGRIX) / GLAXOSMITHKLINE BIOLOGICALS - / 1 - / -

Administered by: Other       Purchased by: ?
Symptoms: Cellulitis
SMQs:

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: CAGLAXOSMITHKLINECA201923

Write-up: cellulitis; This case was reported by a pharmacist via call center representative and described the occurrence of cellulitis in a 83-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis. On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced cellulitis (serious criteria GSK medically significant). On an unknown date, the outcome of the cellulitis was unknown. It was unknown if the reporter considered the cellulitis to be related to Shingrix. Additional case details were reported as follows: The age at vaccination was not reported. The reporter consented to follow up.


VAERS ID: 854871 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2019-12-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: H1N1 influenza, Influenza, Influenza virus test negative, Influenza virus test positive, Malaise, Polymerase chain reaction positive, Vaccination failure
SMQs:, Lack of efficacy/effect (narrow), Infective pneumonia (broad), Opportunistic infections (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: Test Name: Antibody test; Result Unstructured Data: Test Result: see text, Test Result Unit: unknown; Test Name: Polymerase chain reaction; Result Unstructured Data: Test Result: influenza A H1N1 infection, Test Result Unit: unknown
CDC Split Type: CLGLAXOSMITHKLINECL2019GS

Write-up: Suspected vaccination failure; H1N1 influenza; ill; This case was reported in a literature article and described the occurrence of suspected vaccination failure in a adult patient who received Flu unspecified (Flu vaccine) for prophylaxis. On an unknown date, the patient received Flu vaccine at an unknown dose. On an unknown date, less than a year after receiving Flu vaccine, the patient experienced vaccination failure (serious criteria hospitalization and GSK medically significant), h1n1 influenza (serious criteria hospitalization) and unwell (serious criteria hospitalization). On an unknown date, the outcome of the vaccination failure, h1n1 influenza and unwell were unknown. It was unknown if the reporter considered the vaccination failure, h1n1 influenza and unwell to be related to Flu vaccine. Additional details were reported as follows: This case was reported in a literature article and described the suspected vaccination failure in a patient aged between 4 months and 93 years of unspecified gender, who was vaccinated with unspecified influenza vaccine (manufacturer unknown) for prophylaxis. The primary objective of this project was to characterize the clinical, epidemiological and microbiological aspects of patients with health care associated infections (IAAS) by influenza hospitalized in critical patient units (UPC: ICU and Intermediate Care-CI) and Special Care (EC). Secondary objectives assessed compliance with precautions in addition to standard precautions (PAPE) and adherence to influenza vaccination. It was included the patient was hospitalized in CCU and special care with hospital acquired influenza during 2014-2017. [Healthcare-associated infections due to influenza was defined as: symptom onset and/or positive influenza polymerase chain reaction (PCR) after more than 48 hours of hospital admission, without previous respiratory symptoms or previous negative influenza test study. (19/22) of patients had some co-morbidity being the most common high blood pressure (HTA) (13/22). (4/22) of patients were immunocompromised, including patients receiving TOS, TPH, corticosteroid user and newly diagnosed HIV patients]. No information on patient''s medical history, family history, concurrent condition or concomitant medication was provided. On an unspecified date, the patient received unspecified influenza vaccine (administration route and site unspecified, dosage unknown; batch number not provided). The age of vaccination was not provided. On an unspecified date, between 2014 and 2017, an unknown period after the vaccination, the patient fell ill by influenza A H1N1 and did not have a protective antibody titer for A H1N1 (less than 1/40), measured by inhibition of haemagglutination, the first week of onset of symptoms. However, it did have protective titles for influenza A H3N2 (more than or equal to 1/40). The patient had influenza by polymerase chain reaction (PCR) after more than 48 hours of hospital admission. The patient was diagnosed to type A H1N1 influenza infection. [In the institution, RT-PCR is used as a technique of choice in hospitalized patients due to their high sensitivity and specificity, 95% for both viruses. IAAS cases were identified from positive RT-PCR records for influenza viruses processed in the laboratory. The infection was acquired between days 3 and 126 of hospitalization]. This case has been considered as suspected vaccination failure being the time to onset was unknown. This case has been considered serious due to hospitalization and suspected vaccination failure. Treatment was unknown. The outcome of the event was not reported. The author did not comment on the relationship between the event of influenza A H1N1 infection and unspecified influenza vaccine. The author stated, "Before the diagnosis of a patient hospitalized with influenza, the medical conduct is to evaluate the use of antiviral and the appearance of possible complications. With regard to the IAAS handling, it is fundamental to emphasize the adhesion to the recommendations of control of infections, wash of hands and use of PAPE. The vaccination is one of the preventive resources, available and without cost used in programmatic form to protect, between others, the persons older than 65 years and to those with factors of risk of complicated or serious evolution. The effectiveness of the vaccination in these years is not available; nevertheless, do numbers found in the Centers for Disease Control and Prevention (CDC) range between 20 and 48 % from the year 2014 to 2017." The author concluded, "HAI due to influenza occurred in chronic, older and unvaccinated patients. Education about HAIs and continuous high vaccination coverage must be reinforced. IAAS for influenza happened in chronic patients, of major age, which entered for the most part for cause not respiratory and not vaccinated. It is essential in the IAAS prevention for respiratory viruses, the education to the health personnel and the relatives, who can be the source of contagion of these patients, especially in the period peak of the seasonal influenza. As another prop of the prevention, it is necessary to insist on maintaining a high vaccination cover in these patients." This article corresponding to this case is not available for regulatory submission due to copyright restriction. This is 1 of the 2 valid cases reported in the same literature article. Lab Comments: On an unspecified date, between 2014 and 2017, lab test was done. The patient did not have a protective antibody titer for A H1N1 (less than 1/40), measured by inhibition of haemagglutination, the first week of onset of symptoms. However, it did have protective titles for influenza A H3N2 (more than or equal to 1/40).


VAERS ID: 854872 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:2016-05-23
Onset:2016-05-25
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2019-12-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
RV1: ROTAVIRUS (ROTARIX) / GLAXOSMITHKLINE BIOLOGICALS - / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Kawasaki's disease
SMQs:, Vasculitis (narrow), Immune-mediated/autoimmune disorders (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEGLAXOSMITHKLINEDE2019EM

Write-up: Kawasaki Syndrome; This case was reported by a consumer via interactive digital media and described the occurrence of kawasaki''s disease in a infant male patient who received Rota (Rotarix oral suspension) for prophylaxis. Concomitant products included Rota (Rotarix oral suspension). On 23rd May 2016, the patient received the 2nd dose of Rotarix oral suspension (oral). On 25th May 2016, 2 days after receiving Rotarix oral suspension and 30 days after receiving Rotarix oral suspension, the patient experienced kawasaki''s disease (serious criteria GSK medically significant and clinically significant/intervention required). On an unknown date, the outcome of the kawasaki''s disease was not recovered/not resolved. The reporter considered the kawasaki''s disease to be related to Rotarix oral suspension. Additional details were provided as follows: Ther age at vaccination was not provided The patient received Rotarix mit applikator and since 25th May 2016 experienced kawasaki syndrome. The reporter stated that there was no involvement of doctor.


VAERS ID: 854873 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2019-10-18
Onset:2019-10-29
   Days after vaccination:11
Submitted: 0000-00-00
Entered: 2019-12-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
TDAP: TDAP (NO BRAND NAME) / UNKNOWN MANUFACTURER U6116AA4V 6413- / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood test, Computerised tomogram, Dysphagia, Dyspnoea, Gait inability, Gastrointestinal hypomotility, General physical health deterioration, Guillain-Barre syndrome, Heart rate increased, Hypertension, Immunoglobulin therapy, Lumbar puncture, Movement disorder, Paraesthesia, Plasmapheresis, Respiratory distress, Speech disorder
SMQs:, Anaphylactic reaction (broad), Peripheral neuropathy (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Dementia (broad), Akathisia (broad), Dyskinesia (broad), Dystonia (broad), Parkinson-like events (broad), Gastrointestinal perforation, ulcer, haemorrhage, obstruction non-specific findings/procedures (narrow), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Acute central respiratory depression (broad), Psychosis and psychotic disorders (broad), Pulmonary hypertension (broad), Guillain-Barre syndrome (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (broad), Hypertension (narrow), Cardiomyopathy (broad), Demyelination (narrow), Hypersensitivity (broad), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Dehydration (broad), Immune-mediated/autoimmune disorders (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DESA2019SA360667

Write-up: Difficulty swallowing and breathing. Peristalsis partially paralyzed. Difficultly in talking; Unable to move; Chronic Guillain-Barre syndrome; Initial information regarding this unsolicited serious valid case downloaded from Regulatory Authority database without narrative (level 2A), was received on 24-Dec-2019 from a Consumer via the health authority (under the reference number: DE-PEI-CADRPEI-2019005890). The following narrative is based on the information retrieved from all other accessible data. This case involves a 45 years old male patient (184 cm and 95 kg) who experienced difficulty in swallowing, talking and breathing, peristalsis partially paralyzed (Respiratory distress), chronic guillain-barre syndrome (Guillain-Barre syndrome) and unable to move (Movement disorder), while he received vaccine DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [COVAXIS]. The patient medical history, concomitant therapies, medical treatment(s), vaccination(s) and family history were not provided. On 18-Oct-2019, the patient received a dose of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE lot U6116AA4V 6413-C in unknown administration site. On 29-OCT-2019 (first signs noticed), the patient developed a serious chronic guillain-barre syndrome (guillain-barre syndrome)11 days following the administration of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE. This event was assessed as medically significant. The patient was hospitalized for this event. Patient was diagnosed on 30-Oct-2019 as suspected by the general practitioner and since then, patient had been receiving inpatient treatment. On 30-OCT-2019, the patient developed a serious difficulty in swallowing, talking and breathing, peristalsis partially paralyzed (respiratory distress) and unable to move (movement disorder) 12 days following the administration of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE. The event (respiratory distress) was assessed as medically significant. The patient was hospitalized for these events. No lab test was reported. Final diagnosis was chronic guillain-barre syndrome, movement disorder and Respiratory distress. The patient was treated with IMMUNOGLOBULINS (plasmapheresis) and CORTISONE. The patient outcome is reported as Not Recovered / Not Resolved as of 14-Dec-2019 for the events. Causal relationship reported as D. unclassifiable. Sender''s Comments: Not known ; 29.10.2019: First signs of sensation disorders / numbness under feet 30.10.2019: Tingling in hands as well Visit to a family doctor who, with suspected Guillaun-Barree syndrome, refers patients to Hospital for neurology.There, a blood test, CT and lumbar puncture are performed. XX is admitted as an inpatient. 31.10.2019: Deterioration of the health condition - can no longer walk, breathing difficult, is on a monitoring ward. Blood pressure and pulse are very high Approximately 11-1-2019: Start of treatment with immunoglobulins 02.11.2019: Acute condition overcome / survived 07.11.2019: Transfer to hospital XX because immunoglobulins did not help enough. First therapy with plasmapheresis, about 3.5 L per day for 5 days 15.11.2019: Transfer in XX - very fast radical Deterioration of his condition 17.11.2019: Back to XX. Acute condition. Legs and arms no longer movable. Swallowing, breathing, peristalsis very restricted. Pulse, blood pressure very high. Strong colic pain due to constipation Another round of plasmapheresis about 3.5 L per day for 5 days ... a few days after the end of the plasmapheresis the health condition deteriorates again. Another round of plasmapheresis, now 5 L per day for 7 days. Cortisone was added. Currently stable and not in monitoring. May be chronic, possibly lifelong ingestion of immunosuppressive drugs necessary.; Sender''s Comments: Patient experienced chronic Guillain-Barre syndrome, movement disorder and respiratory distress after vaccination. Time to onset is compatible with the role of vaccine. However, further information including patient''s medical history, concomitant medications, previous vaccination and tolerance, laboratory investigations excluding other etiology would be needed to fully assess this case. Based on available information, the role of the vaccine cannot be assessed.


VAERS ID: 854874 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2017-03-31
Onset:2017-04-01
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2019-12-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DT: DT ADSORBED (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Acute disseminated encephalomyelitis, Dysaesthesia, Headache, Monoparesis, Paraesthesia, Rash, Spinal cord oedema, Vaccination complication
SMQs:, Anaphylactic reaction (broad), Peripheral neuropathy (broad), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (narrow), Haemodynamic oedema, effusions and fluid overload (narrow), Demyelination (narrow), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (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: TETAGAM P
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DESA2019SA360668

Write-up: paresis in the right Arm; Acute Disseminated encephalomyelitis (ADEM); Spinal cord edema; Loss / drop of temperature and peak / spiking sensation in the left leg; Paresthesias right shoulder; vaccine reaction; Headache; Exanthem; Initial information regarding this unsolicited serious valid case downloaded from Agency database without narrative (level 2A), was received on 24-Dec-2019 from a Physician via the health authority (under the reference number: DE-PEI-PEI2019008041). The following narrative is based on the information retrieved from all other accessible data. This case involves a 54 years old female patient who experienced paresis in the right arm (Monoparesis), acute disseminated encephalomyelitis (ADEM) (Acute disseminated encephalomyelitis), spinal cord edema (Spinal cord oedema), headache (headache), exanthema (Rash), loss / drop of temperature and peak / spiking sensation in the left leg (Dysaesthesia), paresthesias right shoulder (Paraesthesia) and vaccine reaction (Vaccination complication), while she received vaccines IMMUNOGLOBULIN ANTI-CLOSTRIDIUM TETANI TOXIN (TETAGAM P) and DIPHTHERIA AND TETANUS TOXOIDS (DIPHTHERIA AND TETANUS TOXOIDS). The patient medical history, concomitant therapies, medical treatment(s), vaccination(s) and family history were not provided. On 31-Mar-2017, the patient received a dose of suspect Tetagam P not produced by Sanofi Pasteur lot 32945811F via intramuscular route in unknown administration site. On 31-Mar-2017, the patient received a dose of suspect DIPHTHERIA AND TETANUS TOXOIDS produced by unknown manufacturer lot number not reported via intramuscular route in unknown administration site. On 01-Apr-2017, the patient developed a serious vaccine reaction (vaccination complication), headache (headache), exanthem (rash) 1 day following the administration of DIPHTHERIA AND TETANUS TOXOIDS and TETAGAM P. These events were assessed as medically significant. On 03-Apr-2017, the patient developed a serious paresthesias right shoulder (paraesthesia), loss / drop of temperature and peak / spiking sensation in the left leg (dysaesthesia), paresis in the right arm (monoparesis), acute disseminated encephalomyelitis (ADEM) (acute disseminated encephalomyelitis), spinal cord edema (spinal cord oedema) 3 days following the administration of DIPHTHERIA AND TETANUS TOXOIDS and TETAGAM P. These events were assessed as medically significant. Lab test was not reported. Final diagnosis was Monoparesis, Acute disseminated encephalomyelitis, Spinal cord oedema, headache, Dysaesthesia, Paraesthesia and Vaccination complication. It was not reported if the patient received a corrective treatment. The patient outcome is reported as Recovered / Resolved with Sequelae on an unknown date for the events. (Acute disseminated encephalomyelitis lasted until 12-Dec-2019 after 2 years 8 months 9 days). Reporter assessed the causality with vaccines as Unclassifiable. There will be no information available on the batch number of this case.; Sender''s Comments: Patient experienced Monoparesis, Acute disseminated encephalomyelitis (ADEM), Spinal cord oedema, headache, Dysaesthesia, Paraesthesia and Vaccination complication after use of TETAGAM P and DIPHTHERIA AND TETANUS TOXOIDS (produced by unknown manufacturer). Time to onset is compatible with the role of the suspects. However, further information including patient''s medical history, concomitant medications, previous vaccination and tolerance, laboratory investigations excluding other etiology would be needed to fully assess this case. Based on available information the role of individual suspect product cannot be assessed.


VAERS ID: 854877 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2019-12-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Indifference, Influenza, Malaise, Pyrexia, Somnolence, Vaccination failure
SMQs:, Lack of efficacy/effect (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Infective pneumonia (broad), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: Body temperature; Test Result: 38 {DF}
CDC Split Type: FISA2019SA352978

Write-up: influenza; 38 degree [Celsius] fever; wanted to sleep; influenza was found despite the influenza vaccination; appeared distant; Initial information received on 17-Dec-2019 regarding an unsolicited valid serious case received from a consumer/non-hcp. This case involves a five years old male patient who experienced influenza (influenza), while he received INFLUENZA VACCINE. The patient''s past medical history, medical treatment(s), vaccination(s) and family history were not provided. On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer lot number not reported via unknown route in unknown administration site. On an unknown date, the patient developed a serious influenza with symptoms 38 degree Celsius fever (pyrexia), appeared distant (Indifference) and only wanted to sleep (somnolence) and was getting ill (Unknown latency) following the administration of INFLUENZA VACCINE. On an unknown date, patient was diagnosed with influenza. These events were assessed as medically significant. It is also a case of vaccination failure. Other relevant tests were not reported. Final diagnosis was influenza. It was not reported if the patient received a corrective treatment. The patient outcome was not reported for both the events. There will be no information available on the batch number for this case.; Sender''s Comments: This case concerns a five years old male patient who presented with influenza despite vaccination with the influenza vaccine. The time to onset is unknown. Moreover, there is no information regarding patient''s condition at time of vaccination, immune status, congenital predisposition to respiratory tract infections. Based upon the reported information, the role of the vaccine and a case of vaccination failure cannot be assessed.


VAERS ID: 854882 (history)  
Form: Version 2.0  
Age: 0.17  
Sex: Female  
Location: Foreign  
Vaccinated:2019-10-22
Onset:2019-11-12
   Days after vaccination:21
Submitted: 0000-00-00
Entered: 2019-12-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PPV: PNEUMO (NO BRAND NAME) / UNKNOWN MANUFACTURER A90219 ? / 2 RL / OT
RV1: ROTAVIRUS (ROTARIX) / GLAXOSMITHKLINE BIOLOGICALS AROLC426BC / 2 - / OT
UNK: VACCINE NOT SPECIFIED (NO BRAND NAME) / UNKNOWN MANUFACTURER AOP4A626AC / 2 - / OT
UNK: VACCINE NOT SPECIFIED (NO BRAND NAME) / UNKNOWN MANUFACTURER 220112518A / 2 LL / OT

Administered by: Other       Purchased by: ?
Symptoms: Cough, Diarrhoea, Gastroenteritis, Malaria, Pyrexia, Vaccination failure
SMQs:, Anaphylactic reaction (broad), Lack of efficacy/effect (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Pseudomembranous colitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Noninfectious diarrhoea (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Opportunistic infections (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: Test Date: 20191112; Test Name: Body temperature; Result Unstructured Data: Test Result: more than equal to 38, Test Result Unit: degree C
CDC Split Type: GHGLAXOSMITHKLINEGH2019GS

Write-up: Suspected vaccination failure; Malaria; Infective gastroenteritis; Diarrhoea; Fever; Cough; This case was reported by a other health professional via regulatory authority and described the occurrence of suspected vaccination failure in a 3-month-old female patient who received Rota (Rotarix oral suspension) (batch number AROLC426BC, expiry date unknown) for prophylaxis. Co-suspect products included 10PN-PD-Dit (Pneumococcal vaccine) (batch number A90219 ?, expiry date unknown) for prophylaxis, POLIO SABIN One and Three (batch number AOP4A626AC, expiry date unknown) for prophylaxis and DTPA-HBV+HIB VACCINE (batch number 220112518A, expiry date unknown) for prophylaxis. Additional patient notes included prior to immunization the patient did not have past history of similar event, allergy to vaccine, drug, food, pre- existing illness (30 days) or congenital disorder, hospitalization in last 30 days with cause. On 22nd October 2019, the patient received the 2nd dose of Rotarix oral suspension (oral), the 2nd dose of Pneumococcal vaccine (intramuscular), the 2nd dose of POLIO SABIN One and Three (oral) and the 2nd dose of DTPA-HBV+HIB VACCINE (intramuscular). On 12th November 2019, 21 days after receiving Rotarix oral suspension, Pneumococcal vaccine and POLIO SABIN One and Three and an unknown time after receiving DTPA-HBV+HIB VACCINE, Artesunate, paracetamol, cefuroxime and metronidazole, the patient experienced vaccination failure (serious criteria hospitalization and GSK medically significant), malaria (serious criteria hospitalization and GSK medically significant), infective gastroenteritis (serious criteria hospitalization), diarrhea (serious criteria hospitalization), fever (serious criteria hospitalization) and cough (serious criteria hospitalization). The patient was treated with sodium artesunate (Artesunate), paracetamol, cefuroxime, metronidazole, hedera helix extract (Linctus Syrup (Hedera Helix Extract)), glucose + potassium chloride + sodium bicarbonate + sodium chloride (Ors), zinc and ice pack (no medication). On an unknown date, the outcome of the vaccination failure, malaria, infective gastroenteritis, diarrhea, fever and cough were recovering/resolving. It was unknown if the reporter considered the vaccination failure, malaria, infective gastroenteritis, diarrhea, fever and cough to be related to Rotarix oral suspension, pneumococcal vaccine and POLIO SABIN One and Three. Additional case details were reported as follows: The reporter was patient''s mother. The patient was full term female infant delivered via normal delivery. It was unknown whether the patient had family history of any disease. The patient did not receive concomitant medication. The patient received routine vaccine OPV, pneumococcal vaccine and rotavirus vaccine. The patient received routine vaccines DTPA-HBV+HIB VACCINE in left thigh. The patient received pneumococcal vaccine in right thigh. The auto disable syringes were used for immunization. It was unknown in which session the patient was immunized. The patient was sent to the site on the same day of vaccination and returned from the site on the same day of vaccination, also conditioned ice pack were used. On 12th November 2019, the patient presented with fever (more than equal to 38 Degree Celsius), cough and diarrhea. The patient was then treated as a case of severe malaria and infective gastroenteritis. On 13th November 2019, the patient hospitalized. There was no any similar events reported within the time period, similar to when the adverse event occurred and in the same locality. There was no any error in prescribing or non-adherence to recommendations for use of this vaccine. The reporter does not felt that the vaccine administered could have been unsterile. There was no any abnormal physical condition in the vaccine at the time of administration. There was no any error in vaccine reconstitution or preparation by the vaccinator nor any error in vaccine handling. The reporter did not felt that the vaccine was administered incorrectly. The same reconstitution syringes were not used for multiple vials of same vaccine and different vaccines. The separate reconstitution syringe were used for each vaccine vial and each vaccination. The same vaccines and diluents were used as recommended by the manufacturer. The temperature of the vaccine storage refrigerator was monitored and there was no any deviation outside of 2 to 8 degree Celsius after the vaccine was placed inside. The correct procedure for storage of vaccines, diluents and syringes were followed and there was no any other item was in refrigerator or freezer. It was unknown whether there was any partially used reconstituted vaccine in the freezer or unusable vaccines in the refrigerator. There was no any unusable diluent in the store. On an unknown date, the patient was discharged. The patient was recovering on discharged. It was unknown if the reporter considered the malaria, infective gastroenteritis, diarrhea, fever and cough to be related to DTPA-HBV+HIB VACCINE. As per sales data sheet reported batch number for vaccine OPV was changed from AOP462AC to AOP4A626AC. This case was considered as suspected vaccination failure as details regarding full vaccination schedule and time to onset for the event was unknown at the time of reporting. The case was reported from a Hospital from the Ministry. This is 1 of the 11 linked cases reported by the same reporter. Lab Comments: On 12th November 2019, lab test was performed.


VAERS ID: 854883 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2007-06-01
Onset:2007-06-01
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2019-12-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DT: DT ADSORBED (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / OT
DTAP: DTAP (INFANRIX) / GLAXOSMITHKLINE BIOLOGICALS - / UNK - / OT
HIBV: HIB (HIBERIX) / GLAXOSMITHKLINE BIOLOGICALS - / UNK - / OT
IPV: POLIO VIRUS, INACT. (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / OT
MMR: MEASLES + MUMPS + RUBELLA (PRIORIX) / GLAXOSMITHKLINE BIOLOGICALS - / UNK - / OT
UNK: VACCINE NOT SPECIFIED (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Bronchitis, Chills, Crying, Diarrhoea, Dyspnoea, Ear infection, Ear pain, Food refusal, General physical health deterioration, Henoch-Schonlein purpura, Injection site swelling, Malaise, Pneumonia, Pyrexia, Rhinitis, Sepsis syndrome, Thrombocytopenia, Vomiting
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Haematopoietic thrombocytopenia (narrow), Haemorrhage terms (excl laboratory terms) (narrow), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Pseudomembranous colitis (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Extravasation events (injections, infusions and implants) (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Depression (excl suicide and self injury) (broad), Vasculitis (narrow), Hypersensitivity (narrow), Noninfectious diarrhoea (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (narrow), Infective pneumonia (narrow), Sepsis (narrow), Opportunistic infections (broad), Immune-mediated/autoimmune disorders (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: HRSA2019SA360663

Write-up: otitis/inflammation of the ear; pain in the ear; thrombocytopenia; HS purpura. Autoimmune disease; general poor condition of the child; temperature 40; the leg is swollen; sepsis syndrome; unspecified pneumonia; temperature 40; shaking; temperature +40; vomiting in proximity to every other meal; difficulty breathing; bronchitis; she no longer wanted to eat; she cried inconsolably for hours; unspecified pneumonia; vomiting in proximity to / vomiting in a wide arch; Rhinitis; shaking; high temp; not eating; diarrhea every 15 min; Initial information regarding this unsolicited valid serious case downloaded from database without narrative (level 2A), was received on 24-Dec-2019 from consumer/non-healthcare professional via health authority (under the reference number: HR-HALMED-2019-04040). The following narrative is based on the information retrieved from all other accessible data. This case involves Infant female patient who experienced food refusal (she no longer wanted to eat) (food refusal), unspecified pneumonia (pneumonia), temperature 40/ high temp/pyrexia (pyrexia), bronchitis (bronchitis), vomiting in proximity to every other meal (vomiting), difficulty breathing (dyspnoea), not eating (food refusal), temperature 40/ high temp/pyrexia (pyrexia), cried inconsolably for hours (crying), unspecified pneumonia (pneumonia), serious shaking (chills), the leg is swollen (vaccination site oedema), temperature 40/ high temp/pyrexia (pyrexia), general poor condition of the child (malaise), sepsis syndrome (sepsis syndrome), temperature 40/ high temp/pyrexia (pyrexia), vomiting in proximity to / vomiting in a wide arch (vomiting), shaking (chills), rhinitis (rhinitis), diarrhea every 15 min (diarrhoea), otitis/inflammation of the ear (ear infection), pain in the ear (ear pain), thrombocytopenia (thrombocytopenia) and HS purpura. autoimmune disease (henoch-schonlein purpura), while she received vaccines DIPHTHERIA AND TETANUS TOXOIDS, POLIOMYELITIS VACCINE (INACTIVATED), HIB VACCINE CONJ (TET TOX) [HIBERIX], DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR 3-COMPONENT, TETANUS VACCINE TOXOID [INFANRIX], MEASLES VACCINE LIVE (SCHWARTZ), MUMPS VACCINE LIVE (RIT 4385), RUBELLA VACCINE LIVE (WISTAR RA 27/3) [PRIORIX] and POLIO VACCINE LIVE ORAL. Past medical history, medical treatment(s), vaccination(s) and family history were not provided. In July 2007, the patient received a dose of suspect POLIOMYELITIS VACCINE (INACTIVATED) produced by unknown manufacturer lot number not reported via unknown route in unknown administration site and In June 2007, the patient received a dose of suspect HIBERIX not produced by Sanofi Pasteur lot number not reported via unknown route in unknown administration site. In 2014, the patient received a dose of suspect PRIORIX not produced by Sanofi Pasteur lot number not reported via unknown route in unknown administration site and a dose of suspect DIPHTHERIA AND TETANUS TOXOIDS produced by unknown manufacturer lot number not reported via unknown route in unknown administration site. On an unknown date, the patient received a dose of suspect INFANRIX not produced by Sanofi Pasteur lot number not reported via unknown route in unknown administration site and a dose of suspect POLIO VACCINE LIVE ORAL not produced by Sanofi Pasteur lot number not reported via unknown route in unknown administration site. In Jun-2007, the patient developed a serious food refusal (she no longer wanted to eat) (food refusal), unspecified pneumonia (pneumonia) (unknown latency) following the administration of POLIOMYELITIS VACCINE (INACTIVATED), DIPHTHERIA AND TETANUS TOXOIDS, PRIORIX, POLIO VACCINE LIVE ORAL, INFANRIX and HIBERIX. These events were assessed as medically significant. The patient was hospitalized for these events. In Jul-2007, the patient developed a serious temperature 40/ high temp/pyrexia (pyrexia), bronchitis (bronchitis), vomiting in proximity to every other meal (vomiting), difficulty breathing (dyspnoea), not eating (food refusal) (unknown latency) following the administration of POLIOMYELITIS VACCINE (INACTIVATED), DIPHTHERIA AND TETANUS TOXOIDS, PRIORIX, POLIO VACCINE LIVE ORAL, INFANRIX and HIBERIX. These events were assessed as medically significant. The patient was hospitalized for these events. In Aug-2007, the patient developed a serious temperature 40/ high temp/pyrexia (pyrexia), cried inconsolably for hours (crying), unspecified pneumonia (pneumonia), serious shaking (chills) (unknown latency) following the administration of POLIOMYELITIS VACCINE (INACTIVATED), DIPHTHERIA AND TETANUS TOXOIDS, PRIORIX, POLIO VACCINE LIVE ORAL, INFANRIX and HIBERIX. These events were assessed as medically significant. The patient was hospitalized for these events. On 18-Oct-2007, the patient developed a serious the leg is swollen (vaccination site oedema), (unknown latency) following the administration of POLIOMYELITIS VACCINE (INACTIVATED), DIPHTHERIA AND TETANUS TOXOIDS, PRIORIX, POLIO VACCINE LIVE ORAL, INFANRIX and HIBERIX. This event was assessed as medically significant. The patient was hospitalized for this event. On 26-Oct-2007, the patient developed a serious temperature 40/ high temp/pyrexia (pyrexia), general poor condition of the child (malaise) (unknown latency) following the administration of POLIOMYELITIS VACCINE (INACTIVATED), DIPHTHERIA AND TETANUS TOXOIDS, PRIORIX, POLIO VACCINE LIVE ORAL, INFANRIX and HIBERIX. These events were assessed as medically significant. The patient was hospitalized for these events. In Oct-2007, the patient developed a serious syndrome (sepsis syndrome) (unknown latency) following the administration of POLIOMYELITIS VACCINE (INACTIVATED), DIPHTHERIA AND TETANUS TOXOIDS, PRIORIX, POLIO VACCINE LIVE ORAL, INFANRIX and HIBERIX. This event was assessed as medically significant. The patient was hospitalized for this event. In 2007, the patient developed a serious temperature 40/ high temp/pyrexia (pyrexia), vomiting in proximity to / vomiting in a wide arch (vomiting), shaking (chills), rhinitis (rhinitis), diarrhea every 15 min (diarrhoea) (unknown latency) following the administration of POLIOMYELITIS VACCINE (INACTIVATED), DIPHTHERIA AND TETANUS TOXOIDS, PRIORIX, POLIO VACCINE LIVE ORAL, INFANRIX and HIBERIX. These events were assessed as medically significant. The patient was hospitalized for these events. In 2014, the patient developed a serious otitis/inflammation of the ear (ear infection), pain in the ear (ear pain), thrombocytopenia (thrombocytopenia), HS purpura. autoimmune disease (henoch-schonlein purpura) (unknown latency) following the administration of POLIOMYELITIS VACCINE (INACTIVATED), DIPHTHERIA AND TETANUS TOXOIDS, PRIORIX, POLIO VACCINE LIVE ORAL, INFANRIX and HIBERIX. These events were assessed as medically significant. The patient was hospitalized for these events. Laboratory details were not reported. Final diagnosis was food refusal, pyrexia, bronchitis, vomiting, dyspnoea, pneumonia, crying, chills, vaccination site oedema, malaise, rhinitis, diarrhoea, ear infection, ear pain, thrombocytopenia, henoch-schonlein purpura and sepsis syndrome. It was not reported if the patient received a corrective treatment. The patient had recovered from vaccination site oedema on 20-Oct-2007, in Aug-2007 from pneumonia, pyrexia and chills, in 2007 from pyrexia, chills, food refusal, sepsis syndrome, malaise, vomiting, diarrhea, food refusal and pneumonia and recovered on an unknown date from pyrexia, crying, dyspnoea, vomiting, bronchitis and food refusal. The event outcome for ear infection, ear pain, thrombocytopenia, henoch-schonlein purpura and rhinitis were not reported. There will be no information available on the batch number for this case.; Sender''s Comments: This case concerns an infant female patient who was presented with food refusal, pyrexia, bronchitis, vomiting, dyspnoea, pneumonia, crying, chills, vaccination site oedema, malaise, rhinitis, diarrhoea, ear infection, ear pain, thrombocytopenia, henoch-schonlein purpura and sepsis syndrome following the vaccination with POLIOMYELITIS VACCINE (INACTIVATED) (unknown manufacturer), DIPHTHERIA AND TETANUS TOXOIDS (unknown manufacturer), PRIORIX (other manufacturer), POLIO VACCINE LIVE ORAL (other manufacturer), INFANRIX (other manufacturer) and HIBERIX (other manufacturer). The time to onset is unknown. The patient''s birth history, and lab data ruling out other etiologies would be needed for complete assessment of the case. Based upon the reported information, the role of an individual vaccine cannot be assessed.


VAERS ID: 854884 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:2017-04-19
Onset:2017-04-19
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2019-12-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTP: DTP (NO BRAND NAME) / UNKNOWN MANUFACTURER 20915004A / 3 RA / OT
HIBV: HIB (ACTHIB) / SANOFI PASTEUR M51002V / 3 LL / OT
IPV: POLIO VIRUS, INACT. (NO BRAND NAME) / UNKNOWN MANUFACTURER AIPVB093BB / 2 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Hypotonic-hyporesponsive episode, Vomiting
SMQs:, Acute pancreatitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hypotonic-hyporesponsive episode (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: PLSA2019SA360672

Write-up: Hypotonic-hyporesponsive episode; Vomiting; Initial information regarding this unsolicited serious valid case downloaded from Agency database without narrative (level 2A), was received on 24-Dec-2019 from a Physician via the health authority (under the reference number: PL-URPL-N1225/2017). The following narrative is based on the information retrieved from all other accessible data. This case involves a 6 months old patient of unknown gender who experienced hypotonic-hyporesponsive episode (Hypotonic-hyporesponsive episode) and vomiting (vomiting), while he/she received vaccines DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE, TETANUS VACCINE TOXOID (DTP), POLIO VACCINE INACT 3V (VERO) (POLIORIX) and HIB (PRP/T) VACCINE [ACT-HIB]. The patient medical history, concomitant therapies, medical treatment(s), vaccination(s) and family history were not provided. On 19-Apr-2017, the patient received a 0.5 ml third dose of suspect HIB (PRP/T) VACCINE lot M51002V via unknown route in the left thigh. On 19-Apr-2017, the patient received a 0.5 ml second dose of suspect POLIORIX not produced by Sanofi Pasteur lot AIPVB093BB via intracardiac route in the left arm. On 19-Apr-2017, the patient received a 0.5 ml third dose of suspect DTP not produced by Sanofi Pasteur lot 20915004A via unknown route in the right arm. On 19-Apr-2017, the patient developed a serious hypotonic-hyporesponsive episode (Hypotonic-hyporesponsive episode) and vomiting (vomiting) same day following the administration of HIB (PRP/T) VACCINE, POLIORIX and DTP. The patient was hospitalized for these events. No lab test was reported. Final diagnosis was vomiting and hypotonic-hyporesponsive episode. It was not reported if the patient received a corrective treatment. The patient outcome is reported as Recovered on an unknown date for the events. Reporter assessed the causality with vaccines as Possible.; Reporter''s Comments: Vomiting and hypotonic-hyporesponsive episode are the expected adverse effects and included in the Summary of Product Characteristics of DTP, however vomiting is also expected adverse effect included in the Summary of Product Characteristics of Poliorix. In relation to the listed symptoms, the occurring temporal incidence speaks for a causal relationship. The adverse post-vaccination effect was qualified by the reporting person as non-severe. In accordance with the Pharmaceutical Law due to hospitalization of the child the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products qualified the adverse post-vaccination effect as severe.; Sender''s Comments: Patient experienced Hypotonic-hyporesponsive episode and vomiting after vaccination with ACT-HIB, POLIORIX and DTP.. Time to onset is compatible with the role of vaccine. However, further information including patient''s medical history, concomitant medications, previous vaccination and tolerance, laboratory investigations excluding other etiology would be needed to fully assess this case. Based on available information the role of individual vaccine cannot be assessed.


VAERS ID: 854885 (history)  
Form: Version 2.0  
Age: 0.08  
Sex: Female  
Location: Foreign  
Vaccinated:2015-03-26
Onset:2015-03-26
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2019-12-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTP: DTP (NO BRAND NAME) / UNKNOWN MANUFACTURER 20913002A ? / UNK LL / OT

Administered by: Other       Purchased by: ?
Symptoms: Apnoea, Hypotonic-hyporesponsive episode
SMQs:, Acute central respiratory depression (narrow), Hypotonic-hyporesponsive episode (narrow), Respiratory failure (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? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: PLGLAXOSMITHKLINEPL201923

Write-up: Apnea; Hypotonic-hyporesponsive episode; This case was reported by a physician via regulatory authority and described the occurrence of apnea in a 1-month-old female patient who received DTP (A or W not known) (DTP vaccine) (batch number 20913002A ?, expiry date unknown) for prophylaxis. On 26th March 2015, the patient received DTP vaccine (intramuscular) .5 ml. On 26th March 2015, less than a day after receiving DTP vaccine, the patient experienced apnea (serious criteria hospitalization and GSK medically significant) and hypotonic-hyporesponsive episode (serious criteria hospitalization). On an unknown date, the outcome of the apnea and hypotonic-hyporesponsive episode were recovering/resolving. The reporter considered the apnea and hypotonic-hyporesponsive episode to be probably related to DTP vaccine. Additional details: Patient received vaccine on left thigh. Batch number reported for DTP vaccine 20913002A does not match with any GSK lot number. Other Assessment by agency,WHO, was reported as Probable. Initial information was reported by a physician via regulatory authority on 24th December 2019. Apnea and hypotonic-hyporesponsive episode. Sender''s comments: The hypotonic-hyporeactive episode is a pressure drop accompanied by decreased muscle tone, pallor of the coatings, disturbed consciousness and drowsiness. This is the expected adverse reaction after administration of the DTP vaccine, as described in its Summary of Product Characteristics and also in the medical literature. On the other hand, pneumonia already diagnosed in the hospital is an unexpected reaction for the DTP preparation as well as rarely reported. In the database of adverse reactions reports.


VAERS ID: 854915 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2019-09-01
Onset:2019-09-01
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2019-12-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
VARZOS: ZOSTER (SHINGRIX) / GLAXOSMITHKLINE BIOLOGICALS - / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Abdominal pain upper, Constipation, Death, Decreased appetite, Dermatomyositis, Dyspnoea exertional, Febrile infection, General physical health deterioration, Pain in extremity
SMQs:, Acute pancreatitis (broad), Pulmonary hypertension (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Tendinopathies and ligament disorders (broad), Immune-mediated/autoimmune disorders (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2019-11-12
   Days after onset: 72
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Febrile infection
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEGLAXOSMITHKLINEDE201923

Write-up: Death; Exertional dyspnea; Appetite lost; Pain in arm; General physical health deterioration; Obstipation; Dermatomyositis; Febrile infection; Stomach pain; This case was reported by a physician via regulatory authority and described the occurrence of stomach pain in a 84-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis. The patient''s past medical history included febrile infection. Additional patient notes included Z.n. Hamstring. In September 2019, the patient received Shingrix (unknown). In September 2019, less than a month after receiving Shingrix, the patient experienced stomach pain (serious criteria death and hospitalization), exertional dyspnea (serious criteria death and hospitalization), appetite lost (serious criteria death and hospitalization), pain in arm (serious criteria death and hospitalization), general physical health deterioration (serious criteria death and hospitalization), obstipation (serious criteria death and hospitalization), dermatomyositis (serious criteria death, hospitalization and GSK medically significant) and febrile infection (serious criteria death and hospitalization). On 12th November 2019, the patient experienced death (serious criteria death, hospitalization and GSK medically significant). On an unknown date, the outcome of the stomach pain, death, exertional dyspnea, appetite lost, pain in arm, general physical health deterioration, obstipation, dermatomyositis and febrile infection were fatal. The patient died on 12th November 2019. The reported cause of death was dermatomyositis, febrile infection, stomach pain, exertional dyspnea, appetite lost, pain in arm, general physical health deterioration and obstipation. It was unknown if the reporter considered the stomach pain, death, exertional dyspnea, appetite lost, pain in arm, general physical health deterioration, obstipation, dermatomyositis and febrile infection to be related to Shingrix. Additional details: The age at vaccination was not reported, however the patient could be 83 or 84 years old at a time of vaccination. Agency considered that the stomach pain, death, exertional dyspnea, appetite lost, pain in arm, general physical health deterioration and obstipation to be related to Shingrix. Initial information as received from a physician via regulatory authority on 26th December 2019: Stomach pain, death pain, exertional dyspnea, appetite lost, Pain in arm, general physical health deterioration, obstipation; Reported Cause(s) of Death: Dermatomyositis; Febrile infection; Stomach pain; exertional dyspnea; appetite lost; Pain in arm; general physical health deterioration; obstipation


VAERS ID: 854916 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2015-12-17
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2019-12-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPIPV: DTAP + IPV (UNKNOWN) / UNKNOWN MANUFACTURER - / 3 - / OT
HIBV: HIB (ACTHIB) / SANOFI PASTEUR - / 3 - / OT
MMR: MEASLES + MUMPS + RUBELLA (NO BRAND NAME) / UNKNOWN MANUFACTURER M030820 / UNK - / OT
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH M13062 / 3 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Crying, Dry skin, Emotional distress, Failure to thrive, Frustration tolerance decreased, Injection site erythema, Injection site pruritus, Poor quality sleep, Scratch, Skin hypertrophy, Skin wound, Vaccination site dryness, Vaccination site eczema, Vaccination site granuloma, Vaccination site haemorrhage, Vaccination site irritation, Vaccination site reaction, Vaccination site scar
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Accidents and injuries (narrow), Extravasation events (injections, infusions and implants) (broad), Depression (excl suicide and self injury) (broad), Neonatal disorders (broad), Hypersensitivity (narrow), Dehydration (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DKSA2019SA354174

Write-up: The patient becomes upset and frustrated; The patient is very affected and crying; skin irritation on the right thigh; itching on the right thigh; poor well-being / affected and crying; the skin feels rough and worn; Itching / scratches for blood / scratch marks; wound; Redness; poor sleep; Approximately one in the thigh was observed. 4 cm wide area of eczema; thickened skin; scars due to itching; granuloma; Initial information regarding an unsolicited valid serious case downloaded from regulatory authority database without narrative (level 2A), was received on 17-Dec-2019 from a lawyer and other health care professional via Health Authority (under reference DK-DKMA-ADR 24452414). The following narrative is based on the information retrieved from all other accessible data. This case involves a three months old male patient who experienced failure to thrive (poor well-being / affected and crying) (failure to thrive), redness (vaccination site erythema), poor sleep (sleep disorder), approximately one in the thigh was observed. 4 cm wide area of eczema (vaccination site eczema), itching / scratches for blood / scratch marks (scratch), wound (skin wound), thickened skin (vaccination site hypertrophy), scars due to itching (vaccination site scar), granuloma (vaccination site granuloma), the patient becomes upset and frustrated (frustration tolerance decreased), itching on the right thigh (vaccination site pruritus), the patient is very affected and crying (crying), skin irritation on the right thigh (vaccination site irritation) and the skin feels rough and worn (dry skin), while he received vaccines HIB (PRP/T) VACCINE [ACT-HIB], DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR 1-COMPONENT, POLIO VACCINE INACT 3V (VERO), TETANUS VACCINE TOXOID [DITEKIPOL], MEASLES VACCINE LIVE (ENDERS-EDMONSTON), MUMPS VACCINE LIVE (JERYL LYNN), RUBELLA VACCINE LIVE (WISTAR RA 27/3) [MMRVAXPRO] and PNEUMOCOCCAL VACCINE CONJ 13V (CRM197) [PREVENAR 13]. Past medical history, medical treatment(s) and family history were not provided. The patient received doses (first, second and third) of suspect HIB (PRP/T) VACCINE (solution for injection) and DITEKIPOL (solution for injection) via unknown route in the thigh on 17-Dec-2015, 18-Feb-2016 and 29-Sep-2016 respectively (the reported lot were KOMP 0145, KOMP 0146 and KOMP 0149). The patient received doses (first, second and third) of suspect PREVENAR 13 (solution for injection) via unknown route in the thigh on 17-Dec-2015, 18-Feb-2016 and 29-Sep-2016 respectively (the reported lot were M13062, L70453 and M40877 respectively). On 12-Dec-2016, the patient received a dose (one dosage form) of suspect MMRVAXPRO (not produced by Sanofi Pasteur) lot M030820 via unknown route in the thigh. On an unknown date in 2016 the patient developed a serious failure to thrive (poor well-being / affected and crying) (failure to thrive) (unknown latency) following the first, second and last dose intake of ACT-HIB, PREVENAR 13, DITEKIPOL and MMRVAXPRO VACCINE. This event was assessed as medically significant. On an unknown date in 2016, the patient developed a non-serious redness (vaccination site erythema), poor sleep (sleep disorder), 4 cm wide area of eczema in the thigh (vaccination site eczema), itching / scratches for blood / scratch marks (scratch), wound (skin wound), thickened skin (vaccination site hypertrophy), scars due to itching (vaccination site scar), granuloma (vaccination site granuloma), itching on the right thigh (vaccination site pruritus), crying (crying), skin irritation on the right thigh (vaccination site irritation) and the skin feels rough and worn (dry skin) (unknown latency) following the first, second and last dose intake of ACT-HIB, PREVENAR 13, DITEKIPOL and MMRVAXPRO VACCINE. On an unknown date, the patient developed a non-serious event that the patient becomes upset and frustrated (frustration tolerance decreased) on an unknown latency following the first, second and last dose intake of ACT-HIB, PREVENAR 13, DITEKIPOL and MMRVAXPRO VACCINE. Relevant laboratory data not reported. Final diagnosis was failure to thrive, vaccination site erythema, sleep disorder, vaccination site eczema, scratch, skin wound, vaccination site hypertrophy, vaccination site scar, vaccination site granuloma, frustration tolerance decreased, vaccination site pruritus, crying, vaccination site irritation and dry skin. It was not reported if the patient received a corrective treatment. The patient was not recovered from all the adverse events. Sender''s Comments: Patient compensation/claim; Sender''s Comments: This case involves a three months old male patient who experienced failure to thrive, vaccination site erythema, sleep disorder, vaccination site eczema, scratch, skin wound, vaccination site hypertrophy, vaccination site scar, vaccination site granuloma, frustration tolerance decreased, vaccination site pruritus, crying, vaccination site irritation and dry skin after vaccination with ACT-HIB, DITEKIPOL (other manufacturer), PREVENAR 13 (other manufacturer) and MMRVAXPRO (other manufacturer). The time to onset is unknown. However, patient''s medical history, medical condition at time of vaccination and lab test ruling out alternate etiologies were not reported. Based upon the reported information the role of an individual vaccine cannot be assessed


VAERS ID: 854917 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2014-07-07
Onset:2014-08-17
   Days after vaccination:41
Submitted: 0000-00-00
Entered: 2019-12-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPIPV: DTAP + IPV (INFANRIX TETRA) / GLAXOSMITHKLINE BIOLOGICALS - / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Guillain-Barre syndrome
SMQs:, Peripheral neuropathy (narrow), Guillain-Barre syndrome (narrow), Demyelination (narrow), Immune-mediated/autoimmune disorders (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRGLAXOSMITHKLINEFR201923

Write-up: Guillain-Barre syndrome; This case was reported by a physician via regulatory authority and described the occurrence of guillain barre syndrome in a 11-year-old male patient who received DTPa-IPV (Infanrixtetra) for prophylaxis. On 7th July 2014, the patient received the 1st dose of Infanrixtetra (intramuscular) 1 dosage form(s). On 17th August 2014, 41 days after receiving Infanrixtetra, the patient experienced guillain barre syndrome (serious criteria hospitalization and GSK medically significant). In 2019, the outcome of the guillain barre syndrome was resolved with sequelae. It was unknown if the reporter considered the guillain barre syndrome to be related to Infanrixtetra. Additional details: Age at vaccination was not reported, however the patient could be 11 or 12 years old at time of vaccination. Initial information was reported by a physician via regulatory authority on 20th December 2019: Guillain-Barre syndrome


VAERS ID: 854918 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2019-10-04
Onset:2019-10-14
   Days after vaccination:10
Submitted: 0000-00-00
Entered: 2019-12-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER T13 / UNK - / OT
TYP: TYPHOID VI POLYSACCHARIDE (TYPHIM VI) / SANOFI PASTEUR P1D761V / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Asthenia, Cough, Myalgia, Pyrexia, Rhinorrhoea
SMQs:, Rhabdomyolysis/myopathy (broad), Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Guillain-Barre syndrome (broad), Eosinophilic pneumonia (broad), Tendinopathies and ligament disorders (broad), 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? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRSA2019SA361154

Write-up: Cough; Rhinorrhea; Myalgia; Asthenia; Pyrexia; Initial information regarding this unsolicited valid serious case downloaded from Regulatory Authority database without narrative (level 2A), was received on 26-Dec-2019 from physician via health authority (under the reference number: FR-AFSSAPS-MA20192716). The following narrative is based on the information retrieved from all other accessible data. This case involves a 40 years old male patient who experienced asthenia, cough, pyrexia, rhinorrhea and myalgia, while he received vaccines INFLUENZA VACCINE INACT SAG 4V and TYPHOID VI POLYSACCHARIDE VACCINE [TYPHIM VI]. Past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 04-Oct-2019, the patient received a dose of suspect TYPHOID VI POLYSACCHARIDE VACCINE lot P1D761V via intramuscular route in unknown administration site and the patient received a dose of suspect INFLUENZA VACCINE INACT SAG 4V not produced by Sanofi Pasteur lot T13 via intramuscular route in unknown administration site. On 14-Oct-2019, the patient developed a serious asthenia (asthenia), cough (cough), pyrexia (pyrexia), myalgia (myalgia) and rhinorrhea (rhinorrhoea) 10 days following the administration of TYPHOID VI POLYSACCHARIDE VACCINE and INFLUVAC TETRA. These events were assessed as medically significant. Laboratory details were not reported. Final diagnosis was myalgia, rhinorrhea, pyrexia, cough and asthenia. It was not reported if the patient received a corrective treatment. The patient had recovered from all the events on an unknown date.; Sender''s Comments: This case concerns a 40 year old male patient who presented with asthenia, cough, pyrexia, rhinorrhea and myalgia 10 days following the vaccination with TYPHIM VI and INFLUVAC TETRA (other manufacturer). The time to onset is compatible. The patient''s past medical history, concomitant medications and lab data ruling out other etiologies would be needed for complete assessment of the case. Based upon the reported information, the role of an individual vaccine cannot be assessed.


VAERS ID: 854920 (history)  
Form: Version 2.0  
Age: 0.08  
Sex: Unknown  
Location: Foreign  
Vaccinated:2017-11-02
Onset:2017-11-02
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2019-12-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
6VAX-F: DTAP+IPV+HEPB+HIB (INFANRIX HEXA) / GLAXOSMITHKLINE BIOLOGICALS A21CD103A / 1 RL / OT
RV1: ROTAVIRUS (ROTARIX) / GLAXOSMITHKLINE BIOLOGICALS AROLB860AF / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Anxiety, Crying
SMQs:, Depression (excl suicide and self injury) (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:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: PLGLAXOSMITHKLINEPL201923

Write-up: Anxiety; Crying; This case was reported by a physician via regulatory authority and described the occurrence of anxiety in a 1-month-old patient who received Rota (Rotarix liquid formulation) (batch number AROLB860AF, expiry date September 2019) for prophylaxis. Co-suspect products included DTPa-HBV-IPV+Hib (Infanrix hexa) (batch number A21CD103A, expiry date September 2019) for prophylaxis. On 2nd November 2017 11:55, the patient received the 1st dose of Rotarix liquid formulation (oral) 1.5 ml and the 1st dose of Infanrix hexa (intramuscular) .5 ml. On 2nd November 2017 22:00, 10 hrs 5 min after receiving Rotarix liquid formulation and Infanrix hexa, the patient experienced anxiety (serious criteria other) and persistent crying (serious criteria other). On an unknown date, the outcome of the anxiety and persistent crying were recovered/resolved. The reporter considered the anxiety and persistent crying to be possibly related to Rotarix liquid formulation and Infanrix hexa. Additional details: Patient received Infanrix hexa on right thigh. Batch number for Infanrix hexa was reported as A21CO103A, however on batch number review it was corrected to A21CD103A. Duration of persistent crying was reported as 2 days. Other Assessment by WHO, Possible. Initial information was reported by a physician via regulatory authority on 24th December 2019. Anxiety and persistent crying. Sender''s comments: Anxiety and unceasing crying are expected side effects after administration of the Infanrix Hexa vaccine included in the Summary of Product Characteristics. Irritability is an expected adverse reaction following Rotarix vaccine administration included in the Summary of Product Characteristics. Uncommonly crying is an unexpected adverse reaction after administration of Rotarix not described in the SmPC. NOP was classified as severe.


VAERS ID: 854921 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2017-12-20
Onset:2017-12-01
Submitted: 0000-00-00
Entered: 2019-12-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTP: DTP (NO BRAND NAME) / UNKNOWN MANUFACTURER 20916002B ? / 2 RL / OT
HIBV: HIB (ACTHIB) / SANOFI PASTEUR M54421V / 2 RL / OT
IPV: POLIO VIRUS, INACT. (POLIOVAX) / SANOFI PASTEUR M74982V / 1 LL / OT
PNC10: PNEUMO (SYNFLORIX) / GLAXOSMITHKLINE BIOLOGICALS ASPNA803AB / 2 LL / OT
RV1: ROTAVIRUS (ROTARIX) / GLAXOSMITHKLINE BIOLOGICALS AROLB955BI / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Diarrhoea, Rash, Urticaria, Vomiting
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Angioedema (narrow), Pseudomembranous colitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hypersensitivity (narrow), Noninfectious diarrhoea (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? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: PLGLAXOSMITHKLINEPL201923

Write-up: Vomiting; Generalised rash; Diarrhea; Urticaria; This case was reported by a physician via regulatory authority and described the occurrence of vomiting in a 3-month-old male patient who received 10PN-PD-Dit (Synflorix) (batch number ASPNA803AB, expiry date 31st March 2019) for prophylaxis. Co-suspect products included DTP (A or W not known) (DTP vaccine) (batch number 20916002B ?, expiry date 31st August 2019) for prophylaxis, Rota (Rotarix liquid formulation) (batch number AROLB955BI, expiry date January 2020) for prophylaxis, HAEMOPHILUS INFLUENZA B VACCINE (ACT-HIB) (batch number M54421V, expiry date 31st August 2018) for prophylaxis and IMOVAX POLIO (batch number M74982V, expiry date 30th September 2018) for prophylaxis. On 20th December 2017 13:00, the patient received the 2nd dose of Synflorix (intramuscular) .5 ml, the 2nd dose of DTP vaccine (intramuscular) .5 ml, the 2nd dose of Rotarix liquid formulation (oral) .5 ml, the 2nd dose of ACT-HIB (intramuscular) .5 ml and the 1st dose of IMOVAX POLIO (intramuscular) .5. On 22nd December 2017 18:00, 2 days 5hrs after receiving Synflorix, DTP vaccine and Rotarix liquid formulation, the patient experienced vomiting (serious criteria hospitalization), generalized rash (serious criteria hospitalization), diarrhea (serious criteria hospitalization) and urticaria (serious criteria hospitalization). In December 2017, the outcome of the vomiting, generalized rash, diarrhea and urticaria were recovered/resolved. The reporter considered the vomiting, generalized rash, diarrhea and urticaria to be possibly related to Synflorix, DTP vaccine and Rotarix liquid formulation. Additional details: Age at vaccination was not reported however patient could be 2 or 3 months old at time of vaccination. Patient received Synflorix on upper part of left thigh, DTP on upper part of right thigh. Batch number reported for DTP vaccine 20916002B does not match with any GSK lot number Batch number for Rotarix was reported as AROLB955BIV , however on batch number review it was corrected to AROLB955BI. Other Assessment by regulatory authority,WHO was reported as Possible. The reporter considered the vomiting, generalized rash, diarrhea and urticaria to be possibly related to IMOVAX POLIO and Act hib. Initial information was reported by a physician via regulatory authority on 24th December 2019. Vomiting, generalized rash, diarrhea and urticarial. Sender''s comments: Urticaria, rash - reactions expected for all vaccines (except urticaria for Rotarix - unexpected). Diarrhea, vomiting - reactions expected for DTP, Syntlorix and Rotarix vaccines; unexpected for Act-Hib, Imovax Polio. The temporal relationship speaks for a causal relationship. Due to the simultaneous administration of the vaccines, it is not possible to clearly indicate which of them is responsible for the onset of symptoms. The reporting person qualified NOP as severe.


VAERS ID: 854922 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:2016-12-19
Onset:2016-12-21
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2019-12-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
6VAX-F: DTAP+IPV+HEPB+HIB (INFANRIX HEXA) / GLAXOSMITHKLINE BIOLOGICALS A21CC816A / 1 LL / OT
RV1: ROTAVIRUS (ROTARIX) / GLAXOSMITHKLINE BIOLOGICALS AROLB580AL / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Apnoea, Gaze palsy, Hypotonia, Hypotonic-hyporesponsive episode
SMQs:, Peripheral neuropathy (broad), Acute central respiratory depression (narrow), Guillain-Barre syndrome (broad), Ocular motility disorders (narrow), Hypotonic-hyporesponsive episode (narrow), Generalised convulsive seizures following immunisation (broad), Respiratory failure (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: PLGLAXOSMITHKLINEPL201923

Write-up: Eyeballs raise upward; episode with apnea (lasting 20 seconds); Flaccidity; This case was reported by a physician via regulatory authority and described the occurrence of eyeballs raise upward in a 2-month-old patient who received DTPa-HBV-IPV+Hib (Infanrix hexa) (batch number A21CC816A, expiry date July 2018) for prophylaxis. Co-suspect products included Rota (Rotarix liquid formulation) (batch number AROLB580AL, expiry date September 2018) for prophylaxis. On 19th December 2016, the patient received the 1st dose of Infanrix hexa (subcutaneous) .5 ml and the 1st dose of Rotarix liquid formulation (oral) 1.5 ml. On 21st December 2016, 2 days after receiving Infanrix hexa and Rotarix liquid formulation, the patient experienced eyeballs raise upward (serious criteria hospitalization and GSK medically significant), hypotonic-hyporesponsive episode (serious criteria hospitalization) and flaccidity (serious criteria hospitalization). On 21st December 2016, the outcome of the hypotonic-hyporesponsive episode was recovered/resolved. On an unknown date, the outcome of the eyeballs raise upward and flaccidity were recovered/resolved. It was unknown if the reporter considered the eyeballs raise upward and flaccidity to be related to Infanrix hexa and Rotarix liquid formulation. The reporter considered the hypotonic-hyporesponsive episode to be probably related to Infanrix hexa. The reporter considered the hypotonic-hyporesponsive episode to be possibly related to Rotarix liquid formulation. Additional information: The age at vaccination was not reported however patient could be 1 or 2 months old at the time of vaccination. The WHO assessment was reported as possible and probable. The anatomical location of vaccine Infanrix hexa was reported as left thigh. The reported route of Infanrix hexa was subcutaneous however as per global data sheet correct route was intramuscular but as per recent update kept as it is. Initial information was received from a Physician via regulatory authority on 24th December 2019: Episode with apnea (lasting 20 seconds,Eyeballs raise upward and Flaccidity. Reporter''s comments: Hypotonic-hyporeactive (HHE) episode is a reaction after vaccination, which consists of: inertia or decrease in muscle tone, decreased and weakened reaction to external stimuli, drowsiness, skin color disorder (pallor or cyanosis), age below 10 years, sudden onset symptom within 48 hours from vaccination, duration from one minute to 48 hours. Expected adverse reaction after administration of INFANRlX HEXA vaccine included in its Medicinal Product Characteristics.hyporeactive (HHE), however for a medicinal product ROTARlX is it unexpected action not disclosed not in Product Characteristics Characteristics. Until 13.01.2017 in the regulatory authority database 225 cases were reported HHE after vaccine administration ROTARlX. Due to simultaneous administration of two vaccines, indication is not possible only one that contributes symptoms. The time relationship speaks for relationship causally - and effect. Quenching person NOP knows him for "serious" regulatory authority due to qualification original, necessary hospitalization and nature works unwanted qualify the NOP as "heavy"


VAERS ID: 854923 (history)  
Form: Version 2.0  
Age: 0.17  
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2019-12-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
RV1: ROTAVIRUS (ROTARIX) / GLAXOSMITHKLINE BIOLOGICALS - / 2 - / OT
RV1: ROTAVIRUS (ROTARIX) / GLAXOSMITHKLINE BIOLOGICALS - / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Rotavirus infection, Rotavirus test positive, Vaccination failure
SMQs:, Lack of efficacy/effect (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? Yes, 4 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: Rotavirus test; Result Unstructured Data: Test Result: positive, Test Result Unit: unknown
CDC Split Type: TRGLAXOSMITHKLINETR2019TR

Write-up: lack of efficacy; severe rota infection; This case was reported by a physician via sales rep and described the occurrence of vaccination failure in a 5-month-old female patient who received Rota (Rotarix) for prophylaxis. Co-suspect products included Rota (Rotarix) for prophylaxis. On an unknown date, the patient received the 2nd dose of Rotarix (oral) and the 1st dose of Rotarix (oral). On an unknown date, 1 month 25 days after receiving Rotarix and 3 months 25 days after receiving Rotarix, the patient experienced vaccination failure (serious criteria hospitalization and GSK medically significant) and rotavirus infection (serious criteria hospitalization). On an unknown date, the outcome of the vaccination failure and rotavirus infection were unknown. It was unknown if the reporter considered the vaccination failure and rotavirus infection to be related to Rotarix and Rotarix. Additional details were provided as follows: The Pediatrist stated that, the patient received 1st dose at 2 months of age and 2nd dose at 4 months of age. After vaccination the patient admitted to hospital due to sever rotavirus infection. At the time of reporting the patient was 5 months and twenty five days old. The patient was hospitalized for 4 days. Lab Comments: Lab test performed on an unknown date


VAERS ID: 854939 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2019-07-26
Onset:2019-08-16
   Days after vaccination:21
Submitted: 0000-00-00
Entered: 2019-12-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEPA: HEP A (HAVRIX) / GLAXOSMITHKLINE BIOLOGICALS AHAVB984AQ / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Pancreatitis acute
SMQs:, Acute pancreatitis (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? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Allergy
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRGLAXOSMITHKLINEFR201923

Write-up: Pancreatitis acute; This case was reported by a consumer via regulatory authority and described the occurrence of pancreatitis acute in a 8-year-old male patient who received HAV (Havrix) (batch number AHAVB984AQ, expiry date unknown) for prophylaxis. Concurrent medical conditions included allergy. On 26th July 2019, the patient received Havrix (intramuscular) 1 dosage form(s). On 16th August 2019, 21 days after receiving Havrix, the patient experienced pancreatitis acute (serious criteria GSK medically significant and other: serious as per reporter). On 4th October 2019, the outcome of the pancreatitis acute was recovered/resolved. It was unknown if the reporter considered the pancreatitis acute to be related to Havrix. Additional details: The age at vaccination was not reported, however the patient could be 7 to 8 years old at the time of vaccination. The events duration was reported 50 days. Initial information was reported by a consumer via regulatory authority on 24th December 2019: Pancreatitis acute.


VAERS ID: 854940 (history)  
Form: Version 2.0  
Age: 0.17  
Sex: Female  
Location: Foreign  
Vaccinated:2015-01-15
Onset:2015-01-15
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2019-12-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTP: DTP (NO BRAND NAME) / UNKNOWN MANUFACTURER 20913001C ? / UNK RA / OT
HEP: HEP B (FOREIGN) / MERCK & CO. INC. UFA14005 / UNK LL / OT
HIBV: HIB (HIBERIX) / GLAXOSMITHKLINE BIOLOGICALS A72CA864A / UNK RA / OT

Administered by: Other       Purchased by: ?
Symptoms: Abdominal pain, Bronchitis, Pyrexia
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Retroperitoneal fibrosis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (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? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: PLGLAXOSMITHKLINEPL201923

Write-up: Colic; Fever; Bronchitis; This case was reported by a physician via regulatory authority and described the occurrence of colic in a 2-month-old female patient who received DTP (A or W not known) (DTP vaccine) (batch number 20913001C ?, expiry date June 2016) for prophylaxis. Co-suspect products included Hib (Hiberix) (batch number A72CA864A, expiry date June 2016) for prophylaxis and HEPATITIS B VACCINE (EUVAX B) (batch number UFA 14005, expiry date December 2016) for prophylaxis. On 15th January 2015, the patient received DTP vaccine (unknown) .5 ml, Hiberix (unknown) .5 ml and EUVAX B (unknown) .5 ml. On 15th January 2015, less than a day after receiving DTP vaccine and Hiberix, the patient experienced colic (serious criteria other: serious as per reporter), fever (serious criteria other: serious as per reporter) and bronchitis (serious criteria other: serious as per reporter). In 2015, the outcome of the colic, fever and bronchitis were recovered/resolved. The reporter considered the colic, fever and bronchitis to be possibly related to DTP vaccine and Hiberix. Additional details: The DTP batch number was reported as 20913001C. However based on a batch number review, no identical match was found. The patient received DTP and Hiberix vaccine on right arm, Euvax B on left thigh. Initial information was reported by a physician via regulatory authority on 24th December 2019: Colic, fever and bronchitis. Sender''s comments: Bronchitis is an expected side effect only for the DTP vaccine. It is not included in the Summary of Product Characteristics for the other two vaccines. It is also a rarely reported reaction. In the database of adverse reactions Regulatory Authority, only 6 cases of bronchitis were reported after vaccination with Hiberix and 1 after vaccination with Euvax B. On the other hand, colic is the expected reaction and occurs only after administration of Euvax B.


VAERS ID: 854955 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2019-12-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH - / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Cough, Rhinorrhoea, Sleep disorder
SMQs:, Anaphylactic reaction (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: CAPFIZERINC2019556939

Write-up: Cough; Rhinorrhoea; Sleep disorder; This is a Spontaneous report from a contactable other unspecified healthcare professional. This is a report received from the Regulatory Authority via an on-line database search. The Regulatory authority report number is E2B_02578679. This information was initially reported to Regulatory Authority on 16May2019 from an unknown Market Authorization Holder (AER# 20190515134511_2143). A 60-year-old male patient received pneumococcal 13-val conj vac (dipht crm197 protein) (PREVNAR 13) parenterally on an unspecified date at single dose for prophylaxis/pneumonia/immunization. The patient''s medical history and concomitant medications were not reported. The patient experienced cough, rhinorrhoea and sleep disorder on an unspecified date. The events were serious with criteria disability and other medically important conditions. The outcome of the events was not resolved. No follow-up attempts are possible, information about batch number cannot be obtained.


VAERS ID: 854956 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2019-12-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PPV: PNEUMO (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Asthma, Bacterial disease carrier, Blood count abnormal, Bronchiectasis, Chest discomfort, Cough, Drug ineffective, Dry mouth, Dyspnoea, Fatigue, Malaise, Multiple allergies, Pulmonary function test abnormal, Rales, Respiratory tract infection, Rhonchi, Secretion discharge, Sensitisation, Sinusitis, Sleep disorder, Sputum purulent, Wheezing
SMQs:, Anaphylactic reaction (broad), Angioedema (broad), Asthma/bronchospasm (narrow), Haematopoietic cytopenias affecting more than one type of blood cell (broad), Lack of efficacy/effect (narrow), Anticholinergic syndrome (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Hypersensitivity (narrow), Infective pneumonia (broad), Dehydration (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: GUAIFENESIN; ARNUITY ELLIPTA; CLARITIN ALLERGY + SINUS; FLUTICASONE FUROATE; SINGULAIR; UMECLIDINIUM BROMIDE; VENTOLIN HFA
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: Blood count; Result Unstructured Data: Test Result: abnormal; Test Name: Pulmonary function test; Result Unstructured Data: Test Result: abnormal
CDC Split Type: CAPFIZERINC2019557675

Write-up: Drug ineffective; Respiratory tract infection; Chest discomfort; Cough; Rales; Dyspnoea; Rhonchi; Sputum purulent; Fatigue; Bacterial disease carrier; Blood count abnormal; Dry mouth; Asthma; Wheezing; Malaise; Multiple allergies; Bronchiectasis; Pulmonary function test abnormal; Secretion discharge; Sinusitis; Sensitisation; Sleep disorder; This is a Non-Interventional Study report from a contactable consumer via the Regulatory Authority via an on-line database search. Regulatory authority report number E2B_02576470. This information was initially reported to Regulatory Authority on 15May2019 from an unknown Market Authorization Holder AER# CA2019GSK077646. A 53-year-old male patient received pneumococcal 13-val conj vac (dipht crm197 protein) (manufacturer unknown) on an unspecified date at single dose for immunisation and guaifenesin (manufacturer unknown) oral, fluticasone furoate (ARNUITY ELLIPTA) inhalation, loratadine, pseudoephedrine sulfate (CLARITIN ALLERGY + SINUS), fluticasone furoate/vilanterol trifenatate (manufacturer unknown) inhalation, montelukast sodium (SINGULAIR), umeclidinium bromide (manufacturer unknown), salbutamol sulfate (VENTOLIN HFA) metered-dose (aerosol), all at an unspecified dose, from an unspecified date to an unspecified date for an unspecified indication. The patient medical history and concomitant medications were not reported. On an unspecified date the patient experienced: drug ineffective, asthma, bacterial disease carrier, blood count abnormal, bronchiectasis, chest discomfort, cough, dry mouth, dyspnoea, fatigue, malaise, multiple allergies, pulmonary function test abnormal, rales, respiratory tract infection, rhonchi, secretion discharge, sensitisation, sinusitis, sleep disorder, sputum purulent and wheezing, all considered serious as medically important conditions. The action taken in response to the events for guaifenesin ,fluticasone furoate, loratadine/ pseudoephedrine sulfate, fluticasone furoate/vilanterol trifenatate, montelukast, umeclidinium bromide and salbutamol sulfate was unknown. The final outcome of all the events was unknown. The reporter''s assessment of the causal relationship of the events with the suspect products was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment. No follow-up attempts are possible, information about batch number cannot be obtained.; Sender''s Comments: Based on the information currently available, a lack of efficacy with pneumococcal 13-valent conjugate vaccine towards the occurrence of respiratory tract infection in this patient cannot be completely excluded. Further information like confirmative pathological/serotype results and the specific location of respiratory tract infection are needed for full medical assessment. chest discomfort, cough, rales, rhonchi, sputum purulent, dyspnea are compatible with the symptoms/ signs of respiratory tract infection. A contributory role of the suspected drug in the onset of fatigue cannot be fully excluded. All other events wheezing, asthma, bacterial disease carrier, blood count abnormal, bronchiectasis, pulmonary function test abnormal, secretion discharge, sinusitis, malaise, multiple allergies, sensitization, sleep disorder and dry mouth more likely represent underlying medical conditions unlikely related to both suspected drugs. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.


VAERS ID: 854958 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2019-12-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Aspiration joint, Inflammation, Joint effusion
SMQs:, Haemodynamic oedema, effusions and fluid overload (narrow), Arthritis (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: GCFLU
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: KRPFIZER INC2019555846

Write-up: Inflammation; Water filled in his knee; Inflammation; Water filled in his knee; This is a spontaneous report from a contactable physician via Chongkundang Pharmaceutical Corp (manufacturer control number KR-CKD-20191223002), license party for pneumococcal 13-val conj vac (dipht crm197 protein) (PREVENAR 13). A 60-year-old male patient received vaccination with pneumococcal 13-val conjugate vaccine (dipht crm197 protein) (PREVENAR 13) on an unspecified date, unspecified route of administration, at single dose for immunisation. Relevant medical history was not reported. Concomitant medication included influenza vaccine inact split virion 3v (GCFLU) given at the same time of pneumococcal 13-val conjugate vaccine (dipht crm197 protein). After vaccination, the patient developed inflammation, so he visited a general hospital. No external factor was confirmed. The physician thought that the event occurred as GCFLU and PREVENAR 13 were vaccinated together. Water filled in his knee, so the patient was given action of draining water off from his knee. The outcome of the events was unknown. The information on the batch/lot number has been requested. Amendment: This follow- up report is being submitted to amend previously reported information. The events were upgraded to serious as medically significant.; Sender''s Comments: Based on the information currently available, it cannot be fully excluded that the vaccination with PREVENAR 13 might have played a contributory role in triggering the occurrence of both reported events considering the plausible time association. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.


VAERS ID: 854982 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2019-11-03
Onset:2019-11-22
   Days after vaccination:19
Submitted: 0000-00-00
Entered: 2019-12-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
VARZOS: ZOSTER LIVE (ZOSTAVAX) / MERCK & CO. INC. - / UNK - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Herpes zoster, Pain, Vomiting
SMQs:, Acute pancreatitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Opportunistic infections (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: cetirizine hydrochloride; citalopram hydrochloride; propranolol hydrochloride
Current Illness: Varicella immunisation
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GB0095075131912GBR012157

Write-up: Vomiting; Pain; Developed shingles after having shingles vaccine; Information has been downloaded from regulatory authority (GB-MHRA-ADR 24458643). This spontaneous report was received from a consumer regarding a 62-year-old female patient. The patient''s past drug and medical history, as well as her concurrent medical conditions, were not reported. Her concomitant medications included cetirizine hydrochloride, citalopram hydrochloride, and propranolol hydrochloride. On 03-NOV-2019, the patient was vaccinated with Zoster Vaccine Live (ZOSTAVAX) 1 dosage form, by parenteral route, as varicella immunisation (lot number was unknown; formulation, strength, dose number and frequency in the scheme, anatomical location of vaccination, and expiration date were not reported). On 22-NOV-2019, the patient developed shingles after having shingles vaccine (herpes zoster). Additionally, on unspecified dates, the patient experienced vomiting and pain. At the time of the report, the patient had not recovered from shingles; and the outcome of vomiting and pain was unknown The causal relationship between the occurrence of the events and vaccination with Zoster Vaccine Live (ZOSTAVAX) was not provided. The events of shingles, vomiting, and pain were reported to be medically significant.


VAERS ID: 854987 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2019-12-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEP: HEP B (RECOMBIVAX HB) / MERCK & CO. INC. - / UNK - / -

Administered by: Unknown       Purchased by: ?
Symptoms: Hepatitis B surface antibody negative, Hepatitis B surface antigen positive, Therapy non-responder
SMQs:, Liver infections (narrow), Lack of efficacy/effect (narrow), Opportunistic infections (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: Therapy non-responder
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: anti-HBs; Test Result: Negative ; Test Name: HBsAg; Test Result: Positive
CDC Split Type: US0095075131912USA012700

Write-up: non responsive to Hepatitis B vaccine; This information has been received from the authors of the published literature article as stated above. This report was regarding a male nursing assistant of unknown age. He was evaluated by Occupational Health Service (OHS) at the initiation of employment. On unspecified date, the patient was vaccinated with Hepatitis B Vaccine (Recombinant) (manufacturer unknown) (dosage, route, anatomical location, lot # and expiration date were not provided) for prophylaxis in order to meet criteria as the patient was a healthcare personnel (HCP). He did not have written documentation of his prior hepatitis B immunization, per OHS protocol, so he was offered serologic testing or revaccination. He refused both options and instead signed the Occupational Safety and Health Administration (OSHA)-required declination. He later presented to OHS and requested an anti-HBs titer because he needed documentation to take classes. Because his anti-HBs was negative, per OHS protocol, a HBsAg was obtained on his blood sample and subsequently was reported as positive. He was referred to hepatology for further evaluation and consideration of treatment. The authors considered that the patient failed to respond to a complete HBV vaccine series (vaccination failure). The authors considered the event to be related to suspect therapy. At the reporting time, the patient''s outcome was unknown. A copy of the published article is attached as further documentation of the patient''s experience. This is one of several reports received from the same literature.; Sender''s Comments: US-009507513-1912USA012701: US-009507513-1912USA012702: US-009507513-1912USA011716:


VAERS ID: 854988 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2019-12-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEP: HEP B (RECOMBIVAX HB) / MERCK & CO. INC. - / UNK - / -

Administered by: Unknown       Purchased by: ?
Symptoms: Hepatitis B surface antibody negative, Hepatitis B surface antigen positive, Therapy non-responder
SMQs:, Liver infections (narrow), Lack of efficacy/effect (narrow), Opportunistic infections (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: Therapy non-responder
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: HBsAg; Test Result: Positive
CDC Split Type: US0095075131912USA012701

Write-up: non responsive to Hepatitis B vaccine; This information has been received from the authors of the published literature article as stated above. This report was regarding a female medical resident of unknown age. She stated that she had had 2 hepatitis B vaccine series (6 total doses) and was informed by her medical school that she was a "nonresponder". On unspecified date, the patient was vaccinated with Hepatitis B Vaccine (Recombinant) (manufacturer unknown) (dosage, route, anatomical location, lot # and expiration date were not provided) for prophylaxis in order to meet criteria as the patient was a healthcare personnel (HCP). By her report, a HBsAg was not obtained by her medical school. She refused any further testing and signed the Occupational Safety and Health Administration (OSHA)-required declination. Within her first year of work, she requested clearance for international travel and, per OHS protocol, an anti-HBsAg and HBsAg were obtained; the anti-HBsAb was 47 mIU/mL and the HBsAg was positive. She was referred to hepatology for further evaluation and consideration of treatment. The authors considered that the patient failed to respond to a complete HBV vaccine series (vaccination failure). The authors considered the event to be related to suspect therapy. At the reporting time, the patient''s outcome was unknown. A copy of the published article is attached as further documentation of the patient''s experience. This is one of several reports received from the same literature.; Sender''s Comments: US-009507513-1912USA011716: US-009507513-1912USA012700: US-009507513-1912USA012702:


VAERS ID: 854989 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2019-12-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEP: HEP B (RECOMBIVAX HB) / MERCK & CO. INC. - / UNK - / -

Administered by: Unknown       Purchased by: ?
Symptoms: Hepatitis B surface antibody negative, Hepatitis B surface antigen positive, Therapy non-responder
SMQs:, Liver infections (narrow), Lack of efficacy/effect (narrow), Opportunistic infections (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: Therapy non-responder
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: anti-HBs; Test Result: Negative ; Test Name: HBsAg; Test Result: Positive
CDC Split Type: US0095075131912USA012702

Write-up: non responsive to Hepatitis B vaccine; This information has been received from the authors of the published literature article as stated above. This report was regarding a female medical resident of unknown age. She stated that she had had 5 HBV vaccine doses because she was a "nonresponder" after her first 3-dose series and requested her sixth dose. On unspecified date, the patient was vaccinated with Hepatitis B Vaccine (Recombinant) (manufacturer unknown) (dosage, route, anatomical location, lot # and expiration date were not provided) for prophylaxis in order to meet criteria as the patient was a healthcare personnel (HCP). One month after her sixth dose, per Occupational Health Service (OHS) protocol, an anti-HBs titer was obtained which was negative. Because her anti-HBs was negative, per protocol, a HBsAg was obtained, which was positive. She was referred to hepatology for further evaluation and consideration of treatment. The authors considered that the patient failed to respond to a complete HBV vaccine series (vaccination failure). The authors considered the event to be related to suspect therapy. At the reporting time, the patient''s outcome was unknown. A copy of the published article is attached as further documentation of the patient''s experience. Literature report: This is one of several reports received from the same literature.; Sender''s Comments: US-009507513-1912USA011716: US-009507513-1912USA012700: US-009507513-1912USA012701:


VAERS ID: 854999 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2019-11-13
Onset:2019-11-18
   Days after vaccination:5
Submitted: 0000-00-00
Entered: 2019-12-31
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEPA: HEP A (VAQTA) / MERCK & CO. INC. S021379 / UNK - / OT
YF: YELLOW FEVER (STAMARIL) / SANOFI PASTEUR R3L813V / UNK - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Aggression, Brief psychotic disorder with marked stressors, Logorrhoea, Malaise
SMQs:, Dementia (broad), Psychosis and psychotic disorders (narrow), Hostility/aggression (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? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Immunisation
Preexisting Conditions: Medical History/Concurrent Conditions: Pigmented retinopathy NOS
Allergies:
Diagnostic Lab Data:
CDC Split Type: FR0095075131912FRA012283

Write-up: Aggressiveness; Bouffees delirantes; Malaise; Logorrhea; Information has been downloaded from Regulatory Authority (FR-AFSSAPS-PB20191377). This spontaneous report was received from a physician regarding a 29-year-old female patient. Her concurrent conditions included pigmented retinopathy. Her medical history and concomitant medications were not provided. On 13-NOV-2019, the patient was vaccinated with hepatitis A vaccine, inactivated (VAQTA) 1 dosage form (lot number S021379 has been verified to be a valid lot number, expiration date not reported, but upon internal validation established as 31-AUG-2021) and with yellow fever virus vaccine (STAMARIL) 1 dosage form (lot number reported as R3L813V and expiration date not provided) both administered intramuscularly as vaccination (anatomical location and dose numbers were not provided). Subsequently, on 18-NOV-2019, the patient experienced aggressiveness (aggression), bouffees delirantes (brief psychotic disorder with marked stressors), malaise and logorrhea. All the events required the hospitalization of the patient on an unspecified date in 2019. At the time of this report, the patient had recovered from malaise, and was recovering from aggression, brief psychotic disorder with marked stressors and logorrhea. There was no causality assessment provided between vaccination with hepatitis A vaccine, inactivated (VAQTA) and yellow fever virus vaccine (STAMARIL), and the and the occurrence of the events.


VAERS ID: 855041 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2013-02-15
Onset:2013-03-11
   Days after vaccination:24
Submitted: 0000-00-00
Entered: 2020-01-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPIPV: DTAP + IPV (UNKNOWN) / UNKNOWN MANUFACTURER H0301-16285-A / UNK - / OT
HEPA: HEP A (HAVRIX) / GLAXOSMITHKLINE BIOLOGICALS AHAVB649AE / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Asthenia, Chills, Fatigue, Hallucination, Headache, Hyperhidrosis, Pain in extremity, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Psychosis and psychotic disorders (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DEGLAXOSMITHKLINEDE201923

Write-up: Hallucinations; High fever; Pain in limb; Sweating attack; Exhaustion; Headache; Weakness; Chills; This case was reported by a consumer via regulatory authority and described the occurrence of hallucinations in a 32-year-old male patient who received HAV (Havrix 1440) (batch number AHAVB649AE, expiry date unknown) for prophylaxis. Co-suspect products included DIPHTHERIA TOXOID + PERTUSSIS TOXOID + POLIOMYELITIS VACCINE + TETANUS TOXOID (REPEVAX) (batch number H0301-16285-A, expiry date unknown) for prophylaxis. On 15th February 2013, the patient received Havrix 1440 (unknown) and REPEVAX (intracardiac). On 11th March 2013, 24 days after receiving Havrix 1440, the patient experienced hallucinations (serious criteria GSK medically significant), pyrexia, pain in limb, sweating attack, exhaustion, headache, weakness and chills. On 25th March 2013, the outcome of the hallucinations, pyrexia, pain in limb, sweating attack, exhaustion, headache, weakness and chills were recovered/resolved. It was unknown if the reporter considered the hallucinations, pyrexia, pain in limb, sweating attack, exhaustion, headache, weakness and chills to be related to Havrix 1440. Additional details: The age at vaccination was not reported, however the patient could be 31 to 32 years old at the time of vaccination. The event duration was reported 15 days. The assessment was reported Unclassifiable. Initial information was reported by a consumer via regulatory authority on 20th December 2019: Hallucinations, pyrexia, pain in limb, sweating attack, exhaustion, headache, weakness and chills. Sender''s comments: No


VAERS ID: 855042 (history)  
Form: Version 2.0  
Age: 0.33  
Sex: Male  
Location: Foreign  
Vaccinated:2019-12-10
Onset:2019-12-10
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2020-01-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
6VAX-F: DTAP+IPV+HEPB+HIB (INFANRIX HEXA) / GLAXOSMITHKLINE BIOLOGICALS A21CD491A / UNK - / OT
RV5: ROTAVIRUS (ROTATEQ) / MERCK & CO. INC. S012946 / UNK - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Seizure
SMQs:, Systemic lupus erythematosus (broad), Convulsions (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (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? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Prophylactic vaccination
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DE0095075131912DEU012290

Write-up: Seizure; Information has been downloaded from Regulatory Authority (DE-PEI-PEI2019008046). This spontaneous report has been received from a physician, and refers to a 4 month old male patient. The patient''s medical history, concurrent conditions, and concomitant medications were not provided. On 10-DEC-2019, the patient was vaccinated with rotavirus vaccine, live, oral, pentavalent (ROTATEQ) orally, lot # S012946 (with an expiration date of 31-JAN-2021 upon internal validation); and hib conj vaccine (tet toxoid), diphtheria toxoid, hepatitis b virus vaccine rhbsag (yeast), pertussis acellular 3-component vaccine, poliovirus vaccine inactivated (vero), tetanus toxoid (INFANRIX HEXA) intramuscularly, lot # A21CD491A. Both vaccines were administered for prophylactic vaccination. Then, on the same day, the patient experienced a seizure that lasted for 10 seconds. However, the patient recovered from the event on a non-reported date. The causality assessment between the event and the suspect vaccines was not provided by the agency.


VAERS ID: 855043 (history)  
Form: Version 2.0  
Age: 0.5  
Sex: Unknown  
Location: Foreign  
Vaccinated:2019-10-17
Onset:2019-10-17
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2020-01-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MENB: MENINGOCOCCAL B (BEXSERO) / NOVARTIS VACCINES AND DIAGNOSTICS - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Febrile convulsion, Irritability, Pyrexia, Tremor
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Convulsions (narrow), Parkinson-like events (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hostility/aggression (broad), Generalised convulsive seizures following immunisation (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? Yes
ER Visit? No
ER or Doctor Visit? Yes
Hospitalized? No
Previous Vaccinations:
Other Medications: Bexsero
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20191017; Test Name: Body temperature; Result Unstructured Data: Test Result: 39.9, Test Result Unit: degree C
CDC Split Type: ESGLAXOSMITHKLINEES2019EM

Write-up: seizures/ fever; tremors; irritability; This case was reported by a nurse via sales rep and described the occurrence of febrile seizure in a 6-month-old male patient who received Men B NVS (Bexsero) for prophylaxis. Concomitant products included Men B NVS (Bexsero). On 17th October 2019, the patient received the 2nd dose of Bexsero. On 17th October 2019, 30 min after receiving Bexsero, the patient experienced febrile seizure (serious criteria GSK medically significant), tremor and irritability. On an unknown date, the outcome of the febrile seizure, tremor and irritability were unknown. The reporter considered the febrile seizure, tremor and irritability to be related to Bexsero. Additional details were provided as follows: On 16th August 2019, at the age of 4 months, the patient received 1st dose of Bexsero. The patient was 8 months old at the time of reporting. After 30 minutes of the administration, the patient started with tremors, seizures, irritability and a 39.9 degree C fever. It happened on the 6-month check-up, when the patient was seen by both the pediatrician and the nurse. The patient was referred to the emergency room and they informed that they associate the events with the vaccination. The reporter consented to follow up.


VAERS ID: 855046 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2017-03-03
Onset:2017-03-18
   Days after vaccination:15
Submitted: 0000-00-00
Entered: 2020-01-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MENB: MENINGOCOCCAL B (BEXSERO) / NOVARTIS VACCINES AND DIAGNOSTICS 15E501 ? / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Meningitis, Vaccination failure
SMQs:, Lack of efficacy/effect (narrow), Noninfectious meningitis (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? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: IEGLAXOSMITHKLINEIE201923

Write-up: SEROGROUP B; This case was reported by a other health professional via regulatory authority and described the occurrence of meningitis in a 4-month-old female patient who received Men B NVS (Bexsero) (batch number 15E501 ?, expiry date unknown) for prophylaxis. Additional patient notes included Age appropriately vaccinated. On 3rd March 2017, the patient received Bexsero (unknown). On 18th March 2017, 15 days after receiving Bexsero, the patient experienced meningitis (serious criteria GSK medically significant and other: serious as per reporter). On an unknown date, the outcome of the meningitis was recovered/resolved. It was unknown if the reporter considered the meningitis to be related to Bexsero. Additional details: The age at vaccination was not reported, however the patient could be 3 to 4 months old at the time of vaccination. The Bexsero batch number was reported as 15E501. However based on a batch number review, no identical match was found. The event vaccination failure was removed as the TTO criteria was not meeting. Initial information was reported by a other health professional via regulatory authority on 20th December 2019: Vaccination failure and meningitis.


VAERS ID: 855048 (history)  
Form: Version 2.0  
Age: 0.08  
Sex: Unknown  
Location: Foreign  
Vaccinated:2017-06-27
Onset:2017-06-27
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2020-01-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
RV1: ROTAVIRUS (ROTARIX) / GLAXOSMITHKLINE BIOLOGICALS AROLB856AE / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Anaphylactic shock, Choking, Lividity, Rash macular
SMQs:, Anaphylactic reaction (narrow), Angioedema (broad), Anaphylactic/anaphylactoid shock conditions (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? 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: PLGLAXOSMITHKLINEPL201923

Write-up: Anaphylactic shock; Lividity of right upper limb; Micromacular rash on the torso; Choking; This case was reported by a physician via regulatory authority and described the occurrence of anaphylactic shock in a 1-month-old patient who received Rota (Rotarix liquid formulation) (batch number AROLB856AE, expiry date August 2019) for prophylaxis. On 27th June 2017 17:40, the patient received the 1st dose of Rotarix liquid formulation (oral) 1.5 ml. On 27th June 2017 17:42, 2 min after receiving Rotarix liquid formulation, the patient experienced anaphylactic shock (serious criteria GSK medically significant and other: serious as per reporter), lividity (serious criteria other: serious as per reporter), macular rash (serious criteria other: serious as per reporter) and choking (serious criteria GSK medically significant and other: serious as per reporter). In 2017, the outcome of the anaphylactic shock, lividity, macular rash and choking were recovered/resolved. The reporter considered the anaphylactic shock and lividity to be possibly related to Rotarix liquid formulation. The reporter considered the macular rash to be probably related to Rotarix liquid formulation. It was unknown if the reporter considered the choking to be related to Rotarix liquid formulation. Additional details; The Rotarix batch number was reported as?ARLB856AE. However based on a batch number review, the batch number was corrected to?AROLB856AE.? Initial information was reported by a physician via regulatory authority on 20th December 2019: Anaphylactic shock, lividity, macular rash and choking. Sender''s comments: The rash is an expected side effect for Rotarix. Anaphylactic shock, bruising of the limbs are unexpected symptoms. The temporal relationship speaks for a cause and effect relationship. The person reporting the NOP classified it as mild; agency assessed the NOP as severe due to the nature of the symptoms


VAERS ID: 855076 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2019-05-14
Onset:2019-05-19
   Days after vaccination:5
Submitted: 0000-00-00
Entered: 2020-01-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
JEV1: JAPANESE ENCEPHALITIS (IXIARO) / INTERCELL AG JEV18D76R / UNK - / OT
RAB: RABIES (NO BRAND NAME) / UNKNOWN MANUFACTURER P1D981M / UNK - / OT
TYP: TYPHOID VI POLYSACCHARIDE (TYPHIM VI) / SANOFI PASTEUR R1C312V / UNK - / OT
YF: YELLOW FEVER (STAMARIL) / SANOFI PASTEUR R3C976V / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Arthralgia, Erythema nodosum, Joint swelling
SMQs:, Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (narrow), Arthritis (broad), Tendinopathies and ligament disorders (broad), Immune-mediated/autoimmune disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Infectious mononucleosis; Knee surgery NOS (right ligamentoplasty)
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRSA2019SA191683

Write-up: Erythema nodosum; swelling of ankles; Arthralgia; Initial information regarding this unsolicited valid serious case downloaded from regulatory authority database without narrative (level 2A), was received on 11-Jul-2019 from physician via health authority (under the reference number: FR-AFSSAPS-MP20190809). The following narrative is based on the information retrieved from all other accessible data. This case involves a 30 years old female patient who experienced erythema nodosum (erythema nodosum), ankle swelling (joint swelling) and arthralgia (arthralgia), while she received vaccine RABIES (VERO) VACCINE [VACCIN RABIQUE PASTEUR POUDRE ET SOLVANT POUR SUSPENSION INJECTABLE], JAPANESE ENCEPHALITIS VACCINE INACT (IXIARO), TYPHOID VI POLYSACCHARIDE VACCINE [TYPHIM VI] and YELLOW FEVER VACCINE - [STAMARIL]. The patient''s past medical history included Infectious mononucleosis in 2000 and Knee operation in -2009 with right ligamentoplasty. The patient''s past medical treatment(s), vaccination(s) and family history were not provided. On 14-May-2019, the patient received a dose of suspect RABIES (VERO) VACCINE lot P1D981M via unknown route in unknown administration site. On 21-May-2019 she also received a dose of the same vaccine lot P1D981M. On 14-May-2019, the patient received a dose of suspect TYPHOID VI POLYSACCHARIDE VACCINE lot R1C312V via intramuscular route in unknown administration site. On 14-May-2019, the patient received a dose of suspect YELLOW FEVER VACCINE - lot R3C976V via subcutaneous route in unknown administration site. On 14-May-2019, the patient received a dose of suspect IXIARO not produced by Sanofi Pasteur lot JEV18D76R via intramuscular route in unknown administration site. On 19-May-2019, the patient experienced a serious ankle swelling (joint swelling) and arthralgia 5 days following the administration of RABIES (VERO) VACCINE, TYPHOID VI POLYSACCHARIDE VACCINE, IXIARO and YELLOW FEVER VACCINE. This event was leading to disability. On 23-May-2019, the patient experienced a serious erythema nodosum 9 days following the administration of RABIES (VERO) VACCINE, TYPHOID VI POLYSACCHARIDE VACCINE, IXIARO and YELLOW FEVER VACCINE. This event was leading to disability. (Other relevant tests included no lab data.) Final diagnosis was arthralgia, ankle swelling and erythema nodosum. It was not reported if the patient received a corrective treatment. The event outcome is reported as not recovered for all the events. Additional information downloaded from regulatory authority database was received from a physician via health authority (under the reference number: FR-AFSSAPS-MP20190809) on 26-DEC-2019. Outcome of all the events updated to not recovered from recovered. Therapy details of Rabies vaccine updated. Suspect drugs (TYPHIM VI, Stamaril and IXIARO) added.; Sender''s Comments: Follow-up received on 26-DEC-2019 does not change the previous assessment. This case involves a 30 years old female patient who experienced erythema nodosum, ankle swelling and arthralgia, while she received vaccine RABIES (VERO), TYPHIM VI, Stamaril and IXIARO. Time to onset is compatible with the role of vaccines. However, further information including condition at the time of vaccination, concomitant medications, lab test excluding other etiology would be needed to fully assess this case. Patient''s past medical history included Infectious mononucleosis. Based on available information the role of vaccines cannot be individually assessed.


VAERS ID: 855078 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2019-12-06
Submitted: 0000-00-00
Entered: 2020-01-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Encephalitis, Headache, Petit mal epilepsy, Tonic convulsion
SMQs:, Systemic lupus erythematosus (broad), Convulsions (narrow), Noninfectious encephalitis (narrow), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Generalised convulsive seizures following immunisation (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: HYDROXOCOBALAMIN
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBSA2019SA361342

Write-up: Absence seizure; Headache; Tonic seizure; Encephalitis; Initial information regarding this unsolicited serious case downloaded from Agency database without narrative (level 2A), was received on 26-Dec-2019 from a consumer via health authority (under the reference number: GB-MHRA-EYC 00214480). The following narrative is based on the information retrieved from all other accessible data. This case involves a 38 years old female patient who experienced absence seizure (petit mal epilepsy), encephalitis (encephalitis), headache (headache) and tonic seizure (tonic convulsion), while she received vaccine INFLUENZA VACCINE. The patient''s past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included HYDROXOCOBALAMIN (HYDROXOCOBALAMIN) Injection via Parenteral route. On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer lot number not reported via parenteral route in unknown administration site. On 06-Dec-2019 the patient experienced a serious encephalitis (encephalitis) (unknown latency) following the administration of INFLUENZA VACCINE. This event was assessed as medically significant. The patient was hospitalized for this event. On an unknown date, the patient experienced a serious absence seizure (petit mal epilepsy), headache (headache) and tonic seizure (Tonic convulsion)(Unknown latency) (unknown latency) following the administration of INFLUENZA VACCINE. These events was assessed as medically significant. The patient was hospitalized for these events. Final diagnosis was encephalitis, tonic seizure, headache and absence seizure. It was not reported if the patient received a corrective treatment. The patient was recovering from encephalitis and event outcome was reported as unknown for absence seizure, headache and tonic seizure. There will be no information available on the batch number for this case.; Sender''s Comments: This case involves 38 years old female patient who presented with Petit mal epilepsy, encephalitis, Headache and Dyspnoea after vaccination with INFLUENZA VACCINE produced by unknown manufacturer. Time to onset is unknown. However, patients medical condition at the time of vaccination and lab tests ruling out alternate etiologies were not reported. Based on available information, the role of the vaccine cannot be assessed.


VAERS ID: 855079 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2019-11-22
Onset:2019-12-07
   Days after vaccination:15
Submitted: 0000-00-00
Entered: 2020-01-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLU4: INFLUENZA (SEASONAL) (QIV DRESDEN) / GLAXOSMITHKLINE BIOLOGICALS - / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Pneumonia, Pneumonitis, Pyrexia, Respiration abnormal
SMQs:, Interstitial lung disease (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Acute central respiratory depression (broad), Eosinophilic pneumonia (narrow), Hypersensitivity (broad), Respiratory failure (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (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? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: ITGLAXOSMITHKLINEIT201923

Write-up: fever, abnormal breathing. pneumonia; This case was reported by a physician via regulatory authority and described the occurrence of pneumonitis in a 80-year-old female patient who received Flu Seasonal QIV Dresden (Fluarix Tetra) for prophylaxis. On 22nd November 2019, the patient received Fluarix Tetra (intramuscular) 1 dosage form(s). On 7th December 2019, 15 days after receiving Fluarix Tetra, the patient experienced pneumonitis (serious criteria hospitalization). Fluarix Tetra was discontinued. On an unknown date, the outcome of the pneumonitis was recovering/resolving. It was unknown if the reporter considered the pneumonitis to be related to Fluarix Tetra. Additional details: The age at vaccination was not reported. However, patient could be 79 or 80 years at the time of vaccination. Initial information was received from a Physician via regulatory authority on 20th December 2019: Fever, abnormal breathing. pneumonia. Sender comment: It was not possible to find the batch and the expiry date of the suspect drug despite having contacted the general practitioner.


VAERS ID: 855081 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:2017-07-18
Onset:2017-07-18
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2020-01-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTP: DTP (NO BRAND NAME) / UNKNOWN MANUFACTURER 20915004A ? / 1 RA / OT

Administered by: Other       Purchased by: ?
Symptoms: Anxiety, Injection site extravasation, Tearfulness, Vaccination site erythema, Vaccination site inflammation
SMQs:, Extravasation events (injections, infusions and implants) (narrow), Depression (excl suicide and self injury) (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: PLGLAXOSMITHKLINEPL201923

Write-up: Vaccination site erythema and inflammatory infiltration with diameter of 4 - 5 cm, lasting more than 3 days; Anxiety; Vaccination site erythema and inflammatory infiltration with diameter of 4 - 5 cm, lasting more than 3 days; Tearfulness; This case was reported by a physician via regulatory authority and described the occurrence of anxiety in a 2-month-old patient who received DTP (A or W not known) (DTP vaccine) (batch number 20915004A ?, expiry date December 2018) for prophylaxis. On 18th July 2017 09:20, the patient received the 1st dose of DTP vaccine (intramuscular) .5 ml. On 18th July 2017, less than a day after receiving DTP vaccine, the patient experienced anxiety (serious criteria other: serious as per reporter), vaccination site erythema (serious criteria other: serious as per reporter), tearfulness (serious criteria other: serious as per reporter) and vaccination site inflammation (serious criteria other: serious as per reporter). On unknown date, the outcome of the anxiety, vaccination site erythema, tearfulness and vaccination site inflammation were unknown. The reporter considered the anxiety, vaccination site erythema, tearfulness and vaccination site inflammation to be probably related to DTP vaccine. Additional details: The patient received DTP vaccine on right arm. The reported batch number of suspect vaccine 20915004A does not match with any GSK lot number. DTP vaccine: Other Assessment: WHO,probable for all events. Initial information was reported by a physician via regulatory authority on 20th December 2019: Vaccination site erythema and inflammatory infiltration with diameter of 4 - 5 cm, lasting more than 3 days, Anxiety and Tearfulness. Senders comments: Intense reaction in place injections, anxiety, expected The above measures DTP vaccines not given. by SPC vaccine DTP reactions local: redness, o pain, swelling usually disappears within a short period of time 24 - 48 hours in the analyzed the infiltration persists after 2 weeks, in the form was not provided final health result. The time relationship speaks for the occurrence of a relationship cause-and-effect relationship. Person quitting NOP qualified him as a serious person, Agency will evaluate NOP as heavy with attention to long-term persistence of reaction.


VAERS ID: 855082 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2016-12-20
Onset:2016-12-20
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2020-01-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTP: DTP (NO BRAND NAME) / UNKNOWN MANUFACTURER 20915002A / UNK RA / OT
HEP: HEP B (FOREIGN) / MERCK & CO. INC. UFA15015 / UNK LL / OT
HIBV: HIB (ACTHIB) / SANOFI PASTEUR L5458-1 / UNK RL / OT

Administered by: Other       Purchased by: ?
Symptoms: Cyanosis, Heart rate decreased, Hypotonia, Hypotonic-hyporesponsive episode, Pallor, Somnolence
SMQs:, Anaphylactic reaction (broad), Peripheral neuropathy (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Dementia (broad), Acute central respiratory depression (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypotonic-hyporesponsive episode (narrow), Generalised convulsive seizures following immunisation (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: PLSA2019SA361352

Write-up: Pallor, muscle tone decreased, somnolence, no loss of consciousness, heart rate was decreased for short time, cyanosis around mouth; a one month old female patient received a dose of EUVAX B vaccine via subcutaneous route; a one month old female patient received a dose of Act-hib vaccine; Initial information received on 26-Dec-2019 regarding an unsolicited valid serious case downloaded from regulatory authority database without narrative (level 2A), was received from Physician via Health Authority (under reference number: PL-URPL-N2442/2016). The following narrative is based on the information retrieved from all other accessible data. This case involves a one months old female patient who experienced pallor, muscle tone decreased, somnolence, no loss of consciousness, heart rate was decreased for short time, cyanosis around mouth (Hypotonic-Hyporesponsive Episode), while she received vaccines HEPATITIS B VACCINE LG-LS [EUVAX B], HIB (PRP/T) VACCINE [ACT-HIB] and DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE, TETANUS VACCINE TOXOID [DTP VACCINE]. The patient''s past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 20-Dec-2016 12:00, the patient received a 0.5 ml dose of suspect HEPATITIS B VACCINE LG-LS lot UFA15015, expiry date: MAY-2018 via subcutaneous route in the left thigh. On 20-Dec-2016 12:00, the patient received a 0.5 ml dose of suspect HIB (PRP/T) VACCINE lot L5458-1, expiry date: SEP-2017 via subcutaneous route in the right thigh. On 20-Dec-2016 12:00, the patient received a 0.5 ml dose of suspect DTP VACCINE not produced by Sanofi Pasteur lot 20915002A, expiry date: MAY-2018 via subcutaneous route in the right arm. On 20-Dec-2016 12:05, the patient developed a serious pallor, muscle tone decreased, somnolence, no loss of consciousness, heart rate was decreased for short time, cyanosis around mouth (Hypotonic-Hyporesponsive Episode) five minutes following the administration of HIB (PRP/T) VACCINE, DTP VACCINE and HEPATITIS B VACCINE LG-LS. This event was assessed as medically significant. The patient was hospitalized for this event. It was a case of actual medication error due to inappropriate route of vaccination (for EUVAX B) and inappropriate age at vaccine administration (for ACTHIB). (Other relevant tests included no lab data.) Final diagnosis was Hypotonic-Hyporesponsive Episode. It was not reported if the patient received a corrective treatment. The patient was recovering from the events. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in 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. Senders Comments: A hypotonic-hyporesponsive episode (HHE) is an event following vaccination that includes inertia or decreased muscle tone, reduced and decreased reaction to external stimuli, drowsiness, skin discoloration (paleness or cyanosis), occurring within 48 hours since vaccination, and lasting from 1 minute to 48 hours. HHE is an expected adverse effect, included in the Summary of Product Characteristics of DTP. Even though the effect is considered unexpected to the two other co-administered vaccines, it has been recorded in the regulatory authority database as an effect following the use of each of the vaccines. Due to the co-administration of three vaccines, it is impossible to determine which one contributed to the symptom occurrence. The temporal relationship speaks for the causal relationship. The reporting physician qualified the post vaccination AE as serious. Due to the initial assessment of the post vaccination AE, the nature of the adverse effects, and the hospitalization, the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products recognized the post vaccination AE as severe.; Sender''s Comments: This case involves one month old female patient who presented with Hypotonic-Hyporesponsive Episode after vaccination with EUVAX B, ACT-HIB and DTP VACCINE. Time to onset is compatible. However, condition at time of vaccination and lab tests ruling out alternate etiologies were not reported. Based upon the reported information, the role of vaccines cannot be individually assessed.


VAERS ID: 855083 (history)  
Form: Version 2.0  
Age: 0.08  
Sex: Male  
Location: Foreign  
Vaccinated:2015-02-11
Onset:2015-02-11
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2020-01-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTP: DTP (NO BRAND NAME) / UNKNOWN MANUFACTURER 20913001C / UNK RA / OT
HEP: HEP B (FOREIGN) / MERCK & CO. INC. UFA13040 / UNK RL / OT
HIBV: HIB (ACTHIB) / SANOFI PASTEUR K8255-1 / UNK LL / OT

Administered by: Other       Purchased by: ?
Symptoms: Pallor, Product administered to patient of inappropriate age, Pyrexia, Somnolence
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypotonic-hyporesponsive episode (broad), Medication errors (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? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: PLSA2019SA361336

Write-up: Pallor of skin; Drowsiness; Fever; 1 month old patient received a dose of Act-Hib; Initial information received on 26-Dec-2019 regarding an unsolicited valid serious case downloaded from regulatory authority database without narrative (level 2A), was received from a Physician via Health Authority (under reference number: PL-URPL-N257/2015). The following narrative is based on the information retrieved from all other accessible data. This case involves a one month old male patient who experienced pallor of skin (pallor), fever (pyrexia) and drowsiness (somnolence), while he received vaccines HEPATITIS B VACCINE LG-LS [EUVAX B], HIB (PRP/T) VACCINE [ACT-HIB] and DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE, TETANUS VACCINE TOXOID [DTP]. Medical history, medical treatment(s), vaccination(s) and family history were not provided. On 11-Feb-2015, the patient received a 0.5 ml dose of suspect HEPATITIS B VACCINE LG-LS (lot number: UFA 13040 and expiry date: Aug-2016) via intramuscular route in the right thigh. On 11-Feb-2015, the patient received a 0.5 ml dose of suspect HIB (PRP/T) VACCINE (lot number: K8255-1 and expiry date: Feb-2019) via intramuscular route in the left thigh. On 11-Feb-2015, the patient received a 0.5 ml dose of suspect DTP not produced by Sanofi Pasteur (lot number : 20913001C and expiry date: Jun-2016) via intramuscular route in the right arm. On 11-Feb-2015, the patient experienced pallor of skin (pallor), fever (pyrexia) and drowsiness (somnolence), on the same day following the administration of HIB (PRP/T) VACCINE, HEPATITIS B VACCINE LG-LS and DTP. It was a case of actual medication error due to inappropriate age at vaccine administration as 1 month old patient received a dose of Act-Hib. No lab data was not reported. Final diagnosis was somnolence, pyrexia and pallor. It was not reported if the patient received a corrective treatment. On an unknown date, the patient recovering from all the events. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in 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. Sender comment: Fever is the expected adverse effect after administration of all three vaccines. Increased sensitivity, anxiety, drowsiness, as well as a hypotonic and hyporesponsive episode specified by the manufacturer as possible reaction after administration of the DTP vaccine, one of whose symptoms may be a pale coating. In the Summary of Product Characteristics of Act-Hib, sensitivity and inconsolable crying are listed as expected, while somnolence and sensitivity listed for Euvax B. Due to the simultaneous administration of three vaccines, it is impossible to indicate one that contributed to the occurrence of the symptoms. Temporal relationship does not exclude the causal relationship, but the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products agreed with the reporting doctor treating a child in a hospital that infection may be the illness coexisting with vaccination, not its consequence. Due to the hospitalization the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products assessed the adverse post-vaccination effect as severe.; Sender''s Comments: This case concerns one month old male patient who experienced pallor, pyrexia and somnolence after vaccination with EUVAX B, ACT-HIB and DTP. The time to onset is compatible with the role of vaccines. However, medical condition at the time of vaccination and lab tests ruling out alternate etiologies were not reported. Based upon the reported information, the role of vaccines cannot be individually assessed.


VAERS ID: 855084 (history)  
Form: Version 2.0  
Age: 0.25  
Sex: Female  
Location: Foreign  
Vaccinated:2017-08-03
Onset:2017-08-03
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2020-01-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTP: DTP (NO BRAND NAME) / UNKNOWN MANUFACTURER 20915004B ? / 2 RA / OT

Administered by: Other       Purchased by: ?
Symptoms: Apnoea, Injection site erythema, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Acute central respiratory depression (narrow), Extravasation events (injections, infusions and implants) (broad), Respiratory failure (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? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20170803; Test Name: Body temperature; Result Unstructured Data: Test Result: 38.5 - 38.9 o C, Test Result Unit: degree C
CDC Split Type: PLGLAXOSMITHKLINEPL201923

Write-up: Vaccination site reaction : 3-5 cm (+redness); Fever; Mother''s account: 2x apnea; This case was reported by a physician via regulatory authority and described the occurrence of injection site redness in a 3-month-old female patient who received DTP (A or W not known) (DTP vaccine) (batch number 20915004B ?, expiry date December 2018) for prophylaxis. On 3rd August 2017, the patient received the 2nd dose of DTP vaccine (intramuscular) .5 ml. On 3rd August 2017, less than a day after receiving DTP vaccine, the patient experienced injection site redness (serious criteria other: serious as per reporter), fever (serious criteria other: serious as per reporter) and apnea (serious criteria GSK medically significant and other: serious as per reporter). In 2017, the outcome of the injection site redness was recovered/resolved. On 4th August 2017, the outcome of the fever and apnea were recovered/resolved. The reporter considered the injection site redness, fever and apnea to be probably related to DTP vaccine. Additional details: On 3rd August 2017 the patient body temperature was reported 38.5 to 38.9 degree C. The DTP batch number was reported as 20915004B. However based on a batch number review, no identical match was found. The patient received DTP vaccine on right deltoid. Initial information was reported by a physician via regulatory authority on 20th December 2019: Injection site redness, fever and apnea. Sender''s comments: According to the DTP Medicinal Product Characteristics, the risk of apnea appears only when the primary cycle vaccination dose is given to very immature premature babies - 28 weeks of gestation. At the same time, the expected actions for the DTP vaccine respiratory disorders are undesirable. Fever and severe injection site reaction are the expected side effects after DTP. The temporal relationship speaks for a cause-and-effect relationship. Person reporting NO


VAERS ID: 855085 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:2017-11-08
Onset:2017-11-28
   Days after vaccination:20
Submitted: 0000-00-00
Entered: 2020-01-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
TDAP: TDAP (BOOSTRIX) / GLAXOSMITHKLINE BIOLOGICALS AC37B246AD / 2 LA / OT

Administered by: Other       Purchased by: ?
Symptoms: Abdominal pain, Diarrhoea, Gastrointestinal disorder, Splenomegaly
SMQs:, Acute pancreatitis (broad), Retroperitoneal fibrosis (broad), Pseudomembranous colitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Noninfectious diarrhoea (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: PLGLAXOSMITHKLINEPL201923

Write-up: tumor in one side of the abdomen - suspected splenomegaly; Diarrhea; stomach and intestinal disorders; This case was reported by a physician via regulatory authority and described the occurrence of spleen enlarged in a 13-year-old patient who received DTPa (Reduced antigen) (Boostrix) (batch number AC37B246AD, expiry date May 2019) for prophylaxis. On 8th November 2017, the patient received the 2nd dose of Boostrix (intramuscular) .5 ml. On 28th November 2017, 20 days after receiving Boostrix, the patient experienced spleen enlarged (serious criteria other: Serious as per reported), diarrhea (serious criteria other: Serious as per reported) and pain abdominal (serious criteria other: Serious as per reported). On an unknown date, the outcome of the spleen enlarged, diarrhea and pain abdominal were unknown. The reporter considered the spleen enlarged, diarrhea and pain abdominal to be possibly related to Boostrix. Additional details: The age at vaccination was not reported. However, patient could be 12 or 13 years at the time of vaccination. Anatomical Location was reported as Left shoulder. Initial information was received from a Physician via regulatory authority on 20th December 2019: Tumor in one side of the abdomen suspected splenomegaly, diarrhea and stomach and intestinal disorders. Sender comment: Diarrhea, gastrointestinal disorders - reactions expected for Boostrix. A fairly long time after symptoms occur (vaccination) (20 days) weakens the strength of the causal relationship. Suspected splenomegaly may also indicate a different etiology of symptoms, e.g. infectious mononucleosis? For a more detailed assessment, it is advisable to obtain supplementary information on the results of the tests ordered (e.g. laboratory tests, abdominal ultrasound), possible hospitalization, and the health result. The notifying person qualified NOP as serious. Agency will evaluate the reactions as severe.


VAERS ID: 855086 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:2017-12-01
Onset:2017-12-01
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2020-01-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTPIHI: DT+IPV+HIB+HEPB (NO BRAND NAME) / UNKNOWN MANUFACTURER M7471 / 2 LL / OT
PNC10: PNEUMO (SYNFLORIX) / GLAXOSMITHKLINE BIOLOGICALS ASPNA803AB / 2 RL / OT
RV1: ROTAVIRUS (ROTARIX) / GLAXOSMITHKLINE BIOLOGICALS AROLB860AF / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Crying, Hypokinesia, Pyrexia, Vaccination site discolouration
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Parkinson-like events (broad), Guillain-Barre syndrome (broad), Depression (excl suicide and self injury) (broad), Hypotonic-hyporesponsive episode (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20171201; Test Name: Body temperature; Result Unstructured Data: Test Result: 38-38.4, Test Result Unit: degree C
CDC Split Type: PLGLAXOSMITHKLINEPL201923

Write-up: limitation of left lower limb mobility; Pyrexia; Vaccination site reaction : lividity 2cm; 2h; This case was reported by a physician via regulatory authority and described the occurrence of movements reduced in a 3-month-old patient who received 10PN-PD-Dit (Synflorix) (batch number ASPNA803AB, expiry date unknown) for prophylaxis. Co-suspect products included Rota (Rotarix liquid formulation) (batch number AROLB860AF, expiry date unknown) for prophylaxis and HEXACIMA (batch number M7471, expiry date June 2018) for prophylaxis. On 1st December 2017, the patient received the 2nd dose of Synflorix (unknown) .5 ml, the 2nd dose of Rotarix liquid formulation (oral) 1.5 ml and the 2nd dose of HEXACIMA (unknown) .5 ml. On 1st December 2017, less than a day after receiving Synflorix and Rotarix liquid formulation, the patient experienced movements reduced (serious criteria hospitalization), fever (serious criteria hospitalization), vaccination site lividity (serious criteria hospitalization) and crying (serious criteria hospitalization). On an unknown date, the outcome of the movements reduced, fever, vaccination site lividity and crying were unknown. The reporter considered the movements reduced, fever, vaccination site lividity and crying to be probably related to Synflorix. The reporter considered the movements reduced, fever and crying to be probably related to Rotarix liquid formulation. Additional details: On 1st December 2017, body temperature was 38 to 38.4 degree celsius. The reporter considered the movements reduced, fever, vaccination site reaction and crying to be probably related to HEXACIMA. Initial information was reported by a physician via regulatory authority on 20th December 2019: limitation of left lower limb mobility, Pyrexia, Vaccination site reaction : lividity 2cm and 2h. Senders comments: Cry, fever, reactions expected for all 3 vaccines. Time Relationship speaks for union cause-and-effect relationship. That country grounds administration of vaccines causal cannot be done will exclude any of them. Local reaction (reaction expected) and limitation of limb mobility (unexpected reaction) in which vaccine given Hexacima, points to this preparation as a cause occurrence of a poviat. Person the applicant qualifies NOP as a seriouser. URPL will evaluate reactions as severe.


VAERS ID: 855087 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2015-01-21
Onset:2015-01-24
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2020-01-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
TDAP: TDAP (ADACEL) / SANOFI PASTEUR C4364AF / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Coordination abnormal, Feeling abnormal, Hypoacusis, Nervous system disorder, Slow response to stimuli, Vision blurred, Visual impairment
SMQs:, Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Glaucoma (broad), Optic nerve disorders (broad), Lens disorders (broad), Retinal disorders (broad), Hearing impairment (narrow), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: PLSA2019SA361447

Write-up: slowdown, coordination disorder, slowdown of reaction and blurred vision, feeling of unstable ground; Initial information regarding this unsolicited valid serious case downloaded from Regulatory Authority database without narrative (level 2A), was received on 26-Dec-2019 from physician via health authority (under the reference number: PL-URPL-N359/2015). The following narrative is based on the information retrieved from all other accessible data. This case involves a 33 years old female patient who experienced slowdown, coordination disorder, slowdown of reaction and blurred vision, feeling of unstable ground (nervous system disorder), while she received vaccine DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL]. The patient''s past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 21-Jan-2015, the patient received a 0.5 ml dose of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE lot C4364AF via intramuscular route in unknown administration site. On 24-Jan-2015, the patient developed a serious slowdown, coordination disorder, slowdown of reaction and blurred vision, feeling of unstable ground (nervous system disorder) three days following the administration of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE. The patient was hospitalized for this event. Other relevant tests not reported. Final diagnosis was nervous system disorder. It was not reported if the patient received a corrective treatment. The patient was recovering from nervous system disorder. Sender''s Comments- Fainting and weakness are expected adverse effects following the administration of Adacel, and may lead to impaired consciousness. Other adverse effects experienced by the patient such as visual disturbances, coordination abnormalities, and hearing disturbances are not mentioned in the Summary of Product Characteristics as possible reactions. Also, the effects are rarely reported following vaccination with this product. 10 cases of visual disturbances, 4 cases of hearing discomfort, 3 cases of ear ache, and 5 cases of ataxia (kinetic ataxia) following the use of Adacel vaccine have been recorded in Regulatory Authority database of adverse effects. The temporal relationship speaks for the causal relationship. The adverse post-vaccination effect was qualified by the reporting person as "serious." The Regulatory Authority assessed the adverse post-vaccination effect as "severe." The reporter assessed the causal relationship for event with vaccine as possible.; Sender''s Comments: This case involves a 33 years old female patient who experienced nervous system pathology three days after vaccination with ADACEL. The time to onset is compatible. However, patient''s medical history, medical condition at time of vaccination and lab test ruling out alternate etiologies were not reported. Based upon the reported information, the role of the suspect vaccine cannot be assessed.


VAERS ID: 855088 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:2015-02-24
Onset:2015-02-25
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2020-01-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (INFANRIX) / GLAXOSMITHKLINE BIOLOGICALS AC14B187AA / UNK RA / OT
IPV: POLIO VIRUS, INACT. (POLIOVAX) / SANOFI PASTEUR K7043-2 / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Hypotonic-hyporesponsive episode, Pyrexia, Vaccination site reaction
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Hypotonic-hyporesponsive episode (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? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: PLSA2019SA361444

Write-up: Hypotonic-hyporesponsive episode; Vaccination site reaction; Fever; Initial information regarding this unsolicited valid serious case downloaded from Agency database without narrative (level 2A), was received on 26-Dec-2019 from physician via health authority (under reference PL-URPL-N373/2015). The following narrative is based on the information retrieved from all other accessible data. This case involves a patient (with unknown demographics) who experienced fever (pyrexia), vaccination site reaction (vaccination site reaction) and hypotonic-hyporesponsive episode (hypotonic-hyporesponsive episode), while he/she received vaccines IPV (VERO) [IMOVAX POLIO] and DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR 3-COMPONENT, TETANUS VACCINE TOXOID [INFANRIX DTPA]. The patient''s past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 24-Feb-2015, the patient received a 0.5 ml dose of suspect IPV (VERO) (lot K7043-2, Exp. Date Dec-2015) and INFANRIX DTPA (not produced by Sanofi Pasteur lot AC14B187AA, Exp. Date Mar-2015) via intramuscular route in unknown administration site and in right arm respectively. On 25-Feb-2015, the patient developed a serious fever (pyrexia), vaccination site reaction and hypotonic-hyporesponsive episode one day following the administration of IPV (VERO) and INFANRIX DTPA. These events were assessed as medically significant. Other relevant tests not reported. Final diagnosis was hypotonic-hyporesponsive episode, vaccination site reaction and fever. It was not reported if the patient received a corrective treatment. On an unknown date, the patient recovered from fever, vaccination site reaction and hypotonic-hyporesponsive episode. Sender''s Comments- The hypotonic-hyporesponsive episode (HHE) is the decrease of pressure, which is accompanied by lowered muscle tone, pale coatings, disorders of consciousness and drowsiness. It is an expected adverse effect for Infanrix DTPa vaccine, although it is not indicated in the Summary of Product Characteristics of Imovax Polio is the reported effect of this vaccine (127 cases of hypotonic-hyporeactive episode after this preparation recorded in the Agency reports database). Fever and local reaction are common, expected effects for both vaccines. The temporal relationship speaks for the causal relationship. The reactions occurring in a child were assessed by the reporting person as mild, however, due to the occurrence of a hypotonic-hyporeactive episode the Office assessed the adverse post-vaccination effect as severe. The reporter assessed the causal relationship for events with vaccines as possible.; Sender''s Comments: This case concerns a patient (with unknown demographics) who experienced hypotonic-hyporesponsive episode, vaccination site reaction and fever one day after vaccination with IPV (VERO) and INFANRIX DTPA (other manufacturer). Time to onset is compatible. However, patient''s medical history, medical condition at time of vaccination and lab test ruling out alternate etiologies were not reported. Based upon the reported information, the role of the suspect vaccines cannot be individually assessed.


VAERS ID: 855117 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2020-01-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEP: HEP B (NO BRAND NAME) / UNKNOWN MANUFACTURER - / 2 - / -

Administered by: Other       Purchased by: ?
Symptoms: Aldolase normal, Anaemia, Angioscopy, Anti-cyclic citrullinated peptide antibody negative, Antineutrophil cytoplasmic antibody negative, Antinuclear antibody negative, Arthralgia, Behcet's syndrome, Blood creatine phosphokinase normal, Blood culture, Blood fibrinogen increased, Blood lactate dehydrogenase normal, Borrelia test negative, C-reactive protein increased, Cardiolipin antibody negative, Chest X-ray normal, Chlamydia test negative, Clonus, Complement factor C3, Complement factor C4, Complement factor normal, Conduction disorder, Culture urine, Cytomegalovirus test positive, Dental gangrene, Ecchymosis, Echocardiogram normal, Electrocardiogram normal, Electromyogram abnormal, Epstein-Barr virus antibody negative, Glossodynia, Haemoglobin decreased, Hemiparesis, Hepatitis B surface antigen negative, Hepatitis C virus test, Hyperaesthesia, Hyperreflexia, Hypertonia, Immunoglobulin therapy, Inflammatory marker increased, Interferon gamma release assay, Leukocytosis, Magnetic resonance imaging brain normal, Magnetic resonance imaging spinal normal, Magnetic resonance imaging thoracic normal, Mononeuropathy, Mucosal erosion, Muscular weakness, Mycoplasma test negative, Neutrophil count decreased, Neutrophil count increased, Oedema peripheral, Ophthalmological examination normal, Oral disorder, Pain in extremity, Paraesthesia, Parvovirus B19 test positive, Platelet count increased, Polyarteritis nodosa, Procalcitonin normal, Pyrexia, Red blood cell sedimentation rate increased, Renal function test normal, Rheumatoid factor negative, Scan bone marrow normal, Skin lesion, Skin mass, Splenomegaly, Stomatitis, Stool analysis normal, Tenderness, Thrombocytosis, Tongue discolouration, Tonsillar hypertrophy, Toothache, Ultrasound scan abnormal, Vascular endothelial growth factor assay, White blood cell count increased
SMQs:, Rhabdomyolysis/myopathy (broad), Cardiac failure (broad), Severe cutaneous adverse reactions (broad), Agranulocytosis (broad), Angioedema (broad), Haematopoietic erythropenia (broad), Haematopoietic leukopenia (narrow), Peripheral neuropathy (broad), Haemorrhage terms (excl laboratory terms) (narrow), Haemorrhage laboratory terms (broad), Interstitial lung disease (broad), Neuroleptic malignant syndrome (narrow), Anticholinergic syndrome (broad), Conduction defects (narrow), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Malignancy related therapeutic and diagnostic procedures (narrow), Parkinson-like events (narrow), Gastrointestinal perforation, ulcer, haemorrhage, obstruction non-specific findings/procedures (narrow), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Eosinophilic pneumonia (broad), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (narrow), Vasculitis (narrow), Generalised convulsive seizures following immunisation (broad), Hypersensitivity (broad), Arthritis (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (narrow), Hypokalaemia (broad), Opportunistic infections (broad), Immune-mediated/autoimmune disorders (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? Yes
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Upper respiratory tract infection (occasional)
Allergies:
Diagnostic Lab Data: Test Date: 2017; Test Name: Aldolase; Result Unstructured Data: Test Result: normal, Test Result Unit: unknown; Test Name: Capillaroscopy; Result Unstructured Data: Test Result: No pathological changes were detected, Test Result Unit: unknown; Test Date: 2017; Test Name: Anti-cyclic citrullinated peptide antibody; Result Unstructured Data: Test Result: negative, Test Result Unit: unknown; Test Date: 2017; Test Name: Myeloperoxidase antibody test; Result Unstructured Data: Test Result: negative, Test Result Unit: unknown; Test Date: 2017; Test Name: Proteinase-3 antibody; Result Unstructured Data: Test Result: negative, Test Result Unit: unknown; Test Date: 2017; Test Name: Antinuclear antibody; Result Unstructured Data: Test Result: negative, Test Result Unit: unknown; Test Date: 2017; Test Name: Aspartate aminotransferase; Result Unstructured Data: Test Result: normal, Test Result Unit: unknown; Test Date: 2017; Test Name: Creatine kinase; Result Unstructured Data: Test Result: normal, Test Result Unit: unknown; Test Date: 2017; Test Name: Blood culture; Result Unstructured Data: Test Result: normal, Test Result Unit: unknown; Test Date: 20170320; Test Name: Fibrinogen; Result Unstructured Data: Test Result: 5.14, Test Result Unit: g/L; Test Date: 20170327; Test Name: Fibrinogen; Result Unstructured Data: Test Result: 5.54, Test Result Unit: g/L; Test Date: 20170412; Test Name: Fibrinogen; Result Unstructured Data: Test Result: 5.01, Test Result Unit: g/L; Test Date: 20170420; Test Name: Fibrinogen; Result Unstructured Data: Test Result: 6.04, Test Result Unit: g/L; Test Date: 20170509; Test Name: Fibrinogen; Result Unstructured Data: Test Result: 3.47, Test Result Unit: g/L; Test Date: 20170526; Test Name: Fibrinogen; Result Unstructured Data: Test Result: 2.46, Test Result Unit: g/L; Test Date: 2017; Test Name: Blood lactate dehydrogenase; Result Unstructured Data: Test Result: normal, Test Result Unit: unknown; Test Date: 2017; Test Name: Blood pressure; Result Unstructured Data: Test Result: normal below the 90th percentile, Test Result Unit: unknown; Test Date: 2017; Test Name: Blood smear test; Result Unstructured Data: Test Result: see text, Test Result Unit: unknown; Test Date: 2017; Test Name: Body temperature; Result Unstructured Data: Test Result: 37.5, Test Result Unit: degree C; Test Date: 2017; Test Name: Body temperature; Result Unstructured Data: Test Result: 38, Test Result Unit: degree C; Test Date: 2017; Test Name: Borrelia test; Result Unstructured Data: Test Result: Borrelia not detected, Test Result Unit: unknown; Test Date: 2017; Test Name: Anticardiolipin antibodies; Result Unstructured Data: Test Result: negative, Test Result Unit: unknown; Test Date: 2017; Test Name: CD4 lymphocytes; Result Unstructured Data: Test Result: see text, Test Result Unit: unknown; Test Date: 2017; Test Name: Chest X-ray; Result Unstructured Data: Test Result: No pathological changes were detected, Test Result Unit: unknown; Test Date: 2017; Test Name: Chlamydia test; Result Unstructured Data: Test Result: not detected, Test Result Unit: unknown; Test Date: 2017; Test Name: Complement factor C3; Result Unstructured Data: Test Result: normal, Test Result Unit: unknown; Test Date: 2017; Test Name: Complement factor C4; Result Unstructured Data: Test Result: normal, Test Result Unit: unknown; Test Date: 20170320; Test Name: C-reactive protein; Test Result: 6.3 mg/dl; Test Date: 20170327; Test Name: C-reactive protein; Test Result: 10.7 mg/dl; Test Date: 20170412; Test Name: C-reactive protein; Test Result: 4.4 mg/dl; Test Date: 20170420; Test Name: C-reactive protein; Test Result: 9.7 mg/dl; Test Date: 20170509; Test Name: C-reactive protein; Test Result: 1.9 mg/dl; Test Date: 20170526; Test Name: C-reactive protein; Test Result: 0.5 mg/dl; Test Date: 20171005; Test Name: C-reactive protein; Test Result: 0.1 mg/dl; Test Date: 20180510; Test Name: C-reactive protein; Test Result: 0.1 mg/dl; Test Date: 20181112; Test Name: C-reactive protein; Test Result: 0.2 mg/dl; Test Date: 20190207; Test Name: C-reactive protein; Test Result: 0.3 mg/dl; Test Date: 2017; Test Name: CSF test; Result Unstructured Data: Test Result: No abnormalities were found, Test Result Unit: unknown; Test Date: 2017; Test Name: Stool culture; Result Unstructured Data: Test Result: normal, Test Result Unit: unknown; Test Date: 2017; Test Name: Throat swab; Result Unstructured Data: Test Result: normal, Test Result Unit: unknown; Test Date: 2017; Test Name: Urine culture; Result Unstructured Data: Test Result: sterile, Test Result Unit: unknown; Test Date: 2017; Test Name: Cytomegalovirus antibody; Result Unstructured Data: Test Result: not detected, Test Result Unit: unknown; Test Name: Electrocardiogram; Result Unstructured Data: Test Result: normal, Test Result Unit: unknown; Test Date: 2017; Test Name: Electrocardiogram; Result Unstructured Data: Test Result: No pathological changes were detected, Test Result Unit: unknown; Test Date: 2017; Test Name: Electrocardiogram; Result Unstructured Data: Test Result: myogenic changes with no evidence of polyneuropath, Test Result Unit: unknown; Test Date: 2017; Test Name: Electromyogram; Result Unstructured Data: Test Result: chronic nerve conduction impairment, Test Result Unit: unknown; Test Date: 2017; Test Name: Epstein-Barr virus antibody; Result Unstructured Data: Test Result: not detected, Test Result Unit: unknown; Test Name: Hemoglobin; Result Unstructured Data: Test Result: normal, Test Result Unit: g/dL; Test Date: 20170320; Test Name: Hemoglobin; Result Unstructured Data: Test Result: 11.3, Test Result Unit: g/dL; Test Date: 20170327; Test Name: Hemoglobin; Result Unstructured Data: Test Result: 9.2, Test Result Unit: g/dL; Test Date: 20170412; Test Name: Hemoglobin; Result Unstructured Data: Test Result: 10, Test Result Unit: g/dL; Test Date: 20170420; Test Name: Hemoglobin; Result Unstructured Data: Test Result: 8.3, Test Result Unit: g/dL; Test Date: 20170509; Test Name: Hemoglobin; Result Unstructured Data: Test Result: 9.9, Test Result Unit: g/dL; Test Date: 20170526; Test Name: Hemoglobin; Result Unstructured Data: Test Result: 10.3, Test Result Unit: g/dL; Test Date: 20171005; Test Name: Hemoglobin; Result Unstructured Data: Test Result: 10.7, Test Result Unit: g/dL; Test Date: 20180510; Test Name: Hemoglobin; Result Unstructured Data: Test Result: 11.8, Test Result Unit: g/dL; Test Date: 20181112; Test Name: Hemoglobin; Result Unstructured Data: Test Result: 13.2, Test Result Unit: g/dL; Test Date: 20190207; Test Name: Hemoglobin; Result Unstructured Data: Test Result: 12.7, Test Result Unit: g/dL; Test Date: 2017; Test Name: Pulse rate; Result Unstructured Data: Test Result: normal, Test Result Unit: unknown; Test Date: 2017; Test Name: HBsAg; Test Date: 2017; Test Name: Hepatitis C virus test; Result Unstructured Data: Test Result: not detected, Test Result Unit: unknown; Test Name: Inflammatory marker test; Result Unstructured Data: Test Result: normal, Test Result Unit: unknown; Test Date: 2017; Test Name: Inflammatory marker test; Result Unstructured Data: Test Result: see text, Test Result Unit: unknown; Test Date: 2017; Test Name: Inflammatory marker test; Result Unstructured Data: Test Result: increased activity, Test Result Unit: unknown; Test Date: 2017; Test Name: Liver function test; Result Unstructured Data: Test Result: normal, Test Result Unit: unknown; Test Name: Magnetic resonance imaging; Result Unstructured Data: Test Result: No pathological changes were detected, Test Result Unit: unknown; Test Date: 20170320; Test Name: Neutrophils; Test Result: 80 %; Test Date: 20170327; Test Name: Neutrophils; Test Result: 82.5 %; Test Date: 20170412; Test Name: Neutrophils; Test Result: 66.9 %; Test Date: 20170420; Test Name: Neutrophils; Test Result: 84.4 %; Test Date: 20170509; Test Name: Neutrophils; Test Result: 47.7 %; Test Date: 20170526; Test Name: Neutrophils; Test Result: 75 %; Test Date: 2017; Test Name: Neutrophils; Result Unstructured Data: Test Result: increased, Test Result Unit: %; Test Date: 20171005; Test Name: Neutrophils; Test Result: 41 %; Test Date: 20180510; Test Name: Neutrophils; Test Result: 42 %; Test Date: 20181112; Test Name: Neutrophils; Test Result: 35 %; Test Date: 20190207; Test Name: Neutrophils; Test Result: 40.6 %; Test Date: 2017; Test Name: Ophthalmological examination; Result Unstructured Data: Test Result: failed to detect any abnormalities, Test Result Unit: unknown; Test Date: 2017; Test Name: Parvovirus B19 test; Result Unstructured Data: Test Result: not detected, Test Result Unit: unknown; Test Date: 2017; Test Name: Physical examination; Result Unstructured Data: Test Result: persistent left-side muscle weakness, Test Result Unit: unknown; Test Date: 2017; Test Name: Physical examination; Result Unstructured Data: Test Result: see text, Test Result Unit: unknown; Test Name: Platelet count; Result Unstructured Data: Test Result: normal, Test Result Unit: x10(3)/uL; Test Date: 20170320; Test Name: Platelet count; Result Unstructured Data: Test Result: 656, Test Result Unit: x10(3)/uL; Test Date: 20170327; Test Name: Platelet count; Result Unstructured Data: Test Result: 1125, Test Result Unit: x10(3)/uL; Test Date: 20170412; Test Name: Platelet count; Result Unstructured Data: Test Result: 1025, Test Result Unit: x10(3)/uL; Test Date: 20170420; Test Name: Platelet count; Result Unstructured Data: Test Result: 996, Test Result Unit: x10(3)/uL; Test Date: 20170509; Test Name: Platelet count; Result Unstructured Data: Test Result: 791, Test Result Unit: x10(3)/uL; Test Date: 20170526; Test Name: Platelet count; Result Unstructured Data: Test Result: 580, Test Result Unit: x10(3)/uL; Test Date: 2017; Test Name: Platelet count; Result Unstructured Data: Test Result: incresead, Test Result Unit: x10(3)/uL; Test Date: 20171005; Test Name: Platelet count; Result Unstructured Data: Test Result: 528, Test Result Unit: x10(3)/uL; Test Date: 20180510; Test Name: Platelet count; Result Unstructured Data: Test Result: 411, Test Result Unit: x10(3)/uL; Test Date: 20181112; Test Name: Platelet count; Result Unstructured Data: Test Result: 405, Test Result Unit: x10(3)/uL; Test Date: 20190207; Test Name: Platelet count; Result Unstructured Data: Test Result: 426, Test Result Unit: x10(3)/uL; Test Date: 2017; Test Name: Procalcitonin; Result Unstructured Data: Test Result: normal, Test Result Unit: unknown; Test Date: 20170320; Test Name: Erythrocyte sedimentation rate; Result Unstructured Data: Test Result: 47, Test Result Unit: mm/h; Test Date: 20170327; Test Name: Erythrocyte sedimentation rate; Result Unstructured Data: Test Result: 60, Test Result Unit: mm/h; Test Date: 20170412; Test Name: Erythrocyte sedimentation rate; Result Unstructured Data: Test Result: 45, Test Result Unit: mm/h; Test Date: 20170420; Test Name: Erythrocyte sedimentation rate; Result Unstructured Data: Test Result: 56, Test Result Unit: mm/h; Test Date: 20170509; Test Name: Erythrocyte sedimentation rate; Result Unstructured Data: Test Result: 28, Test Result Unit: mm/h; Test Date: 20170526; Test Name: Erythrocyte sedimentation rate; Result Unstructured Data: Test Result: 12, Test Result Unit: mm/h; Test Date: 20171005; Test Name: Erythrocyte sedimentation rate; Result Unstructured Data: Test Result: 2, Test Result Unit: mm/h; Test Date: 20180510; Test Name: Erythrocyte sedimentation rate; Result Unstructured Data: Test Result: 2, Test Result Unit: mm/h; Test Date: 20181112; Test Name: Erythrocyte sedimentation rate; Result Unstructured Data: Test Result: 4, Test Result Unit: mm/h; Test Date: 20190207; Test Name: Erythrocyte sedimentation rate; Test Date: 2017; Test Name: Renal function test; Result Unstructured Data: Test Result: normal, Test Result Unit: unknown; Test Date: 2017; Test Name: Renal function test; Result Unstructured Data: Test Result: normal, Test Result Unit: unknown; Test Date: 2017; Test Name: Respiratory rate; Result Unstructured Data: Test Result: normal, Test Result Unit: unknown; Test Date: 2017; Test Name: Rheumatoid factor; Result Unstructured Data: Test Result: negative, Test Result Unit: unknown; Test Date: 2017; Test Name: T-lymphocyte count; Result Unstructured Data: Test Result: see text, Test Result Unit: unknown; Test Date: 2017; Test Name: Ultrasound scan; Result Unstructured Data: Test Result: splenic enlargement and effusion in left hip joint, Test Result Unit: unknown; Test Date: 2017; Test Name: Ultrasound scan; Result Unstructured Data: Test Result: No pathological changes were detected (see text), Test Result Unit: unknown; Test Name: White blood cell count; Result Unstructured Data: Test Result: normal, Test Result Unit: x10(3)/uL; Test Date: 20170320; Test Name: White blood cell count; Result Unstructured Data: Test Result: 23.3, Test Result Unit: x10(3)/uL; Test Date: 20170327; Test Name: White blood cell count; Result Unstructured Data: Test Result: 42.9, Test Result Unit: x10(3)/uL; Test Date: 20170412; Test Name: White blood cell count; Result Unstructured Data: Test Result: 22.9, Test Result Unit: x10(3)/uL; Test Date: 20170420; Test Name: White blood cell count; Result Unstructured Data: Test Result: 35.1, Test Result Unit: x10(3)/uL; Test Date: 20170509; Test Name: White blood cell count; Result Unstructured Data: Test Result: 15.6, Test Result Unit: x10(3)/uL; Test Date: 20170526; Test Name: White blood cell count; Result Unstructured Data: Test Result: 13, Test Result Unit: x10(3)/uL; Test Date: 20171005; Test Name: White blood cell count; Result Unstructured Data: Test Result: 7.4, Test Result Unit: x10(3)/uL; Test Date: 20180510; Test Name: White blood cell count; Result Unstructured Data: Test Result: 10.4, Test Result Unit: x10(3)/uL; Test Date: 20181112; Test Name: White blood cell count; Result Unstructured Data: Test Result: 7.1, Test Result Unit: x10(3)/uL; Test Date: 20190207; Test Name: White blood cell count; Result Unstructured Data: Test Result: 7, Test Result Unit: x10(3)/uL
CDC Split Type: PLGLAXOSMITHKLINEPL2019GS

Write-up: ecchymosis near the left anterior iliac spine; Muscle force was weakened especially on the left side; Reduced left hip abduction; tongue with a whitish coating; tonsils were enlarged; Thrombocythemia; leukocytosis; splenic enlargement; nerve conduction impairment; multifocal mononeuropathy; increased muscle tone; Mucosal erosion; enhanced left patellar reflex; enhanced left ankle clonus; Cutaneous polyarteritis nodosa; Behcet''s disease; pyrexia; strong pain in the knee, ankle, wrist and left hip joints; lower limb paresthesia; oral mucosa lesions; stomatitis; toothache; hyperesthesia/whole-body hyperesthesia; palpable soft, tender subcutaneous nodules about 2 cm in diameter in the sternal area/nodular skin lesions; palpable soft, tender subcutaneous nodules about 2 cm in diameter in the sternal area; edema around the knee, ankle and wrist joints; pain in the left lower extremity and upper extremities; gangrenous teeth; This case was reported in a literature article and described the occurrence of polyarteritis nodosum in a 7-year-old male patient who received Hepatitis B vaccine for prophylaxis. The patient''s past medical history included upper respiratory tract infection (occasional). On an unknown date, the patient received the 2nd dose of Hepatitis B vaccine. On an unknown date, less than 6 months after receiving Hepatitis B vaccine and an unknown time after starting nystatin, the patient experienced polyarteritis nodosum (serious criteria hospitalization and GSK medically significant), behcet''s disease (serious criteria hospitalization and GSK medically significant), fever (serious criteria hospitalization), pain in extremity (serious criteria hospitalization), arthralgia (serious criteria hospitalization), hyperesthesia (serious criteria hospitalization), subcutaneous nodule (serious criteria hospitalization), tenderness (serious criteria hospitalization), peripheral edema (serious criteria hospitalization), ecchymosis (serious criteria hospitalization), muscle weakness (serious criteria hospitalization), tender tongue (serious criteria hospitalization), tongue white (serious criteria hospitalization), tonsillar hypertrophy (serious criteria hospitalization), anemia (serious criteria hospitalization), thrombocythemia (serious criteria hospitalization), leukocytosis (serious criteria hospitalization), spleen enlarged (serious criteria hospitalization), conduction disorder (serious criteria hospitalization), mononeuropathy (serious criteria hospitalization), increased muscle tone (serious criteria hospitalization), mucosal erosion (serious criteria hospitalization), patellar tendon reflex increased (serious criteria hospitalization), clonus of limbs (serious criteria hospitalization), dental gangrene (serious criteria hospitalization and GSK medically significant), paresthesia lower limb (serious criteria hospitalization), oral soft tissue disorder (serious criteria hospitalization), stomatitis and toothache. The patient was treated with nystatin, methylprednisolone, prednisone, naproxen, immunoglobulins nos (Immunoglobulin), methotrexate and corticosteroid nos (Corticosteroids Nos). On an unknown date, the outcome of the polyarteritis nodosum, behcet''s disease, fever, pain in extremity, arthralgia, hyperesthesia, subcutaneous nodule, tenderness, peripheral edema, ecchymosis, muscle weakness, tender tongue, tongue white, tonsillar hypertrophy, anemia, thrombocythemia, leukocytosis, spleen enlarged, conduction disorder, mononeuropathy, increased muscle tone, mucosal erosion, clonus of limbs, dental gangrene, paresthesia lower limb, oral soft tissue disorder and toothache were recovered/resolved and the outcome of the patellar tendon reflex increased and stomatitis were unknown. The reporter considered the polyarteritis nodosum, behcet''s disease, fever, pain in extremity, arthralgia, hyperesthesia, subcutaneous nodule, tenderness, peripheral edema, ecchymosis, muscle weakness, tender tongue, tongue white, tonsillar hypertrophy, anemia, thrombocythemia, leukocytosis, spleen enlarged, conduction disorder, mononeuropathy, increased muscle tone, mucosal erosion, patellar tendon reflex increased, clonus of limbs, dental gangrene, paresthesia lower limb, oral soft tissue disorder, stomatitis and toothache to be possibly related to Hepatitis B vaccine. Additional details were provided as follows: This case was reported in a literature article and described the occurrence of cutaneous polyarteritis nodosa (cPAN) in an 7-year and 6 month-old male patient, who was vaccinated with unspecified hepatitis B vaccine (HBV) (manufacturer unknown) for prophylaxis. The patient''s past medical history showed no chronic diseases. The boy had previously suffered from occasional upper respiratory tract infections. The patient''s parents denied recent lack of appetite, weight loss, hyperhidrosis, abdominal pain, headache or testicular pain. No information on patient''s family history, or concomitant medication was provided. On an unspecified date, the patient received 2nd dose of unspecified hepatitis B vaccine (HBV) (administration site unspecified; batch number not provided) five months prior to the hospitalization. The age of vaccination was not provided. On an unspecified date, unknown period after vaccination and three weeks prior to hospitalization, the patient had toothache which subsided without dentist intervention. One week prior to the hospital, the patient had been diagnosed with stomatitis and showed no response to treatment on an outpatient basis. On an unspecified date, 5 month after vaccination, the patient was admitted to the hospital with fever and pain in the extremities. At 3 days, the patient initially developed mild pyrexia, followed by fever above 38 degree C and increased pain in the left lower extremity and upper extremities. On admission the patient condition was moderately severe condition; he was pyrexial and suffering. Pain in the extremities impeded normal movement; both active and passive movements were accompanied by very strong pain in the knee, ankle, wrist and left hip joints. During physical examination the boy complained of severe pain in the form of whole-body hyperesthesia. Physical examination revealed palpable soft, tender subcutaneous nodules about 2 cm in diameter in the sternal area, subcutaneous edema around the knee, ankle and wrist joints, as well as ecchymosis near the left anterior iliac spine. Muscle force was weakened, especially on the left side. Reduced left hip abduction was observed. Moreover, the tongue was tender, with a whitish coating, the tonsils were enlarged and erosions were observed in the mucosa and tonsils. Arterial pressure was normal, below the 90th percentile, and the remaining vital signs, such as pulse and breathing, were normal for the boy''s age. The conducted tests revealed high inflammatory marker activity with normal pro-calcitonin levels, anemia, thrombocythemia and leukocytosis with a predominance of neutrophils on peripheral blood smear, and a high tetrazolium reduction test result (82 percent), with a normal value of up to 12 percent). The activity of aminotransferases, lactic dehydrogenase, creatine kinase and aldolase, kidney function tests, and the levels of complement components C3c and C4 were normal. Anti-CMV lgM and anti-parvovirus B19 lgM antibodies were detected. In contrast, no HbsAg or antibodies against Epstein-Barr virus, hepatitis C virus, Borrelia, Chlamydia trachomatis or Mycop/asma pneumonia were detected. Gamma-interferon release assay was negative. Similarly, anti-cyclic citrullinated peptide autoantibodies (ACPA), rheumatoid factor (RF), anti-nuclear antibodies (ANA), myeloperoxidase anti-neutrophil cytoplasmic antibodies (MPO-ANCA), proteinase-3 anti-neutrophil cytoplasmic antibodies (PR3-ANCA), anti-cardiolipin antibodies (ACA), the Venereal Diseases Research Laboratory {VDRL) test and anti-vascular endothelial cell antibodies (AECA) levels were all negative. Bone marrow features excluded neoplasm. Multiple blood and urine cultures were sterile, and swabs and cultures of the upper respiratory tract and stool material were normal. Ultrasound imaging revealed splenic enlargement and an effusion in the left hip joint. Electromyography (EMG) showed chronic nerve conduction impairment consistent with multifocal mononeuropathy. No pathological changes were detected in imaging and function tests, including chest radiographs, echocardiography, electrocardiography, ultrasound imaging of the remaining peripheral joints, magnetic resonance imaging (MRI) of the head and the thoracic and lumbosacral spine, and capillaroscopy. No abnormalities were found in the cerebrospinal fluid. A consulting neurologist found increased muscle tone and muscle weakness in the boy''s upper extremities, enhanced left patellar reflex and left ankle clonus. Dental assessment revealed several gangrenous teeth, while an ophthalmological examination failed to detect any abnormalities. The boy''s condition remained moderately severe; he was feverish and suffering. In the following days, cyanotic, tender, soft subcutaneous nodules emerged and quickly expanded (up to 3 cm) within the chest and thorax, the auricles, above the left knee joint and on the fingers of the right hand. Ultrasound imaging revealed that these were dilated subcutaneous vessels with thickened walls and impaired flow, as well as a subcutaneous peri-vascular inflammatory infiltrate. The clinical manifestations were inconclusive and suggested systemic vasculitis (SV); given the clinical manifestations and disease course, as well as the conducted diagnostic tests, PAN, Behcet''s disease (BD) and autoimmune/autoinflammatort sndrome inducted but adjuvants (ASIA) were included for differential diagnosis. Due to the child''s severe condition and clinical manifestations suggestive of SV, systemic steroid therapy was first implemented with methylprednisolone IV at 300 mg/day for three consecutive days and subsequently prednisone orally at 1 mg/kg body weight. Additionally, broad-spectrum antibiotics, nystatin, naproxen and acetylsalicylic acid were administered. Dental procedures were carried out. As a result of treatment, the fever, pain and hyperesthesia, subcutaneous edema, nodular skin lesions and oral mucosal lesions resolved. During the 1st hospitalization on 20th March 2017, the laboratory results were hemoglobin (HGB) 11.3 g/dl (11.0-14.6 g/dl); platelets (PLT) 656x10E3/microL (140-440 x10E3/microL); white blood cells 23.3x10E3/microL (4.5-13.5 x10E3/microL); Neutrophils 80 percent (40-60 percent); erythocyte sedimentation rate (ESR) 47 mm/h (less than 15 mm/h); C-reactive protein (CRP) 6.3 mg/dl (0.0-0.50 mg/dl) and Fibrinogen 5.14g/l (2.00-4.00 g/l). On 27th March 2017, the laboratory results were hemoglobin (HGB) 9.2 g/dl (11.0-14.6 g/dl); platelets (PLT) 1125x10E3/microL (140-440 x10E3/microL); white blood cells 42.9x10E3/microL (4.5-13.5 x10E3/microL); Neutrophils 82.5 percent (40-60 percent); erythocyte sedimentation rate (ESR) 60 mm/h (less than 15 mm/h); C-reactive protein (CRP) 10.7 mg/dl (0.0-0.50 mg/dl) and Fibrinogen 5.54g/l (2.00-4.00 g/l). On 12th April 2017, the laboratory results were hemoglobin (HGB) 10 g/dl (11.0-14.6 g/dl); platelets (PLT) 1025x10E3/microL (140-440 x10E3/microL); white blood cells 22.9x10E3/microL (4.5-13.5 x10E3/microL); Neutrophils 66.9 percent (40-60 percent); erythocyte sedimentation rate (ESR) 45 mm/h (less than 15 mm/h); C-reactive protein (CRP) 4.4 mg/dl (0.0-0.50 mg/dl) and Fibrinogen 5.01 g/l (2.00-4.00 g/l). Laboratory test results gradually returned to normal, while physical examination revealed persistent left-side muscle weakness. At four weeks from admission, the boy was discharged home with a recommendation to continue treatment with oral methylprednisolone at 16 mg/day and undergo follow-up at an outpatient rheumatology clinic.One week after discharge, the patient was once again admitted to hospital due to renewed subcutane-ous nodule formation and mild pyrexia of up to 37.5 degree C. On admission, the boy''s condition was moderate. Small (up to 5 mm), tender subcutaneous nodules were observed in bilateral forearms and the left hand, his tongue had a white coating, he complained of whole-body hyperesthesia and lower limb paresthesia, and muscle weakness was observed in bilateral upper extremities and the left lower extremity. During the 2nd hospitalization on 20th April 2017, the laboratory results were hemoglobin (HGB) 8.3 g/dl (11.0-14.6 g/dl); platlets (PLT) 996x10E3/microL (140-440 x10E3/microL); white blood cells 35.1x10E3/microL (4.5-13.5 x10E3/microL); Neutrophils 84.4 percent (40-60 percent); erythocyte sedimentation rate (ESR) 56 mm/h (less than 15 mm/h); C-reactive protein (CRP) 9.7 mg/dl (0.0-0.50 mg/dl) and Fibrinogen 6.04 g/l (2.00- 4.00 g/l). On 9th May 2017, the laboratory results were hemoglobin (HGB) 9.9 g/dl (11.0-14.6 g/dl); platlets (PLT) 791x10E3/microL (140-440 x10E3/microL); white blood cells 15.6x10E3/microL (4.5-13.5 x10E3/microL); Neutrophils 47.7 percent (40-60 percent); erythocyte sedimentation rate (ESR) 28 mm/h (less than 15 mm/h); C-reactive protein (CRP) 1.9 mg/dl (0.0-0.50 mg/dl) and Fibrinogen 3.47 g/l (2.00- 4.00 g/l).Laboratory tests revealed increased activity of in-flammation markers, platelet (PLT) count and percentage of neutrophils on peripheral blood smear, as well as enhanced anemia compared with previous test results. The electromyography (EMG) showed myogenic changes with no evidence of polyneuropathy. Muscle enzyme activity and liver and kidney function tests remained normal. Sections of the skin and subcutaneous tissue were collected from a nodule on the wrist (a) and from the calf muscle (b) for histopathological assess-ment. These were described as follows: increase in small vessels, surrounding infiltration: made up primarily of CD4+ lymphocytes; aggregates of CD3+ and CD4+ lymphocytes, neutrophils (CD15+) and histiocytes (CD68+) between adipose tissue lobules in the subcutaneous tissue, increase in vessels in the adipose tissue between: muscle fibers, surrounded by aggregates of B lymphocytes (CD20+) and T lymphocytes (CD3+, CD4+, CDS+), granulocytes (CD15+), individual plasma cells (CD138+) and histiocytes (CD68+). Based on the clinical manifestations and test results, the patient was ultimately diagnosed with cPAN. The patient once again received intravenous methylpredniso-lone at 300 mg, followed by intravenous immunoglobulin (IVIG) at 1 g/kg body weight and methotrexate (MTX) at 7.5 mg/week. As a result of the implemented treatment, the fever, subcutaneous nodules, hyperesthesia and paresthesia re-solved, muscle strength improved and test results gradually returned to normal: leukocyte and PLT count, percent-age of neutrophils and activity of acute phase markers. At three weeks from admission, the boy was discharged home in overall good condition, with a recommendation to continue MTX treatment at 15 mg/week (15.5 mg/m2) and methylprednisolone at 16 mg/day. On follow up on 26th May 2017, the laboratory results were hemoglobin (HGB) 10.3 g/dl (11.0-14.6 g/dl); platlets (PLT) 580x10E3/microL (140-440 x10E3/microL); white blood cells 13x10E3/microL (4.5-13.5 x10E3/microL); Neutrophils 75 percent (40-60 percent); erythocyte sedimentation rate (ESR) 12 mm/h (less than 15 mm/h); C-reactive protein (CRP) 0.5 mg/dl (0.0-0.50 mg/dl) and Fibrinogen 2.46 g/l (2.00-4.00 g/l). On follow up on 5th October 2017, the laboratory results were hemoglobin (HGB) 10.7 g/dl (11.0-14.6 g/dl); platlets (PLT) 528x10E3/microL (140-440 x10E3/microL); white blood cells 7.4x10E3/microL (4.5-13.5 x10E3/microL); Neutrophils 41 percent (40-60 percent); erythocyte sedimentation rate (ESR) 2 mm/h (less than 15 mm/h); C-reactive protein (CRP) 0.1 mg/dl (0.0-0.50 mg/dl). On follow up on 10th May 2018, the laboratory results were hemoglobin (HGB) 11.8 g/dl (11.0-14.6 g/dl); platlets (PLT) 411x10E3/microL (140-440 x10E3/microL); white blood cells 10.4x10E3/microL (4.5-13.5 x10E3/microL); Neutrophils 42 percent (40-60 percent); erythocyte sedimentation rate (ESR) 2 mm/h (less than 15 mm/h); C-reactive protein (CRP) 0.1 mg/dl (0.0-0.50 mg/dl). On follow up on 12th November 2018, the laboratory results were hemoglobin (HGB) 13.2 g/dl (11.0-14.6 g/dl); platlets (PLT) 405x10E3/microL (140-440 x10E3/microL); white blood cells 7.1x10E3/microL (4.5-13.5 x10E3/microL); Neutrophils 35 percent (40- 60 percent); erythocyte sedimentation rate (ESR) 2 mm/h (less than 15 mm/h); C-reactive protein (CRP) 0.2 mg/dl (0.0-0.50 mg/dl). On follow up on 7th February 2019, the laboratory results were hemoglobin (HGB) 12.7 g/dl (11.0-14.6 g/dl); platlets (PLT) 426x10E3/microL (140-440 x10E3/microL); white blood cells 7x10E3/microL (4.5-13.5 x10E3/microL); Neutrophils 40.6 percent (40-60 percent); erythocyte sedimentation rate (ESR) 4 mm/h (less than 15 mm/h); C-reactive protein (CRP) 0.3 mg/dl (0.0-0.50 mg/dl). During follow-up, no recurrence of symptoms was observed, the patient reported no complaints, left lower limb muscle weakness subsided completely, and laboratory test results returned to normal, including hemoglobin concentration, leukocyte and PLT count, acute phase marker levels, and EMG results. Full clinical remission was observed within seven months of diagnosis and implementation of treatment. Treatment was later continued with a gradual decrease in the dosage of corticosteroids (CS), which were ultimately discontinued after 17 months of treatment. During the following 2 months, the patient was given the dose of the hepatitis B vaccine that had been scheduled for earlier and no adverse effects or disease recurrence was observed. The boy was currently receiving MTX and was feeling well; laboratory test results are normal. This case has been considered as serious due to the Hospitalization (twice). The author commented, "Diagnosis of PAN, BD and, due to the recent vaccination in the patient''s medical history, ASIA seemed most likely in the differential diagnosis. Each of the proposed diagnoses was equally plausible." The author concluded, "The case presented here exemplifies the possible difficulties in diagnosing vasculitis due to inconclusive clinical manifestations, which is especially true for rare disease entities, such as PAN in children. In the case of our patient, the symptoms and laboratory test results were indicative of several disease entities. The nature of the skin and oral mucosal lesions, as well as the neurological symptoms, were important. Laboratory test results turned out to be critical: ANCA negativity, ultrasound features of the nodular skin lesions, histo-pathological results, EMG results, and imaging of the nervous system. According to the international classification criteria for BD in children (2015), the diagnosis requires mucosal inflammation to occur at least three times in one year, which was not observed during follow-up of our patient, perhaps due to the implemented treatment. With regard to Country, the vaccination was with a booster dose. No disturbing symptoms had been observed after the primary dose. Following remission, the boy received another dose of the vaccine and no features suggesting disease recurrence have been observed to date. We suspected PAN, but the histopathological results were inconclusive. The fact that no internal organs were affected was also important. In light of the observed disease course and response to treatment, cPAN seems to be the most plausible diagnosis in this case." This article corresponding to this case is not available for regulatory submission due to copyright restriction. Lab Comments: Physical examination revealed palpable soft, tender subcutaneous nodules about 2 cm in diameter in the sternal area, subcutaneous edema around the knee, ankle and wrist joints, as well as ecchymosis near the left anterior iliac spine. Muscle force weakened on the left side. Reduced left hip abduction. The tongue was tender, with a whitish coating, tonsils enlarged and erosions were observed in the mucosa and tonsils. The conducted tests revealed high inflammatory marker activity with normal pro-calcitonin levels, anemia, thrombocythemia and leukocytosis with a predominance of neutrophils on peripheral blood smear, and a high tetrazolium reduction test result (82 percent), with a normal value of up to 12 percent). Mycoplasma pneumonia were not detected. Gamma-interferon release assay, the Venereal Diseases Research Laboratory (VDRL) test and anti-vascular endothelial cell antibodies (AECA) levels were negative. Bone marrow features excluded neoplasm. Ultrasound imaging revealed that these were dilated subcutaneous vessels with thickened walls and impaired flow, as well as a subcutaneous peri?vascular inflammatory infiltrate. Sections of the skin and subcutaneous tissue were collected from a nodule on the wrist (a) and from the calf muscle (b) for histopathological assess?ment. These were described as follows: increase in small vessels, surrounding infiltration: made up primarily of CD4+ lymphocytes; aggregates of CD3+ and CD4+ lymphocytes, neutrophils (CD15+) and histiocytes (CD68+) between adipose tissue lobules in the subcutaneous tissue, increase in vessels in the adipose tissue between: muscle fibers, surrounded by aggregates of B lym?phocytes (CD20+) and T lymphocytes (CD3+, CD4+, CDS+), granulocytes (CD15+), individual plasma cells (CD138+) and histiocytes (CD68+).) .Laboratory test results gradually returned to normal while physical examina?tion revealed persistent left-side muscle weakness.


VAERS ID: 855129 (history)  
Form: Version 2.0  
Age: 0.25  
Sex: Female  
Location: Foreign  
Vaccinated:2019-11-05
Onset:2019-11-05
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2020-01-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PPV: PNEUMO (NO BRAND NAME) / UNKNOWN MANUFACTURER X60012 ? / 1 RL / -
RV1: ROTAVIRUS (ROTARIX) / GLAXOSMITHKLINE BIOLOGICALS AROLC382AA / 1 - / OT
UNK: VACCINE NOT SPECIFIED (NO BRAND NAME) / UNKNOWN MANUFACTURER 03167207 / 1 LA / -
UNK: VACCINE NOT SPECIFIED (NO BRAND NAME) / UNKNOWN MANUFACTURER AOP4A653AB / 1 - / OT
UNK: VACCINE NOT SPECIFIED (NO BRAND NAME) / UNKNOWN MANUFACTURER 22011311817 ? / 1 LL / -

Administered by: Other       Purchased by: ?
Symptoms: Cough, Irritability, Pyrexia, Rhinorrhoea, Upper respiratory tract infection, Vaccination failure
SMQs:, Anaphylactic reaction (broad), Lack of efficacy/effect (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hostility/aggression (broad), 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? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Adverse drug reaction; Congenital anomaly
Allergies:
Diagnostic Lab Data: Test Date: 20191105; Test Name: Body temperature; Result Unstructured Data: Test Result: more than equal to 38, Test Result Unit: degree C
CDC Split Type: GHGLAXOSMITHKLINEGH2019GS

Write-up: Upper respiratory tract infection; Cough; Running nose; Fever; Became irritable; This case was reported by a other health professional via regulatory authority and described the occurrence of suspected vaccination failure in a 5-month-old female patient who received pneumococcal vaccine (batch number X60012 ?, expiry date unknown) for prophylaxis. Co-suspect products included penta vaccine (batch number 22011311817 ?, expiry date unknown) for prophylaxis, POLIO SABIN One and Three (batch number AOP4A653AB, expiry date unknown) for prophylaxis, Rotarix liquid formulation (batch number AROLC382AA, expiry date unknown) for prophylaxis and BCG (BACILLUS CALMETTE GUERIN) (batch number 03167207, expiry date unknown) for prophylaxis. Historical condition included pre-existing illness and congenital disorder. Additional patient notes included prior to immunization the patient did not have past history of similar event and adverse event after previous vaccinations, family history of any disease and history of hospitalization in last 30 days with cause. On 5th November 2019, the patient received the 1st dose of Pneumococcal vaccine, the 1st dose of POLIO SABIN One and Three (oral) and the 1st dose of penta vaccine, the 1st dose of Rotarix liquid formulation (oral) and the 1st dose of BCG (BACILLUS CALMETTE GUERIN).On 5th November 2019, less than a day after receiving Pneumococcal vaccine, POLIO SABIN One and Three, penta vaccine, Rotarix liquid formulation, BCG (BACILLUS CALMETTE GUERIN) and paracetamol the patient experienced upper respiratory tract infection (serious criteria hospitalization), cough (serious criteria hospitalization), runny nose (serious criteria hospitalization), fever (serious criteria hospitalization) and irritability (serious criteria hospitalization). The patient was treated with paracetamol. On an unknown date, the outcome of the respiratory tract infection, cough, runny nose, fever and irritability were recovering/resolving. It was unknown if the reporter considered the respiratory tract infection, cough, runny nose, fever and irritability to be related to pneumococcal vaccine, POLIO SABIN One and Three, penta vaccine and Rotarix liquid formulation. Additional case details were reported as follows: The patient was a full term female infant. It was unknown whether patient had allergy to vaccine, drug, food. The patient did not receive concomitant medication. The patient received BCG vaccine in left arm, Penta vaccine in left thigh and PCV vaccine in right thigh. The type of site was fixed. The patent was well until 5th November 2019. The patient presented with coughing, having running nose, fever (more than equal to 38 Degree Celsius) and became irritable. The patient was diagnosed with upper respiratory tract infection. On 6th November 2019, the patient hospitalized. The patient was recovering and doing better. It was unknown if the reporter considered the respiratory tract infection, cough, runny nose, fever and irritability to be related to BCG (BACILLUS CALMETTE GUERIN). The case was reported from a Hospital from the regulatory authority. This is 1 of the 11 linked cases reported by the same reporter.


VAERS ID: 855130 (history)  
Form: Version 2.0  
Age: 0.08  
Sex: Female  
Location: Foreign  
Vaccinated:2016-05-05
Onset:2016-05-05
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2020-01-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTP: DTP (NO BRAND NAME) / UNKNOWN MANUFACTURER 20914001A / 1 RA / OT
HEP: HEP B (FOREIGN) / MERCK & CO. INC. UFA15005 / 2 RA / OT
HIBV: HIB (ACTHIB) / SANOFI PASTEUR L1114 / 1 LL / OT

Administered by: Other       Purchased by: ?
Symptoms: Crying, Product administered to patient of inappropriate age, Vaccination site reaction
SMQs:, Depression (excl suicide and self injury) (broad), 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? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: PLSA2019SA362570

Write-up: Vaccination site reaction on left thigh, with a diameter of 6-9 cm; Persistent crying lasting more than 3 hours; a one month old female patient received a dose of Act-Hib vaccine; Initial information received on 27-Dec-2019 regarding an unsolicited valid serious case downloaded from Regulatory Authority database without narrative (level 2A), was received from physician via Health Authority (under reference number: PL-URPL-N800/2016). The following narrative is based on the information retrieved from all other accessible data. This case involves a one month old female patient who experienced vaccination site reaction on left thigh, with a diameter of 6-9 cm (vaccination site reaction) and persistent crying lasting more than 3 hours (crying), while she received vaccines and HEPATITIS B VACCINE LG-LS [EUVAX B], HIB (PRP/T) VACCINE [ACT-HIB] and DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE, TETANUS VACCINE TOXOID [DTP]. The patient''s past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 05-May-201616:30, the patient received a 0.5 ml Second dose of suspect HEPATITIS B VACCINE LG-LS lot UFA15005 via intramuscular route in the right arm. On 05-May-2016 16:30, the patient received a 0.5 ml First dose of suspect HIB (PRP/T) VACCINE lot L1114 via intramuscular route in the left thigh. On 05-May-2016 16:30, the patient received a 0.5 ml First dose of suspect DTP not produced by Sanofi Pasteur lot 20914001A via intramuscular route in the right arm. On 05-May-2016, the patient developed a serious vaccination site reaction on left thigh, with a diameter of 6-9 cm (vaccination site reaction), on the same day following the administration of HEPATITIS B VACCINE LG-LS, HIB (PRP/T) VACCINE and DTP. The patient was hospitalized for this event. On 05-May-2016 19:00, the patient developed a serious persistent crying lasting more than 3 hours (crying) 2 hours 30 minutes following the administration of HEPATITIS B VACCINE LG-LS, HIB (PRP/T) VACCINE and DTP. The patient was hospitalized for this event. It was an actual medication error due to Inappropriate age at vaccine administration as one month old female patient received a dose of Act-Hib vaccine. (Other relevant tests included no lab data.) Final diagnosis was vaccination site reaction and crying. It was not reported if the patient received a corrective treatment. The patient was recovered from the events. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in 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. Senders Comments: Severe injection site reaction manifested as redness, induration, or swelling is an expected adverse effect to all three vaccines, and it is included in their Summaries of Product Characteristics. The physician has specified the reaction site (left thigh), and therefore the relationship with the Act-HIB vaccine, which was administered to that area, has been established. Persistent crying is defined as child''s crying or screaming lasting continuously for 3 hours or more that occurs within 24 hours after vaccination. It is an expected adverse effect following the administration of DTP. (Inconsolable, unusual) crying is an expected effect to Act-HIB, whereas crying without an apparent cause is an effect to EUVAX B, included in the Summary of Product Characteristics Due to the co-administration of three vaccines, it is impossible to determine which one contributed to the symptom occurrence. The temporal relationship speaks for the causal relationship. The reporting person classified the AEFI as mild. Due to the nature of the adverse effects (persistent crying), the Agency assessed the AEFI as severe.; Sender''s Comments: This case involves a one month old female patient who presented with Vaccination site reaction and crying after vaccination with EUVAX B, ACT-HIB and DTP VACCINE. Time to onset is compatible. However, patient''s lab tests ruling out alternate etiologies were not reported. Based upon the reported information, the role of vaccines cannot be individually assessed.


VAERS ID: 855137 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2018-02-12
Onset:2018-02-13
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2020-01-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK LA / -
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH - / UNK RA / OT

Administered by: Other       Purchased by: ?
Symptoms: Vaccination site reaction
SMQs:

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: NOPFIZER INC2019561365

Write-up: VACCINATION SITE REACTION, RIGHT ARM; This is a spontaneous report downloaded from the regulatory authority-WEB NO-NOMAADVRE-FHI-2019-01278. A contactable physician reported that a 39-year-old female patient received a single dose of pneumococcal 13-val conj vac (dipht crm197 protein) (PREVENAR 13), via intramuscular route, on 12Feb2018, into right arm, for immunization, and influenza vaccine via an unspecified route of administration on 12Feb2018, a single dose administered into left arm for immunization. The patient''s medical history and concomitant medications were not reported. The patient experienced a vaccination site reaction, on the right arm on 13Feb2018, with outcome of resolved with sequelae on an unspecified date. The event was serious per hospitalization. Reporter comment: 05Dec2019: Regulatory authority has requested additional information. This is a preliminary report. Sender comment: Other Assessment: The Regional Pharmacovigilance Center has assessed the causal relationship between the event and Prevenar 13 as probable, while it was assessed that there was no causal relationship between the event and the influenza vaccine. No follow-up attempts are possible, information about batch number cannot be obtained.; Reporter''s Comments: 05Dec2019: regulatory authority has requested additional information. This is a preliminary report


VAERS ID: 855138 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:2017-06-07
Onset:2017-06-07
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2020-01-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
6VAX-F: DTAP+IPV+HEPB+HIB (INFANRIX HEXA) / GLAXOSMITHKLINE BIOLOGICALS A1CC93CA / 4 RL / OT
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH SI2065 / 4 LL / OT

Administered by: Other       Purchased by: ?
Symptoms: Dysstasia, Gait disturbance, Pyrexia
SMQs:, Peripheral neuropathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Parkinson-like events (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20170607; Test Name: Body temperature; Result Unstructured Data: Test Result: fever 38 - 38.4, Test Result Unit: Centigrade
CDC Split Type: PLPFIZER INC2019561021

Write-up: Fever 38 - 38.4 Celsius degrees; Walking difficulties - child couldn''t stand on the legs; This is a spontaneous report from a contactable physician. This is a report received from the regulatory authority. Regulatory authority report number PL-URPL-N1520/2017. The reporter is contactable to HA only. A 1-year-old patient of an unspecified gender received fourth dose of pneumococcal 13-val conj vac (dipht crm197 protein) (PREVENAR 13, lot# SI2065, Expiration Date: 31May2019), intramuscularly in left thigh on 07Jun2017 08:15 at 0.5 single dose for routine childhood immunization, fourth dose of diphtheria vaccine toxoid, hepatitis b vaccine rhbsag (yeast), hib vaccine conj, pertussis vaccine acellular 3-component, polio vaccine inact 3v (vero), tetanus vaccine toxoid (INFANRIX HEXA, lot# A1CC93CA, Expiration Date: 31Mar2019), intramuscularly in right thigh on 07Jun2017 08:15 at 0.5 ml for immunisation. The patient''s medical history and concomitant medications were not reported. The patient previously took first dose, second dose and third dose of pneumococcal 13-val conj vac (dipht crm197 protein) and diphtheria vaccine toxoid, hepatitis b vaccine rhbsag (yeast), hib vaccine conj, pertussis vaccine acellular 3-component, polio vaccine inact 3v (vero), tetanus vaccine toxoid respectively on an unspecified date for immunisation. The patient experienced fever 38 - 38.4 celsius degrees and walking difficulties - child couldn''t stand on the legs on 07Jun2017 14:00 with outcome of recovered. SENDER COMMENT: Fever is an expected adverse reaction for both vaccines. Walking disability is an unexpected reaction for both vaccines. In the regulatory authority database so far 108 cases of gait disturbance, 19 cases of gait inability and 3 cases of walking disability were noted after using vaccine INFANRIX HEXA and 118 cases of gait disturbance, 26 cases of gait disturbance and 6 cases of walking disability after using vaccine PREENAR 13. Temporal relationship speaks for cause-and-effect relationship. Person reporting post vaccination adverse reaction considered it as serious, regulatory authority assessed post vaccination adverse reaction as serious. Other Case Identifiers in Previous Transmissions: false. Reaction / Event as Reported by the Primary Source for Translation: Fever 38 - 38.4 Celsius degrees, Walking difficulties - child couldn''t stand on the legs. Caused / Prolonged Hospitalisation: false. Medicinal Product Name as Reported by the Primary Source: PREVENAR 13, INFANRIX HEXA. Reaction(s) /Event(s) Assessed: Fever, Walking disability. Source of assessment: Agency. Method of assessment: WHO. Result of Assessment: probable. No follow-up attempts needed. No further information expected.


VAERS ID: 855153 (history)  
Form: Version 2.0  
Age: 0.17  
Sex: Female  
Location: Foreign  
Vaccinated:2019-09-30
Onset:2019-10-17
   Days after vaccination:17
Submitted: 0000-00-00
Entered: 2020-01-02
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PPV: PNEUMO (NO BRAND NAME) / UNKNOWN MANUFACTURER AD4069 ? / 2 RL / -
RV1: ROTAVIRUS (ROTARIX) / GLAXOSMITHKLINE BIOLOGICALS AROLC373AA / 2 - / OT
UNK: VACCINE NOT SPECIFIED (NO BRAND NAME) / UNKNOWN MANUFACTURER AOP4A626AC / 2 - / OT
UNK: VACCINE NOT SPECIFIED (NO BRAND NAME) / UNKNOWN MANUFACTURER 220112518A / 2 LL / -

Administered by: Other       Purchased by: ?
Symptoms: Anaemia, Cough, Pneumonia, Pyrexia, Respiratory rate increased
SMQs:, Anaphylactic reaction (broad), Haematopoietic erythropenia (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Eosinophilic pneumonia (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (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? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GHGLAXOSMITHKLINEGH2019GS

Write-up: Bronchopneumonia; Anemia; Cough; Faster breathing; Fever; This case was reported by a other health professional via regulatory authority and described the occurrence of Bronchopneumonia in a 3-month-old female patient who received Rotavirus (Rotarix liquid vaccine) (batch number AROLC373AA,expiry date unknown) for prophylaxis. Co-suspect products included POLIO SABIN One and Three (batch number AOP4A626AC, expiry date unknown) for prophylaxis, Pneumococcal vaccine (batch number AD4069 ?, expiry date unknown) for prophylaxis, DTPA-HBV+HIB vaccine (batch number 220112518A, expiry date unknown) for prophylaxis. On 30th September 2019, the patient received 2nd dose of Rotarix liquid formulation(oral) and POLIO SABIN One and Three(oral), Pneumococcal vaccine(right thigh), DTPa-HBV-HIB(left thigh). On 17th October 2019, 17 days after receiving the Rotarix liquid vaccine, POLIO SABIN One and Three, Pneumococcal vaccine and DTPA-HBV+HIB vaccine, the patient experienced Bronchopneumonia (serious criteria hospitalization and GSK medically significant), anemia (serious criteria hospitalization), cough (serious criteria hospitalization), Respiratory rate increased (serious criteria hospitalization) and fever(serious criteria hospitalization). The patient was treated with paracetamol syrup. On an unknown date, the outcome of the Bronchopneumonia, anemia, cough, respiratory rate increased and fever were recovering/resolving. It was unknown if the reporter considered the Bronchopneumonia, anemia, cough, respiratory rate increased and fever to be related to Rotarix liquid formulation, POLIO SABIN One and Three, Pneumococcal vaccine and DTPA-HBV+HIB vaccine. Additional details were provided as follows: On 30th September 2019, the patient received Rotarix vaccine orally, POLIO SABIN One and Three vaccine orally, Pneumococcal vaccine on right thigh and DTPA-HBV+HIB vaccine on left thigh. Until 17th October 2019, the patient was welled. On 17th October 2019, the patient started breathing faster than usual and coughing. On 22nd October 2019, the patient was hospitalized. The patient had no past history of similar events. The patient had adverse event after previous vaccinations. The patient did not have allergy of vaccine, drug or food. The patient did not have pre-existing illness (30days) or congenital disorder. The patient did not have history of hospitalization in last 30 days with cause. The was not on any concomitant medication The patient was full term infant with birth weight 3.4 kilogram. The patient was diagnosed of Bronchopneumonia and Anaemia. The patient was treated with Paracetamol syrup. The patient had been treated and discharged. General condition improved. This case has been linked with GH2019GSK233842, reported by same reporter. Case reported from a Hospital from the regulatory authority.


VAERS ID: 855194 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2020-01-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEP: HEP B (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / OT
UNK: VACCINE NOT SPECIFIED (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Foetal exposure during pregnancy, Hepatitis B, Hepatitis B DNA assay positive, Hepatitis B surface antigen, Immunology test, Intrauterine infection, Liver function test, Polymerase chain reaction positive, Vertical infection transmission
SMQs:, Liver infections (narrow), Pregnancy, labour and delivery complications and risk factors (excl abortions and stillbirth) (narrow), Foetal disorders (narrow), Opportunistic infections (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: HEPATITIS B IMMUNOGLOBULIN
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: CNGLAXOSMITHKLINECN2019GS

Write-up: Hepatitis B virus infection; Intrauterine hepatitis B virus infection; Vertical infection transmission; Fetal exposure during pregnancy; This retrospective pregnancy case was reported in a literature article and described the occurrence of hepatitis b in an infant patient exposed to Hepatitis B vaccine in utero while the mother was treated for prophylaxis. Co-suspect product exposures included immunoglobulin antihepatitis b (Hepatitis B Immunoglobulin). On an unknown date, the mother received Hepatitis B vaccine and Hepatitis B Immunoglobulin at an unknown dose and frequency. The patient was exposed to Hepatitis B vaccine at an unknown time during the pregnancy. On an unknown date, at an unknown weeks gestation, the patient was born via unknown delivery. On an unknown date, less than a year after vaccination, the patient was diagnosed with hepatitis b (serious criteria GSK medically significant and other: serious as per reporter), intrauterine infection (serious criteria GSK medically significant and other: serious as per reporter), vertical infection transmission and fetal exposure during pregnancy. On an unknown date, the outcome of the hepatitis b, intrauterine infection, vertical infection transmission and fetal exposure during pregnancy were unknown. The reporter considered the hepatitis b, intrauterine infection and vertical infection transmission to be related to Hepatitis B vaccine. See case CN2019APC233689 for details regarding the mother case. Additional details were provided as follows: This retrospective pregnancy case was reported in a literature article and described the intrauterine hepatitis B virus infection; vertical infection transmission and fetal exposure during pregnancy in a patient of unspecified age and gender, whose mother was vaccinated with unspecified hepatitis B vaccine (manufacturer unknown) during pregnancy for prophylaxis. The patient''s mother was a part of study that aimed to analyze the effect of clinical application of hepatitis B vaccine and globulin in controlling intrauterine hepatitis B virus infection. The patient''s mother was tested positive for hepatitis B and was registered in the hospital from January 2018 to January 2019. The patient''s mother was randomly selected and was a part of group C, according to the different method for blocking infection being applied. The mother''s last menstrual period and estimated date of delivery was unknown. No information on patient''s medical history or concomitant medication was provided. On an unspecified date, the patient''s mother had received combined unspecified hepatitis B vaccine (administration route and site unspecified, dosage unknown; batch number not provided) and immunoglobulin during pregnancy (trimester unknown). The age of vaccination was not provided. On an unspecified date between January 2018 and January 2019, an unknown period after vaccination, for the newborn patient, the nursing staff drew 3 mL femoral venous blood soon after birth so as to test liver function, Hepatitis B virus deoxyribonucleic acid (HBV DNA), hepatitis B surface antigen (HBsAg). Of which, HBV-DNA was tested for by polymerase chain reaction (PCR) assay, with HBV serum markers being detected by enzyme linked immunosorbent assay (ELISA) kit. The patient was diagnosed with intrauterine hepatitis B virus infection via vertical infection transmission. After drawing the blood, hepatitis B vaccine and immunoglobulin were to be injected in good time. It was important to note that the immunoglobulin dose needed to be small, being regulated at just 200 U. The hepatitis B vaccine was then injected 2 weeks following the immunoglobulin injection at a dosage of 5 micog. Treatment was unknown. Outcome of the event was not reported. The authors stated, "In a global context, the incidence of hepatitis B is still relatively high with intrauterine infection as a primary transmission route, thus presenting a serious threat to the health of both mother and baby. The corresponding literature has indicated that the use of immunoglobulin or hepatitis B vaccine on their own in isolation are able to block the infection and limit the spread of the virus to a certain extent. In short, in order to effectively control the spread of hepatitis B virus and reduce the rate of viral infection, the combined use of immunoglobulin and hepatitis B vaccine is a good route. The author believes that the hepatitis B virus may be completely controlled and eliminated in the near future, so that the health of all human beings, and especially that of mother and baby may be fully protected". The authors concluded "the results of this study have shown that the combined use of hepatitis B vaccine and immunoglobulin can significantly reduce the infection rate of hepatitis B virus and limit its spread; which has high practical application value at this stage and is well worthy of the recommendation". This article is not available for regulatory submission due to copyright restriction. This is 1 of the 2 valid cases reported in the same literature article.


VAERS ID: 855198 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2020-01-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUN4: INFLUENZA (SEASONAL) (FLUENZ TETRA) / MEDIMMUNE VACCINES, INC. - / UNK - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Headache, Infection via vaccinee, Musculoskeletal stiffness, Nausea, Oropharyngeal pain, Pain, Rhinorrhoea, Vaccine virus shedding
SMQs:, Acute pancreatitis (broad), Dystonia (broad), Parkinson-like events (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Noninfectious encephalitis (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Arthritis (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: Comments: None
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBAstraZeneca2019SF88445

Write-up: ACHING BODY, SORE THROAT, RUNNY NOSE, HEADACHES, NAUSEA, STIFF NECK..; Aching body, sore throat, runny nose, headaches, nausea, stiff neck; ACHING BODY, SORE THROAT, RUNNY NOSE, HEADACHES, NAUSEA, STIFF NECK,.,; Aching body, sore throat, runny nose, headaches, nausea, stiff neck; INFECTION VIA VACCINEE; VACCINE VIRUS SHEDDING; ACHING BODY, SORE THROAT, RUNNY NOSE, HEADACHES, NAUSEA, STIFF NECK; ACHING BODY, SORE THROAT, RUNNY NOSE, HEADACHES, NAUSEA, STIFF NECK.; Aching body, sore throat, runny nose, headaches, nausea, stiff neck; ACHING BODY, SORE THROAT, RUNNY NOSE, HEADACHES, NAUSEA, STIFF NECK,; Aching body, sore throat, runny nose, headaches, nausea, stiff neck; ACHING BODY, SORE THROAT, RUNNY NOSE, HEADACHES, NAUSEA, STIFF NECK.,; Aching body, sore throat, runny nose, headaches, nausea, stiff neck; A spontaneous report has been received from the consumer via Agency via regulatory authority, concerning a 28 year old female patient of unknown ethnic origin with height 162 cm and weight 57 kg. Patient''s medical history and concomitant products were not reported. Parent details were not provided. The patient received Fluenz Tetra (influenza virus vaccine live, intranasal) once/single administration, via nasal route, on an unknown date. On an unknown date, the patient experienced aching body (preferred term: Pain), sore throat (preferred term: Oropharyngeal pain), runny nose (preferred term: Rhinorrhoea), headaches (preferred term: Headache), nausea (preferred term: Nausea), stiff neck (preferred term: Musculoskeletal stiffness), infection via vaccinee (preferred term: Infection via vaccinee) and vaccine virus shedding (preferred term: Vaccine virus shedding). At the time of reporting, the event of aching body, sore throat, runny nose, headaches, nausea and stiff neck was ongoing. The outcome of the events of infection via vaccinee and vaccine virus shedding was unknown. The events aching body, sore throat, runny nose, headaches, nausea, stiff neck, infection via vaccinee and vaccine virus shedding were considered serious (important medical event) by reporter.; Sender''s Comments: Nausea, musculoskeletal stiffness, infection via vaccine, vaccine virus shedding and oropharyngeal pain are not listed in the company core data sheet for fluenz tetra. Due to limited information on patient relevant medical history, onset date of the events, circumstances leading to the events, treatment, other comorbidities and concomitant medications, exposure to persons with similar symptoms, onset date of suspect drug, detailed diagnostic and etiologic workup (such as infection work up, immunology work up, complete blood profile), it is not possible to make a conclusive assessment of the causal relationship of the event and the suspect drug.


VAERS ID: 855199 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2019-12-09
Onset:2019-12-11
   Days after vaccination:2
Submitted: 0000-00-00
Entered: 2020-01-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUN4: INFLUENZA (SEASONAL) (FLUENZ TETRA) / MEDIMMUNE VACCINES, INC. - / UNK - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Body temperature, Cough, Lethargy, Nausea, Pain in extremity
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Tendinopathies and ligament disorders (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Comments: None
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBAstraZeneca2019SF92032

Write-up: ACHING LIMBS; Temperature, nausea, cough, lethargy, aching limbs.; NAUSEA; Temperature, nausea, cough, lethargy, aching limbs.; COUGH; Temperature, nausea, cough, lethargy, aching limbs.; TEMPERATURE; Temperature, nausea, cough, lethargy, aching limbs.; LETHARGY; Temperature, nausea, cough, lethargy, aching limbs.; A spontaneous report has been received from the consumer via MA via regulatory authority (MHRA), concerning a 5 year old male patient of unknown ethnic origin with height 98 cm and weight 13 kg. Patient''s medical history and concomitant products were not reported. Parent details were not provided. The patient received Fluenz Tetra (influenza virus vaccine live, intranasal) once/single administration, via nasal route, on 09-Dec-2019. On 11-Dec-2019, the patient had aching limbs (preferred term: Pain in extremity), nausea (preferred term: Nausea), cough (preferred term: Cough), temperature (preferred term: Pyrexia) and lethargy (preferred term: Lethargy). At the time of reporting, the event of aching limbs, nausea, cough, temperature and lethargy was ongoing. The events aching limbs, nausea, cough, temperature and lethargy were considered serious (important medical event) by reporter.; Sender''s Comments: Pain in extremity, nausea and cough are not listed in the company core data sheet for Q/LAIV (Fluenz Tetra). Pyrexia has been associated with use of LAIV in children but not in adults. Due to limited information on exact onset date of events, concurrent diseases, concomitant medication, relevant medical history, risk factors (infections), etiologic and diagnostic workup (complete blood panel), it is not possible to make conclusive assessment of causal relationship of events with suspect drug.


VAERS ID: 855200 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:2017-06-06
Onset:2017-06-01
Submitted: 0000-00-00
Entered: 2020-01-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTP: DTP (NO BRAND NAME) / UNKNOWN MANUFACTURER 20915003A ? / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Abscess, Crying, Vaccination site reaction
SMQs:, Depression (excl suicide and self injury) (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: PLGLAXOSMITHKLINEPL201923

Write-up: Vaccination site reaction; Abscess; Inconsolable crying; This case was reported by a physician via regulatory authority and described the occurrence of vaccination site reaction in a 1-month-old patient who received DTP (A or W not known) (DTP vaccine) (batch number 20915003A ?, expiry date 31st October 2018) for prophylaxis. On 6th June 2017 15:49, the patient received the 1st dose of DTP vaccine (intramuscular) .5 ml. In June 2017, 1 day 18 hrs 11 min after receiving DTP vaccine, the patient experienced vaccination site reaction (serious criteria other: Serious as per reported), abscess (serious criteria other: Serious as per reported) and inconsolable crying (serious criteria other: Serious as per reported). In June 2017, the outcome of the vaccination site reaction, abscess and inconsolable crying were recovered/resolved. The reporter considered the vaccination site reaction and inconsolable crying to be probably related to DTP vaccine. The reporter considered the abscess to be possibly related to DTP vaccine. Additional details: The age at vaccination was not reported. However, patient could be 1 year or less than 1year Infant at the time of vaccination. Anatomical Location was reported as Unknown thigh. The reported batch number for DTP vaccine was 20915003A, which does not match with any GSK batch or lot number. Initial information was received from a Physician via regulatory authority on 20th December 2019: Vaccination site reaction, abscess and Inconsolable crying. Sender comment: DTP - diphtheria, tetanus and pertussis vaccine, adsorbed. Constant crying is an expected side effect for DTP. An abscess is an unexpected symptom. To date, 4 cases of abscess after using the DTP vaccine have been reported in the Regulatory Authority database.The temporal relationship speaks for a causal relationship. The person reporting NOP found it mild, Regulatory Authority considered NOP severe because of the nature of the symptom.


VAERS ID: 855224 (history)  
Form: Version 2.0  
Age: 0.25  
Sex: Female  
Location: Foreign  
Vaccinated:2019-11-08
Onset:2019-11-01
Submitted: 0000-00-00
Entered: 2020-01-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PPV: PNEUMO (NO BRAND NAME) / UNKNOWN MANUFACTURER X60012 ? / 2 - / OT
RV1: ROTAVIRUS (ROTARIX) / GLAXOSMITHKLINE BIOLOGICALS AROLC382AA / 2 - / OT
UNK: VACCINE NOT SPECIFIED (NO BRAND NAME) / UNKNOWN MANUFACTURER 220104919A ? / 2 - / OT
UNK: VACCINE NOT SPECIFIED (NO BRAND NAME) / UNKNOWN MANUFACTURER AOP4A626AC / 2 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Diarrhoea, Malaria, Pneumonia, Pyrexia, Vomiting
SMQs:, Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Pseudomembranous colitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Eosinophilic pneumonia (broad), Noninfectious diarrhoea (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (narrow), Opportunistic infections (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: Test Date: 201911; Test Name: Body temperature; Result Unstructured Data: Test Result: More than 38, Test Result Unit: degree C
CDC Split Type: GHGLAXOSMITHKLINEGH2019GS

Write-up: Severe malaria; Bronchopneumonia; Vomiting; Fever; watery stool/ Diarrhoea; This case was reported by a other health professional via regulatory authority and described the occurrence of malaria in a 12-week-old female patient who received Rota (Rotarix liquid formulation) (batch number AROLC382AA, expiry date unknown) for prophylaxis. Co-suspect products included DTPa-IPV+Hib (Penta vaccine) (batch number 220104919A ?, expiry date unknown, reported batch number did not match with GSK lot number) for prophylaxis, 10PN-PD-Dit (Pneumococcal vaccine) (batch number X60012 ?, expiry date unknown batch number did not match with GSK lot number) for prophylaxis and Polio Bivalent T1 T3 oral (POLIO SABIN One and Three) (batch number AOP4A626AC, expiry date unknown) for prophylaxis. On 8th November 2019, the patient received the 2nd dose of Rotarix liquid formulation (oral), the 2nd dose of Penta vaccine (intramuscular), the 2nd dose of Pneumococcal vaccine (intramuscular) and the 2nd dose of POLIO SABIN One and Three (oral). In November 2019, less than a month after receiving Rotarix liquid formulation, Penta vaccine, Pneumococcal vaccine and POLIO SABIN One and Three, the patient experienced malaria (serious criteria hospitalization and GSK medically significant), bronchopneumonia (serious criteria hospitalization and GSK medically significant), vomiting (serious criteria hospitalization), fever (serious criteria hospitalization) and stools watery (serious criteria hospitalization). The patient was treated with ampicillin trihydrate (Ampicillin), gentamicin sulphate (Gentamycin) and paracetamol. On an unknown date, the outcome of the malaria, bronchopneumonia, vomiting, fever and stools watery were recovering/resolving. It was unknown if the reporter considered the malaria, bronchopneumonia, vomiting, fever and stools watery to be related to Rotarix liquid formulation, Penta vaccine, Pneumococcal vaccine and POLIO SABIN One and Three. Additional case details were reported as follows: The case was reported by patient''s mother. The patient was full term female infant delivered via normal delivery. Prior to immunization the patient did not have past history of similar event. It was unknown if the patient had allergy to vaccine, drug, food. The patient did not have pre- existing illness (30 days) or congenital disorder, hospitalization in last 30 days with cause. It was unknown whether there was any adverse event after the previous vaccination and family history of any disease. The patient did not receive concomitant medication. The patient received routine vaccine Penta vaccine in left side and Pneumococcal vaccine in right side. It was reported that mother brought the child to the hospital when she noticed the child was vomiting and passing watery stool. The patient experienced fever more than 38 degree C. The patient was hospitalized on 10th November 2019. The patient was managed as case of severe malaria and bronchopneumonia. The patient was treated with Ampicillin trihydrate (Ampicillin) 350 mgx5/7 (intravenous), Gentamicin sulphate (Gentacin) 35 ug DWX 5/4, and paracetamol 125 MG TDS. On an unknown date, the patient was discharged. The case was reported from a Regulatory Authority. The batch number of Polio Sabine was reported as AOP4A361AA, it was changed to AOP4A626AC as per sales data sheet.


VAERS ID: 855234 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2019-11-14
Onset:2019-11-14
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2020-01-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
IPV: POLIO VIRUS, INACT. (NO BRAND NAME) / UNKNOWN MANUFACTURER P3L891M / UNK - / -
RV5: ROTAVIRUS (ROTATEQ) / MERCK & CO. INC. - / UNK - / OT

Administered by: Private       Purchased by: ?
Symptoms: Febrile convulsion, Pyrexia, Tic
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Convulsions (narrow), Dyskinesia (broad), Dystonia (broad), 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? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: CN0095075131912CHN010752

Write-up: The patient experienced fever and tic that night/ symptom of febrile convulsion; This spontaneous report was received from the Center for Disease Control and Prevention (CDC), concerning a 61-days-old female patient. The patient''s medical history, concurrent conditions, drug allergies or reactions and concomitant therapies were not reported. On 14-NOV-2019, the patient was vaccinated with one dose of Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ) oral liquid, for prophylaxis (strength, expiration date, and anatomical location were not reported; Lot number reported as S003312. On the same date, the patient was vaccinated with one dose of poliomyelitis vaccine (inactivated; manufactured by Pasteur) (strength, route of administration, indication, and anatomical location were not reported; lot number reported as P3L891M and expiration date (reported as valid date) 31-AUG-2020) at physician office visit (POV). On the same day, after vaccination, the patient experienced fever and tic (febrile convulsion) that night, for which she required hospitalization on an unspecified day in November 2019. On an unknown date in 2019, the patient recovered after hospitalization treatment. The CDC investigation concluded that it could not be ruled out that the symptom of febrile convulsion was caused by vaccination with Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ) or poliomyelitis vaccine (inactivated; manufactured by Pasteur); and it could not be distinguished which vaccine caused the event as the patient was vaccinated with the two vaccines at the same time.


VAERS ID: 855235 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2019-11-21
Onset:2019-11-22
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2020-01-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
TDAP: TDAP (ADACEL) / SANOFI PASTEUR - / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Application site erythema, Application site pain, Cellulitis, Inflammatory marker decreased, Injection site oedema, Microbiology test normal, Nausea, Smear site unspecified normal, Ultrasound scan abnormal
SMQs:, Acute pancreatitis (broad), Malignancy related therapeutic and diagnostic procedures (narrow), Extravasation events (injections, infusions and implants) (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), 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? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20191123; Test Name: Inflammatory marker test; Result Unstructured Data: low; Test Date: 20191123; Test Name: smear of the skin at injection site; Test Result: Negative ; Test Date: 20191123; Test Name: USG of soft tissues; Result Unstructured Data: swelling
CDC Split Type: CZSA2019SA361257

Write-up: Phlegmon; Nauseous; Application site pain; Edema injection site; Application site redness; Initial information regarding this unsolicited valid serious case downloaded from the Agency database without narrative (level 2A), was received on 26-Dec-2019 from a physician via the health authority (under the reference number: CZ-CZSUKL-19004329). The following narrative is based on the information retrieved from all other accessible data. This case involves a five years old male patient who developed phlegmon (cellulitis), application site pain (application site pain), edema injection site (injection site edema), feeling nauseous (nausea) and application site redness (application site erythema), while he received vaccine DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL]. The patient had no medical history and no concomitant therapies were received by the patient. On 21-Nov-2019, the patient received a dose of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE (suspension for injection in pre-filled syringe) (lot number and expiration date was not reported) via an intramuscular route at an unknown administration site. On 22-Nov-2019, the patient developed serious phlegmon (cellulitis) 1 day following the administration of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE. This event was assessed as medically significant. The patient was hospitalized for this event. On 22-Nov-2019, the patient developed non-serious application site pain (application site pain), edema injection site (injection site oedema), feeling nauseous (nausea) and application site redness (application site erythema) 1 day following the administration of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE. Relevant laboratory test results included: On 23-Nov-2019, inflammatory marker test resulted low, microbiology test was negative and ultrasound scan shows swelling. Final diagnosis were application site erythema, nausea, injection site edema, application site pain and cellulitis. There will be no information available on the batch number for this case.; Sender''s Comments: This case concerns a five years old patient who presented with cellulitis, injection site pain, edema, erythema and nausea one day after vaccination with ADACEL. The time to onset is compatible. There is, however, no information regarding patient''s medical condition at time of vaccination, identification of the causative organism, safety of the vaccination procedure and lab tests ruling out alternate etiologies. There is a possibility that the cellulitis is due to a pre-existing nidus of infection or introduction of skin commensals during inoculation. Based upon the reported information, the role of the vaccine cannot be assessed.


VAERS ID: 855241 (history)  
Form: Version 2.0  
Age: 0.17  
Sex: Female  
Location: Foreign  
Vaccinated:2019-10-07
Onset:2019-10-07
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2020-01-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MENB: MENINGOCOCCAL B (BEXSERO) / NOVARTIS VACCINES AND DIAGNOSTICS ABX789AD / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Hyperhidrosis, Hypotonia, Pallor, Presyncope, Somnolence
SMQs:, Peripheral neuropathy (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypotonic-hyporesponsive episode (narrow), Generalised convulsive seizures following immunisation (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? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: ITGLAXOSMITHKLINEIT201923

Write-up: HYPOTONUS AND SWEATING AFTER THE POPPATURE WITH SONNOLENCE FOR PPROXIMATELY 30 MINUTES (AFTER 7 HOURS FROM MENINGIOCOCCUS B VACCINATION), DIAGNOSTICED AT THE FIRST AID AS A VASOVAGAL HYPOTONUS; HYPOTONUS AND SWEATING AFTER THE POPPATURE WITH SONNOLENCE FOR PPROXIMATELY 30 MINUTES (AFTER 7 HOURS FROM MENINGIOCOCCUS B VACCINATION), DIAGNOSTICED AT THE FIRST AID AS A VASOVAGAL HYPOTONUS; HYPOTONUS AND SWEATING AFTER THE POPPATURE WITH SONNOLENCE FOR PPROXIMATELY 30 MINUTES (AFTER 7 HOURS FROM MENINGIOCOCCUS B VACCINATION), DIAGNOSTICED AT THE FIRST AID AS A VASOVAGAL HYPOTONUS; This case was reported by a physician via regulatory authority and described the occurrence of sweating in a 2-month-old female patient who received Men B NVS (Bexsero) (batch number ABX789AD, expiry date unknown) for prophylaxis. On 7th October 2019, the patient received Bexsero (intramuscular). On 7th October 2019, less than a day after receiving Bexsero, the patient experienced sweating (serious criteria hospitalization), pallor (serious criteria hospitalization) and hypotonia (serious criteria hospitalization). On 8th October 2019, the outcome of the sweating, pallor and hypotonia were recovered/resolved. It was unknown if the reporter considered the sweating, pallor and hypotonia to be related to Bexsero. Additional details: The reported batch number ABX789AA was reported for bexsero, however the on sales data review, it was corrected to ABX789AD. Initial information was reported by a physician via regulatory authority on 20th December 2019: HYPOTONUS AND SWEATING AFTER THE POPPATURE WITH SONNOLENCE FOR PPROXIMATELY 30 MINUTES (AFTER 7 HOURS FROM MENINGIOCOCCUS B VACCINATION), DIAGNOSTICED AT THE FIRST AID AS A VASOVAGAL HYPOTONUS EPISODE.


VAERS ID: 855242 (history)  
Form: Version 2.0  
Age: 0.17  
Sex: Male  
Location: Foreign  
Vaccinated:2017-04-20
Onset:2017-04-20
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2020-01-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
6VAX-F: DTAP+IPV+HEPB+HIB (INFANRIX HEXA) / GLAXOSMITHKLINE BIOLOGICALS A21CC861A / 1 RL / OT
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH R91824 / 1 LL / OT
RV1: ROTAVIRUS (ROTARIX) / GLAXOSMITHKLINE BIOLOGICALS AROLB756AJ / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Cough, Seizure, Urticaria, Vomiting
SMQs:, Anaphylactic reaction (narrow), Acute pancreatitis (broad), Angioedema (narrow), Systemic lupus erythematosus (broad), Convulsions (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Generalised convulsive seizures following immunisation (narrow), 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? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: PLGLAXOSMITHKLINEPL201923

Write-up: Seizures; Urticaria; Cough; Vomiting; This case was reported by a physician via regulatory authority and described the occurrence of seizures in a 2-month-old male patient who received DTPa-HBV-IPV+Hib (Infanrix hexa) (batch number A21CC861A, expiry date March 2019) for prophylaxis. Co-suspect products included Rota (Rotarix liquid formulation) (batch number AROLB756AJ, expiry date March 2019) for prophylaxis and PNEUMOCOCCAL VACCINE (PREVENAR 13) (batch number R91824, expiry date May 2018) for prophylaxis. On 20th April 2017, the patient received the 1st dose of Infanrix hexa (intramuscular) .5 ml, the 1st dose of Rotarix liquid formulation (oral) 1.5 ml and the 1st dose of PREVENAR 13 (intramuscular) .5 ml. On 20th April 2017, less than a day after receiving Infanrix hexa and Rotarix liquid formulation, the patient experienced seizures (serious criteria hospitalization and GSK medically significant), urticaria (serious criteria hospitalization), cough (serious criteria hospitalization) and vomiting (serious criteria hospitalization). On an unknown date, the outcome of the seizures, urticaria, cough and vomiting were unknown. The reporter considered the seizures, urticaria, cough and vomiting to be possibly related to Infanrix hexa and Rotarix liquid formulation. Additional details: The batch number of Rotarix was reported as AROLB756A7. However based on batch number review as per sales data sheet it was corrected to AROLB756AJ. The reporter considered the seizures, urticaria, cough and vomiting to be possibly related to Prevenar 13 Anatomical Location was reported as Right thigh for the suspect Infanrix hexa. Anatomical Location was reported as Left thigh for the suspect Prevenar 13. Initial information was received from a Physician via regulatory authority on 20th December 2019: Seizures, urticaria, cough and vomiting. Reporter Comment: Infanrix hexa - vaccine against bionic (D), tetanus (T), pertussis (acellular component) (Pa), hepatitis B (rDNA) (HBV), poliomyelitis (inactivated) (IPY) and against Haemophillls influenzae type b (Hib) conjugated (adsorbed). Prevenar 13 - anti-saccharide pneumococcal vaccine, conjugated, adsorbed (13-valent). Rotarix - rotavirus vaccine, live. Vomiting, urticaria and convulsions are the expected side effects of Infvenar hex vaccines 13. Cough is an expected effect in relation to Infanrix hexa vaccine. Section 4.8 of the SPC Prevenar 13 does not include coughing but mentions shortness of breath and bronchospasm which may result in coughing. All reported side effects are unexpected with Rotarix. To date, 1026 cases of cough after pneumococcal, polysaccharide, conjugate, adsorbed vaccines have been reported in the Agency database; 2,484 cases of pneumococcal vaccines have been reported in the Agency database. To date, 12 cases of cough, 123 cases of vomiting, 18 cases of urticaria and 58 cases of convulsions after rotavirus vaccines, live, oral have been reported in the Agency database; 502 cases of cough, 849 cases of convulsions, 720 cases of urticaria and 5347 cases of vomiting after rota vaccines have been reported in the Agency database. The temporal relationship speaks for a cause and effect relationship. Due to the simultaneous administration of three vaccines, it is not possible to identify the one that contributed to the occurrence of side effects. In addition, at the same time the child was introduced a new type of modified milk, which could also have contributed to the reported symptoms. The person reporting the NOP classified him as serious. Agency found the NOP heavy


VAERS ID: 855280 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2019-12-01
Onset:2019-12-01
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2020-01-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH - / UNK RA / -

Administered by: Other       Purchased by: ?
Symptoms: Erythema, Pain, Peripheral swelling, Swelling
SMQs:, Cardiac failure (broad), Anaphylactic reaction (broad), Angioedema (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Hypersensitivity (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, 10 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: BRPFIZER INC2019558233

Write-up: arm is always more swollen and red / high in the region where was applied; autoimmune health problem; worried and scared; sleeping pain; swelled to the chest; swelling of the arm that was previously just above the elbow is reaching the wrist; bubbles are appearing in the lower part of the arm; arm is always more swollen and red / high in the region where was applied; This is a spontaneous initial report received from a contactable consumer (patient). A female patient of an unspecified age received pneumococcal 13-val conj vac (dipht crm197 protein) (PREVENAR 13) via an unspecified route of administration at 0.5 ml, single at right arm in Dec2019 (probably 18Dec2019) for immunisation. The patient medical history and concomitant medications were not reported. The patient previously received PNEUMO 23 and several others for immunization. The patient experienced right arm is always more swollen and red on an unspecified date in Dec2019. After the application her right arm became white and high in the region where was applied. Just red where it was really applied. On Wednesday 18Dec2019, Thursday 19Dec2019 and Friday 20Dec2019 it was reddish where was applied. On Saturday 21Dec2019 it began to have a bigger swelling and the sleeping pain that she had been feeling worsened. On Sunday 22Dec2019 it has gone even more worse and has even swelled to the chest. The arm was the right. She went to the hospital and she will be hospitalized for 10 days. They entered with antibiotic. The patient has been taking antibiotic and analgesic since 23Dec2019. After medications, the swelling of the chest decreases. The swelling of the arm that was previously just above the elbow was reaching the wrist. The patient was getting desperate. The patient was worried and scared of the direction it took after she got this vaccine, as there is no infectologist physician specialized in vaccines in the hospital. She still found her right arm in this situation at time of reporting. The patient stated there are two photos to compare one swollen arm and the other not. She pointed out that bubbles are appearing in the lower part of the arm. She was not having a fever. She was very scared and that she has discovered an autoimmune health problem and she was using vaccines to strengthen her. She has already taken PNEUMO 23 and several others, but the reaction occurred with the Prevenar. The outcome of events was not recovered. Information on the lot/batch number has been requested. Follow-up (27Dec2019 and 27Dec2019): New information reported from a contactable consumer (patient) received from Pfizer medical information team includes: past vaccination history; suspect details (Pfizer trade name, strength, anatomical localization); event details (right); events arm is always more swollen and red updated and recoded; new events added (autoimmune health problem, worried and scared, sleeping pain, swelled to the chest, swelling of the arm that was previously just above the elbow is reaching the wrist, bubbles are appearing in the lower part of the arm); hospitalization; treatment; outcome confirmed; seriousness; course of events.


VAERS ID: 855281 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2019-08-26
Onset:2019-09-15
   Days after vaccination:20
Submitted: 0000-00-00
Entered: 2020-01-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
IPV: POLIO VIRUS, INACT. (NO BRAND NAME) / UNKNOWN MANUFACTURER P3A295V / UNK - / OT
RAB: RABIES (RABIPUR) / NOVARTIS VACCINES AND DIAGNOSTICS ARBA461D / 2 - / OT
TYP: TYPHOID VI POLYSACCHARIDE (TYPHIM VI) / SANOFI PASTEUR PIE422V / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Chorioretinopathy, Subretinal fluid, Visual impairment
SMQs:, Anticholinergic syndrome (broad), Accidents and injuries (broad), Glaucoma (broad), Optic nerve disorders (broad), Lens disorders (broad), Retinal disorders (narrow), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DESA2019SA361750

Write-up: Sub-retinal fluid left eye; Suspicion of atypical Chronic central serous chorioretinopathy or Chorioretinopathia Centralis Serosa; Consecutive visual disturbance; Initial information regarding this unsolicited valid serious case downloaded from regulatory authority database without narrative (level 2A), was received on 24-Dec-2019 from a physician via health authority (under reference DE-PEI-PEI2019008139). The following narrative is based on the information retrieved from all other accessible data. This case involves a 43 years old male patient who experienced sub-retinal fluid left eye (subretinal fluid), suspicion of atypical chronic central serous chorioretinopathy or chorioretinopathia centralis serosa (chorioretinopathy) and consecutive visual disturbance (visual impairment), while he received vaccines IPV (VERO) [IPV MERIEUX], TYPHOID VI POLYSACCHARIDE VACCINE [TYPHIM VI] and RABIES VACCINE INACT (CHICK EMBRYO) [RABIPUR]. The patient''s past medical history, medical treatment(s) and family history were not provided. On 26-Aug-2019, the patient received a dose of suspect TYPHOID VI POLYSACCHARIDE VACCINE (lot PIE422V) and IPV (VERO) (lot P3A295V) via intramuscular route in an unknown administration site. On 12-Sep-2019, the patient received a dose of suspect RABIPUR (not produced by Sanofi Pasteur) (lot ARBA461D) via unknown route in an unknown administration site. On 15-Sep-2019 the patient developed sub-retinal fluid left eye (subretinal fluid), suspicion of atypical chronic central serous chorioretinopathy or chorioretinopathia centralis serosa (chorioretinopathy) and consecutive visual disturbance (visual impairment) 20 days following the administration of TYPHOID VI POLYSACCHARIDE VACCINE, IPV (VERO) and three days following the administration of RABIPUR. Events subretinal fluid and chorioretinopathy were assessed as medically significant. On 19-Sep-2019, the patient again received a dose of suspect RABIPUR (not produced by Sanofi Pasteur, lot ARBA461D) via unknown route in an unknown administration site. Other relevant tests not reported. Final diagnosis were subretinal fluid, chorioretinopathy and visual impairment. It was not reported if the patient received a corrective treatment. The patient had not recovered from subretinal fluid, chorioretinopathy and visual impairment. The reporter assessed the causal relationship with for events with vaccines as unclassifiable.; Sender''s Comments: This case involves a 43 years old male patient who experienced subretinal fluid, chorioretinopathy and visual impairment while he received vaccines TYPHIM VI, IPV MERIEUX and RABIPUR. The time to onset was compatible. However, patient''s medical history, medical condition at time of vaccination and lab test ruling out alternate etiologies were not reported. Based upon the reported information the role of the suspect vaccine cannot be assessed.


VAERS ID: 855282 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2020-01-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUN4: INFLUENZA (SEASONAL) (FLUENZ TETRA) / MEDIMMUNE VACCINES, INC. - / UNK - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Asthma, Condition aggravated, Cough, Dyspnoea, Infection via vaccinee, Influenza like illness, Tonsillitis, Vaccine virus shedding
SMQs:, Anaphylactic reaction (broad), Agranulocytosis (broad), Asthma/bronchospasm (narrow), Oropharyngeal infections (narrow), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Hypersensitivity (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Difficulty breathing (have not had breathing issues for over three years prior to ADRs); Immunocompromised
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBAstraZeneca2019SF88202

Write-up: DIFFICULTY BREATHING; VACCINE VIRUS SHEDDING; COUGH; CONDITION AGGRAVATED; TONSILLITIS; ASTHMATIC ATTACK; FLU-LIKE ACHING; INFECTION VIA VACCINEE; A spontaneous report has been received from consumer via regulatory authority in concerning a male patient (age not provided) of Unknown ethnic origin. The patient''s past and current medical history included immunocompromised (ongoing) and difficulty breathing (ongoing). No concomitant products were reported. The patient received Fluenz Tetra (influenza virus vaccine live, intranasal) once/single administration, via nasal route, on an unknown date. It was reported that on an unknown date, the patient had difficulty breathing (preferred term: Dyspnoea). On an unknown date, the patient experienced vaccine virus shedding (preferred term: Vaccine virus shedding). On an unknown date, the patient had cough (preferred term: Cough). On an unknown date, the patient had condition aggravated (preferred term: Condition aggravated). On an unknown date, the patient had tonsillitis (preferred term: Tonsillitis). On an unknown date, the patient experienced asthmatic attack (preferred term: Asthma). On an unknown date, the patient had flu-like aching (preferred term: Influenza like illness). On an unknown date, the patient had infection via vaccinee (preferred term: Infection via vaccinee). It is unknown if any action was taken with Fluenz Tetra (influenza virus vaccine live, intranasal). The outcome of the events of difficulty breathing, vaccine virus shedding, cough, condition aggravated, tonsillitis, asthmatic attack, flu-like aching and infection via vaccinee were unknown. The events of difficulty breathing, vaccine virus shedding, cough, condition aggravated, tonsillitis, asthmatic attack, flu-like aching and infection via vaccinee were considered serious due to seriousness criteria of hospitalisation by the reporter.; Sender''s Comments: Dyspnoea, vaccine virus shedding, cough, condition aggravated, tonsillitis, asthma, influenza like illness and infection via vaccine are not listed in the company core data sheet of Quadrivalent live attenuated influenza vaccine (Q/LAIV). Patients asthma could be contributory to dyspnoea and cough. The events influenza like illness, infection via vaccine, vaccine virus shredding, could be in association. Patients immunocompromised condition could be a possible risk factor for the events. Due to limited information on patients age, event onset dates and outcome, suspect drug indication and action taken, other concomitant diseases, risk factors, concomitant medications, detailed diagnostic workup, it is not possible to make a conclusive assessment of the causal relationship of events and suspect drug.


VAERS ID: 855283 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2019-12-09
Onset:2019-12-10
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2020-01-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUN4: INFLUENZA (SEASONAL) (FLUENZ TETRA) / MEDIMMUNE VACCINES, INC. 7002871 / UNK - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Decreased appetite, Fatigue, Hallucination, Headache, Lagophthalmos, Nightmare, Pyrexia, Rhinorrhoea
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Psychosis and psychotic disorders (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Periorbital and eyelid disorders (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: DESMOPRESSIN; OXYBUTYNIN
Current Illness:
Preexisting Conditions: Comments: None
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBAstraZeneca2019SF88214

Write-up: LAGOPHTHALMOS; BAD DREAMS; HALLUCINATIONS; FEVER; Runny nose, fever, headache, tiredness, loss of appetite; HEADACHE; Runny nose, fever, headache, tiredness, loss of appetite; TIREDNESS; Runny nose, fever, headache, tiredness, loss of appetite; RUNNY NOSE; Runny nose, fever, headache, tiredness, loss of appetite; APPETITE LOST; Runny nose, fever, headache, tiredness, loss of appetite; A spontaneous report has been received from the regulatory authority. The report concerns a male patient of Unknown ethnic origin (age 7 years, height 134 cm, weight 27 kg). No medical history was reported. The following demography was reported for the patient''s parent: Sex: Unknown. Concomitant medication included desmopressin and oxybutynin. It was rpeorted that the patient received Fluenz Tetra vaccine (influenza virus vaccine live, intranasal) (batch number(s) 7002871) 0.2 mL once/single administration, nasal, on 09-Dec-2019. On 10-Dec-2019, the patient experienced appetite lost (preferred term: Decreased appetite), fever (preferred term: Pyrexia), headache (preferred term: Headache), tiredness (preferred term: Fatigue) and runny nose (preferred term: Rhinorrhoea). On an unknown date, the patient experienced lagophthalmos (preferred term: Lagophthalmos), bad dreams (preferred term: Nightmare), and hallucinations (preferred term: Hallucination). At the time of reporting, the outcome of the events of appetite lost, lagophthalmos, bad dreams, hallucinations, fever, headache, tiredness and runny nose was reported as ongoing. The reporter considered the events appetite lost, lagophthalmos, bad dreams, hallucinations, fever, headache, tiredness and runny nose to be serious (important medical event).; Sender''s Comments: Lagophthalmos, Nightmare and Hallucination are not listed in the company core data sheet of Fluenz Tetra. Decreased appetite and Pyrexia have been associated with the use of Fluenz Tetra in children but not in adults, this case concerns a child, and these events are considered listed. Concomitant oxybutynin could be risk factor for the events. Due to missing information on start/stop date and indication of oxybutynin and desmopressin, indication of the suspect drug, onset date of all events, diagnostic workup, medical history, comorbidities it is not possible to make a conclusive assessment of the causal relationship of events and suspect drug.


VAERS ID: 855285 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2019-12-13
Onset:2019-12-14
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2020-01-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUN4: INFLUENZA (SEASONAL) (FLUENZ TETRA) / MEDIMMUNE VACCINES, INC. - / UNK - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Headache, Lymphadenopathy, Myalgia, Pyrexia, Rash papular, Vomiting
SMQs:, Rhabdomyolysis/myopathy (broad), Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Eosinophilic pneumonia (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (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: Comments: None
Allergies:
Diagnostic Lab Data:
CDC Split Type: GBAstraZeneca2019SF90202

Write-up: SWOLLEN GLANDS; Swollen glands, rash, fever, headache, aching muscles.; RAISED RASH; Swollen glands, rash, fever, headache, aching muscles.; FEVER; Swollen glands, rash, fever, headache, aching muscles.; VOMITING; HEADACHE; Swollen glands, rash, fever, headache, aching muscles.; MUSCLE ACHE; Swollen glands, rash, fever, headache, aching muscles.; A spontaneous report has been received from the regulatory authority. The report concerns a female patient of Unknown ethnic origin (age 8 years, weight 28 kg). No medical history was reported. The following demography was reported for the patient''s parent: Sex: Unknown. No concomitant products were reported. It was reported that the patient received Fluenz Tetra vaccine (influenza virus vaccine live, intranasal) 1 df once/single administration, via nasal route, for flu vaccination on 13-Dec-2019. On 14-ecC-2019, the patient experienced headache (preferred term: Headache) and muscle ache (preferred term: Myalgia). On 15-Dec-2019, the patient had vomiting (preferred term: Vomiting) and fever (preferred term: Pyrexia). On 16-Dec-2019, the patient had swollen glands (preferred term: Lymphadenopathy) and raised rash (preferred term: Rash papular). At the time of reporting, the outcome of the events swollen glands and raised rash was reported as ongoing. At the time of reporting, the outcome of the events vomiting, fever, headache and muscle ache was reported as recovering. The reporter considered the events swollen glands, raised rash, vomiting, fever, headache and muscle ache to be serious (important medical event).; Sender''s Comments: Pyrexia has been associated with use of LAIV in children but not in adults. This case concerns a 8 years old female child with reported event of Pyrexia in association with use of Quadrivalent live attenuated influenza vaccine (Q/LAIV). Vomiting and lymphadenopathy are not listed in the company core data sheet of Quadrivalent live attenuated influenza vaccine (Q/LAIV). Lymphadenopathy could be in association with reported event of pyrexia. Due to limited information on circumstances surrounding the event, concurrent conditions, relevant history, aetiological and diagnostic workup (infection workup, imaging studies). It is not possible to make conclusive assessment of causal relationship of the events with suspect drug.


VAERS ID: 855286 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2019-11-13
Onset:2019-11-21
   Days after vaccination:8
Submitted: 0000-00-00
Entered: 2020-01-03
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
VARCEL: VARICELLA (VARIVAX) / MERCK & CO. INC. R036096 / UNK - / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Conjunctivitis, Cough, Death, Neisseria test positive, Polymerase chain reaction positive, Productive cough, Purpura, Pyrexia, Rhinitis, Rhinorrhoea, Skin discolouration, Somnolence, Vomiting
SMQs:, Severe cutaneous adverse reactions (broad), Anaphylactic reaction (broad), Acute pancreatitis (broad), Haemorrhage terms (excl laboratory terms) (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Conjunctival disorders (narrow), Ocular infections (broad), Hypotonic-hyporesponsive episode (broad), Hypersensitivity (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Infective pneumonia (broad), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2019-11-27
   Days after onset: 6
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Varicella immunisation
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: HU0095075131912HUN012397

Write-up: purple hematomas all over the body, mouth became black; somnolence; high fever; vomited several times; eyes were phlegmy; nasal discharge; cough; Information has been downloaded from regulatory authority (HU-OGYI-175819). This spontaneous report as received from an other health professional concerning a 14 month old male patient. No concurrent condition, medical history, or concomitant therapy was reported. On 13-NOV-2019, the patient was vaccinated with varicella virus vaccine live (oka/merck)(VARIVAX) powder and solvent for suspension for injection, 0.5 mL (strength and frequency unknown; lot# R036096 has been verified to be a valid lot number, expiration date not reported, but upon internal validation established as 30-NOV-2020), intramuscularly for varicella immunisation. On 21-NOV-2019, the patient experienced nasal discharge and cough, and his eyes were phlegmy. On 26-NOV-2019, the patient vomited several times, and experienced high fever (40 degree Celsius) and somnolence. On the same day, the patient experienced purple hematomas all over the body, mouth became black. After 4 hours, the patient died on 27-NOV-2019. The cause of death was not reported. Autopsy was performed. On 29-NOV-2019, multi-pathogen polymerase chain reaction (PCR) test showed presence of Neisseria meningitidis. The outcome of all events was reported as fatal. The causality assessment was not provided by the reporter. Sender Comments (agency): According to the SmPC rhinitis, cough, conjunctivitis, fever, vomiting, somnolence and haematomas are all known adverse events of varicella virus vaccine live (oka/merck)(VARIVAX). Time to onset was 8 days for rhinitis, cough, and conjunctivitis, and 13 days for fever, vomiting, somnolence and haematomas, which do not allow for strong causality. The events fever, vomiting, somnolence and haematomas are rather related to the Neisseria meningitidis infection. The case was investigated by the national competent authority for vaccines. The investigator assessed the relationship between the adverse events and vaccination as ''impossible''. In the assessor''s opinion, the immune system weakening caused by the vaccination could have resulted in infections including Neisseria meningitidis, but due to lack of close temporality and the existence of other possible reasons, assessed the causality as ''unlikely''. No further information is expected. Company Causality Assessment: Based on the clinically relevant information currently available for this individual case, the reported events Purpura, somnolence, rhinitis, cough, pyrexia, vomiting and conjunctivitis are considered unlikely related to Varivax vaccine therapy. The evidence is not sufficient to suggest a relationship between the investigational therapy and the reported serious adverse events. Causality assessment is impacted by the confounding factor of findings of presence of Neisseria meningitidis which is associated with the events. Company Comment- No changes to Varivax vaccine product safety information are warranted at this time. Merck and Co., Inc, known as MSD outside of the certain countries, continues to monitor the safety profile of the product.; Autopsy-determined Cause(s) of Death: presence of Neisseria meningitidis


VAERS ID: 855403 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2019-02-26
Onset:2019-02-27
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2020-01-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MENB: MENINGOCOCCAL B (BEXSERO) / NOVARTIS VACCINES AND DIAGNOSTICS ABX764AA / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: C-reactive protein increased, Erysipelas, White blood cell count increased
SMQs:, Neuroleptic malignant syndrome (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Opportunistic infections (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, 2 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20190227; Test Name: C-reactive protein; Test Result: 4.35 mg/dl; Test Date: 20190301; Test Name: C-reactive protein; Test Result: 1.85 mg/dl; Test Date: 20190227; Test Name: Leukocyte count; Result Unstructured Data: Test Result: 15.74, Test Result Unit: /uL
CDC Split Type: ATGLAXOSMITHKLINEAT201923

Write-up: Erysipelas; This case was reported by a physician via regulatory authority and described the occurrence of erysipelas in a 30-month-old male patient who received Men B NVS (Bexsero) (batch number ABX764AA, expiry date unknown) for prophylaxis. Previously administered products included Bexsero with an associated reaction of no adverse event and Bexsero with an associated reaction of no adverse event. Additional patient notes included 1. and 2. Bexsero vaccination (23.02.2017 und 21.04.2017) well tolerated.. On 26th February 2019, the patient received Bexsero (intramuscular) 1 dosage form(s). On 27th February 2019, 1 days after receiving Bexsero and an unknown time after starting Augmentin and ibuprofen, the patient experienced erysipelas (serious criteria hospitalization, GSK medically significant and other: serious as per reporter). The patient was treated with amoxicillin sodium, potassium clavulanate (Augmentin), ibuprofen and unasyn (nos) (Unasyn). On an unknown date, the outcome of the erysipelas was recovering/resolving. It was unknown if the reporter considered the erysipelas to be related to Bexsero. Additional details: Age at vaccination was not reported, however the patient could be 30 months old or less than that at time of vaccination. On 27th February 2019, Leucocyte count was 15.74/uL and C-reactive protein was 4.35 mg/dl . On 1st March 2019, C-reactive protein was 1.85 mg/dl. Initial information was reported by a physician via regulatory authority on 24th December 2019: Erysipelas.


VAERS ID: 855404 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2019-11-29
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2020-01-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MENB: MENINGOCOCCAL B (BEXSERO) / NOVARTIS VACCINES AND DIAGNOSTICS - / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: C-reactive protein increased, Cough, Injection site induration, Lymphadenopathy, Pyrexia
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Extravasation events (injections, infusions and implants) (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Atopic eczema
Preexisting Conditions: Medical History/Concurrent Conditions: Normal delivery (physiological pregnancy, spontaneous birth, physiological newborn,); Normal newborn; Comments: none previous hospitalisations, no surgeries, no traumas
Allergies:
Diagnostic Lab Data: Test Name: C-reactive protein; Result Unstructured Data: Test Result: 48.7, Test Result Unit: mg/L; Test Name: C-reactive protein; Result Unstructured Data: Test Result: 81.2, Test Result Unit: mg/L
CDC Split Type: CZGLAXOSMITHKLINECZ201923

Write-up: Feverish; Lymphadenopathy cervical; Cough; Injection site induration; This case was reported by a physician via regulatory authority and described the occurrence of injection site induration in a 1-year-old male patient who received Men B NVS (Bexsero) for prophylaxis. The patient''s past medical history included normal newborn and normal delivery (physiological pregnancy, spontaneous birth, physiological newborn,). Concurrent medical conditions included atopic eczema. Additional patient notes included none previous hospitalisations, no surgeries, no traumas. On 29th November 2019, the patient received the 1st dose of Bexsero (intramuscular) 1 dosage form(s). On 1st December 2019, 2 days after receiving Bexsero, the patient experienced injection site induration (serious criteria other: Serious as per reporter), fever (serious criteria hospitalization and other: Serious as per reporter), lymphadenopathy cervical (serious criteria hospitalization and disability) and cough (serious criteria other: Serious as per reporter). On an unknown date, the outcome of the injection site induration, fever, lymphadenopathy cervical and cough were recovering/resolving. It was unknown if the reporter considered the injection site induration, fever, lymphadenopathy cervical and cough to be related to Bexsero. Additional details: The age at vaccination was not reported, however the patient could be 1 or less than 1 year old at the time of vaccination. On an unknown date, the patient''s C-reactive protein was 48.7 and 81.2 mg/dL. Initial information was received from a physician via regulatory authority on 20th December 2019: Injection site induration, feverish, lymphadenopathy cervical, cough. Lab Comments: 10006824 (22.1) the next day;


VAERS ID: 855406 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2019-11-28
Onset:2019-12-01
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2020-01-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER T28 / 1 LA / OT
VARZOS: ZOSTER (SHINGRIX) / GLAXOSMITHKLINE BIOLOGICALS 4B54R / 1 RA / OT

Administered by: Other       Purchased by: ?
Symptoms: Facial paresis
SMQs:, Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious meningitis (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: DEGLAXOSMITHKLINEDE201923

Write-up: Peripheral idiopathic facial palsy; This case was reported by a physician via regulatory authority and described the occurrence of facial paresis in a 63-year-old male patient who received Herpes zoster (Shingrix) (batch number 4B54R, expiry date unknown) for prophylaxis. Co-suspect products included INFLUENZA VIRUS VACCINE INACTIVATED (INFLUVAC TETRA 2019/2020) (batch number T28, expiry date unknown) for prophylaxis. Previously administered products included Shingrix (On 8th August 2019) and INFLUENZA VACCINE. On 28th November 2019, the patient received the 1st dose of Shingrix (intramuscular) and the 1st dose of INFLUVAC TETRA 2019/2020 (intramuscular). On 1st December 2019, 3 days after receiving Shingrix, the patient experienced facial paresis (serious criteria hospitalization). On an unknown date, the outcome of the facial paresis was not recovered/not resolved. It was unknown if the reporter considered the facial paresis to be related to Shingrix. Additional details: It was unknown if the reporter considered the facial paresis to be related to Influvac Tetra 2019/2020. The age at vaccination was not reported. However, patient could be 62 or 63 years at the time of vaccination. Anatomical Location was reported as right deltoid for the suspect Shingrix. Anatomical Location was reported as Left deltoid for the suspect Influvac Tetra 2019/2020. Initial information was received from a Physician via regulatory authority on 23rd December 2019: Peripheral idiopathic facial palsy.


VAERS ID: 855407 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2019-03-06
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2020-01-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEP: HEP B (ENGERIX-B) / GLAXOSMITHKLINE BIOLOGICALS AHBVC759AC / UNK - / OT
HEP: HEP B (ENGERIX-B) / GLAXOSMITHKLINE BIOLOGICALS - / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Arthralgia, Headache, Myalgia, Weight decreased
SMQs:, Rhabdomyolysis/myopathy (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Eosinophilic pneumonia (broad), Arthritis (broad), Tendinopathies and ligament disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? Yes
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRGLAXOSMITHKLINEFR201923

Write-up: Headache; Myalgia; Arthralgia; Weight decreased; This case was reported by a consumer via regulatory authority and described the occurrence of headache in a 40-year-old male patient who received HBV (Engerix B) (batch number AHBVC759AC, expiry date unknown) for prophylaxis. Co-suspect products included HBV (Engerix B) for prophylaxis. On 6th March 2019, the patient received Engerix B (unknown) 1 dosage form(s). On 20th May 2019, the patient received Engerix B (unknown) 1 dosage form(s). On an unknown date, less than 3 months after receiving Engerix B and less than 9 months after receiving Engerix B, the patient experienced headache (serious criteria disability), muscular pain (serious criteria disability), joint pain (serious criteria disability) and weight loss (serious criteria disability). On an unknown date, the outcome of the headache, muscular pain, joint pain and weight loss were recovering/resolving. It was unknown if the reporter considered the headache, muscular pain, joint pain and weight loss to be related to Engerix B and Engerix B. Additional details: The age at vaccination was not reported, however the patient could be 39 or 40 years old at the time of vaccination. Initial information was received from a consumer via regulatory authority on 20th December 2019: Headache, Muscular pain, Joint pain and weight loss.


VAERS ID: 855408 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2019-10-29
Onset:2019-11-21
   Days after vaccination:23
Submitted: 0000-00-00
Entered: 2020-01-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / OT
MNQ: MENINGOCOCCAL CONJUGATE (MENVEO) / NOVARTIS VACCINES AND DIAGNOSTICS - / UNK - / OT
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH - / UNK - / OT
UNK: VACCINE NOT SPECIFIED (NO BRAND NAME) / UNKNOWN MANUFACTURER 19L06691 / UNK - / OT
UNK: VACCINE NOT SPECIFIED (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / OT
UNK: VACCINE NOT SPECIFIED (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Rash maculo-papular
SMQs:, 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? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: DISULONE; PLAQUENIL; CLAIRYG
Current Illness: Migraine headache
Preexisting Conditions: Medical History/Concurrent Conditions: Antiphospholipid syndrome; Herpes simplex; Idiopathic thrombocytopenic purpura; Thyroiditis
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRSA2019SA361258

Write-up: Maculo-papular exanthema; Initial information received on 26-Dec-2019 regarding an unsolicited valid serious case downloaded from Regulatory Authority database without narrative (level 2A), was received Physician via Health Authority (under reference FR-AFSSAPS-PP20190763). The following narrative is based on the information retrieved from all other accessible data. This case involves a 35 years old female patient who experienced Maculo-papular exanthema (Rash maculo-papular), while she received vaccines INFLUENZA VACCINE, PNEUMOCOCCAL VACCINE CONJ 13V (CRM197) (PREVENAR 13), MENINGOCOCCAL VACCINE A/C/Y/W CONJ (CRM197) (MENVEO), DAPSONE, FERROUS OXALATE [DISULONE], HYDROXYCHLOROQUINE SULFATE [PLAQUENIL] and IMMUNOGLOBULIN HUMAN NORMAL [CLAIRYG]. The patient''s medical history included Idiopathic thrombocytopenic purpura, Antiphospholipid syndrome, Herpes simplex and Thyroiditis. The patient''s past medical treatment(s), vaccination(s) and family history were not provided. At the time of the event, the patient had ongoing Migraine headache. On 29-Oct-2019, the patient started taking DISULONE (DAPSONE, FERROUS OXALATE) divisible tablet 100 mg oral (with an unknown batch number) for Immune thrombocytopenic purpura and PLAQUENIL (HYDROXYCHLOROQUINE SULFATE) film-coated tablet 400 mg oral (with an unknown batch number) for Immune thrombocytopenic purpura. On 01-Nov-2019, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number not reported) via intramuscular route in unknown administration site. On 14-Nov-2019, the patient started taking CLAIRYG (IMMUNOGLOBULIN HUMAN NORMAL) Solution for infusion 50 mg/mL iv drip (lot - 19L06691) for Immune thrombocytopenic purpura. On 16-Nov-2019, the patient received a dose of suspect PREVENAR 13 not produced by Sanofi Pasteur (lot number not reported) via intramuscular route in unknown administration site. On 19-Nov-2019, the patient received a dose of suspect MENVEO not produced by Sanofi Pasteur (lot number not reported) via intramuscular route in unknown administration site. On 21-Nov-2019, the patient developed a serious Maculo-papular exanthema (rash maculo-papular) 23 days following the first dose intake of DAPSONE, FERROUS OXALATE, 23 days following the first dose intake of HYDROXYCHLOROQUINE SULFATE, 20 days following the administration of INFLUENZA VACCINE and 7 days following the first dose intake and 6 days following the last dose intake of IMMUNOGLOBULIN HUMAN NORMAL, 5 days following the administration of PREVENAR 13 and 2 days following the administration of MENVEO. The patient was hospitalized for this event. Other relevant tests were not reported. Final diagnosis was Rash maculo-papular. HYDROXYCHLOROQUINE SULFATE (PLAQUENIL) was discontinued on 27-Nov-2019. DAPSONE, FERROUS OXALATE (DISULONE) was discontinued on 27-Nov-2019. It was not reported if the patient received a corrective treatment. The patient was recovering from rash maculo-papular. There will be no information available on the batch number for this case.; Sender''s Comments: This case involves 35 years old female patient who presented with rash maculo-papular after vaccination with INFLUENZA VACCINE, DISULONE, PLAQUENIL, PREVENAR 13, MENVEO and CLAIRYG. Time to onset is compatible. However, patients lab tests ruling out alternate etiologies were not reported but the patient had ongoing Migraine. Based on available information the role of individual product cannot be assessed.


VAERS ID: 855410 (history)  
Form: Version 2.0  
Age: 0.33  
Sex: Unknown  
Location: Foreign  
Vaccinated:2019-11-30
Onset:2019-12-18
   Days after vaccination:18
Submitted: 0000-00-00
Entered: 2020-01-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
UNK: VACCINE NOT SPECIFIED (NO BRAND NAME) / UNKNOWN MANUFACTURER - / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Diarrhoea, Gastroenteritis rotavirus, Rotavirus infection, Rotavirus test positive
SMQs:, Pseudomembranous colitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Noninfectious diarrhoea (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? 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: Test Date: 20191218; Test Name: Rotavirus test positive; Result Unstructured Data: Test Result: Positive, Test Result Unit: unknown
CDC Split Type: HKGLAXOSMITHKLINEHK2019AP

Write-up: Rotavirus infection/diarrhea; This case was reported by a physician via sales rep and described the occurrence of diarrhea rotavirus in a 5-month-old female patient who received Rota (Rotarix oral suspension) for prophylaxis. On 30th November 2019, the patient received the 1st dose of Rotarix oral suspension (oral). On 18th December 2019, 18 days after receiving Rotarix oral suspension, the patient experienced diarrhea rotavirus (serious criteria hospitalization and GSK medically significant). On an unknown date, the outcome of the diarrhea rotavirus was unknown. It was unknown if the reporter considered the diarrhea rotavirus to be related to Rotarix oral suspension. Additional details were provided as follows: After administeration of Rotarix the patient developed diarrhea and was admitted to hospitalization shortly after found rotavirus infection. The patient was discharged from hospital but not yet come back for the second dose. The schedule for next dose was last week, but parent will bring the patient for second dose after full recovery.


VAERS ID: 855411 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2019-10-09
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2020-01-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV9: HPV (GARDASIL 9) / MERCK & CO. INC. S015761 / 1 LA / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Injection site induration, Injection site swelling, Pain in extremity, Peripheral swelling
SMQs:, Cardiac failure (broad), Angioedema (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Tendinopathies and ligament disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: BOOSTRIX
Current Illness: Prophylaxis
Preexisting Conditions: Comments: The patient''s medical history / concurrent conditions were unknown.
Allergies:
Diagnostic Lab Data:
CDC Split Type: IE0095075131912IRL012562

Write-up: DEVELOPED A LARGE, ROUND, HARD, CIRCULAR SWELLING ON OUTER ASPECT OF LEFT ARM AT SITE OF HPV 9 INJECTION; PAINFUL SWOLLEN ARM FOR MORE THAN 2 WEEKS; Information has been downloaded from Regulatory Authority (IE-HPRA-2019-053930). This spontaneous report was received from a physician and refers to a 13-year-old male patient. The patient''s concurrent conditions and medical history were not reported. On 09-OCT-2019, the patient was vaccinated with the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9), 0.5 ml intramuscularly, lot # S015761, expiration date 31-DEC-2021. The second dose of the vaccine was due in 2020. Concomitant therapies included diphtheria toxoid, pertussis acellular 3-component vaccine, tetanus toxoid (BOOSTRIX). On an unknown date, the patient experienced a large, round, hard, circular swelling on outer aspect of left arm at site of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) and painful swollen arm which lasted more than 2 weeks. The outcome of the events was reported as recovering/resolving. The relatedness between the events and hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) was unknown. The events of large, round, hard, circular swelling on outer aspect of left arm and painful swollen arm were considered to be serious by the Agency.


VAERS ID: 855413 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:2017-05-25
Onset:2017-05-30
   Days after vaccination:5
Submitted: 0000-00-00
Entered: 2020-01-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MMR: MEASLES + MUMPS + RUBELLA (NO BRAND NAME) / UNKNOWN MANUFACTURER L043137 / 1 LL / OT

Administered by: Unknown       Purchased by: ?
Symptoms: Induration, Injection site haemorrhage, Injection site oedema, Lymphadenopathy
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), 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:
Other Medications:
Current Illness: Routine childhood immunisation
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: PL0095075131912POL012351

Write-up: petechiae limited to left lower limb, some with edema; enlarged lymph nodes behind ear lobes, hard, size of pea; Information has been downloaded from Regulatory Authority (PL-URPL-N1706/2017). This spontaneous report was received from a physician referring to a 2 years old patient of unknown gender. The patient''s concurrent condition, medical history and concomitant medication were not reported. On 25-MAY-2017 at 10:55, the patient was vaccinated with the first dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-RVAXPRO) 0.5 milliliter (lot # L043137 and expiration date 02-NOV-2017) intramuscularly in the left thigh as routine childhood immunisation. On 30-MAY-2017 at 13:00, the patient experienced petechiae limited to left lower limb, some with edema and enlarged lymph nodes behind ear lobes, hard, size of pea. At the reporting time, the outcome of the events were unknown. The events were considered to be expected reactions, and qualified by local Health Authority as serious (medically significant). The temporal relationship with vaccination suggested a causal relationship (probable/likely related) by agency.


VAERS ID: 855414 (history)  
Form: Version 2.0  
Age: 0.08  
Sex: Unknown  
Location: Foreign  
Vaccinated:2016-12-07
Onset:2016-12-01
Submitted: 0000-00-00
Entered: 2020-01-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTP: DTP (NO BRAND NAME) / UNKNOWN MANUFACTURER 20915003A ? / 1 RA / OT

Administered by: Other       Purchased by: ?
Symptoms: Crying, Hypotonia, Pain, Vaccination site movement impairment, Vaccination site pain
SMQs:, Peripheral neuropathy (broad), Guillain-Barre syndrome (broad), Depression (excl suicide and self injury) (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: PLGLAXOSMITHKLINEPL201923

Write-up: Crying; difficulty moving the right upper limb, limited movement in comparison...; pain upon movement of the right upper limb; decreased muscle tone in the right upper limb; pain of the right upper limb when touched; This case was reported by a physician via regulatory authority and described the occurrence of crying in a 1-month-old patient who received DTP (A or W not known) (DTP vaccine) (batch number 20915003A ?, expiry date October 2018) for prophylaxis. On 7th December 2016 12:23, the patient received the 1st dose of DTP vaccine (unknown) .5 ml. On 7th December 2016 18:00, 5 hrs 37 min after receiving DTP vaccine, the patient experienced crying (serious criteria hospitalization) and vaccination site movement impairment (serious criteria other: Serious as per reported). In December 2016, the patient experienced pain upon movement (serious criteria other: Serious as per reported), muscle tone decreased (serious criteria other: Serious as per reported) and vaccination site pain (serious criteria other: Serious as per reported). In December 2016, the outcome of the crying, vaccination site movement impairment, pain upon movement, muscle tone decreased and vaccination site pain were recovered/resolved. The reporter considered the crying, vaccination site movement impairment, pain upon movement, muscle tone decreased and vaccination site pain to be related to DTP vaccine. Additional details: Anatomical Location was reported as Right arm. The reported batch number for DTP vaccine was 20915003A, which does not match with any GSK batch or lot number. Initial information was received from a Physician via regulatory authority on 24th December 2019: muscle tone decreased in the right upper limb, difficulty moving the right upper limb, limited movement in comparison to the left side, right upper limb placed alongside the body, was able to lift only the forearm, crying and pain of the right upper limb when touched. Sender comment: Crying and injection site reactions in the form of pain and tenderness, and consequently limitation of limb movements, as well as muscular tone disorders are expected adverse reactions after administration of the DTP vaccine, included in the Summary of Product Characteristics. The temporal relationship speaks for a cause-and-effect relationship. the person reporting NOP classified it as mild, Agency considered NOP severe due to the need for hospitalization.


VAERS ID: 855415 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2016-11-15
Submitted: 0000-00-00
Entered: 2020-01-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTP: DTP (NO BRAND NAME) / UNKNOWN MANUFACTURER 20916001A ? / 2 LL / OT
IPV: POLIO VIRUS, INACT. (NO BRAND NAME) / UNKNOWN MANUFACTURER AIPVB093BB / 1 RL / OT

Administered by: Other       Purchased by: ?
Symptoms: Anxiety, Crying, Petechiae, Pyrexia, Rash morbilliform, Rash rubelliform
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), 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? 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: Test Date: 20161115; Test Name: Body temperature; Result Unstructured Data: Test Result: 39-39.4, Test Result Unit: degree C
CDC Split Type: PLGLAXOSMITHKLINEPL201923

Write-up: Petechiae; Anxiety; Crying; Pyrexia; Rash morbilliform; within the head (scalp); This case was reported by a physician via regulatory authority and described the occurrence of petechiae in a neonate male patient who received DTP (A or W not known) (DTP vaccine) (batch number 20916001A ?, expiry date February 2019) for prophylaxis. Co-suspect products included Polio Trivalent Inactivated (Poliorix) (batch number AIPVB093BB, expiry date October 2017) for prophylaxis. On an unknown date, the patient received the 2nd dose of DTP vaccine (intramuscular) .5 ml and the 1st dose of Poliorix (intramuscular) .5 ml. On 15th November 2016, unknown after receiving DTP vaccine and Poliorix, the patient experienced petechiae (serious criteria other: Serious as per reporter), anxiety (serious criteria other: Serious as per reporter), persistent crying (serious criteria other: Serious as per reporter), fever (serious criteria other: Serious as per reporter), morbilliform rash (serious criteria other: Serious as per reporter) and rash rubelliform (serious criteria other: Serious as per reporter). On an unknown date, the outcome of the petechiae, anxiety, persistent crying, fever, morbilliform rash and rash rubelliform were recovered/resolved. The reporter considered the petechiae, anxiety, persistent crying, fever, morbilliform rash and rash rubelliform to be probably related to DTP vaccine and Poliorix. Additional details: The patient received Poliorix on right thigh. The patient received DTP vaccine in left thigh. On 15th November 2016, body temperature was 39.0-39.4 degree C. The batch number of DTP vaccine was reported as 20916001A, which does not matches with any GSK number. Initial information was received from a physician via regulatory authority on 20th December 2019: Petechiae, anxiety, persistent crying, fever, rash morbilliform within the head (scalp) Note: Age at the event was reported as 0 days, we have kept it blank and captured age group as neonate. The event onset dates were reported as 15th November 2016, which was before vaccine adminihstartion date 14th November 2017. More information regarding discrepancy of vaccination date and event onset date in expected follow up. Sender''s comment: Reactions expected for DTP vaccine. For Poliorix, fever and unusual crying are expected (remaining unexpected). The temporal association with vaccination suggests a causal relationship. Regulatory Authority rated the reactions as severe.


VAERS ID: 855452 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:2014-05-12
Onset:2014-05-01
Submitted: 0000-00-00
Entered: 2020-01-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
TDAP: TDAP (BOOSTRIX) / GLAXOSMITHKLINE BIOLOGICALS AC37B136AB / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Acute disseminated encephalomyelitis, Adjustment disorder, Amnesia, Anxiety, Aphasia, Asthenia, Atrial fibrillation, Biopsy brain abnormal, Blindness, Blindness transient, Blood acid phosphatase increased, Blood glucose normal, Brain injury, Brain scan abnormal, Central nervous system lesion, Chromatopsia, Colour blindness, Conjunctivitis, Depression, Disorientation, Disturbance in attention, Dysgraphia, Electroencephalogram, Epilepsy, Fatigue, Gastric disorder, Headache, Hypoaesthesia, Immunoglobulin therapy, Inflammation, Insomnia, Laboratory test, Loss of consciousness, Magnetic resonance imaging, Magnetic resonance imaging brain abnormal, Memory impairment, Migraine, Multiple sclerosis, Muscular weakness, Nausea,