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From the 10/8/2021 release of VAERS data:

Found 1,624,273 cases where Symptom is Immune system disorder or Immunodeficiency or Immunoglobulins decreased or Lymphadenopathy



Case Details (Sorted by Age)

This is page 278 out of 1,625

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VAERS ID: 743137 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2018-03-12
Onset:2018-03-13
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2018-04-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTIPV: DT + IPV (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / SYR
MEN: MENINGOCOCCAL (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / SYR

Administered by: Other       Purchased by: ?
Symptoms: Fatigue, Headache, Malaise
SMQs:

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: GBSA2018SA092838

Write-up: Initial information regarding this unsolicited case downloaded from Regulatory Authority database without narrative (level 2A), was received on 27-Mar-2018 from a consumer via health authority (under the reference number: GB-MHRA-EYC 00176054 and GB-MHRA-ADR 24296073). The following narrative is based on the information retrieved from all other accessible data. This case involves a 14-year-old male patient, who was vaccinated with a dose of REVAXIS and a dose of MENINGOCOCCAL A, C, W135, Y VACCINE) (Batch number, expiry date, dose, dose in series and site of administration were not reported for both the vaccines) via parenteral route on 12-Mar-2018. Patient''s medical history and concomitant medications were not reported. On 13-Mar-2018, one day following the vaccination, the patient experienced headache, tiredness and feeling unwell. Laboratory data and corrective treatment was not reported. On 14-Mar-2018, the patient was recovered from all the events. This case was reported as serious due to medically significant events. List of documents held by sender: none. Sender''s Comments: This is a poorly documented case without narrative, retrieved from Regulatory Authority with coded events of Feeling unwell, headache and tiredness after vaccination. Time to onset is compatible. Further information regarding confirmed diagnosis, symptoms and their evolution, medical history as well as concurrent condition during vaccination, previous vaccination and tolerance, allergic history, laboratory investigations excluding alternative etiologies for the reported event are needed to fully assess this case. Based upon the given information the role of the vaccine cannot be assessed.


VAERS ID: 743138 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2018-04-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Anticoagulant therapy, Contusion, Death, Drug interaction, Haemoptysis, International normalised ratio decreased, Platelet count decreased, Pyrexia
SMQs:, Haematopoietic thrombocytopenia (narrow), Haemorrhage terms (excl laboratory terms) (narrow), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Accidents and injuries (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: HYDROXYCHLOROQUINE; HYDROCHLOROTHIAZIDE; MONTELUKAST; LORAZEPAM; CELECOXIB; ASA; warfarin
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: international normalized ratio; Result Unstructured Data: 8
CDC Split Type: ITSA2018SA095111

Write-up: Initial unsolicited report received from literature on 26 Mar 2018. This case is linked with 2018SA095112, 2018SA095116 and 2018SA095117 (same literature). The following is verbatim from the article: Background: An increasing number of reports indicates that vaccines against influenza may interact with specific drugs via drug metabolism. To date, actual impact of vaccine-drug interactions observed in the real world clinical practice has not been investigated. Results: 116 AEFI reports submitted to VAERS and 83 from another database were included in our analysis; antiepileptics and statins were related to the highest number of indeterminate/consistent (93.7%; 65.3%) and possible/probable (50%; 57.7%) cases according to the AEFI and DIPS, respectively. The majority of cases occurred within the first week after vaccine administration (5-7 days). Conclusion: The relative paucity of detected interactions does not impact on the benefit of the vaccination against influenza, which remains strongly recommended; this does not exclude that closer monitoring for selected patients exposed to concomitant chronic pharmacological therapies and affected by predisposing factors may be useful. This case involves 67 years old female patient who was vaccinated with dose of INACTIVATED SPLIT VIRUS INFLUENZA VACCINE (batch number, expiry date, route and site of administration were not reported). The patient also received dose of warfarin (batch number, expiry date and route were not reported) on an unspecified date. The patient''s medical history was not reported. Patient concomitant medication includes hydroxychloroquine, hydrochlorothiazide, montelukast, lorazepam, celecoxib, ACETYLSALICYLIC ACID (ASA). On an unspecified date, six days post vaccination patient had contusion, hemoptysis, international normalized ratio decreased (8 revealed in lab test), platelet count decreased, pyrexia and she died. Other laboratory investigation showed coughing up blood. Corrective treatment was not reported. It was unknown whether autopsy was performed or not. The reporter assessed the causal relationship with INACTIVATED SPLIT VIRUS INFLUENZA VACCINE and WARFARIN for the events as indeterminate and drug interaction probability scale reported as possible (3). List of documents held by sender: none. Sender''s Comments: A 67year-old female experienced contusion, hemoptysis, INR decreased, Platelet count decreased, pyrexia and died 6 days post vaccination with Inactivated, split-virus influenza vaccine. Neither medical history was reported nor patient medical condition at the time of vaccination. Lab tests revealed blood in cough which is indicative of a possible preexisting underlying infectious etiology. The patient was also receiving warfarin at the time of vaccination which is indicative of a preexisting medical condition. Additional information regarding patient''s medical history, condition at the time of vaccination, vaccine name or lot number and tests performed to identify alternate causes must be provided. Based upon reported information the role of the vaccine cannot be assessed. Reported Cause(s) of Death: contusion; hemoptysis; INR decreased; platelet count decreased; pyrexia.


VAERS ID: 743139 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2018-04-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / UNK - / UN

Administered by: Unknown       Purchased by: ?
Symptoms: Postural orthostatic tachycardia syndrome
SMQs:, 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? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Epilepsy
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: SE0095075131804SWE000390

Write-up: Information has been downloaded from Agency (SE-MPA-2018-001690). This spontaneous report has been received from a physician and refers to a female patient of unknown age. The patient''s concurrent conditions included epilepsy, and no information was provided regarding the patient''s medical history or concomitant medications. On an unspecified date, the patient was vaccinated with a dose of GARDASIL for an unknown indication (strength, dose, frequency, route of administration, lot number and expiration date were not reported). On an unknown date, the patient experienced a postural orthostatic tachycardia syndrome (POTS) and was hospitalized. The outcome of the event POTS was not recovered and the reporter did not assess the causal relationship between vaccination with GARDASIL and the event of POTS. The agency considered the event to be serious for the following reason: medically significant and hospitalization.


VAERS ID: 743157 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2012-10-02
Onset:2014-05-01
   Days after vaccination:576
Submitted: 0000-00-00
Entered: 2018-04-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. H008259 / UNK - / -

Administered by: Unknown       Purchased by: ?
Symptoms: Abdominal pain, Gastric disorder, Gastritis, Genital rash, Kidney infection, Menorrhagia, Ovarian cyst
SMQs:, Acute pancreatitis (broad), Haemorrhage terms (excl laboratory terms) (narrow), Retroperitoneal fibrosis (broad), Gastrointestinal nonspecific inflammation (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), 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? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Constipation
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: IE0095075131804IRL001419

Write-up: Information was received from Agency (# IE-HPRA-2018-036384) on 03-APR-2018. This spontaneous report as received from a consumer refers to a female patient of unknown age with constipation. On 02-OCT-2012, the patient was vaccinated with GARDASIL) lot # H008259, expiration date 31-JAN-2015 for prophylaxis. Another doses were given on 27-NOV-2012 (lot # H013055; expiration date 28-FEB-2015) and 19-MAR-2013 (lot # H013135; expiration date 28-FEB-2015). In May 2014, the patient experienced gastritis (hospitalization). On an unknown date, the patient experienced abdominal pain (medically significant), gastric disorder (hospitalization), genital rash (medically significant), menorrhagia (medically significant), kidney infection (hospitalization) and ovarian cyst (medically significant). The outcome of gastritis, gastric disorder, genital rash, menorrhagia, kidney infection and abdominal pain was reported as not recovered/not resolved. The outcome of ovarian cyst was reported as recovered/resolved.


VAERS ID: 743173 (history)  
Form: Version 1.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2018-04-05
Entered: 2018-04-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
TDAP: TDAP (BOOSTRIX) / GLAXOSMITHKLINE BIOLOGICALS - / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Bordetella test positive, Pertussis, 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? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: 12/2017, Bordetella test, Pertussis confirmed
CDC Split Type: NZ2018GSK055854

Write-up: This case was reported by a nurse via sales rep and described the occurrence of vaccination failure in a 62-year-old female patient who received BOOSTRIX. In November 2015, the patient received BOOSTRIX. In December 2017, 2 years after receiving BOOSTRIX, the patient experienced vaccination failure (serious criteria GSK medically significant) and pertussis (serious criteria GSK medically significant). On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the pertussis was not reported. It was unknown if the reporter considered the vaccination failure and pertussis to be related to BOOSTRIX. Additional details were provided as follows: The age at vaccination was not reported. Two years later, the patient contracted Pertussis and was confirmed in December 2017. Follow up would be conducted.


VAERS ID: 743185 (history)  
Form: Version 2.0  
Age: 0.08  
Sex: Female  
Location: Foreign  
Vaccinated:2018-03-13
Onset:2018-03-13
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2018-04-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
RV5: ROTAVIRUS (ROTATEQ) / MERCK & CO. INC. - / UNK - / UN

Administered by: Unknown       Purchased by: ?
Symptoms: Crying, Dehydration, Diarrhoea, Hypersomnia, Irritability, Lethargy, Muscle spasms, Pyrexia, Rash, Vomiting, Vomiting projectile, Weight decreased
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Pseudomembranous colitis (broad), Dystonia (broad), Gastrointestinal perforation, ulcer, haemorrhage, obstruction non-specific findings/procedures (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hostility/aggression (broad), Depression (excl suicide and self injury) (broad), Hypersensitivity (narrow), Noninfectious diarrhoea (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Dehydration (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: ZA0095075131803ZAF011156

Write-up: This spontaneous report as received from a consumer via Centre refers to a 6-week-old female patient. There was no information about the patient''s prominent medical history and concomitant therapies. On 13-MAR-2018, the patient was administered a dose of ROTATEQ (dose, route of administration, lot # and expiration date were not reported) for prophylaxis for her 6 week vaccinations. On 13-MAR-2018 (also reported as "started 4 hours after the vaccine"), the patient experienced diarrhoea which continued well beyond 48 hours. Since that day, the patient had also fever which was never higher than 38 degrees however she came and went to hospital over next 3 days until she was admitted. On an unknown date in March 2018, the patient experienced dehydration, irritability, rash over her face and upper body, severe cramping which lead to her crying uncontrollably, she was also lethargic, she slept quite a lot and over 48-72 hours she gained no weight and only lost weight. On 15-MAR-2018, she was admitted to hospital for severe dehydration and diarrhea. On the same day (also reported as "upon admission" and "started following 48 hours"), the patient experienced projectile vomiting. During her stay in hospital she was on an intravenous (IV) fluids and a course of antibiotics, she was also given REUTERINA drops to take and continue for 1 week upon discharge. As it stood she did not show any lasting effects from all the above, she was still feeding exclusively on the breast and gaining weight however not as much as she was initially but her doctor advised that it was all good and that she would start gaining better weight again over time. The outcome of the events was recovered. The causality assessment was not provided.


VAERS ID: 743194 (history)  
Form: Version 1.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2018-04-05
Entered: 2018-04-05
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
RAB: RABIES (RABIPUR) / NOVARTIS VACCINES AND DIAGNOSTICS - / 3 UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Henoch-Schonlein purpura, Pain in extremity
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Vasculitis (narrow), Hypersensitivity (narrow), Tendinopathies and ligament disorders (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: No other medications
Current Illness: Unknown
Preexisting Conditions: RABIPUR, prophylaxis, received 1st and 2nd dose for tolerance see case CN2018GSK057928
Allergies:
Diagnostic Lab Data:
CDC Split Type: CN2018GSK053995

Write-up: This case was reported by a physician via sales rep and described the occurrence of anaphylactoid purpura in a child patient who received RABIPUR. Previously administered products included RABIPUR (received 1st and 2nd dose for tolerance see case CN2018GSK057928). On an unknown date, the patient received the 3rd dose of RABIPUR. On an unknown date, several days after receiving RABIPUR, the patient experienced anaphylactoid purpura (serious criteria hospitalization) and leg pain. On an unknown date, the outcome of the anaphylactoid purpura and leg pain were unknown. It was unknown if the reporter considered the anaphylactoid purpura and leg pain to be related to RABIPUR. Additional details were provided as follows: The age at vaccination was could be 6 or 7 year. The patient received RABIPUR as per 2, 1, 1 procedure, after receiving the 3rd dose, several days later, the patient developed pain in both legs. Then the patient went to see a doctor and was diagnosed as anaphylactoid purpura. The patient was admitted to the hospital. At the time of reporting, the patient did not discharge. This case has been linked with case CN2018GSK057928, reported by the same reporter for the same patient.


VAERS ID: 743264 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2018-02-23
Onset:2018-02-23
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2018-04-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MMR: MEASLES + MUMPS + RUBELLA (NO BRAND NAME) / UNKNOWN MANUFACTURER - / 1 - / UN

Administered by: Unknown       Purchased by: ?
Symptoms: Cold sweat, Nausea, Pain, Pain in extremity, Pyrexia, Rash, Vomiting
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hypersensitivity (narrow), 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: Routine childhood immunisation
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GB0095075131803GBR011463

Write-up: Information has been downloaded from regulatory authority (GB-MHRA-ADR 24293916). This Spontaneous report has been received from a 14 years old male consumer reporting on himself. The patient medical history, concurrent conditions and concomitant medications were not reported. On 23-FEB-2018, the patient was vaccinated with M-M-RVAXPRO, parenterally (dose, strength, frequency, lot # and expiration date were not reported). On 23-FEB-2018, the patient experienced Pyrexia, Nausea, Vomiting, Abdominal pain, Cold sweat, Pain in extremity, Rash and Headache (reported as "High temperature, nausea and vomiting, severe headache and upper torso and arm pain, clammy skin and a rash and ended up being taken to hospital in an ambulance"). The action taken with M-M-RVAXPRO was not applicable. The Outcome of the events was reported as recovered. The causal relationship between the events with M-M-RVAXPRO was not reported. The agency considered the events as medically significant.


VAERS ID: 743265 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2005-03-29
Onset:2018-03-01
   Days after vaccination:4720
Submitted: 0000-00-00
Entered: 2018-04-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MMR: MEASLES + MUMPS + RUBELLA (PRIORIX) / GLAXOSMITHKLINE BIOLOGICALS A69CA215A / UNK - / -
MMR: MEASLES + MUMPS + RUBELLA (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / -

Administered by: Unknown       Purchased by: ?
Symptoms: Mumps, Swelling, Vaccination failure
SMQs:, Anaphylactic reaction (broad), Angioedema (broad), Lack of efficacy/effect (narrow), Oropharyngeal infections (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? No
Previous Vaccinations:
Other Medications:
Current Illness: Prophylaxis
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: IE0095075131803IRL012547

Write-up: Information has been downloaded from regulatory authority (IE-HPRA-2018-036285). Information was received from a consumer referring to a 20 year old female patient. The patient''s concurrent condition, medical history and concomitant therapy were not reported. On 29-MAR-2005, the patient was vaccinated with M-M-RVAXPRO (dosage unknown, lot# reported HF70820 (which was invalid), intramuscular) for prophylaxis. Other suspect therapies included (Schwartz) PRIORIX. The patient experienced neck swelling on 01-MAR-2018 and mumps on 06-MAR-2018. On an unknown date, the patient experienced vaccination failure. Therapy with M-M-RVAXPRO was reported as unknown. The outcome of events was reported as not recovered. Relationship between events and M-M-RVAXPRO was unknown. Agency considered vaccination failure to be medically significant.


VAERS ID: 743266 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2017-05-11
Onset:2017-05-11
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2018-04-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MMR: MEASLES + MUMPS + RUBELLA (NO BRAND NAME) / UNKNOWN MANUFACTURER M041493 / 1 - / -
VARCEL: VARICELLA (VARIVAX) / MERCK & CO. INC. - / 1 - / -

Administered by: Unknown       Purchased by: ?
Symptoms: Diarrhoea, Hyperpyrexia, Rash, Vomiting
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), 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? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 20170511; Test Name: Body temperature; Result Unstructured Data: Lab result: 40 ?C; Test Date: 20170511; Test Name: Body temperature; Result Unstructured Data: Lab result: 38 ?C
CDC Split Type: IT0095075131706ITA005531

Write-up: This is a solicited report received on 12-JUN-2017 from a physician, via the Agency (HA#414074), concerning a 16 month old female patient, included in a solicited Program, who, on 11-MAY-2017, at 04:00 p.m. underwent the administration of the first dose of VARIVAX (lot # reported as M044591) and of M-M-RVAXPRO (lot # M041493). After 7 days from the vaccination (onset date also coded as 11-MAY-2017), the patient experienced fever with 40?C lasted 24 hand with 38 ?C lasted other 4 days, with vomiting and diarrhea. The patient was treated with TACHIPIRINA and lactic ferments. After 30 days from the vaccination, the patient experienced rash lasted 24 h. Lot number M044591 is an invalid lot number for varicella virus vaccine live.


VAERS ID: 743267 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2018-01-26
Onset:2018-01-31
   Days after vaccination:5
Submitted: 0000-00-00
Entered: 2018-04-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MMR: MEASLES + MUMPS + RUBELLA (NO BRAND NAME) / UNKNOWN MANUFACTURER N026894 / UNK - / IM

Administered by: Unknown       Purchased by: ?
Symptoms: Alanine aminotransferase increased, Aspartate aminotransferase increased, Pyrexia, Rash maculo-papular, Transaminases increased
SMQs:, Liver related investigations, signs and symptoms (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? 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: Test Date: 20180202; Test Name: Alanine aminotransferase; Result Unstructured Data: Lab result: 412 IU/l; Test Date: 20180208; Test Name: Alanine aminotransferase; Result Unstructured Data: Lab result: 90 IU/l; Test Date: 20180202; Test Name: Aspartate aminotransferase; Result Unstructured Data: Lab result: 154 IU/l; Test Date: 20180206; Test Name: Aspartate aminotransferase; Result Unstructured Data: Lab result: 66 IU/l
CDC Split Type: IT0095075131802ITA012740

Write-up: Information has been downloaded from Regulatory Authority (IT-MINISAL02-458376). This spontaneous report was received from a physician and refers to a 1 year old male patient. The patient''s concurrent conditions, medical history and concomitant therapies were not reported. On 26-JAN-2018, the patient was vaccinated with a dose of M-M-RVAXPRO, lot # N026894, expiration date not provided, intramuscularly for prophylaxis. On 31-JAN-2018, the patient experienced fever, transaminases increased and rash maculo-papular. On 02-FEB-2018, the aspartate aminotransferase was 154 IU/l and alanine aminotransferase was 412 IU/l. On 06-FEB-2018, aspartate aminotransferase was 66 IU/l. On the same day, tests for Epstein-Barr virus antibody, cytomegalovirus and parvovirus B19 were performed (results not reported). On 08-FEB-2018, alanine aminotransferase was 90 IU/l. On the same day, the patient recovered from fever, transaminases increased and rash maculopapular. The causality between the events and M-M-RVAXPRO was not reported. Follow up information was downloaded from Regulatory Authority (IT-MINISAL02-458376) on 29-MAR-2018. The patient was hospitalized for all events on an unspecified date. Sender''s Comments: On 18-MAR-2018 the seriousness criterion of the AEs was updated.


VAERS ID: 743268 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2018-04-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Anticoagulant therapy, Cerebral infarction, Computerised tomogram abnormal, Death, Drug interaction, Haemorrhage intracranial, International normalised ratio fluctuation, International normalised ratio increased, Rectal haemorrhage, Unresponsive to stimuli
SMQs:, Liver-related coagulation and bleeding disturbances (narrow), Haemorrhage terms (excl laboratory terms) (narrow), Haemorrhage laboratory terms (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Ischaemic central nervous system vascular conditions (narrow), Haemorrhagic central nervous system vascular conditions (narrow), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Gastrointestinal haemorrhage (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Ischaemic colitis (broad), Hypotonic-hyporesponsive episode (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Warfarin
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: ITSA2018SA095112

Write-up: Initial unsolicited report received from literature on 26 Mar 2018. This case is linked with 2018SA095111, 2018SA095116, 2018SA095117 (same literature). The following is verbatim from the article: Background: An increasing number of reports indicates that vaccines against influenza may interact with specific drugs via drug metabolism. To date, actual impact of vaccine-drug interactions observed in the real world clinical practice has not been investigated. Methods: From VAERS and agency, we collected Adverse Event Following Immunization (AEFI) reports for individuals receiving vaccines against influenza recorded as suspect and selected cases where predictable toxicity was recorded with oral anticoagulants, antiepileptics and statins (i.e. hemorrhages, over dosage and rhabdomyolysis, respectively). We applied AEFI and Drug Interaction Probability Scale (DIPS) Algorithms to assess causality of drug-vaccine interactions. Results: 116 AEFI reports submitted to VAERS and 83 from agency were included in our analysis; antiepileptics and statins were related to the highest number of indeterminate/consistent (93.7%; 65.3%) and possible/probable (50%; 57.7%) cases according to the AEFI and DIPS, respectively. The majority of cases occurred within the first week after vaccine administration (5-7 days). Conclusion: The relative paucity of detected interactions does not impact on the benefit of the vaccination against influenza, which remains strongly recommended; this does not exclude that closer monitoring for selected patients exposed to concomitant chronic pharmacological therapies and affected by predisposing factors may be useful. This case involves 64 years old male patient who was vaccinated with a dose of Influenza vaccine and dose of Warfarin (batch number, expiry date, route and site of administration were not reported for both suspect product) on an unspecified date. Patient''s medical history and concomitant medication was not reported. On an unspecified date, thirty days post vaccination and administration of Warfarin, patient had cerebral infarction, computerized tomogram abnormal, hemorrhage intracranial, INR fluctuation, rectal hemorrhage, unresponsive to stimuli and patient died. It was also a case of possible drug interaction. Corrective treatment were not reported. It was unknown whether autopsy was performed or not. The reporter assessed the adverse events following immunization and drug interaction probability scale as indeterminate (possible). The Horn Drug Interaction Probability Scale indicated a possible interaction between warfarin and the influenza vaccination. List of documents held by sender: none. Sender''s Comments: This literature article reports about a 64 year old adult male who died experiencing intracranial hemorrhage, rectal hemorrhage and elevated INR (International Normalized Ratio) 30 days after having received Influenza vaccine. The time to onset is compatible. However, there is no autopsy report confirming the cause of death. Patient''s past medical history includes fluctuations in INR and ongoing treatment with warfarin. INR elevation is an expected event with Warfarin therapy, with or without drug interaction with Influenza vaccine, and it is a possible cause of intracranial and rectal hemorrhages. Moreover, considering the age and past medical history of the patient, it is not possible to comment on the fatal outcome without ascertaining the cause of death first. Reported Cause(s) of Death: Cerebral infarction; Elevated INR; Intracranial hemorrhage; Rectal hemorrhage; Unresponsive to stimuli.


VAERS ID: 743269 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2018-04-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Albumin CSF increased, Arrhythmia, CD4/CD8 ratio, CSF immunoglobulin increased, CSF oligoclonal band, CSF protein increased, Cardiac failure, Cardiopulmonary failure, Chromaturia, Death, Guillain-Barre syndrome, Hypoaesthesia, Hypotonia, Mobility decreased, Muscular weakness, Nephropathy, Pain in extremity, Paralysis, Pneumonia, Renal impairment, Rhabdomyolysis, Sepsis, Supraventricular tachycardia
SMQs:, Rhabdomyolysis/myopathy (narrow), Acute renal failure (narrow), Cardiac failure (narrow), Peripheral neuropathy (narrow), Neuroleptic malignant syndrome (broad), Supraventricular tachyarrhythmias (narrow), Retroperitoneal fibrosis (broad), Parkinson-like events (broad), Acute central respiratory depression (broad), Guillain-Barre syndrome (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Cardiomyopathy (broad), Demyelination (narrow), Eosinophilic pneumonia (broad), Cardiac arrhythmia terms, nonspecific (narrow), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (broad), Hypotonic-hyporesponsive episode (broad), Generalised convulsive seizures following immunisation (broad), Chronic kidney disease (broad), Tumour lysis syndrome (broad), Respiratory failure (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (narrow), Sepsis (narrow), Opportunistic infections (broad), Immune-mediated/autoimmune disorders (narrow), Sexual dysfunction (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: TAMSULOSIN; HYDROCHLOROTHIAZIDE; CLONIDINE; GEMFIBROZIL; ACETYLSALICYLIC ACID; TORSEMIDE; QUINAPRIL; VALSARTAN; PREGABALIN; INSULIN; PARICALCITOL; CALCIUM; simvastatin
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Diabetic nephropathy; End stage renal disease (DUE TO GBS); Guillain Barre syndrome; Stroke; Type 2 diabetes mellitus
Allergies:
Diagnostic Lab Data: Test Name: CD4/CD8 ratio; Result Unstructured Data: NORMAL; Test Name: CSF oligoclonal band; Result Unstructured Data: UNK; Comments: ISOELECTRIC FOCUSING; Test Name: Protein total; Test Result: 133 mg/dl; Test Name: IgG; Test Result: 11.20 mg/dl; Test Name: albumin; Test Result: 77.7 mg/dl
CDC Split Type: ITSA2018SA095116

Write-up: Initial unsolicited report received from literature on 26 Mar 2018. This case is linked with 2018SA095111, 2018SA095112 and 2018SA095117 (same literature). The following is verbatim from the article: Background: An increasing number of reports indicates that vaccines against influenza may interact with specific drugs via drug metabolism. To date, actual impact of vaccine-drug interactions observed in the real world clinical practice has not been investigated. Methods: From VAERS and Database, we collected Adverse Event Following Immunization (AEFI) reports for individuals receiving vaccines against influenza recorded as suspect and selected cases where predictable toxicity was recorded with oral anticoagulants, antiepileptics and statins (i.e. hemorrhages, overdosage and rhabdomyolysis, respectively). We applied AEFI and Drug Interaction Probability Scale (DIPS) Algorithms to assess causality of drug-vaccine interactions. Results: 116 AEFI reports submitted to VAERS and 83 from Database were included in our analysis; antiepileptics and statins were related to the highest number of indeterminate/consistent (93.7%; 65.3%) and possible/probable (50%; 57.7%) cases according to the AEFI and DIPS, respectively. The majority of cases occurred within the first week after vaccine administration (5-7 days). Conclusion: The relative paucity of detected interactions does not impact on the benefit of the vaccination against influenza, which remains strongly recommended; this does not exclude that closer monitoring for selected patients exposed to concomitant chronic pharmacological therapies and affected by predisposing factors may be useful. This case involves 63-year-old male patient who was vaccinated with dose of INFLUENZA VACCINE TRIVALENT (dose in series not reported) and also received a dose of SIMVASTATIN (batch number, expiry date, route and site of administration were not reported for both suspect product) on an unspecified date. Patient had a medical history of type 2 diabetes mellitus, diabetic nephropathy, end stage renal disease due to Guillain-Barre syndrome and stroke on an unknown date. Concomitant medication included TAMSULOSIN, HYDROCHLOROTHIAZIDE, CLONIDINE, GEMFIBROZIL, CALCIUM, FISH OIL, ACETYLSALICYLIC ACID, TORSEMIDE, QUINAPRIL, VALSARTAN, PREGABALIN, INSULIN and PARICALCITROL on an unknown date. On an unspecified date, 22 days post vaccination and administration of SIMVASTATIN, patient had Cardiac or Cardiopulmonary failure, arrhythmia, supraventricular tachycardia, Guillain-Barre syndrome, muscular weakness, paralysis, hypotonia, hypoesthesia, pain in extremity, mobility decreased, rhabdomyolysis, nephropathy, chromaturia, renal impairment, pneumonia, sepsis and death and patient died. Laboratory data included patient was performed CD4/CD8 ratio which result was normal, CSF oligoclonal band for isoelectric focusing (result: unknown), total protein of 133 mg/dl, immunoglobulin G of 11.20 mg/dl and albumin test of 77.7 mg/dl. Corrective treatment were not reported. It was unknown whether autopsy was performed or not. The reporter assessed the adverse events following immunization and drug interaction probability scale as inconsistent (not applicable). It was reported that pharmacodynamic drug interactions included with "Acetylsalicylic Acid; Gemfibrozil; Torsemide; Quinapril; Valsartan; Pregabalin; Insulin; Paricalcitol" and pharmacokinetic drug interactions included with Gemfibrozil. List of documents held by sender: none. Sender''s Comments: This literature article reports about a 63 year old adult male who died experiencing Cardiopulmonary failure, Pneumonia, Rhabdomyolysis, GBS and Sepsis 22 days after having received INFLUENZA VACCINE. The time to onset is compatible. However, there is no autopsy report confirming the cause of death. Patient''s past medical history includes diabetes, kidney disease and stroke and ongoing treatment with swimvastatin. There is a possibility that the events are related to SIMVASTATIN therapy. Moreover, considering the age and past medical history of the patient, it is not possible to comment on the fatal outcome without ascertaining the cause of death first. Reported Cause(s) of Death: arrhythmia; Cardiopulmonary failure; chromaturia; Guillain Barre Syndrome; hypoesthesia; hypotonia; mobility decreased; muscular weakness; nephropathy; pain in extremity; paralysis; Pneumonia; renal impairment; Rhabdomyolysis; Sepsis; supraventricula


VAERS ID: 743270 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2018-04-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER UNKNOWN / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Anticoagulant therapy, Coagulopathy, Death, Drug interaction, International normalised ratio increased
SMQs:, Liver-related coagulation and bleeding disturbances (narrow), Haemorrhage laboratory terms (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Warfarin
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: DVT (DEEP VEIN THROMBOSIS); Non-Hodgkin''s lymphoma
Allergies:
Diagnostic Lab Data:
CDC Split Type: ITSA2018SA095117

Write-up: Initial unsolicited report received from literature on 26 Mar 2018. This case is linked with 2018SA095111, 2018SA095112 and 2018SA095116 (same literature). The following is verbatim from the article: Background: An increasing number of reports indicates that vaccines against influenza may interact with specific drugs via drug metabolism. To date, actual impact of vaccine-drug interactions observed in the real world clinical practice has not been investigated. Results: 116 AEFI reports submitted to VAERS and 83 from agency were included in our analysis; antiepileptics and statins were related to the highest number of indeterminate/consistent (93.7%; 65.3%) and possible/probable (50%; 57.7%) cases according to the AEFI and DIPS, respectively. The majority of cases occurred within the first week after vaccine administration (5-7 days). Conclusion: The relative paucity of detected interactions does not impact on the benefit of the vaccination against influenza, which remains strongly recommended; this does not exclude that closer monitoring for selected patients exposed to concomitant chronic pharmacological therapies and affected by predisposing factors may be useful. This case involves 75 years old female patient who was vaccinated with dose of INFLUENZA H1N1 MONOVALENT (Batch number, expiry date, dose, route and site of administration were not reported). Patient also received dose of warfarin (batch number, expiry date, route of administration were not reported) on an unspecified date. Patient had predisposition condition of non-Hodgkin''s lymphoma and chronic DVT (deep vein thrombosis). Concomitant medication was not reported. On an unspecified date, three days post vaccination patient had coagulopathy, drug interaction international normalized ratio increased and she died. Laboratory investigation and corrective treatment were not reported. It was unknown whether autopsy was performed or not. The reporter assessed the causal relationship with INFLUENZA H1N1 MONOVALENT and Warfarin for the events as indeterminate and drug interaction probability reported as possible (3). List of documents held by sender: none. Sender''s Comments: This literature article reports about a 75 year old elderly female who died experiencing coagulopathy 3 days after having received INFLUENZA VACCINE. The time to onset is compatible. However, there is no autopsy report confirming the cause of death. Patient''s past medical history includes Non-Hodgkin''s Lymphoma (NHL) and deep venous thrombosis (DVT) and ongoing treatment with warfarin. Coagulopathy is an expected event with Warfarin therapy, with or without drug interaction with Influenza vaccine. Moreover, considering the age and past medical history of the patient, it is not possible to comment on the fatal outcome without ascertaining the cause of death first. Reported Cause(s) of Death: Coagulopathy; death; Death NOS; INR increased.


VAERS ID: 743271 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2018-04-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Abdominal pain, Asthenia, Decreased appetite, Depression, Hypokalaemia, Hyponatraemia, Vomiting
SMQs:, Acute pancreatitis (broad), Retroperitoneal fibrosis (broad), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Hyponatraemia/SIADH (narrow), Depression (excl suicide and self injury) (narrow), Chronic kidney disease (broad), Hypokalaemia (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: phenobarbital; amitriptyline; propranolol; hydrochlorothiazide/triamterine
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Depression
Allergies:
Diagnostic Lab Data:
CDC Split Type: ITSA2018SA096332

Write-up: Initial unsolicited report received from literature on 26 Mar 2018. This case is linked with 2018SA095111, 2018SA095117, 2018SA095112, 2018SA095116, 2018SA096247, 2018SA096279, 2018SA096304, 2018SA096286, 2018SA096338, 2018SA096354, 2018SA096379, 2018SA096401, 2018SA096428, 2018SA096432, 2018SA096439, 2018SA096448, 2018SA096456, 2018SA096464, 2018SA096468, 2018SA096471, 2018SA096475, 2018SA096477, 2018SA096479, 2018SA096482, 2018SA096366, 2018SA096377, 2018SA096383, 2018SA096413, 2018SA096421, 2018SA096433, 2018SA096450, 2018SA096460, 2018SA096465, 2018SA096469, 2018SA096473, 2018SA096478, 2018SA096483, 2018SA096485,2018SA096488, 2018SA096500, 2018SA096502, 2018SA096505, 2018SA096506, 2018SA096508 (same literature). The following is verbatim from the article: Background: An increasing number of reports indicates that vaccines against influenza may interact with specific drugs via drug metabolism. To date, actual impact of vaccine-drug interactions observed in the real world clinical practice has not been investigated. Methods: From VAERS and agency, we collected Adverse Event Following Immunization (AEFI) reports for individuals receiving vaccines against influenza recorded as suspect and selected cases where predictable toxicity was recorded with oral anticoagulants, antiepileptics and statins (i.e. hemorrhages, over dosage and rhabdomyolysis, respectively). We applied AEFI and Drug Interaction Probability Scale (DIPS) Algorithms to assess causality of drug-vaccine interactions. Results: 116 AEFI reports submitted to VAERS and 83 from agency were included in our analysis; antiepileptics and statins were related to the highest number of indeterminate/consistent (93.7%; 65.3%) and possible/probable (50%; 57.7%) cases according to the AEFI and DIPS, respectively. The majority of cases occurred within the first week after vaccine administration (5-7 days). Conclusion: The relative paucity of detected interactions does not impact on the benefit of the vaccination against influenza, which remains strongly recommended; this does not exclude that closer monitoring for selected patients exposed to concomitant chronic pharmacological therapies and affected by predisposing factors may be useful. This case involves 76-year-old female patient who was vaccinated with dose of INFLUENZA VACCINE TRIVALENT (dose in series not reported) and also received phenobarbital, amitriptyline, propranolol, hydrochlorothiazide/triamterine (batch number, expiry date, route and site of administration were not reported for both suspect product) on an unspecified date. Patient had a medical history of depression. Concomitant medication included were not reported. On an unspecified date, 15 days post vaccination, administration of phenobarbital and unspecified date after administration of amitriptyline, propranolol, hydrochlorothiazide/triamterine, patient had abdominal pain, anorexia, asthenia, depression, hypokalaemia, hyponatreamia and vomiting. Authors pointed out that suspect drugs amitriptyline, propranolol, hydrochlorothiazide/triamterine are known to have pharmacokinetic drug-drug interactions. Laboratory data and corrective treatment were not reported. On an unknown date, patient got recovered from the events. Case was reported as serious for medically significant events. The reporter assessed the adverse events following immunization and drug interaction probability scale as Indeterminate (Doubtful). List of documents held by sender: none. Sender''s Comments: This patient developed reported events following vaccination with Influenza vaccine (unknown manufacturer) while she was on Phenobarbital treatment. Time to onset is unknown. Past medical history included depression. To be noted, Authors pointed out that suspect drugs amitriptyline, propranolol, hydrochlorothiazide/triamterine are known to have pharmacokinetic drug-drug interactions. Additional information including vaccination details with manufacturer, onset time, and concomitant vaccinations, past vaccination history with tolerance data, concurrent conditions and laboratory test ruling out other etiologies is needed for further assessment. Based on available information role of vaccine cannot be assessed.


VAERS ID: 743272 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2017-11-09
Onset:2017-11-10
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2018-04-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTP: DTP (NO BRAND NAME) / UNKNOWN MANUFACTURER 20915004B / 2 RA / SC
HIBV: HIB (ACTHIB) / SANOFI PASTEUR M54421V / 2 RL / IM
IPV: POLIO VIRUS, INACT. (POLIOVAX) / SANOFI PASTEUR M74982V / 1 LL / IM

Administered by: Other       Purchased by: ?
Symptoms: Administration site reaction, Brachial plexopathy, Injected limb mobility decreased, Injection site reaction, Monoparesis
SMQs:, Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (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: IMOVAX POLIO
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: PLSA2018SA091241

Write-up: Initial information regarding this unsolicited case downloaded from Agency database without narrative (level 2A), was received on 26-Mar-2018 from a physician via health authority (under the reference number: PL-URPL-N90/2018). The following narrative is based on the information retrieved from all other accessible data. This case involves a three-month-old female patient, who was vaccinated with 0.5 ml second dose of ACT-HIB (Batch number: M54421V, expiry date: 31-Aug-2018) via intramuscular route in right thigh and also with 0.5 ml second dose of Diphtheria and Tetanus Toxoids and Pertussis (DTP) (Batch number: 20915004B, expiry date: 31-Dec-2018) via subcutaneous route in right shoulder on 09-Nov-2017. Patient''s medical history was not reported. Concomitant medications included patient received 0.5 ml first dose of IMOVAX POLIO (Batch number: M74982V, expiry date: 30-Sep-2018) via intramuscular route in left thigh on 09-Nov-2017. On 10-Nov-2017, one day following the vaccination, the patient experienced brachial plexus lesion and administration site reaction. Laboratory data and Corrective treatment was not reported. The patient was still recovering from both the events. This case was consider as serious due to medically significant events. The reporter assessed the causal relationship between the suspected vaccines with the events as reasonable possibility. Sender`s comments: Intensive reaction at the injection site that occurred at the injection site of DTP and limitation of extremity mobility (right upper extremity), flaccid paresis are expected adverse symptoms for this vaccine. Intensive reaction at the injection site (right thigh) is also an expected symptom after vaccination with ACT-HIB. Time relation indicates causal relationship. The person reporting the adverse post-vaccinal reaction qualified it as severe; the Office assessed the adverse post-vaccinal reaction as serious. List of documents held by sender: none. Sender''s Comments: This is a poorly documented case without narrative, retrieved from Agency in which patient had Brachial plexus lesion and administration site reaction post vaccination. Time to onset was not reported. No information regarding patients medical history, condition at the time of vaccination was reported. No lab test results were provided. Possibility of an alternate etiology can not be ruled out completely. Additional information regarding lab tests and medical history would be required to assess the causal relationship with the vaccine. Based on available information the role of vaccine cannot be evaluated.


VAERS ID: 743297 (history)  
Form: Version 1.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2018-03-13
Onset:2018-03-20
   Days after vaccination:7
Submitted: 2018-04-06
   Days after onset:17
Entered: 2018-04-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
VARZOS: ZOSTER (SHINGRIX) / GLAXOSMITHKLINE BIOLOGICALS - / 2 UN / UN

Administered by: Other       Purchased by: Other
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, 5 days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions: Diarrhoea infectious, patient travelled in the moth prior to reporting and developed diarrhea due to a parasite
Allergies:
Diagnostic Lab Data:
CDC Split Type: CA2018GSK057693

Write-up: This case was reported by a physician via sales rep and described the occurrence of Guillain Barre syndrome in a male patient who received SHINGRIX. The patient''s past medical history included infections diarrhea (patient travelled in the month prior to reporting and developed diarrhea due to a parasite). On 13th March 2018, the patient received the 1st dose of SHINGRIX. On 20th March 2018, 7 days after receiving SHINGRIX, the patient experienced Guillain Barre syndrome (serious criteria hospitalization and GSK medically significant). On an unknown date, the outcome of the Guillain Barre syndrome was recovering/resolving. It was unknown if the reporter considered the Guillain Barre syndrome to be related to SHINGRIX. Additional information was not reported. The batch number for SHINGRIX was not provided. The patient experienced confirmed Guillain Barre syndrome, subsequent after receiving SHINGRIX. The patient was hospitalized for 5 days and was better at the time of reporting.


VAERS ID: 743299 (history)  
Form: Version 1.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2018-04-06
Entered: 2018-04-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MENB: MENINGOCOCCAL B (BEXSERO) / NOVARTIS VACCINES AND DIAGNOSTICS - / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Heart rate increased, Somnolence, Staring, Unresponsive to stimuli
SMQs:, Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Dementia (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Hypotonic-hyporesponsive episode (broad), Hypoglycaemia (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: Paracetamol
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GB2018056552

Write-up: This case was reported by a consumer via regulatory authority and described the occurrence of unresponsive to verbal stimuli in a 12-week-old male patient who received BEXSERO. Concomitant products included paracetamol. On an unknown date, the patient received BEXSERO (parenteral). On an unknown date, less than a year after receiving BEXSERO, the patient experienced unresponsive to verbal stimuli (serious criteria GSK medically significant and other: Serious per reporter), staring (serious criteria other: Serious per reporter), heart rate high (serious criteria other: Serious per reporter) and drowsiness (serious criteria other: Serious per reporter). On an unknown date, the outcome of the unresponsive to verbal stimuli, staring and drowsiness were recovered/resolved and the outcome of the heart rate high was unknown. It was unknown if the reporter considered the unresponsive to verbal stimuli, staring, heart rate high and drowsiness to be related to BEXSERO. Additional details The age at vaccination was not reported. Initial information was reported by a consumer via regulatory authority on 30th March 2018. Drowsiness, not responding to mother/fathers voice, staring in to thin air, making strange noises, blinking slowly.


VAERS ID: 743300 (history)  
Form: Version 1.0  
Age: 0.25  
Sex: Female  
Location: Foreign  
Vaccinated:2017-05-29
Onset:2018-03-20
   Days after vaccination:295
Submitted: 2018-04-06
   Days after onset:17
Entered: 2018-04-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
RV1: ROTAVIRUS (ROTARIX) / GLAXOSMITHKLINE BIOLOGICALS - / 2 MO / PO

Administered by: Other       Purchased by: Other
Symptoms: Intussusception, Rotavirus infection, Vaccination failure
SMQs:, Lack of efficacy/effect (narrow), Gastrointestinal obstruction (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: No other medications
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DE2018GSK057730

Write-up: This case was reported by a physician via sales rep and described the occurrence of vaccination failure in a 13-month-old female patient received ROTARIX liquid formulation. Co-suspect products included ROTARIX liquid formulation. On 27th April 2017, the patient received the 1st dose of ROTARIX liquid formulation (oral) 1.5 ml. On 29th May 2017, the patient received the 2nd dose of ROTARIX liquid formulation (oral) 1.5 ml. On 20th March 2018, 327 days after receiving ROTARIX liquid formulation and 295 days after receiving ROTARIX liquid formulation, the patient experienced vaccination failure (serious criteria GSK medically significant), rotavirus infection (serious criteria hospitalization) and intussusception (serious criteria GSK medically significant). On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the rotavirus infection and intussusception were not reported. It was unknown if the reporter considered the vaccination failure, rotavirus infection and intussusception to be related to ROTARIX liquid formulation and ROTARIX liquid formulation. Additional details were provided as follows: After receiving ROTARIX liquid formulation, approximately 9 months later, on 20th March 2018, the patient was hospitalized for rotavirus infection (vaccination failure) with intussusception. This case was considered as a suspected vaccination failure since the details regarding laboratory confirmation for rotavirus infection was not provided.


VAERS ID: 743301 (history)  
Form: Version 1.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2017-08-10
Onset:2017-08-15
   Days after vaccination:5
Submitted: 2018-04-06
   Days after onset:234
Entered: 2018-04-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
RV1: ROTAVIRUS (ROTARIX) / GLAXOSMITHKLINE BIOLOGICALS - / UNK MO / PO

Administered by: Other       Purchased by: Unknown
Symptoms: Autopsy, Death, Necrotising enterocolitis neonatal, Neonatal hypoxia
SMQs:, Acute central respiratory depression (broad), Neonatal disorders (narrow), Respiratory failure (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2017-08-15
   Days after onset: 0
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Paracetamol; Domperidone; Morphine sulfate; Phenobarbital; Caffeine Citrate; Omeprazole; Metronidazole; Fluconazole; VISCOTEARS; Flucloxacillin; Nystatin; Acyclovir; Vancomycin; CERATONIA; Furosemide; Cyclopentolate; Gentamicin; Hyoscine hy
Current Illness: Gastrooesophageal reflux disease, Severe; Intensive care; Dysphagia, inability to swallow own saliva; Cytogenetic abnormality, Chromosome 3 duplication
Preexisting Conditions: Premature baby, Born at 29 weeks gestation, birth weight 1490g, poor condition at birth; Neonatal hypoxia, Perinatal hypoxia ischemia; Breech delivery, Obstructed breech delivery. (mother delivery related); Apgar score, Apgar''s 0,0,0 & 3 at 1, 5, 10 & 20 minutes of age
Allergies:
Diagnostic Lab Data:
CDC Split Type: GB2018056559

Write-up: This case was reported by a physician via regulatory authority and described the occurrence of necrotizing enterocolitis neonatal in a 65-day-old male patient who received ROTARIX. The patient''s past medical history included neonatal hypoxia (Perinatal hypoxia ischemia), breech delivery (mother delivery related) and Apgar''s 0,0,0 & 3 at 1,5,10 and 20 minutes of age). Previously administered products included Premature baby (Born at 29 weeks gestation, birth weight 1490g, poor condition at birth). Concurrent medical conditions included gastroesophageal reflux (Severe), intensive care, unable to swallow (Inability to swallow own saliva) and Chromosome 3 duplication). Concomitant products included BEXSERO, INFANRIX-IPV + Hib), Morphine Sulfate, phenobarbital, omeprazole, metronidazole, fluconazole, Flucloxacillin, nystatin, Aciclovir, nutritional supplement, Gentamicin, Furosemide, Glycopyrronium, Phenylephrine, clotrimazole, PREVENAR 13, CISCOTEARS, Vancomycin, ceratonia, Cyclopentolate, meropenem, (NOS) Infant GAVISCON), ABIDEC. On August 2017, the patient received ROTARIX (oral) 1.4 ml. On 11 August 2017, 1 days after receiving ROTARIX, the patient experienced neonatal oxygen desaturation (serious criteria GSK medically significant and other: serious per reporter). On 15th August 2017, 5 days after receiving ROTARIX, the patient experienced necrotizing enterocolitis neonatal (serious criteria death, GSK medically significant and other: serious per reporter). On 15th August 2017, the outcome of the necrotizing enterocolitis neonatal was fatal. On an unknown date, the outcome of the neonatal oxygen desaturation was unknown. The patient died on 15th August 2017. The reported cause of death was necrotizing enterocolitis neonatal. An autopsy was performed. The autopsy determined cause of death was necrotizing enterocolitis neonatal. It was unknown if the reporter considered the necrotizing enterocolitis neonatal and neonatal oxygen desaturation to be related to ROTARIX. Additional information: The age at vaccination was not reported. ABIDEC concomitant product was reported for unknown indication. Product brand name Certonia was reported as Carobel. Initial information was received from a physician via regulatory authority no 30th March 2018: Necrotising enterocolitis neonatal and neonatal oxygen desaturation.


VAERS ID: 743307 (history)  
Form: Version 1.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2018-02-08
Onset:2018-02-17
   Days after vaccination:9
Submitted: 2018-04-06
   Days after onset:47
Entered: 2018-04-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEPA: HEP A (HAVRIX) / GLAXOSMITHKLINE BIOLOGICALS A71CB212A / UNK UN / SC
MMRV: MEASLES + MUMPS + RUBELLA + VARICELLA (NO BRAND NAME) / UNKNOWN MANUFACTURER AHAV882AB / UNK UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Hyperpyrexia, Productive cough, Rash
SMQs:, Anaphylactic reaction (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: 02/17/2018, Body temperature, 39.5 degree C
CDC Split Type: IT2018056176

Write-up: This case was reported by a pharmacist via regulatory authority and described the occurrence of hyperpyrexia in a 1-year-old male patient who received MMRV (batch number A71CB212A, expiry date unknown). Co-suspect products included HAVRIX pediatric (batch number AHAVB882AB, expiry date unknown). On 8th February 2018, the patient received MMRV (subcutaneous) 1 dosage form(s) and HAVRIX pediatric (intramuscular) 1 dosage form(s). On 17th February 2018, 9 days after receiving MMRV and HAVRIX pediatric, the patient experienced hyperpyrexia (serious criteria GSK medically significant and other: As per reporter), productive cough (serious criteria other: As per reporter) and rash (serious criteria other: As per reporter). In February 2018, the outcome of the hyperpyrexia, productive cough and rash were recovered/resolved. It was unknown if the reporter considered the hyperpyrexia, productive cough and rash to be related to MMRV and HAVRIX pediatric. Additional information: The age at vaccination was not reported. Initial information was received from a pharmacist via regulatory authority on 30th March 2018: Mother reported skin rash at the abdomen from 9th to 11th day after vaccination, then hyperpyrexia (up to 39.5 degree C) from 9th to 10th day after vaccination and strong catarrhal cough from 9th to 14th day. Reporter''s comments: the report comes from an active PV surveillance project.


VAERS ID: 743308 (history)  
Form: Version 1.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2018-02-26
Onset:2018-02-27
   Days after vaccination:1
Submitted: 2018-04-06
   Days after onset:37
Entered: 2018-04-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
RAB: RABIES (RABIPUR) / NOVARTIS VACCINES AND DIAGNOSTICS 636011C / UNK UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Hypoaesthesia, Paraesthesia oral
SMQs:, Peripheral neuropathy (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Guillain-Barre syndrome (broad), Sexual dysfunction (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GB2018056554

Write-up: This case was reported by a pharmacist via regulatory authority and described the occurrence of numbness of upper arm in a 51-year-old female patient who received RABIPUR (batch number 636011C, expiry date unknown). Concomitant products included RABIPUR. On 26th February 2018, the patient received RABIPUR (intramuscular). On 27th February 2018, the patient received RABIPUR (intramuscular). On 27th February 2018, 1 days after receiving RABIPUR, the patient experienced numbness of upper arm (serious criteria other: serious as per reporter) and tingling tongue (serious criteria other: serious as per reporter). On 27th February 2018, the outcome of the tingling tongue was recovered/resolved. In 2018, the outcome of the numbness of upper arm was recovered/resolved. It was unknown if the reporter considered the numbness of upper arm and tingling tongue to be related to RABIPUR. Additional information: The age at vaccination was not reported. Initial information was reported by a pharmacist via regulatory authority on 30th March 2018: Numbness of upper arm and tingling tongue.


VAERS ID: 743313 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2018-04-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH T75569 / UNK - / SYR

Administered by: Other       Purchased by: ?
Symptoms: Local reaction, Vaccination site cellulitis, Vaccination site erythema, Vaccination site inflammation, Vaccination site warmth
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: ESPFIZER INC2018138580

Write-up: This is a spontaneous report from a healthcare professional (only contactable for the Drug Agency) reported through the Drug Agency and supplied to Safety by PQC Group. Internal tracking reference ID for National Agency: DC_087/2018. Regulatory Authority report number not available. The healthcare professional reported similar events for 4 patients. This is the 1st of 4 reports. A female patient of an unspecified age and ethnicity received PREVENAR 13 (injectable suspension 1 prefilled syringe of 0.5 ml+1 needle; Reference number: 09590002; National code: 654443, Lot # T75569) via an unspecified route of administration at single dose on an unspecified date for immunization. The patient medical history was and concomitant medications were not reported. One week after the administration of PREVENAR 13, the patient experienced a local reaction with warmth, redness and inflammation. The patient was finally diagnosed of cellulitis which required antibiotic treatment. The cellulitis on an unspecified date with outcome of unknown. No seriousness criteria was provided. No follow up attempts are possible. Information about lot number already provided. No further information is needed. Sender''s Comments: Linked Report(s) : ES-PFIZER INC-2018138666 Same reporter, same event, same product, different patient; ES-PFIZER INC-2018138667 Same reporter, same event, same product, different patient; ES-PFIZER INC-2018138668 Same reporter, same event, same product, different patient.


VAERS ID: 743314 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2018-04-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH T75569 / UNK UN / UN

Administered by: Other       Purchased by: ?
Symptoms: Local reaction, Vaccination site cellulitis, Vaccination site erythema, Vaccination site inflammation, Vaccination site warmth
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: ESPFIZERINC2018138666

Write-up: This is a spontaneous report from a healthcare professional (only contactable for the Drug Agency) reported through the Drug Agency and supplied to Safety by Group. Internal tracking reference ID for Agency: DC-087/2018. Regulatory Authority report number not available. The healthcare professional reported similar events for four patients. This is the second of four reports. A patient of an unspecified gender, age and ethnicity received PREVENAR 13 (lot T75569 Reference number: 09590002; National code: 654443), on an unspecified date, at a single dose, for immunization. The patient medical history and concomitant medications were not reported. After the administration of pneumococcal 13-val conj vaccine, the patient experienced a local reaction with warmth, rubor and inflammation. The patient was finally diagnosed with cellulitis which required antibiotic treatment. The cellulitis outcome was unknown. No follow up attempts are possible. No further information is needed. Sender''s Comments: Linked Report(s): ES-PFIZER INC-2018138580 Same reporter, same event, same product, different patient.


VAERS ID: 743315 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2018-04-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH T75569 / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Local reaction, Vaccination site cellulitis, Vaccination site erythema, Vaccination site inflammation, Vaccination site warmth
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: ESPFIZER INC2018138667

Write-up: This is a spontaneous report from a healthcare professional (only contactable for the Agency) reported through the Agency and supplied to Safety by Group. Internal tracking reference ID for Agency: DC_087/2018. Regulatory Authority report number not available. The healthcare professional reported similar events for four patients. This is the third of four reports. A patient of an unspecified gender age and ethnicity received PREVENAR 13; (lot T75569 Reference number: 09590002; code: 654443), on an unspecified date at an single dose for immunization. The patient medical history and concomitant medications were not reported. After the administration of pneumococcal 13-val conj vaccine, the patient experienced a local reaction with warmth, rubor and inflammation. The patient was finally diagnosed with cellulitis which required antibiotic treatment. The cellulitis outcome was unknown. No follow up attempts are possible. No further information is needed. Sender''s Comments: Linked Report(s): ES-PFIZER INC-2018138580 Same reporter, same event, same product, different patient.


VAERS ID: 743316 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2018-04-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH T75569 / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Local reaction, Vaccination site cellulitis, Vaccination site erythema, Vaccination site inflammation, Vaccination site warmth
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: ESPFIZER INC2018138668

Write-up: This is a spontaneous report from a healthcare professional (only contactable for the Drug Agency) reported through the Drug Agency and supplied to Safety by PQC Group. Internal tracking reference ID for National Agency: DC_087/2018. Regulatory Authority report number not available. The healthcare professional reported similar events for four patients. This is the fourth of four reports. A patient of an unspecified age, race/ethnicity and gender received PREVENAR 13; (lot number T75569, reference number: 09590002; National code: 654443), via an unspecified route of administration, on an unspecified date, at single dose, for immunisation. The patient medical history was not reported. The patient''s concomitant medications were not reported. After the administration of PREVENAR 13, on an unspecified date, the patient experienced a local reaction with warmth, redness and inflammation. The patient was finally diagnosed with cellulitis which required antibiotic treatment. Cellulitis outcome was unknown. No follow up attempts are possible. No further information is needed. Sender''s Comments: Linked Report(s) : ES-PFIZER INC-2018138580 Same reporter, same event, same product, different patient.


VAERS ID: 743318 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2018-04-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Anticonvulsant drug level increased, Drug interaction
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: phenytoin; phenobarbital
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: ITSA2018SA096379

Write-up: Initial unsolicited report received from literature on 26 Mar 2018. This case was linked to 2018SA095111, 2018SA095117, 2018SA095112, 2018SA095116, 2018SA096247, 2018SA096279, 2018SA096286, 2018SA096304, 2018SA096332, 2018SA096338, 2018SA096354, 2018SA096475, 2018SA096401, 2018SA096428, 2018SA096432, 2018SA096439, 2018SA096448, 2018SA096456, 2018SA096464, 2018SA096468, 2018SA096471, 2018SA096508, 2018SA096477, 2018SA096482, 2018SA096366, 2018SA096377, 2018SA096383, 2018SA096413, 2018SA096421, 2018SA096433, 2018SA096450, 2018SA096460, 2018SA096465, 2018SA096469, 2018SA096473, 2018SA096478, 2018SA096483, 2018SA096485, 2018SA096488, 2018SA096500, 2018SA096502, 2018SA096505, 2018SA096506 and 2018SA096479 (Same Literature) The following is verbatim from the article: Background: An increasing number of reports indicates that vaccines against influenza may interact with specific drugs via drug metabolism. To date, actual impact of vaccine-drug interactions observed in the real world clinical practice has not been investigated. Methods: From VAERS and agency, we collected Adverse Event Following Immunization (AEFI) reports for individuals receiving vaccines against influenza recorded as suspect and selected cases where predictable toxicity was recorded with oral anticoagulants, antiepileptics and statins (i.e. hemorrhages, over dosage and rhabdomyolysis, respectively). We applied AEFI and Drug Interaction Probability Scale (DIPS) Algorithms to assess causality of drug-vaccine interactions. Results: 116 AEFI reports submitted to VAERS and 83 from agency were included in our analysis; antiepileptics and statins were related to the highest number of indeterminate/consistent (93.7%; 65.3%) and possible/probable (50%; 57.7%) cases according to the AEFI and DIPS, respectively. The majority of cases occurred within the first week after vaccine administration (5-7 days). Conclusion: The relative paucity of detected interactions does not impact on the benefit of the vaccination against influenza, which remains strongly recommended; this does not exclude that closer monitoring for selected patients exposed to concomitant chronic pharmacological therapies and affected by predisposing factors may be useful. This case involves 47 years old male patient who was vaccinated with dose of Influenza vaccine and also received phenytoin and phenobarbital (batch number, expiry date, route and site of administration were not reported) on an unspecified date. The patient''s medical history and concomitant medication were not reported. On an unspecified date, 26 days following the vaccination, patient had drug level increased. Patient was hospitalized on an unspecified date. Authors pointed out that suspect drugs phenytoin and phenobarbital (pharmacokinetic drug interactions) are known to have drug-drug interactions Laboratory investigation and corrective treatment were not reported. Outcome of event was not reported. The reporter assessed the adverse events following immunization and drug interaction probability scale as indeterminate (possible). List of documents held by sender: none. Sender''s Comments: This literature article reports about a 47 year old male patient who experienced drug level increased due to interaction, in relation to Influenza vaccine and phenytoin and phenobarbital therapy. Time to onset is a bit long to be compatible. Patient''s past medical history was not reported. There is a possibility that the events are due to the suspect drug or as a result of the pre-existing medical conditions or infection. There was also exposure to phenobarbital (time of exposure not reported) which could have significant effect on pharmacodynamic levels. Based upon the limited reported information, the role of the vaccine cannot be assessed.


VAERS ID: 743319 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2018-04-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH - / UNK - / IM

Administered by: Other       Purchased by: ?
Symptoms: Cardiac failure
SMQs:, Cardiac failure (narrow), Cardiomyopathy (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: JPPFIZER INC2018135416

Write-up: This is a spontaneous report from a contactable physician (respirologist) through a Pfizer sales representative. A patient of unspecified age (elder than 65 years old), ethnicity, and gender received PREVENAR 13, intramuscular at single dose on an unspecified date for immunisation. The patient''s relevant medical history, concomitant medications, and lab data were not reported. Two days after the administration of pneumococcal 13-val conj vac (dipht crm197 protein), the patient experienced cardiac failure. The patient was in the hospital at the time of this report. The outcome of the event was unknown. The information on the lot number has been requested. Sender''s Comments: There is no plausible mechanism to implicate the suspect vaccine to the occurrence of the serious event "cardiac failure" due to insufficient information. More information such as medical history, concomitant medication and lab data especially EKG, echocardiography and myocardial enzymes are needed for further medical evaluation. 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: 743320 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:2017-04-24
Onset:2017-04-25
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2018-04-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPIPV: DTAP + IPV (UNKNOWN) / UNKNOWN MANUFACTURER 20CB339D / 4 RL / IM
HIBV: HIB (NO BRAND NAME) / UNKNOWN MANUFACTURER 20CB339D / 4 RL / IM
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH R70613 / 4 LL / IM

Administered by: Other       Purchased by: ?
Symptoms: Febrile convulsion, Pyrexia, Respiratory tract infection
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Convulsions (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Generalised convulsive seizures following immunisation (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (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: PLPFIZER INC2018138436

Write-up: This is a spontaneous report downloaded from the Medicines Agency (MA) WEB PL-URPL-N1198/2017. A contactable physician reported via Health Authority that a 1-year-old patient of an unspecified ethnicity and gender received on 24Apr2017 fourth dose of PREVENAR 13 (lot R70613, expiration date 31Jan2019), intramuscular at 0.5 ml, single in the left thigh and fourth dose of INFANRIX IPV & HIB (lot 20CB339D, expiration date 30Apr2018) intramuscular at 0.5 ml in the right thigh, both for immunization. Medical history and concomitant medications were not reported. On 25Apr2017, the patient experienced fever convulsions (the first episode ) and pyrexia, both with outcome of unknown. Additionally it was reported that patient had respiratory tract infection on an unspecified date with outcome of unknown. All the events were considered serious due to hospitalization. Sender comment: Fever and febrile seizures are the expected side effects of both reported vaccines. Section 4.8 of the SPC INFANRIX IPV & HIB lists upper respiratory tract infection and bronchitis, so respiratory infection may be considered to be the expected side effect of this vaccine. Respiratory infection is an unexpected effect for the PREVENAR 13 vaccine. So far, 105 cases of respiratory tract infection have been recorded in the database after pneumococcal, polysaccharide, conjugated, adsorbed vaccines; in the database, so far 121 cases of respiratory tract infections after pneumococcal vaccines have been reported. The temporal relation supports the occurrence of a cause-and-effect relationship. Due to the simultaneous administration of two vaccines, it is not possible to indicate one that has contributed to the occurrence of side effects. Respiratory infection could also develop independently of vaccination (the child was vaccinated in the spring, so when there is an increased incidence of respiratory infections), and the fever and associated seizures may have been the result of this infection. The person reporting the NOP classified him as benign. URPL found the NOP too heavy. No follow up attempts are possible. No further information expected.


VAERS ID: 743321 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2012-03-21
Onset:2012-03-21
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2018-04-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HIBV: HIB (ACTHIB) / SANOFI PASTEUR G95511 / 1 - / IM

Administered by: Other       Purchased by: ?
Symptoms: Cyanosis, Erythema
SMQs:, Anaphylactic reaction (narrow), Acute central respiratory depression (broad), Hypotonic-hyporesponsive episode (broad), Hypersensitivity (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: RSSA2018SA095739

Write-up: Initial unsolicited report received from literature on 28-Mar-2018. This case was linked to case 2018SA015041. This case involves four-month-old female patient who was vaccinated with primary first dose of ACT-HIB (Batch number: G9551-1, expiration date, dose and site of administration were not reported) via intramuscular route on 21 Mar 2012. The patient''s medical history and concomitant medications were not reported. On 21 Mar 2012, 2-3 minutes post vaccination, the patient experienced intense redness of the whole leg, which had immediately expanded to the whole body. On 21 Mar 2012, same day post vaccination, the patient''s feet went blue. Lab data was not reported. Corrective treatment includes antishock therapy. On 21 Mar 2012, the patient recovered from the events. This case was considered as serious due to medically significant events. List of documents held by sender: none. Sender''s Comments: This case concerns an infant who developed generalized body redness and peripheral cyanosis after vaccination with ACTHIB. The time to onset is compatible with the role of vaccine. However, we will need more information regarding medical condition at time of vaccination, lab tests ruling out alternate etiologies and the course of the event for proper assessment of this case. Based upon the reported information, the role of the vaccine cannot be assessed.


VAERS ID: 743340 (history)  
Form: Version 1.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:1979-08-28
Onset:1979-09-18
   Days after vaccination:21
Submitted: 2018-04-06
   Days after onset:14080
Entered: 2018-04-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (INFANRIX) / GLAXOSMITHKLINE BIOLOGICALS - / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Bronchitis, Otitis media
SMQs:

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: No other medications
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: DE2018056127

Write-up: This case was reported by a consumer via regulatory authority and described the occurrence of otitis media in a 5-month-old male patient who received DTP vaccine. On 28th August 1979, the patient received DTP vaccine (unknown). On 18th September 1979, 21 days after receiving DTP vaccine, the patient experienced otitis media (serious criteria hospitalization) and bronchitis (serious criteria hospitalization). In November 1979, the outcome of the otitis media was recovered/resolved. On an unknown date, the outcome of the bronchitis was recovered/resolved. The reporter considered the otitis media and bronchitis to be unlikely related to DTP vaccine. Additional information: The age at vaccination was not reported. The patient also received DTP vaccine on 25th September 1978. Initial information was reported by a consumer via regulatory authority on 30th March 2018. Otitis media and bronchitis.


VAERS ID: 743364 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2018-03-01
Onset:2018-03-05
   Days after vaccination:4
Submitted: 0000-00-00
Entered: 2018-04-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MEN: MENINGOCOCCAL (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN
MMR: MEASLES + MUMPS + RUBELLA (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN

Administered by: Unknown       Purchased by: ?
Symptoms: Body temperature increased, Listless, Lymph node abscess, Swelling face
SMQs:, Anaphylactic reaction (broad), Angioedema (narrow), Neuroleptic malignant syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (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? 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: Routine childhood immunisation
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: NL0095075131803NLD013042

Write-up: Information has been downloaded from database (NL-LRB-00276440). This spontaneous report was received from a consumer and refers to a 14 month old male patient. There was no information about the patient''s concurrent conditions, concomitant therapies or medical history provided. On 01-MAR-2018 the patient was vaccinated with M-M-RVAXPRO, 1 dose form, as a apart of National Immunization Program (route of administration, lot # and expiration date were not reported). At the same date, the patient was also vaccinated with NEISVAC-C 1 dose form, as a apart of National Immunization Program. (route of administration, lot # and expiration date were not reported). On 05-MAR-2018, experienced listless, increased body temperature and swollen cheek, red hard painful place under cheek, turned out to be a neck lymph node abscess, due to which the patient was hospitalized on an unknown date in March 2018. The outcome of all the events was reported as recovering/resolving. The reporter considered listless, increased body temperature and swollen cheek, red hard painful place under cheek, turned out to be a neck lymph node abscess to be possibly related to M-M-RVAXPRO and NEISVAC-C. Sender''s comments: brand name of reported M-M-RVAXPRO was the most plausible vaccine that was used in the Childhood Immunization Program at reported date of administration. Brand name of reported Meningococcal C vaccine was not specified. NEISVAC-C was the most plausible vaccine that was used in the Childhood Immunization Program at reported date of administration. Since the nature of the reported reaction does imply seriousness according to one of the CIOMS criteria, the reaction lymph node abscess was considered as serious by the Pharmacovigilance Centre.


VAERS ID: 743375 (history)  
Form: Version 1.0  
Age: 0.25  
Sex: Female  
Location: Foreign  
Vaccinated:2018-03-09
Onset:2018-03-09
   Days after vaccination:0
Submitted: 2018-04-06
   Days after onset:27
Entered: 2018-04-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
6VAX-F: DTAP+IPV+HEPB+HIB (INFANRIX HEXA) / GLAXOSMITHKLINE BIOLOGICALS - / UNK UN / IM
MENB: MENINGOCOCCAL B (BEXSERO) / NOVARTIS VACCINES AND DIAGNOSTICS - / UNK UN / IM
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH - / UNK UN / IM
RV1: ROTAVIRUS (ROTARIX) / GLAXOSMITHKLINE BIOLOGICALS - / UNK MO / PO

Administered by: Other       Purchased by: Other
Symptoms: Electrocardiogram normal, Hypotonia, Pallor, Unresponsive to stimuli
SMQs:, Peripheral neuropathy (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (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: No other medications
Current Illness: Cardiac murmur
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Electrocardiogram was on an unknown date, Electrocardiogram, High voltage, other wise normal.
CDC Split Type: GB2018056557

Write-up: This case was reported by a other health professional via regulatory authority and described the occurrence of unresponsive to pain stimuli in a 2-month-old female patient who received INFANRIX HEXA. Co-suspect products included BEXSERO, ROTARIX and PREVENAR 13. Concurrent medical conditions included heart murmur. Additional patient notes included Allergy status is unknown. On 9th March 2018, the patient received INFANRIX HEXA (intramuscular), BEXSERO (intramuscular), ROTARIX (oral) and PREVENAR 13 (intramuscular). On 9th March 2018, less than a day after receiving INFANRIX HEXA, BEXSERO and ROTARIX, the patient experienced unresponsive to pain stimuli (serious criteria hospitalization and GSK medically significant), pallor of skin (serious criteria hospitalization) and floppy (serious criteria hospitalization). On 9th March 2018, the outcome of the unresponsive to stimuli, pallor of skin and floppy were recovered/resolved. It was unknown if the reporter considered the unresponsive to pain stimuli, pallor of skin and floppy to be related to INFANRIX HEXA, BEXSERO and ROTARIX. Additional information: On an unknown date ECG laboratory test was done. The result was reported as high voltage, other wise normal. Initial information was received from a other health professional via regulatory authority on 30th March 2018: Pain stimuli, pallor of skin and floppy.


VAERS ID: 743379 (history)  
Form: Version 1.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2018-04-06
Entered: 2018-04-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEPAB: HEP A + HEP B (TWINRIX) / GLAXOSMITHKLINE BIOLOGICALS - / 2 UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Abnormal faeces, Anal incontinence, Colitis ulcerative, Crohn's disease
SMQs:, Gastrointestinal premalignant disorders (narrow), Gastrointestinal ulceration (narrow), Biliary system related investigations, signs and symptoms (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Ischaemic colitis (broad), Noninfectious diarrhoea (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? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions: TWINRIX, prophylaxis, 1st dose received on an unknown date
Allergies:
Diagnostic Lab Data:
CDC Split Type: SE2018GSK053181

Write-up: This case was reported by a physician via local affiliate and described the occurrence of Crohn''s colitis in a patient who received TWINRIX. Previously administered products included TWINRIX (1st dose received on an unknown date). On an unknown date, the patient received the 2nd dose of TWINRIX. On an unknown date, unknown after receiving TWINRIX, the patient experienced Crohn''s colitis (serious criteria GSK medically significant), ulcerative colitis (serious criteria GSK medically significant), fecal incontinence and abnormal stools. On an unknown date, the outcome of the Crohn''s colitis and ulcerative colitis were unknown and the outcome of the fecal incontinence and abnormal stools were not reported. It was unknown if the reporter considered the Crohn''s colitis, ulcerative colitis, fecal incontinence and abnormal stools to be related to TWINRIX. Additional information was reported as follows: The report was obtained from the infectious disease specialist in a news letter. The age at vaccination was not reported. The patient had got an appointment for receiving 3rd dose of TWINRIX and 1st dose of ENCEPUR. The patient was under investigation for Crohn''s or Ulcerative Colitis and the time set for investigation was within 40 days. The patient had no fever. There was no information if the patient experienced the faecal incontinence and faeces change before or after receiving 1st dose of TWINRIX or 2nd dose of TWINRIX. The HCP asked whether the patient should be given doses as planned or shall they wait until the investigation was done and the patient becomes stable. The infectious disease specialist replied to HCP that there was no problem to administer 3rd dose of TWINRIX and 1st dose of ENCEPUR now, but it would cause feeling of incontinence to the and patient''s condition gets worse without being related to the vaccines and then it would be that the vaccines would be considered the cause of it.


VAERS ID: 743392 (history)  
Form: Version 1.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2018-03-20
Submitted: 2018-04-06
   Days after onset:17
Entered: 2018-04-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MENB: MENINGOCOCCAL B (BEXSERO) / NOVARTIS VACCINES AND DIAGNOSTICS ABX719AA / UNK LA / IM

Administered by: Other       Purchased by: Other
Symptoms: Febrile convulsion, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Convulsions (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Generalised convulsive seizures following immunisation (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions: 12/29/2017, BEXSERO, prophylaxis, on 29th December 2017
Allergies:
Diagnostic Lab Data:
CDC Split Type: DE2018056131

Write-up: This case was reported by a physician via regulatory authority and described the occurrence of febrile seizure in a 28-month-old female patient who received BEXSERO (batch number ABX719AA, expiry date unknown). Previously administered products included BEXSERO (on 29th December 2017). In 2018, the patient received BEXSERO (intramuscular). On 20th March 2018, less than a year after receiving BEXSERO, the patient experienced febrile seizure (serious criteria GSK medically significant) and fever. In March 2018, the outcome of the febrile seizure and fever were recovered/resolved. It was unknown if the reporter considered the febrile seizure and fever to be related to BEXSERO. Additional details: Age at vaccination was not reported: Anatomical location was reported as left upper arm. Initial information was reported by a physician via regulatory authority on 30th March 2018: febrile seizure and fever.


VAERS ID: 743394 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2017-10-16
Onset:2017-10-25
   Days after vaccination:9
Submitted: 0000-00-00
Entered: 2018-04-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (INFANRIX) / GLAXOSMITHKLINE BIOLOGICALS A21CC911A / UNK UN / IM
PPV: PNEUMO (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / SYR

Administered by: Unknown       Purchased by: ?
Symptoms: Injection site abscess, Injection site induration, Injection site swelling, Pyrexia
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Prophylaxis
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 201710; Test Name: Body temperature; Result Unstructured Data: Lab result: 40 ?C
CDC Split Type: DE0095075131802DEU011758

Write-up: Information has been downloaded from database (DE-GLAXOSMITHKLINE-DE2018GSK022828). This spontaneous report was received from a physician referring to a 6 month old female patient. Information regarding the patient''s pertinent medical history, concurrent conditions, drug allergies/drug reactions and concomitant medications were not reported. On an unknown date the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent)(manufacturer unknown) for prophylaxis (strength and dosage schedule, lot number and expiration date not reported). On 16-OCT-2017, she also received INFANRIX for prophylaxis (strength, dosage schedule, route of administration, anatomical location, lot number and expiration date were not reported). On 25-OCT-2017 at 1:00, 9 days 1 hr after onset of therapy the patient experienced injection site abscess and pyrexia. The outcome of injection site abscess and pyrexia was unknown. The reported causality between the events and the suspect vaccines was unknown. Follow up information has been received from database (DE-GLAXOSMITHKLINE-DE2018GSK022828). On 25-OCT-2017, 10 days after the application of the vaccine, the patient experienced, besides recurrent fever and injection site abscess, injection site erythema, injection site induration and injection site swelling, all of which required hospitalization (dates of hospitalization duration was not reported). In October 2017, the patient body temperature was 40 degrees Celsius and an ultrasound was performed on 30-OCT-2017 (no results provided). The lot number for INFANRIX was reported as A21CC911A, and the route of administration was intramuscular. The outcome of pyrexia, injection site erythema, injection site induration and injection site swelling was reported as resolved. The outcome of injection site abscess was reported as resolved with sequelae. The reported causality between the events and the suspect vaccines was unknown.


VAERS ID: 743428 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2014-03-19
Onset:2014-04-05
   Days after vaccination:17
Submitted: 0000-00-00
Entered: 2018-04-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
RV5: ROTAVIRUS (ROTATEQ) / MERCK & CO. INC. H021856 / UNK MO / PO

Administered by: Unknown       Purchased by: ?
Symptoms: Diarrhoea, Gastroenteritis rotavirus, 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? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: JP0095075131804JPN000390J

Write-up: Information has been received from a physician concerning a 3-month-old female infant without medical history. From 02-APR-2014, an outbreak of wild-type strain G9P[8] rotavirus happened in the same facility. On 19-MAR -2014, the patient was orally vaccinated with ROTATEQ, 2 mL for prophylaxis vaccination ((lot number/lot number:H021856/ H021856). No concomitant medications were reported. On 05-APR-2014, diarrhea developed. On 10-APR-2014, G9P [8] was detected from the infant''s stool ("gastroenteritis rotavirus; diarrhoea" developed). On 12-APR-2014, G9P [8] was detected from the infant''s stool. On 14-APR-2014, G9P [8] was detected from the infant''s stool. On 16-APR-2014, diarrhea resolved. At the time of the report, the outcome of "gastroenteritis rotavirus; diarrhoea" was unknown. Reporter''s comment: not provided. The reporting physician felt that "gastroenteritis rotavirus; diarrhoea" was not related to rotavirus vaccine, live, oral, pentavalent. The reporting physician considered "gastroenteritis rotavirus; diarrhoea" to be non-serious. Upon internal review, "gastroenteritis rotavirus; diarrhoea" was determined to be medically significant. Lot number [H021856, H021856] has been verified to be valid lot number for rotavirus vaccine, live, oral, pentavalent. This is one of 12 reports from the same source. Company Causality Assessment: Based on the clinically relevant information currently available for this individual case, the reported event of gastroenteritis rotavirus is considered unlikely related to ROTATEQ. The evidence is not sufficient to suggest a relationship between the vaccination and the reported serious adverse event. Incidental infection due to in-hospital outbreak constitutes a more plausible alternative explanation for the event. Company Comment- No changes to the ROTATEQ product safety information are warranted at this time. Merck and Co., Inc., continues to monitor the safety profile of the product.; Sender''s Comments: JP-MSD-1804JPN000389J: JP-MSD-1804JPN000391J: JP-MSD-1804JPN000392J: JP-MSD-1804JPN000393J: JP-MSD-1804JPN000394J: JP-MSD-1804JPN000395J: JP-MSD-1804JPN000396J: JP-MSD-1804JPN000406J: JP-MSD-1804JPN000407J: JP-MSD-1804JPN000408J: JP-MSD-1804JPN000581J:


VAERS ID: 743429 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2014-02-24
Onset:2014-04-04
   Days after vaccination:39
Submitted: 0000-00-00
Entered: 2018-04-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
UNK: VACCINE NOT SPECIFIED (NO BRAND NAME) / UNKNOWN MANUFACTURER H021856 / UNK MO / PO

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Comments: Familial history: from 02-APR-2014, there was wild-type strain (G9P [8]) rota outbreak in the same facility.
Allergies:
Diagnostic Lab Data:
CDC Split Type: JP0095075131804JPN000391J

Write-up: Information has been received from a physician concerning a 4-month-old female infant without medical history. From 02-APR-2014, there was wild-type strain (G9P (8)) rota outbreak in the same facility. On 24-FEB-2014, the infant was orally vaccinated with ROTATEQ ORAL SOLUTION, 2 mL for prophylaxis (lot number/lot number: H021856/ H021856). No concomitant medications were reported. On 04-APR-2014, the patient developed vomiting and diarrhea ("gastroenteritis rotavirus; vomiting, diarrhoea" developed). On 05-APR-2014, vomiting resolved. On 12-APR-2014, G9P (8) was detected from the reporting infant''s faeces. On 13-APR-2014, diarrhoea resolved. At the time of the report, the outcome of "gastroenteritis rotavirus; vomiting, diarrhoea" was unknown. Reporter''s comment: not provided. The reporting physician felt that "gastroenteritis rotavirus; vomiting, diarrhoea" was not related to rotavirus vaccine, live, oral, pentavalent. The reporting physician considered "gastroenteritis rotavirus; vomiting, diarrhoea" to be non-serious. Upon internal review, "gastroenteritis rotavirus; vomiting, diarrhoea" was determined to be medically significant. Lot number (H021856, H021856) have been verified to be valid lot numbers for rotavirus vaccine, live, oral, pentavalent. This is one of several reports received from the same source. Company Causality Assessment: Based on the clinically relevant information currently available for this individual case, the reported event of gastroenteritis rotavirus is considered unlikely related to ROTATEQ. The evidence is not sufficient to suggest a relationship between the vaccination and the reported serious adverse event. Other incidental wild strain rotavirus infection constitutes a more plausible alternative explanation for the event. Company Comment- No changes to the Rotateq product safety information are warranted at this time. Merck and Co., Inc., continues to monitor the safety profile of the product.; Sender''s Comments: JP-MSD-1804JPN000389J: JP-MSD-1804JPN000390J: JP-MSD-1804JPN000392J: JP-MSD-1804JPN000393J: JP-MSD-1804JPN000394J: JP-MSD-1804JPN000395J: JP-MSD-1804JPN000396J: JP-MSD-1804JPN000406J: JP-MSD-1804JPN000407J: JP-MSD-1804JPN000408J: JP-MSD-1804JPN000581J:


VAERS ID: 743430 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2013-07-17
Onset:2014-04-05
   Days after vaccination:262
Submitted: 0000-00-00
Entered: 2018-04-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
RV5: ROTAVIRUS (ROTATEQ) / MERCK & CO. INC. - / 2 MO / PO

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Comments: Familial history: from 02-APR-2014, there was wild-type strain (G9P [8]) rota outbreak in the same facility.
Allergies:
Diagnostic Lab Data:
CDC Split Type: JP0095075131804JPN000392J

Write-up: Information has been received from a physician concerning a 10-month-old male infant with no medical history. From 02-APR-2014, there was wild-type strain (G9P [8]) rota outbreak in the same facility. On 21-OCT-2013, the patient was orally vaccinated with ROTATEQ, 2mL for prophylactic vaccination (lot number not reported). No concomitant medications were reported. On 17-JUL-2013, the patient was orally vaccinated with rotavirus vaccine, live, oral, pentavalent, 2 mL for prophylactic vaccination (lot number not reported). On 30-AUG-2013, the patient was orally re-vaccinated with rotavirus vaccine, live, oral, pentavalent, 2 mL for prophylactic vaccination (lot number not reported). On 05-APR-2014, the patient developed vomiting and diarrhea ("gastroenteritis rotavirus; vomiting, diarrhoea" developed). On 06-APR-2014, vomiting resolved. On 08-APR-2014, diarrhoea resolved. On 12-APR-2014, G9P [8] was detected from the infant''s faeces. At the time of the report, the outcome of "gastroenteritis rotavirus; vomiting, diarrhoea" was unknown. Reporter''s comment: not provided. The reporting physician felt that "gastroenteritis rotavirus; vomiting, diarrhoea" was not related to rotavirus vaccine, live, oral, pentavalent. The reporting physician considered "gastroenteritis rotavirus; vomiting, diarrhoea" to be non-serious. Upon internal review, "gastroenteritis rotavirus; vomiting, diarrhoea" was determined to be medically significant. This is one of several reports received from the same source. Company Causality Assessment: Based on the clinically relevant information currently available for this individual case, the reported event of gastroenteritis rotavirus is considered unlikely related to Rotateq. The evidence is not sufficient to suggest a relationship between the vaccination and the reported serious adverse event. Incidental infection due to in-hospital outbreak constitutes a more plausible alternative explanation for the event. Company Comment- No changes to the ROTATEQ product safety information are warranted at this time. Merck and Co., Inc., continues to monitor the safety profile of the product.; Sender''s Comments: JP-MSD-1804JPN000389J: JP-MSD-1804JPN000390J: JP-MSD-1804JPN000391J: JP-MSD-1804JPN000393J: JP-MSD-1804JPN000394J: JP-MSD-1804JPN000395J: JP-MSD-1804JPN000396J: JP-MSD-1804JPN000406J: JP-MSD-1804JPN000407J: JP-MSD-1804JPN000408J: JP-MSD-1804JPN000581J:


VAERS ID: 743510 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2011-01-04
Onset:2011-01-05
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2018-04-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEP: HEP B (GENHEVAC B) / SANOFI PASTEUR D6283 / UNK UN / IM

Administered by: Unknown       Purchased by: ?
Symptoms: Vestibular neuronitis
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: Immunisation
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: FR0095075131804FRA001786

Write-up: Information has been downloaded from a database (FR-AFSSAPS-NT20110457). This spontaneous report has been received from a 43 year old male patient. The patient''s medical history concurrent conditions and concomitant medications were not provided. On 04-JAN-2011, the patient was vaccinated with VACCIN GENHEVAC B PASTEUR 1 dose intramuscularly with lot number D6283-1 for immunization (frequency and expiration date were not provided). On 05-JAN-2011, the patient experienced vestibular neuronitis for 5 months and recovered with sequelae on an unknown date in June 2011. Therapy with HEPATITIS B VACCINE (RECOMBINANT) was reported as discontinued. The agency did not provide the causality assessment between the event and suspect therapy. The agency considered the event to be serious for the following reason: Medically significant.


VAERS ID: 743511 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2018-04-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN

Administered by: Other       Purchased by: ?
Symptoms: Coma, Myocardial infarction, Pyrexia, Tachycardia
SMQs:, Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Myocardial infarction (narrow), Anticholinergic syndrome (broad), Arrhythmia related investigations, signs and symptoms (broad), Embolic and thrombotic events, arterial (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Dehydration (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: CARBAMAZEPINE; PHENYTOIN; PHENOBARBITAL; VERAPAMIL
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: ITSA2018SA096247

Write-up: Initial unsolicited report received from literature on 26 Mar 2018. 2018SA095111, 2018SA095117, 2018SA095112, 2018SA095116, 2018SA096508, 2018SA096279, 2018SA096286, 2018SA096304, 2018SA096332, 2018SA096338, 2018SA096354, 2018SA096379, 2018SA096401, 2018SA096428, 2018SA096432, 2018SA096439, 2018SA096448, 2018SA096456, 2018SA096464, 2018SA096468, 2018SA096471, 2018SA096475, 2018SA096477, 2018SA096482, 2018SA096366, 2018SA096377, 2018SA096383, 2018SA096413, 2018SA096421, 2018SA096433, 2018SA096450, 2018SA096460, 2018SA096465, 2018SA096469, 2018SA096473, 2018SA096478, 2018SA096483, 2018SA096485, 2018SA096488, 2018SA096500, 2018SA096502, 2018SA096505, 2018SA096506, 2018SA096508 (Same literature). The following is verbatim from the article: Background: An increasing number of reports indicates that vaccines against influenza may interact with specific drugs via drug metabolism. To date, actual impact of vaccine-drug interactions observed in the real world clinical practice has not been investigated. Methods: From VAERS and database, we collected Adverse Event Following Immunization (AEFI) reports for individuals receiving vaccines against influenza recorded as suspect and selected cases where predictable toxicity was recorded with oral anticoagulants, antiepileptics and statins (i.e. hemorrhages, overdosage and rhabdomyolysis, respectively). We applied AEFI and Drug Interaction Probability Scale (DIPS) Algorithms to assess causality of drug-vaccine interactions. Results: 116 AEFI reports submitted to VAERS and 83 from database were included in our analysis; antiepileptics and statins were related to the highest number of indeterminate/consistent (93.7%; 65.3%) and possible/probable (50%; 57.7%) cases according to the AEFI and DIPS, respectively. The majority of cases occurred within the first week after vaccine administration (5-7 days). Conclusion: The relative paucity of detected interactions does not impact on the benefit of the vaccination against influenza, which remains strongly recommended; this does not exclude that closer monitoring for selected patients exposed to concomitant chronic pharmacological therapies and affected by predisposing factors may be useful. This case involves 74 year female patient who was vaccinated with dose of INFLUENZA VACCINE, carbamazepine, phenytoin, phenobarbital and verapamil (batch number, expiry date, route and site of administration were not reported) on an unspecified date. The patient''s medical history was not reported. Concomitant medication were not reported. On an unspecified date, same day following the vaccination, patient had coma, myocardial infarction, tachycardia and pyrexia. Authors pointed out that suspect drugs carbamazepine, phenytoin, phenobarbital and verapamil (pharmacodynamic drug interactions) are known to have drug-drug interactions. Laboratory investigation and corrective treatment were not reported. On an unspecified date, patient was recovered from events. This case was considered as serious by the reporter due to medically significant events. The reporter assessed the causal relationship INFLUENZA VACCINE and CARBAMAZEPINE, phenytoin, phenobarbital and verapamil for the events as indeterminate and drug interaction probability scale reported as doubtful (1). List of documents held by sender: none. Sender''s Comments: This literature article reports about an elderly patient who experienced Coma, Myocardial infarction, Tachycardia and Pyrexia in relation to INFLUENZA vaccine and CARBAMAZEPINE therapy. The time to onset is compatible. However, patient''s past medical condition at the time of vaccination was not reported. Her past drug therapy includes various anti-seizure medications. There is a possibility that the events are due to the other suspect drug or a pre-existing medical condition. To be noted, Authors pointed out that suspect drugs carbamazepine, phenytoin, phenobarbital and verapamil are known to have drug-drug interactions. Based upon the reported information and with special consideration to the age of the patient, the role of the vaccine cannot be assessed.


VAERS ID: 743512 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2018-04-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN

Administered by: Other       Purchased by: ?
Symptoms: Anuria, Myalgia, Pharyngitis, Rhabdomyolysis, Rhinitis
SMQs:, Rhabdomyolysis/myopathy (narrow), Acute renal failure (narrow), Agranulocytosis (broad), Neuroleptic malignant syndrome (broad), Retroperitoneal fibrosis (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (broad), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (broad), Toxic-septic shock conditions (broad), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Oropharyngeal infections (narrow), Eosinophilic pneumonia (broad), Tumour lysis syndrome (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (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? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: ATENOLOL; DOXAZOSIN; SIMVASTATIN; CYCLOSPORIN; OMEPRAZOLE; PREDNISOLONE; SIROLIMUS WARFARIN
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: End stage renal failure; Kidney transplant; Pharyngitis
Allergies:
Diagnostic Lab Data:
CDC Split Type: ITSA2018SA096366

Write-up: Initial unsolicited report received from literature in the Unites States on 26 Mar 2018. This case is linked with This case is linked with 2018SA095111, 2018SA095117, 2018SA095112, 2018SA095116, 2018SA096247, 2018SA096279, 2018SA096286,2018SA096304, 2018SA096332,2018SA096338, 2018SA096354, 2018SA096379, 2018SA096401, 2018SA096428, 2018SA096432, 2018SA096439, 2018SA096448, 2018SA096456, 2018SA096464, 2018SA096468, 2018SA096471, 2018SA096475, 2018SA096477, 2018SA096479, 2018SA096482, 2018SA096366, 2018SA096377, 2018SA096383, 2018SA096413, 2018SA096421, 2018SA096433, 2018SA096450, 2018SA096460, 2018SA096465, 2018SA096469, 2018SA096473, 2018SA096478, 2018SA096483, 2018SA096485,2018SA096488, 2018SA096500, 2018SA096502, 2018SA096505, 2018SA096506, 2018SA096508 (same literature). The following is verbatim from the article: Background: An increasing number of reports indicates that vaccines against influenza may interact with specific drugs via drug metabolism. To date, actual impact of vaccine-drug interactions observed in the real world clinical practice has not been investigated. Methods: From VAERS and VigiBase, we collected Adverse Event Following Immunization (AEFI) reports for individuals receiving vaccines against influenza recorded as suspect and selected cases where predictable toxicity was recorded with oral anticoagulants, antiepileptics and statins (i.e. hemorrhages, overdosage and rhabdomyolysis, respectively). We applied AEFI and Drug Interaction Probability Scale (DIPS) Algorithms to assess causality of drug-vaccine interactions. Results: 116 AEFI reports submitted to VAERS and 83 from Vigibase were included in our analysis; antiepileptics and statins were related to the highest number of indeterminate/consistent (93.7%; 65.3%) and possible/probable (50%; 57.7%) cases according to the AEFI and DIPS, respectively. The majority of cases occurred within the first week after vaccine administration (5-7 days). Conclusion: The relative paucity of detected interactions does not impact on the benefit of the vaccination against influenza, which remains strongly recommended; this does not exclude that closer monitoring for selected patients exposed to concomitant chronic pharmacological therapies and affected by predisposing factors may be useful. This case involves 54 years old male patient who was vaccinated with dose of INFLUENZA VACCINE and SIMVASTATIN, CICLOSPORIN, OMEPRAZOLE, Prednisolone, SIROLIMUS WARFARIN (batch number, expiry date, route and site of administration were not reported) on an unspecified date. Patient''s medical history including end stage renal failure, kidney transplant. Concomitant medications including ATENOLOL, DOXAZOSIN. On an unspecified date, eight days following the vaccination, patient experienced anuria, myalgia, pharyngitis, rhabdomyolysis and rhinitis. On an unknown date patient was hospitalized. Laboratory investigation reported as Pharyngitis and corrective treatment were not reported. The outcome of the event was not reported. The reporter assessed the causal relationship with TRIVALENT, INACTIVATED SUBUNIT INFLUENZA VIRUS VACCINE and SIMVASTATIN for the events are Indeterminate possible with DIPS score 3. List of documents held by sender: none. Sender''s Comments: This patient developed anuria, myalgia, pharyngitis, rhabdomyolysis and rhinitis post-vaccination with Influenza vaccine (unknown manufacturer). Time to onset is 8 days. Past medical history included end-stage renal failure and transplant kidney which might have contributed to reported events. Additional information including vaccination details with manufacturer, onset time, concomitant vaccinations, past vaccination history with tolerance data, concurrent conditions and laboratory test ruling out other infectious etiology is needed for further assessment. Based on available information role of vaccine cannot be assessed.


VAERS ID: 743513 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2018-04-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Blood creatine increased, Blood creatine phosphokinase decreased, Blood urea increased, Dysstasia, Haematuria, Myalgia, Rhabdomyolysis
SMQs:, Rhabdomyolysis/myopathy (narrow), Acute renal failure (broad), Haemorrhage terms (excl laboratory terms) (narrow), Neuroleptic malignant syndrome (broad), Retroperitoneal fibrosis (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Eosinophilic pneumonia (broad), Chronic kidney disease (broad), Tumour lysis syndrome (broad), Tubulointerstitial diseases (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? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: GLUCOSAMINE; VITAMIN D3; SIMVASTATIN; METFORMIN; PERINDOPRIL; CALCIUM CARBONATE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Type 2 diabetes mellitus
Allergies:
Diagnostic Lab Data: Test Name: Blood creatine; Result Unstructured Data: 197; Test Name: blood creatine phosphokinase; Result Unstructured Data: 30.453; Test Name: blood urea; Result Unstructured Data: 22.2
CDC Split Type: ITSA2018SA096413

Write-up: Initial unsolicited report received from literature on 26 Mar 2018. This case was linked to 2018SA095111, 2018SA095117, 2018SA095112, 2018SA095116, 2018SA096247, 2018SA096379, 2018SA096286, 2018SA096304, 2018SA096332, 2018SA096338, 2018SA096354, 2018SA096475, 2018SA096401, 2018SA096428, 2018SA096432, 2018SA096439, 2018SA096448, 2018SA096456, 2018SA096464, 2018SA096468, 2018SA096471, 2018SA096508, 2018SA096477, 2018SA096482, 2018SA096366, 2018SA096377, 2018SA096383, 2018SA096279, 2018SA096421, 2018SA096433, 2018SA096450, 2018SA096460, 2018SA096465, 2018SA096469, 2018SA096473, 2018SA096478, 2018SA096483, 2018SA096485, 2018SA096488, 2018SA096500, 2018SA096502, 2018SA096505, 2018SA096506 and 2018SA096479 (Same Literature). The following is verbatim from the article: Background: An increasing number of reports indicates that vaccines against influenza may interact with specific drugs via drug metabolism. To date, actual impact of vaccine-drug interactions observed in the real world clinical practice has not been investigated. Methods: From VAERS and database, we collected Adverse Event Following Immunization (AEFI) reports for individuals receiving vaccines against influenza recorded as suspect and selected cases where predictable toxicity was recorded with oral anticoagulants, antiepileptics and statins (i.e. hemorrhages, overdosage and rhabdomyolysis, respectively). We applied AEFI and Drug Interaction Probability Scale (DIPS) Algorithms to assess causality of drug-vaccine interactions. Results: 116 AEFI reports submitted to VAERS and 83 from database were included in our analysis; antiepileptics and statins were related to the highest number of indeterminate/consistent (93.7%; 65.3%) and possible/probable (50%; 57.7%) cases according to the AEFI and DIPS, respectively. The majority of cases occurred within the first week after vaccine administration (5-7 days). Conclusion: The relative paucity of detected interactions does not impact on the benefit of the vaccination against influenza, which remains strongly recommended; this does not exclude that closer monitoring for selected patients exposed to concomitant chronic pharmacological therapies and affected by predisposing factors may be useful. This case involves 85 years old male patient who was vaccinated with a dose of INFLUENZA VACCINE and also received SIMVASTATIN, METFORMIN, PERINDOPRIL and CALCIUM CARBONATE (batch number, expiry date, route and site of administration were not reported) on an unspecified date. Patient''s medical history included Type 2 diabetes mellitus. Concomitant medication included Glucosamine and vitamin D3 (batch number, expiry date and route were not reported) taken on an unknown date. There was also PhDI: pharmacodynamics drug interactions. On an unspecified date, ten days following the vaccination and after receiving drug, patient had developed Abasia, dysstasia, hematuria and rhabdomyolysis from myalgia. Patient was hospitalized on an unspecified date. Authors pointed out that suspect drugs metformin, perindopril and calcium carbonate are known to have drug-drug interaction. Laboratory investigations included Blood creatine: 197; blood CPK: 30,453 (units not reported); blood urea 22.2; urine analysis: abnormal: 4 + protein and 4 + hematuria. Corrective treatment was not reported. Outcome of events was not reported. The reporter assessed the adverse events following immunization and drug interaction probability scale as indeterminate possible. List of documents held by sender: none. Sender''s Comments: This literature article reports about an elderly patient who experienced Rhabdomyolysis, Abasia, Dysstasia and hematuria in relation to INFLUENZA vaccine and SIMVASTATIN therapy. The time to onset is compatible. However, patient''s medical condition at the time of vaccination was not reported and her past history includes Diabetic Mellitus. There is a possibility that the events are due to the other suspect drug or an aggravation of the pre-existing medical condition. Based upon the reported information and with special consideration to the age and past medical history of the patient, the role of the vaccine cannot be assessed.


VAERS ID: 743514 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2018-04-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN

Administered by: Other       Purchased by: ?
Symptoms: Anticoagulant therapy, Coagulation time prolonged, Condition aggravated
SMQs:, Haemorrhage laboratory terms (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: DOXAZOSIN; WARFARIN
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: ITSA2018SA096428

Write-up: Coagulation time prolonged; condition aggravated; Initial unsolicited report received from literature on 26-Mar-2018. This case is linked with 2018SA095111, 2018SA095117, 2018SA095112, 2018SA095116, 2018SA096247, 2018SA096279, 2018SA096286, 2018SA096304, 2018SA096332, 2018SA096338, 2018SA096354, 2018SA096379, 2018SA096401, 2018SA096432, 2018SA096478, 2018SA096439, 2018SA096448, 2018SA096456, 2018SA096464, 2018SA096468, 2018SA096471, 2018SA096508, 2018SA096477, 2018SA096482, 2018SA096366, 2018SA096377, 2018SA096383, 2018SA096413, 2018SA096421, 2018SA096433, 2018SA096450, 2018SA096460, 2018SA096465, 2018SA096469, 2018SA096473, 2018SA096475, 2018SA096483, 2018SA096485, 2018SA096488, 2018SA096500, 2018SA096502, 2018SA096505, 2018SA096506 and 2018SA096479 (Same Literature). The following is verbatim from the article: Background: An increasing number of reports indicates that vaccines against influenza may interact with specific drugs via drug metabolism. To date, actual impact of vaccine-drug interactions observed in the real world clinical practice has not been investigated. Methods: From VAERS and database, we collected Adverse Event Following Immunization (AEFI) reports for individuals receiving vaccines against influenza recorded as suspect and selected cases where predictable toxicity was recorded with oral anticoagulants, antiepileptics and statins (i.e. hemorrhages, overdosage and rhabdomyolysis, respectively). We applied AEFI and Drug Interaction Probability Scale (DIPS) Algorithms to assess causality of drug-vaccine interactions. Results: 116 AEFI reports submitted to VAERS and 83 from Vigibase were included in our analysis; antiepileptics and statins were related to the highest number of indeterminate/consistent (93.7%; 65.3%) and possible/probable (50%; 57.7%) cases according to the AEFI and DIPS, respectively. The majority of cases occurred within the first week after vaccine administration (5-7 days). Conclusion: The relative paucity of detected interactions does not impact on the benefit of the vaccination against influenza, which remains strongly recommended; this does not exclude that closer monitoring for selected patients exposed to concomitant chronic pharmacological therapies and affected by predisposing factors may be useful. This case involves 83 years old male patient who was vaccinated with dose of INFLUENZA VACCINE (batch number, expiry date, route and site of administration were not reported). The patient also received dose of WARFARIN (batch number, expiry date and route were not reported) on an unspecified date. The patient''s medical history was not reported. Patient concomitant medication included DOXAZOSIN. On an unspecified date, 26-day post vaccination and after receiving drug patient had Coagulation time prolonged and condition aggravated. On an unknown date patient was hospitalized. Laboratory investigation and corrective treatment was not reported. Outcome of the events were not reported. The reporter assessed the causal relationship with INFLUENZA VACCINE and WARFARIN for the events as inconsistent. List of documents held by sender: none. Sender''s Comments: This literature article reports about an elderly patient who experienced coagulation time prolongation and aggravation of condition in relation to INFLUENZA vaccine and WARFARIN therapy. The time to onset is compatible. However, patient''s past medical history and condition at the time of vaccination was not reported. Coagulation time prolongation is an expected event with Warfarin therapy, with or without drug interaction with Influenza vaccine. There is a possibility that the events are due to the other suspect drug or a pre-existing medical condition. Based upon the reported information, the role of the vaccine cannot be assessed.


VAERS ID: 743515 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2018-04-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN

Administered by: Other       Purchased by: ?
Symptoms: Anticoagulant therapy, Ear haemorrhage, Epistaxis, Injection site haemorrhage, International normalised ratio increased, Mouth haemorrhage, Platelet count decreased
SMQs:, Liver-related coagulation and bleeding disturbances (narrow), Haematopoietic thrombocytopenia (narrow), Haemorrhage terms (excl laboratory terms) (narrow), Haemorrhage laboratory terms (broad), Systemic lupus erythematosus (broad), Oropharyngeal conditions (excl neoplasms, infections and allergies) (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: WARFARIN; ASA; CLOPIDOGREL
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: international normalized ratio; Result Unstructured Data: 5; Test Name: prothrombin time; Result Unstructured Data: 62.6; Test Name: platelet count; Result Unstructured Data: 7000
CDC Split Type: ITSA2018SA096432

Write-up: Initial unsolicited report received from literature on 26-Mar-2018. This case is linked with 2018SA095111, 2018SA095117, 2018SA095112, 2018SA095116, 2018SA096247, 2018SA096279, 2018SA096286, 2018SA096304, 2018SA096332, 2018SA096338, 2018SA096354, 2018SA096379, 2018SA096401, 2018SA096428, 2018SA096478, 2018SA096439, 2018SA096448, 2018SA096456, 2018SA096464, 2018SA096468, 2018SA096471, 2018SA096508, 2018SA096477, 2018SA096482, 2018SA096366, 2018SA096377, 2018SA096383, 2018SA096413, 2018SA096421, 2018SA096433, 2018SA096450, 2018SA096460, 2018SA096465, 2018SA096469, 2018SA096473, 2018SA096475, 2018SA096483, 2018SA096485, 2018SA096488, 2018SA096500, 2018SA096502, 2018SA096505, 2018SA096506 and 2018SA096479 (Same Literature). The following is verbatim from the article: Background: An increasing number of reports indicates that vaccines against influenza may interact with specific drugs via drug metabolism. To date, actual impact of vaccine-drug interactions observed in the real world clinical practice has not been investigated. Methods: From VAERS and database, we collected Adverse Event Following Immunization (AEFI) reports for individuals receiving vaccines against influenza recorded as suspect and selected cases where predictable toxicity was recorded with oral anticoagulants, antiepileptics and statins (i.e. hemorrhages, overdosage and rhabdomyolysis, respectively). We applied AEFI and Drug Interaction Probability Scale (DIPS) Algorithms to assess causality of drug-vaccine interactions. Results: 116 AEFI reports submitted to VAERS and 83 from Vigibase were included in our analysis; antiepileptics and statins were related to the highest number of indeterminate/consistent (93.7%; 65.3%) and possible/probable (50%; 57.7%) cases according to the AEFI and DIPS, respectively. The majority of cases occurred within the first week after vaccine administration (5-7 days). Conclusion: The relative paucity of detected interactions does not impact on the benefit of the vaccination against influenza, which remains strongly recommended; this does not exclude that closer monitoring for selected patients exposed to concomitant chronic pharmacological therapies and affected by predisposing factors may be useful. This case involves 53 years old male patient who was vaccinated with dose of INFLUENZA VACCINE (batch number, expiry date, route and site of administration were not reported). The patient also received dose of WARFARIN, ACETYLSALICYLIC ACID (ASA) and CLOPIDOGREL (batch number, expiry date and route were not reported) on an unspecified date. The patient''s medical history was not reported. Patient concomitant medication was not reported. On an unspecified date, 13-day post vaccination and after receiving drugs, patient had epistaxis, mouth hemorrhage, ear hemorrhage, platelet count decreased, INR increased, injection site hemorrhage. Authors pointed out that suspect drugs ACETYLSALICYLIC ACID and CLOPIDOGREL are known to have drug-drug interactions. Laboratory investigation included- international normalized ratio 5, prothrombin time- 62.6 and platelet count- 7000. Corrective treatment was not reported. On an unknown date patient got recovered from all the events. Case was considered as serious by the reporter due to medically significant events. The reporter assessed the causal relationship with vaccine and dugs for the events as Indeterminate and drug interaction probability scale reported as possible (4). List of documents held by sender: none. Sender''s Comments: This literature article reports about a 53 year old male patient who experienced Ear hemorrhage, epistaxis, injection site hemorrhage, INR increased, mouth hemorrhage, platelet count decreased in relation to INFLUENZA vaccine and WARFARIN therapy. The time to onset was compatible. He had also received ASA and clopidogrel at an unspecified time. Patient''s past medical history was not reported. There is a possibility that the events are due to the suspect drug (an anti-coagulants) or as a result of the pre-existing medical conditions. Based upon the limited reported information, the role of the vaccine cannot be assessed.


VAERS ID: 743516 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2018-04-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN

Administered by: Other       Purchased by: ?
Symptoms: Anticoagulant therapy, Epistaxis, Injection site discolouration, Mouth haemorrhage
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: TRAMADOL; WARFARIN
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: ITSA2018SA096439

Write-up: Initial unsolicited report received from literature on 26-Mar-2018. This case is linked with 2018SA095111, 2018SA095117, 2018SA095112, 2018SA095116, 2018SA096247, 2018SA096279, 2018SA096286, 2018SA096304, 2018SA096332, 2018SA096338, 2018SA096354, 2018SA096379, 2018SA096401, 2018SA096428, 2018SA096478, 2018SA096432, 2018SA096448, 2018SA096456, 2018SA096464, 2018SA096468, 2018SA096471, 2018SA096508, 2018SA096477, 2018SA096482, 2018SA096366, 2018SA096377, 2018SA096383, 2018SA096413, 2018SA096421, 2018SA096433, 2018SA096450, 2018SA096460, 2018SA096465, 2018SA096469, 2018SA096473, 2018SA096475, 2018SA096483, 2018SA096485, 2018SA096488, 2018SA096500, 2018SA096502, 2018SA096505, 2018SA096506 and 2018SA096479 (Same Literature). The following is verbatim from the article: Background: An increasing number of reports indicates that vaccines against influenza may interact with specific drugs via drug metabolism. To date, actual impact of vaccine-drug interactions observed in the real world clinical practice has not been investigated. Methods: From VAERS and database, we collected Adverse Event Following Immunization (AEFI) reports for individuals receiving vaccines against influenza recorded as suspect and selected cases where predictable toxicity was recorded with oral anticoagulants, antiepileptics and statins (i.e. hemorrhages, overdosage and rhabdomyolysis, respectively). We applied AEFI and Drug Interaction Probability Scale (DIPS) Algorithms to assess causality of drug-vaccine interactions. Results: 116 AEFI reports submitted to VAERS and 83 from database were included in our analysis; antiepileptics and statins were related to the highest number of indeterminate/consistent (93.7%; 65.3%) and possible/probable (50%; 57.7%) cases according to the AEFI and DIPS, respectively. The majority of cases occurred within the first week after vaccine administration (5-7 days). Conclusion: The relative paucity of detected interactions does not impact on the benefit of the vaccination against influenza, which remains strongly recommended; this does not exclude that closer monitoring for selected patients exposed to concomitant chronic pharmacological therapies and affected by predisposing factors may be useful. This case involves 74 years old female patient who was vaccinated with dose of INFLUENZA VACCINE (batch number, expiry date, route and site of administration were not reported). The patient also received dose of WARFARIN (batch number, expiry date and route were not reported) on an unspecified date. The patient''s medical history was not reported. Patient concomitant medication included-TRAMADOL. On an unspecified date, 19-day post vaccination and after receiving drugs patient had epistaxis, mouth hemorrhage and injection site discoloration. Lab test were not reported. Corrective treatment was not reported. On an unknown date patient got recovered from all the events. Case was considered as serious by the reporter due to medically significant events. The reporter assessed the causal relationship with vaccine and dugs for the events as Indeterminate and Doubtful (1). List of documents held by sender: none. Sender''s Comments: This literature article reports about an elderly patient who experienced epistaxis, mouth hemorrhage and vaccination site discolouration in relation to INFLUENZA vaccine and WARFARIN therapy. The time to onset is compatible. However, past medical condition and condition at the time of vaccination was not reported. Coagulation defect is an expected event with Warfarin therapy, with or without drug interaction with Influenza vaccine and is a possible reason for the hemorrhages. Based upon the reported information and with special consideration to the age of the patient, the role of the vaccine cannot be assessed.


VAERS ID: 743517 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2018-04-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN

Administered by: Other       Purchased by: ?
Symptoms: Drug interaction, Prothrombin time ratio decreased, Prothrombin time shortened, Renal haemorrhage, Renal pain
SMQs:, Haemorrhage terms (excl laboratory terms) (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: SIMVASTATIN; ATORVASTATIN; WARFARIN
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: prothrombin time; Test Result: 13 s; Test Name: Prothrombin time; Test Result: 6 s
CDC Split Type: ITSA2018SA096448

Write-up: Initial unsolicited report received from literature on 26 Mar 2018. This case was linked to 2018SA095111, 2018SA095117, 2018SA095112, 2018SA095116, 2018SA096247, 2018SA096279, 2018SA096286, 2018SA096304, 2018SA096332, 2018SA096338, 2018SA096354, 2018SA096379, 2018SA096401, 2018SA096428, 2018SA096432, 2018SA096439, 2018SA096456, 2018SA096464, 2018SA096468, 2018SA096471, 2018SA096475, 2018SA096477, 2018SA096479, 2018SA096482, 2018SA096366, 2018SA096377, 2018SA096413, 2018SA096421, 2018SA096450, 2018SA096460, 2018SA096465, 2018SA096473, 2018SA096478, 2018SA096483, 2018SA096485, 2018SA096500, 2018SA096502, 2018SA096505, 2018SA096506, 2018SA096508, 2018SA096383, 2018SA096433, 2018SA096488, 2018SA096469 (Same Literature). The following is verbatim from the article: Background: An increasing number of reports indicates that vaccines against influenza may interact with specific drugs via drug metabolism. To date, actual impact of vaccine-drug interactions observed in the real world clinical practice has not been investigated. Methods: From VAERS and database, we collected Adverse Event Following Immunization (AEFI) reports for individuals receiving vaccines against influenza recorded as suspect and selected cases where predictable toxicity was recorded with oral anticoagulants, antiepileptics and statins (i.e. hemorrhages, overdosage and rhabdomyolysis, respectively). We applied AEFI and Drug Interaction Probability Scale (DIPS) Algorithms to assess causality of drug-vaccine interactions. Results: 116 AEFI reports submitted to VAERS and 83 from database were included in our analysis; antiepileptics and statins were related to the highest number of indeterminate/consistent (93.7%; 65.3%) and possible/probable (50%; 57.7%) cases according to the AEFI and DIPS, respectively. The majority of cases occurred within the first week after vaccine administration (5-7 days). Conclusion: The relative paucity of detected interactions does not impact on the benefit of the vaccination against influenza, which remains strongly recommended; this does not exclude that closer monitoring for selected patients exposed to concomitant chronic pharmacological therapies and affected by predisposing factors may be useful. This case involves a male patient (age reported as greater than 18 years) who was vaccinated with dose of INFLUENZA VACCINE (batch number, expiry date, route and site of administration were not reported) and received Warfarin (batch number and expiry date were not reported) on an unknown date. The patient''s medical history were not reported. Concomitant medications included Simvastatin and Atorvastatin. On an unspecified date, post vaccination and post drug administration, the patient developed renal hemorrhage, renal pain, prothrombin time ratio decreased and prothrombin time shortened. On an unknown date, the patient was hospitalized due to the events. It was a case of drug interaction. Relevant laboratory investigations included prothrombin time 13 seconds and prothrombin time 6 seconds on an unknown dates. Corrective treatment were not reported. The outcome of the events was not reported. The reporter assessed the causal relationship with INFLUENZA VACCINE and Warfarin as unclassifiable doubtful (0) as per drug interaction probability scale. List of documents held by sender: none. Sender''s Comments: This patient developed reported events following vaccination with Influenza vaccine (unknown manufacturer) while he was on Warfarin treatment. Time to onset is unknown. Additional information including vaccination details with manufacturer, onset time, concomitant vaccinations, past vaccination history with tolerance data, concurrent conditions, medical history and laboratory test ruling out other etiologies is needed for further assessment. Based on available information role of vaccine cannot be assessed.


VAERS ID: 743518 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2018-04-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX(H1N1): INFLUENZA (H1N1) (H1N1 (MONOVALENT) (UNKNOWN)) / UNKNOWN MANUFACTURER - / UNK UN / UN

Administered by: Other       Purchased by: ?
Symptoms: Anticoagulant therapy, Prothrombin time prolonged
SMQs:, Liver-related coagulation and bleeding disturbances (narrow), Haemorrhage laboratory terms (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: WARFARIN
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Atrial fibrillation; CABG; Congestive heart failure; Coronary artery disease; Depression; Essential tremor; Hyperlipidemia; Hypertension; Ischemic cardiomyopathy; Myocardial infarction; Pacemaker insertion (cardiac); VIth nerve palsy
Allergies:
Diagnostic Lab Data:
CDC Split Type: ITSA2018SA096456

Write-up: PT Prolonged; Initial unsolicited report received from literature on 26 Mar 2018. This case is linked with 2018SA095111, 2018SA095117, 2018SA095112, 2018SA095116, 2018SA096247, 2018SA096279, 2018SA096286, 2018SA096304, 2018SA096332, 2018SA096338, 2018SA096354, 2018SA096379, 2018SA096401, 2018SA096428, 2018SA096432, 2018SA096439, 2018SA096448, 2018SA096456, 2018SA096464, 2018SA096468, 2018SA096471, 2018SA096475, 2018SA096477, 2018SA096479, 2018SA096482, 2018SA096366, 2018SA096377, 2018SA096383, 2018SA096413, 2018SA096421, 2018SA096433, 2018SA096450, 2018SA096460, 2018SA096465, 2018SA096469, 2018SA096473, 2018SA096478, 2018SA096483, 2018SA096485, 2018SA096488, 2018SA096500, 2018SA096502, 2018SA096505, 2018SA096506 ,2018SA096508 (same literature). The following is verbatim from the article: Background: An increasing number of reports indicates that vaccines against influenza may interact with specific drugs via drug metabolism. To date, actual impact of vaccine-drug interactions observed in the real world clinical practice has not been investigated. Methods: From VAERS and database, we collected Adverse Event Following Immunization (AEFI) reports for individuals receiving vaccines against influenza recorded as suspect and selected cases where predictable toxicity was recorded with oral anticoagulants, antiepileptics and statins (i.e. hemorrhages, overdosage and rhabdomyolysis, respectively). We applied AEFI and Drug Interaction Probability Scale (DIPS) Algorithms to assess causality of drug-vaccine interactions. Results: 116 AEFI reports submitted to VAERS and 83 from database were included in our analysis; antiepileptics and statins were related to the highest number of indeterminate/consistent (93.7%; 65.3%) and possible/probable (50%; 57.7%) cases according to the AEFI and DIPS, respectively. The majority of cases occurred within the first week after vaccine administration (5-7 days). Conclusion: The relative paucity of detected interactions does not impact on the benefit of the vaccination against influenza, which remains strongly recommended; this does not exclude that closer monitoring for selected patients exposed to concomitant chronic pharmacological therapies and affected by predisposing factors may be useful. This case involves 73 years old male patient who was vaccinated with INFLUENZA VACCINE and also received WARFARIN (batch number, expiry date, route and site of administration were not reported) on an unspecified date. Patient''s medical history including Congestive heart failure. Ischemic cardiomyopathy, atrial fibrillation, coronary artery disease, 5-vessel CABG, pacemaker placement, essential tremor, myocardial infarction. Hypertension, hyperlipidemia, depression. Congenital 6th (Cranial) nerve palsy. Concomitant medications were not reported. On an unspecified date, eleven days following the vaccination patient experienced PT Prolonged (Prothrombin time prolonged). On an unknown date patient was hospitalized. Laboratory investigation and corrective treatment were not reported. The outcome of the event was not reported. The reporter assessed the adverse events following immunization and drug interaction probability scale as indeterminate (possible). List of documents held by sender: none. Sender''s Comments: This literature article reports about an elderly patient who experienced prolongation of Prothrombin Time (PT) in relation to INFLUENZA vaccine and WARFARIN therapy. The time to onset is compatible. PT prolongation is an expected event with Warfarin therapy, with or without drug interaction with Influenza vaccine. Based upon the reported information, the role of the vaccine cannot be assessed.


VAERS ID: 743520 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2018-04-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN

Administered by: Other       Purchased by: ?
Symptoms: Blood creatine phosphokinase increased, Dizziness, Echocardiogram abnormal, Lymphocyte percentage decreased, Myoglobin blood increased, Nausea, Neutrophil count increased, Presyncope, Swelling, Vomiting, White blood cell count increased
SMQs:, Rhabdomyolysis/myopathy (narrow), Anaphylactic reaction (broad), Acute pancreatitis (broad), Angioedema (broad), Haematopoietic leukopenia (broad), Neuroleptic malignant syndrome (broad), Myocardial infarction (broad), Anticholinergic syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad), Vestibular disorders (broad), Hypotonic-hyporesponsive episode (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: ATORVASTATIN
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: CK; Result Unstructured Data: 181; Test Name: creatine phosphokinase; Result Unstructured Data: 181; Test Name: WBC; Result Unstructured Data: 11.5; Test Name: Lymphocytes; Test Result: 12.2 %; Test Name: Neutrophils; Result Unstructured Data: 9.2
CDC Split Type: ITSA2018SA096485

Write-up: Initial unsolicited report received from literature on 26 Mar 2018. This case is linked with 2018SA095111, 2018SA095117, 2018SA095112, 2018SA095116, 2018SA096247, 2018SA096279, 2018SA096286, 2018SA096304, 2018SA096332, 2018SA096338, 2018SA096354, 2018SA096379, 2018SA096401, 2018SA096428, 2018SA096432, 2018SA096439, 2018SA096448, 2018SA096456, 2018SA096473, 2018SA096468, 2018SA096471, 2018SA096475, 2018SA096477, 2018SA096479, 2018SA096482, 2018SA096366, 2018SA096377, 2018SA096383, 2018SA096413, 2018SA096421, 2018SA096433, 2018SA096450, 2018SA096460, 2018SA096465, 2018SA096469, 2018SA096508, 2018SA096478, 2018SA096483, 2018SA096464, 2018SA096488, 2018SA096500, 2018SA096502, 2018SA096505 and 2018SA096506 (Same literature). The following is verbatim from the article: Background: An increasing number of reports indicates that vaccines against influenza may interact with specific drugs via drug metabolism. To date, actual impact of vaccine-drug interactions observed in the real world clinical practice has not been investigated. Methods: From VAERS and database, we collected Adverse Event Following Immunization (AEFI) reports for individuals receiving vaccines against influenza recorded as suspect and selected cases where predictable toxicity was recorded with oral anticoagulants, antiepileptics and statins (i.e. hemorrhages, overdosage and rhabdomyolysis, respectively). We applied AEFI and Drug Interaction Probability Scale (DIPS) Algorithms to assess causality of drug-vaccine interactions. Results: 116 AEFI reports submitted to VAERS and 83 from database were included in our analysis; antiepileptics and statins were related to the highest number of indeterminate/consistent (93.7%; 65.3%) and possible/probable (50%; 57.7%) cases according to the AEFI and DIPS, respectively. The majority of cases occurred within the first week after vaccine administration (5-7 days). Conclusion: The relative paucity of detected interactions does not impact on the benefit of the vaccination against influenza, which remains strongly recommended; this does not exclude that closer monitoring for selected patients exposed to concomitant chronic pharmacological therapies and affected by predisposing factors may be useful. This case involves 72 years old female patient who was vaccinated with dose of INFLUENZA VACCINE (batch number, expiry date, route and site of administration were not reported) and ATORVASTATIN (batch number, expiry date, route of administration was not reported) on an unspecified date. The patient''s medical history and concomitant medication were not reported. On an unspecified date, same day following the vaccination and after receiving drug, patient had dizziness, local swelling, nausea, presyncope and vomiting. Laboratory investigation includes CK 181; l; Myoglobin 167.7 LABS: Echocardiogram w/mild left atrial enlargement, mitral insufficiency and tricuspid insufficiency. Myoglobin 167 (H), CPK (creatine phosphokinase test): 181 (H). WBC 11.5 (H), lymphs 12.2 percent (L), neutros 9.2 (H). Corrective treatment was not reported. On an unspecified date, patient was recovered from events. This case was considered as serious by the reporter due to medically significant events. The reporter assessed the causal relationship between Trivalent, inactivated subunit influenza virus vaccine and ATORVASTATIN for the events as inconsistent. List of documents held by sender: none. Sender''s Comments: This literature article reports about an elderly patient who experienced Presyncope, Vomiting and local swelling in relation to INFLUENZA vaccine and ATORVASTATIN therapy. The time to onset is compatible. However, patient''s past medical history & medical condition at the time of vaccination was not reported. There is a possibility that the events are due to the other suspect drug or a pre-existing medical condition. Based upon the reported information and with special consideration to the age of the patient, the role of the vaccine cannot be assessed.


VAERS ID: 743521 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2018-04-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX(H1N1): INFLUENZA (H1N1) (H1N1 (MONOVALENT) (UNKNOWN)) / UNKNOWN MANUFACTURER - / UNK UN / UN

Administered by: Other       Purchased by: ?
Symptoms: Back pain, Blood creatine phosphokinase MB increased, Blood creatine phosphokinase increased, Blood glucose increased, Condition aggravated, Electrocardiogram abnormal, Foaming at mouth, Gaze palsy, Generalised tonic-clonic seizure, Hyperglycaemia, Leukocytosis, Lymphocyte count decreased, Lymphocyte percentage decreased, Neutrophil percentage increased, Rhabdomyolysis, Seizure, Tonic convulsion, Vomiting
SMQs:, Rhabdomyolysis/myopathy (narrow), Acute pancreatitis (broad), Haematopoietic leukopenia (narrow), Hyperglycaemia/new onset diabetes mellitus (narrow), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (narrow), Myocardial infarction (narrow), Arrhythmia related investigations, signs and symptoms (broad), Retroperitoneal fibrosis (broad), Convulsions (narrow), Oropharyngeal conditions (excl neoplasms, infections and allergies) (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Ocular motility disorders (narrow), 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? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: ATORVASTATIN
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: ITSA2018SA096488

Write-up: Initial unsolicited report received from literature on 26 Mar 2018. This case is linked to 2018SA095111, 2018SA095117, 2018SA095112, 2018SA095116, 2018SA096247, 2018SA096279, 2018SA096286, 2018SA096304, 2018SA096332, 2018SA096338, 2018SA096354, 2018SA096379, 2018SA096401, 2018SA096428, 2018SA096432, 2018SA096439, 2018SA096448, 2018SA096456, 2018SA096464, 2018SA096468, 2018SA096471, 2018SA096475, 2018SA096477, 2018SA096479, 2018SA096482, 2018SA096366, 2018SA096377, 2018SA096413, 2018SA096421, 2018SA096450, 2018SA096460, 2018SA096465, 2018SA096469, 2018SA096473, 2018SA096478, 2018SA096483, 2018SA096485, 2018SA096500, 2018SA096502, 2018SA096505, 2018SA096506, 2018SA096508, 2018SA096383, 2018SA096433 (Same Literature). The following is verbatim from the article: Background: An increasing number of reports indicates that vaccines against influenza may interact with specific drugs via drug metabolism. To date, actual impact of vaccine-drug interactions observed in the real world clinical practice has not been investigated. Methods: From VAERS and database, we collected Adverse Event Following Immunization (AEFI) reports for individuals receiving vaccines against influenza recorded as suspect and selected cases where predictable toxicity was recorded with oral anticoagulants, antiepileptics and statins (i.e. hemorrhages, overdosage and rhabdomyolysis, respectively). We applied AEFI and Drug Interaction Probability Scale (DIPS) Algorithms to assess causality of drug-vaccine interactions. Results: 116 AEFI reports submitted to VAERS and 83 from database were included in our analysis; antiepileptics and statins were related to the highest number of indeterminate/consistent (93.7%; 65.3%) and possible/probable (50%; 57.7%) cases according to the AEFI and DIPS, respectively. The majority of cases occurred within the first week after vaccine administration (5-7 days). Conclusion: The relative paucity of detected interactions does not impact on the benefit of the vaccination against influenza, which remains strongly recommended; this does not exclude that closer monitoring for selected patients exposed to concomitant chronic pharmacological therapies and affected by predisposing factors may be useful. This case involves a 60-year-old male patient who was vaccinated with dose of INFLUENZA VIRUS VACCINE H1N1 MONOVALENT (batch number, expiry date, route and site of administration were not reported) and received Atorvastatin (batch number and expiry date were not reported) on an unknown date. The patient''s medical history and concomitant medication were not reported. On an unspecified date, four days post vaccination and post drug administration, the patient developed convulsion, tonic convulsion, foaming at mouth with the diagnosis of grand mal convulsion. On an unspecified date, four days post vaccination and post drug administration, the patient developed back pain, condition aggravated, gaze palsy, hyperglycaemia, leukocytosis, rhabdomyolysis and vomiting. Relevant laboratory investigations included blood creatinine phosphokinase increased, blood creatinine phosphokinase mb increased, blood glucose increased, electrocardiogram abnormal, lymphocyte count decreased, lymphocyte percentage decreased and neutrophil percentage increased. Corrective treatment were not reported. On an unknown date, the patient was recovered from the events. This case was considered as serious by the reporter due to medically significant events. The reporter assessed the causal relationship with INFLUENZA VACCINE and Atorvastatin as inconsistent not applicable as per drug interaction probability scale. List of documents held by sender: none. Sender''s Comments: This literature article reports about an adult patient who experienced Generalized convulsions, back pain, gaze palsy, hyperglycemia, leukocytosis, rhabdomyolysis and vomiting in relation to INFLUENZA vaccine and ATORVASTATIN therapy. The time to onset is compatible. However, patient''s past medical history & medical condition at the time of vaccination was not reported. There is a possibility that the events are due to the other suspect drug or a pre-existing medical condition. Based upon the reported information and with special consideration to the age of the patient, the role of the vaccine cannot be assessed.


VAERS ID: 743522 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2018-04-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN

Administered by: Other       Purchased by: ?
Symptoms: Myositis
SMQs:, Rhabdomyolysis/myopathy (broad), 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? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: HYDROCHLOROTHIAZIDE; CALCIUM; VITAMIN D; ASPIRIN; ROSUVASTATIN
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: ITSA2018SA096500

Write-up: Initial unsolicited report received from literature on 26 Mar 2018. This case was linked to 2018SA095111, 2018SA095117, 2018SA095112, 2018SA095116, 2018SA096247, 2018SA096279, 2018SA096286, 2018SA096304, 2018SA096332, 2018SA096338, 2018SA096354, 2018SA096379, 2018SA096401, 2018SA096428, 2018SA096432, 2018SA096439, 2018SA096448, 2018SA096456, 2018SA096464, 2018SA096468, 2018SA096471, 2018SA096475, 2018SA096477, 2018SA096479, 2018SA096482, 2018SA096366, 2018SA096377, 2018SA096413, 2018SA096421, 2018SA096433, 2018SA096450, 2018SA096460, 2018SA096465, 2018SA096469, 2018SA096473, 2018SA096478, 2018SA096483, 2018SA096485, 2018SA096488, 2018SA096502, 2018SA096505, 2018SA096506, 2018SA096508, 2018SA096383 (Same Literature). The following is verbatim from the article: Background: An increasing number of reports indicates that vaccines against influenza may interact with specific drugs via drug metabolism. To date, actual impact of vaccine-drug interactions observed in the real world clinical practice has not been investigated. Results: 116 AEFI reports submitted to VAERS and 83 from database were included in our analysis; antiepileptics and statins were related to the highest number of indeterminate/consistent (93.7%; 65.3%) and possible/probable (50%; 57.7%) cases according to the AEFI and DIPS, respectively. The majority of cases occurred within the first week after vaccine administration (5-7 days). Conclusion: The relative paucity of detected interactions does not impact on the benefit of the vaccination against influenza, which remains strongly recommended; this does not exclude that closer monitoring for selected patients exposed to concomitant chronic pharmacological therapies and affected by predisposing factors may be useful. This case involves 66 years old female patient who was vaccinated with dose of INFLUENZA VACCINE (batch number, expiry date, route and site of administration were not reported). The patient also received dose of ROSUVASTATIN (batch number, expiry date and route were not reported) on an unspecified date. The patient''s medical history was not reported. Patient concomitant medication included Hydrochlorothiazide, Calcium, vitamin D and Aspirin. On an unspecified date, 15 days post vaccination patient experienced Myositis. Corrective treatment and other laboratory investigation was not reported. On an unknown date the patient recovered from the event. The case was considered serious due to medically significant. The reporter assessed the causal relationship with TRIVALENT, INACTIVATED SUBUNIT INFLUENZA VIRUS VACCINE and ROSUVASTATIN for the event reported as unclassifiable possible. List of documents held by sender: none. Sender''s Comments: This literature article reports of a 66 year old female who developed myositis after influenza vacination and therapy with rosuvastatin. Further information regarding vaccination details(MFR), symptoms and their evolution, medical history as well as concurrent condition during vaccination, previous vaccination and tolerance, allergic history, laboratory investigations excluding alternative etiologies for the reported event are needed to fully assess this case. There is a possibility that the events might be related to statin therapy. Based upon the given information the role of the vaccine cannot be assessed.


VAERS ID: 743551 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2018-04-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN

Administered by: Other       Purchased by: ?
Symptoms: Aphasia, Asthenia, Bronchitis, Cough, Decreased activity, Demyelination, Dry eye, Epstein-Barr virus infection, Epstein-Barr virus test positive, Erythema, Eye discharge, Eye irritation, Facial paralysis, Fatigue, Gaze palsy, Generalised erythema, Headache, Hemiparesis, Impaired driving ability, Laboratory test abnormal, Loss of personal independence in daily activities, Memory impairment, Neurological symptom, Photophobia, Pyrexia, Sensorimotor disorder, Sneezing, Tremor, Vision blurred, Vitamin D decreased, Vitamin D deficiency
SMQs:, Anaphylactic reaction (narrow), Peripheral neuropathy (narrow), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Parkinson-like events (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (narrow), Glaucoma (broad), Optic nerve disorders (broad), Demyelination (narrow), Lens disorders (broad), Corneal disorders (broad), Retinal disorders (broad), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (narrow), Depression (excl suicide and self injury) (broad), Hearing impairment (broad), Conjunctival disorders (narrow), Lacrimal disorders (narrow), Ocular motility disorders (narrow), Hypersensitivity (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Dehydration (broad), Opportunistic infections (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: CARBAMAZEPINE; CLONAZEPAM; ARMODAFINIL
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Hypersomnia
Allergies:
Diagnostic Lab Data:
CDC Split Type: ITSA2018SA096279

Write-up: Initial unsolicited report received from literature on 26 Mar 2018. This case was linked to 2018SA095111, 2018SA095117, 2018SA095112, 2018SA095116, 2018SA096247 2018SA096379, 2018SA096286, 2018SA096304, 2018SA096332, 2018SA096338, 2018SA096354, 2018SA096475, 2018SA096401, 2018SA096428, 2018SA096432, 2018SA096439, 2018SA096448, 2018SA096456, 2018SA096464, 2018SA096468, 2018SA096471, 2018SA096508, 2018SA096477, 2018SA096482, 2018SA096366, 2018SA096377, 2018SA096383, 2018SA096413, 2018SA096421, 2018SA096433, 2018SA096450, 2018SA096460, 2018SA096465, 2018SA096469, 2018SA096473, 2018SA096478, 2018SA096483, 2018SA096485, 2018SA096488, 2018SA096500, 2018SA096502, 2018SA096505, 2018SA096506 and 2018SA096479 (Same Literature). The following is verbatim from the article: Background: An increasing number of reports indicates that vaccines against influenza may interact with specific drugs via drug metabolism. To date, actual impact of vaccine-drug interactions observed in the real world clinical practice has not been investigated. Methods: From VAERS and database, we collected Adverse Event Following Immunization (AEFI) reports for individuals receiving vaccines against influenza recorded as suspect and selected cases where predictable toxicity was recorded with oral anticoagulants, antiepileptics and statins (i.e. hemorrhages, overdosage and rhabdomyolysis, respectively). We applied AEFI and Drug Interaction Probability Scale (DIPS) Algorithms to assess causality of drug-vaccine interactions. Results: 116 AEFI reports submitted to VAERS and 83 from database were included in our analysis; antiepileptics and statins were related to the highest number of indeterminate/consistent (93.7%; 65.3%) and possible/probable (50%; 57.7%) cases according to the AEFI and DIPS, respectively. The majority of cases occurred within the first week after vaccine administration (5-7 days). Conclusion: The relative paucity of detected interactions does not impact on the benefit of the vaccination against influenza, which remains strongly recommended; this does not exclude that closer monitoring for selected patients exposed to concomitant chronic pharmacological therapies and affected by predisposing factors may be useful. This case involves 52 years old female patient who was vaccinated with a dose of INFLUENZA VACCINE. The patient also received dose of Carbamazepine, Armodafinil and clonazepam (batch number, expiry date, route and site of administration were not reported) on an unspecified date for all products. The patient''s medical history was reported as Hypersomnia. Concomitant medication was not reported. On an unspecified date, three days following the vaccination and after receiving drug, patient''s activities of daily living impaired, had aphasia, tremors, vision blurred, vitamin D deficiency, all over body redness, photophobia, asthenia, bronchitis, cough, decreased activity, dry eye, erythema, eye discharge, eye irritation, facial paralysis, fatigue, gaze palsy, headache, hemiparesis, impaired driving ability, memory impairment, neurological symptom, pyrexia, sensorimotor disorder, sneezing. Authors pointed out that suspect drugs Armodafinil and clonazepam were known to have drug-drug interactions. Patient was hospitalized on an unspecified date. Laboratory investigations were performed which resulted that patient had Epstein-Barr virus infection, demyelination and vitamin D deficiency. Corrective treatment was not reported. Outcome of events was not reported. Reporter assessed the causality with INFLUENZA VACCINE and Carbamazepine as Indeterminate Probable with DIPS score 5. List of documents held by sender: none. Sender''s Comments: This literature article reports about an adult patient who experienced Eye discharge, Facial and hemiparesis, tremore, Vitamin D deficinecy, bronchitis, fatigue, pyrexia and neurological symptoms in relation to INFLUENZA vaccine and CARBAMAZEPINE therapy. The time to onset is compatible. However, medical condition at the time of vaccination was not reported. There is a possibility that the events are due to the other suspect drug or a pre-existing medical condition. Based upon the reported information and with special consideration to the age of the patient, the role of the vaccine cannot be assessed.


VAERS ID: 743552 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2018-04-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX(H1N1): INFLUENZA (H1N1) (H1N1 (MONOVALENT) (UNKNOWN)) / UNKNOWN MANUFACTURER - / UNK UN / UN

Administered by: Other       Purchased by: ?
Symptoms: CSF protein increased, Coordination abnormal, Demyelination, Diabetic neuropathy, Electromyogram abnormal, Guillain-Barre syndrome, Loss of personal independence in daily activities, Mobility decreased, Nerve conduction studies abnormal, Paraesthesia, Paraplegia, Plasmapheresis, Respiratory failure
SMQs:, Rhabdomyolysis/myopathy (broad), Anaphylactic reaction (broad), Peripheral neuropathy (narrow), Anticholinergic syndrome (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (broad), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (broad), Toxic-septic shock conditions (broad), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Dementia (broad), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Parkinson-like events (broad), Acute central respiratory depression (narrow), Guillain-Barre syndrome (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Optic nerve disorders (broad), Demyelination (narrow), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (broad), Hypersensitivity (broad), Respiratory failure (narrow), Tendinopathies and ligament disorders (broad), Hypoglycaemia (broad), Hypokalaemia (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: CARBAMAZEPINE; AMLODIPINE; LEVETIRACETAM; LOSARTAN; ATENOLOL; ROSUVASTATIN; METFORMIN; LISINOPRIL; HYDROCHLORTHIAZIDE; TAMSULOSIN; INSULIN
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Diabetic neuropathy
Allergies:
Diagnostic Lab Data: Test Name: CSF protein; Test Result: 138 mg/dl
CDC Split Type: ITSA2018SA096286

Write-up: Initial unsolicited report received from literature on 26 Mar 2018. This case is linked with 2018SA095111, 2018SA095117, 2018SA095112, 2018SA095116, 2018SA096247, 2018SA096279, 2018SA096304, 2018SA096332, 2018SA096338, 2018SA096354, 2018SA096379, 2018SA096401, 2018SA096428, 2018SA096432, 2018SA096439, 2018SA096448, 2018SA096456, 2018SA096464, 2018SA096468, 2018SA096471, 2018SA096475, 2018SA096477, 2018SA096479, 2018SA096482, 2018SA096366, 2018SA096377, 2018SA096383, 2018SA096413, 2018SA096421, 2018SA096433, 2018SA096450, 2018SA096460, 2018SA096465, 2018SA096469, 2018SA096473, 2018SA096478, 2018SA096483, 2018SA096485,2018SA096488, 2018SA096500, 2018SA096502, 2018SA096505, 2018SA096506, 2018SA096508 (same literature). The following is verbatim from the article: Background: An increasing number of reports indicates that vaccines against influenza may interact with specific drugs via drug metabolism. To date, actual impact of vaccine-drug interactions observed in the real world clinical practice has not been investigated. Methods: From VAERS and database, we collected Adverse Event Following Immunization (AEFI) reports for individuals receiving vaccines against influenza recorded as suspect and selected cases where predictable toxicity was recorded with oral anticoagulants, antiepileptics and statins (i.e. hemorrhages, overdosage and rhabdomyolysis, respectively). We applied AEFI and Drug Interaction Probability Scale (DIPS) Algorithms to assess causality of drug-vaccine interactions. Results: 116 AEFI reports submitted to VAERS and 83 from database were included in our analysis; antiepileptics and statins were related to the highest number of indeterminate/consistent (93.7%; 65.3%) and possible/probable (50%; 57.7%) cases according to the AEFI and DIPS, respectively. The majority of cases occurred within the first week after vaccine administration (5-7 days). Conclusion: The relative paucity of detected interactions does not impact on the benefit of the vaccination against influenza, which remains strongly recommended; this does not exclude that closer monitoring for selected patients exposed to concomitant chronic pharmacological therapies and affected by predisposing factors may be useful. This case involves 65-year-old male patient who was vaccinated with dose of Influenza H1N1 monovalent vaccine (dose in series not reported) and also received CARBAMAZEPINE, AMLODIPINE, LEVETIRACETAM, LOSARTAN POTASSIUM, ATENOLOL, ROSUVASTATIN, METFORMIN, LISINOPRIL, HYDROCHLOROTHIAZIDE, TAMSULOSIN, and INSULIN (batch number, expiry date, route and site of administration were not reported for both suspect product) on an unspecified date. Patient had a medical history of diabetic neuropathy. Other concomitant medication not reported. On an unspecified date, 31 days post vaccination and administration of CARBAMAZEPINE and also after the administartions of AMLODIPINE, LEVETIRACETAM, LOSARTAN POTASSIUM, ATENOLOL, ROSUVASTATIN, METFORMIN, LISINOPRIL, HYDROCHLOROTHIAZIDE, TAMSULOSIN, patient had diabetic neuropathy, coordination abnormal, paraesthesia, Activities of daily living impaired, Guillain Barre Syndrome (GBS), plasmapheresis, mobility decreased, paraplegia, respiratory failure. On an unknown date, patient was hospitalized. Authors pointed out that suspect drugs carbamazepine, amlodipine, levetiracetam, losartan, atenolol, rosuvastatina, metformin Lisinopril / hydrochlorthiazide, tamsulosin, insulinl are known to have drug-drug interactions. Laboratory data included CSF protein 138 mg/dl, EMG/NCS (Nerve Conduction Studies and Electromyography): primarily demyelination with absence of F-waves; prolonged distal latency of motor nerves; neurogenic changes superimposed with mild diabetic neuropathy; no myopathic findings. Corrective treatment were not reported. Outcome of the events were not reported. The reporter assessed the adverse events following immunization and drug interaction probability scale as Indeterminate (Possible). List of documents held by sender: none. Sender''s Comments: This literature article reports about an elderly patient who experienced Diabetic neuropathy, Guillain Barre syndrome and respiratory failure in relation to INFLUENZA vaccine and CARBAMAZEPINE therapy. The time to onset is compatible. However, patient''s medical condition at the time of vaccination was not reported and her past history includes Diabetic neuropathy. There is a possibility that the events are due to the other suspect drug or an aggravation of the pre-existing medical condition. Based upon the reported information and with special consideration to the age and past medical history of the patient, the role of the vaccine cannot be assessed.


VAERS ID: 743553 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2018-04-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Abdominal pain, Jaundice cholestatic, Pancreatitis, Vomiting
SMQs:, Cholestasis and jaundice of hepatic origin (narrow), Acute pancreatitis (narrow), Retroperitoneal fibrosis (broad), Biliary system related investigations, signs and symptoms (narrow), Biliary tract disorders (narrow), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Immune-mediated/autoimmune disorders (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: Carbamazepine; Valproic acid
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Lennox-Gastaut syndrome
Allergies:
Diagnostic Lab Data:
CDC Split Type: ITSA2018SA096338

Write-up: Initial unsolicited report received from literature on 26 Mar 2018. This case was linked to 2018SA095111, 2018SA095117, 2018SA095112, 2018SA095116, 2018SA096247, 2018SA096279, 2018SA096286, 2018SA096304, 2018SA096332, 2018SA096354, 2018SA096379, 2018SA096401, 2018SA096428, 2018SA096432, 2018SA096439, 2018SA096448, 2018SA096456, 2018SA096464, 2018SA096468, 2018SA096471, 2018SA096475, 2018SA096477, 2018SA096479, 2018SA096482, 2018SA096366, 2018SA096377, 2018SA096413, 2018SA096421, 2018SA096433, 2018SA096450, 2018SA096460, 2018SA096465, 2018SA096469, 2018SA096473, 2018SA096478, 2018SA096483, 2018SA096485, 2018SA096488, 2018SA096500, 2018SA096502, 2018SA096505, 2018SA096506, 2018SA096508, 2018SA096383 (Same Literature). Background: An increasing number of reports indicates that vaccines against influenza may interact with specific drugs via drug metabolism. To date, actual impact of vaccine-drug interactions observed in the real world clinical practice has not been investigated. Methods: From VAERS and database, we collected Adverse Event Following Immunization (AEFI) reports for individuals receiving vaccines against influenza recorded as suspect and selected cases where predictable toxicity was recorded with oral anticoagulants, antiepileptics and statins (i.e. hemorrhages, over dosage and rhabdomyolysis, respectively). We applied AEFI and Drug Interaction Probability Scale (DIPS) Algorithms to assess causality of drug-vaccine interactions. Results: 116 AEFI reports submitted to VAERS and 83 from database were included in our analysis; antiepileptics and statins were related to the highest number of indeterminate/consistent (93.7%; 65.3%) and possible/probable (50%; 57.7%) cases according to the AEFI and DIPS, respectively. The majority of cases occurred within the first week after vaccine administration (5-7 days). Conclusion: The relative paucity of detected interactions does not impact on the benefit of the vaccination against influenza, which remains strongly recommended; this does not exclude that closer monitoring for selected patients exposed to concomitant chronic pharmacological therapies and affected by predisposing factors may be useful. This case involves 31-year-old female patient who was vaccinated with dose of INFLUENZA VACCINE and received Carbamazepine, Valproic Acid (batch number, expiry date, route and site of administration were not reported) on an unknown date. The patient''s predisposing conditions included Lennox-Gastaut. Other medical history and other concomitant medications were not reported. On an unspecified date, six days post vaccination and post administration of Carbamazepine and also after the administration of Valproic Acid, the patient had abdominal pain, jaundice cholestatic vomiting and pancreatitis. On an unknown date, the patient was hospitalized. Authors pointed out that suspect drugs Valproic Acid Carbamazepine are known to have drug-drug interactions. Relevant laboratory investigation and corrective treatment were not reported. The outcome of the events were not reported. The reporter assessed the adverse events following immunization and drug interaction probability scale as indeterminate (doubtful). List of documents held by sender: none. Sender''s Comments: This literature article reports about an adult patient who developed Pancreatitis in relation to influenza nd CARBAMAZEPINE therapy. The time to onset is compatible. However, patient''s past medical condition, medical condition at time of vaccination and alcohol history was not reported. Her past drug therapy includes Valproic acid use. There is a possibility that the events are due to the other suspect drug or a pre-existing medical condition. Based upon the reported information, the role of the vaccine cannot be assessed.


VAERS ID: 743554 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2018-04-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN

Administered by: Other       Purchased by: ?
Symptoms: Acute kidney injury, Alanine aminotransferase increased, Aspartate aminotransferase increased, Blood creatine phosphokinase increased, Blood creatinine increased, Blood lactate dehydrogenase increased, Blood thyroid stimulating hormone normal, Gamma-glutamyltransferase increased, Glomerular filtration rate decreased, Muscular weakness, Myopathy, Protein urine present, Proteinuria, Pyrexia, Rhabdomyolysis, Upper respiratory tract infection
SMQs:, Rhabdomyolysis/myopathy (narrow), Acute renal failure (narrow), Liver related investigations, signs and symptoms (narrow), Peripheral neuropathy (broad), Neuroleptic malignant syndrome (narrow), Systemic lupus erythematosus (broad), Myocardial infarction (broad), Anticholinergic syndrome (broad), Retroperitoneal fibrosis (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (broad), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (broad), Toxic-septic shock conditions (broad), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Guillain-Barre syndrome (broad), Noninfectious encephalopathy/delirium (broad), Chronic kidney disease (broad), Tumour lysis syndrome (broad), Proteinuria (narrow), Tubulointerstitial diseases (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Dehydration (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: calcitriol; ezetimibe; simvastatin; acetylsalicylic acid; tacrolimus; azathioprine; prednisolone
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Diabetic nephropathy; Renal transplant (8 years ago)
Allergies:
Diagnostic Lab Data: Test Name: alanine aminotransferase; Result Unstructured Data: 319 unit(s)/litre; Test Name: Aspartate aminotransferase; Result Unstructured Data: 394 unit(s)/litre; Test Name: Creatine phosphokinase; Result Unstructured Data: 7851 unit(s)/litre; Test Name: Blood creatinine; Result Unstructured Data: 161 millimole(s)/litre; Test Name: Lactate dehydrogenase; Result Unstructured Data: 1400 unit(s)/litre; Test Name: thyroid stimulating hormone; Result Unstructured Data: 0.33 milli international unit(s)/litre; Test Name: Gamma-glutamyltransferase; Result Unstructured Data: 62 unit(s)/litre; Test Name: Glomerular filtration rate; Result Unstructured Data: 40 ML/MIN/1.73 M2 millilitre(s)/minute
CDC Split Type: ITSA2018SA096450

Write-up: Initial unsolicited report received from literature on 26 Mar 2018. This case was linked to 2018SA095111, 2018SA095117, 2018SA095112, 2018SA095116, 2018SA096247,2018SA096279, 2018SA096286, 2018SA096304, 2018SA096332, 2018SA096338, 2018SA096354, 2018SA096379, 2018SA096401, 2018SA096428, 2018SA096432, 2018SA096439, 2018SA096448, 2018SA096456, 2018SA096464, 2018SA096468, 2018SA096471, 2018SA096475, 2018SA096477, 2018SA096479, 2018SA096482, 2018SA096366, 2018SA096377, 2018SA096413, 2018SA096421, 2018SA096433, 2018SA096460, 2018SA096465, 2018SA096469, 2018SA096473, 2018SA096478, 2018SA096483, 2018SA096485, 2018SA096488, 2018SA096500, 2018SA096502, 2018SA096505, 2018SA096506, 2018SA096508, 2018SA096383. The following is verbatim from the article: Background: An increasing number of reports indicates that vaccines against influenza may interact with specific drugs via drug metabolism. To date, actual impact of vaccine-drug interactions observed in the real world clinical practice has not been investigated. Results: 116 AEFI reports submitted to VAERS and 83 from database were included in our analysis; antiepileptics and statins were related to the highest number of indeterminate/consistent (93.7%; 65.3%) and possible/probable (50%; 57.7%) cases according to the AEFI and DIPS, respectively. The majority of cases occurred within the first week after vaccine administration (5-7 days). Conclusion: The relative paucity of detected interactions does not impact on the benefit of the vaccination against influenza, which remains strongly recommended; this does not exclude that closer monitoring for selected patients exposed to concomitant chronic pharmacological therapies and affected by predisposing factors may be useful. This case involves 64 years old male patient who was vaccinated with dose of influenza vaccine (batch number, expiry date, dose, route and site of administration were not reported). The patient also received simvastatin, acetylsalicylic acid, tacrolimus, azathioprine and prednisolone (batch number, expiry date and route were not reported) on an unspecified date. The patient had a medical history of diabetic nephropathy and 8 years ago had a renal transplant. Patient concomitant medication included calcitriol and ezetimibe. On an unspecified date, one day post vaccination patient experienced rhabdomyolysis, muscular weakness, myopathy, acute kidney injury, proteinuria, upper respiratory tract infection and pyrexia. Case was consider as serious because of permanent disability. Authors pointed out that suspect drugs acetylsalicylic acid, tacrolimus, azathioprine, prednisolone are known to have drug-drug interactions. Corrective treatment was not reported. Laboratory investigation included ALT (alanine aminotransferase) 319 U/l; AST (Aspartate aminotransferase) 394 U/l; CPK (Creatine phosphokinase) 7851 U/l; Blood creatinine, 161 umol/l; LDH (Lactate dehydrogenase) 1400 U/l; TSH (thyroid stimulating hormone) 0.33 mIU/l; GGT (gamma-glutamyl transferase) 62 U/l; GFR (Glomerular filtration rate) 40 ml/min/1.73 m2; Proteinuria 1.8 g/day. At the time of this report, the outcome of events was unknown. The reporter assessed the causal relationship with influenza vaccine, simvastatin, acetylsalicylic acid, tacrolimus, azathioprine and Prednisolone for the events reported as Indeterminate Possible (2). List of documents held by sender: none. Sender''s Comments: This literature article reports of a 81 year old female who developed Rhabdomyolysis, acute kidney injury, upper respiratory tract infection, muscular weakness, proteinuria, myopathy and pyrexia after influenza vaccination and therapy with Simvastatin. Further information regarding vaccination details (MFR), symptoms and their evolution, medical history as well as concurrent condition during vaccination, previous vaccination and tolerance, allergic history, laboratory investigations excluding alternative etiologies for the reported event are needed to fully assess this case. There is a possibility that the events might be related to statin therapy. Based upon the given information the role of the vaccine cannot be assessed.


VAERS ID: 743555 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2018-04-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / -
VARCEL: VARICELLA (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Areflexia, Back pain, Blood creatine phosphokinase increased, CSF cell count increased, Computerised tomogram normal, General physical health deterioration, Hypoaesthesia, Muscular weakness, Myoglobin blood increased, Myopathy, Pain in extremity, Paraesthesia, Pleocytosis, Rhabdomyolysis, Sensory loss, Tenderness
SMQs:, Rhabdomyolysis/myopathy (narrow), Peripheral neuropathy (narrow), Neuroleptic malignant syndrome (broad), Myocardial infarction (broad), Retroperitoneal fibrosis (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Sexual dysfunction (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: SIMVASTATIN
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: Myoglobin blood; Result Unstructured Data: 243
CDC Split Type: ITSA2018SA096460

Write-up: Initial unsolicited report received from literature on 26 Mar 2018. This case is linked with 2018SA095111, 2018SA095117, 2018SA095112, 2018SA095116, 2018SA096247, 2018SA096279 2018SA096286, 2018SA096304, 2018SA096332, 2018SA096338, 2018SA096354, 2018SA096379 2018SA096401, 2018SA096428, 2018SA096432, 2018SA096439, 2018SA096448, 2018SA096456 2018SA096464, 2018SA096468, 2018SA096471, 2018SA096475, 2018SA096477, 2018SA096479 2018SA096482, 2018SA096366, 2018SA096377, 2018SA096383, 2018SA096413, 2018SA096421 2018SA096433, 2018SA096450, 2018SA096460, 2018SA096465, 2018SA096469, 2018SA096473 2018SA096478, 2018SA096483, 2018SA096485, 2018SA096488, 2018SA096500, 2018SA096502, 2018SA096505, 2018SA096506, 2018SA096508 (same literature). The following is verbatim from the article: Background: An increasing number of reports indicates that vaccines against influenza may interact with specific drugs via drug metabolism. To date, actual impact of vaccine-drug interactions observed in the real world clinical practice has not been investigated. Methods: From VAERS and database, we collected Adverse Event Following Immunization (AEFI) reports for individuals receiving vaccines against influenza recorded as suspect and selected cases where predictable toxicity was recorded with oral anticoagulants, antiepileptics and statins (i.e. hemorrhages, overdosage and rhabdomyolysis, respectively). We applied AEFI and Drug Interaction Probability Scale (DIPS) Algorithms to assess causality of drug-vaccine interactions. Results: 116 AEFI reports submitted to VAERS and 83 from database were included in our analysis; antiepileptics and statins were related to the highest number of indeterminate/consistent (93.7%; 65.3%) and possible/probable (50%; 57.7%) cases according to the AEFI and DIPS, respectively. The majority of cases occurred within the first week after vaccine administration (5-7 days). Conclusion: The relative paucity of detected interactions does not impact on the benefit of the vaccination against influenza, which remains strongly recommended; this does not exclude that closer monitoring for selected patients exposed to concomitant chronic pharmacological therapies and affected by predisposing factors may be useful. This case involves 65 years old female patient who was vaccinated with dose of INFLUENZA VACCINE, SIMVASTATIN and VARICELLA VIRUS (batch number, expiry date, route and site of administration were not reported) on an unspecified date. Medical history and concomitant medications were not reported. On an unspecified date, two days following the vaccination patient experienced rhabdomyolysis, general physical health deterioration, myopathy, pleocytosis, sensory loss, paraesthesia, hypoesthesia, areflexia with the symptoms of back pain, pain in extremity, tenderness and muscular weakness. On an unknown date creatinine phosphokinase CPK was measured and the count was 2900, cerebrospinal fluid CSF test revealed pleocytosis. Computerized tomogram was negative. On an unknown date patient did Myoglobin blood test and the result was 243 (unit not reported). On an unknown date patient was hospitalized. Other laboratory investigation and corrective treatment were not reported. The outcome of the event was reported as unknown. The reporter assessed the causal relationship with INFLUENZA VACCINE and SIMVASTATIN for the events were Indeterminate doubtful. List of documents held by sender: none. Sender''s Comments: This literature article reports about a 65 year old female patient who experienced Rhabdomyolysis, Myopathy, sensory system abnormalities and general health deterioration in relation to INFLUENZA vaccine and SIMVASTATIN therapy. The time to onset is compatible. However, patient''s past medical history and condition at the time of vaccination was not reported. There is a possibility that the events are due to the suspect drug or a pre-existing medical condition. Based upon the reported information and with special consideration to the age of the patient, the role of the vaccine cannot be assessed.


VAERS ID: 743556 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2018-04-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN

Administered by: Other       Purchased by: ?
Symptoms: Gait inability, Haematuria, Mobility decreased, Muscular weakness, Platelet count decreased, Urinary tract infection
SMQs:, Rhabdomyolysis/myopathy (broad), Haematopoietic thrombocytopenia (narrow), Peripheral neuropathy (broad), Haemorrhage terms (excl laboratory terms) (narrow), Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Dystonia (broad), Parkinson-like events (broad), Guillain-Barre syndrome (broad), Noninfectious encephalopathy/delirium (broad), Tubulointerstitial diseases (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? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: BISOPROLOL; LACTULOSE; MICONAZOL; OMEPRAZOLE; PREDNISOLONE; TAMSULOSIN; WARFARIN
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Atrial fibrillation; Benign prostatic hyperplasia; Rheumatoid arthritis; Tricuspid insufficiency
Allergies:
Diagnostic Lab Data: Test Name: platelet count; Result Unstructured Data: DECREASED
CDC Split Type: ITSA2018SA096464

Write-up: Initial unsolicited report received from literature on 26 Mar 2018. This case is linked with 2018SA095111, 2018SA095117, 2018SA095112, 2018SA095116, 2018SA096247, 2018SA096279, 2018SA096286, 2018SA096304, 2018SA096332, 2018SA096338, 2018SA096354, 2018SA096379, 2018SA096401, 2018SA096428, 2018SA096432, 2018SA096439, 2018SA096448, 2018SA096456, 2018SA096473, 2018SA096468, 2018SA096471, 2018SA096475, 2018SA096477, 2018SA096479, 2018SA096482, 2018SA096366, 2018SA096377, 2018SA096383, 2018SA096413, 2018SA096421, 2018SA096433, 2018SA096450, 2018SA096460, 2018SA096465, 2018SA096469, 2018SA096508, 2018SA096478, 2018SA096483, 2018SA096485, 2018SA096488, 2018SA096500, 2018SA096502, 2018SA096505 and 2018SA096506 (Same literature). The following is verbatim from the article: Background: An increasing number of reports indicates that vaccines against influenza may interact with specific drugs via drug metabolism. To date, actual impact of vaccine-drug interactions observed in the real world clinical practice has not been investigated. Methods: From VAERS and database, we collected Adverse Event Following Immunization (AEFI) reports for individuals receiving vaccines against influenza recorded as suspect and selected cases where predictable toxicity was recorded with oral anticoagulants, antiepileptics and statins (i.e. hemorrhages, overdosage and rhabdomyolysis, respectively). We applied AEFI and Drug Interaction Probability Scale (DIPS) Algorithms to assess causality of drug-vaccine interactions. Results: 116 AEFI reports submitted to VAERS and 83 from database were included in our analysis; antiepileptics and statins were related to the highest number of indeterminate/consistent (93.7%; 65.3%) and possible/probable (50%; 57.7%) cases according to the AEFI and DIPS, respectively. The majority of cases occurred within the first week after vaccine administration (5-7 days). Conclusion: The relative paucity of detected interactions does not impact on the benefit of the vaccination against influenza, which remains strongly recommended; this does not exclude that closer monitoring for selected patients exposed to concomitant chronic pharmacological therapies and affected by predisposing factors may be useful. This case involves 75 years old male patient who was vaccinated with dose of INFLUENZA VACCINE (batch number, expiry date, route and site of administration were not reported) and received Warfarin (batch number and expiry date were not reported) on an unspecified date. The patient''s predisposing conditions was reported as atrial fibrillation, benign prostatic hyperplasia; rheumatoid arthritis and tricuspid insufficiency. The patient''s concomitant medication includes Bisoprolol; lactulose, miconazol, omeprazole, prednisolone and tamsulosin. On an unspecified date, same day following the vaccination and after receiving drug, patient had abasia, hematuria, mobility decreased, muscular weakness, platelet count decreased and urinary tract infection. Patient was hospitalized on an unspecified date. Other laboratory investigation and corrective treatment were not reported. Outcome of events was not reported. The reporter assessed the causal relationship between INFLUENZA VIRUS VACCINE and WARFARIN for the events as indeterminate possible and drug interaction probability scale score reported as (3). List of documents held by sender: none. Sender''s Comments: This patient developed reported events following vaccination with Influenza vaccine (unknown manufacturer) while he was on Warfarin treatment. Time to onset is unknown. Past medical history included benign prostatic hyperplasia, atrial fibrillation,tricuspid insufficiency and rheumatoid arthritis. There is a possibility that reported events might be attributed to medical history. Additional information including vaccination details with manufacturer, onset time, concomitant vaccinations, past vaccination history with tolerance data, condition at the time of vaccination and laboratory test ruling out other etiologies is needed for further assessment. Based on available information role of vaccine cannot be assessed.


VAERS ID: 743557 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2018-04-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN
VARZOS: ZOSTER (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN

Administered by: Other       Purchased by: ?
Symptoms: Blood pressure increased, Dehydration, Diplopia, Haemorrhage intracranial, Headache, Hypoacusis, Nuclear magnetic resonance imaging brain abnormal, Parosmia, Photosensitivity reaction, Spinal pain
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (broad), Taste and smell disorders (narrow), Haemorrhagic central nervous system vascular conditions (narrow), Hypertension (narrow), Hearing impairment (narrow), Ocular motility disorders (broad), Hypersensitivity (broad), Arthritis (broad), Hypoglycaemia (broad), Dehydration (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: PREGABALIN; CLONIDINE; LISINOPRIL; INSULINE; AMLODIPINE; WARFARIN; ROSUVASTATIN; GLIPLIZIDE; TORSEMIDE
Current Illness: Diabetes mellitus
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: ITSA2018SA096477

Write-up: Initial unsolicited report received from literature on 26 Mar 2018. This case was linked to 2018SA095111, 2018SA095117, 2018SA095112, 2018SA095116, 2018SA096247, 2018SA096279, 2018SA096286, 2018SA096304, 2018SA096332, 2018SA096338, 2018SA096379, 2018SA096401, 2018SA096428, 2018SA096432, 2018SA096439, 2018SA096448, 2018SA096456, 2018SA096464, 2018SA096468, 2018SA096471, 2018SA096475, 2018SA096479, 2018SA096482, 2018SA096366, 2018SA096354, 2018SA096383, 2018SA096413, 2018SA096421, 2018SA096433, 2018SA096450, 2018SA096460, 2018SA096465, 2018SA096469, 2018SA096473, 2018SA096478, 2018SA096485, 2018SA096488, 2018SA096500, 2018SA096502, 2018SA096483, 2018SA096505, 2018SA096506, 2018SA096508, 2018SA096377 (same Literature). The following is verbatim from the article: Background: An increasing number of reports indicates that vaccines against influenza may interact with specific drugs via drug metabolism. To date, actual impact of vaccine-drug interactions observed in the real world clinical practice has not been investigated. Methods: From VAERS and database, we collected Adverse Event Following Immunization (AEFI) reports for individuals receiving vaccines against influenza recorded as suspect and selected cases where predictable toxicity was recorded with oral anticoagulants, antiepileptics and statins (i.e. hemorrhages, overdosage and rhabdomyolysis, respectively). We applied AEFI and Drug Interaction Probability Scale (DIPS) Algorithms to assess causality of drug-vaccine interactions. Results: 116 AEFI reports submitted to VAERS and 83 from database were included in our analysis; antiepileptics and statins were related to the highest number of indeterminate/consistent (93.7%; 65.3%) and possible/probable (50%; 57.7%) cases according to the AEFI and DIPS, respectively. The majority of cases occurred within the first week after vaccine administration (5-7 days). Conclusion: The relative paucity of detected interactions does not impact on the benefit of the vaccination against influenza, which remains strongly recommended; this does not exclude that closer monitoring for selected patients exposed to concomitant chronic pharmacological therapies and affected by predisposing factors may be useful. This case involves 68-year-old female patient who was vaccinated with dose of INFLUENZA VACCINE (batch number, expiry date, route and site of administration were not reported), HERPES ZOSTER VACCINE and administrated with Warfarin, Gliplizide, Torsemide and Rosuvastatin (batch number, expiry date, route were not reported) on an unspecified date. The patient''s medical history includes diabetes mellitus. Concomitant medication includes Pregabalin, clonidine, lisinopril, insuline, amlodipine. On an unspecified date, 27 day following the vaccination and after receiving warfarin drug, patient''s blood pressure increased, had dehydration, diplopia, hemorrhage intracranial, headache, hypoacusis, parosmia, photosensitivity reaction and spinal pain. Authors pointed out that suspect drugs Glipizide, Torsemide and Rosuvastatin are known to have drug-drug interactions. Patient was hospitalized on an unspecified date. Lab data includes nuclear magnetic resonance imaging brain abnormal. Corrective treatment was not reported. Outcome of events was not reported. The reporter assessed the causal relationship with Influenza Vaccine and Warfarin as Indeterminate doubtful with DIPS score 1. List of documents held by sender: none. Sender''s Comments: This literature article reports about an elderly patient who experienced Intracranial hemorrhage, spinal pain and dehydration in relation to INFLUENZA vaccine and WARFARIN therapy. The time to onset is compatible. However, condition at the time of vaccination was not reported. The past medical history includes Diabetes mellitus in this patient. Coagulation defcet is an expected event with Warfarin therapy, with or without drug interaction with Influenza vaccine and is a possible reason for intracranial hemorrhage. Based upon the reported information, the role of the vaccine cannot be assessed.


VAERS ID: 743558 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2018-04-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN

Administered by: Other       Purchased by: ?
Symptoms: Acute kidney injury, Blood creatine phosphokinase increased, Blood creatinine increased, Blood potassium increased, Blood urea increased, Hyperkalaemia, Laboratory test abnormal, Muscular weakness, Myalgia, Myoglobin blood increased, Myoglobin urine present, Myoglobinuria, Rhabdomyolysis, Urine analysis abnormal
SMQs:, Rhabdomyolysis/myopathy (narrow), Acute renal failure (narrow), Peripheral neuropathy (broad), Neuroleptic malignant syndrome (broad), Myocardial infarction (broad), Retroperitoneal fibrosis (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (broad), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (broad), Toxic-septic shock conditions (broad), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Guillain-Barre syndrome (broad), Noninfectious encephalopathy/delirium (broad), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Chronic kidney disease (broad), Tumour lysis syndrome (narrow), Proteinuria (narrow), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Dehydration (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: ACETYLSALICYLIC ACID; SIMVASTATIN; CERIVASTATIN; BEZAFIBRATE
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: Creatinine; Test Result: 3.5 mg/dl; Test Name: Potassium; Result Unstructured Data: UNK; Comments: 5.2 MEG/L; Test Name: CPK; Result Unstructured Data: 93000 unit(s)/litre; Test Name: Myoglobin blood; Result Unstructured Data: 43400 microgram(s)/litre; Test Name: Urea; Test Result: 149 mg/dl; Test Name: myoglobin urine; Result Unstructured Data: 18600 microgram(s)/litre
CDC Split Type: ITSA2018SA096479

Write-up: Initial unsolicited report received from literature on 26 Mar 2018. This case was linked to 2018SA095111, 2018SA095117, 2018SA095112, 2018SA095116, 2018SA096247, 2018SA096279, 2018SA096286, 2018SA096304, 2018SA096332, 2018SA096338, 2018SA096354, 2018SA096379, 2018SA096401, 2018SA096428, 2018SA096432, 2018SA096439, 2018SA096448, 2018SA096456, 2018SA096464, 2018SA096468, 2018SA096471, 2018SA096475, 2018SA096477, 2018SA096482, 2018SA096366, 2018SA096377, 2018SA096383, 2018SA096413, 2018SA096421, 2018SA096433, 2018SA096450, 2018SA096460, 2018SA096465, 2018SA096469, 2018SA096473, 2018SA096478, 2018SA096483, 2018SA096485, 2018SA096488, 2018SA096500, 2018SA096502, 2018SA096505, 2018SA096506, 2018SA096508 (Same Literature). The following is verbatim from the article: Background: An increasing number of reports indicates that vaccines against influenza may interact with specific drugs via drug metabolism. To date, actual impact of vaccine-drug interactions observed in the real world clinical practice has not been investigated. Methods: From VAERS and database, we collected Adverse Event Following Immunization (AEFI) reports for individuals receiving vaccines against influenza recorded as suspect and selected cases where predictable toxicity was recorded with oral anticoagulants, antiepileptics and statins (i.e. hemorrhages, overdosage and rhabdomyolysis, respectively). We applied AEFI and Drug Interaction Probability Scale (DIPS) Algorithms to assess causality of drug-vaccine interactions. Results: 116 AEFI reports submitted to VAERS and 83 from database were included in our analysis; antiepileptics and statins were related to the highest number of indeterminate/consistent (93.7%; 65.3%) and possible/probable (50%; 57.7%) cases according to the AEFI and DIPS, respectively. The majority of cases occurred within the first week after vaccine administration (5-7 days). Conclusion: The relative paucity of detected interactions does not impact on the benefit of the vaccination against influenza, which remains strongly recommended; this does not exclude that closer monitoring for selected patients exposed to concomitant chronic pharmacological therapies and affected by predisposing factors may be useful. This case involves 68-year-old male patient who was vaccinated with dose of INFLUENZA VACCINE (batch number, expiry date, route and site of administration were not reported) and received Simvastatin (batch number and expiry date were not reported) on an unknown date. The patient also received Cerivastatin and Bezafibrate (batch number and expiry date were not reported) on an unknown date. The patient''s medical history were not reported. Concomitant medication included acetylsalicylic acid. On an unspecified date, four days post vaccination and post drug administration with Simvastatin, the patient developed blood creatinine increased, blood urea increased and hyperkalemia and renal failure acute, blood creatinine phosphokinase increased, myoglobinuria, myalgia and muscular weakness, rhabdomyolysis (revealed in lab test). On an unknown date, four days post vaccination and post drug administration, the patient also had laboratory test abnormal. Authors pointed out that suspect drugs Simvastatin, Cerivastatin and Bezafibrate are known to have drug-drug interactions. Laboratory investigation also included Creatinine 3.5 mg/dl, Potassium 5.2 mEg/l, serum CPK 93,000 u/l, serum myoglobin 43,400 mcg/l, Urea 149 mg/dl, Urinalysis showed positive orthotoluidine and urine myoglobin 18,600 mcg/l. Corrective treatment were not reported. On an unknown date, the patient was recovered from the events. This case was reported as serious by the reporter due to medically significant events. The reporter assessed the adverse events following immunization and drug interaction probability scale as indeterminate (possible). List of documents held by sender: none. Sender''s Comments: This literature article reports about a 68 year old male patient who experienced Acute renal failure, Rhabdomyolysis in relation to INFLUENZA vaccine and SIMVASTATIN therapy. The time to onset is compatible. However, patient''s past medical history and condition at the time of vaccination was not reported. There is a possibility that the events are due to the suspect drug or a pre-existing medical condition. Based upon the reported information and with special consideration to the age of the patient, the role of the vaccine cannot be assessed.


VAERS ID: 743561 (history)  
Form: Version 1.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2018-04-09
Entered: 2018-04-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEP: HEP B (ENGERIX-B) / GLAXOSMITHKLINE BIOLOGICALS - / UNK UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Autoimmune thyroiditis, Hypersensitivity, Pancreatitis acute, Rheumatoid arthritis
SMQs:, Acute pancreatitis (narrow), Angioedema (broad), Hypothyroidism (broad), Hyperthyroidism (broad), Hypersensitivity (narrow), Arthritis (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Immune-mediated/autoimmune disorders (narrow)

Life Threatening? Yes
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: No other medications
Current Illness: Unknown
Preexisting Conditions: 10/12/1983, Hepatitis B, Prophylaxis, On 12th November 1983; 11/16/1983, Hepatitis B, Prophylaxis, On 16th November 1983
Allergies:
Diagnostic Lab Data:
CDC Split Type: DE2018056126

Write-up: This case was reported by a consumer via regulatory authority and described the occurrence of rheumatoid arthritis in a 25-year-old female patient who received Hepatitis B vaccine. Previously administered products included Hepatitis B (On 12th October 1983) and Hepatitis B (On 16th November 1983). On an unknown date, the patient received Hepatitis B vaccine (intramuscular). On 22nd December 1983, unknown after receiving Hepatitis B vaccine, the patient experienced acute pancreatitis (serious criteria hospitalization, GSK medically significant and life threatening). In 1997, the patient experienced allergy (serious criteria hospitalization and life threatening). In 2013, the patient experienced rheumatoid arthritis (serious criteria hospitalization, GSK medically significant and life threatening). In 2016, the patient experienced Hashimoto''s thyroiditis (serious criteria hospitalization, GSK medically significant and life threatening). On 2nd February 1984, the outcome of the acute pancreatitis was recovered/resolved. On an unknown date, the outcome of the rheumatoid arthritis, Hashimoto''s thyroiditis and allergy were not recovered/not resolved. The reporter considered the rheumatoid arthritis, acute pancreatitis, Hashimoto''s thyroiditis and allergy to be unlikely related to Hepatitis B vaccine. Additional information: The age at vaccination was not reported. PEI assessment: Inconsistent causal association. Initial information was reported by a consumer via regulatory authority on 03 April 2018: Rheumatoid arthritis, acute pancreatitis, Hashimoto''s thyroiditis and allergy.


VAERS ID: 743567 (history)  
Form: Version 1.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2018-04-09
Entered: 2018-04-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MNQ: MENINGOCOCCAL CONJUGATE (MENVEO) / NOVARTIS VACCINES AND DIAGNOSTICS - / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Nausea, Syncope
SMQs:, Torsade de pointes/QT prolongation (broad), Acute pancreatitis (broad), Arrhythmia related investigations, signs and symptoms (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Cardiomyopathy (broad), Hypotonic-hyporesponsive episode (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GB2018056412

Write-up: This case was reported by a consumer via regulatory authority and described the occurrence of fainting in a 15-year-old female patient who received Meningococcal ACWY (potential MENVEO). Co-suspect products included GARDASIL 9. On an unknown date, the patient received Meningococcal ACWY (potential MENVEO) (unknown). On 1st September 2017, the patient received the 1st dose of GARDASIL 9 (parenteral). On an unknown date, unknown after receiving Meningococcal ACWY (potential MENVEO), the patient experienced fainting (serious criteria other: Serious as per reporter) and nausea (serious criteria other: Serious as per reporter). On an unknown date, the outcome of the fainting and nausea were recovered/resolved. It was unknown if the reporter considered the fainting and nausea to be related to Meningococcal ACWY (potential MENVEO). Additional details: Age at vaccination was not reported. Initial information was received from a consumer via regulatory authority on 3rd April 2018: Fainting and nausea.


VAERS ID: 743576 (history)  
Form: Version 1.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2018-03-17
Submitted: 2018-04-09
   Days after onset:23
Entered: 2018-04-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HEPA: HEP A (HAVRIX) / GLAXOSMITHKLINE BIOLOGICALS AHAVB879AK / UNK UN / IM
RAB: RABIES (NO BRAND NAME) / UNKNOWN MANUFACTURER M116671M / UNK UN / IM

Administered by: Other       Purchased by: Other
Symptoms: Skin lesion
SMQs:, 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: No other medications
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: FR2018056189

Write-up: This case was reported by a physician via regulatory authority and described the occurrence of skin lesion nos in a 1-year-old female patient who received HAVRIX (batch number AHAVB879AK, expiry date unknown). Co-suspect products included Rabies Vaccine (batch number M116671M, expiry date unknown). On an unknown date, the patient received HAVRIX (intramuscular) 1 dosage form(s) and Rabies Vaccine (intramuscular) 1 dosage form(s). On 17th March 2018, unknown after receiving HAVRIX, the patient experienced skin lesion nos (serious criteria other: serious per reporter). On an unknown date, the outcome of the skin lesion nos was recovering/resolving. It was unknown if the reporter considered the skin lesion nos to be related to HAVRIX. Additional information: The age at vaccination was not reported. Initial information was received from a physician via regulatory authority on 3rd April 2018: Skin lesion nos.


VAERS ID: 743585 (history)  
Form: Version 1.0  
Age: 0.75  
Sex: Male  
Location: Foreign  
Vaccinated:2018-03-08
Onset:2018-03-08
   Days after vaccination:0
Submitted: 2018-04-08
   Days after onset:30
Entered: 2018-04-09
   Days after submission:1
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MENB: MENINGOCOCCAL B (BEXSERO) / NOVARTIS VACCINES AND DIAGNOSTICS 170201 / UNK UN / IM

Administered by: Other       Purchased by: Other
Symptoms: C-reactive protein increased, Electroencephalogram normal, Hyperpyrexia, Hypertonia, Muscle rigidity, White blood cell count normal
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Parkinson-like events (narrow), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypokalaemia (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: No other medications
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: 03/09/2018, C-reactive protein, 26.1 mg/L; 03/10/2018, Electroencephalogram, Negative; 03/13/2018, Electroencephalogram, negative; 03/09/2018, White blood count, 11480 mm3
CDC Split Type: IT2018057190

Write-up: This case was reported by a physician via regulatory authority and described the occurrence of hyperpyrexia in a 9-month-old male patient who received BEXSERO (batch number 170201, expiry date unknown). On 8th March 2018, the patient received BEXSERO (intramuscular) .5 ml. On 8th March 2018, less than a day after receiving BEXSERO, the patient experienced hyperpyrexia (serious criteria hospitalization and GSK medically significant), rigidity (serious criteria hospitalization) and hypertonus (serious criteria hospitalization). In March 2018, the outcome of the hyperpyrexia, rigidity and hypertonus were recovered/resolved. It was unknown if the reporter considered the hyperpyrexia, rigidity and hypertonus to be related to BEXSERO. Initial information was received from a physician via regulatory authority on 3rd April 2018: Hyperpyrexia with Hypertone of trunk and upper limbs. About 1 week after hospitalization the mother informed us of reported episode and hospitalization. Hematic exams 09/03/18: Leukocytes = 11480/MMS, C-reactive protein = 26.1 MG/L; electroencephalogram 10/03 AND 13/03: Negative.


VAERS ID: 743588 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2018-03-29
Onset:2018-03-01
Submitted: 0000-00-00
Entered: 2018-04-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MMR: MEASLES + MUMPS + RUBELLA (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN

Administered by: Unknown       Purchased by: ?
Symptoms: Contraindication to vaccination, Immunosuppressant drug therapy
SMQs:, Medication errors (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Back pain
Allergies:
Diagnostic Lab Data:
CDC Split Type: FR0095075131804FRA003551

Write-up: This spontaneous report was received from a pharmacist and refers to a female patient of unknown age. The patient''s medical history included back pain. On 29-MAR-2018, the patient was vaccinated with M-M-RVAXPRO 1 dose (route of administration, anatomical location, lot # and expiration date were not reported). On approximately 29-MAR-2018, reported as "at the same time", the patient had prescribed a dose of SOLUPRED more than 10mg/day for more than 2 weeks (reported also as immunosuppressive dose). The patient had medical history of back pain that started before vaccination (it was not confirmed if the back pain reoccurred after the vaccination in approximately March 2018). The outcome of the events was not reported. The reporter determined the event of back pain to be not related to the M-M-RVAXPRO. The relatedness between the prescribing an immunosuppressive dose of SOLUPRED and M-M-RVAXPRO was not provided. Upon internal review, the event of prescribing an immunosuppressive dose of SOLUPRED was determined to be medically significant.


VAERS ID: 743589 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2018-04-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER UNKNOWN / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Asthenia, Haematuria, Mobility decreased, Muscular weakness, Platelet count decreased, Urinary tract infection
SMQs:, Rhabdomyolysis/myopathy (broad), Haematopoietic thrombocytopenia (narrow), Peripheral neuropathy (broad), Haemorrhage terms (excl laboratory terms) (narrow), Systemic lupus erythematosus (broad), Parkinson-like events (broad), Guillain-Barre syndrome (broad), Noninfectious encephalopathy/delirium (broad), Tubulointerstitial diseases (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? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: Bisoprolol; Lactulose PHI; Omeprazole; Prednisolone; Tamsulosin HCL; Calcium carbonate; miconazole; warfarin
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Atrial fibrillation; Benign prostatic hyperplasia; Idiopathic thrombocytopenic purpura; Rheumatoid arthritis; Tricuspid insufficiency
Allergies:
Diagnostic Lab Data:
CDC Split Type: ITSA2018SA096471

Write-up: Initial unsolicited literature report received from a physician on 26-Mar-2018. This case was linked to 2018SA095111, 2018SA095117, 2018SA095112, 2018SA095116, 2018SA096247, 2018SA096279, 2018SA096286, 2018SA096304, 2018SA096332, 2018SA096338, 2018SA096354, 2018SA096379, 2018SA096401, 2018SA096428, 2018SA096432, 2018SA096439, 2018SA096448, 2018SA096456, 2018SA096464, 2018SA096468, 2018SA096475, 2018SA096477, 2018SA096479, 2018SA096482, 2018SA096366, 2018SA096377, 2018SA096413, 2018SA096421, 2018SA096433, 2018SA096450, 2018SA096460, 2018SA096465, 2018SA096469, 2018SA096473, 2018SA096478, 2018SA096483, 2018SA096485, 2018SA096488, 2018SA096500, 2018SA096502, 2018SA096505, 2018SA096506, 2018SA096508, 2018SA096383 (Same Literature). Background: An increasing number of reports indicates that vaccines against influenza may interact with specific drugs via drug metabolism. To date, actual impact of vaccine-drug interactions observed in the real world clinical practice has not been investigated. Methods: From VAERS and database, we collected Adverse Event Following Immunization (AEFI) reports for individuals receiving vaccines against influenza recorded as suspect and selected cases where predictable toxicity was recorded with oral anticoagulants, antiepileptics and statins (i.e. hemorrhages, overdosage and rhabdomyolysis, respectively). We applied AEFI and Drug Interaction Probability Scale (DIPS) Algorithms to assess causality of drug-vaccine interactions. Results: 116 AEFI reports submitted to VAERS and 83 from database were included in our analysis; antiepileptics and statins were related to the highest number of indeterminate/consistent (93.7%; 65.3%) and possible/probable (50%; 57.7%) cases according to the AEFI and DIPS, respectively. The majority of cases occurred within the first week after vaccine administration (5-7 days). Conclusion: The relative paucity of detected interactions does not impact on the benefit of the vaccination against influenza, which remains strongly recommended; this does not exclude that closer monitoring for selected patients exposed to concomitant chronic pharmacological therapies and affected by predisposing factors may be useful. This case involves a 75-year-old male patient who was vaccinated with a dose of influenza vaccine (Lot number, expiry date, route, dose, dose in series and site of administration were not reported), also received warfarin (Lot number, expiry date, route and site of administration were not reported) and miconazole (Lot number, expiry date, route and site of administration were not reported) on an unknown date. The patient''s pre-disposing conditions were reported as atrial fibrillation, benign prostatic hyperplasia, rheumatoid arthritis, tricuspid insufficiency, idiopathic thrombocytopenic purpura. Concomitant medications included Bisoprolol, Lactulose Phi, Omeprazole, Prednisolone, Tamsulosin Hcl and Calcium Carbonate. On an unknown date, same day following the vaccination, the patient experienced urinary tract infection, hematuria, muscular weakness, asthenia, mobility decreased and platelet count decreased. On an unknown date the patient was hospitalized. Authors pointed out that suspect drugs Miconazole was known to have drug-drug interactions. The patient''s laboratory data and corrective treatment were not reported. The outcome of events was unknown. List of documents held by sender: none. Sender''s Comments: This literature article reports about a 75 year old male patient who experienced Urinary Tract infection, Muscular weakness and decreased platelet count in relation to influenza vaccine and warfarin therapy. The time to onset is compatible. Patient''s past medical history includes Atrial fibrillation, Benign prostatic hyperplasia, Idiopathic thrombocytopenic purpura, Rheumatoid arthritis and Tricuspid insufficiency. There is a possibility that the events are due to the suspect drug (an anti-coagulant) or as a result of the pre-existing medical conditions. Based upon the reported information and with special consideration to the age and medical history of the patient, the role of the vaccine cannot be assessed.


VAERS ID: 743590 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2018-04-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN

Administered by: Other       Purchased by: ?
Symptoms: Asthenia, Electromyogram abnormal, Guillain-Barre syndrome, Myasthenic syndrome, Myopathy, Pain
SMQs:, Rhabdomyolysis/myopathy (narrow), Peripheral neuropathy (narrow), Malignancy related conditions (narrow), Guillain-Barre syndrome (narrow), Demyelination (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (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? No
Previous Vaccinations:
Other Medications: SULINDAC; SIMVASTATIN
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: ITSA2018SA096473

Write-up: Initial unsolicited report received from literature on 26 Mar 2018. This case is linked with 2018SA095111, 2018SA095117, 2018SA095112, 2018SA095116, 2018SA096247, 2018SA096279, 2018SA096286, 2018SA096304, 2018SA096332, 2018SA096338, 2018SA096354, 2018SA096379, 2018SA096401, 2018SA096428, 2018SA096432, 2018SA096439, 2018SA096448, 2018SA096456, 2018SA096464, 2018SA096468, 2018SA096471, 2018SA096475, 2018SA096477, 2018SA096479, 2018SA096482, 2018SA096366, 2018SA096377, 2018SA096383, 2018SA096413, 2018SA096421, 2018SA096433, 2018SA096450, 2018SA096460, 2018SA096465, 2018SA096469, 2018SA096508, 2018SA096478, 2018SA096483, 2018SA096485, 2018SA096488, 2018SA096500, 2018SA096502, 2018SA096505 and 2018SA096506 (Same literature). The following is verbatim from the article: Background: An increasing number of reports indicates that vaccines against influenza may interact with specific drugs via drug metabolism. To date, actual impact of vaccine-drug interactions observed in the real world clinical practice has not been investigated. Methods: From VAERS and database, we collected Adverse Event Following Immunization (AEFI) reports for individuals receiving vaccines against influenza recorded as suspect and selected cases where predictable toxicity was recorded with oral anticoagulants, antiepileptics and statins (i.e. hemorrhages, overdosage and rhabdomyolysis, respectively). We applied AEFI and Drug Interaction Probability Scale (DIPS) Algorithms to assess causality of drug-vaccine interactions. Results: 116 AEFI reports submitted to VAERS and 83 from database were included in our analysis; antiepileptics and statins were related to the highest number of indeterminate/consistent (93.7%; 65.3%) and possible/probable (50%; 57.7%) cases according to the AEFI and DIPS, respectively. The majority of cases occurred within the first week after vaccine administration (5-7 days). Conclusion: The relative paucity of detected interactions does not impact on the benefit of the vaccination against influenza, which remains strongly recommended; this does not exclude that closer monitoring for selected patients exposed to concomitant chronic pharmacological therapies and affected by predisposing factors may be useful. This case involves 62 years old female patient who was vaccinated with dose of INFLUENZA VACCINE (batch number, expiry date, route and site of administration were not reported) and also received Simvastatin (batch number, expiry date were not reported) on an unspecified date. The patient''s medical history was not reported. The patient''s concomitant medication includes Sulindac. On an unspecified date, same day following the vaccination and after receiving drug, patient had asthenia, guillain-barre syndrome, myasthenic syndrome, myopathy, pain. Laboratory investigation includes EMG + deneration. Patient''s corrective treatment was not reported. On an unspecified date, patient was recovered from events. This case was considered as serious by the reporter due to medically significant events. The reporter assessed the causal relationship between INFLUENZA VACCINE and SIMVASTATIN for the events as indeterminate and drug interaction probability scale reported as possible (2). List of documents held by sender: none. Sender''s Comments: This patient developed reported events following vaccination with Influenza vaccine (unknown manufacturer) while she was on Simvastatin treatment. Time to onset is unknown. Additional information including vaccination details with manufacturer, onset time, concomitant vaccinations, past vaccination history with tolerance data, concurrent conditions/medical history and laboratory test ruling out other etiologies is needed for further assessment. Based on available information role of vaccine cannot be assessed.


VAERS ID: 743591 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2018-04-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN

Administered by: Other       Purchased by: ?
Symptoms: International normalised ratio increased, Subarachnoid haemorrhage
SMQs:, Liver-related coagulation and bleeding disturbances (narrow), Haemorrhage terms (excl laboratory terms) (narrow), Haemorrhage laboratory terms (broad), Haemorrhagic central nervous system vascular conditions (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: WARFARIN SODIUM
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: ITSA2018SA096475

Write-up: Initial unsolicited report received from literature on 26 Mar 2018. This case was linked to 2018SA095111, 2018SA095117, 2018SA095112, 2018SA095116, 2018SA096247, 2018SA096279, 2018SA096286, 2018SA096304, 2018SA096332, 2018SA096338, 2018SA096354, 2018SA096379, 2018SA096401, 2018SA096428, 2018SA096432, 2018SA096439, 2018SA096448, 2018SA096456, 2018SA096464, 2018SA096468, 2018SA096471, 2018SA096508, 2018SA096477, 2018SA096482, 2018SA096366, 2018SA096377, 2018SA096383, 2018SA096413, 2018SA096421, 2018SA096433, 2018SA096450, 2018SA096460, 2018SA096465, 2018SA096469, 2018SA096473, 2018SA096478, 2018SA096483, 2018SA096485, 2018SA096488, 2018SA096500, 2018SA096502, 2018SA096505, 2018SA096506 and 2018SA096479 (Same Literature). The following is verbatim from the article: Background: An increasing number of reports indicates that vaccines against influenza may interact with specific drugs via drug metabolism. To date, actual impact of vaccine-drug interactions observed in the real world clinical practice has not been investigated. Methods: From VAERS and database, we collected Adverse Event Following Immunization (AEFI) reports for individuals receiving vaccines against influenza recorded as suspect and selected cases where predictable toxicity was recorded with oral anticoagulants, antiepileptics and statins (i.e. hemorrhages, overdosage and rhabdomyolysis, respectively). We applied AEFI and Drug Interaction Probability Scale (DIPS) Algorithms to assess causality of drug-vaccine interactions. Results: 116 AEFI reports submitted to VAERS and 83 from database were included in our analysis; antiepileptics and statins were related to the highest number of indeterminate/consistent (93.7%; 65.3%) and possible/probable (50%; 57.7%) cases according to the AEFI and DIPS, respectively. The majority of cases occurred within the first week after vaccine administration (5-7 days). Conclusion: The relative paucity of detected interactions does not impact on the benefit of the vaccination against influenza, which remains strongly recommended; this does not exclude that closer monitoring for selected patients exposed to concomitant chronic pharmacological therapies and affected by predisposing factors may be useful. This case involves 70 years old female patient who was vaccinated with dose of INFLUENZA VACCINE and also received WARFARIN (batch number, expiry date, route and site of administration were not reported) on an unspecified date. The patient''s medical history and concomitant medication were not reported. On an unspecified date, following the vaccination and after receiving drug, patient had Subarachnoid hemorrhage and INR increased (reported that INR was more than 8 high and after INFLUENZA VACCINE, INR got stable within range of 2-3) for over 12 months. Patient was hospitalized on an unspecified date. Other laboratory investigation and corrective treatment were not reported. Outcome of events was not reported. Reporter assessed the causality with INFLUENZA VACCINE and WARFARIN as Unclassifiable Possible with DIPS score 2. List of documents held by sender: none. Sender''s Comments: This case corresponds to a literature report in which a 70 year old female was reported to experience Subarachnoid hemorrhage and INR increased after combined therapy with Influenza vaccine and warfarin. No other details regarding the condition of the patient during vaccination and other previous medical history have been reported. Additional information regarding the time to onset, vaccination details(MFR), symptoms and their evolution, medical history as well as concurrent condition during vaccination, previous vaccination and tolerance, allergic history, laboratory investigations excluding alternative etiologies for the reported event are needed to fully assess this case. There is a possibility that the events might be related to Warfarin. Based upon the given information the role of the vaccine cannot be assessed.


VAERS ID: 743592 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2018-04-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN

Administered by: Other       Purchased by: ?
Symptoms: Amblyopia, Asthenia, Diarrhoea, Enzyme abnormality, Hypokinesia, Myopathy, Rhabdomyolysis, Vomiting
SMQs:, Rhabdomyolysis/myopathy (narrow), Acute pancreatitis (broad), Neuroleptic malignant syndrome (broad), Pseudomembranous colitis (broad), Parkinson-like events (broad), Guillain-Barre syndrome (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Optic nerve disorders (broad), Hypotonic-hyporesponsive episode (broad), 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? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: GEMFIBROZIL; CERIVASTATIN
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: ITSA2018SA096478

Write-up: Initial unsolicited report received from literature on 26-Mar-2018. This case is linked with 2018SA095111, 2018SA095117, 2018SA095112, 2018SA095116, 2018SA096247, 2018SA096279, 2018SA096286, 2018SA096304, 2018SA096332, 2018SA096338, 2018SA096354, 2018SA096379, 2018SA096401, 2018SA096428, 2018SA096432, 2018SA096439, 2018SA096448, 2018SA096456, 2018SA096464, 2018SA096468, 2018SA096471, 2018SA096508, 2018SA096477, 2018SA096482, 2018SA096366, 2018SA096377, 2018SA096383, 2018SA096413, 2018SA096421, 2018SA096433, 2018SA096450, 2018SA096460, 2018SA096465, 2018SA096469, 2018SA096473, 2018SA096475, 2018SA096483, 2018SA096485, 2018SA096488, 2018SA096500, 2018SA096502, 2018SA096505, 2018SA096506 and 2018SA096479 (Same Literature). The following is verbatim from the article: Background: An increasing number of reports indicates that vaccines against influenza may interact with specific drugs via drug metabolism. To date, actual impact of vaccine-drug interactions observed in the real world clinical practice has not been investigated. Methods: From VAERS and database, we collected Adverse Event Following Immunization (AEFI) reports for individuals receiving vaccines against influenza recorded as suspect and selected cases where predictable toxicity was recorded with oral anticoagulants, antiepileptics and statins (i.e. hemorrhages, overdosage and rhabdomyolysis, respectively). We applied AEFI and Drug Interaction Probability Scale (DIPS) Algorithms to assess causality of drug-vaccine interactions. Results: 116 AEFI reports submitted to VAERS and 83 from database were included in our analysis; antiepileptics and statins were related to the highest number of indeterminate/consistent (93.7%; 65.3%) and possible/probable (50%; 57.7%) cases according to the AEFI and DIPS, respectively. The majority of cases occurred within the first week after vaccine administration (5-7 days). Conclusion: The relative paucity of detected interactions does not impact on the benefit of the vaccination against influenza, which remains strongly recommended; this does not exclude that closer monitoring for selected patients exposed to concomitant chronic pharmacological therapies and affected by predisposing factors may be useful. This case involves 67 years old male patient who was vaccinated with dose of INFLUENZA VACCINE (batch number, expiry date, route and site of administration were not reported). The patient also received dose of CERIVASTATIN (batch number, expiry date and route were not reported) on an unspecified date. The patient''s medical history was not reported. Patient concomitant medication included GEMFIBROZIL. On an unspecified date, one-day post vaccination and after receiving drug patient had rhabdomyolysis, hypokinesia, Amblyopia, asthenia, diarrhea, enzyme abnormality, myopathy and vomiting. On an unknown date patient was hospitalized. Laboratory investigation were not reported. Corrective treatment was not reported. Outcome of the events were not reported. The reporter assessed the causal relationship with TRIVALENT, INACTIVATED SUBUNIT INFLUENZA VIRUS VACCINE and CERIVASTATIN for the events as Indeterminate and drug interaction probability scale reported as possible (3). List of documents held by sender: none.; Sender''s Comments: This literature article reports about an elderly patient who experienced Rhabdomyolysis, Hypokinesia, Amblyopia, Asthenia, diarrhea, Enzyme abnormality and vomiting in relation to INFLUENZA vaccine and CERIVASTATIN therapy. The time to onset is compatible. However, patient''s past medical history & medical condition at the time of vaccination was not reported. There is a possibility that the events are due to the other suspect drug or a pre-existing medical condition. Based upon the reported information and with special consideration to the age of the patient, the role of the vaccine cannot be assessed.


VAERS ID: 743593 (history)  
Form: Version 2.0  
Age: 0.25  
Sex: Male  
Location: Foreign  
Vaccinated:2014-03-31
Onset:2014-04-05
   Days after vaccination:5
Submitted: 0000-00-00
Entered: 2018-04-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
RV5: ROTAVIRUS (ROTATEQ) / MERCK & CO. INC. H021856 / UNK MO / PO

Administered by: Unknown       Purchased by: ?
Symptoms: Diarrhoea, Gastroenteritis rotavirus, Pyrexia, Stool analysis abnormal
SMQs:, 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)

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: JP0095075131804JPN000389J

Write-up: Information has been received from a physician concerning a 3-month-old male patient with no historical conditions. There was a rotavirus outbreak in the same facility since 02-APR-2014. On 31-MAR-2014, the patient was vaccinated with ROTATEQ ORAL SOLUTION, 2 mL for prophylaxis vaccination lot number: H021856). No concomitant medications were reported. On 05-APR-2014, pyrexia and diarrhoea developed. ("gastroenteritis rotavirus; pyrexia, diarrhoea" developed). On 07-APR-2014, pyrexia resolved. On 11-APR-2014, G9P [8] was also detected from the stool of the patient. On 16-APR-2014, diarrhoea was resolved. At the time of the report, the outcome of "gastroenteritis rotavirus; pyrexia, diarrhoea" was unknown. Reporter''s comment: not provided. The reporting physician felt that "gastroenteritis rotavirus; pyrexia, diarrhoea" was not related to rotavirus vaccine, live, oral, pentavalent. The reporting physician considered "gastroenteritis rotavirus; pyrexia, diarrhoea" to be non-serious. Upon internal review, "gastroenteritis rotavirus; pyrexia, diarrhoea" was determined to be medically significant. Lot number H021856 has been verified to be a valid lot number for rotavirus vaccine, live, oral, pentavalent. This is one of 12 reports from the same source. Company Causality Assessment: Based on the clinically relevant information currently available for this individual case, the reported event of gastroenteritis rotavirus is considered unlikely related to Rotateq therapy. The evidence is not sufficient to suggest a relationship between the vaccination and the reported serious adverse event. Other incidental rotavirus infection due to outbreak constitutes a more plausible alternative explanation for the event. Company Comment- No changes to the rotavirus product safety information are warranted at this time. Merck and Co., Inc., also known as MSD, continues to monitor the safety profile of the product. Sender''s Comments: JP-MSD-1804JPN000390J: JP-MSD-1804JPN000391J: JP-MSD-1804JPN000392J: JP-MSD-1804JPN000393J: JP-MSD-1804JPN000394J: JP-MSD-1804JPN000395J: JP-MSD-1804JPN000396J: JP-MSD-1804JPN000406J: JP-MSD-1804JPN000407J: JP-MSD-1804JPN000408J: JP-MSD-1804JPN000581J.


VAERS ID: 743594 (history)  
Form: Version 2.0  
Age: 0.0  
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2014-04-05
Submitted: 0000-00-00
Entered: 2018-04-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
RV5: ROTAVIRUS (ROTATEQ) / MERCK & CO. INC. - / UNK - / -

Administered by: Unknown       Purchased by: ?
Symptoms: Diarrhoea, Gastroenteritis rotavirus, Stool analysis abnormal, Vomiting
SMQs:, Acute pancreatitis (broad), Pseudomembranous colitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Noninfectious diarrhoea (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? 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: JP0095075131804JPN000396J

Write-up: Information has been received from a physician concerning a 5-month-old female infant without medical history, who was orally vaccinated with ROTATEQ for prophylaxis (start date, dose and lot number not reported). There was no concomitant medication reported. On 02-APR-2014, outbreak of wild-type strain G9P[8] rotavirus happened in the hospital. On 05-APR-2014, the patient developed gastroenteritis rotavirus. The symptoms were vomiting and diarrhea. On 10-APR-2014, G9P[8] was detected in the patient''s stool. She had recovered from vomiting. On 15-APR-2014, the patient had recovered from diarrhea. At the time of the report, the outcome of "gastroenteritis rotavirus; vomiting, diarrhoea" was unknown. Reporter''s comment: not provided. The reporting physician felt that "gastroenteritis rotavirus; vomiting, diarrhea" was unrelated to rotavirus vaccine, live, oral, pentavalent. The reporting physician considered "gastroenteritis rotavirus; vomiting, diarrhea" to be non-serious. Upon internal review, "gastroenteritis rotavirus; vomiting, diarrhea" was determined to be medically significant. This is one of several reports received from the same source. Company Causality Assessment: Based on the clinically relevant information currently available for this individual case, the reported event of gastroenteritis rotavirus is considered unlikely related to ROTATEQ. The evidence is not sufficient to suggest a relationship between the therapy and the reported serious adverse event. Incidental infection due to in-hospital outbreak constitutes a more plausible alternative explanation for the event. Company Comment- No changes to the ROTATEQ product safety information are warranted at this time. Merck and Co., continues to monitor the safety profile of the product. Sender''s Comments: JP-MSD-1804JPN000389J: JP-MSD-1804JPN000390J: JP-MSD-1804JPN000391J: JP-MSD-1804JPN000392J: JP-MSD-1804JPN000393J: JP-MSD-1804JPN000394J: JP-MSD-1804JPN000395J: JP-MSD-1804JPN000406J: JP-MSD-1804JPN000407J: JP-MSD-1804JPN000408J: JP-MSD-1804JPN000581J.


VAERS ID: 743620 (history)  
Form: Version 2.0  
Age: 0.17  
Sex: Male  
Location: Foreign  
Vaccinated:2017-10-05
Onset:2017-10-05
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2018-04-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAP: DTAP (INFANRIX) / GLAXOSMITHKLINE BIOLOGICALS - / UNK UN / IM
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH - / UNK UN / IM

Administered by: Other       Purchased by: ?
Symptoms: Apnoea, Bradycardia, Neonatal hypoxia
SMQs:, Arrhythmia related investigations, signs and symptoms (broad), Acute central respiratory depression (narrow), Neonatal disorders (narrow), Respiratory failure (narrow)

Life Threatening? Yes
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: ADRIGYL; VITAMIN K; FERROSTRANE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Anaemia of prematurity; Neonatal hypoglycemia; Neonatal jaundice associated with preterm delivery; Prematurity; Primary apnoea of premature newborns
Allergies:
Diagnostic Lab Data:
CDC Split Type: FRPFIZER INC2018138435

Write-up: This is a spontaneous report received from a contactable physician via the regulatory authority and downloaded from the database, regulatory authority report number FR-AFSSAPS-ST20180371. A 2-month-old male patient of an unspecified race and ethnicity received a single dose of the suspect products by intramuscular route on 05Oct2017 for vaccination: PREVENAR 13 and INFANRIX. Relevant medical history included prematurity, anaemia of prematurity, neonatal hypoglycemia, neonatal jaundice associated with preterm delivery and primary apnoea of premature newborns. Concomitant medications included ADRIGYL VITAMIN K and FERROSTRANE. On 05Oct2017, the patient experienced neonatal oxygen desaturation, apnoea and bradycardia, all considered as life-threatening and requiring hospitalization on an unspecified date in Oct2017. The patient had fully recovered from all the events on 08Oct2017. No follow-up attempts are possible, information about batch number cannot be obtained.


VAERS ID: 743621 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2018-02-28
Onset:2018-03-06
   Days after vaccination:6
Submitted: 0000-00-00
Entered: 2018-04-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MMR: MEASLES + MUMPS + RUBELLA (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN

Administered by: Unknown       Purchased by: ?
Symptoms: Crying, Measles post vaccine, Poor feeding infant, Tonsillitis
SMQs:, Agranulocytosis (broad), Oropharyngeal infections (narrow), Depression (excl suicide and self injury) (broad), Neonatal 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:
Current Illness: Routine childhood immunisation
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GB0095075131804GBR003022

Write-up: Information has been downloaded from Agency (GB-MHRA-EYC 00175926). Information has been received from a consumer referring to a 1 year old male infant. Information regarding the patient''s medical history, concurrent conditions and concomitant medications was not reported. On 28-FEB-2018, the patient was vaccinated with a dose of M-M-RVAXPRO, parenteral route, (lot # and expiry date were not reported) for routine childhood immunization. On 06-MAR-2018, the patient experienced tonsillitis. Then, on 10-MAR-2018, the patient experienced measles. On an unknown date, the patient also experienced crying and poor feeding infant. The outcome of measles was reported as not recovered/not resolved; the outcome of crying and poor feeding infant was unknown; and the outcome of tonsillitis was reported as recovering/resolving. No causality assessment between the events and the vaccine was provided by the reporter. The events were considered to be medically significant by the agency.


VAERS ID: 743623 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2018-04-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN

Administered by: Other       Purchased by: ?
Symptoms: Blood creatine phosphokinase increased, Infection, Leukocytosis, Pain, Rhabdomyolysis, Sensory disturbance
SMQs:, Rhabdomyolysis/myopathy (narrow), Peripheral neuropathy (narrow), Neuroleptic malignant syndrome (broad), Myocardial infarction (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (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: TAMSULOSIN; ACETAMINOPHEN; SIMVASTATIN; OMEPRAZOLE; DICLOFENAC; CODEINE; DEXTROPROPOXYPHENE
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Arthritis
Allergies:
Diagnostic Lab Data: Test Name: CPK; Result Unstructured Data: 39500
CDC Split Type: ITSA2018SA096482

Write-up: Initial unsolicited report received from literature on 26 Mar 2018. This case was linked to 2018SA095111, 2018SA095117, 2018SA095112, 2018SA095116, 2018SA096247, 2018SA096279, 2018SA096286, 2018SA096304, 2018SA096332, 2018SA096338, 2018SA096354, 2018SA096379, 2018SA096401, 2018SA096428, 2018SA096432, 2018SA096439, 2018SA096456, 2018SA096464, 2018SA096468, 2018SA096471, 2018SA096475, 2018SA096477, 2018SA096479, 2018SA096366, 2018SA096377, 2018SA096413, 2018SA096421, 2018SA096450, 2018SA096460, 2018SA096465, 2018SA096473, 2018SA096478, 2018SA096483, 2018SA096485, 2018SA096500, 2018SA096502, 2018SA096505, 2018SA096506, 2018SA096508, 2018SA096383, 2018SA096433, 2018SA096488, 2018SA096469, 2018SA096448 (Same Literature). The following is verbatim from the article: Background: An increasing number of reports indicates that vaccines against influenza may interact with specific drugs via drug metabolism. To date, actual impact of vaccine-drug interactions observed in the real world clinical practice has not been investigated. Methods: From VAERS and database, we collected Adverse Event Following Immunization (AEFI) reports for individuals receiving vaccines against influenza recorded as suspect and selected cases where predictable toxicity was recorded with oral anticoagulants, antiepileptics and statins (i.e. hemorrhages, overdosage and rhabdomyolysis, respectively). We applied AEFI and Drug Interaction Probability Scale (DIPS) Algorithms to assess causality of drug-vaccine interactions. Results: 116 AEFI reports submitted to VAERS and 83 from database were included in our analysis; antiepileptics and statins were related to the highest number of indeterminate/consistent (93.7 percent; 65.3 percent) and possible/probable (50 percent; 57.7 percent) cases according to the AEFI and DIPS, respectively. The majority of cases occurred within the first week after vaccine administration (5-7 days). Conclusion: The relative paucity of detected interactions does not impact on the benefit of the vaccination against influenza, which remains strongly recommended; this does not exclude that closer monitoring for selected patients exposed to concomitant chronic pharmacological therapies and affected by predisposing factors may be useful. This case involves a 65-year-old male patient who was vaccinated with dose of INFLUENZA VACCINE (batch number, expiry date, route and site of administration were not reported) and received Simvastatin (batch number and expiry date were not reported) on an unknown date and the patient was also received omeprazole, diclofenac, Dextropropoxyphene, acetaminophen and codeine on an unknown date. The patient''s medical history included arthritis. Concomitant medications included Tamsulosin. On an unspecified date, 29 days post vaccination and post drug administration, the patient developed Blood creatine phosphokinase increased, infection leukocytosis, pain, rhabdomyolysis, sensory disturbance. On an unknown date, the patient was hospitalized. Authors pointed out that suspect drugs omeprazole, diclofenac, Dextropropoxyphene, acetaminophen and codeine are known to have drug-drug interactions. Lab test CPK showed 39500 (unit reported). Corrective treatment was not reported. The outcome of the events was not reported. The reporter assessed the causal relationship with INFLUENZA VACCINE and Simvastatin as inconsistent not applicable as per drug interaction probability scale. List of documents held by sender: none. Sender''s Comments: Patient developed Rhabdomyolysis, increased CPK levels, leukocytosis and sensory disturbance after vaccination. Time to onset is compatible. Patient was also on simvastatin, acetaminophen, omeprazole, diclofenac. Further information regarding vaccination details (MFR), symptoms and their evolution, medical history as well as concurrent condition during vaccination, previous vaccination and tolerance, allergic history, laboratory investigations excluding alternative etiologies for the reported event are needed to fully assess this case. There is a possibility that the events might be related to other drugs mentioned. Based upon the given information the role of the vaccine cannot be assessed.


VAERS ID: 743624 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2018-04-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN

Administered by: Other       Purchased by: ?
Symptoms: Alanine aminotransferase increased, Aspartate aminotransferase increased, Asthenia, Blood creatine phosphokinase increased, Blood creatinine increased, Blood potassium increased, Blood urea increased, Cardiovascular disorder, Condition aggravated, Diabetes mellitus, Dysuria, Hepatic function abnormal, Hyperbilirubinaemia, Hyperkalaemia, Hypertension, Mean cell volume increased, Myasthenic syndrome, Mycobacterium tuberculosis complex test, Myopathy, Myositis, Renal failure, Renal impairment, Rhabdomyolysis, Right ventricular failure
SMQs:, Rhabdomyolysis/myopathy (narrow), Acute renal failure (narrow), Cardiac failure (narrow), Liver related investigations, signs and symptoms (narrow), Cholestasis and jaundice of hepatic origin (narrow), Acute pancreatitis (broad), Hyperglycaemia/new onset diabetes mellitus (narrow), Neuroleptic malignant syndrome (broad), Myocardial infarction (broad), Retroperitoneal fibrosis (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (broad), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (broad), Toxic-septic shock conditions (broad), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Malignancy related conditions (narrow), Biliary system related investigations, signs and symptoms (narrow), Biliary tract disorders (narrow), Pulmonary hypertension (narrow), Guillain-Barre syndrome (broad), Hypertension (narrow), Cardiomyopathy (broad), Chronic kidney disease (narrow), Tumour lysis syndrome (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (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: PREDNISONE; AZATHIOPRINE; ASA; ALDACTONE; GLIPIZIDE; ENALAPRIL; METFORMIN; INSULIN; TERAZOSIN; DIGOXIN
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: SGOT; Result Unstructured Data: 1046; Test Name: SGPT; Result Unstructured Data: 487; Test Name: CPK; Result Unstructured Data: 71280; Test Name: Potassium; Result Unstructured Data: 6.6; Test Name: MCV; Result Unstructured Data: 101 Normal low value: 7.2 Normal high value: 157
CDC Split Type: ITSA2018SA096483

Write-up: Initial unsolicited report received from literature on 26 Mar 2018. This case was linked to 2018SA095111, 2018SA095117, 2018SA095112, 2018SA095116, 2018SA096247, 2018SA096279, 2018SA096286, 2018SA096304, 2018SA096332, 2018SA096354, 2018SA096379, 2018SA096401, 2018SA096428, 2018SA096432, 2018SA096439, 2018SA096448, 2018SA096456, 2018SA096464, 2018SA096471, 2018SA096475, 2018SA096477, 2018SA096479, 2018SA096482, 2018SA096366, 2018SA096377, 2018SA096413, 2018SA096421, 2018SA096433, 2018SA096450, 2018SA096460, 2018SA096465, 2018SA096469, 2018SA096473, 2018SA096478, 2018SA096485, 2018SA096488, 2018SA096500, 2018SA096502, 2018SA096505, 2018SA096506, 2018SA096508, 2018SA096383, 2018SA096338, 2018SA096468 (Same Literature). The following is verbatim from the article: Background: An increasing number of reports indicates that vaccines against influenza may interact with specific drugs via drug metabolism. To date, actual impact of vaccine-drug interactions observed in the real world clinical practice has not been investigated. Methods: From VAERS and database, we collected Adverse Event Following Immunization (AEFI) reports for individuals receiving vaccines against influenza recorded as suspect and selected cases where predictable toxicity was recorded with oral anticoagulants, antiepileptics and statins (i.e. hemorrhages, overdosage and rhabdomyolysis, respectively). We applied AEFI and Drug Interaction Probability Scale (DIPS) Algorithms to assess causality of drug-vaccine interactions. Results: 116 AEFI reports submitted to VAERS and 83 from database were included in our analysis; antiepileptics and statins were related to the highest number of indeterminate/consistent (93.7%; 65.3%) and possible/probable (50%; 57.7%) cases according to the AEFI and DIPS, respectively. The majority of cases occurred within the first week after vaccine administration (5-7 days). Conclusion: The relative paucity of detected interactions does not impact on the benefit of the vaccination against influenza, which remains strongly recommended; this does not exclude that closer monitoring for selected patients exposed to concomitant chronic pharmacological therapies and affected by predisposing factors may be useful. This case involves 64-year-old male patient who was vaccinated with dose of INFLUENZA VACCINE (Influenza virus vaccine) (batch number, expiry date, route and site of administration were not reported), received Lovastatin and Cyclosporine (batch number and expiry date were not reported) on an unknown date. The patient''s medical history were not reported. Concomitant medication included prednisone, azathioprine, acetylsalicylic acid (ASA), aldactone, glipizide, enalapril, metformin, insulin, terazosin and digoxin. On an unspecified date, nine days post vaccination and post drug administration, the patient developed Rhabdomyolysis, asthenia, cardiovascular disorder, condition aggravated, diabetes mellitus, dysuria, hepatic function abnormal, hyperbilirubinaemia, hyperkalaemia, hypertension, myasthenic syndrome, myopathy, myositis, renal failure, renal impairment, right ventricular failure. On an unknown date, the patient was hospitalized. Authors pointed out that suspect drug Cyclosporine is known to have drug-drug interactions. Relevant laboratory investigation included SGOT (serum glutamic oxaloacetic transaminase) 1046; SGPT (serum glutamic-pyruvic transaminase) 487; CPK (Creatine phosphokinase) 71,280; TB (tubercolosis) 1.4; Potassium (K) 6.6; BUN/creatinine 93/2.9 on adm, MCV (Mean corpuscular volume) 101 max (157/7.2). Corrective treatment were not reported. The outcome of the events was not reported. The reporter assessed the causal relationship with INFLUENZA VACCINE and Lovastatin as indeterminate possible (3) as per drug interaction probability scale. List of documents held by sender: none.; Sender''s Comments: This literature article reports about a 64 year old male patient who experienced Rhabdomyolysis, Cardiovascular disorder aggravation, Diabetes mellitus, hepatic and renal impairment & myasthenic syndrome in relation to INFLUENZA vaccine and LOVASTATIN therapy. The time to onset is compatible. However, patient''s past medical history and condition at the time of vaccination was not reported. There is a possibility that the events are due to the suspect drug or a pre-existing medical condition. Based upon the reported information, the role of the vaccine cannot be assessed.


VAERS ID: 743625 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2018-04-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN

Administered by: Other       Purchased by: ?
Symptoms: Blood creatine phosphokinase increased, Electromyogram abnormal, Muscular weakness, Myositis
SMQs:, Rhabdomyolysis/myopathy (broad), Peripheral neuropathy (broad), Neuroleptic malignant syndrome (broad), Myocardial infarction (broad), Guillain-Barre syndrome (broad), Noninfectious encephalopathy/delirium (broad), 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? No
Previous Vaccinations:
Other Medications: LEVOTHYROXINE; LISINOPRIL; ESOMEPRAZOLE; CARBOXYMETHYL; ATORVASTATIN
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: ITSA2018SA096502

Write-up: Initial unsolicited report received from literature on 26 Mar 2018. This case is linked with 2018SA095111, 2018SA095117, 2018SA095112, 2018SA095116, 2018SA096247, 2018SA096279 2018SA096286, 2018SA096304, 2018SA096332, 2018SA096338, 2018SA096354, 2018SA096379 2018SA096401, 2018SA096428, 2018SA096432, 2018SA096439, 2018SA096448, 2018SA096456 2018SA096464, 2018SA096468, 2018SA096471, 2018SA096475, 2018SA096477, 2018SA096479 2018SA096482, 2018SA096366, 2018SA096377, 2018SA096383, 2018SA096413, 2018SA096421 2018SA096433, 2018SA096450, 2018SA096460, 2018SA096465, 2018SA096469, 2018SA096473 2018SA096478, 2018SA096483, 2018SA096485, 2018SA096488, 2018SA096500, 2018SA096502, 2018SA096505, 2018SA096506, 2018SA096508 (same literature). The following is verbatim from the article: Background: An increasing number of reports indicates that vaccines against influenza may interact with specific drugs via drug metabolism. To date, actual impact of vaccine-drug interactions observed in the real world clinical practice has not been investigated. Methods: From VAERS and database, we collected Adverse Event Following Immunization (AEFI) reports for individuals receiving vaccines against influenza recorded as suspect and selected cases where predictable toxicity was recorded with oral anticoagulants, antiepileptics and statins (i.e. hemorrhages, overdosage and rhabdomyolysis, respectively). We applied AEFI and Drug Interaction Probability Scale (DIPS) Algorithms to assess causality of drug-vaccine interactions. Results: 116 AEFI reports submitted to VAERS and 83 from database were included in our analysis; antiepileptics and statins were related to the highest number of indeterminate/consistent (93.7%; 65.3%) and possible/probable (50%; 57.7%) cases according to the AEFI and DIPS, respectively. The majority of cases occurred within the first week after vaccine administration (5-7 days). Conclusion: The relative paucity of detected interactions does not impact on the benefit of the vaccination against influenza, which remains strongly recommended; this does not exclude that closer monitoring for selected patients exposed to concomitant chronic pharmacological therapies and affected by predisposing factors may be useful. This case involves 69 years old female patient who was vaccinated with dose of INFLUENZA VACCINE and ATORVASTATIN (batch number, expiry date, route and site of administration were not reported) on an unspecified date. Patient''s medical history was not reported. Concomitant medications including LEVOTHYROXINE, LISINOPRIL, ESOMEPRAZOLE, CARBOXYMETHYL. On an unspecified date, 70 days following the vaccination patient experienced muscular weakness and myositis on an unknown date Ck eleveted to 15,000. EMG (electromyography) positive for inflamation and degradation of nerves. Other laboratory investigation and corrective treatment were not reported. This case considered serious due to medically significant events myositis and muscular weakness. The reporter assessed the causal relationship with INACTIVATED, SPLIT-VIRION INFLUENZA VACCINE and ATORVASTATIN for the events are Inconsistent Not applicable. List of documents held by sender: none. Sender''s Comments: This elderly patient developed muscular weakness and myositis following vaccination with Influenza vaccine (unknown manufacturer) while he was on statin treatment. Time to onset is 70 days. Additional information including vaccination details with manufacturer, onset time, concomitant vaccinations, past vaccination history with tolerance data, medical history, lab test ruling out other infectious etiology is needed for further assessment. Based on available information role of vaccine cannot be assessed.


VAERS ID: 743626 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2018-04-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Dizziness, Excessive eye blinking, Fatigue, Seizure, Somnolence, Tic
SMQs:, Systemic lupus erythematosus (broad), Anticholinergic syndrome (broad), Dementia (broad), Convulsions (narrow), Dyskinesia (broad), Dystonia (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Vestibular disorders (broad), Ocular motility disorders (narrow), Generalised convulsive seizures following immunisation (narrow), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Lamotrigine; oxcarbazepine
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: ITSA2018SA096505

Write-up: Initial unsolicited report received from literature on 26 Mar 2018. This case is linked with 2018SA095111, 2018SA095117, 2018SA095112, 2018SA095116, 2018SA096247, 2018SA096279 2018SA096286, 2018SA096304, 2018SA096332, 2018SA096338, 2018SA096354, 2018SA096379 2018SA096401, 2018SA096428, 2018SA096432, 2018SA096439, 2018SA096448, 2018SA096456 2018SA096464, 2018SA096468, 2018SA096471, 2018SA096475, 2018SA096477, 2018SA096479 2018SA096482, 2018SA096366, 2018SA096377, 2018SA096383, 2018SA096413, 2018SA096421 2018SA096433, 2018SA096450, 2018SA096460, 2018SA096465, 2018SA096469, 2018SA096473 2018SA096478, 2018SA096483, 2018SA096485, 2018SA096488, 2018SA096500, 2018SA096502, 2018SA096505, 2018SA096506, 2018SA096508 (same literature). Background: An increasing number of reports indicates that vaccines against influenza may interact with specific drugs via drug metabolism. To date, actual impact of vaccine-drug interactions observed in the real world clinical practice has not been investigated. Methods: From VAERS and database, we collected Adverse Event Following Immunization (AEFI) reports for individuals receiving vaccines against influenza recorded as suspect and selected cases where predictable toxicity was recorded with oral anticoagulants, antiepileptics and statins (i.e. hemorrhages, overdosage and rhabdomyolysis, respectively). We applied AEFI and Drug Interaction Probability Scale (DIPS) Algorithms to assess causality of drug-vaccine interactions. Results: 116 AEFI reports submitted to VAERS and 83 from database were included in our analysis; antiepileptics and statins were related to the highest number of indeterminate/consistent (93.7%; 65.3%) and possible/probable (50%; 57.7%) cases according to the AEFI and DIPS, respectively. The majority of cases occurred within the first week after vaccine administration (5-7 days). Conclusion: The relative paucity of detected interactions does not impact on the benefit of the vaccination against influenza, which remains strongly recommended; this does not exclude that closer monitoring for selected patients exposed to concomitant chronic pharmacological therapies and affected by predisposing factors may be useful. This case involves a male patient (age not reported) who was vaccinated with influenza vaccine and oxycarbazepine (batch number, expiry date, route and site of administration were not reported) on an unspecified date. Patient''s medical history was not reported. Concomitant medications included Lamotrigine. On an unspecified date, following the vaccination patient experienced Seizure with symptoms dizziness, excessive eye blinking, fatigue, somnolence and tic. Laboratory investigation and corrective treatment were not reported. The outcome of the event was reported as unknown. This case considered serious due to medically significant event: seizure. The completeness score was reported as 0.30. List of documents held by sender: none; Sender''s Comments: This literature article reports of a male subject who experienced seizure after influenza vaccination and therapy with oxcarbazepine. Further information regarding vaccination details(MFR), symptoms and their evolution, time to onset, medical history as well as concurrent condition during vaccination, previous vaccination and tolerance, allergic history, laboratory investigations excluding alternative etiologies for the reported event are needed to fully assess this case. There is a possibility that the events might be related to other suspects. Based upon the given information the role of the vaccine cannot be assessed.


VAERS ID: 743635 (history)  
Form: Version 2.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2018-04-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH - / UNK UN / UN

Administered by: Other       Purchased by: ?
Symptoms: Antibody test abnormal, Pneumonia haemophilus
SMQs:, Vasculitis (broad), Hypersensitivity (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? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: Antibody test; Result Unstructured Data: Test Result: insufficient antibody levels
CDC Split Type: ZAPFIZERINC2018140548

Write-up: This is a spontaneous report from a non-contactable physician via a sales representative. A 12-month-old patient of an unspecified ethnicity and gender received PREVENAR 13 on an unspecified date at single dose for immunization. The patient medical history and concomitant medications were not reported. On an unspecified date the patient was diagnosed with pneumonia with h. influenza, considered serious. Doctor had to revaccinate patient, who was tested for antibodies showing insufficient antibody levels on an unspecified date. The outcome of the events was unknown. No follow-up attempts are possible, information about batch number cannot be obtained. Sender''s Comments: pneumonia with h. influenza represents intercurrent infectious disease unrelated to the vaccination with PREVENAR 13. 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: 743649 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2014-07-01
Onset:2014-09-01
   Days after vaccination:62
Submitted: 0000-00-00
Entered: 2018-04-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
HPV4: HPV (GARDASIL) / MERCK & CO. INC. - / UNK UN / IM

Administered by: Unknown       Purchased by: ?
Symptoms: Hypersomnia
SMQs:, Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Depression (excl suicide and self injury) (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: Infection prophylaxis
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: FR0095075131804FRA000908

Write-up: Information has been downloaded from Agency (FR-AFSSAPS-PP20180228). This spontaneous report was received from a physician referring to a 14 year old female patient. The patient''s pertinent medical history, concurrent conditions and concomitant medications were not reported. On an unknown date, July 2014, the patient was vaccinated with GARDASIL (lot # reported as INCONNU), intramuscular for infection prophylaxis. In September 2014, the patient experienced hypersomnia which lead to hospitalization. The outcome of hypersomnia was reported as not recovered/not resolved. The causal assessment between the events and GARDASIL was not reported. Hypersomnia was considered as disability by reporter.


VAERS ID: 743721 (history)  
Form: Version 1.0  
Age: 0.5  
Sex: Female  
Location: Foreign  
Vaccinated:2018-03-26
Onset:2018-03-26
   Days after vaccination:0
Submitted: 2018-04-09
   Days after onset:14
Entered: 2018-04-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MENB: MENINGOCOCCAL B (BEXSERO) / NOVARTIS VACCINES AND DIAGNOSTICS 163601 / UNK UN / IM

Administered by: Other       Purchased by: Other
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: No other medications
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: IT2018057388

Write-up: This case was reported by a physician via regulatory authority and described the occurrence of convulsive seizure in a 6-month-old female patient who received BEXSERO (batch number 163601, expiry date unknown). On 26th March 2018, the patient received BEXSERO (intramuscular) 1 dosage form(s). On 26th March 2018, 5 hrs after receiving BEXSERO, the patient experienced convulsive seizure (serious criteria hospitalization and GSK medically significant). In March 2018, the outcome of the convulsive seizure was recovered/resolved. It was unknown if the reporter considered the convulsive to be related to BEXSERO. Initial information was received from a physician via regulatory authority on 03rd April 2018: Convulsive crisis arising after 5 hours from the administration of antimeningococcus vaccine B.


VAERS ID: 743726 (history)  
Form: Version 1.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2018-04-09
Entered: 2018-04-09
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MENB: MENINGOCOCCAL B (BEXSERO) / NOVARTIS VACCINES AND DIAGNOSTICS - / 1 UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Bacterial infection, C-reactive protein increased, Lumbar puncture abnormal, Pyrexia, White blood cell count normal
SMQs:, Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Guillain-Barre syndrome (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? Yes
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications: No other medications
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Lab test performed on unspecified date; The patient had a lumbar puncture and found with confirmed unspecified bacterial infection. In this study, the median C-reactive protein (CRP) was 12 mg/L and median white cell count (WCC) was 16 x 10E9/L
CDC Split Type: GB2018GSK060022

Write-up: This case was reported in a literature article and described the occurrence of bacterial infection in a infant subject who received Meningococcal B Recom vaccine + AIOH + OMV. On an unknown date, 2 days 6hrs after receiving Meningococcal B Recom vaccine + AIOH + OMV, the subject developed bacterial infection. Serious criteria included hospitalization. Additional event(s) included fever with serious criteria of hospitalization. The outcome of bacterial infection was unknown. The outcome(s) of the additional event(s) included fever (unknown). The investigator considered that there was a reasonable possibility that the bacterial infection and fever may have been caused by Meningococcal B Recom vaccine + AIOH + OMV. Relevant Tests: Lab test performed on unspecified date. The patient had a lumbar puncture and found with confirmed unspecified bacterial infection. In this study, the median C-reactive protein (CRP) was 12 mg/L and median white cell count (WCC) was 16 x 10E9/L Diagnostic results (unless otherwise stated, normal values were not provided): On an unknown date, C-reactive protein result was see text. On an unknown date, Lumbar puncture result was see text unknown. On an unknown date, White blood cell count result was see text unknown. Additional information was provided. This case was reported in a literature and described the occurrence of fever; unspecified bacterial infection of an infant aged less than or equal to 3 month of unspecified gender who was vaccinated with BEXSERO (GlaxoSmithKline). The patient was part of the prospective case series over a 12 month period in a tertiary hospital. The objective of the study was to document the clinical features and management of infants presenting with fever after their first meningococcal B vaccination, and develop guidance for clinicians. No information on patient''s medical or family history or concomitant medication or concurrent condition was provided. On an unspecified date, the patient received 1st dose of BEXSERO (administration route and site unspecified, batch number not provided). The patient had also received the first set of unspecified immunisations. The age of vaccination was not provided. On an unspecified date, 54 hours after vaccination, the patient developed fever and subsequently admitted to hospital. The patient had a lumbar puncture and found with confirmed unspecified bacterial infection. [In this study, the median C-reactive protein (CRP) was 12 mg/L and median white cell count (WCC) was 16 x 10E9/L]. This case has been considered serious due to hospitalisation. The patient was treated with unspecified antibiotics. The outcome of the event was not provided. The authors considered the event of fear and unspecified bacterial infection related to BEXSERO. The author concluded "Post immunization fever is a common presenting problem to the emergency department. Based on our findings, routine investigations are not warranted if the infant appears well on examination. Where other common side effects are present and there is clinical concern, a period of observation may be a reasonable option. We suggest selective use of investigations, especially inflammatory markers, that are unlikely to discriminate between serious bacterial infection and post-immunization response. We advocate extra caution in infants presenting with fever more than 48 hours after immunization."


VAERS ID: 743676 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2018-04-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Coma, Cough, Delirium, Diplopia, Disorientation, Eye disorder, Eye pain, Headache, Mental impairment, Movement disorder, Nausea, Nervous system disorder, Pyrexia, Respiratory distress, Stupor, Torticollis, Vomiting
SMQs:, Anaphylactic reaction (broad), Acute pancreatitis (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (narrow), Dementia (broad), Akathisia (broad), Dyskinesia (broad), Dystonia (narrow), Parkinson-like events (broad), Acute central respiratory depression (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (narrow), Noninfectious meningitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Glaucoma (broad), Corneal disorders (broad), Retinal disorders (broad), Ocular motility disorders (broad), Hypersensitivity (broad), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Dehydration (broad)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Phenytoin; celecoxib; lisinopril; atenolol; acetylsalicylic acid; esterified estrogens
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: ITSA2018SA096304

Write-up: Initial unsolicited report received from literature on 26 Mar 2018. This case is linked with 2018SA095111, 2018SA095117, 2018SA095112, 2018SA095116, 2018SA096247, 2018SA096279, 2018SA096286, 2018SA096508, 2018SA096332, 2018SA096338, 2018SA096354, 2018SA096379, 2018SA096401, 2018SA096428, 2018SA096432, 2018SA096439, 2018SA096448, 2018SA096456, 2018SA096464, 2018SA096468, 2018SA096471, 2018SA096475, 2018SA096477, 2018SA096479, 2018SA096482, 2018SA096366, 2018SA096377, 2018SA096383, 2018SA096413, 2018SA096421, 2018SA096433, 2018SA096450,2018SA096460, 2018SA096465, 2018SA096469, 2018SA096473, 2018SA096478, 2018SA096483, 2018SA096485, 2018SA096488, 2018SA096500, 2018SA096502, 2018SA096505 and 2018SA096506 (Same literature). The following is verbatim from the article: Background: An increasing number of reports indicates that vaccines against influenza may interact with specific drugs via drug metabolism. To date, actual impact of vaccine-drug interactions observed in the real world clinical practice has not been investigated. Methods: From VAERS and DataBase, we collected Adverse Event Following Immunization (AEFI) reports for individuals receiving vaccines against influenza recorded as suspect and selected cases where predictable toxicity was recorded with oral anticoagulants, antiepileptics and statins (i.e. hemorrhages, overdosage and rhabdomyolysis, respectively). We applied AEFI and Drug Interaction Probability Scale (DIPS) Algorithms to assess causality of drug-vaccine interactions. Results: 116 AEFI reports submitted to VAERS and 83 from Database were included in our analysis; antiepileptics and statins were related to the highest number of indeterminate/consistent (93.7%; 65.3%) and possible/probable (50%; 57.7%) cases according to the AEFI and DIPS, respectively. The majority of cases occurred within the first week after vaccine administration (5-7 days). Conclusion: The relative paucity of detected interactions does not impact on the benefit of the vaccination against influenza, which remains strongly recommended; this does not exclude that closer monitoring for selected patients exposed to concomitant chronic pharmacological therapies and affected by predisposing factors may be useful. This case involves 70 years old female patient who was vaccinated with dose of INFLUENZA VIRUS VACCINE TRIVALENT, PHENYTOIN, CELECOXIB, LISINOPRIL, ATENOLOL, ACETYLSALICYLIC ACID, ESTERIFIED ESTROGENS (batch number, expiry date and route of administration were not reported) on an unspecified date. The patient''s medical history was not reported. The patient''s concomitant medication was not reported. On an unspecified date, 29 days following the vaccination and after receiving drug, patient had Coma, cough, delirium, diplopia, disorientation, nausea, vomiting, respiratory distress, eye disorder, eye pain, headache, mental impairment, movement disorder, nervous system disorder, pyrexia, stupor and torticollis. Authors pointed out that suspect drugs CELECOXIB, LISINOPRIL, ATENOLOL, ACETYLSALICYLIC ACID, ESTERIFIED ESTROGENS are known to have drug-drug interactions. Laboratory investigation includes CT scan of brain and MRI of brain: abnormal. Patient''s corrective treatment was not reported. On an unspecified date, patient was recovered from events. This case was considered as serious by the reporter due to medically significant events. The reporter assessed the causal relationship INFLUENZA VIRUS VACCINE TRIVALENT and PHENYTOIN for the events as indeterminate and drug interaction probability scale reported as possible (4). List of documents held by sender: none. Sender''s Comments: This patient developed reported events following vaccination with Influenza vaccine (unknown manufacturer) while she was on Phenytoin treatment. Time to onset is 29 days. Additional information including vaccination details with manufacturer, onset time, concomitant vaccinations, past vaccination history with tolerance data, concurrent conditions, medical history and laboratory test ruling out other etiologies is needed for further assessment. Based on available information role of vaccine cannot be assessed.


VAERS ID: 743677 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2018-04-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Condition aggravated, Encephalopathy, Hypoxia, Leukocytosis, Pneumonia, Respiratory acidosis, Somnolence, Stupor
SMQs:, Asthma/bronchospasm (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Acute central respiratory depression (broad), Pulmonary hypertension (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (narrow), Noninfectious meningitis (broad), Eosinophilic pneumonia (broad), Chronic kidney disease (broad), Respiratory failure (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Infective pneumonia (narrow), 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: Carbamazepine; diltiazem; digoxin; isosorbide; dipyridamole
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: ITSA2018SA096354

Write-up: Initial unsolicited report received from literature on 26 Mar 2018. This case was linked to 2018SA095111, 2018SA095117, 2018SA095112, 2018SA095116, 2018SA096247, 2018SA096279, 2018SA096286, 2018SA096304, 2018SA096332, 2018SA096338, 2018SA096379, 2018SA096401, 2018SA096428, 2018SA096432, 2018SA096439, 2018SA096448, 2018SA096456, 2018SA096464, 2018SA096468, 2018SA096471, 2018SA096475, 2018SA096477, 2018SA096479, 2018SA096482, 2018SA096366, 2018SA096377, 2018SA096383, 2018SA096413, 2018SA096421, 2018SA096433, 2018SA096450, 2018SA096460, 2018SA096465, 2018SA096469, 2018SA096473, 2018SA096478, 2018SA096485, 2018SA096488, 2018SA096500, 2018SA096502, 2018SA096483, 2018SA096505, 2018SA096506, 2018SA096508 (same Literature). The following is verbatim from the article: Background: An increasing number of reports indicates that vaccines against influenza may interact with specific drugs via drug metabolism. To date, actual impact of vaccine-drug interactions observed in the real world clinical practice has not been investigated. Methods: From VAERS and DataBase, we collected Adverse Event Following Immunization (AEFI) reports for individuals receiving vaccines against influenza recorded as suspect and selected cases where predictable toxicity was recorded with oral anticoagulants, antiepileptics and statins (i.e. hemorrhages, overdosage and rhabdomyolysis, respectively). We applied AEFI and Drug Interaction Probability Scale (DIPS) Algorithms to assess causality of drug-vaccine interactions. Results: 116 AEFI reports submitted to VAERS and 83 from Database were included in our analysis; antiepileptics and statins were related to the highest number of indeterminate/consistent (93.7%; 65.3%) and possible/probable (50%; 57.7%) cases according to the AEFI and DIPS, respectively. The majority of cases occurred within the first week after vaccine administration (5-7 days). Conclusion: The relative paucity of detected interactions does not impact on the benefit of the vaccination against influenza, which remains strongly recommended; this does not exclude that closer monitoring for selected patients exposed to concomitant chronic pharmacological therapies and affected by predisposing factors may be useful. This case involves 89-year-old female patient who was vaccinated with dose of INFLUENZA VIRUS VACCINE and Carbamazepine, Diltiazem, Digoxin, Isosorbide and Dipyridamole (batch number, expiry date, route and site of administration were not reported) on an unspecified date. The patient''s medical history was not reported. Concomitant medication was not reported. On an unspecified date, one day following the vaccination and administration with Carbamazepine and also after receiving Diltiazem, Digoxin, Isosorbide and Dipyridamole, patient''s condition aggravated, had encephalopathy, hypoxia, leukocytosis, pneumonia, respiratory acidosis, somnolence and stupor. Patient was hospitalized on an unspecified date. Authors pointed out that suspect drugs Carbamazepine, diltiazem, digoxin, isosorbide and dipyridamole are known to have drug-drug interactions. Lab data and corrective treatment were not reported. Outcome of events was not reported. The reporter assessed the adverse events following immunization and drug interaction probability scale as indeterminate (possible). List of documents held by sender: none. Sender''s Comments: This literature article reports of a 89 year old female who developed Encephalopathy, Pneumonia, Respiratory acidosis, leukocytosis after influenza vaccination and carbamazepine, diltiazem, digoxin, isosorbide and dipyridamole. Further information regarding vaccination details (MFR), symptoms and their evolution, time to onset, medical history as well as concurrent condition during vaccination, previous vaccination and tolerance, allergic history, laboratory investigations excluding alternative etiologies for the reported event are needed to fully assess this case. There is a possibility that the events might be related to the other antiepileptic or other medications or their interactions. Based upon the given information the role of the vaccine cannot be assessed.


VAERS ID: 743678 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2018-04-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Acute kidney injury, Antinuclear antibody positive, Blood creatine phosphokinase increased, Blood urea increased, Gait inability, Infectious mononucleosis, Muscular weakness, Protein urine present, Red blood cell sedimentation rate increased, Rhabdomyolysis
SMQs:, Rhabdomyolysis/myopathy (narrow), Acute renal failure (narrow), Peripheral neuropathy (broad), Neuroleptic malignant syndrome (broad), Systemic lupus erythematosus (narrow), Myocardial infarction (broad), Anticholinergic syndrome (broad), Retroperitoneal fibrosis (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (broad), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (broad), Toxic-septic shock conditions (broad), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Dystonia (broad), Guillain-Barre syndrome (broad), Noninfectious encephalopathy/delirium (broad), Chronic kidney disease (broad), Tumour lysis syndrome (broad), Proteinuria (narrow), Tubulointerstitial diseases (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Dehydration (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: Simvastatin; diltiazem; pioglitazone; furosemide; lisinopril; insulin
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Chronic kidney disease; Diabetes mellitus
Allergies:
Diagnostic Lab Data: Test Name: Creatine Phosphokinase; Result Unstructured Data: 42000; Test Name: Protein urine; Result Unstructured Data: 150; Test Name: ANA; Test Result: Positive; Test Name: Blood urea; Result Unstructured Data: INCREASED
CDC Split Type: ITSA2018SA096377

Write-up: Initial unsolicited report received from literature on 26 Mar 2018. This case was linked to 2018SA095111, 2018SA095117, 2018SA095112, 2018SA095116, 2018SA096247, 2018SA096279, 2018SA096286, 2018SA096304, 2018SA096332, 2018SA096338, 2018SA096379, 2018SA096401, 2018SA096428, 2018SA096432, 2018SA096439, 2018SA096448, 2018SA096456, 2018SA096464, 2018SA096468, 2018SA096471, 2018SA096475, 2018SA096477, 2018SA096479, 2018SA096482, 2018SA096366, 2018SA096354, 2018SA096383, 2018SA096413, 2018SA096421, 2018SA096433, 2018SA096450, 2018SA096460, 2018SA096465, 2018SA096469, 2018SA096473, 2018SA096478, 2018SA096485, 2018SA096488, 2018SA096500, 2018SA096502, 2018SA096483, 2018SA096505, 2018SA096506, 2018SA096508 (same Literature). The following is verbatim from the article: Background: An increasing number of reports indicates that vaccines against influenza may interact with specific drugs via drug metabolism. To date, actual impact of vaccine-drug interactions observed in the real world clinical practice has not been investigated. Methods: From VAERS and DataBase, we collected Adverse Event Following Immunization (AEFI) reports for individuals receiving vaccines against influenza recorded as suspect and selected cases where predictable toxicity was recorded with oral anticoagulants, antiepileptics and statins (i.e. hemorrhages, overdosage and rhabdomyolysis, respectively). We applied AEFI and Drug Interaction Probability Scale (DIPS) Algorithms to assess causality of drug-vaccine interactions. Results: 116 AEFI reports submitted to VAERS and 83 from Database were included in our analysis; antiepileptics and statins were related to the highest number of indeterminate/consistent (93.7%; 65.3%) and possible/probable (50%; 57.7%) cases according to the AEFI and DIPS, respectively. The majority of cases occurred within the first week after vaccine administration (5-7 days). Conclusion: The relative paucity of detected interactions does not impact on the benefit of the vaccination against influenza, which remains strongly recommended; this does not exclude that closer monitoring for selected patients exposed to concomitant chronic pharmacological therapies and affected by predisposing factors may be useful. This case involves 74-year-old female patient who was vaccinated with dose of INFLUENZA VACCINE (batch number, expiry date, route and site of administration were not reported) and Simvastatin, Diltiazem, Pioglitazone, Insulin, Furosemide and Lisinopril (batch number, expiry date, route were not reported) on an unspecified date. The patient''s medical history includes diabetes mellitus and chronic kidney disease. Concomitant medication was not reported. On an unspecified date, one day following the vaccination and administration of Simvastatin and also after the administration of Diltiazem, Pioglitazone, Insulin, Furosemide and Lisinopril, patient had rhabdomyolysis, muscular weakness, abasia, had acute kidney injury and mononucleosis. Authors pointed out that suspect drugs Simvastatin, Diltiazem, Pioglitazone, Insulin, Furosemide and Lisinopril are known to have drug-drug interactions. Patient was hospitalized on an unspecified date. Lab data includes ANA positive; CPK (Creatine Phosphokinase) of 42,000, Sedimentation rate 76; urine protein 150 and blood urea increased. Corrective treatment was not reported. Outcome of events was not reported. The reporter assessed the adverse events following immunization and drug interaction probability scale as indeterminate (possible). List of documents held by sender: none. Sender''s Comments: This patient developed reported events following vaccination with Influenza vaccine (unknown manufacturer) while he was on statin treatment. Time to onset is unknown. Past vaccination history included diabetes mellitus and chronic kidney disease. Additional information including vaccination details with manufacturer, onset time, concomitant vaccinations, past vaccination history with tolerance data, concurrent conditions, and laboratory test ruling out other infectious etiology is needed for further assessment. Based on available information role of vaccine cannot be assessed.


VAERS ID: 743679 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2018-04-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK - / -

Administered by: Other       Purchased by: ?
Symptoms: Renal impairment, Rhabdomyolysis
SMQs:, Rhabdomyolysis/myopathy (narrow), Acute renal failure (narrow), Neuroleptic malignant syndrome (broad), Retroperitoneal fibrosis (broad), Tumour lysis syndrome (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: ATENOLOL; ISOSORBIDE MONONITRATE; Simvastatin; ramipril; clopidogrel; acetylsalicylic acid; bendrofluazide
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: ITSA2018SA096383

Write-up: Initial unsolicited report received from literature on 26 Mar 2018. This case was linked to 2018SA095111, 2018SA095117, 2018SA095112, 2018SA095116, 2018SA096247, 2018SA096279, 2018SA096286, 2018SA096304, 2018SA096332, 2018SA096338, 2018SA096354, 2018SA096379, 2018SA096401, 2018SA096428, 2018SA096432, 2018SA096439, 2018SA096448, 2018SA096456, 2018SA096464, 2018SA096468, 2018SA096471, 2018SA096475, 2018SA096477, 2018SA096479, 2018SA096482, 2018SA096366, 2018SA096377, 2018SA096413, 2018SA096421, 2018SA096433, 2018SA096450, 2018SA096460, 2018SA096465, 2018SA096469, 2018SA096473, 2018SA096478, 2018SA096483, 2018SA096485, 2018SA096488, 2018SA096500, 2018SA096502, 2018SA096505, 2018SA096506, 2018SA096508 (Same Literature). The following is verbatim from the article: Background: An increasing number of reports indicates that vaccines against influenza may interact with specific drugs via drug metabolism. To date, actual impact of vaccine-drug interactions observed in the real world clinical practice has not been investigated. Methods: From VAERS and DataBase, we collected Adverse Event Following Immunization (AEFI) reports for individuals receiving vaccines against influenza recorded as suspect and selected cases where predictable toxicity was recorded with oral anticoagulants, antiepileptics and statins (i.e. hemorrhages, overdosage and rhabdomyolysis, respectively). We applied AEFI and Drug Interaction Probability Scale (DIPS) Algorithms to assess causality of drug-vaccine interactions. Results: 116 AEFI reports submitted to VAERS and 83 from Database were included in our analysis; antiepileptics and statins were related to the highest number of indeterminate/consistent (93.7%; 65.3%) and possible/probable (50%; 57.7%) cases according to the AEFI and DIPS, respectively. The majority of cases occurred within the first week after vaccine administration (5-7 days). Conclusion: The relative paucity of detected interactions does not impact on the benefit of the vaccination against influenza, which remains strongly recommended; this does not exclude that closer monitoring for selected patients exposed to concomitant chronic pharmacological therapies and affected by predisposing factors may be useful. This case involves 71-year-old male patient who was vaccinated with dose of INFLUENZA VIRUS VACCINE (batch number, expiry date, route and site of administration were not reported) and received Simvastatin (batch number and expiry date were not reported) on an unknown date. The patient also received Clopidogrel, Acetylsalicylic acid, Bendrofluazide and Ramipril (batch number and expiry date were not reported) on an unknown date. The patient''s medical history were not reported. Concomitant medication included atenolol and Isosorbide mononitrate. On an unspecified date, 15 days post vaccination and post drug administration with Simvastatin and also after the administrations of Clopidogrel, Acetylsalicylic acid, Bendrofluazide and Ramipril, the patient developed renal impairment and rhabdomyolysis. Authors pointed out that suspect drugs Simvastatin, Clopidogrel, Acetylsalicylic acid, Bendrofluazide and Ramipril are known to have drug-drug interactions. Relevant laboratory investigation and corrective treatment were not reported. On an unknown date, the patient was recovered from the events. This case was considered as serious by the reporter due to medically significant events. The reporter assessed the adverse events following immunization and drug interaction probability scale as indeterminate (possible). List of documents held by sender: none. Sender''s Comments: This elderly patient developed renal impairment and rhabdomyolysis following vaccination with Influenza vaccine (unknown manufacturer) while he was on statin treatment. Time to onset is unknown. Additional information including vaccination details with manufacturer, onset time, concomitant vaccinations, past vaccination history with tolerance data, medical history, lab test ruling out other infectious etiology is needed for further assessment. Based on available information role of vaccine cannot be assessed.


VAERS ID: 743681 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2018-04-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER UNKNOWN / UNK UN / UN

Administered by: Other       Purchased by: ?
Symptoms: Acute kidney injury, Alanine aminotransferase increased, Areflexia, Aspartate aminotransferase increased, Back pain, Blood creatine phosphokinase increased, Blood creatinine increased, Blood lactate dehydrogenase increased, Blood potassium increased, Blood urea increased, Dehydration, Dysuria, Gait disturbance, Haemodialysis, Hepatic pain, Hepatomegaly, Localised oedema, Myalgia, Oedema peripheral, Oliguria, Pain in extremity, Platelet count normal, Pulmonary congestion, Quadriparesis, Rhabdomyolysis, Scrotal oedema
SMQs:, Rhabdomyolysis/myopathy (narrow), Acute renal failure (narrow), Cardiac failure (broad), Liver related investigations, signs and symptoms (narrow), Angioedema (broad), Peripheral neuropathy (broad), Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Myocardial infarction (broad), Anticholinergic syndrome (broad), Retroperitoneal fibrosis (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (broad), Torsade de pointes, shock-associated conditions (broad), Hypovolaemic shock conditions (broad), Toxic-septic shock conditions (broad), Anaphylactic/anaphylactoid shock conditions (broad), Hypoglycaemic and neurogenic shock conditions (broad), Embolic and thrombotic events, vessel type unspecified and mixed arterial and venous (narrow), Parkinson-like events (broad), Guillain-Barre syndrome (broad), Extravasation events (injections, infusions and implants) (broad), Haemodynamic oedema, effusions and fluid overload (narrow), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Conditions associated with central nervous system haemorrhages and cerebrovascular accidents (broad), Chronic kidney disease (narrow), Hypersensitivity (narrow), Tumour lysis syndrome (narrow), Tendinopathies and ligament disorders (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Infective pneumonia (broad), Dehydration (narrow)

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: Diabetes mellitus
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Name: alanine aminotransferase; Result Unstructured Data: 630 international unit(s)/litre; Test Name: aspartate aminotransferase; Result Unstructured Data: 592 international unit(s)/litre; Test Name: blood Creatine phosphokinase; Result Unstructured Data: 7600 international unit(s)/litre; Test Name: Blood creatinine; Test Result:3.5 mg/dl; Test Name: LDH; Result Unstructured Data: 2828 international unit(s)/litre; Test Name: blood potassium; Result Unstructured Data: 5.4 milliequivalent(s)/litre; Test Name: blood urea; Test Result: 203 mg/dl
CDC Split Type: ITSA2018SA096433

Write-up: Initial unsolicited report received from literature on 26 Mar 2018. This case is linked to 2018SA095111, 2018SA095117, 2018SA095112, 2018SA095116, 2018SA096247, 2018SA096279, 2018SA096286, 2018SA096304, 2018SA096332, 2018SA096338, 2018SA096354, 2018SA096379, 2018SA096401, 2018SA096428, 2018SA096432, 2018SA096439, 2018SA096448, 2018SA096456, 2018SA096464, 2018SA096468, 2018SA096471, 2018SA096475, 2018SA096477, 2018SA096479, 2018SA096482, 2018SA096366, 2018SA096377, 2018SA096413, 2018SA096421, 2018SA096450, 2018SA096460, 2018SA096465, 2018SA096469, 2018SA096473, 2018SA096478, 2018SA096483, 2018SA096485, 2018SA096488, 2018SA096500, 2018SA096502, 2018SA096505, 2018SA096506, 2018SA096508, 2018SA096383 (Same Literature). No signal of interactions between influenza vaccines and drugs used for chronic diseases: a case-by-case analysis of the vaccine adverse event reporting system and database. Expert Review of Vaccines. 2018:1-19. To date, actual impact of vaccine-drug interactions observed in the real world clinical practice has not been investigated. Methods: From VAERS and database, we collected Adverse Event Following Immunization (AEFI) reports for individuals receiving vaccines against influenza recorded as suspect and selected cases where predictable toxicity was recorded with oral anticoagulants, antiepileptics and statins (i.e. hemorrhages, overdosage and rhabdomyolysis, respectively). We applied AEFI and Drug Interaction Probability Scale (DIPS) Algorithms to assess causality of drug-vaccine interactions. Results: 116 AEFI reports submitted to VAERS and 83 from database were included in our analysis; antiepileptics and statins were related to the highest number of indeterminate/consistent (93.7%; 65.3%) and possible/probable (50%; 57.7%) cases according to the AEFI and DIPS, respectively. The majority of cases occurred within the first week after vaccine administration (5-7 days). Conclusion: The relative paucity of detected interactions does not impact on the benefit of the vaccination against influenza, which remains strongly recommended; this does not exclude that closer monitoring for selected patients exposed to concomitant chronic pharmacological therapies and affected by predisposing factors may be useful. This case involves a 58-year-old male patient who was vaccinated with dose of INFLUENZA VACCINE (batch number, expiry date, route and site of administration were not reported) and received Simvastatin (batch number, expiry date were not reported) on an unknown date. The patient also received Glibenclamide, Spironolactone and Acetylsalicylic acid (batch number, expiry date were not reported) on an unknown date. The patient''s predisposing conditions included diabetes mellitus. Other medical history and Concomitant medications were not reported. On an unspecified date, one day post vaccination and administration of Simvastatin and also after the administration of Glibenclamide, Spironolactone and Acetylsalicylic acid, the patient had dysuria, oliguria and acute kidney injury. On an unspecified date, one day post vaccination and administration of Simvastatin and also after the administration of Glibenclamide, Spironolactone and Acetylsalicylic acid, the patient developed areflexia, back pain, dehydration, gait disturbance, hemodialysis, hepatic pain, hepatomegaly, localized odema, myalgia, edema peripheral, pain in extremity, pulmonary congestion, quadriparesis, rhabdomyolysis and scrotal edema. Platelet count was normal. On an unknown date, the patient was hospitalized. Authors pointed out that suspect drugs Simvastatin, Glibenclamide, Spironolactone and Acetylsalicylic acid are known to have drug-drug interactions. Relevant laboratory investigations included alanine aminotransferase (ALT) 630 IU/l, aspartate aminotransferase (AST) 592 IU/l, Blood CPK 7600 IU/l, Blood creatinine 3.5 mg/dl, LDH 2828 IU/l, blood potassium 5.4 mEq/L and blood urea 203 mg/dl. Corrective treatment were not reported. It was reported that patient underwent hemodialysis. The outcome of the events was not reported. The reporter assessed the adverse events following immunization and drug interaction probability scale as indeterminate possible. List of documents held by sender: none. Sender''s Comments: This patient with medical history of diabetes mellitus, developed reported events following vaccination with Influenza vaccine (unknown manufacturer) while he was on Simvastatin treatment. Time to onset is unknown. There is a possibility that patient''s medical history might have contributed in developing kidney injury. Additional information including vaccination details with manufacturer, onset time, concomitant vaccinations, past vaccination history with tolerance data, condition at the time of vaccination and laboratory test ruling out other etiologies is needed for further assessment. Based on available information role of vaccine cannot be assessed.


VAERS ID: 743683 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2018-04-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
FLUX: INFLUENZA (SEASONAL) (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK UN / UN

Administered by: Other       Purchased by: ?
Symptoms: Anaemia, Ecchymosis, Haematoma, International normalised ratio increased, Pain in extremity, Peripheral swelling, Prothrombin time prolonged
SMQs:, Cardiac failure (broad), Liver-related coagulation and bleeding disturbances (narrow), Angioedema (broad), Haematopoietic erythropenia (broad), Haemorrhage terms (excl laboratory terms) (narrow), Haemorrhage laboratory terms (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? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Aortic valve replacement; Coronary artery disease; Hypertensive heart disease
Allergies:
Diagnostic Lab Data:
CDC Split Type: ITSA2018SA096468

Write-up: Initial unsolicited report received from literature on 26 Mar 2018. This case was linked to 2018SA095111, 2018SA095117, 2018SA095112, 2018SA095116, 2018SA096247, 2018SA096279, 2018SA096286, 2018SA096304, 2018SA096332, 2018SA096354, 2018SA096379, 2018SA096401, 2018SA096428, 2018SA096432, 2018SA096439, 2018SA096448, 2018SA096456, 2018SA096464, 2018SA096471, 2018SA096475, 2018SA096477, 2018SA096479, 2018SA096482, 2018SA096366, 2018SA096377, 2018SA096413, 2018SA096421, 2018SA096433, 2018SA096450, 2018SA096460, 2018SA096465, 2018SA096469, 2018SA096473, 2018SA096478, 2018SA096483, 2018SA096485, 2018SA096488, 2018SA096500, 2018SA096502, 2018SA096505, 2018SA096506, 2018SA096508, 2018SA096383, 2018SA096338 (Same Literature). The following is verbatim from the article: Background: An increasing number of reports indicates that vaccines against influenza may interact with specific drugs via drug metabolism. To date, actual impact of vaccine-drug interactions observed in the real world clinical practice has not been investigated. Methods: From VAERS and DataBase, we collected Adverse Event Following Immunization (AEFI) reports for individuals receiving vaccines against influenza recorded as suspect and selected cases where predictable toxicity was recorded with oral anticoagulants, antiepileptics and statins (i.e. hemorrhages, overdosage and rhabdomyolysis, respectively). We applied AEFI and Drug Interaction Probability Scale (DIPS) Algorithms to assess causality of drug-vaccine interactions. Results: 116 AEFI reports submitted to VAERS and 83 from Database were included in our analysis; antiepileptics and statins were related to the highest number of indeterminate/consistent (93.7%; 65.3%) and possible/probable (50%; 57.7%) cases according to the AEFI and DIPS, respectively. The majority of cases occurred within the first week after vaccine administration (5-7 days). Conclusion: The relative paucity of detected interactions does not impact on the benefit of the vaccination against influenza, which remains strongly recommended; this does not exclude that closer monitoring for selected patients exposed to concomitant chronic pharmacological therapies and affected by predisposing factors may be useful. This case involves 78-year-old female patient who was vaccinated with dose of INFLUENZA VACCINE (INACTIVATED, SPLIT-VIRUS INFLUENZA VACCINE) and received Warfarin and Clopidogrel (batch number, expiry date, route and site of administration were not reported) on an unknown date. The patient''s predisposing conditions included Coronary artery disease, aortic valve replacement and hypertensive heart disease. Other medical history were not reported. On an unspecified date, on the same day post vaccination and post drug administration, the patient developed anemia, ecchymosis, hematoma, pain in extremity and peripheral swelling. On an unknown date, the patient was hospitalized. Authors pointed out that suspect drugs Warfarin and Clopidogrel are known to have drug-drug interactions. Relevant laboratory investigation showed PT and INR increased. Corrective treatment were not reported. The outcome of the events was not reported. The reporter assessed the causal relationship with INFLUENZA VACCINE and Warfarin as inconsistent not applicable. List of documents held by sender: none.; Sender''s Comments: This elderly patient with medical history of heart diseases, developed reported events following vaccination with Influenza vaccine (unknown manufacturer). Time to onset is unknown. Additional information including vaccination details with manufacturer, onset time, concomitant vaccinations, past vaccination history with tolerance data lab test ruling out other infectious etiology is needed for further assessment. Based on available information role of vaccine cannot be assessed.


VAERS ID: 743711 (history)  
Form: Version 1.0  
Age:   
Sex: Unknown  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2018-04-10
Entered: 2018-04-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
MENB: MENINGOCOCCAL B (BEXSERO) / NOVARTIS VACCINES AND DIAGNOSTICS - / 3 UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Meningococcal bacteraemia, Vaccination failure
SMQs:, Lack of efficacy/effect (narrow), Sepsis (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: No other medications
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: AT2018GSK057634

Write-up: This case was reported by a physician via other and described the occurrence of vaccination failure in a child patient who received BEXSERO. Co-suspect products included BEXSERO and BEXSERO. On an unknown date, the patient received the 1st dose of BEXSERO, the 2nd dose of BEXSERO and the 3rd dose of BEXSERO. On an unknown date, unknown after receiving BEXSERO, BEXSERO and BEXSERO, the patient experienced vaccination failure (serious criteria GSK medically significant) and meningococcal bacteremia (serious criteria GSK medically significant). On an unknown date, the outcome of the vaccination failure and meningococcal bacteremia were unknown. It was unknown if the reporter considered the vaccination failure and meningococcal bacteremia to be related to BEXSERO, BEXSERO and BEXSERO. Additional information was provided as follows: The patient''s age at vaccination was not reported. The patient experienced a mild meningococcal B infection. This case was considered suspected vaccination failure since the exact time to onset of event and confirmatory test were unknown at the time of receipt of the case.


VAERS ID: 743723 (history)  
Form: Version 1.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 2018-04-10
Entered: 2018-04-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPIPV: DTAP + IPV (UNKNOWN) / UNKNOWN MANUFACTURER - / UNK UN / UN

Administered by: Other       Purchased by: Other
Symptoms: Erythema, Extensive swelling of vaccinated limb, Injection site erythema, Injection site induration, Injection site mass, Injection site warmth, Skin warm
SMQs:, Anaphylactic reaction (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? Yes
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: PIRITON
Current Illness: Unknown
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: GB2018056424

Write-up: This case was reported by a consumer via regulatory authority and described the occurrence of extensive swelling of vaccinated limb in a 40-month-old female patient who received DTPa-IPV (batch number NIASI4V ?, expiry date unknown). Concomitant products included PIRITON. On an unknown date, the patient received DTPa-IPV (parenteral). On an unknown date, unknown after receiving DTPa-IPV, the patient experienced extensive swelling of vaccinated limb (serious criteria other: Serious per reporter), injection site induration (serious criteria other: Serious per reporter), skin warm (serious criteria other: Serious per reporter) and localized erythema (serious criteria other: Serious per reporter). On an unknown date, the outcome of the extensive swelling of vaccinated limb, injection site induration, skin warm and localized erythema were recovered/resolved. It was unknown if the reporter considered the extensive swelling of vaccinated limb, injection site induration, skin warm and localized erythema to be related to DTPa-IPV. Additional details: The age at vaccination was not reported. The reported lot number DTPa-IPV vaccine NIASI4V does not match with any GSK lot number. Initial information was reported by a consumer via regulatory authority on 3rd April 2018: Red and swollen arm - entire upper arm red, hot and a large hard lump over 10 cm in diameter at injection site.


VAERS ID: 743728 (history)  
Form: Version 1.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2018-03-12
Onset:2018-03-13
   Days after vaccination:1
Submitted: 2018-04-10
   Days after onset:28
Entered: 2018-04-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
DTAPIPV: DTAP + IPV (UNKNOWN) / UNKNOWN MANUFACTURER - / UNK UN / UN

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: Benzydamine hydrochloride; Flucloxacillin
Current Illness: Unknown
Preexisting Conditions: Food allergy, Allergic to dairy, wheat and soya.
Allergies:
Diagnostic Lab Data:
CDC Split Type: GB2018056420

Write-up: This case was reported by a consumer via regulatory authority and described the occurrence of cellulitis in a 3-year-old male patient who received DTPa-IPV (batch number NDS11V?, expiry date unknown). Concurrent medical conditions included food allergy (Allergic to dairy, wheat and soya). Additional patient notes included Possible Ehlers-Danlos Syndrome/Bleeding disorder. Concomitant products included Flucloxacillin and benzydamine hydrochloride. On 12th March 2018, the patient received DTPa-IPV (parenteral). On 13th March 2018, 1 days after receiving DTPa-IPV, the patient experienced cellulitis (serious criteria GSK medically significant and other) and allergic rash (serious criteria other). In March 2018, the patient experienced swelling arm (serious criteria other). On an unknown date, the outcome of the cellulitis, allergic rash and swelling arm were recovering/resolving. It was unknown if the reporter considered the cellulitis, allergic rash and swelling arm to be related to DTPa-IPV. Additional information: Age at vaccination was not reported. The reported batch number of DTPa IPV (NDS11V) does not match with GSK batch number. Initial information was received from a consumer via regulatory authority on 03rd April 2018: Bacterial infection (cellulitis), allergic rash and swelling arm.


VAERS ID: 743737 (history)  
Form: Version 2.0  
Age: 0.17  
Sex: Unknown  
Location: Foreign  
Vaccinated:2018-01-24
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2018-04-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
RV5: ROTAVIRUS (ROTATEQ) / MERCK & CO. INC. - / 1 MO / PO

Administered by: Unknown       Purchased by: ?
Symptoms: Inappropriate schedule of drug administration, Malaise
SMQs:, Medication errors (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: JP0095075131804JPN000162J

Write-up: Information has been received from a pharmacist concerning a 0 year old infant (gender unknown) who on 24-JAN-2018 was vaccinated with ROTATEQ ORAL SOLUTION orally as the first vaccination for prophylaxis(Japan lot. Number, US lot. number and dose not reported). There was no concomitant medication reported. On 24-JAN-2018, the infant was vaccinated with rotavirus vaccine, live, oral, pentavalent for the first time (described above). In 2018(after that), the infant was hospitalized due to illness not related to ROTATEQ, so the second vaccination didn''t performed. At the time of this report, the outcome of "illness not related to ROTATEQ" was unknown. Reporter''s comment: The second vaccination is scheduled on 11-APR-2018. Although there was quite a long interval from the first time, I think we can finish the third time by the 32th week. The reporting pharmacist felt that "illness not related to ROTATEQ" was not related to rotavirus vaccine, live, oral, pentavalent. The reporting pharmacist considered "illness not related to ROTATEQ" to be serious due to hospitalization. Company Causality Assessment: Based on the limited information currently available for this case, a reasonable causal association between Rotateq and the reported event of "adverse event" cannot be established. Missing clinically important information includes the reason for hospitalization and the clinical course including the event onset and hospitalization dates. Company Comment- No changes to the Rotateq product safety information are warranted at this time. Merck and Co., Inc., continues to monitor the safety profile of the product.


VAERS ID: 743738 (history)  
Form: Version 2.0  
Age: 0.0  
Sex: Female  
Location: Foreign  
Vaccinated:2013-10-21
Onset:2014-04-05
   Days after vaccination:166
Submitted: 0000-00-00
Entered: 2018-04-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
RV5: ROTAVIRUS (ROTATEQ) / MERCK & CO. INC. H018776 / 3 MO / PO

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

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? 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: JP0095075131804JPN000393J

Write-up: Gastroenteritis rotavirus; vomiting, diarrhoea; Information has been received from a physician concerning a 9-month-old female infant with no historical conditions. There was a rotavirus outbreak of wild strain (G9P [8]) in the same facility from 02-APR-2014. On 17-FEB-2014, the infant was orally vaccinated with ROTATEQ ORAL SOLUTION, 2 mL as the third vaccination for prophylaxis (lot number was not reported). No concomitant medications were reported. On 21-OCT-2013, the infant was vaccinated with rotavirus vaccine, live, oral, pentavalent, 2 mL as the first vaccination for prophylaxis (lot number: H018776). On 13-DEC-2013, the infant was vaccinated with rotavirus vaccine, live, oral, pentavalent, 2 mL as the second vaccination for prophylaxis (lot number was not reported). On 17-FEB-2014, the infant was vaccinated with rotavirus vaccine, live, oral, pentavalent, 2 mL as the third vaccination for prophylaxis (lot number was not reported). From 02-APR-2014, there was a rotavirus outbreak of wild strain (G9P [8]) in the same facility. On 05-APR-2014, vomiting and diarrhoea developed. On 12-APR-2014, rotavirus test of faeces showed positive (G9P [8]). (Gastroenteritis rotavirus developed). On 14-APR-2014, vomiting resolved. On 17-APR-2014, diarrhoea resolved. At the time of the report, the outcome of gastroenteritis rotavirus was unknown. Reporter''s comment: not provided. The reporting physician felt that "gastroenteritis rotavirus; vomiting, diarrhoea" was not related to rotavirus vaccine, live, oral, pentavalent. The reporting physician considered that "gastroenteritis rotavirus; vomiting, diarrhoea" was non-serious. Upon internal review, "gastroenteritis rotavirus; vomiting, diarrhoea" was determined to be medically significant. Lot number H018776 have been verified to be valid lot numbers for rotavirus vaccine, live, oral, pentavalent. This is one of multiple reports from the same source. Company Causality Assessment: Based on the clinically relevant information currently available for this individual case, the reported event of gastroenteritis rotavirus is considered unlikely related to Rotateq. The evidence is not sufficient to suggest a relationship between the vaccinatin and the reported seriouadverse event. Causality assessment is impacted by the confounding factors of prolonged interval between reported event and the vaccination and information reporting outbreak of wild strain rotavirus infection Company Comment- No changes to the Rotateq product safety information are warranted at this time. Merck and Co., Inc., continues to monitor the safety profile of the product.; Sender''s Comments: JP-MSD-1804JPN000389J: JP-MSD-1804JPN000390J: JP-MSD-1804JPN000391J: JP-MSD-1804JPN000392J: JP-MSD-1804JPN000394J: JP-MSD-1804JPN000395J: JP-MSD-1804JPN000396J: JP-MSD-1804JPN000406J: JP-MSD-1804JPN000407J: JP-MSD-1804JPN000408J: JP-MSD-1804JPN000581J:


VAERS ID: 743740 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2014-04-02
Onset:2014-04-05
   Days after vaccination:3
Submitted: 0000-00-00
Entered: 2018-04-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
RV5: ROTAVIRUS (ROTATEQ) / MERCK & CO. INC. - / UNK MO / PO

Administered by: Unknown       Purchased by: ?
Symptoms: Diarrhoea, Gastroenteritis rotavirus, Stool analysis abnormal
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? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: JP0095075131804JPN000395J

Write-up: Information has been received from a physician concerning a 5-month-old female infant without medical history. From 02-APR-2014, an outbreak of wild-type strain G9P[8] rotavirus happened in the same facility. On 02-APR-2014, the infant was orally vaccinated with ROTATEQ ORAL SOLUTION, 2 mL for prophylaxis vaccination (lot number/lot number: J000762/ J000762). No concomitant medications were reported. On 05-APR-2014, diarrhea developed. On 09-APR-2014, diarrhea resolved. On 12-APR-2014, G 9P [8] was detected from the infant''s tool ("gastroenteritis rotavirus; diarrhoea" developed). At the time of the report, the outcome of "gastroenteritis rotavirus; diarrhoea" was unknown. Reporter''s comment: not provided. The reporting physician felt that "gastroenteritis rotavirus; diarrhoea" was not related to rotavirus vaccine, live, oral, pentavalent. The reporting physician considered "gastroenteritis rotavirus; diarrhoea" to be non-serious. Upon internal review, "gastroenteritis rotavirus; diarrhoea" was determined to be medically significant. Lot number [J000762, J000762] has been verified to be valid lot number for rotavirus vaccine, live, oral, pentavalent. This is one of 12 reports from the same source. Company Causality Assessment: Based on the clinically relevant information currently available for this individual case, the reported event of gastroenteritis rotavirus is considered unlikely related to Rotateq. The evidence is not sufficient to suggest a relationship between the vaccination and the reported serious adverse event. Other incidental wild strain rotavirus infection constitutes a more plausible alternative explanation for the event. Company Comment- No changes to the Rotateq product safety information are warranted at this time. Merck and Co., Inc., continues to monitor the safety profile of the product.; Sender''s Comments: JP-MSD-1804JPN000389J: JP-MSD-1804JPN000390J: JP-MSD-1804JPN000391J: JP-MSD-1804JPN000392J: JP-MSD-1804JPN000393J: JP-MSD-1804JPN000394J: JP-MSD-1804JPN000396J: JP-MSD-1804JPN000406J: JP-MSD-1804JPN000407J: JP-MSD-1804JPN000408J: JP-MSD-1804JPN000581J:


VAERS ID: 743741 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:0000-00-00
Onset:2014-04-05
Submitted: 0000-00-00
Entered: 2018-04-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
RV5: ROTAVIRUS (ROTATEQ) / MERCK & CO. INC. - / UNK MO / PO

Administered by: Unknown       Purchased by: ?
Symptoms: Diarrhoea, Gastroenteritis rotavirus, Stool analysis abnormal, Vomiting
SMQs:, Acute pancreatitis (broad), Pseudomembranous colitis (broad), Gastrointestinal nonspecific symptoms and therapeutic procedures (narrow), Noninfectious diarrhoea (narrow)

Life Threatening? No
Birth Defect? No
Died? No
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions: Comments: Family history:From 02-APR-2014, wild-type strain G9P[8] rotavirus outbreak occurred within the same facility.
Allergies:
Diagnostic Lab Data:
CDC Split Type: JP0095075131804JPN000406J

Write-up: Information has been received from a physician concerning a 9 month-old female infant with no medical history, who was orally vaccinated with ROTATEQ ORAL SOLUTION 2mL for prophylaxis (start date, lot number and lot number not reported). From 02-APR-2014, wild-type strain G9P[8] rotavirus outbreak occurred within the same facility. No concomitant medications were reported. On 05-APR-2014, the patient developed vomiting and diarrhea ("gastroenteritis rotavirus; vomiting, diarrhea" was developed). On 07-APR-2014, vomiting was resolved. On 09-APR-2014, diarrhea was resolved. On 11-APR-2014, G9P[8] was detected in the patient''s stool. At the time of the report, the outcome of "gastroenteritis rotavirus; vomiting, diarrhea" was unknown. Reporter''s comment: not provided. The reporting physician felt that "gastroenteritis rotavirus; vomiting, diarrhea" was unrelated to rotavirus vaccine, live, oral, pentavalent. The reporting physician considered "gastroenteritis rotavirus; vomiting, diarrhea" to be non-serious. Upon internal review, "gastroenteritis rotavirus; vomiting, diarrhea" was determined to be medically significant. This is one of 12 reports from the same source. Company Causality Assessment: Based on the clinically relevant information currently available for this individual case, the reported event of gastroenteritis rotavirus is considered unlikely related to Rotateq. The evidence is not sufficient to suggest a relationship between the vaccination and the reported serious adverse event. Incidental infection due to in-hospital outbreak constitutes a more plausible alternative explanation for the event. Company Comment- No changes to the ROTATEQ product safety information are warranted at this time. Merck and Co., Inc., continues to monitor the safety profile of the product.; Sender''s Comments: JP-MSD-1804JPN000389J: JP-MSD-1804JPN000390J: JP-MSD-1804JPN000391J: JP-MSD-1804JPN000392J: JP-MSD-1804JPN000393J: JP-MSD-1804JPN000394J: JP-MSD-1804JPN000395J: JP-MSD-1804JPN000396J: JP-MSD-1804JPN000407J: JP-MSD-1804JPN000408J: JP-MSD-1804JPN000581J:


VAERS ID: 743742 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:2014-08-13
Onset:2015-04-25
   Days after vaccination:255
Submitted: 0000-00-00
Entered: 2018-04-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
RV5: ROTAVIRUS (ROTATEQ) / MERCK & CO. INC. - / UNK MO / PO

Administered by: Unknown       Purchased by: ?
Symptoms: