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From the 1/14/2022 release of VAERS data:

Found 81 cases where Vaccine is RVX and Patient Died

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Case Details

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VAERS ID: 899590 (history)  
Form: Version 2.0  
Age:   
Sex: Female  
Location: Foreign  
Vaccinated:2018-06-07
Onset:2018-06-08
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2020-12-01
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
PNC10: PNEUMO (SYNFLORIX) / GLAXOSMITHKLINE BIOLOGICALS - / UNK - / IM
RVX: ROTAVIRUS (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK MO / PO
UNK: VACCINE NOT SPECIFIED (OTHER) / UNKNOWN MANUFACTURER - / UNK - / IM

Administered by: Unknown       Purchased by: ?
Symptoms: Cardiac arrest, Death, Infantile vomiting
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (broad), Arrhythmia related investigations, signs and symptoms (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Acute central respiratory depression (broad), Cardiomyopathy (broad), Neonatal disorders (narrow), Respiratory failure (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:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: KRGLAXOSMITHKLINEKR2020AP

Write-up: Asystolia; Vomiting neonatal; This case was reported by a consumer (Regulatory Authority: 451250840) via regulatory authority and described the occurrence of asystole in a infant female patient who received 10PN-PD-Dit (Synflorix) for prophylaxis. Co-suspect products included Rotavirus vaccine for prophylaxis and DTPa-IPV+Hib (DTPa-IPV+Hib vaccine) for prophylaxis. On 7th June 2018, the patient received Synflorix (intramuscular), Rotavirus vaccine (oral) and DTPa-IPV+Hib vaccine (intramuscular). On 8th June 2018, 1 days after receiving Synflorix, Rotavirus vaccine and DTPa-IPV+Hib vaccine, the patient experienced asystole (serious criteria death and GSK medically significant) and vomiting neonatal (serious criteria death). On an unknown date, the outcome of the asystole and vomiting neonatal were fatal. The reported cause of death was asystole and vomiting neonatal. It was unknown if the reporter considered the asystole and vomiting neonatal to be related to Synflorix, Rotavirus vaccine and DTPa-IPV+Hib vaccine. Additional details were reported as follows: Regulatory Authority has been made aware of this case on 30th July 2018. This report was received from regulatory authority and it was reported as voluntary Report to the authority. The age at vaccination was not reported. The patient experienced asystolia and vomiting neonatal. Suspects have been coded per GSK coding conventions.; Reported Cause(s) of Death: Asystolia; Vomiting Neonatal


VAERS ID: 946701 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-01-15
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
RVX: ROTAVIRUS (NO BRAND NAME) / UNKNOWN MANUFACTURER - / UNK MO / PO

Administered by: Unknown       Purchased by: ?
Symptoms: Death, Hypersensitivity, Peritonitis
SMQs:, Angioedema (broad), Gastrointestinal perforation (narrow), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (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? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: BRGLAXOSMITHKLINEBR2021GS

Write-up: acute abdomen; peritonitis; Unknown cause of death; This case was reported by a physician via licensee and described the occurrence of unknown cause of death in a male patient who received Rotavirus vaccine for prophylaxis. On an unknown date, the patient received Rotavirus vaccine (oral). On an unknown date, 3 days after receiving Rotavirus vaccine, the patient experienced unknown cause of death (serious criteria death and GSK medically significant), acute abdomen (serious criteria hospitalization and GSK medically significant) and peritonitis (serious criteria hospitalization and GSK medically significant). On an unknown date, the outcome of the unknown cause of death was fatal and the outcome of the acute abdomen and peritonitis were unknown. The reported cause of death was unknown cause of death. It was unknown if the reporter considered the unknown cause of death, acute abdomen and peritonitis to be related to Rotavirus vaccine. Additional details were provided as follows: The patient was a baby boy. The age at vaccination was not reported. The physician stated that the patient received Rotavirus vaccine and was hospitalized due to acute abdomen 2 days after vaccination. The physician stated that surgery was needed, and no invagination was observed, but primary peritonitis. The patient died on the next day of hospitalization. No further information was reported.; Reported Cause(s) of Death: Unknown cause of death


VAERS ID: 1414834 (history)  
Form: Version 2.0  
Age: 0.25  
Sex: Male  
Location: Foreign  
Vaccinated:2020-08-13
Onset:2020-08-01
Submitted: 0000-00-00
Entered: 2021-06-21
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
IPV: POLIO VIRUS, INACT. (POLIOVAX) / SANOFI PASTEUR P1D04 / 1 RL / IM
PPV: PNEUMO (NO BRAND NAME) / UNKNOWN MANUFACTURER 170VPN017B / 1 RL / IM
RVX: ROTAVIRUS (NO BRAND NAME) / UNKNOWN MANUFACTURER 193VRT010B / 1 MO / PO
UNK: VACCINE NOT SPECIFIED (NO BRAND NAME) / UNKNOWN MANUFACTURER E5VO19019 / 1 LL / IM
UNK: VACCINE NOT SPECIFIED (NO BRAND NAME) / UNKNOWN MANUFACTURER AMCA816A / 1 RL / IM

Administered by: Unknown       Purchased by: ?
Symptoms: Death, Melaena
SMQs:, Haemorrhage terms (excl laboratory terms) (narrow), Gastrointestinal haemorrhage (narrow)

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:
Current Illness: Breast feeding; Down''s syndrome
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: BRGLAXOSMITHKLINEBR2021AM

Write-up: This case was reported by a other health professional via regulatory authority and described the occurrence of melena in a 3-month-old male patient who received Men C NVS (Menjugate Liquid) (batch number AMCA816A ?, expiry date unknown) for prophylaxis. Co-suspect products included Polio Trivalent Inactivated (Inactivated polio vaccine) (batch number P1D04, expiry date unknown) for prophylaxis, Rotavirus vaccine (batch number 193VRT010B, expiry date unknown) for prophylaxis, 10PN-PD-Dit (Pneumococcal vaccine) (batch number 170VPN017B, expiry date unknown) for prophylaxis and DTP + HB + HIB (batch number E5VO19019, expiry date unknown) for prophylaxis. Concurrent medical conditions included breast feeding and down''s syndrome. On 13th August 2020, the patient received the 1st dose of Menjugate Liquid (intramuscular), the 1st dose of Inactivated polio vaccine (intramuscular), the 1st dose of Rotavirus vaccine (oral), the 1st dose of Pneumococcal vaccine (intramuscular) and the 1st dose of DTP + HB + HIB (intramuscular). In August 2020, less than 2 weeks after receiving Menjugate Liquid, Inactivated polio vaccine, Rotavirus vaccine and Pneumococcal vaccine, the patient experienced melena (serious criteria death and GSK medically significant). On an unknown date, the outcome of the melena was fatal. The reported cause of death was melena. It was unknown if the reporter considered the melena to be related to Menjugate Liquid, Inactivated polio vaccine, Rotavirus vaccine and Pneumococcal vaccine. Additional case details were reported as follows: The filing date immunization program was 25th August 2020. The patient''s age at time of reporting was reported as 1 year, 28 days however as per reported information it was captured as 3 months. The patient was on breast feeding. The patient received a dose of Menjugate liquid in right thigh vastus lateralis, Inactivated polio in right thigh vastus lateralis, DTP/HB/Hib in left thigh vastus lateralis, Pneumococcal 10V vaccine in right thigh vastus lateralis. The patient was in assistance with the basic health unit team and was evaluated and notified adverse event after vaccination on 25th August 2020. After medical care/evaluation, patient was referred to children''s emergency room. The patient received ambulatory care/assistance on 25th August 2020. On 26th August 2020, family health strategy performed an active search in a home visit to check patient''s situation and identified that the patient''s mother did not go to children''s emergency room according to medical advice. The patient went to a cardiologist on 26th August 2020, in the afternoon, returned home and at night he passed away at his house. There were no records of laboratory tests. It was unknown if the reporter considered the melena to be related to DTP-HB-HIB. The batch number for menjugate liquid vaccine was reported as AMCA816A, however it was captured as AMCA816A ? as per sales data sheet. This report is one of several cases received as part of a line-listing, each containing minimal information. No further information was expected. The follow up was not required. Reported Cause(s) of Death: Melena


VAERS ID: 1466142 (history)  
Form: Version 2.0  
Age: 0.08  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-03
Onset:2021-06-04
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-07-13
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
6VAX-F: DTAP+IPV+HEPB+HIB (NO BRAND NAME) / UNKNOWN MANUFACTURER T3K46 / 1 LL / OT
OPV: POLIO VIRUS, ORAL (NO BRAND NAME) / UNKNOWN MANUFACTURER - / 1 - / -
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH 042J20 / 1 RL / OT
RVX: ROTAVIRUS (NO BRAND NAME) / UNKNOWN MANUFACTURER ARO/C835AB / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Autopsy, Blood glucose decreased, Breath sounds absent, Cardiac arrest, Computerised tomogram abdomen abnormal, Computerised tomogram thorax abnormal, Crying, Heart sounds abnormal, Histology, Malaise, Pneumopericardium, Pneumoperitoneum, Pulse absent, Pupil fixed, Respiratory arrest, Resuscitation, Sudden infant death syndrome, Whole body scan
SMQs:, Torsade de pointes/QT prolongation (broad), Anaphylactic reaction (narrow), Arrhythmia related investigations, signs and symptoms (broad), Retroperitoneal fibrosis (broad), Shock-associated circulatory or cardiac conditions (excl torsade de pointes) (narrow), Gastrointestinal perforation (narrow), Acute central respiratory depression (narrow), Pulmonary hypertension (broad), Guillain-Barre syndrome (broad), Cardiomyopathy (broad), Depression (excl suicide and self injury) (broad), Neonatal disorders (narrow), Hypersensitivity (broad), Respiratory failure (narrow), Hypoglycaemia (narrow)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-04
   Days after onset: 0
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: Hospitalization (Long stay admission in hospital ward for weight gain); Premature baby
Allergies:
Diagnostic Lab Data: Test Name: apgar score; Result Unstructured Data: Test Result:at 1 min: 6; Test Name: apgar score; Result Unstructured Data: Test Result:at 5 min: 9; Test Date: 20210604; Test Name: HGT; Result Unstructured Data: Test Result:1.6 low; Test Date: 20210604; Test Name: HGT; Result Unstructured Data: Test Result:Repeat - 2.4 low; Test Date: 20210609; Test Name: Post mortem CT scan; Result Unstructured Data: Test Result:Confirmed air in the pericardium and the abdomen; Test Name: head circumference at birth; Result Unstructured Data: Test Result:28; Test Name: length at birth; Result Unstructured Data: Test Result:38; Test Date: 20210609; Test Name: Examination; Result Unstructured Data: Test Result:No vascular lines in the neck; Test Name: weight at birth; Test Result: 1.2 kg; Test Date: 20210609; Test Name: Lodox xray; Result Unstructured Data: Test Result:Air noted in the pericardial sac
CDC Split Type: ZAPFIZER INC2021803118

Write-up: sudden unexpected death - SIDS; This is a spontaneous report from a contactable physician. A 7-week-old female patient received pneumococcal 13-val conj vac (dipht crm197 protein) (PREVENAR 13) dose 1 intramuscular administered in right thigh on 03Jun2021 at age of 7 week (Lot Number: 042J20) as single dose for vaccination; polio vaccine live oral (OPV) dose 1 (pending clarification) via an unspecified route of administration on 03Jun2021 (Batch/Lot number was not reported) at unspecified dose for vaccination; rotavirus vaccine (ROTAVIRUS VACCINE) dose 1 oral on 03Jun2021 (Lot Number: ARO/C835AB) at unspecified dose for vaccination; diphtheria vaccine toxoid, hepatitis b vaccine rhbsag, hib vaccine conj, pertussis vaccine acellular 2-component, polio vaccine inact 3v (vero), tetanus vaccine toxoid (HEXAXIM) dose 1 intramuscular in left thigh on 03Jun2021 (Lot Number: T3K46) at unspecified dose for vaccination. The patient medical history and concomitant medications were not reported. Background history included premature baby with birth weight 1.2kg. Long stay admission in hospital ward for weight gain. Delivery procedure was normal. APGAR score at 1 min was 6 on and at 5 min was 9 on date of birth. Head circumference at birth was 28, length at birth was 38. The patient previously received BCG (Batch number 038520) given on intradermal right arm and OPV (Batch number C3G14) given orally on 29May2021 for immunization. The patient experienced sudden unexpected death - sudden infant death syndrome (SIDS) on 04Jun2021. The patient was hospitalized on 04Jun2021. Mother reported that patient received 6 weeks immunization today (03Jun2021). No cough, no vomiting or diarrhea. Reports being well. Woke up at 3 am on 04Jun2021 for a feed and noticed baby was not breathing. The patient arrived at hospital (admission time 03h20) with no signs of life, no carotid or femoral pulse. CPR commenced. IV access established on right hand. HGT 1.6 low and bolus of 6ml of 10% dextrose given IVI. Bolus of 60ml N/S given IVI as cap refill $g 4 seconds. Repeat HGT 2.4 low and bolus of 6 ml 10% dextrose repeated IVI. Adrenaline 0.3ml of 1: 10000 solution given. At each pulse check asystole was noted on monitor. CPR was continued for 30 mins. Reassessed an still no signs of life. Unable to attain blood. Pupils were fixed and dilated, no breath/heartsounds. Patent declared dead. According to the family, the baby was usually crying but that day 04Jun2021, she did not cry. The father noticed that the patient was not well. Then suddenly he took the baby to the hospital on 04Jun2021. At the hospital they confirmed that the patient passed away. Autopsy was conducted on 09Jun2021: At autopsy - air noted in the pericardial sac on Lodox X-ray. The patient was sent for post mortem CT scan which confirmed air in the pericardium and the abdomen. On examination, no vascular lines in the neck. Intravenous cannulation noted on the right hand. Autopsy did not reveal obvious cause of death, histology was pending. The outcome of event was fatal.; Sender''s Comments: One day latency elapsed between the death and vaccination for the infant having premature history with low birth weight requiring long stay admission; the underlying contributory factors might predispose this young infant to increased risk of severe medical conditions. More information including medical history and concomitant medications especially autopsy results with histology findings are needed for identifying the death cause. 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.; Reported Cause(s) of Death: sudden unexpected death - SIDS


VAERS ID: 1531181 (history)  
Form: Version 2.0  
Age: 0.08  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-04
Onset:2021-06-01
Submitted: 0000-00-00
Entered: 2021-08-06
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
6VAX-F: DTAP+IPV+HEPB+HIB (NO BRAND NAME) / UNKNOWN MANUFACTURER T3E97 / 1 LL / IM
OPV: POLIO VIRUS, ORAL (NO BRAND NAME) / UNKNOWN MANUFACTURER T3F58 / 2 MO / PO
PPV: PNEUMO (NO BRAND NAME) / UNKNOWN MANUFACTURER 042320 / 1 RL / IM
RVX: ROTAVIRUS (NO BRAND NAME) / UNKNOWN MANUFACTURER AROLC8815AA / 1 MO / PO

Administered by: Unknown       Purchased by: ?
Symptoms: Autopsy, CSF culture positive, Crying, Human herpesvirus 6 infection, Restlessness, Roseolovirus test positive, Sudden infant death syndrome, Unresponsive to stimuli
SMQs:, Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Anticholinergic syndrome (broad), Dementia (broad), Akathisia (broad), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Depression (excl suicide and self injury) (broad), Neonatal disorders (narrow), Hypotonic-hyporesponsive episode (broad), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Hypoglycaemia (broad), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-05
   Days after onset: 4
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications:
Current Illness: Breast feeding
Preexisting Conditions:
Allergies:
Diagnostic Lab Data: Test Date: 202106; Test Name: CSF culture; Result Unstructured Data: (Test Result:showed HHV6,Unit:unknown,Normal Low:,Normal High:); Test Name: Rhesus; Result Unstructured Data: (Test Result:positive,Unit:unknown,Normal Low:,Normal High:); Test Name: Rpr test; Result Unstructured Data: (Test Result:Negative,Unit:unknown,Normal Low:,Normal High:)
CDC Split Type: ZAGLAXOSMITHKLINEZA2021EM

Write-up: HHV6 cultured from CSF; excessive crying; Restless; Found unresponsive; Sudden infant death; This case was reported by a other health professional and described the occurrence of sudden infant death syndrome in a 6-week-old female patient who received Rotavirus vaccine (batch number AROLC8815AA, expiry date unknown) for prophylaxis. Co-suspect products included DTPa-HBV-IPV+Hib (DTPa-HBV-IPV-HIB) (batch number T3E97, expiry date unknown) for prophylaxis, Polio Bivalent T1 T3 oral (OPV) (batch number T3F58, expiry date unknown) for prophylaxis and 10PN-PD-Dit (Pneumococcal vaccine) (batch number 042320, expiry date unknown) for prophylaxis. Previously administered products included BCG vaccine (received BCG vaccine on April 2021, batch number:031G20, intradermal in right arm) and OPVO (received OPVO vaccine on April 2021, batch number:T3D48, Oral). Concurrent medical conditions included breast feeding. On 4th June 2021, the patient received the 1st dose of Rotavirus vaccine (oral), the 1st dose of DTPa-HBV-IPV-HIB (intramuscular), the 2nd dose of OPV (oral) and the 1st dose of Pneumococcal vaccine (intramuscular). On 4th June 2021, less than a day after receiving Rotavirus vaccine, DTPa-HBV-IPV-HIB, OPV and Pneumococcal vaccine, the patient experienced crying and restlessness. On 5th June 2021, the patient experienced human herpesvirus 6 infection (serious criteria death). In June 2021, the patient experienced sudden infant death syndrome (serious criteria death and GSK medically significant) and unresponsive to stimuli (serious criteria GSK medically significant). On an unknown date, the outcome of the sudden infant death syndrome and human herpesvirus 6 infection were fatal and the outcome of the unresponsive to stimuli, crying and restlessness were unknown. The patient died on 5th June 2021. The reported cause of death was sudden infant death syndrome and human herpesvirus 6 infection. An autopsy was performed. The reporter considered the sudden infant death syndrome, human herpesvirus 6 infection, unresponsive to stimuli, crying and restlessness to be related to Rotavirus vaccine, DTPa-HBV-IPV-HIB, OPV and Pneumococcal vaccine. Additional details were provided as follows: It was reported that the patient was full term patient born by normal delivery (birth weight 3560 g, length at birth 51 cm, head circumference 33 cm, gestational age 39 weeks). The APGAR score was at 1 min was 9, at 5 min was 10. The patient''s RPR test was negative, rhesus was positive. The patient''s antenatal history G2P2 RVO negative, intrapartum history was NVOX2. The patient received her routine 6 weeks vaccination, the patient was crying excessively and restless after immunization and this continued into the night. The patient found unresponsive in the morning of 5th June 2021 at 6:50 am (within 24 hrs of vaccine administration), when ambulance was called. The patient had died (sudden infant death). Full autopsy was performed with ancillary investigation. The final diagnosis was reported as Sudden infant death syndrome Vs viral infection (HHV6 cultured from CSF). It was reported that the patient had not any history of similar event. It was unknown if the patient had any previous reactions after immunization, any history of allergies, family history of any allergies or any diseases or allergies. The patient was not suffered from any medical condition/ congenital disorder in the past. The patient was not suffering from any medical condition currently. The patient was not taking any medication. The patient had not received any herbal and/or traditional medicines. There was no error in prescribing or non-adherence to recommendations for use of this vaccine. Based on investigation, the vaccine (ingredients) administered were not unsterile. The vaccine''s physical condition (e.g. color, turbidity, foreign substances etc) was not abnormal at the time of administration. There was no error in vaccine reconstitution/preparation by the vaccinator (e.g. wrong product, wrong diluent, improper mixing, improper syringe etc). There was no error in vaccine handling (e.g. break in cold chain during transport, storage and/or immunization session etc. The vaccine was not administered incorrectly (e,g, wrong dose, site or route of administration, wrong needle size, not following good injection practice etc.; Reported Cause(s) of Death: Sudden infant death syndrome; Human herpesvirus 6 infection


VAERS ID: 1534540 (history)  
Form: Version 2.0  
Age: 0.08  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-03
Onset:2021-06-03
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-07
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
6VAX-F: DTAP+IPV+HEPB+HIB (NO BRAND NAME) / UNKNOWN MANUFACTURER T3K46 / 1 LL / OT
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH 042J20 / 1 RL / OT
RVX: ROTAVIRUS (NO BRAND NAME) / UNKNOWN MANUFACTURER AROLC835AB / UNK - / OT

Administered by: Other       Purchased by: ?
Symptoms: Respiratory distress, Sepsis neonatal
SMQs:, Anaphylactic reaction (broad), Acute central respiratory depression (broad), Neonatal disorders (narrow), Hypersensitivity (broad), Respiratory failure (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Sepsis (narrow), Opportunistic infections (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-04
   Days after onset: 1
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: VIDAYLIN [ASCORBIC ACID;BIOTIN;COLECALCIFEROL;FOLIC ACID;NICOTINAMIDE;PANTOTHENIC ACID;PYRIDOXINE HY; VITAMIN D [COLECALCIFEROL]; FERRO [IRON]
Current Illness:
Preexisting Conditions: Medical History/Concurrent Conditions: Birth premature; Birth weight low (1200g); Neonatal sepsis; Respiratory distress
Allergies:
Diagnostic Lab Data: Test Date: 2021; Test Name: APGAR; Result Unstructured Data: Test Result:06 at 1min; Test Date: 2021; Test Name: APGAR; Result Unstructured Data: Test Result:09 at 5 min; Test Date: 2021; Test Name: Head circumference; Result Unstructured Data: Test Result:28 at birth; Test Date: 2021; Test Name: length at birth; Result Unstructured Data: Test Result:38; Test Date: 2021; Test Name: rhesus; Test Result: Positive ; Test Date: 2021; Test Name: Birth weight; Test Result: 1200 g
CDC Split Type: ZAPFIZER INC202100946498

Write-up: looking tired from the clinic following immunization; looked more weak at night following immunization; This is a spontaneous report from a contactable other healthcare professional (HCP). A 7-week-old female patient received pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein) (PREVENAR 13, Solution for injection in pre-filled syringe), intramuscularly, administered in the right thigh on 03Jun2021 at the age of 7 weeks (Batch/Lot Number: 042J20; Expiration Date: Apr2023) as dose 1, single for immunization; diphtheria vaccine toxoid, hepatitis b vaccine rhbsag, hib vaccine conj, pertussis vaccine acellular 2-component, polio vaccine inact 3v (vero), tetanus vaccine toxoid (HEXAXIM), intramuscularly from 03Jun2021 (Batch/Lot Number: T3K46; Expiration Date: Mar2022) to 03Jun2021, at an unknown dosage, single for immunization; and rotavirus vaccine (ROTAVIRUS VACCINE), orally from an unspecified date (Batch/Lot Number: AROLC835AB; Expiration Date: Jan2022) to an unspecified date, at an unknown dosage, single as dose number 13202 (as reported) for immunization. Relevant medical history included that the patient was a preterm and low birth weight at 1200 g, and had respiratory distress and neonatal sepsis, both from an unknown date and unknown if ongoing. Concomitant medications included ascorbic acid, biotin, colecalciferol, folic acid, nicotinamide, pantothenic acid, pyridoxine hydrochloride, retinol, riboflavin, thiamine hydrochloride, vitamin b12 nos, vitamin e nos (VIDAYLIN); colecalciferol (VITAMIN D); and iron (FERRO), all taken for an unspecified indication, start and stop date were not reported. The patient previously received bcg vaccine (BCG) on 29May2021 (Batch number: 038J20), administered intradermally in the right arm and polio vaccine live oral (OPV 0) on 29May2021 (Batch number: C3G14), administered orally. On 03Jun2021, the patient was looking tired from the clinic following immunization and looked more weak at night following immunization, which both led to death on 04Jun2021. According to the father, the child did not receive any herbal or traditional medicines. Delivery procedure for the baby was normal. Breastfeeding at birth was confirmed. The patient had no human immunodeficiency virus (HIV) exposure at birth. RPR (as reported) result at birth was negative. After immunization on 03Jun2021, the patient was fed well - breast and formula feeding. The patient underwent lab tests and procedures, which included APGAR of 06 at 1 minute (min) and 09 at 5 min; head circumference of 28 (unit not provided) at birth; length at birth of 38 (unit not provided); birth weight of 1200 g; and rhesus: positive; all on 15Apr2021. The patient died on 04Jun2021 at 02:00. It was not reported if an autopsy was performed.; Sender''s Comments: Based on the information available and on the pathophysiology of the events company does not reasonably attribute the reported events as related to suspect product. The events were most likely due to subject underlying contributory factors 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.; Reported Cause(s) of Death: looking tired from the clinic following immunization; looked more weak at night following immunization


VAERS ID: 1653604 (history)  
Form: Version 2.0  
Age: 0.08  
Sex: Female  
Location: Foreign  
Vaccinated:2021-06-04
Onset:2021-06-04
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-08-29
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
6VAX-F: DTAP+IPV+HEPB+HIB (NO BRAND NAME) / UNKNOWN MANUFACTURER - / 1 LL / OT
OPV: POLIO VIRUS, ORAL (NO BRAND NAME) / UNKNOWN MANUFACTURER - / 2 - / OT
PNC13: PNEUMO (PREVNAR13) / PFIZER/WYETH - / 1 RL / OT
RVX: ROTAVIRUS (NO BRAND NAME) / UNKNOWN MANUFACTURER - / 1 - / OT

Administered by: Other       Purchased by: ?
Symptoms: Apgar score abnormal, Crying, Death, Laboratory test, Restlessness, Sudden infant death syndrome
SMQs:, Anticholinergic syndrome (broad), Dementia (broad), Akathisia (broad), Noninfectious encephalopathy/delirium (broad), Depression (excl suicide and self injury) (broad), Neonatal disorders (narrow), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-06-05
   Days after onset: 1
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: APGARS; Result Unstructured Data: Test Result:1 min 9; Test Name: APGARS; Result Unstructured Data: Test Result:5 min 10; Test Name: head circumference at birth; Result Unstructured Data: Test Result:33 cm; Test Name: length at birth; Result Unstructured Data: Test Result:51 cm; Test Name: Birth Weight; Result Unstructured Data: Test Result:3560 g
CDC Split Type: ZAPFIZER INC202100979725

Write-up: sudden infant death; Crying; restless; This is a spontaneous report from a contactable physician. A 6-weeks-old female patient received pneumococcal 13-val conj vac (dipht crm197 protein) (PREVENAR 13), dose 1 intramuscular, administered in Thigh Right on 04Jun2021 (Batch number 042J20) as single dose for immunization; rotavirus vaccine (ROTAVIRUS VACCINE), via oral route of administration on 04Jun2021 (Batch number AROLC895AA) , at single dose for immunization; polio vaccine live oral (OPV) dose 2, via an unspecified route of administration on 04Jun2021 (Batch number T3F58) at single dose for immunization; diphtheria vaccine toxoid, hepatitis b vaccine rhbsag, hib vaccine conj, pertussis vaccine acellular 2-component, polio vaccine inact 3v (vero), tetanus vaccine toxoid (HEXAXIM), intramuscular on 04Jun2021 (Batch number T3E97) , at single dose for immunization. The patient medical history and concomitant medications were not reported. On 23Apr2021 the patient received BCG vaccine and the first dose of OPV vaccine. It is reported that the child was crying and was restless after the immunization and this continued into the night on 04Jun2021. The infant was found unresponsive on the 05Jun2021 morning at 06:50, when ambulance was called. (Sudden death) The patient underwent lab tests and procedures which included apgar score: 1 min 9 , apgar score: 5 min 10, head circumference: 33 cm, length at birth: 51 cm, weight: 3560g. The patient died on 05Jun2021. Follow up information has been requested; Sender''s Comments: Apart from the temporal association, there is not a biological plausibility that sudden death is related to PREVENAR 13 use. Additional information such as relevant medical history, concomitant medications and death cause/ autopsy results if available will necessitate the reassessment of this case. 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; Reported Cause(s) of Death: sudden infant death


VAERS ID: 1688305 (history)  
Form: Version 2.0  
Age:   
Sex: Male  
Location: Foreign  
Vaccinated:0000-00-00
Onset:0000-00-00
Submitted: 0000-00-00
Entered: 2021-09-10
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
RVX: ROTAVIRUS (NO BRAND NAME) / UNKNOWN MANUFACTURER UNK / UNK - / -

Administered by: Unknown       Purchased by: ?
Symptoms: Chest X-ray abnormal, Dermatitis, Echocardiogram normal, Failure to thrive, Gastroenteritis rotavirus, Gastrooesophageal reflux disease, HIV test negative, Lymphocyte count, Mycobacterium tuberculosis complex test negative, Natural killer cell count, Pneumonia, Sepsis, Upper respiratory tract infection, Vaccine virus shedding, White blood cell count
SMQs:, Gastrointestinal nonspecific dysfunction (narrow), Cardiomyopathy (broad), Eosinophilic pneumonia (broad), Neonatal disorders (broad), Hypersensitivity (narrow), Drug reaction with eosinophilia and systemic symptoms syndrome (broad), Infective pneumonia (narrow), Sepsis (narrow), Opportunistic infections (broad), Immune-mediated/autoimmune disorders (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 0000-00-00
Permanent Disability? No
Recovered? No
Office Visit? Yes
ER Visit? No
ER or Doctor Visit? No
Hospitalized? Yes, ? days
   Extended hospital stay? No
Previous Vaccinations:
Other Medications:
Current Illness: Combined immunodeficiency (Severe)
Preexisting Conditions: Medical History/Concurrent Conditions: Pneumonia (male sibling death in early childhood from severe pneumonia)
Allergies:
Diagnostic Lab Data: Test Name: Chest X-ray; Result Unstructured Data: (Test Result:pneumonia,Unit:unknown,Normal Low:,Normal High:); Test Name: 2D echocardiogram; Result Unstructured Data: (Test Result:normal,Unit:unknown,Normal Low:,Normal High:); Test Name: HIV test; Result Unstructured Data: (Test Result:negative,Unit:unknown,Normal Low:,Normal High:); Test Name: Immunoglobulin levels; Result Unstructured Data: (Test Result:Low,Unit:iu/ml,Normal Low:,Normal High:); Test Name: Absolute lymphocyte count; Result Unstructured Data: (Test Result:1.13 X10E3,Unit:/L,Normal Low:,Normal High:); Test Name: Mycobacterium tuberculosis test; Result Unstructured Data: (Test Result:negative,Unit:unknown,Normal Low:,Normal High:); Test Name: Natural killer cell count; Result Unstructured Data: (Test Result:156,Unit:unknown,Normal Low:170,Normal High:830); Test Name: T-cell Subsets; Result Unstructured Data: (Test Result:36,Unit:unknown,Normal Low:2500,Normal High:5600); Test Name: white blood cell; Result Unstructured Data: (Test Result:6.28X10E3,Unit:/L,Normal Low:,Normal High:)
CDC Split Type: KEGLAXOSMITHKLINEKE2021GS

Write-up: severe sepsis; Persistent Rotavirus infection; Failure to thrive; Pneumonia; Upper respiratory tract infection; Gastroesophageal reflux disease; Dermatitis; Vaccine virus shedding; This case was reported in a literature article and described the occurrence of sepsis in a infant male patient who received Rotavirus vaccine for prophylaxis. The patient''s past medical history included pneumonia (Family History) (male sibling death in early childhood from severe pneumonia). Previously administered products included BCG vaccination (at birth as per national expanded programmed on immunization). Concurrent medical conditions included combined immunodeficiency (Severe). On an unknown date, the patient received Rotavirus vaccine. On an unknown date, less than 3 months after receiving Rotavirus vaccine, the patient experienced sepsis (serious criteria death, hospitalization and GSK medically significant), rotavirus gastroenteritis (serious criteria GSK medically significant), failure to thrive (serious criteria GSK medically significant), pneumonia (serious criteria GSK medically significant), upper respiratory tract infection, gastroesophageal reflux disease, dermatitis and vaccine virus shedding. The patient was treated with antibiotics nos and immunoglobulins nos (Immunoglobulins Intravenous). On an unknown date, the outcome of the sepsis was fatal and the outcome of the rotavirus gastroenteritis, failure to thrive, pneumonia, upper respiratory tract infection, gastroesophageal reflux disease, dermatitis and vaccine virus shedding were unknown. The reported cause of death was sepsis. It was unknown if the reporter considered the sepsis, rotavirus gastroenteritis, failure to thrive, pneumonia, upper respiratory tract infection, gastroesophageal reflux disease, dermatitis and vaccine virus shedding to be related to Rotavirus vaccine. Additional details were reported as follows: This case was reported in a literature article and described the occurrence of Persistent Rotavirus infection in a male Patient of unknown age, who was vaccinated with unspecified Rotavirus vaccine (manufacturer unknown) for prophylaxis. The patient family history included male sibling death in early childhood from severe pneumonia. The patient received BCG vaccination at birth as per national expanded programmed on immunization. The patient and parent were ethnic Africans and no 1st or 2nd degree consanguinity was noted. The patient underlying condition included Severe Combined Immunodeficiency (SCID). No information on patient''s medical history or concomitant medication was provided. On an unspecified date, the patient received unspecified Rotavirus vaccine (Route and site of administration unknown; batch number not provided; dosage unknown). The age of vaccination was not provided. On an unspecified date, an unknown period after the vaccination, the patient suffered from persistent rotavirus infection which might have been a vaccine-acquired disease and later developed severe sepsis. At the age of 3 months, the patient was previously treated for upper respiratory tract infection and gastroesophageal reflux disease as an outpatient case. At 4-month age, the patient presented with severe pneumonia and rotavirus gastroenteritis. The patient also had severe progressive dermatitis and failure to thrive. The Chest X-ray revealed pneumonia and a 2D echocardiogram was normal. The pneumonia was treated with appropriate antibiotics. Immunological profiles of the patient showed T -B+ cell profile, white blood cell 6.28X10E3/L, Absolute lymphocyte count was 1.13 X10E3/L, T-cell Subsets was 36 (2500-5600); B-cell subsets was 849 (74-441), Natural killer (NK) cells was 156 (170-830) and Immunoglobulin levels (IU/mL) was low. At the age of 8 months, the patient was diagnosed to have T -B+ SCID with low immunoglobulin levels. Further genetic studies were planned, and the patient also got human leucocyte antigen (HLA) typing for a matched donor for Hematopoietic stem cell transplantation (HSCT) abroad. Tests for Human immunodeficiency virus (HIV) and GeneXpert for Mycobacterium tuberculosis was negative. BCG vaccine-induced disseminated tuberculosis was not seen. The patient received regular intravenous immunoglobulins and prophylactic antimicrobials awaiting transplant. On an unspecified date, at the age of 10 months, the patient was admitted in the Intensive Care Unit and died due to overwhelming sepsis, before receiving definitive treatment for their immune defect. It was unknown whether the patient''s autopsy was performed or not. This case has been considered as serious due to Death & Hospitalization. The authors commented, "The initial clue to diagnosis in our cases was persistent lymphopenia, HIV negative, early onset and severe recurrent infections with a sibling death due to severe infection. Despite the high incidence of consanguinity expected in our region, none of the cases above had a parental consanguinity similar to that seen in South Africa which had only 1.2%. We were unable to do further genetic studies to specify the inborn immune defect in our cases due to lack of diagnostic resources in the country and thus did not know the type of inheritance that existed in our SCID patients. The benefit of early diagnosis includes early interventions that may improve prognosis like HSCT, enables counselling of parents with regards to the risk to their subsequent children and better utilization of resources for managing common PIDs on a national scale, once the prevalence is known. apart from being a retrospective study which has its own limitations, we did not get an opportunity to conduct further genetic studies in these patients which would have provided better information that would aid in better counselling of the families for future pregnancies." The authors concluded, "Primary Immunodeficiency Disorders (PIDs) are likely prevalent in East Africa. A thorough patient and family history taking together with investigations like a full hemogram, peripheral blood film to assess for lymphopenia and morphology, HIV status, followed by specific immunological tests like immunoglobulin levels, lymphocyte subsets, B and T cell markers, can give clues to the diagnosis of SCID. High index of suspicion and early diagnosis is the key to improve outcomes. HSCT and Gene therapies for management of SCID are unavailable locally but can be developed as the awareness and diagnosis continues to increase. A registry for future cases and prospective studies to determine the common defects should be instituted nationally."; Reported Cause(s) of Death: severe sepsis


VAERS ID: 1879718 (history)  
Form: Version 2.0  
Age: 0.08  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-01
Onset:2021-07-01
   Days after vaccination:0
Submitted: 0000-00-00
Entered: 2021-11-18
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
6VAX-F: DTAP+IPV+HEPB+HIB (NO BRAND NAME) / UNKNOWN MANUFACTURER T3E971V / UNK LL / IM
OPV: POLIO VIRUS, ORAL (NO BRAND NAME) / UNKNOWN MANUFACTURER T3G14 / UNK MO / PO
PPV: PNEUMO (NO BRAND NAME) / UNKNOWN MANUFACTURER D49L20 / UNK - / IM
RVX: ROTAVIRUS (NO BRAND NAME) / UNKNOWN MANUFACTURER AROLC895AA / UNK MO / PO

Administered by: Unknown       Purchased by: ?
Symptoms: Autopsy, Death, Dysmorphism, Illness, Injury, Rhesus antigen positive, Treponema test negative, Unresponsive to stimuli
SMQs:, Hyperglycaemia/new onset diabetes mellitus (broad), Neuroleptic malignant syndrome (broad), Congenital, familial and genetic disorders (narrow), Guillain-Barre syndrome (broad), Noninfectious encephalitis (broad), Noninfectious encephalopathy/delirium (broad), Noninfectious meningitis (broad), Accidents and injuries (narrow), Hostility/aggression (broad), Hypotonic-hyporesponsive episode (broad), Hypoglycaemia (broad)

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-02
   Days after onset: 1
Permanent Disability? No
Recovered? No
Office Visit? No
ER Visit? No
ER or Doctor Visit? No
Hospitalized? No
Previous Vaccinations:
Other Medications: OPV (ORAL POLIOVIRUS VACCINE); BCG (BACILLUS CALMETTE GUERIN)
Current Illness: Breast feeding; Preterm labor
Preexisting Conditions: Medical History/Concurrent Conditions: Fetal distress; Primary ovarian failure (mother history of Primary ovarian insufficiency)
Allergies:
Diagnostic Lab Data: Test Date: 2021; Test Name: Rhesus; Result Unstructured Data: (Test Result:Posiitive,Unit:unknown,Normal Low:,Normal High:); Test Date: 2021; Test Name: RPR; Result Unstructured Data: (Test Result:Negative,Unit:unknown,Normal Low:,Normal High:)
CDC Split Type: ZAGLAXOSMITHKLINEZA2021EM

Write-up: Found Unresponsive; signs of trauma; dysmorphic features; evidence of acute illness; This case was reported by a other health professional via regulatory authority and described the occurrence of unresponsive to stimuli in a 6-week-old female patient who received Rotavirus vaccine (batch number AROLC895AA, expiry date unknown) for prophylaxis. Co-suspect products included DTPa-HBV-IPV+Hib (DTPa-HBV-IPV-HIB) (batch number T3E971V, expiry date unknown) for prophylaxis, 10PN-PD-Dit (Pneumococcal vaccine) (batch number D49L20, expiry date unknown) for prophylaxis and Polio Bivalent T1 T3 oral (OPV) (batch number T3G14, expiry date unknown) for prophylaxis. The patient''s past medical history included fetal distress and primary ovarian failure (Family History) (mother history of Primary ovarian insufficiency). Concurrent medical conditions included preterm labor and breast feeding. Concomitant products included OPV (ORAL POLIOVIRUS VACCINE) and BCG (BACILLUS CALMETTE GUERIN). On 1st July 2021, the patient received Rotavirus vaccine (oral), DTPa-HBV-IPV-HIB (intramuscular), Pneumococcal vaccine (intramuscular) and OPV (oral). In July 2021, less than a day after receiving Rotavirus vaccine, DTPa-HBV-IPV-HIB, Pneumococcal vaccine and OPV, the patient experienced unresponsive to stimuli (serious criteria death and GSK medically significant), injury (serious criteria death), dysmorphism (serious criteria death) and illness (serious criteria death). On an unknown date, the outcome of the unresponsive to stimuli, injury, dysmorphism and illness were fatal. The patient died on 2nd July 2021. The reported cause of death was unresponsive to stimuli, injury, dysmorphism and illness. An autopsy was performed. It was unknown if the reporter considered the unresponsive to stimuli, injury, dysmorphism and illness to be related to Rotavirus vaccine, DTPa-HBV-IPV-HIB, Pneumococcal vaccine and OPV. Additional details were reported as follows: The patient had not suffered from any medical condition/congenital disorder in the past. The patient had not suffered from any medical condition currently. The patient was a pre term infant. The patient was delivered by caesarian procedure. RPR was negative and rhesus was positive. A patient previously healthy, received 6 week immunization. On 21st May 2021 the patient received oral polio vaccine by oral route. On 21st May 2021 the patient received BCG by Intradermal route in right arm. The patient received Pneumococcal vaccine in right thigh. The patient received Hexa valent vaccine in right thigh. According to patient''s mother the patient was well and put to sleep in the evening and found unresponsive in the following morning. Additional reported as the patient was signs of trauma, dysmorphic features, evidence of acute illness The patient was died on 2nd July 2021,2.55 and autopsy also performed on 6th July 2021. Said that please provide with preliminary forensic reports and findings at your earliest convenience of the postmortem in order to submit; Reported Cause(s) of Death: Found Unresponsive; trauma; dysmorphic features; evidence of acute illness


VAERS ID: 1901215 (history)  
Form: Version 2.0  
Age: 0.08  
Sex: Female  
Location: Foreign  
Vaccinated:2021-07-01
Onset:2021-07-02
   Days after vaccination:1
Submitted: 0000-00-00
Entered: 2021-11-26
Vaccin­ation / Manu­facturer Lot / Dose Site / Route
6VAX-F: DTAP+IPV+HEPB+HIB (HEXAVAC) / SANOFI PASTEUR TE991V / UNK - / -
OPV: POLIO VIRUS, ORAL (NO BRAND NAME) / UNKNOWN MANUFACTURER TEG14 / UNK - / -
PPV: PNEUMO (NO BRAND NAME) / UNKNOWN MANUFACTURER 049L20 / UNK - / -
RVX: ROTAVIRUS (NO BRAND NAME) / UNKNOWN MANUFACTURER AROLC895AA / UNK - / -

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

Life Threatening? No
Birth Defect? No
Died? Yes
   Date died: 2021-07-02
   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:
Current Illness:
Preexisting Conditions:
Allergies:
Diagnostic Lab Data:
CDC Split Type: ZAPFIZER INC202101578135

Write-up: Death; This is a spontaneous report from a contactable physician. A 6-week-old female patient received 6 weeks immunization pneumococcal 13-val conj vac (dipht crm197 protein), via an unspecified route of administration on 01Jul2021 at age of 6 weeks old (Batch/Lot Number: 049L20) as DOSE NUMBER UNKNOWN, SINGLE for immunisation; rotavirus vaccine (MANUFACTURER UNKNOWN), via an unspecified route of administration on 01Jul2021 (Batch/Lot Number: AROLC895AA), at unspecified dose for an unspecified indication; polio vaccine live oral (OPV), via an unspecified route of administration on an unspecified date (Batch/Lot Number: TEG14), at unspecified dose for an unspecified indication; diphtheria vaccine toxoid, hepatitis b vaccine rhbsag, hib vaccine conj, pertussis vaccine acellular 2-component, polio vaccine inact 3v (vero), tetanus vaccine toxoid (HEXAVAC), via an unspecified route of administration on 01Jul2021 (Batch/Lot Number: TE991V), at unspecified dose for an unspecified indication. The patient medical history and concomitant medications were not reported. The child was found unresponsive (death) on 02Jul2021 02:55. The child was reported to have been well prior to death, she was put to sleep in the evening of 01Jul2021. No sign of trauma, no evidence of acute illness. The infant was well nourished. Pfizer is a marketing authorization holder of pneumococcal 13-val conj vac (dipht crm197 protein) in the country of incidence or the country where the product was purchased (if different). This may be a duplicate report if another marketing authorization holder of pneumococcal 13-val conj vac (dipht crm197 protein) has submitted the same report to the regulatory authorities. No follow-up attempts are possible. No further information is expected.; Sender''s Comments: The limited information in this report precludes a full assessment of the case. However, per company guidance, "death cause unknown" is processed as "related" until sufficient information becomes available to confirm an unrelated cause of death. Case will be reassessed when follow-up information such medical history, concomitant medications and event term details especially death cause and autopsy results is received. 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; Reported Cause(s) of Death: death


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