chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 1.0
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a medical assistant(also reported as office manager) referring to a12 month old patient of unknown gender. The patient's concurrent condition, medical history and concomitant therapy were not provided. On 18-APR-2017, the patient was vaccinated with the second improperly stored dose of VAQTA (lot # M039202, expiration date: 11-MAR-2018; dose and route of administration were not provided) for prophylaxis (Incorrect product storage). No adverse effects were reported. The vaccine was involved in Vaccines For Children Program(VFC) stock and the VFC status appointment was reported as 1. The patient received the vaccine with the temperature excursion of 17.6 degrees Celsius for 74 hours and 8 minutes (also reported as 1 hour and 38 minutes). The vaccine was previously exposed to a temperature excursion in 13 degrees Celsius for 72 hours 30 minutes. Data logger was involved. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter. Additional information is not expected as all correspondence was received. ; Sender's Comments: US-009507513-1704USA014784:
Age: 1.0
Sex: U
Vaccine: HEPA, HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a medical assistant(also reported as office manager) referring to a12 month old patient of unknown gender. The patient's concurrent condition, medical history and concomitant therapy were not provided. On 26-APR-2017, the patient was vaccinated with the second improperly stored dose of VAQTA (lot # M039202, expiration date: 11-MAR-2018; dose and route of administration were not provided) for prophylaxis (Incorrect product storage). No adverse effects were reported. The vaccine was involved in Vaccines For Children Program(VFC) stock and the VFC status appointment was reported as 1. The patient received the vaccine with the temperature excursion of 17.6 degrees Celsius for 74 hours and 8 minutes (also reported as 1 hour and 38 minutes). The vaccine was previously exposed to a temperature excursion in 13 degrees Celsius for 72 hours 30 minutes. Data logger was involved. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter. Additional information is not expected as all correspondence was received. ; Sender's Comments: US-009507513-1704USA014784:
Age: 1.0
Sex: U
Vaccine: HEPA, HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a medical assistant(also reported as office manager) referring to a12 month old patient of unknown gender. The patient's concurrent condition, medical history and concomitant therapy were not provided. On 26-APR-2017, the patient was vaccinated with the second improperly stored dose of VAQTA (lot # M039202, expiration date: 11-MAR-2018; dose and route of administration were not provided) for prophylaxis (Incorrect product storage). No adverse effects were reported. The vaccine was involved in Vaccines For Children Program(VFC) stock and the VFC status appointment was reported as 1. The patient received the vaccine with the temperature excursion of 17.6 degrees Celsius for 74 hours and 8 minutes (also reported as 1 hour and 38 minutes). The vaccine was previously exposed to a temperature excursion in 13 degrees Celsius for 72 hours 30 minutes. Data logger was involved. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter. Additional information is not expected as all correspondence was received. Sender's Comments: US-009507513-1704USA014784:
Age: 1.0
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a medical assistant(also reported as office manager) referring to a 12 month old patient of unknown gender. The patient's concurrent condition, medical history and concomitant therapy were not provided. On 03-MAY-2017, the patient was vaccinated with the second improperly stored dose of VAQTA (lot # M039202, expiration date: 11-MAR-2018; dose and route of administration were not provided) for prophylaxis (Incorrect product storage). No adverse effects were reported. The vaccine was involved in Vaccines For Children Program(VFC) stock and the VFC status appointment was reported as 1. The patient received the vaccine with the temperature excursion of 17.6 degrees Celsius for 74 hours and 8 minutes (also reported as 1 hour and 38 minutes). The vaccine was previously exposed to a temperature excursion in 13 degrees Celsius for 72 hours 30 minutes. Data logger was involved. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter. Additional information is not expected as all correspondence was received. ; Sender's Comments: US-009507513-1704USA014784:
Age: 1.0
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a medical assistant(also reported as office manager) referring to a12 month old patient of unknown gender. The patient's concurrent condition, medical history and concomitant therapy were not provided. On 24-APR-2017, the patient was vaccinated with the second improperly stored dose of VAQTA (lot # M039202, expiration date: 11-MAR-2018; dose and route of administration were not provided) for prophylaxis (Incorrect product storage). No adverse effects were reported. The vaccine was involved in Vaccines For Children Program(VFC) stock and the VFC status appointment was reported as 1. The patient received the vaccine with the temperature excursion of 17.6 degrees Celsius for 74 hours and 8 minutes (also reported as 1 hour and 38 minutes). The vaccine was previously exposed to a temperature excursion in 13 degrees Celsius for 72 hours 30 minutes. Data logger was involved. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter. Additional information is not expected as all correspondence was received. Sender's Comments:  US-009507513-1704USA014784:
Age: 1.0
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a medical assistant(also reported as office manager) referring to a12 month old patient of unknown gender. The patient's concurrent condition, medical history and concomitant therapy were not provided. On 24-APR-2017, the patient was vaccinated with the second improperly stored dose of VAQTA (lot # M039202, expiration date: 11-MAR-2018; dose and route of administration were not provided) for prophylaxis (Incorrect product storage). No adverse effects were reported. The vaccine was involved in Vaccines For Children Program(VFC) stock and the VFC status appointment was reported as 1. The patient received the vaccine with the temperature excursion of 17.6 degrees Celsius for 74 hours and 8 minutes (also reported as 1 hour and 38 minutes). The vaccine was previously exposed to a temperature excursion in 13 degrees Celsius for 72 hours 30 minutes. Data logger was involved. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter. Additional information is not expected as all correspondence was received. ; Sender's Comments: US-009507513-1704USA014784:
Age: 1.0
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a medical assistant(also reported as office manager) referring to a 12 month old patient of unknown gender. The patient's concurrent condition, medical history and concomitant therapy were not provided. On 26-APR-2017, the patient was vaccinated with the second improperly stored dose of VAQTA (lot # M039202, expiration date: 11-MAR-2018; dose and route of administration were not provided) for prophylaxis (Incorrect product storage). No adverse effects were reported. The vaccine was involved in Vaccines For Children Program (VFC) stock and the VFC status appointment was reported as 1. The patient received the vaccine with the temperature excursion of 17.6 degrees Celsius for 74 hours and 8 minutes (also reported as 1 hour and 38 minutes). The vaccine was previously exposed to a temperature excursion in 13 degrees Celsius for 72 hours 30 minutes. Data logger was involved. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter. Additional information is not expected as all correspondence was received. ; Sender's Comments: US-009507513-1704USA014784:
Age: 1.0
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a medical assistant(also reported as office manager) referring to a12 month old patient of unknown gender. The patient's concurrent condition, medical history and concomitant therapy were not provided. On 03-MAY-2017, the patient was vaccinated with the second improperly stored dose of VAQTA (lot # M039202, expiration date: 11-MAR-2018; dose and route of administration were not provided) for prophylaxis (Incorrect product storage). No adverse effects were reported. The vaccine was involved in Vaccines For Children Program(VFC) stock and the VFC status appointment was reported as 1. The patient received the vaccine with the temperature excursion of 17.6 degrees Celsius for 74 hours and 8 minutes (also reported as 1 hour and 38 minutes). The vaccine was previously exposed to a temperature excursion in 13 degrees Celsius for 72 hours 30 minutes. Data logger was involved. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter. Additional information is not expected as all correspondence was received.; Sender's Comments: US-009507513-1704USA014784:
Age: 1.0
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a medical assistant(also reported as office manager) referring to a12 month old patient of unknown gender. The patient's concurrent condition, medical history and concomitant therapy were not provided. On 10-MAY-2017, the patient was vaccinated with the second improperly stored dose of VAQTA (lot # M039202, expiration date: 11-MAR-2018; dose and route of administration were not provided) for prophylaxis (Incorrect product storage). No adverse effects were reported. The vaccine was involved in Vaccines For Children Program (VFC) stock and the VFC status appointment was reported as 1. The patient received the vaccine with the temperature excursion of 17.6 degrees Celsius for 74 hours and 8 minutes (also reported as 1 hour and 38 minutes). The vaccine was previously exposed to a temperature excursion in 13 degrees Celsius for 72 hours 30 minutes. Data logger was involved. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter. Additional information is not expected as all correspondence was received. Sender's Comments: US-009507513-1704USA014784:
Age: 1.0
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a medical assistant(also reported as office manager) referring to a12 month old patient of unknown gender. The patient's concurrent condition, medical history and concomitant therapy were not provided. On 17-MAY-2017, the patient was vaccinated with the second improperly stored dose of VAQTA (lot # M039202, expiration date: 11-MAR-2018; dose and route of administration were not provided) for prophylaxis (Incorrect product storage). No adverse effects were reported. The vaccine was involved in Vaccines For Children Program(VFC) stock and the VFC status appointment was reported as 1. The patient received the vaccine with the temperature excursion of 17.6 degrees Celsius for 74 hours and 8 minutes (also reported as 1 hour and 38 minutes). The vaccine was previously exposed to a temperature excursion in 13 degrees Celsius for 72 hours 30 minutes. Data logger was involved. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter. Additional information is not expected as all correspondence was received. Sender's Comments: US-009507513-1704USA014784:
Age: 1.0
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a medical assistant(also reported as office manager) referring to a12 month old patient of unknown gender. The patient's concurrent condition, medical history and concomitant therapy were not provided. On 20-APR-2017, the patient was vaccinated with the second improperly stored dose of VAQTA (lot # M039202, expiration date: 11-MAR-2018; dose and route of administration were not provided) for prophylaxis (Incorrect product storage). No adverse effects were reported. The vaccine was involved in Vaccines For Children Program (VFC) stock and the VFC status appointment was reported as 1. The patient received the vaccine with the temperature excursion of 17.6 degrees Celsius for 74 hours and 8 minutes (also reported as 1 hour and 38 minutes). The vaccine was previously exposed to a temperature excursion in 13 degrees Celsius for 72 hours 30 minutes. Data logger was involved. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter. Additional information is not expected as all correspondence was received. Sender's Comments: US-009507513-1704USA014784:
Age: 1.0
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a medical assistant(also reported as office manager) referring to a12 month old patient of unknown gender. The patient's concurrent condition, medical history and concomitant therapy were not provided. On 03-MAY-2017, the patient was vaccinated with the second improperly stored dose of VAQTA (lot # M039202, expiration date: 11-MAR-2018; dose and route of administration were not provided) for prophylaxis (Incorrect product storage). No adverse effects were reported. The vaccine was involved in Vaccines For Children Program (VFC) stock and the VFC status appointment was reported as 1. The patient received the vaccine with the temperature excursion of 17.6 degrees Celsius for 74 hours and 8 minutes (also reported as 1 hour and 38 minutes). The vaccine was previously exposed to a temperature excursion in 13 degrees Celsius for 72 hours 30 minutes. Data logger was involved. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter. Additional information is not expected as all correspondence was received. Sender's Comments: US-009507513-1704USA014784:
Age: 1.0
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a medical assistant(also reported as office manager) referring to a12 month old patient of unknown gender. The patient's concurrent condition, medical history and concomitant therapy were not provided. On 16-MAY-2017, the patient was vaccinated with the second improperly stored dose of VAQTA (lot # M039202, expiration date: 11-MAR-2018; dose and route of administration were not provided) for prophylaxis (Incorrect product storage). No adverse effects were reported. The vaccine was involved in Vaccines For Children Program(VFC) stock and the VFC status appointment was reported as 1. The patient received the vaccine with the temperature excursion of 17.6 degrees Celsius for 74 hours and 8 minutes (also reported as 1 hour and 38 minutes). The vaccine was previously exposed to a temperature excursion in 13 degrees Celsius for 72 hours 30 minutes. Data logger was involved. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter. Additional information is not expected as all correspondence was received. Sender's Comments: US-009507513-1704USA014784:
Age: 5.0
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a medical assistant(also reported as office manager) referring to a 5 year old patient of unknown gender. The patient's concurrent condition, medical history and concomitant therapy were not provided. On 08-MAY-2017, the patient was vaccinated with the second improperly stored dose of VAQTA (lot # M039202, expiration date: 11-MAR-2018; dose and route of administration were not provided) for prophylaxis (Incorrect product storage). No adverse effects were reported. The vaccine was involved in Vaccines For Children Program (VFC) stock and the VFC status appointment was reported as 1. The patient received the vaccine with the temperature excursion of 17.6 degrees Celsius for 74 hours and 8 minutes (also reported as 1 hour and 38 minutes). The vaccine was previously exposed to a temperature excursion in 13 degrees Celsius for 72 hours 30 minutes. Data logger was involved. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter. Additional information is not expected as all correspondence was received. Sender's Comments: US-009507513-1704USA014784:
Age: 1.5
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a medical assistant (also reported as office manager) referring to a 18 month old patient of unknown gender. The patient's concurrent condition, medical history and concomitant therapy were not provided. On 18-APR-2017, the patient was vaccinated with the second improperly stored dose of VAQTA (lot # M039202, expiration date: 11-MAR-2018; dose and route of administration were not provided) for prophylaxis (Incorrect product storage). No adverse effects were reported. The vaccine was involved in Vaccines For Children Program (VFC) stock and the VFC status appointment was reported as 1. The patient received the vaccine with the temperature excursion of 17.6 degrees Celsius for 74 hours and 8 minutes (also reported as 1 hour and 38 minutes). The vaccine was previously exposed to a temperature excursion in 13 degrees Celsius for 72 hours 30 minutes. Data logger was involved. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter. Additional information is not expected as all correspondence was received. Sender's Comments: US-009507513-1704USA014784:
Age: 1.0
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a medical assistant(also reported as office manager) referring to a 12 month old patient of unknown gender. The patient's concurrent condition, medical history and concomitant therapy were not provided. On 25-APR-2017, the patient was vaccinated with the second improperly stored dose of VAQTA (lot # M039202, expiration date: 11-MAR-2018; dose and route of administration were not provided) for prophylaxis (Incorrect product storage). No adverse effects were reported. The vaccine was involved in Vaccines For Children Program (VFC) stock and the VFC status appointment was reported as 2. The patient received the vaccine with the temperature excursion of 17.6 degrees Celsius for 74 hours and 8 minutes (also reported as 1 hour and 38 minutes). The vaccine was previously exposed to a temperature excursion in 13 degrees Celsius for 72 hours 30 minutes. Data logger was involved. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter. Additional information is not expected as all correspondence was received.; Sender's Comments: US-009507513-1704USA014784:
Age: 1.17
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a medical assistant(also reported as office manager) referring to a 14 month old patient of unknown gender. The patient's concurrent condition, medical history and concomitant therapy were not provided. On 28-APR-2017, the patient was vaccinated with the second improperly stored dose of VAQTA (lot # M039202, expiration date: 11-MAR-2018; dose and route of administration were not provided) for prophylaxis (Incorrect product storage). No adverse effects were reported. The vaccine was involved in Vaccines For Children Program (VFC) stock and the VFC status appointment was reported as 1. The patient received the vaccine with the temperature excursion of 17.6 degrees Celsius for 74 hours and 8 minutes (also reported as 1 hour and 38 minutes). The vaccine was previously exposed to a temperature excursion in 13 degrees Celsius for 72 hours 30 minutes. Data logger was involved. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter. Additional information is not expected as all correspondence was received. Sender's Comments: US-009507513-1704USA014784:
Age: 1.5
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a medical assistant (also reported as office manager) referring to a 18 month old patient of unknown gender. The patient's concurrent condition, medical history and concomitant therapy were not provided. On 01-MAY-2017, the patient was vaccinated with the second improperly stored dose of VAQTA (lot # M039202, expiration date: 11-MAR-2018; dose and route of administration were not provided) for prophylaxis (Incorrect product storage). No adverse effects were reported. The vaccine was involved in Vaccines For Children Program (VFC) stock and the VFC status appointment was reported as 1. The patient received the vaccine with the temperature excursion of 17.6 degrees Celsius for 74 hours and 8 minutes (also reported as 1 hour and 38 minutes). The vaccine was previously exposed to a temperature excursion in 13 degrees Celsius for 72 hours 30 minutes. Data logger was involved. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter. Additional information is not expected as all correspondence was received. Sender's Comments: US-009507513-1704USA014784:
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse and refers to unspecified patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant medications were not provided. On unknown dates, the patients were vaccinated with improperly stored doses of PROQUAD lot # M041509, expiration date 09-APR-2018 (dose, route and site of administration were not reported). No adverse effects reported. Administered doses of vaccine experienced the temperature excursion between -14 to -10 degrees Celsius for 1 hour and 28 minutes. The vaccine experienced previous temperature excursion between -14 to -10 degrees Celsius for 22 minutes. Data logger was involved. No product quality complaint (PQC) was involved. This is one of several cases received from the same reporter. Additional information is not expected, because there was no consent to contact the reporter. Sender's Comments: US-009507513-1706USA007130: US-009507513-1706USA006072.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse and refers to unspecified patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant medications were not provided. On unknown dates, the patients were vaccinated with improperly stored doses of VARIVAX lot# M037642, expiration date 01-SEP-2018 and lot# M043305, expiration date 26-OCT-2018 (dose, route and site of administration were not reported). No adverse effects reported. Administered doses of vaccine experienced the temperature excursion between -14 to -10 degrees Celsius for 1 hour and 28 minutes. The vaccine experienced previous temperature excursion between -14 to -10 degrees Celsius for 22 minutes. Data logger was involved. No product quality complaint (PQC) was involved. This is one of several cases received from the same reporter. Additional information is not expected, because there was no consent to contact the reporter.  Sender's Comments:  US-009507513-1706USA007129: US-009507513-1706USA006072:
Age: 15.0
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a medical assistant(also reported as office manager) referring to a15 year old patient of unknown gender. The patient's concurrent condition, medical history and concomitant therapy were not provided. On 24-APR-2017, the patient was vaccinated with an improperly stored dose of VAQTA (lot # reported as  L025738, expiration date: 14-AUG-2017; dose and route of administration were not provided) for prophylaxis (Incorrect product storage). No adverse effects were reported. The vaccine was involved in Vaccines For Children Program(VFC) stock and the VFC status appointment was reported as 1. The patient received the vaccine with the temperature excursion of 17.6 degrees Celsius for 74 hours and 8 minutes (also reported as 1 hour and 38 minutes). The vaccine was previously exposed to a temperature excursion in 13 degrees Celsius for 72 hours 30 minutes. Data logger was involved. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter. Additional information is not expected as all correspondence was received. Sender's Comments: US-009507513-1704USA014784:
Age: 0.75
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a medical assistant(also reported as office manager) referring to a 9 month old patient of unknown gender. The patient's concurrent condition, medical history and concomitant therapy were not provided. On 09-MAY-2017, the patient was vaccinated with an improperly stored dose of VAQTA (lot # reported as  L025738, expiration date: 14-AUG-2017; dose and route of administration were not provided) for prophylaxis (Incorrect product storage). No adverse effects were reported. The vaccine was involved in Vaccines For Children Program (VFC) stock and the VFC status appointment was reported as 2. The patient received the vaccine with the temperature excursion of 17.6 degrees Celsius for 74 hours and 8 minutes (also reported as 1 hour and 38 minutes). The vaccine was previously exposed to a temperature excursion in 13 degrees Celsius for 72 hours 30 minutes. Data logger was involved. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter. Additional information is not expected as all correspondence was received.; Sender's Comments: US-009507513-1704USA014784:
Age: 0.5
Sex: M
Vaccine: DTAP, FLU4, HIBV, PNC13, RV5
Symptoms: Cyanosis, Death, Dyspnoea, Pneumonia, Serology test
Clinical narrative: This is a spontaneous report from a contactable nurse received via a sales representative. A 8-month-old male patient of an unspecified race/ethnicity was fully vaccinated with PREVNAR 13 on unspecified date(s), at single dose(s), for immunisation. The reporter stated the patient was sick but did not provide further details. Concomitant medications were not reported.  The patient died on an unspecified date in 2017 from pneumonia which developed on an unspecified date, after being fully vaccinated up to 8 months. Clinical course of event included the following information: the patient was sick and he had gone to the hospital. He first came to the doctor's office who sent him to the hospital for an X-ray. He was sent home, then he went to see the doctor for follow-up and he was blue, he could not breathe. He went back to the hospital and died that night. It was not reported if an autopsy was performed. Sero-grouping test to confirm the strain was performed on an unknown date (pending result).; Sender's Comments: Based on the information currently available, a lack of efficacy with pneumococcal 13-valent conjugate vaccine in this patient cannot be completely excluded.  Further information like confirmative pathological/serotype results and vaccination schedule are needed for full medical assessment.  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: died from pneumonia and was fully vaccinated up to 8 months; died from pneumonia and was fully vaccinated up to 8 months.
Age: 0.5
Sex: M
Vaccine: DTAP, FLU4, HIBV, PNC13, RV5
Symptoms: X-ray
Clinical narrative: This is a spontaneous report from a contactable nurse received via a sales representative. A 8-month-old male patient of an unspecified race/ethnicity was fully vaccinated with PREVNAR 13 on unspecified date(s), at single dose(s), for immunisation. The reporter stated the patient was sick but did not provide further details. Concomitant medications were not reported.  The patient died on an unspecified date in 2017 from pneumonia which developed on an unspecified date, after being fully vaccinated up to 8 months. Clinical course of event included the following information: the patient was sick and he had gone to the hospital. He first came to the doctor's office who sent him to the hospital for an X-ray. He was sent home, then he went to see the doctor for follow-up and he was blue, he could not breathe. He went back to the hospital and died that night. It was not reported if an autopsy was performed. Sero-grouping test to confirm the strain was performed on an unknown date (pending result).; Sender's Comments: Based on the information currently available, a lack of efficacy with pneumococcal 13-valent conjugate vaccine in this patient cannot be completely excluded.  Further information like confirmative pathological/serotype results and vaccination schedule are needed for full medical assessment.  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: died from pneumonia and was fully vaccinated up to 8 months; died from pneumonia and was fully vaccinated up to 8 months.
Age: 0.17
Sex: F
Vaccine: DTAP, HIBV, PNC13
Symptoms: Eye movement disorder, Gaze palsy
Clinical narrative: Abnormal eye movements. Eyes migrate down, cross in middle, and vibrate horizontally.
Age: 0.33
Sex: F
Vaccine: DTAP, HIBV, PNC13
Symptoms: Eye movement disorder, Gaze palsy
Clinical narrative: Abnormal eye movements. Eyes migrate down, cross in middle, and then vibrate horizontally.
Age: 0.08
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Pallor, Respiratory arrest
Clinical narrative: Within minutes after vaccine administration, parents called from that she was not breathing, her eyes closed and her color changed (pale). Upon assessment she had independent respiratory effort, oxygen saturation was 100%, heart rate 1:30 to 140, eyes closed, pale, no twitching noted. A code was called, she was evaluated, blow by oxygen provided and transferred to emergency Department and then admitted for observation. Diagnosis of BRUE.
Age: 63.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Injection site pain
Clinical narrative: I have continual pain in my right upper arm where the pneumonia shot was administered.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse and refers to multiple unspecified patients of unknown demographics. No information about the patient's pertinent medical histories, drug reactions or allergies was provided. On unspecified dates, the patients were vaccinated with doses of improperly stored VARIVAX injection, lot # M040137 with expiration date on 28-SEP-2018, lot # M042858 with expiration date on 21-OCT-2018, lot # M042496 with expiration date on 19-OCT-2018, lot # M044347 with expiration date on 04-NOV-2018 and lot # M044349 with expiration date on 04-NOV-2018 (dose and route of administrations were not reported). All of the VARIVAX vaccines were reconstituted with properly stored sterile diluent (MERCK STERILE DILUENT) injection, lot # M046372 with expiration date on 08-JUL-2019. Administered doses of vaccine underwent a temperature excursion of 32 to 35 degrees Fahrenheit for 20 minutes. Digital data logger was involved in recording the temperature excursion. The vaccine underwent a previous temperature excursion of 32 to 35 degrees Fahrenheit for 40 minutes. No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Extra dose administered, No adverse event
Clinical narrative: This spontaneous report has been received from a medical assistant referring to a three unspecified patients of unknown age and gender. The patient's medical history, concurrent conditions, drugs reactions or allergies and concomitant therapies were not provided. On multiple unknown dates, the patients were vaccinated with doses of M-M-R II dose, (route of administration, lot number and expiration date were not provided) for prophylaxis, reconstituted with sterile diluent (lot # and expiration date were not provided), after each patient was individually vaccinated one time before with M-M-R (dose, route of administration, lot number and expiration date were not provided), M-M-R II several years ago. No adverse effects were reported. Additional information has been requested.
Age: 0.42
Sex: U
Vaccine: HIBV
Symptoms: Extra dose administered, No adverse event, Product label confusion
Clinical narrative: This spontaneous report was received from a medical assistant and refers to an 11 year old patient of unknown gender. The patient was vaccinated with LIQUID PEDVAXHIB on 07-MAR-2006, 19-MAY-2006 and 09-FEB-2007 (dose, route of administration, lot # and expiration date were not reported). No other information regarding the patient's pertinent medical history, concomitant medications, drug reactions or allergies was provided. On 26-MAY-2017, the patient was supposed to receive a dose of MENACTRA (manufactured by Sanofi). Instead, the patient was vaccinated with an extra dose of LIQUID PEDVAXHIB injection via intramuscular route, lot number M046140 with expiration date on 27-SEP-2019 (dose and site of administration were not reported) in error. The label of LIQUID PEDVAXHIB said "Meningococcal Protein Conjugate" and so it was confused with MENACTRA because both products had "meningococcal" on the label. No adverse effects have been reported. There was no product quality complaint involved. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse and refers to multiple unspecified patients of unknown ages and genders. No information about the patients' pertinent medical history, concomitant medications, drug reactions or allergies was provided. On unspecified dates, starting on or after 02-FEB-2017, the patients were vaccinated with doses of improperly stored ROTATEQ lot # M038846 with expiration date on 26-APR-2018 (dose of administration were not reported). The vaccine underwent a temperature excursion of 32 to 35 degrees Fahrenheit for 2 hours. Digital data logger was used to record the excursion. The vaccine did not undergo any previous temperature excursions. No adverse effects were reported. This is one of two reports received from the same source. Additional information has been requested.; Sender's Comments: US-009507513-1706USA006089:
Age: 1.33
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report was received from a physician and refers to a 16-month-old patient of unknown gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On an unknown date, the patient was inadvertently administered GARDASIL 9 lot # M041990, expiration date 268-JUN-2019 (dose, dose number, route of administration and anatomical location were not reported). No adverse effects were reported. The physician confirmed that it was a medication error and not a product confuse error. No product quality complaint was involved. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant and refers to multiple unspecified patients of unknown age and gender. No information about the patients' pertinent medical history, concomitant medications, drug reactions or allergies was provided. On unspecified dates, since 05-MAR-2017, the patients were vaccinated with doses of improperly stored VARIVAX lot number M010480 with expiration date on 01-MAR-2018 (dose and routes of administration were not reported). The vaccine underwent a temperature excursion of -14 to 10 degrees Celsius for 3 hours and 25 minutes on 03-MAY-2017 and for 6 minutes on 03-JUN-2017. Digital data logger was used to record the excursion. The vaccine underwent unspecified previous temperature excursions. No adverse effects were reported. A properly stored sterile diluent (MERCK STERILE DILUENT) (lot number and expiration date were not reported) was used to reconstitute the doses of VARIVAX. Vaccination occurred 05-MAR-2017 through 30-MAY-2017. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a Registered Nurse refers to 13 patients of unknown age and gender. No information on the patient's concomitant medications, concurrent conditions, pertinent medical history, drug reactions or allergies was reported. On unknown dates, 8 patients received improperly stored VARIVAX injection, with lot number: M040137, expiry date: 28-SEP-2018 (dose, route of administration were unknown) and 5 patients received improperly stored VARIVAX injection with lot number: M044349, expiry date: 04-NOV-2018 (dose, route of administration were unknown). Doses of vaccine were stored in temperature range from -14 to -10 degrees Celsius for 1 hour and 25 minutes. Another temperature excursion in temperature range from -14 to -10 degrees Celsius occurred and lasted for 1hour. Digital data logger was involved in recording the temperature excursion. No adverse events were reported. Additional information has been requested.
Age: 1.33
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse referring to a 16 months old patient of an unknown gender. Information regarding the patient's pertinent medical history, drug reactions or allergies andconcomitant therapies was not provided. On 02-MAR-2017, an improperly stored dose of VARIVAX injection (lot # L050561 with expiration date of 14-DEC-2017 or lot # M019841 with expiration date of 20-APR-2018; dose and route of administration were not reported) reconstituted with properly stored sterile diluent (manufacturer unknown), was administered to the patient. No adverse effects were reported. Administered vaccine was exposed to temperatures between 6 and 14 degrees Fahrenheit for 30 minutes. No previous temperature excursion was reported. Data logger was involved in recording the excursion. This was one of several reports received from the same reporter. Additional information is not expected as all scheduled correspondence was received.; Sender's Comments: US-009507513-1704USA010916: US-009507513-1704USA009837:
Age: 4.0
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse and refers to 4-year-old patient of unknown gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 23-FEB-2017, the patient was vaccinated with improperly stored dose of PROQUAD lot # L046506, expiration date of 17-MAY-2017 (dose and route of administration were not reported). The vaccine was reconstituted with properly stored sterile diluent (MRK). Administered dose of vaccine experienced the temperature excursion between 6 and 14 degrees Fahrenheit for 30 minutes. Digital Data logger was involved. The dose of PROQUAD underwent two separate temperature excursions: the first on 18-APR-2016 (also reported as on 18-APR-2017) and the next on 03-FEB-2017 (also reported as first one). No product quality complaint was involved. No adverse effects were reported. This is one of several reports received from the same source. Additional information is not expected as all relevant information has already been received. Sender's Comments: US-009507513-1704USA009837: US-009507513-1704USA010916.
Age: 3.0
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse and refers to 3-year-old patient of unknown gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 07-FEB-2017, the patient was vaccinated with improperly stored dose of PROQUAD lot # L046506, expiration date of 17-MAY-2017 (dose and route of administration were not reported). The vaccine was reconstituted with properly stored sterile diluent (MRK). Administered dose of vaccine experienced the temperature excursion between 6 and 14 degrees Fahrenheit for 30 minutes. Digital Data logger was involved. The dose of PROQUAD underwent two separate temperature excursions: the first on 18-APR-2016 (also reported as on 18-APR-2017) and the next on 03-FEB-2017 (also reported as first one). No product quality complaint was involved. No adverse effects were reported. This is one of several reports received from the same source. Additional information is not expected as all relevant information has already been received. Sender's Comments: US-009507513-1704USA009837: US-009507513-1704USA010916.
Sex: U
Vaccine: MENB, MENB
Symptoms: Arthralgia, Body temperature increased, Injection site pain, Laboratory test, Pyrexia
Clinical narrative: This is a spontaneous report from a contactable physician. A 18-year-old patient of an unspecified race/ethnicity and gender received TRUMENBA, via an unspecified route of administration, on an unspecified date, at single dose, for immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced extreme pain on the site of the injection 5 hours after vaccination. The day after the patient experienced 102 temperature, extreme joint pain. The patient underwent lab tests and procedures which included body temperature (unspecified date): 102. Therapeutic measures were taken as a result of pyrexia and included treatment with Tylenol. The outcome of the events was unknown. No follow-up attempts possible. No further information expected.
Sex: U
Vaccine: MENB, MENB
Symptoms: Body temperature increased, Malaise, Myalgia, Pain
Clinical narrative: This is a spontaneous report from a contactable physician. A 18-year-old patient of an unspecified race/ethnicity and gender received TRUMENBA, via an unspecified route of administration, on an unspecified date, at single dose, for immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced extreme pain on the site of the injection 5 hours after vaccination. The day after the patient experienced 102 temperature, extreme joint pain. The patient underwent lab tests and procedures which included body temperature (unspecified date): 102. Therapeutic measures were taken as a result of pyrexia and included treatment with Tylenol. The outcome of the events was unknown. No follow-up attempts possible. No further information expected.
Age: 66.0
Sex: F
Vaccine: TDAP
Symptoms: Urticaria
Clinical narrative: Patient stated that she experienced welts. Patient called her primary care doctor and they told her to take benadryl, famotidine and zyrtec. patient stated that those treaments are successful.
Age: 0.58
Sex: F
Vaccine: DTAPIPV
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: KINRIX administered to a 7 month old. No symptoms of vaccine reaction reported by parent.
Age: 63.0
Sex: M
Vaccine: FLU4
Symptoms: Back pain, Fall, Injury, Multi-organ disorder, Pain
Clinical narrative: Started with pain to back shingle like rash from back to left nipple on chest no blistering pain (in arm left) crippling shooting pains loss of feeling to left side caused to fall with additional injury etc as of mid June still active pain. Internal organ issues.
Age: 63.0
Sex: M
Vaccine: FLU4
Symptoms: Pain in extremity, Rash vesicular, Sensory loss
Clinical narrative: Started with pain to back shingle like rash from back to left nipple on chest no blistering pain (in arm left) crippling shooting pains loss of feeling to left side caused to fall with additional injury etc as of mid June still active pain. Internal organ issues.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant and refers to an unspecified multiple number of patients of unknown age and gender. No information regarding the patients' pertinent medical histories, drug reactions or allergies and concomitant therapies was provided. On unknown dates, the patients were vaccinated with improperly stored doses of VARIVAX lot # M036293, expiry date 17-AUG-2018; lot # M040138, expiry date 28-SEP-2018; lot # M045204, expiry date 11-NOV-2018 (dose and route of administration were not reported). There was no adverse effect reported. Administered doses of vaccines experienced the temperature excursion of 15 to 46 degrees Fahrenheit for 5hours. Data logger was involved. There were no previous excursions reported. No product quality complaint was involved. This is one of two reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1706USA007391:
Sex: U
Vaccine: HEPA
Symptoms: Extra dose administered, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 64 year old patient (gender was not reported). On 17-APR-2017, the patient was vaccinated with the first dose of VAQTA (lot # was not reported), intramuscular for prophylaxis. On 17-MAY-2017, the patient was vaccinated with the second dose of VAQTA lot # N002921, expiration date 08-APR-2018, intramuscular for prophylaxis. No adverse effects were reported. Additional information has been requested.